Spectrum Operators Manual

Spectrum Operators Manual
VAULT COPY
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LNOP® is a U.S. registered trademark of Masimo Corp.
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OxiMax® is a US registered trademark of Nellcor Puritan Bennett Inc.
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Copyright © Mindray DS USA, 2003. All rights reserved. Contents of this publication may not be reproduced in any form
without permission of Mindray DS USA.
0070-10-0648-02
Spectrum® Operating Instructions
Table of Contents
Foreword ....................................................................................................................................................... v
Warnings, Precautions and Notes..................................................................................................................... v
Warnings ...................................................................................................................................................... vi
Precautions .................................................................................................................................................... x
Notes ............................................................................................................................................................ xiv
Indication For Use ........................................................................................................................................... xiv
Unpacking ..................................................................................................................................................... xv
Symbols and Descriptions ................................................................................................................................ xvi
General Product Description.............................................................................................. 1 - 1
General Product Description.............................................................................................................................1 - 2
Key Features ..................................................................................................................................................1 - 3
Keys and Front Panel.......................................................................................................................................1 - 4
Display ..........................................................................................................................................................1 - 9
Rear View ......................................................................................................................................................1 - 11
Left Side Panel ................................................................................................................................................1 - 12
Right Side Panel .............................................................................................................................................1 - 14
Gas Module (Optional) ...................................................................................................................................1 - 16
Front Panel .............................................................................................................................................1 - 16
Rear Panel ..............................................................................................................................................1 - 17
Comm-Ports ....................................................................................................................................................1 - 18
External Parameter Modules (Optional)..............................................................................................................1 - 20
External Parameter Module Top View.........................................................................................................1 - 21
External Parameter Module Front View .......................................................................................................1 - 22
Left Side View with External Parameter Module ...........................................................................................1 - 23
Rear View with External Parameter Module.................................................................................................1 - 25
Operations ....................................................................................................................... 2 - 1
Getting Started ...............................................................................................................................................2 - 1
Installation Mode ............................................................................................................................................2 - 3
Installation Menu .....................................................................................................................................2 - 3
System Information Menu..........................................................................................................................2 - 6
Main Menus...................................................................................................................................................2 - 8
Patient Menu...........................................................................................................................................2 - 8
Monitor Setup Menu ................................................................................................................................2 - 10
Print Setup Menu .....................................................................................................................................2 - 13
Parameters Menu.....................................................................................................................................2 - 14
Functions Menu .......................................................................................................................................2 - 15
Remote View ..................................................................................................................................2 - 16
Parameter Menus and Monitoring .....................................................................................................................2 - 22
ECG Monitoring ......................................................................................................................................2 - 22
ECG Menu .............................................................................................................................................2 - 22
Skin Preparation .............................................................................................................................2 - 25
Electrode Patch Location ...................................................................................................................2 - 25
Lead Placement ...............................................................................................................................2 - 27
Arrhythmia Algorithm .......................................................................................................................2 - 34
Arrhythmia Alarms ..........................................................................................................................2 - 36
Arrhythmia Analysis (Optional) .........................................................................................................2 - 40
ST Analysis (Optional) .....................................................................................................................2 - 42
Relearning ST or Arrhythmia Analysis ................................................................................................2 - 44
12-lead ECG (Optional) ...................................................................................................................2 - 45
ECG Troubleshooting .......................................................................................................................2 - 46
Non-Invasive Blood Pressure Measurements (NIBP) ......................................................................................2 - 48
Manual NIBP Measurements .............................................................................................................2 - 48
Spectrum® Operating Instructions
0070-10-0648-02
i
Table of Contents
Automatic Interval NIBP Measurements ..............................................................................................2 - 50
NIBP Troubleshooting ......................................................................................................................2 - 53
SpO2 Pulse Oximetry ...............................................................................................................................2 - 55
Masimo SET® SpO2 ........................................................................................................................2 - 57
Nellcor® SpO2 ...............................................................................................................................2 - 57
SpO2 Troubleshooting and SpO2 Menu Performance Considerations ....................................................2 - 58
Temperature Menu...................................................................................................................................2 - 60
Temperature Troubleshooting ............................................................................................................2 - 61
Respiration Menu ....................................................................................................................................2 - 61
Thoracic Impedance ........................................................................................................................2 - 61
Microstream® CO2 Monitoring (Optional) ..........................................................................................2 - 62
Microstream® CO2 Menu ................................................................................................................2 - 63
Respiration and CO2 Troubleshooting ................................................................................................2 - 64
Gas Monitoring with Gas Module .............................................................................................................2 - 66
Gas Module 3 Pre-use Test .......................................................................................................................2 - 68
Gas Monitor Calibration ..................................................................................................................2 - 69
Gas Module Troubleshooting ............................................................................................................2 - 72
IBP - Invasive Blood Pressure Menu (Optional) .............................................................................................2 - 75
Measuring IBP ................................................................................................................................2 - 76
IBP Troubleshooting .........................................................................................................................2 - 77
Pulmonary Artery Wedge Pressure (PAWP).................................................................................................2 - 78
Measuring PAWP ............................................................................................................................2 - 78
PAWP Troubleshooting ....................................................................................................................2 - 79
Cardiac Output (CO) (Optional)................................................................................................................2 - 80
External Parameter Module (EPM) .....................................................................................................2 - 80
Edwards Vigilance® Monitor (Vigilance) ............................................................................................2 - 86
CO from both Vigilance and EPM .....................................................................................................2 - 89
Calculations ...................................................................................................................................................2 - 90
Drug Calculations ....................................................................................................................................2 - 90
Hemodynamic Calculations ......................................................................................................................2 - 95
Alarms...........................................................................................................................................................2 - 96
Adjusting Alarms .....................................................................................................................................2 - 96
Alarm Limits ............................................................................................................................................2 - 97
Alarm Troubleshooting .............................................................................................................................2 - 101
Trends ...........................................................................................................................................................2 - 102
List Trends...............................................................................................................................................2 - 102
Graph Trends..........................................................................................................................................2 - 105
OxyCRG Trends ......................................................................................................................................2 - 107
Trends Troubleshooting.............................................................................................................................2 - 108
Printing (Optional) ..........................................................................................................................................2 - 109
Internal Recorder (Optional)......................................................................................................................2 - 109
Printing 12-lead to the Laser Printer ............................................................................................................2 - 116
Printer / Recorder Troubleshooting ............................................................................................................2 - 116
Connection to PatientNet® Central Station .........................................................................................................2 - 117
Connection to Panorama™ Central Station .........................................................................................................2 - 118
Connection to Panorama™ Gateway .................................................................................................................2 - 119
Monitor/Display Troubleshooting......................................................................................................................2 - 120
User Maintenance ............................................................................................................. 3 - 1
Introduction ....................................................................................................................................................3 - 1
Care and Cleaning of Monitor .........................................................................................................................3 - 1
Decontamination of Monitor .............................................................................................................................3 - 2
Care and Cleaning of SpO2 Sensors.................................................................................................................3 - 2
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Spectrum® Operating Instructions
Table of Contents
Sterilization and Cleaning of Reusable Bladderless Cuffs .....................................................................................3 - 3
Battery Replacement and Maintenance ..............................................................................................................3 - 3
Battery Replacement ................................................................................................................................3 - 3
Battery Maintenance ................................................................................................................................3 - 3
Recorder Paper Replacement............................................................................................................................3 - 4
Care and Storage of Thermal Chart Paper .........................................................................................................3 - 4
Care and Cleaning of Gas Module ...................................................................................................................3 - 5
Gas Module II and Gas Module SE ...........................................................................................................3 - 5
Gas Module 3 ........................................................................................................................................3 - 6
Care and Cleaning of 3 and 5-lead ECG Cables and Leadwires ..........................................................................3 - 7
Care and Cleaning of View 12™ ECG Analysis Module......................................................................................3 - 7
Accessories ....................................................................................................................... 4 - 1
Optional Accessories ......................................................................................................................................4 - 1
NIBP Accessories.....................................................................................................................................4 - 1
Oximetry Sensors and Accessories.............................................................................................................4 - 2
Pulse Oximetry-Masimo SET® LNOP® SpO2 .......................................................................................4 - 2
Pulse Oximetry-Masimo Set® LNCS® SpO2 .........................................................................................4 - 3
Pulse Oximetry-Nellcor® OxiMax® SpO2* .........................................................................................4 - 4
Oridion CO2 Accessories .........................................................................................................................4 - 4
Gas Module Accessories ..........................................................................................................................4 - 5
Gas Module II and Gas Module SE ...................................................................................................4 - 5
Gas Module 3 ................................................................................................................................4 - 5
Reusable Temperature Probes....................................................................................................................4 - 6
Disposable Temperature Probes.................................................................................................................4 - 6
ECG Accessories .....................................................................................................................................4 - 7
ECG Cables ...................................................................................................................................4 - 7
ECG Leadwires ...............................................................................................................................4 - 7
12 Lead ECG Accessories ................................................................................................................4 - 8
Electrodes ......................................................................................................................................4 - 9
IBP Accessories .......................................................................................................................................4 - 9
Comm-Port Accessories ............................................................................................................................4 - 9
Base Station Accessories ..........................................................................................................................4 - 10
Miscellaneous Accessories........................................................................................................................4 - 11
Mounting Kits and Accessories ..................................................................................................................4 - 11
Upgrade Kits...........................................................................................................................................4 - 12
Central Station Accessories.......................................................................................................................4 - 13
External Parameter Module Accessories .....................................................................................................4 - 13
Appendix ......................................................................................................................... 5 - 1
Safety Designations.........................................................................................................................................5 - 1
Safety designations per IEC 60601-1 Standard...........................................................................................5 - 1
Patient Parameter Specifications .......................................................................................................................5 - 3
ECG ......................................................................................................................................................5 - 3
ECG Respiration Performance Requirements................................................................................................5 - 7
NIBP Performance and Functional Characteristics ........................................................................................5 - 7
IBP Performance Characteristics.................................................................................................................5 - 10
Temperature Parameter Performance Characteristics ....................................................................................5 - 12
SpO2 Performance Requirements...............................................................................................................5 - 13
Masimo SET SpO2 Performance Requirements ....................................................................................5 - 13
Nellcor SpO2 Performance Requirements ...........................................................................................5 - 15
CO2 Performance Characteristics ..............................................................................................................5 - 15
MediCO2 Microstream® (Only in monitors with serial numbers below MS05000.) .................................5 - 15
MiniMediCO2 Microstream® (Only in monitors with serial number MS05000 and higher.) ......................5 - 17
Spectrum® Operating Instructions
0070-10-0648-02
iii
Table of Contents
Cardiac Output .......................................................................................................................................5 - 19
Special Functions ............................................................................................................................................5 - 20
ST Segment Analysis Performance Requirements ..........................................................................................5 - 20
Arrhythmia Analysis .................................................................................................................................5 - 21
ECG Interpretation...................................................................................................................................5 - 22
Calculations............................................................................................................................................5 - 22
Hemodynamic Calculations ......................................................................................................................5 - 22
Information Display and Control .......................................................................................................................5 - 25
Input/Output Communications ..........................................................................................................................5 - 27
Communication Protocols.................................................................................................................................5 - 28
Power Supply .................................................................................................................................................5 - 30
Battery Power..........................................................................................................................................5 - 30
Sealed Lead Acid (P/N0146-00-0043) .............................................................................................5 - 30
Lithium-Ion Battery (P/N 0146-00-0069) ............................................................................................5 - 31
Data Storage..................................................................................................................................................5 - 32
Printing..........................................................................................................................................................5 - 33
Monitor Physical Characteristics .......................................................................................................................5 - 34
Comm-Port Physical Characteristics ...................................................................................................................5 - 36
External Parameter Module Physical Characteristics ............................................................................................5 - 37
Environmental and Safety Characteristics ...........................................................................................................5 - 38
Spectrum ................................................................................................................................................5 - 38
Gas Module 3 ........................................................................................................................................5 - 39
Agency Compliance........................................................................................................................................5 - 40
Spectrum ................................................................................................................................................5 - 40
Gas Module II and Gas Module SE ...........................................................................................................5 - 40
Gas Module 3 ........................................................................................................................................5 - 41
Electromagnetic Capability ..............................................................................................................................5 - 41
Spectrum ................................................................................................................................................5 - 41
Gas Module SE and Gas Module 3 ...........................................................................................................5 - 45
Warranty Statements .......................................................................................................................................5 - 49
Phone Numbers and How To Get Assistance......................................................................................................5 - 51
Mindray’s Responsibility ..................................................................................................................................5 - 51
Glossary........................................................................................................................... 6 - 1
Glossary of Terms ...........................................................................................................................................6 - 1
iv
0070-10-0648-02
Spectrum® Operating Instructions
Foreword
Introduction
Foreword
The Spectrum Operating Instructions are intended to provide information for proper
operation.
General knowledge of monitoring and an understanding of the features and functions of the
Mindray Spectrum Monitor are prerequisites for its proper use.
NOTE:
Do not operate this monitor before reading these
instructions.
Information for servicing this instrument is contained in the Spectrum Monitor Service
Manual, part number 0070-00-0556-02. For additional information or assistance, please
contact an authorized Mindray representative in your area.
CAUTION:
U.S. Federal Law restricts this device to sale by or on the
order of a physician or other practitioner licensed by state
law to use or order the use of this device.
NOTE:
Figures in this manual are provided for reference purposes
only. Screens will likely differ based on the monitoring
device configuration, licenses available, parameters
selected and patient configuration of the Spectrum Monitor.
Patents: This device is covered under one or more of the following U.S. Patents 4,621,643,
4,653,498, 4,700,708, 4,770,179, 4,869,254, 4,911,167, 4,928,692, 4,934,372,
5,078,136, 5,368,224, 5,482,036, 5,490,505, 5,632,272, 5,685,299, 5,758,644,
5,769,785, 6,002,952, 6,036,642, 6,067,462, 6,157,850, 6,206,830, 6,247,674,
6,377,845, 4,802,486, 4,960,126, 5,485,847, 5,743,263, 5,865,736, 6,035,223,
6,298,252, 6,463,310, 6,591,123, 6,675,031, 6,708,049, 6,801,797, 6,589,028,
6,896,713, Re.35,122 and foreign equivalents. Possession or purchase of this device does
not convey any express or implied license to use the device with replacement parts which
would, alone, or in combination with this device, fall within the scope of one or more of the
patents relating to this device.
Warnings, Precautions and Notes
Please read and adhere to all warnings, precautions and notes listed here and in the
appropriate areas throughout this manual.
A WARNING is provided to alert the user to potential serious outcomes (death, injury, or
serious adverse events) to the patient or the user.
A CAUTION is provided to alert the user to use special care necessary for the safe and
effective use of the device. They may include actions to be taken to avoid effects on patients
or users that may not be potentially life threatening or result in serious injury, but about which
the user should be aware. Cautions are also provided to alert the user to adverse effects on
this device of use or misuse and the care necessary to avoid such effects.
A NOTE is provided when additional general information is applicable.
Spectrum® Operating Instructions
0070-10-0648-02
v
Introduction
Warnings
Warnings
WARNING: Internal Electrical Shock Hazard - This unit does not contain
any user-serviceable parts. Do not remove instrument
covers. Refer Servicing to qualified personnel.
WARNING: Trace Gas Hazard - When using the optional Gas Module, a
health hazard exists when trace amounts of vaporized
anesthetic agents are chronically inspired by operating
room personnel. See Appendix A in NFPA 56A on Inhalation
Anesthetics. During any procedure where such agents are
employed, the Gas Module exhaust output should be
connected to a medical gas-scavenging system.
WARNING: Do not use this monitor during MRI (Magnetic Resonance
Imaging) scanning. Induced current could potentially cause
burns. Accuracy of measurements on this unit and the MRI
unit may also be affected.
WARNING: For continued protection against a fire hazard, replace all
fuses with the specified type and rating.
WARNING: This unit uses a common isolation path for the ECG leads
and the Invasive Pressure Channels. Ensure that conductive
parts of the ECG electrodes do not contact other conductive
parts including earth ground. Do not connect any nonisolated accessories to the Spectrum or to the ECG or
invasive pressure channel inputs when connected to a
patient. Insure that the total chassis leakage currents of all
connected units does not exceed 300µA. Use an IEC 60601-1
approved isolation / separation transformer if required. Do
not simultaneously touch the patient and any piece of
electrical equipment if any cover has been removed from
the equipment.
WARNING: The AC line cord and interface cables (i.e. non-patient
cables) may utilize the same ground. Therefore, removal of
the AC line cord does not necessarily isolate the Spectrum, if
non-patient interface cables are attached.
WARNING: Observe extreme caution when a defibrillator is used on a
patient. Do not touch any part of patient, table, or monitor
when a defibrillator is in use.
WARNING: Do not incinerate battery, possible explosion may occur.
WARNING: Do not put MPSO (Multiple Portable Socket Outlets i.e.
Multiple outlet extension cords) used with the Spectrum or
its accessories on the floor. Connect only Spectrum
accessories to the same MPSO as the Spectrum. Do not
overload the MPSO.
WARNING: Do not connect other equipment to the same MPSO with the
Spectrum, as it may increase system leakage current.
WARNING: Reliably attach Potential Equalization connector to the safety
ground when interconnecting Spectrum with other medical
or non-medical electrical equipment to minimize the risk of
excessive leakage current and/or shock hazard.
WARNING: Do not reuse disposable devices.
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0070-10-0648-02
Spectrum® Operating Instructions
Warnings
Introduction
WARNING: Compressed gasses are considered Dangerous Goods/
Hazardous Materials per I.A.T.A. And D.O.T. regulations. It is
a violation of federal and international law to offer any
package or over pack of dangerous goods for
transportation without the package being appropriately
identified, packed, marked, classified, labeled and
documented according to D.O.T. and I.A.T.A. regulations.
Please refer to the applicable I.A.T.A. Dangerous Goods
Regulations and/or the Code of Federal Regulations 49
(Transportation, Parts 171-180) for further information.
WARNING: Route cables neatly. Ensure cables, hoses and wires are
kept away from patient’s neck to avoid strangulation. Keep
floors and walkways free of cables to reduce risk to
hospital personnel, patients and visitors.
WARNING: Do not use a damaged or broken unit or accessory.
WARNING: Inaccurate Cardiac Output measurements may be caused
by:
•
Incorrect placement or position of the catheter
•
Excessive variation in pulmonary artery blood
temperature
•
Clot formation on the thermistor
•
Anatomical abnormalities, (for example, cardiac shunts)
•
Excessive patient movement
•
Repeated intermittent flushes of cold fluid through the
fluid lumens of the catheter
•
Use of a manual pump such as the Abbott® Blood Set
with Pump and CAIR clamp
•
Electrocautery or electrosurgical unit interference
•
Rapid changes in cardiac output
•
Using an incorrect computation constant
WARNING: Ensure that the conductive parts of ECG electrodes do not
contact other conductive parts, including earth ground.
WARNING: Pacemaker patients’ rate meters may continue to count the
pacemaker rate during occurrences of cardiac arrest or
some arrhythmias. Do not rely entirely upon rate meter
alarms. Keep pacemaker patients under close surveillance.
See the Appendix section of this manual for disclosure of the
pacemaker pulse rejection capability of this instrument.
WARNING: Due to physiologic differences in the patient population, the
Spectrum may occasionally not alarm or may sound a false
alarm for some arrhythmia patterns. The arrhythmia
analysis feature is intended to detect ventricular rhythms
only. High-risk patients should be kept under close
surveillance.
WARNING: The View 12™ ECG Analysis Module is not intended for use
during electrosurgery. If the electrosurgical ground
connection is not satisfactory, there exists a possibility of
patient burns at the ECG electrode sites.
WARNING: Computerized ECG Analysis should be reviewed by qualified
medical personnel. It should not be used exclusively for
treatment or non-treatment of patients.
Spectrum® Operating Instructions
0070-10-0648-02
vii
Introduction
Warnings
WARNING: ST segment measurements may be affected by one or more
of the following ECG rhythm morphologies: wide complex
QRS such as bundle branch blocks, ventricular pacemaker
rhythm, left ventricular hypertrophy or Wolff-ParkinsonWhite Syndrome. Consult with qualified medical personnel
prior to treatment or non-treatment.
WARNING: When monitoring CO2 with a Spectrum, the maximum
sampling rate at the nasal cannula is 58 ml/min. This device
should not be used on patients whose breathing could be
impaired by this vacuum flow rate.
WARNING: When monitoring CO2, connection from the exhaust port of
the Spectrum to the hospital’s waste gas scavenging system
is recommended to prevent exposure of hospital personnel
to the patient’s respiratory sample.
WARNING: When using the Gas Module, the maximum sampling rate at
the nasal cannula is 200 ml/min (120 ml/min for Gas
Module 3 with a neonatal water trap). This device should
not be used on patients whose breathing could be impaired
by this vacuum flow rate.
WARNING: Connection of the Gas Module exhaust port to the hospital’s
waste gas scavenging system is strongly recommended to
prevent exposure of hospital personnel to the patient’s
respiratory sample. Vacuum (negative pressure) should not
exceed 1 mmHg at the Gas Module Pump Exhaust fitting.
Excessive scavenge vacuum may result in damage to the
Gas Modules internal pump.
WARNING: Do not clean the monitor while it is on and/or plugged in.
WARNING: Operation of the Spectrum below the minimum amplitude or
value of PATIENT physiological signal may cause inaccurate
results.
WARNING: Use of ACCESSORIES, transducers and cables other than
those specified in the manual may result in increased
Electromagnetic Emissions or decreased Electromagnetic
Immunity of the Spectrum. It can also cause delayed
recovery after the discharge of a cardiac defibrillator.
WARNING: The use of gas sampling accessories in Gas Module 3 other
than specified by Mindray may cause significant
measurement errors and patient risk.
WARNING: Use of accessories, transducers and cables other than those
specified in the manual may result in increased
Electromagnetic Emissions or decreased Electromagnetic
Immunity of the Gas Module 3.
WARNING: With the exception of stacking on a Gas Module with the
appropriate mounting brackets, the Spectrum should not be
used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the Spectrum should
be observed to verify normal operation in the configuration
in which it will be used.
viii
0070-10-0648-02
Spectrum® Operating Instructions
Warnings
Introduction
WARNING: With the exception of stacking under a Spectrum with the
appropriate mounting brackets, the Gas Module 3 should
not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the Gas Module 3
should be observed to verify normal operation in the
configuration in which it will be used.
WARNING: The arrhythmia analysis feature is intended to detect
ventricular rhythms, however, due to physiologic differences
in patient populations, the Spectrum may occasionally
sound a false alarm or may not recognize some arrhythmia
patterns.
WARNING: Ensure that the ECG lead wires are neatly secured in a
manner that will prevent them from encircling the patient’s
neck, creating a strangulation hazard.
WARNING: Perform the decontamination process with the unit powered
down and power cord removed.
WARNING: If the water trap breaks or becomes damaged during
operation, there is a risk that bacteria and/or mucus may
contaminate the Gas Module.
WARNING: Do not use Adult/Pediatric type water traps and/or
sampling lines with neonates to avoid high sampling flow.
WARNING: The Gas Module must not be used with flammable
anesthetic agents.
WARNING: The Gas Module water trap, sampling line and airway
adapter should be disposed of in accordance with local
regulations for contaminated and biologically hazardous
items.
WARNING: Do not clean the Gas Module while it is on and/or plugged
in.
WARNING: Connect only DRYLINE™ gas sampling lines to the water
trap. Note that there may be other compatible tubes present
that must not be used, e.g. IV lines.
WARNING: Do not use DRYLINE™ Neonatal sampling lines (blue Luer
lock nuts) with DRYLINE™ Adult/Pediatric water traps as this
could result in incorrect measurement data.
WARNING: Do not use DRYLINE™ Adult/Pediatric sampling lines
(colorless Luer lock nuts) with DRYLINE™ Neonatal water
traps as this could result in incorrect measurement data.
WARNING: The contents of the water trap should be handled as a
potential infection hazard.
WARNING: Do not use other cleaning methods for the DRYLINE™ water
traps. Do not clean or wash the filter housing of the water
trap. Never allow alcohol to enter the filter housing. Never
force air through the water trap.
Spectrum® Operating Instructions
0070-10-0648-02
ix
Introduction
Precautions
Precautions
x
CAUTION:
Always place the monitor on a rigid, flat surface or on
approved mounts. Do not block ventilation or speaker
vents.
CAUTION:
Never place fluids on top of this monitor. In case of
accidental spillage, wipe clean immediately and have the
monitor serviced to ensure no hazard exists.
CAUTION:
This unit must only be operated with Mindray approved
software.
CAUTION:
To avoid possible damage to the Spectrum, use only ECG
cables and accessories available from Mindray.
CAUTION:
Operation of the Spectrum below the minimum amplitude or
value of patient physiological signal may cause inaccurate
results.
CAUTION:
Use of accessories, transducers and cables other than those
specified in the manual may result in increased
Electromagnetic Emissions or decreased Electromagnetic
Immunity of the Spectrum. It can also cause delayed
recovery after the discharge of a cardiac defibrillator.
CAUTION:
Dispose of single use items in accordance with hospital
policy.
CAUTION:
To prevent condensation, allow the Spectrum to warm up
and dry if it is moved from a cold area to a warm one.
CAUTION:
The Spectrum may not meet its performance specifications if
stored or operated outside of specified temperature and
humidity ranges.
CAUTION:
Prior to use, be sure the rail supporting the bed rail
mounting hook can support the weight of the monitor.
Consult the bed manufacturer’s specifications if necessary.
Mindray cannot be responsible for injury or damage
resulting from improper or inadequate support of the
monitor.
CAUTION:
Use recommended Mindray supplied power cords. If a
substitute is necessary use only hospital grade power cords.
CAUTION:
Sudden changes in PA blood temperature such as those
caused by patient movement or bolus drug administration
may cause a CO or CI value to be computed. To avoid falsely
triggered curves, you should inject as soon as possible after
the INJECT message appears.
CAUTION:
Line Isolation Monitor transients may resemble actual
cardiac waveforms, thus inhibiting heart rate alarms. Check
lead wires for damage and ensure good skin contact prior
to and during use. Always use fresh electrodes and follow
proper skin preparation techniques.
0070-10-0648-02
Spectrum® Operating Instructions
Precautions
Introduction
CAUTION:
To assure successful triggering of a Mindray Intra-Aortic
balloon pump from the Spectrum monitor, set the “ECG
Filter” to “Extended” and set “Pacer Enhancement” to
“On”. Both of these settings are located in the ECG setup
menu of the Spectrum.
CAUTION:
The Analog Output on the Spectrum supports triggering the
Intra-Aortic Balloon Pump (IABP) for 3 Lead and 5 Lead ECG
cable monitoring only. Invasive Blood Pressure triggering is
not supported. ECG analog output is disabled when 12 Lead
ECG analysis is enabled.
CAUTION:
Removal of the View 12™ ECG Analysis Module without first
disabling the 12-lead ECG card may cause a temporary
disruption in patient monitoring.
CAUTION:
Cuffs must be used with the correct Mindray hoses.
CAUTION:
Please consult a physician for interpretation of blood
pressure measurements.
CAUTION:
A blood pressure measurement can be affected by the
position of the patient, and his / her physiological condition
as well as other factors, such as patient movement.
CAUTION:
Observe caution on all patients (Neonates, Pediatrics, and
Adults) when NIBP is set to the Continuous Mode and the 1
minute interval. When the NIBP continuous interval is
selected, the Spectrum will continually take back to back
blood pressure readings. As a safety precaution, a limit is
placed on continuous and 1 minute interval measurements.
In continuous mode, after 5 minutes, the NIBP interval will
automatically switch to one measurement taken every 5
minutes. In 1 minute mode, after 10 minutes the NIBP
interval automatically switches to measurements taken once
every 10 minutes. Reports have been made of nerve injury
occurring during use of automatically cycled blood pressure
cuffs.
CAUTION:
Tissue damage or inaccurate measurements may be caused
by incorrect sensor application or use, such as wrapping too
tightly, applying supplemental tape, failing to inspect the
sensor site periodically, or failing to position appropriately.
Carefully read the sensor directions for use, the Spectrum
Operating Instructions, and all precautionary information
before use.
CAUTION:
Inaccurate SpO2 measurements may be caused by:
Spectrum® Operating Instructions
•
Incorrect sensor application or use
•
Significant levels of dysfunctional hemoglobins, (e.g.,
carboxyhemoglobin or methemoglobin)
•
Intra-vascular dyes such as indocyanine green or
methylene blue
•
Exposure to excessive illumination such as surgical
lamps (especially ones with a xenon light source),
bilirubin lamps, fluorescent lights, infrared heating
lamps, or excessive ambient light. In such cases, cover
the sensor site with opaque material.
•
Excessive patient movement
0070-10-0648-02
xi
Introduction
xii
Precautions
•
Venous pulsations
•
Electro-surgical interference
•
Placement of a sensor on an extremity that has a blood
pressure cuff, arterial catheter, or intra-vascular line.
•
Nail polish or fungus
CAUTION:
In certain situations in which perfusion and signal strength
are low, such as in patients with thick or pigmented skin,
inaccurately low SpO2 readings will result. Verification of
oxygenation should be made, especially in preterm infants
and patients with chronic lung disease, before instituting
any therapy or intervention.
CAUTION:
Many patients suffer from poor peripheral perfusion due to
hypothermia, hypovolemia, severe vasoconstriction,
reduced cardiac output, etc. These symptoms may cause a
loss in vital sign readings.
CAUTION:
The SpO2 sensor site should be checked at least every eight
(8) hours (every four (4) hours with the Adult re-usable
finger sensor). Ensure proper adhesion, skin integrity, and
proper alignment. Exercise extreme caution with poorly
perfused patients. Skin erosion and pressure necrosis can
be caused when sensors are not frequently monitored.
Assess the site every two (2) hours with poorly perfused
patients and neonates.
CAUTION:
When equipped with Masimo SET® SpO2, use only Masimo
SET Oxygen Transducers including Masimo SET LNOP® and
LNCS™ Patient Dedicated Adhesive, Sensors and Masimo SET
PC Series Patient Cables. Use of other oxygen transducers
may cause improper oximeter performance.
CAUTION:
When equipped with Nellcor® SpO2, use only Nellcor
oxygen transducers including Nellcor Oxisensor® and
OxiMax® patient dedicated adhesive sensors. Use of other
oxygen transducers may cause improper oximeter
performance.
CAUTION:
Vacuum (negative pressure) should not exceed 1 mmHg at
the Spectrum Pump Exhaust fitting. Excessive scavenge
vacuum may result in an Occlusion message or damage to
the Spectrum’s internal pump. The scavenging system must
be on during calibration.
CAUTION:
Microstream® CO2 waste and CO2 FilterLine® should be
treated as biohazardous waste.
CAUTION:
When cleaning sensors, do not use excessive amounts of
liquid. Wipe the sensor surface with a soft cloth, dampened
with cleaning solution. Do not attempt to sterilize.
CAUTION:
The internal sampling system of the Gas Module does not
need to be cleaned or sterilized. There is no reverse flow
back to the patient. If the internal sampling system is
suspected to be clogged or dirty, the module should be
serviced by an authorized service person only.
0070-10-0648-02
Spectrum® Operating Instructions
Precautions
Introduction
CAUTION:
If the dust filter for the fan cannot be cleaned or is
damaged, replace it with part number 0378-00-0040. Use
of another type of filter may decrease the cooling effectivity
and cause damage to the Gas Module.
CAUTION:
To avoid permanent damage, do not expose metal
components (pins, sockets, snaps) to disinfectants, soaps or
chemicals.
CAUTION:
Only connect NIBP Luer fittings to Blood Pressure Cuff or
Monitor.
CAUTION:
Sudden changes in blood temperature such as those caused
by bolus drug administration may cause a CO or CI value to
be computed. To avoid falsely triggered curves, inject as
soon as possible after the “Inject when Ready” message is
displayed.
CAUTION:
Some pacemakers may contain a respiratory sensor that
may produce artifact on an ECG waveform.
CAUTION:
During the decontamination process, do not get the LpH SE
Germicidal detergent into any vent openings.
CAUTION:
The monitor display provides data and waveform
information over its entire area. Do not cover any part of
the monitor display with tape or labels.
CAUTION:
The 2.4 GHz radio optionally used in this device must be at
least 20 cm away from the user and/or patient during
normal operating conditions.
CAUTION:
Replace sealed lead acid batteries with Mindray P/N 014600-0043 ONLY. Replace lithium-ion batteries with Mindray
P/N 0146-00-0069 ONLY.
CAUTION:
Gas Module 3 must be moisture protected whenever
transported. This can be done with a protective plastic bag
in which water-absorbing materials (e.g. silica gel) have
been included.
CAUTION:
Contamination with CO2, N2O or Anesthetic Agent in the air
surrounding the Gas Module 3 may cause significant
measurement errors.
Spectrum® Operating Instructions
0070-10-0648-02
xiii
Introduction
Notes
Notes
NOTE:
This unit is not designed to be used with a peripheral pulse
sensor. SpO2 is a standard function in this monitor, and may
be used to obtain a plethysmograph waveform and heart
rate.
NOTE:
The comparison testing conducted via the auscultatory
method used both Phase 4 and Phase 5 Korotkoff sounds.
Reports of study findings for both the auscultatory method
as well as the intra-arterial methods are available by
contacting Mindray Technical Support (800) 288-2121, ext.
8116 or (201) 995-8237.
NOTE:
Potential hazards due to errors in software or hardware
have been minimized by actions taken in accordance with
IEC 60601-1-4.
Indication For Use
The Spectrum Monitor is intended for intra hospital use under the direct supervision of a
licensed healthcare practitioner. The indications for use for the Spectrum Monitor include the
monitoring of the following human physiological parameters:
• ECG waveform derived from 3, 5 or 12 lead measurements
• Heart Rate derived from selected sources (ECG, SpO2, IBP, NIBP)
• Pulse Oximetry (SpO2)
• ST Segment Analysis derived from 3, 5 or12 ECG lead measurements
• Arrhythmia Detection derived from 3, 5 or 12 ECG lead measurements
• Interpretation of Resting 12 lead ECG
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) - up to four (4) channels
• Cardiac Output
• Respiration Rate/waveform derived from ECG or CO2
• CO2, inspired and end tidal microstream/waveform
• Temperature - up to two (2) channels
• Hemodynamic Calculations
• IV Drug Calculations
The target populations are adult, pediatric and neonate with the exception of:
• Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations,
and Pulmonary Artery Wedge Pressure measurements for which the target populations
are adult and pediatric only, and
• Interpretation of Resting 12 Lead ECG and IV Drug Calculations, for which the target
population is adult only.
The Spectrum Monitor has the capability of interfacing with Mindray's Intra Aortic Balloon
Pumps, Central Stations, and Gas Module products.
xiv
0070-10-0648-02
Spectrum® Operating Instructions
Unpacking
Introduction
Unpacking
Remove the instrument from the shipping carton and examine it for signs of shipping
damage. Save all packing materials, invoice and bill of lading. These may be required to
process a claim with the carrier. Check all materials against the packing list. Contact the
Mindray Service Department at (800) 288-2121 or (201) 995-8237 for prompt assistance
in resolving shipping problems.
Spectrum® Operating Instructions
0070-10-0648-02
xv
Introduction
Symbols and Descriptions
Symbols and Descriptions
SYMBOL DESCRIPTION
xvi
SYMBOL
DESCRIPTION
Attention, Consult
Accompanying Documents /
Refer to Manual
Type B Equipment
Dangerous Voltage
Type BF Equipment
Equipotentiality
Defibrillator Proof Type BF
Equipment
Alternating Current (AC)
Defibrillator Proof Type CF
Equipment
Direct Current (DC)
Alarm Off Icon
On (only for a part
of the equipment)
Alarm Mute Icon
OFF (only for a part
of the equipment)
Earth (Ground)
Data Input
Protective Earth (Ground)
Data Output
Battery Charging
Data Input / Output
Full Battery
Gas Port Input
Low Battery
Gas Port Output
No Battery Present
NIBP Connection
IABP
Analog ECG and IBP output for
communication to an
Intra-Aortic Balloon Pump
Latex-free product
DEFIB
Analog ECG out and Sync Pulse for
connection to a Defibrillator
Crossed out wheelie bin
indicates separate treatment
from general waste at end
of life
Interference may occur in the
vicinity of equipment marked with
this symbol
For single-patient use only, do
not reuse.
Manufacturer’s reference/catalogue
number
0070-10-0648-02
Spectrum® Operating Instructions
Symbols and Descriptions
Spectrum® Operating Instructions
Introduction
For Neonatal use
Manufacturer’s batch number
Not for Neonatal use
Serial number
Conformité Européenne (CE)
Marking of Conformity to
European Medical Device
Directive. CEXXXX represents the
Notified Body number
Software Version
0070-10-0648-02
xvii
Introduction
Symbols and Descriptions
This page intentionally left blank.
xviii
0070-10-0648-02
Spectrum® Operating Instructions
1.0
General Product Description
FIGURE 1-1 The Mindray Spectrum Patient Monitor
Spectrum® Operating Instructions
0070-10-0648-02
1-1
General Product Description
1.1
General Product Description
General Product Description
The Spectrum is a vital signs monitor intended for intrahospital use on human patients. The
Spectrum is a three (3) to eight (8) trace monitor. The unit has many features and functions,
yet is easy to use through an integrated keypad, Navigator™ Knob and an intuitive menu
system.
The Spectrum has a 12.1 inch color display and comes standard with 3 or 5-lead ECG,
Masimo SET® SpO2, Non-invasive Blood Pressure, Respiration, Continuous Temperature and
IV Drug Calculations.
The Spectrum may be configured to suit your department by adding software and
hardware optional features. Optional software features include ST and Arrhythmia analysis.
Optional hardware features include View 12™ ECG Analysis Module (which includes ST,
Arrhythmia and 12-lead interpretation), Up to 4 Invasive Blood Pressure Channels,
MicroStream® CO2, Anesthetic Gases, Nellcor® Oxismart® and OxiMax® SpO2, a second
temperature source, dual trace recorder, and Cardiac Output. A comprehensive calculation
package, including hemodynamic calculations, is available if the Spectrum is equipped
with an External Parameter Module.
Digital displays are provided for Heart Rate, Non-invasive Blood Pressure (NIBP), Pulse
Oximetry (SpO2), Respiration Rate and Temperature (T1). Optional digital areas provided for
Invasive Blood Pressure (up to four), Anesthetic Agents, O2 and NO2, ST, and CO2. The
optional internal recorder provides hard copies of all digital data and waveforms as well as
trend information.
The Spectrum Monitor can be mounted on a rolling stand, a wall mount bracket, gas
machine arm, bedrail, Gas Module or operated as a tabletop instrument.
The View 12 ECG Analysis Module for the Spectrum enables 12-lead acquisition,
continuous 12-lead ST analysis and arrhythmia analysis with print capability. The View 12
ECG analysis module consists of a PCMCIA card for insertion into the Spectrum and a
detachable leadwire set.
The Spectrum has the capability of interfacing with Mindray’s Central Stations, Gas
Module, IABP Systems, Edwards Vigilance® Monitor, Remote Displays and Nurse Call
Systems.
The Spectrum monitor is powered by an AC connection or internal batteries.
1-2
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
1.2
Key Features
Key Features
FEATURES
STANDARD
OPTIONAL
Display
12.1 inch color liquid crystal
display
External Remote Color Display
Automatic Sensor Detection and
Waveform Display
8-trace erase bar refresh
ECG
3 or 5-lead
(I, II, III, aVR, aVL, aVF, V)
12-lead (I, II, III, aVR, aVL, aVF, V1, V2, V3,
V4, V5, V6)
ECG Cascade
3 or 12-lead ST Analysis
ESIS Capability (3 or 5-lead)
Arrhythmia Analysis
12-lead ECG Interpretation
Blood Pressure
Non-Invasive Blood Pressure
Up to 4 channels of Invasive Blood Pressure
Wedge Pressure with reference line
Cardiac Output
Mindray External Parameter Module (EPM)
Edwards Vigilance® Monitor
SpO2
Masimo SET®
Nellcor® OxiMax®
Temperature
One YSI 400/700 channel
Second YSI 400/700 channel
Respirations
Lead-selectable Impedance
Microstream® CO2
Gas Module with Automatic Agent ID
Trend
Power
Tabular and Graphic trends with
120 entries
Extended trend display with up to 500
entries
OxyCRG trending, 6 minutes
OxyCRG trending, 12 hours
Internal isolated power module
Sealed lead acid batteries
Lithium-ion batteries
Printing
Internal recorder
12-lead ECG data to Laser Printer
External
Interfaces
Mindray’s Central Stations, Gas
Module, IABP Systems, Remote
Displays, Nurse Call Systems,
Serial Communications
Edwards Vigilance® Monitor
Calculation
IV drug calculations
Hemodynamic calculations
Soft Grip Handle
Mounting kits
Navigator™ Knob
Patient and monitor data transfer
Other
Dedicated keys
Dual PCMCIA Ports
Edwards Vigilance® Monitor
SvO2
Spectrum® Operating Instructions
0070-10-0648-02
1-3
Keys and Front Panel
1.3
General Product Description
Keys and Front Panel
The front panel keys are used to access many main functions quickly and easily. The figure
below shows the keys and a brief explanation follows.
5
2
1
7
4
8
10
11
13
14
16
17
19
20
21
DISPLAY
ECG
NIBP
ALARMS
PRINT
LEAD
START
ZERO
ALL IBP
LIMITS
STRIP
STANDBY
TRENDS
SIZE
INTERVAL
C.O.
MUTE
ALL
CONT
ECG
DISCHARGE
FREEZE
VIEW
STOP
PAWP
MUTE
PRINT
TREND
MARK
EVENT
3
6
NORMAL
SCREEN
9
12
23
15
18
25
26
22
24
FIGURE 1-2 Keypad
1. LEAD
Press this key to select the next ECG lead to display in Waveform 1. Each time you press this
key, the next available ECG lead displays.
2. SIZE
Press this key to select the next available size of ECG for Waveform 1. Each time you press
this key, the next available ECG size displays. When the largest ECG size is displayed, the
next key press displays the smallest size.
3. VIEW
Press the VIEW key to see multiple leads of ECG when using the View 12™ ECG Analysis
Module or the 5-lead ECG cable. Press this key to toggle between multi-lead view and
normal display.
4. START
Press this key to begin an NIBP measurement or to begin or re-start automatic interval
measurements.
5. INTERVAL
Press this key to modify the NIBP interval measurement time. The choices are: Off,
Continuous, 1 min, 2 min, 2.5 min, 3 min, 5 min, 10 min, 15 min, 20 min,
30 min, 1 hr, 2 hr or 4 hr. The Off selection means that NIBP measurements can only be
initiated manually. The Continuous selection means that measurements will be continuous
(one right after the other). The continuous measurement interval will only last for 5 minutes
and then automatically change to a 5 minute interval. The 1 minute interval will last for 10
minutes and then automatically change to a 5 minute interval.
1-4
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
Keys and Front Panel
6. STOP
Press this key to stop any NIBP measurement. If the interval mode is activated, pressing this
key disables the interval mode measurements. An NIBP Idle message displays until the
interval mode is restarted. If a Press STOP to clear. message is displayed, pressing this
key will clear a Cuff Overpressure condition.
7. ZERO ALL IBP
Press this key to set the current pressure for all invasive pressure channels to zero. This key
does not affect any channels monitoring pressure. During the zeroing process, the message
Zeroing is displayed. The message Zero Complete displays when the zeroing process is
successful. If the zero process is not successful, the message Unable to Zero is displayed.
8. C.O.
Press this key to open the Cardiac Output Menu or the Vigilance CO Menu. If the
Cardiac Output Menu is already open and the “Ready” message is displayed, pressing
the C.O. key activates the CO run sequence. Pressing the C.O. key while the Vigilance CO
Menu is open will have no effect.
9. PAWP
Press this key to open the Pulmonary Artery Wedge Pressure (PAWP) Menu and
measure the PAWP. The key is active if a pressure channel has been labeled PA.
10. LIMITS
Press this key to display the Alarm Limits Menu. The Alarm Limits Menu provides
access to view or change alarm values.
11. MUTE ALL
Press this key to suspend audio alarms on all parameters. The alarms remain suspended for a
user selected amount of time. This amount of time is set in the Alarms Setup Menu. While
the alarms are suspended, an Alarm Mute icon is displayed next to each silenced parameter.
Also, the message ALL ALARMS MUTED FOR XX:XX mins displays. XX:XX is the time
remaining in minutes and seconds. Press this key again during the suspended alarm time to
re-enable the audio alarm. If the suspend time was set to Permanent, the message ALL
ALARMS MUTED PERMANENTLY is displayed.
12. MUTE
Press this key to suspend audio alarms on all currently alarming parameters. The alarms
remain suspended for a user selected amount of time as set in the Alarms Setup Menu or
until the alarm condition is no longer present. Any new alarms that occur while the alarm
tone is silenced will disable the silence and sound the alarm tone. While the alarms are
suspended, an Alarm Mute icon is displayed next to each silenced parameter.
Spectrum® Operating Instructions
0070-10-0648-02
1-5
Keys and Front Panel
General Product Description
13. STRIP
Press this key to initiate a printout to the selected device.
• If the print destination is the internal recorder, then pressing this key will produce a 16second strip of up to two (2) waveforms. Pressing this key during a print job will abort the
strip printout.
• If the print destination is a remote Central Station, then pressing this key will initiate a
printout at the Central Station.
• If the View 12™ ECG Analysis Module is installed, and the View All ECG screen is active,
pressing this key will initiate a 12-lead interpretative report that will be printed at either
the internal recorder or a laser printer.
14. CONT ECG
Press this key to initiate a continuous ECG 1 and 2 waveform printout from the internal
printer. Press this key again to abort printing.
15. PRINT TREND
Press this key to initiate printing of the desired trend. By default, the monitor’s stored trend
information will be printed by the internal printer. Pressing this key during a print job will
abort printing.
If the print destination is a remote Central Station, then pressing this key will initiate a trend
report at the Central Station.
16. STANDBY
Press this key to place the Spectrum into a STANDBY mode. While in STANDBY mode,
monitoring is discontinued and the alarms are in permanent suspension, interval NIBP
measurements are placed in idle mode, CO2 pump is shut off, and the display shuts down.
When in the STANDBY mode, the message STANDBY. TO BEGIN MONITORING,
PRESS STANDBY is displayed. Press the STANDBY key again to exit the STANDBY mode
and return to the normal screen.
NOTE:
1-6
Trend data is not cleared in the STANDBY mode. When the
STANDBY mode is released, NIBP INTERVAL is in IDLE MODE
and requires reactivation via the START key. The CO2 pump
automatically reactivates if the Microstream® sensor is in
place.
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
Keys and Front Panel
17. DISCHARGE
Press this key to initiate the process of discharging the patient from the monitor. A menu titled
Patient Discharge will be displayed. Depending on the monitor’s configuration, the
Normal Screen menu choice will be provided along with one or more of the following
selections: Discharge From Monitor, Discharge From Central and Discharge
From Both. If any discharge option is selected, a confirmation box will be displayed.
(Discharging a patient from the monitor deletes all patient trend and demographic data and
places the monitor in STANDBY mode.) An onscreen message will display as follows:
• For Main Module Software Versions H.xx and earlier, the message STANDBY. TO
BEGIN MONITORING, PRESS STANDBY is displayed.
• For Main Module Software Versions J.xx and later, the message PATIENT
DISCHARGED. MONITOR IN STANDBY MODE - TO BEGIN MONITORING,
PRESS STANDBY is displayed.
Upon exiting STANDBY mode, the monitor configuration reverts to currently saved settings.
Selecting Normal Screen from the menu aborts the discharge.
18. MARK EVENT
Press this key to cause a time stamp event marker to be noted in the trend memory. If
connected to a Panorama Central Station, a time stamp event marker will also be noted in
the Central Station’s trend memory.
19. TRENDS
Press this key to display the List Trend screen. Press this key a second time to display the
Graph Trend screen. Press this key a third time to return to the normal display. If Neonate
or Pediatric is selected as the patient size, a third press will display the OxyCRG Trend
screen. When OxyCRG trend is available a fourth press will return the monitor to normal
display.
20. FREEZE
Press this key to freeze the waveform display. When waves are frozen, the message Waves
Frozen is displayed. Digital data will continue to be updated.
21. NORMAL SCREEN
Press this key at any time to return the screen to the normal monitoring mode. All menus are
closed.
22. Navigator™ Knob
Rotate this knob to highlight the various menus on the display. Press the center of the knob to
display the highlighted menu. Once a menu is displayed, rotate the knob to highlight the
menu items listed. Press the center of the knob to select a highlighted item.
23. Warning LED
LED used to indicate that an alarm has been tripped. The WARNING (or Priority 1) LED is
red.
Spectrum® Operating Instructions
0070-10-0648-02
1-7
Keys and Front Panel
General Product Description
24. Caution LED
LED used to indicate that an alarm has been tripped. The CAUTION (or Priority 2) LED is
yellow.
25. Battery Charging LED
A green LED located below the battery icon indicates that the battery charger is active. The
charger will not always be active when AC power is present. It is dependent on the battery
type (sealed lead acid vs. lithium-ion) and battery charge condition. The LED is not an
indication of the condition of the batteries or their charge level. Charged batteries must be
installed in the monitor to ensure uninterrupted operation while switching from AC to battery
power.
26. AC Power LED
A green LED beside the Battery Charging LED that is used to indicate that the unit is
connected to the AC Power within the facility.
1-8
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
1.4
Display
Display
The display of the Spectrum provides menus, waveforms, parameter information, and
messages. The Spectrum includes a display setup function that allows customization of the
display. Preferred setup details can be programmed and saved.
Main Menus
Message
Area A
2
6
Pat ient
Monit or Set up
Print Set up
Paramet ers
Functions
11/01/04
2:05 PM
JONES, ERIC
HR
A dult
bpm
P S A
170
PVC/min: 4 5
Source: Aut o
Lead
mm
II
I
+ 2.2 -2.1
55
V
-3.0
PR bpm
OFF
%
94
mmHg
A
r
t
mmHg
P
A
Insp
0
mmHg
Exp
/ 38
Resp
mmHg
17 rpm Source: CO2
mmHg
mmHg
mmHg
CPP
80
mmHg
1
Waveform
Area
T1
T2
100.6
100.4
ΔT
0.2
CO
ºF
20.0
CI
NIBP: Idle
l/min
mmHg
@ 15:21
l/min/m 2
10.0 Source: Module
Int erval: 15 min ET: 13 min
7
Message
Area B
3
Parameter
Menus
8
4
Parameter
Areas
5
Radio
Icon
Battery
Indicator
9
Panorama
Icon
FIGURE 1-3 Display
1. Waveform Area
The waveform area is used to display windows which contain parameter waveforms. Up to 8
waveforms may be displayed. The top window is always set to display the ECG waveform
and cannot be changed. By default, SpO2 (Pleth) waveform will appear as the second
waveform, if connected. Respiration or CO2 will appear as the third waveform. If pressure
transducers are plugged into IBP1 and IBP2 the screen will reformat to display additional
waveforms and the IBP waveforms will appear as the fourth and fifth waveform. The setup
can be changed to display any of the available parameters and waveforms.
2. Main Menus
The Main Menus enable the user to enter patient specific data, customize the monitor, setup
printing or transfer patient data. Use the Navigator™ Knob to access these functions.
Spectrum® Operating Instructions
0070-10-0648-02
1-9
Display
General Product Description
3. Parameter Menus
The Parameter Menus enable the user to review and customize various parameter display
and alarm attributes. Use the Navigator Knob to access these menus.
4. Parameter Areas
The parameter area contains the digital data for each available parameter.
5. Battery Indicator
When batteries are installed and the monitor is functioning on battery power, the battery
indicator provides a visual reference for the approximate charge level of the batteries. See
the following examples.
Full Battery
Low Battery
No Battery Present
(Lithium-Ion batteries only)
If the monitor is configured for lithium-ion batteries, when there are no batteries installed, the
battery indicator will be displayed with an “X” through it as shown in the example.
When the battery charge is low, but not below the cutoff voltage, the battery indicator will
begin to flash and a low pitched double beep will be generated every minute.
NOTE:
When the battery indicator begins to flash, less than 15
minutes of operating time remains, depending upon the
number of functions that are operational.
NOTE:
The internal recorder may not be operational when the
battery charge is low.
6. Message Area A
This message area is located above the ECG waveform window. Messages regarding the
ECG/heart rate and alarm status are displayed here.
7. Message Area B
This message area is located below the last row of parameter tiles. Messages regarding
NIBP, IBP, printer status, SpO2, CO2, and Gas Module are displayed here.
8. Radio Icon
If a Panorama Instrument Radio - 608 is installed and “WMTS Enabled” is set to “Yes” (in the
Installation Menu), this icon will be displayed.
9. Panorama Icon 1 or V
This icon will display in one of two possible formats as follows:
• If the Spectrum 608 radio is sending data but it is not being displayed at a
Panorama Central Station, then this icon will display the number “1”.
• If the Spectrum data is being displayed at a Panorama Central Station, then this icon
will display the capital letter “V”.
1 - 10
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
1.5
Rear View
Rear View
3
5
6
2
4
1
FIGURE 1-4 Rear Panel
1. AC Receptacle
Insert an AC power cord into this connector.
2. Equipotential Lug
Provides Equipotential grounding of hospital equipment.
3. Soft Grip Handle
Used for carrying the monitor.
4. Main I/O Connector Port (DM1)
Area dedicated for the use of an optional communication port.
5. Expansion Slot
Used for connecting an optional Panorama Instrument Radio - 608.
6. External Parameter Module Port (EM1)
Port used to connect the External Parameter Module to the Spectrum.
Spectrum® Operating Instructions
0070-10-0648-02
1 - 11
Left Side Panel
1.6
General Product Description
Left Side Panel
9
1
CO22 Exhaust
CO 2 Input
2
T1
IBP 1
IBP 2
8
3
ECG
SpO 2
4
5
6
7
FIGURE 1-5 Left Side Panel
1. CO2 Exhaust Connector (Optional)
This connector is used to attach an exhaust line which can be used to connect to a gas
scavenging system.
2. T1 Connector
This connector mates with either the YSI series 400 or series 700 temperature probes. The
monitor automatically detects which probe is connected.
3. IBP 1 Connector (Optional)
This connector is used for Channel 1 Pressure Transducer connection.
1 - 12
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
Left Side Panel
4. IBP 2 Connector (Optional)
This connector is used for the Channel 2 Pressure Transducer connection.
5. SpO2 Connector
This connector is used to attach the SpO2 sensor to the monitor, either Masimo SET®,
Nellcor® Oxismart® or Nellcor® OxiMax® technology.
6. Battery Compartment
This compartment houses the two optional, user replaceable, rechargeable batteries (sealed
lead acid or lithium-ion). These batteries provide power to the unit when it is not connected to
an AC receptacle. The batteries can be independently removed and replaced while the unit
is operating.
7. NIBP Rectus Connector
This connector is used to attach the NIBP hose to the unit.
8. ECG Connector
This connector is used to attach a 3 or 5-lead ECG cable.
9. CO2 Input Connector (Optional)
This connector is used to attach a Microstream® CO2 FilterLine® to the unit.
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Right Side Panel
1.7
General Product Description
Right Side Panel
1
2
5
3
4
FIGURE 1-6 Right Side Panel
1. PCM1 and PCM2 Card Slots
These sockets are used for extended trend memory, software download to the CPU, patient
data transfer, monitor set-up transfers, View 12™ ECG Analysis Module, and Panorama
Instrument Radio - 2.4.
2. Power Switch
A momentary switch that turns power ON or OFF but does not prevent charging of the
batteries. Press the top of the switch once to turn the unit ON. Press the top of the switch
again to turn the unit OFF.
3. DEFIB Connector
Used to connect a defibrillator sync cable.
1 - 14
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
Right Side Panel
4. IABP Connector
Used for triggering an Intra-Aortic Balloon Pump from the Spectrum when using a 3-lead or
5-lead ECG cable.
5. Recorder (Optional)
A two trace thermal strip chart recorder with integral paper spool.
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1 - 15
Gas Module (Optional)
1.8
General Product Description
Gas Module (Optional)
NOTE:
1.8.1
The following models are referenced in this manual: Gas
Module II, Gas Module SE, and Gas Module 3. When
information is common to all models, the generic name
“Gas Module” is used. Information that is unique to a
specific model is identified accordingly.
Front Panel
2
6
3
1
4
5
FIGURE 1-7 Gas Module II and SE
2
6
1
5
FIGURE 1-8 Gas Module 3
1. Input Port
This port is used to connect the sampling tubing to the Gas Module.
2. Water Trap Assembly (includes Water Trap Reservoir)
• Gas Module II and SE – (P/N 0202-00-0129)
• Gas Module 3 – (Adult/Pediatric P/N 0202-00-0182-10, Neonate P/N 0202-000181-10)
The Water Trap Assembly is used to capture moisture drawn in with the patient sample. The
Water Trap Reservoir must be emptied and rinsed (with water only) whenever more than half
full or whenever changing patients. Refer to section 3.9 for more details.
3. Dust Filter
The Dust Filter (P/N 0378-00-0040) protects the Gas Module from airborne dust. It should
be removed and cleaned on a regular basis. Refer to section 3.9 for more details.
4. Dust Filter Cover
The Dust Filter Cover is removed to access the filter.
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Spectrum® Operating Instructions
General Product Description
Gas Module (Optional)
5. Power Indicator Lamp
This lamp illuminates when the Power Switch is in the ON position.
6. Power Switch
A switch used to power the unit ON and OFF. It is located on the front of the Gas Module SE
and Gas Module 3. It is located on the back of the Gas Module II.
1.8.2
Rear Panel
11
10
9
8
7
FIGURE 1-9 Gas Module II and SE
11
10
7
8
FIGURE 1-10 Gas Module 3
7. AC Power Input
This input is used to attach the special “Y” Shaped Power Cord.
8. Exhaust Port
This panel mount coupling is used for attaching a gas scavenging system
(P/N 0997-00-0923 or P/N 0997-00-0984) to the Gas Module.
9. Reference Port
This port is used only to measure room air. This port is not to be connected to anything. Do
not block this port.
10. External Interface Port
A communication interface port used to connect the Gas Module to the Spectrum.
11. Equipotential lug
Provides Equipotential grounding of hospital equipment.
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1 - 17
Comm-Ports
1.9
General Product Description
Comm-Ports
NOTE:
Figures 1-12 to 1-15 depict four distinct sub-models of the
Comm-Port that have different interface capabilities. Only
one sub-model at a time can be connected to the Spectrum.
1
Main I/O Connector
FIGURE 1-11 Comm-Port
1. Comm-Port to Main I/O Connector (DB1)
This is the female connector that will engage the equivalent male connector when connected
to the Spectrum.
3
2
4
FIGURE 1-12 CS1/MB1/SP1Comm-Port
2. Ethernet Connector (CS1)
Ethernet connection port used for networking connections or devices requiring ethernet
communication such as the Panorama™ Central Station or a Laser Printer.
3. Module Bus Connector (MB1)
Port used for future enhancements.
4. Serial Port Connector (SP1/SP2)
Proprietary serial port used to connect to the PatientNet® Central Station, Gas Module,
Edwards Vigilance® Monitor, or other devices.
1 - 18
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
Comm-Ports
!
RD1
5
NC1
SP1
6
4
FIGURE 1-13 RD1/NC1/SP1 Comm-Port
5. Remote Display Connector (RD1)
Port used to connect a color remote display to the Spectrum monitor.
6. Nurse Call Connector (NC1)
Port used to connect a nurse call cable to the Spectrum monitor.
2
5
3
FIGURE 1-14 CS1/MB1/RD1 Comm-Port
SP1
4
NC1
6
SP2
4
FIGURE 1-15 SP1/NC1/SP2 Comm-Port
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External Parameter Modules (Optional)
1.10
General Product Description
External Parameter Modules (Optional)
The module contains a YSI 400/700 temperature port and may also contain one or both of
the following:
• Two Invasive Blood pressure ports
• Cardiac Output port
To connect the External Parameter Module to the Spectrum:
1. Line up the connectors on the front of the Module (security posts, module hooks and EM1
port).
2. Slide the module forward, towards the monitor front until an audible “click” is heard as
the module hooks are engaged.
To remove the External Parameter Module from the Spectrum:
1. Press the two release buttons on the top of the module.
2. Slide the module straight back until all connectors are clear.
3. Lift the module straight up for complete disengagement.
WARNING: Do not clean the monitor while it is on and/or plugged in.
1 - 20
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
1.10.1
External Parameter Modules (Optional)
External Parameter Module Top View
1
2
FIGURE 1-16 Diagram of Top View
1. Soft Grip Module Handle
This integrated grip handle is used for carrying the Spectrum with the External Parameter
Module attached.
2. Release Buttons
There are two release buttons at the top. Press these two release buttons, simultaneously
during the removal of the External Parameter Module from the Spectrum.
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1 - 21
External Parameter Modules (Optional)
1.10.2
General Product Description
External Parameter Module Front View
2
1
3
FIGURE 1-17 Front View of EPM
1. Module Connector (EB1)
This module bus port connects the External Parameter Module to the EM1 port on the
Spectrum.
2. Module Latches
These latches secure the module to the Spectrum.
3. Guide Pins
These pins guide the EB1 connector into the EM1 port on the Spectrum.
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0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
1.10.3
External Parameter Modules (Optional)
Left Side View with External Parameter Module
3
5
4
2
6
1
C.O.
T2
IBP 4
IBP 3
CO22 Exhaust
CO2 Input
T1
IBP 1
SpO2
IBP 2
ECG
FIGURE 1-18 Left Side View with External Parameter Module
1. T2 Connector
This connector mates with either the YSI series 400 or 700 temperature probes. The monitor
automatically detects which probe is connected.
2. IBP3 Connector
This connector is used for the Channel 3 Pressure Transducer connection.
3. ZERO ALL IBP Key
Press this key to zero all invasive blood pressure simultaneously. This key operates the same
as the ZERO ALL IBP key on the monitor keypad.
4. IBP4 Connector
This connector is used for the Channel 4 Pressure Transducer connection.
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1 - 23
External Parameter Modules (Optional)
General Product Description
5. C.O. Key
Press this key to open the Cardiac Output Menu. If the Cardiac Output Menu is
already open and the “Ready” message is displayed, pressing the C.O. key activates the
CO run sequence.
NOTE:
Pressing this key will not open the Vigilance CO Menu.
6. CO Connector
A port used to connect the Cardiac Output cable.
1 - 24
0070-10-0648-02
Spectrum® Operating Instructions
General Product Description
1.10.4
External Parameter Modules (Optional)
Rear View with External Parameter Module
1
2
!
RD1
NC1
SP1
FIGURE 1-19 Rear View with External Parameter Module
1. Module Bus Port (MB2)
This is used for connection to future devices.
2. Rear Module Hooks
These two hooks secure the module to the Spectrum.
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External Parameter Modules (Optional)
General Product Description
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0070-10-0648-02
Spectrum® Operating Instructions
2.0
Operations
2.1
Getting Started
The Spectrum comes with default factory settings which enable you to begin monitoring
without setting any of the waveforms, parameters, alarms, or functions. However, all of these
settings can be changed for specific patient or departmental needs.
Certain operating characteristics are based on the selected patient size (e.g. NIBP start
pressure). The patient size selection should be matched to the actual patient before
monitoring begins.
Setting-up Patients
1. Turn the monitor on using the ON/OFF switch. Ensure the previous patient’s data has
been removed from the monitor by discharging previous patient.
2. Connect the patient to the monitor, apply appropriate accessories such as ECG
electrodes, NIBP cuff, SpO2 probe, CO2 Fiterline®, etc.
3. Enter patient information into the Spectrum via the Patient Menu, check patient size.
4. If desired, press the START key to initiate a non-invasive blood pressure measurement.
Spectrum® Operating Instructions
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2-1
Getting Started
Operations
How to Set the Clock / Date and Time
The date and time are set in the Monitor Setup Menu.
1. Using the Navigator™ Knob, highlight Monitor Setup. Press the Navigator Knob to
open the menu.
2. Use the Navigator Knob to select Advanced Setup, then select either Date or Time.
3. Turn the Navigator Knob to select a new setting. Once the desired choice is highlighted,
press the Navigator Knob.
4. This setting is saved when Yes is selected via the confirmation prompt.
NOTE:
Patient trend data is cleared if the Time and/or Date are
changed on the monitor.
If the Spectrum is connected to a Panorama Central Station, the Time and Date settings of the
Central Station will be acquired by the Spectrum in one of three ways as follows:
• the Time and/or Date are changed on the Spectrum
• “Clear Trends” is chosen from the List Trend or Graph Trend menus
• the patient is discharged
Transferring Monitor Default Settings
When installing several Spectrum monitors with identical display and alarm settings it is not
necessary to set each unit separately. A Transfer Card may be used to copy the settings from
monitor to monitor.
1. Insert the Transfer Card into the PCM2 slot on the right side of the source monitor.
2. Enter the Installation Menu, (Press and hold the DISCHARGE key during power-up).
Select “Copy Monitor defaults to card” from the menu. A status message will
report completion of the transfer.
3. Remove the card and insert it into the PCM2 slot of the receiving monitor.
4. Enter Installation Mode on the receiving monitor (Press and hold the DISCHARGE key
during power-up), and select “Copy monitor defaults from card”. A status
message will report completion of the transfer.
5. Select “Save Current” and power-cycle the receiving monitor to enter normal
monitoring mode.
2-2
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Spectrum® Operating Instructions
Operations
Installation Mode
2.2
Installation Mode
2.2.1
Installation Menu
FIGURE 2-1 Installation Menu
The Installation Mode is accessed by pressing and holding the DISCHARGE key during
power on. See the table that follows for descriptions of the Installation Menu choices.
To enter Installation Mode proceed as follows:
1. Power up the Spectrum while holding down the DISCHARGE key.
2. Set each item as necessary. To save all of the chosen settings, choose “Save current”
before leaving this menu. To return to normal operating mode, power the unit Off and
On again.
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2-3
Installation Mode
Operations
The following table describes the Installation Menu structure:
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
Save current
Select to save current
settings as defaults.
Select Language
Set up at factory
Select to change language.
Select Country
Set up at factory
Select to change country.
Date Format
M/D/Y, D/M/Y,
Y/M/D
Per country
Select to change date
format
Time Format
12, 24 hour
Per country
Select to change time
format
NIBP Timeout
15, 30, 45, 60 mins
15 min
Select to change NIBP
display time out
CO & PAWP Timeout
15, 30, 45 mins, 1, 2,
4 hr
15 min
Select to change CO and
PAWP timeout.
Enable EPM
No, Yes
No
Select to enable or disable
the External Parameter
Module.
Temperature units
°F, °C
°F - USA
°C - All others
Select to change
temperature units
Weight Units
lbs, kg
lbs - USA
kg - All others
Select to change weight
units
Height Units
Ft/inches, cm
Ft/inches - USA
cm - All others
Select to change height
units
CO2 Units
mmHg, %, kPa
mmHg
Select to change CO2 units
Copy monitor defaults
to card.
Select to copy the monitor
defaults and settings to a
data transfer card.
Copy monitor defaults
from card.
Select to copy the monitor
defaults and settings from a
data transfer card inserted
into PCM2.
SetUp Serial Port 1
None, Visa with
admit,1 DIAP,
Accutorr,2 Gas
Module, PatientNet,1,2
Vigilance3
None
Select to set up a serial
output protocol port. An
item enabled in SetUp
Serial Port 1 will be
removed from the
selections in SetUp Serial
Port 2.
SetUp Serial Port 2
None, Visa with
admit,1 DIAP,
Accutorr,2 Gas
Module, PatientNet,1,2
Vigilance3
None
Select to set up a serial
output protocol port. An
item enabled in SetUp
Serial Port 2 will be
removed from the
selections in SetUp Serial
Port 1.
1
2
3
4
2-4
ACTIONS/COMMENTS
“Visa with admit” and “PatientNet” will not be available as menu choices if “WMTS Enabled” is set to
“Yes” or if “Enable Network” is set to “Wired” in the System Information menu.
“Accutorr” will not be available as a menu choice if “WMTS Enabled” is set to “Yes”
“Vigilance” will only be available as a menu choice if it has been installed.
Country, language and system information are not affected by restoring defaults.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Installation Mode
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
ACTIONS/COMMENTS
WMTS Enabled
No, Yes
No
Set to “YES” to enable the
use of the Panorama
Instrument Radio - 608.
Re-boot in demo mode
No, Yes
No
Set to “YES” to start the
monitor in demonstration
mode on next power-up.
Normal monitoring will
resume after cycling power
in demonstration mode.
Restore factory
defaults4
Select to restore factory
defaults
System Information
Select to setup owner’s
screen.
Options
Select to add/view
options.
1
2
3
4
“Visa with admit” and “PatientNet” will not be available as menu choices if “WMTS Enabled” is set to
“Yes” or if “Enable Network” is set to “Wired” in the System Information menu.
“Accutorr” will not be available as a menu choice if “WMTS Enabled” is set to “Yes”
“Vigilance” will only be available as a menu choice if it has been installed.
Country, language and system information are not affected by restoring defaults.
Spectrum® Operating Instructions
0070-10-0648-02
2-5
Installation Mode
2.2.2
Operations
System Information Menu
FIGURE 2-2 System Information Menu
This screen is accessed by rotating to the System Information selection on the Installation
Menu and pressing the Navigator™ Control Knob. Each item on this screen is accessed in the
same manner as the other menus on the monitor. Some items provide menu choices while
others require information to be entered via a keypad-like entry screen. To enter information,
rotate to the desired letter or number and then press the Navigator™ Control Knob to select.
When finished, rotate to the Previous Menu tag and press the Navigator™ Control Knob. See
the table that follows for descriptions of the System Information menu choices.
2-6
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Installation Mode
MENU TITLE ON
SCREEN
MENU
CHOICES
DEFAULT
TEXT STRINGS
Previous Menu
Select to return to Previous Menu
Property Of
Select to set up Property name
Location
Select to set up Location
Department
Select to set up Department
Contact
Select to set up Contact
Phone
Select to set up Phone
Accutorr Baud Rate
1200, 9600
9600
Select to change the Accutorr
protocol baud rate
DIAP Baud Rate
9600, 19200
9600
Select to change the DIAP
protocol baud rate
Enable Network1
No, Wired
No
Select to enable Panorama
communications
IP Address:2
Subnet Mask ID:
Select to set up IP Address
2
Select to set up Subnet Mask ID
Wireless IP Address2
Select to set up Wireless IP Address
Wireless Subnet
Mask ID2
Select to set up Wireless Subnet
Mask ID
Laser Printer IP Address
Select to set up laser printer IP Address
Network Name:2
Select to set up Network name
Device ID3
1
2
3
If a serial port is set to “Visa with admit” or “PatientNet”, or if “WMTS Enabled” is set to “Yes” in the
Installation Menu, “Enable Network” will not be available as a menu choice.
Refer to the Panorama Service Manual for information on network settings.
Device ID is an information field that displays a unique, factory defined, device ID number.
It is not user selectable.
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2-7
Main Menus
2.3
Operations
Main Menus
The Main Menus of the Spectrum are always displayed at the top of the screen and are
accessed using the Navigator™ Knob.
The Main Menu headings are Patient, Monitor Setup, Print Setup, Parameters and
Functions.
2.3.1
Patient Menu
FIGURE 2-3 Patient Menu
The Patient Menu stores patient demographic data, identification data and bed number.
The Patient Menu contains the following patient information: Patient’s Size (Adult,
Pediatric or Neonate), Gender, Date of Birth, First Name, Last Name, Identification Number,
Bed Number, measurements of Height and Weight and IV Drug Calculations.
2-8
NOTE:
Changes that are made in the Patient Menu do not become
effective until the menu is closed.
NOTE:
Verify monitoring settings when the patient size is changed.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Main Menus
Entering a Patient’s First / Last Name, ID Number and Bed Number
To enter the patient’s First Name, Last Name, ID Number and Bed Number
complete the following steps:
1. Open the Patient Menu and scroll down through the menu using the Navigator
Knob.
2. Select the patient data you wish to enter or change.
3. Press the Navigator Knob and a keypad will appear on the screen.
4. To enter Patient information highlight the appropriate characters.
5. When finished entering the data select Done and press the Navigator™ Knob to
close the keypad.
6. The patient information will appear in the upper right hand corner of the display. This
data will also appear on printouts.
NOTE:
Although the “Bed #” field can accept a maximum of 15
characters, if a Spectrum 608 radio is communicating with a
Panorama Central Station, only the first 5 characters will be
displayed in the “Bed” field at the Central Station. Also,
since Remote View requires selecting a “Bed #”, a unique
number for each bed should be used. The following
standard format for this demographic is recommended:
• Start the string with a room # that has a fixed number of
digits. For example, if the maximum number of digits that is
used in numbering the rooms is 4, then for room 102, a
leading zero would be added to get the 4th digit - 0102.
• Follow the room # with a letter to identify the particular bed
within the room. For example, a room with 2 beds would
have bed A and bed B.
• An example of a complete “Bed #”: Bed B in room 513 (in
a facility where the maximum number of digits that is used in
numbering the rooms is 4) would be identified as 0513B.
NOTE:
If the monitor is communicating with the EMR (Electronic
Medical Records) system through a Panorama Gateway,
any changes to patient demographics made at the monitor
will not be sent to the EMR system. For further explanation,
refer to section 2.11, “Connection to Panorama™ Gateway”.
Entering a Patient’s Date of Birth
To enter the patient’s Date of Birth complete the following steps:
1. Open the Patient Menu and scroll down through the menu using the Navigator
Knob.
2. Select Date of Birth from the menu. Press the Navigator Knob and a pop-up
window will emerge with day, month and year choices for Date of Birth.
3. To enter the patient’s Date of Birth, turn the Navigator Knob and scroll until you
reach the desired dates.
4. When finished with the Date of Birth, press the Navigator Knob to return to the
Patient Menu.
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2-9
Main Menus
2.3.2
Operations
Monitor Setup Menu
FIGURE 2-4 Monitor Setup Menu
FIGURE 2-5 Advanced Setup Menu
Monitor Setup Menu
MENU ITEM
SELECTIONS
Normal Screen
Select to return to normal screen.
Save Current
A confirmation prompt appears. Select Yes to save
the current settings as the “monitor” defaults.
Display Setup
Open an additional menu that enables changing the
positions of the parameters and waveforms.
View ECG Setup
Open an additional menu that enables changing the
ECG leads that are displayed when the “VIEW” key
is pressed.
Rescale Waves
2 - 10
FACTORY DEFAULT/COMMENTS
Select to auto-scale all waveforms.
Alarm Volume
Variable from
Minimum to
Maximum
Mid-Scale / Displays a slide bar to adjust the setting
of the alarm volume. Use the Navigator™ Control
Knob to adjust the volume.
Beep Volume
Variable from Off to
Maximum
Mid-Scale / Displays a slide bar to adjust the setting
of the systole beep volume. Use the Navigator™
Control Knob to adjust the volume.
ECG Speed
6.25, 12.5, 25,
50 mm/sec
25 mm/sec / Select to change trace speed of ECG &
Pleth waveforms.
IBP Speed
6.25, 12.5, 25,
50 mm/sec
25 mm/sec / Select to change trace speed of
pressure waveforms.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Main Menus
Monitor Setup Menu (Continued)
MENU ITEM
SELECTIONS
FACTORY DEFAULT/COMMENTS
Resp/Gas Speed
3.125, 6.25, 12.5,
25 mm/sec
12.5 mm/sec / Select to change trace speed.
Advanced Setup
Select to set these menu items:
Set Date
Set Time
Trend Interval
NIBP Trend
Alarm Trend
Nurse Call
Arrhythmia Menu
NIBP Start Mode
Apnea Latch
Advanced Setup Menu
MENU ITEM
SELECTIONS
FACTORY DEFAULT/COMMENTS
Previous Menu
Select to return to previous menu.
Set Date
Select to change date. Changing the date will clear
the trend information. A confirmation message will
display.
Set Time
Select to change time. Changing the date will clear
the trend information. A confirmation message will
display.
Trend Interval
Off, 1, 2.5, 5,10,
15, 20, 30 min, 1
hr, 2 hr
Off / Select to change time of trend data collection.
NIBP Trend
On, Off
On / Select to save numeric data to trend on NIBP
measurements.
Alarm Trend
On, Off
Off / Select to save numeric data to trend on Alarms.
Nurse Call
Off, 1 second,
Continuous
Off / Select to choose the Nurse Call activation time.
Arrhythmia Menu
This selection will open the Arrhythmia Menu.
NIBP Start Mode
Interval Mode, Timer
Mode
Interval Mode / Select the Interval mode to
synchronize NIBP start with the integral clock. Select
Timer Mode to synchronize NIBP start with the interval
selected in relation to the real time clock.
Apnea Latch
On, Off
On / Select to turn apnea alarm latching on or off.
Arrhythmia Menu (Optional)
MENU ITEM
SELECTIONS
Previous Menu
FACTORY DEFAULT/COMMENTS
Select to return to previous menu.
Arrhythmia
All On, All Off, Non-lethals
Off
Factory default is All On. Use
Navigator Control knob to turn
arrhythmia analysis on or off.
Irregular HR**
On, Off
Factory default is On. Use Navigator
Control knob to turn Irregular HR on or
off.
**
Only available with 3-lead or 5-lead.
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2 - 11
Main Menus
Operations
Arrhythmia Menu (Optional) (Continued)
MENU ITEM
SELECTIONS
FACTORY DEFAULT/COMMENTS
V-Tach
3 to 15 beats
Factory default is 3 beats. Use
Navigator Control knob to select how
many ventricular beats in a row will
constitute V-Tach.
V-Tach Rate
100 to 180 bpm
Factory default is 120 bpm. Use
Navigator Control knob to select the
heart rate threshold which must be
reached to constitute V-Tach.
Asystole Delay
3 to 10 seconds (3/5 lead)
3 to 8 seconds (12 lead)
Factory default is 4 seconds for 3/5
Lead and 3 seconds for 12 Lead. Use
Navigator Control knob to select the
number of seconds with an absence of
an R wave that will constitute asystole.
Relearn
ECG Noise Delay**
**
2 - 12
Use Navigator Control knob to select to
relearn Arrhythmia and ST.
3 to 30 seconds
Factory default is 5 seconds. Use
Navigator Control knob to select the
number of seconds to delay the ECG
Noise Alarm.
Only available with 3-lead or 5-lead.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
2.3.3
Main Menus
Print Setup Menu
FIGURE 2-6 Print Setup Menu
Printing of Waveform Data
The Print Setup Menu allows the user to set up waveforms for printing and gives the user
the ability to change the print destination.
Waveforms may be printed at the time of an alarm by selecting Yes in response to Print on
Alarm. Waveforms may also be printed at regular intervals by selecting Print Every.
Available selections are 1, 5, 10, 15, 20, 30, 60 and 120 min.
To choose which waveform will print to the internal printer select Waveform 1 or 2 and then
select any of the waveforms: ECG 1 - 6, IBP 1 - 4, Pleth, Resp, CO2, O2, and Agent.
NOTE:
If a 3-lead cable is installed, the ECG 2 through ECG 6
references will not be displayed.
The following printer options may be available: Local, Remote and Laser. A default
printer or combination of printers can be set.
Local printing will initiate a printout delivered via the internal printer.
Remote printing will send a printout to the printer associated with the Central Station.
Laser printing sends 12-lead data to the laser printer.
Spectrum® Operating Instructions
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Main Menus
2.3.4
Operations
Parameters Menu
FIGURE 2-7 Parameters Menu
The Parameters Menu selections vary according to the optional features installed on the
the monitor. The possible selections are: ECG, ST, NIBP, IBP1, IBP2, IBP3, IBP4, SpO2, CO2,
Resp, Gases, Temperature, and CO.
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Spectrum® Operating Instructions
Operations
2.3.5
Main Menus
Functions Menu
FIGURE 2-8 Functions Menu
The Functions Menu provides the following choices: Normal Screen, Remote View,
Drug Calculator, Hemo Calcs Menu, Disable 12 Lead ECG, Copy patient data
to card and Copy patient data from card.
The Normal Screen selection returns the view to the normal screen.
The Remote View selection opens the Remote View Menu shown in FIGURE 2-10. This
menu enables the user to view the numeric and waveform data of another patient who is
being monitored at a remote location. A more detailed description of this function is
provided in the next subsection.
The Drug Calculator selection opens the (IV) Drug Calculation Menu. This menu
calculates both the infusion rate and the concentration rate of IV medications.
The Hemo Calcs Menu selection opens the Hemodynamic Calculations Menu. This
menu calculates the patient’s hemodynamic status.
The Disable 12 Lead ECG selection toggles between Enable and Disable with regard to
the View 12™ ECG Analysis Module. This selection activates or deactivates access to the 12lead software. This menu selection is only available when the View 12™ ECG Analysis
Module is installed.
There are two options for data transfer. Copy patient data to card and Copy patient
data from card options allow for the transfer of patient specific data from monitor to
monitor.
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Main Menus
2.3.5.1
Operations
Remote View
The Remote View feature allows the simultaneous display of data from two patients on a
single monitor. The monitor at the user’s current location is defined as the host monitor. While
maintaining visibility of the primary patient at the host monitor, the Remote View Menu
enables the user to view the numeric data and two selectable waveforms of another patient
who is being monitored at a remote location. The monitor at the remote location is defined as
the remote monitor. Visual and audio alarms occurring at the remote monitor are also
received through the Remote View Menu at the host monitor.
FIGURE 2-9 Remote View Menu on Main Display
Hardwired Spectrum monitors can function as host monitors with the ability to view other
hardwired Spectrum monitors and 2.4 GHz wireless Spectrum monitors.
NOTE:
2.4 GHz wireless Spectrum monitors cannot function as host
monitors.
All Remote View controls are contained within the Remote View Menu. Opening other
menus from the monitor’s keypad or by pressing the NORMAL SCREEN key will close the
Remote View Menu.
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Spectrum® Operating Instructions
Operations
Main Menus
Remote View Menu Display
The Remote View Menu displays data as follows:
• The waveforms that are displayed are user-selectable through the Remote View
Setup Menu, as described in the table on page 2-19. Corresponding numeric tiles
are displayed to the right of the waveforms. The numeric data for a maximum of fifteen
(15) parameters that are not related to the waveforms is displayed in the “Numeric
Data Area” located directly below the waveforms. The following is a hierarchical
listing of the parameters as they will display if they are not assigned to numeric tiles.
• HR and PVC/min
• SpO2 and PR
• IBP1, IBP2, IBP3, IBP4
• CPP
• PAWP
• NIBP
• Resp
• CO2
• SvO2
• ST1
• ST2
• ST3
• O2
• N2O
• Agent
• T1, T2, TBlood, ΔT
• CO
• CI
NOTE:
Respiration alarm text messages are also displayed in the
“Numeric Data Area” as follows:
• If Apnea is detected, the message “APNEA” is displayed.
• If CVA is detected, the message “CVA” is displayed.
• If high impedance is detected from the ECG electrodes, the
message “CHK LEAD” is displayed.
• The colors of the waveforms and all numeric data correspond to the settings of the host
monitor (not the remote monitor).
• When numeric data for a particular parameter is unavailable, dashes (– –) are
displayed.
• If a high or low alarm limit has not been set, an Alarm Off icon is displayed.
• Remote View alarms follow the alarm settings at the remote monitor, displaying in a
priority-appropriate, reverse video color.
• If the remote monitor is placed into Standby mode, the message “Viewed Monitor is
Currently in Standby” is displayed in the message area.
Spectrum® Operating Instructions
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Main Menus
Operations
Wave 1
(Selectable)
Wave 2
(Selectable)
Message Area
Numeric Data Area
FIGURE 2-10 Remote View Menu
The Remote View Menu also provides the following menu choices: Normal Screen,
Setup, Remote Mute, Remote Mute All, and Remote Print.
1. Normal Screen — this selection removes the Remote View Menu from the display.
2. Setup — this selection opens the Remote View Setup Menu shown in FIGURE 211. This menu enables the user to configure the display and functionality of the Remote
View Menu.
FIGURE 2-11 Remote View Setup Menu
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NOTE:
With the exception of the “New Bed” menu choice, the
current settings in the Remote View Setup Menu are saved
when “Save Current” is selected from the Host Monitor.
There is one set of saved settings for each patient size.
NOTE:
The saved settings in the Remote View Setup Menu are
transferable with the monitor defaults via a PCMCIA card.
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Spectrum® Operating Instructions
Operations
Main Menus
The following table provides a listing of the Remote View Setup Menu items:
Remote View Setup Menu
MENU ITEM
SELECTIONS
FACTORY DEFAULT/COMMENTS
New Bed
All available beds on a
single network.
This menu item provides a list of monitor devices
that are available in the Mindray approved
hardwired network and have Bed numbers
assigned. The chosen Bed # displays at the top of
the Remote View Menu.
Wave 1
All waveforms available
on the remote monitor.
Only waveforms available on the remote monitor
will be listed as selections for this menu item. The
menu selections for Wave 1 will not include the
waveform that is currently selected as Wave 2.
Wave 2
All waveforms available
on the remote monitor.
Only waveforms available on the remote monitor
will be listed as selections for this menu item. The
menu selections for Wave 2 will not include the
waveform that is currently selected as Wave 1.
Remote Mute For
1 min, 2 min, 5 min*,
10 min*
Select to choose duration of Remote Mute.
Remote Mute
All For
Permanent*, 1 min,
2 min, 5 min*, 10 min*
Select to choose duration of Remote Mute All.
Previous Menu
*
Select to return to previous menu.
These selections will not be available if the country chosen in the Installation Menu is France.
3. Remote Mute — this selection silences the audio portion of a remote alarm for the
duration that is selected from the Remote Mute For list in the Remote View Setup
Menu. The factory default is 2 minutes. While the audio alarm is silenced:
• the visual alarm indicators remain displayed
• the message ALARMS MUTED FOR XX:XX mins is displayed in the message area
of the Remote View Menu. The XX:XX in the message is a digital timer for the
mute time remaining
• if a new remote alarm occurs during this time, the current alarm will remain silenced
while its digital timer continues to count down, and the new alarm tone will sound
• an Alarm Mute icon (resembling a crossed speaker) is displayed in the numeric tile of
each muted parameter, and in the “Numeric Data Area” if one or more parameters in
that area are muted
If Remote Mute is selected again, the digital timer is reset.
NOTE:
Spectrum® Operating Instructions
The Remote Mute selection silences only the alarms
indicated in the Remote View Menu. It does not silence the
primary patient's alarms or alarm sounds at the remote
location.
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Main Menus
Operations
4. Remote Mute All — this selection silences the audio alarm tones of all remote alarms
for the duration that is selected from the Remote Mute All For list in the Remote
View Setup Menu. The factory default is 2 minutes. While the audio alarms are
silenced:
• the visual alarm indicators remain displayed
• the message ALL ALARMS MUTED FOR XX:XX mins is displayed in the message
area of the Remote View Menu. The XX:XX in the message is a digital timer for
the mute time remaining
NOTE:
If “Permanent” is selected from the Remote Mute All For list,
“ALL ALARMS MUTED PERMANENTLY” is displayed in the
message area of the Remote View Menu. If a new bed is
chosen while all remote alarms are permanently muted, the
permanent mute condition will continue for the new bed.
• an Alarm Mute icon (resembling a crossed speaker) is displayed in the numeric tiles
and in the “Numeric Data Area”
If Remote Mute All is selected again, the audio alarm tones are re-enabled.
NOTE:
The Remote Mute All selection silences only the alarms
indicated in the Remote View Menu. It does not silence the
primary patient's alarms or alarm sounds at the remote
location.
5. Remote Print — this selection sends a print request to the remote monitor. The printout
will be as configured in the Print Setup menu of the remote monitor.
NOTE:
When a Remote Print is requested, there is no indication that
the printout was completed as requested. The user should
verify the successful print at the printer.
Remote View Message Area
The Message Area shown in FIGURE 2-10 displays status and alarm messages as follows:
• If more than one message is being received, they are alternately displayed.
• All arrhythmia alarms, priority one and priority two alarms generate the appropriate
audio alerts at the host monitor and the associated alarm text messages are displayed
in the Remote View Message Area. Refer to section 2.4.2.5, “Arrhythmia Alarms” for
the specific arrhythmia alarm text messages that can be displayed.
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Spectrum® Operating Instructions
Operations
Main Menus
NOTE:
The Lethal Arrhythmia alarms (V-Tach, V-Fib, and Asystole)
are latched alarms. Even after the alarming condition is
resolved at the remote monitor, a latched alarm will
continue at the host monitor until it is acknowledged by
selecting “Remote Mute” or “Remote Mute All” from the
“Remote View Menu”. If the alarm is acknowledged while
the lethal condition still exists, the audio portion of the
alarm will be muted for the duration that is selected from
the “Remote Mute For” list or the “Remote Mute All For” list
of the “Remote View Setup Menu”, but the alarm message
will remain in the Remote View Message Area. If a new
lethal condition occurs while the initial lethal alarm is
muted, the new lethal alarm will not break through and will
be muted for the remainder of the mute duration. If the
lethal condition is resolved while the alarm is muted, the
alarm will be terminated.
• Only alarm text messages for parameters that are not currently displayed in a Wave 1
or Wave 2 numeric tile or in the “Numeric Data Area” are displayed in the Remote
View Message Area.
• If Apnea is detected, the message “Respiratory Apnea alarm.” is displayed.
• If CVA is detected, the message “CVA” is displayed.
• Status Messages that are supported by the Remote View are:
• Leads Off
• SpO2: Sensor Fault
• SpO2: Check Sensor
• SpO2: Failure
• SpO2: Interference
• SpO2: Low Perfusion
• SpO2: Motion
• SpO2: No Pulse
• SpO2: No Sensor
• SpO2: Pulse Search
• SpO2: Sensor Off
NOTE:
Spectrum® Operating Instructions
Status Messages are not displayed if high priority alarms
are alternately displaying.
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Parameter Menus and Monitoring
2.4
Operations
Parameter Menus and Monitoring
Each parameter’s menu can be accessed from the Parameters menu or by selecting its
menu target on the normal operating screen.
2.4.1
ECG Monitoring
ECG is a continuous waveform of a patient's cardiac electrical activity. The ECG waveform
will display in the first waveform area of the Spectrum.
The quality of an ECG signal is directly affected by electrode site skin preparation, electrode
patch quality and ECG lead placement. If artifact is present on the ECG waveform, then the
arrhythmia processing, alarm processing, and quality of the monitoring function may be
affected. The presence of artifact can prevent the monitor from establishing an accurate ECG
reference waveform, increasing the difficulty experienced in assessing the ECG rhythm.
Optimizing the ECG signal is imperative for accurate monitoring. Use high quality
electrodes, designed to acquire the ECG with excellent base line stability, recovery from
defibrillation and minimum artifact from patient movement.
With the Spectrum, ECG can be obtained by using a 3 Lead, 5 Lead or 12 Lead ECG
cable in conjunction with a lead set and skin electrodes. For best performance and safety,
inspect the ECG cables and electrodes daily.
2.4.2
ECG Menu
FIGURE 2-12 ECG Menu
FIGURE 2-13 ECG Setup Menu
The ECG Menu provides the following choices: Normal Screen, ECG 1 — ECG 6,
Arrhythmia Menu, Relearn, ST Menu, ECG Sizes Menu, ECG Setup and Resp
Menu.
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Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
• The Normal Screen selection returns the view to the normal screen.
• The ECG 1 — ECG 6 selections define the ECG labels for printing and trends.
• The Arrhythmia Menu selection opens the Arrhythmia Menu.
• The Relearn selection is only available if the ST or Arrhythmia options are installed and
is used to manually initiate the learning process for ST measurements or Arrhythmia
analysis.
• The ST Menu selection opens the ST Menu.
• The ECG Sizes Menu selection opens the ECG Sizes Menu.
• The ECG Setup selection opens the ECG Setup Menu that is detailed in the following
table.
• The Resp Menu selection opens the Resp Menu.
ECG Setup Menu
MENU ITEM
SELECTIONS
FACTORY DEFAULT/COMMENTS
Monitor, Extended,
ST
Select to change the filter mode for ECG. Extended or
ST must be used for ST analysis. The filter setting
affects both the display output and the printer output.
Previous Menu
Filter
Returns to the previous menu.
Monitor = 0.5 - 40 Hz
Extended, 3 or 5-lead = 0.05 - 100 Hz
Extended, 12-lead = 0.05 - 150 Hz
ST = 0.05 - 40 Hz
HR Source
Auto, ECG, <IBP1
Label>, <IBP2
Label>, <IBP3
Label>, <IBP4
Label>, SpO2
Dependent on current settings, the IBP Label
selections may remain as numbered or may be
substituted with one of the following: Art, PA, CVP,
ICP, RA, UA, LV, LA, IABP.
Pacer Reject
On, Off
When set to On, pacers are eliminated from the
display.
Pacer
Enhancement
On, Off
When set to On, all detected pacemaker spikes are
displayed.
Notch Filter
Off, 50 Hz, 60 Hz
This menu item is used to filter out AC line noise from
the ECG waveform. The Off selection is not saved
with the Save Current function and will be reset when
the monitor is power cycled.
ESU Filter
Auto, Disable
This menu item is used to filter out high frequency
electrosurgical noise from the ECG waveform. The
Disable selection is not saved with the Save Current
function and will be reset when the monitor is power
cycled. This function is not supported in 12 lead
mode.
ECG Cable
Auto Detect, 3 lead,
5 lead
This menu item is used to manually set the mode of
operation for the chosen ECG cable type.
NOTE: When using Mindray cables, the Auto Detect
selection will automatically detect the cable type and
switch the mode of operation accordingly.
Grid
On, Off
Select to turn the ECG grid On or Off.
Color
List of 16 colors
Select to change the display color for all ECG waves
and for the HR and ST parameters.
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Parameter Menus and Monitoring
Operations
WARNING: Ensure that the conductive parts of ECG electrodes do not
contact other conductive parts, including earth ground.
CAUTION:
To avoid possible damage to the Spectrum, use only ECG
cables and accessories available from Mindray.
CAUTION:
Line Isolation Monitor transients may resemble actual
cardiac waveforms, thus inhibiting heart rate alarms. Check
lead wires for damage and ensure good skin contact prior
to and during use. Always use fresh electrodes and follow
proper skin preparation techniques.
NOTE:
This device is not intended for direct cardiac application.
CAUTION:
To assure successful triggering of a Mindray Intra-Aortic
balloon pump from the Spectrum monitor, set the “ECG
Filter” to “Extended” and set “Pacer Enhancement” to
“On”. Both of these settings are located in the ECG setup
menu of the Spectrum.
CAUTION:
The Analog Output on the Spectrum supports triggering the
Intra-Aortic Balloon Pump (IABP) for 3 Lead and 5 Lead ECG
cable monitoring only. Invasive Blood Pressure triggering is
not supported. ECG analog output is disabled when 12 Lead
ECG analysis is enabled.
ECG Lead Fault Messages
A “Lead Fault” message will be displayed if an ECG lead becomes disconnected from the
patient.
A “Check Lead Connection” message will be displayed if 3-lead or 5-lead ECG has an
intermittent or poor connection.
NOTE:
If a 3 or 5-lead ECG cable and the View 12™ ECG Analysis
Module are both in use, then Lead Fault messages refer to
the 12-lead cable only.
NOTE:
When monitoring 12-lead ECG, a Lead Fault message will
not be displayed if Right Leg Lead (RL or R) becomes
disconnected from the patient.
Symbols in Heart Rate Tile
The following symbols can appear in the HR Parameter tile.
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Arrhythmia
This indicates arrhythmia option is installed and active.
ST Analysis
This indicates ST Analysis option is installed and active.
Pacemaker
This indicates pacemaker rejection is On.
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Spectrum® Operating Instructions
Operations
2.4.2.1
Parameter Menus and Monitoring
Skin Preparation
Proper skin preparation is essential in obtaining an accurate ECG reading. Electrode sites
should be clean and dry and should provide a smooth flat surface. Incidental electrical
activity and inaccurate readings may arise from incorrect skin preparation.
The following procedure is recommended for secure electrode patch application:
1. Shave the chest hair from the electrode sites in a circular area with a diameter of
2 – 4 inches.
2. Use a dry gauze pad to remove excess skin oils, skin cells and residue from the
electrode sites. Never rub the skin until it is raw or bleeding.
NOTE:
2.4.2.2
Prepare the electrode site with alcohol only if the skin is
extremely greasy. If alcohol is used as a drying agent,
always allow the skin to dry before placing the electrode
patch on the skin.
Electrode Patch Location
NOTE:
Store electrode patches at room temperature and open just
prior to use.
NOTE:
Avoid more than one type of electrode on a patient because
of variations in electrical resistance.
NOTE:
Avoid placing electrode patches directly over bone
prominences or over any high activity movement areas such
as shoulders or arms because muscle motion produces
electrical activity. If an electrode patch is placed over a large
muscle such as the pectorals, the monitor may detect this
additional muscle activity and could lead to false
arrhythmia calls.
1. To prevent evaporation of the contact gel medium, peel the backing off of the electrode
patch only when it is ready for use. Visually inspect the contact gel medium for
moistness. If the gel medium is not moist, do not use the electrode patch. Dry electrode
patches are not conductive.
NOTE:
If using the snap type electrode wires, attach the electrode
patch to the lead wire before placing patch on the patient.
2. Attach the electrode patch to the skin at the prepared site. Smooth the electrode patch
down in a circular motion to ensure proper skin contact. If using soft gel electrodes,
never push down directly over the contact gel medium as this may displace the gel and
cause monitoring artifact. If using hard gel electrodes, it is recommended that during
application, the center of the electrode should be slightly pressed onto the skin to ensure
direct contact. Consult the electrode patch manufacturer’s instructions for specific use.
3. Secure the lead wires to the patient according to hospital practice. For additional
information see section 2.4.2.3, “Lead Placement”.
WARNING: Ensure that the ECG lead wires are neatly secured in a
manner that will prevent them from encircling the patient’s
neck, creating a strangulation hazard.
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Parameter Menus and Monitoring
NOTE:
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Operations
It is recommended that electrode patches be changed at least every
24 – 36 hours to maintain proper contact with the skin. Some
patients may require electrodes to be changed more often.
Electrode patches are disposable and should be applied only once.
Try to avoid reusing the exact same electrode site during
reapplication. If an electrode becomes wet with fluid, change the
electrode patch.
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Spectrum® Operating Instructions
Operations
2.4.2.3
Parameter Menus and Monitoring
Lead Placement
The computerized arrhythmia algorithm works best when the patient’s R wave is significantly
larger than the P wave or the T wave. If the R wave is not significantly larger than other lower
voltage waves on the ECG tracing, the computer may have some difficulty in identifying the
appropriate waves. On some patients, electrode patch placement and/or the viewed ECG
lead may need to be adjusted in order to obtain a significant R wave.
This section outlines lead placement according to the guidelines of the American Heart
Association (AHA) and the International Electro-Technical Commission (IEC).
Standard 3-wire Lead Sets
A 3-wire lead set can monitor one of three ECG vectors (I, II, or III). The recommended 3-wire
lead placement is as follows.
White
Black
RA
Red
Yellow
R
LA
L
Green
Red
F
LL
FIGURE 2-14 3-wire Lead Placement
(AHA)
FIGURE 2-15 3-wire Lead Placement
(IEC)
• Place the RA (white) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the L (yellow) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
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Parameter Menus and Monitoring
Operations
Standard 5-wire Lead Sets
A 5-wire lead set can monitor seven ECG vectors (I, II, III, aVR, aVL, aVF, and V)
simultaneously. The recommended 5-wire lead placement is as follows.
Black
White
Yellow
Red
Green
RA
LA
Brown
V Lead
(any V
position)
Black
R
L
V
White
C Lead
(any C
position)
C
Green
RL
LL
N
F
Red
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FIGURE 2-16 5-wire Lead Placement
(AHA)
FIGURE 2-17 5-wire Lead Placement
(IEC)
• Place the RA (white) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the L (yellow) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the RL (green) electrode on the
patient’s lower right abdomen within the
rib cage frame.
• Place the N (black) electrode on the
patient’s lower right abdomen within the
rib cage frame.
• Place the V (brown) electrode in one of
the V-lead positions (V1 – V6) depicted
in the following section.
• Place the C (white) electrode in one of
the C-lead (C1 – C6) positions depicted
in the following section.
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Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
View 12™ Card
A View 12™ card utilizes a 10-wire ECG lead set that can monitor 12 ECG vectors (I, II, III,
aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6) simultaneously. The recommended lead
placement for a View 12™ card is as follows.
LA
RA
R
L
V6
C6
V5
V1
C1
V4
C5
C4
LL
F
N
RL
V2
V3
C2 C3
FIGURE 2-18 View 12™ Card
Lead Placement (AHA)
FIGURE 2-19 View 12™ Card
Lead Placement (IEC)
• Place RA (white) electrode under the right
clavicle, mid-clavicular line within the rib
cage frame.
• Place R (red) electrode under the right
clavicle, mid-clavicular line within the rib
cage frame.
• Place LA (black) electrode under the left
clavicle, mid-clavicular line within the rib
cage frame.
• Place L (yellow) electrode under the left
clavicle, mid-clavicular line within the rib
cage frame.
• Place LL (red) electrode on the lower left
abdomen within the rib cage frame.
• Place F (green) electrode on the lower left
abdomen within the rib cage frame.
• Place RL (green) electrode on lower right
abdomen within the rib cage frame.
• Place N (black) electrode on lower right
abdomen within the rib cage frame.
• Place V1 (brown) chest lead in the fourth
intercostal space, right sternal border.
• Place C1 (white) chest lead in the fourth
intercostal space, right sternal border.
• Place V2 (brown) chest lead in the fourth
intercostal space, left sternal border.
• Place C2 (white) chest lead in the fourth
intercostal space, left sternal border.
• Place V3 (brown) chest lead midway
between V2 and V4 on a straight line.
• Place C3 (white) chest lead midway
between C2 and C4 on a straight line.
• Place V4 (brown) chest lead in the fifth
intercostal space, mid-clavicular line.
• Place C4 (white) chest lead in the fifth
intercostal space, mid-clavicular line.
• Place V5 (brown) chest lead in the fifth
intercostal space, anterior axillary line.
• Place C5 (white) chest lead in the fifth
intercostal space, anterior axillary line.
• Place V6 (brown) chest lead in the fifth
intercostal space, mid-axillary line.
• Place C6 (white) chest lead in the fifth
intercostal space, mid-axillary line.
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Parameter Menus and Monitoring
Operations
Lead II Monitoring
The recommended lead placement for Lead II monitoring is as follows.
White
Black
RA
LA
Red
Yellow
R
L
Red
LL
2 - 30
Green
F
FIGURE 2-20 Lead II Monitoring (AHA)
FIGURE 2-21 Lead II Monitoring (IEC)
• Place the RA (white) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the L (yellow) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
Select ECG Lead II on the monitor. Lead II is
Select ECG Lead II on the monitor. Lead II is
the direct electrical line between the RA
the direct electrical line between the R (red)
(white) electrode and the LL (red) electrode.
electrode and the F (green) electrode.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
Modified Chest Lead (MCL) Monitoring
The recommended lead placement for MCL monitoring is as follows.
Red
White
Black
Yellow
RA
R
Red
LA
L
LL
Green
F
FIGURE 2-22 MCL Monitoring with a
3-wire Lead Set (AHA)
FIGURE 2-23 MCL Monitoring with a
3-wire Lead Set (IEC)
• Place the RA (white) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode on the
right sternal border, at the fourth
intercostal space within the rib cage
frame.
• Place the L (yellow) electrode on the
right sternal border, at the fourth
intercostal space within the rib cage
frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
Select ECG Lead I for MCL1 monitoring.
Select ECG Lead I for MCL1 monitoring.
Lead I is the direct electrical line between
Lead I is the direct electrical line between
the RA (white) electrode and the LA (black)
the R (red) electrode and the L (yellow)
electrode.
electrode.
Select ECG Lead II for MCL6 monitoring.
Select ECG Lead II for MCL6 monitoring.
Lead II is the direct electrical line between
Lead II is the direct electrical line between
the RA (white) electrode and the LL (red)
the L (red) electrode and the F (green)
electrode.
electrode.
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Parameter Menus and Monitoring
Operations
Neonatal Electrode Placement
Using a 3-wire lead set, ECG lead placement on a neonate is usually directed towards
obtaining the best possible respiration data through the ECG thoracic impedance technique.
Thoracic impedance is usually measured between the Right Arm and Left Arm electrode
patches. These patches should be placed on the chest directly across from each other to
optimize the measuring of the neonate’s chest movement. The recommended lead placement
for neonate monitoring is as follows.
Black
Yellow
Red
RA
LA
R
L
Green
Red
LL
F
White
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FIGURE 2-24 Neonatal 3-wire Lead
Placement (AHA)
FIGURE 2-25 Neonatal 3-wire Lead
Placement (IEC)
• Place the RA (white) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the L (yellow) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
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Parameter Menus and Monitoring
Monitoring a Pacemaker Patient
The recommended lead placement for monitoring a pacemaker patient is as follows.
Pacer
White
Pacer
Red
Yellow
Black
Red
FIGURE 2-26 3-wire Lead Placement for a
Pacemaker Patient (AHA)
FIGURE 2-27 3-wire Lead Placement for a
Pacemaker Patient (IEC)
Pacer
White
V
Brown
Green
Green
Red
Pacer
Yellow
Black
V
White
Red
FIGURE 2-28 5-wire Lead Placement for a
Pacemaker Patient (AHA)
Black
Green
FIGURE 2-29 5-wire Lead Placement for a
Pacemaker Patient (IEC)
A pacemaker patient usually requires a different electrode patch placement configuration
than a non-pacemaker patient.
Do not place an ECG electrode directly over the pacemaker generator. Place the electrode
patches 3 – 5 inches away from the pacemaker generator area. For example, if the
pacemaker generator is located in the right subclavian area, relocate the Right Arm
electrode closer in towards the center of the chest.
WARNING: Pacemaker patients’ rate meters may continue to count the
pacemaker rate during occurrences of cardiac arrest or
some arrhythmias. Do not rely entirely upon rate meter
alarms. Keep pacemaker patients under close surveillance.
See the Appendix section of this manual for disclosure of the
pacemaker pulse rejection capability of this instrument.
CAUTION:
Spectrum® Operating Instructions
Some pacemakers may contain a respiratory sensor that
may produce artifact on an ECG waveform.
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Parameter Menus and Monitoring
Operations
Using a Transcutaneous Electrical Nerve Stimulator (TENS)
Since a TENS unit transmits electrical impulses, avoid placing ECG electrode patches near
the TENS electrodes. ECG electrode patches may need to be repositioned and the ECG lead
viewed may need to be adjusted until the optimum ECG tracing is obtained.
2.4.2.4
Arrhythmia Algorithm
The Spectrum uses an arrhythmia algorithm to monitor ECG waveform data. The algorithm
creates ECG waveform templates based on a patient’s normal ECG data and uses them to
analyze newly received data. The algorithm verifies that data is free from noise and artifact,
and that it does not deviate from the patient’s normal ECG rhythms.
A normal ECG waveform typically includes consistent spacing between R waves, a sharp
and well defined QRS complex, and an ECG baseline that is free of noise and artifact.
R
ST Point
J Point
P
ISO Point
ST deviation
(Depression or Elevation)
T
Q
40 to 80 msec
S
ST Segment
FIGURE 2-30 Sample Waveform
Noise and Artifact
The presence of noise or artifact in an ECG waveform makes the accurate detection and
classification of heart beats difficult. To best optimize performance, all leads should be free
of noise.
Some of the causes of ECG noise include poor skin preparation, improperly attached
electrodes, dried electrode gel, defective lead wires, and patient movement. The algorithm
uses several techniques to differentiate a patient’s QRS complexes from noise sources.
If noise levels are too high for a particular lead, a message is posted, and the data is
dropped from analysis until the signal quality is re-established.
If noise levels are too high, the following will occur until the signal quality is re-established:
• Beat detection is suspended
• All rhythm calls are suspended
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Parameter Menus and Monitoring
• An ECG Noise message is displayed when ECG noise is detected in one or more
ECG leads. If ECG noise continues beyond the configured noise delay, an alarm is
triggered, and ECG rhythm analysis is stopped.
Heart Rate Meter
Heart Rate is computed using the 16 most recent R-R intervals for heart rates above 48 beats
per minute. If the heart rate calculated using the last 4 beats is less than 48 beats per minute,
then this rate is used. All detected beats are used to compute the heart rate. A separate
ventricular rate is used in the algorithm to determine rhythms like ventricular tachycardia and
ventricular run.
Filtering Pacer Signals
In order to prevent pacer pulses from being mistaken for QRS complexes, they are removed
from the ECG data that is sent to the arrhythmia algorithm for analysis. Pacer pulses are
shown on the Spectrum as exaggerated vertical lines.
ECG Amplitude
The QRS detection threshold algorithm setting is fixed between 0.15 and 0.45 mV to avoid
detecting noise spikes or P-waves as valid beats. Changing the display gain on the monitor
does not affect the signal that is used by the algorithm for beat detection. For optimal
performance, the leads selected for monitoring should have an amplitude of 0.5 to 1 mV or
more.
Learning
The process of learning is used to establish a normal beat template for a patient. The learn
period is dependent on the heart rate and the dominant pattern. Learning should not be
initiated during a primarily ventricular rhythm because an ectopic beat may be established
as normal.
A learn should be initiated when beats are not being properly detected, or when they are
being erroneously classified. However, if a signal is not strong enough, or lead data is
extremely noisy, better signal quality must be established before a learn can be effective.
Beat Detection and Typing
The following table describes the leads that are used to measure beat detection and beat
typing.
DESCRIPTION
3-WIRE LEAD SET
5-WIRE LEAD SET
VIEW 12™ CARD
Leads used for
Beat Detection
Determined by viewed lead
II and V
V1 and V5
Leads used for
Beat Typing
Determined by viewed lead
II, V, and I
V1, V5, and II
Leads used for
V-Fib Detection
Determined by viewed lead
II and V
V1 and V5
The search for the next beat begins after a refractory period to avoid detecting T- waves as
valid QRS complexes. For all patient sizes, the minimum QRS amplitude that can be detected
is between 0.15 and 0.45 mV depending on the width of the QRS complexes.
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Parameter Menus and Monitoring
Operations
Beat typing aligns and compares each new heart beat to reference templates that were
previously stored in the system. A beat typing algorithm classifies the beats.
• If an incoming beat matches a template that has already been classified, it is given the
same label as the template. The template parameters are updated with the features from
this new beat.
The real time ECG analysis library incorporates ventricular ectopic beat detection as a part
of arrhythmia analysis.
• Beats are measured for compensatory pause, QRS width, QRS positive and negative
areas, and R wave positive and negative amplitudes. This process uses multiple leads
when available.
• A scoring algorithm is then applied to those measurements to determine whether or not a
beat is ectopic.
2.4.2.5
Arrhythmia Alarms
Arrhythmia alarms are activated based on the patterns in the patient ECG waveform rhythms.
Beat detection for a 5-lead wire set is determined by using a combination of leads II and V.
When using a 3-lead wire set, beat detection is determined by using the lead being viewed.
The following lethal and non-lethal arrhythmia alarms may be detected by the arrhythmia
algorithm.
NOTE:
2.4.2.5.1
Arrhythmia alarms are not available for the Neonate
patient size.
Lethal Arrhythmia Alarms
A lethal arrhythmia is an arrhythmia that can be life threatening to a patient if left untreated.
Ventricular Tachycardia (V-Tach), Ventricular Fibrillation (V-Fib), and Asystole alarms are
classified as lethal arrhythmia alarms. These alarms automatically default to Alarm Priority 1.
NOTE:
2 - 36
Lethal arrhythmia alarms are latched alarms. Even after the
alarming condition is resolved, a latched alarm will continue
until it is acknowledged by pressing the MUTE or MUTE ALL
key on the front panel keypad. If the alarm is
acknowledged while the lethal condition still exists, the
audio portion of the alarm will be muted for the duration
that is selected from the “Mute For” list in the “Alarm
Setup” menu, but the alarm message will remain in
message area A. If a new lethal condition occurs while the
initial lethal alarm is muted, the new lethal alarm will not
break through and will be muted for the remainder of the
mute duration. If the lethal condition is resolved while the
alarm is muted, the alarm will be terminated.
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Parameter Menus and Monitoring
Asystole Alarm
An Asystole alarm is activated when no QRS complexes are detected for the configured
time period in the absence of Ventricular Fibrillation.
For 3-Lead and 5-Lead ECG – The time period range for an Asystole alarm is user
selectable from 3 to 10 seconds.
For 12-Lead ECG – The time period range for an Asystole alarm is user selectable from 3 to
8 seconds.
The Asystole alarm is a Priority 1 alarm event that produces:
• Alarm Priority 1 visual and audio alarm indicators.
• An Asystole text message above the ECG1 waveform area.
Ventricular-Fibrillation (V-FIB) Alarm
A V-FIB alarm is activated when a fibrillated waveform (P, QRS or T waves can no longer be
identified) is detected. V-FIB is defined as “irregular, disorganized electrical activity of the
heart”. The V-FIB detection algorithm runs in parallel to the beat detection algorithm and
continuously examines the incoming data.
The V-FIB alarm is a Priority 1 alarm event that produces:
• Alarm Priority 1 visual and audio alarm indicators.
• A V-FIB text message above the ECG1 waveform area.
Ventricular Tachycardia (V-TACH) Alarm
A V-TACH alarm is activated as follows:
• The range of the V-TACH rate is between 100 to 180 beats per minute.
AND
• The V-TACH lethal arrhythmia alarm is activated when the configured number of
consecutive PVCs is reached. The range for the V-TACH threshold is 3 – 15 beats per
minute.
A V-TACH alarm is a Priority 1 alarm event that produces:
• Alarm Priority 1 visual and audio alarm indicators.
• A V-TACH text message above the ECG1 waveform area.
2.4.2.5.2
Non-Lethal Arrhythmia Alarms
A Non-Lethal Arrhythmia is an arrhythmia that is most likely not life threatening to a patient.
Bigeminy, Bradycardia, Couplet, Irregular Heart Rate, Pause, PVC/min, Run, Trigeminy, and
Ventricular Rhythm (V-Rhythm) alarms are classified as non-lethal arrhythmia alarms. With the
exception of PVC/min, all other Non-Lethal Arrhythmias are Alarm Priority 2. The Alarm
Priority for PVC/min is user selectable between 1 and 2.
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Parameter Menus and Monitoring
NOTE:
Operations
Non-lethal arrhythmia alarms are not latched alarms and
can be acknowledged at any time. To acknowledge a nonlethal arrhythmia alarm, press the MUTE key on the
keypad.
Bigeminy Alarm
The Bigeminy alarm is activated when three or more cycles of one PVC coupled to one
normal beat are detected.
The Bigeminy alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A BIGEMINY text message above the ECG1 waveform area.
Bradycardia (Brady) Alarm
The Brady alarm is activated when the heart rate falls to a value 10% lower than the user
selected value for low heart rate alarm.
NOTE:
The Bradycardia alarm is not available when using a View
12™ card.
The Brady alarm is an alarm event that produces:
• Alarm Priority 1 visual and audio alarm indicators.
• A Brady text message above the ECG1 waveform area.
Couplet Alarm
The Couplet alarm is activated when two consecutive PVCs are detected between normal
beats.
The Couplet alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A COUPLET text message above the ECG1 waveform area.
Irregular Heart Rate Alarm
The Irregular Heart Rate alarm is activated when the measured variations in the R-R
interval over a period of time exceeds a preset limit established by the arrhythmia algorithm.
NOTE:
The Irregular Heart Rate alarm is not available when using
a View 12™ card.
The Irregular Heart Rate alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• An IRREGULAR HR text message above the ECG1 waveform area.
Pause Alarm
The Pause alarm is activated when no beat is detected during an interval that is greater
than 1.8 R-R and the next beat is not a PVC.
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Operations
Parameter Menus and Monitoring
NOTE:
The Pause alarm is only available when using a View 12™
card.
The Pause alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A PAUSE text message above the ECG1 waveform area.
PVC/minute Alarm
The High PVC alarm is activated when the number of PVCs detected per minute exceeds the
configured threshold. The PVC limit can be set to Off, or 1 to 30 PVCs per minute.
The High PVC alarm has priority settings of 1 or 2, and behaves as follows:
• If the High PVC alarm priority is set to 1, Alarm Priority 1 visual and audio alarm
indicators are produced.
• If the High PVC alarm priority is set to 2, Alarm Priority 2 visual and audio alarm
indicators are produced.
• A High PVC text message is produced above the ECG1 waveform area.
NOTE:
PVC/min will not be displayed during periods of Ventricular
Rhythms, V-TACH, V-FIB and Asystole.
Run Alarm
The Run alarm is activated when the number of consecutive PVCs occur at a rate that equals
or exceeds the user defined V-Tach Rate. The number of consecutive PVCs that constitute a
Run is one beat less than the minimum used to identify V-Tach.
The Run alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A RUN text message above the ECG1 waveform area.
Trigeminy Alarm
The Trigeminy alarm is activated when three or more cycles of one PVC coupled to two
normal beats are detected. This rhythm could also cause an Irregular HR alarm.
The Trigeminy alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A TRIGEMINY text message above the ECG1 waveform area.
Ventricular Rhythm (V-Rhythm) Alarm
The V-Rhythm alarm is activated when more than 2 consecutive PVCs occur at a rate that is
less than the user defined V-Tach Rate.
The V-Rhythm alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A VENTRICULAR RHYTHM text message above the ECG1 waveform area.
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Parameter Menus and Monitoring
2.4.2.6
Operations
Arrhythmia Analysis (Optional)
WARNING: The arrhythmia analysis feature is intended to detect
ventricular rhythms, however, due to physiologic differences
in patient populations, the Spectrum may occasionally
sound a false alarm or may not recognize some arrhythmia
patterns.
The Spectrum is capable of identifying ventricular arrhythmia patterns in Adult and
Pediatric size patients. Arrhythmia analysis may be enabled or disabled via the Arrhythmia
Menu. By default, arrhythmia analysis is enabled.
FIGURE 2-31 Arrhythmia Menu
(3/5 lead)
FIGURE 2-32 Arrhythmia Menu
(12 lead)
Arrhythmia alarm calls are classified as Priority 1 or Priority 2.
Asystole, Ventricular Tachycardia, and Ventricular Fibrillation are classified as Priority 1
and the priority level cannot be changed by the user. In addition, these alarms will
sound continuously until the user presses the MUTE or MUTE ALL key, regardless of
whether the patient’s condition has improved.
The other arrhythmia alarms (listed below) are classified as Priority 2 by default. The
characteristics and priority level of the “PVC/min” alarm can be changed at the user’s
discretion via the Alarm Limits Setup menu.
The following alarm calls can be made when Arrhythmia Analysis is set to “All On” (default
setting):
• Asystole, Ventricular Tachycardia, Ventricular Fibrillation, Ventricular Rhythm, Run,
PVC/Min, Couplet, Bigeminy, and Trigeminy.
For 3-lead or 5-lead ECG, the following additional calls can be made:
• Irregular HR and Bradycardia
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Operations
Parameter Menus and Monitoring
For 12-lead ECG, the following additional call will be made:
• Pause
The following alarm calls will be made when Arrhythmia analysis is set to “Non-lethals Off”:
• Asystole, Ventricular Tachycardia, and Ventricular Fibrillation.
When Arrhythmia analysis is set to “All Off,” no arrhythmia alarm calls will be made.
The Spectrum initiates the Learning process for Arrhythmia measurements after one of the
following:
• Unit Power-Up
• Return to normal monitoring from Standby mode
• Enabling Arrhythmia analysis
• The lead has been changed in ECG 1 waveform (3 lead only)
• Patient Size is changed
• Whenever the “Relearn” function is selected from the ST, ECG or Arrhythmia Menus.
It is recommended that a Relearn be initiated after one or more of the following:
• The ECG electrodes have been repositioned
• Sufficient time has passed since the last Relearn
• Any significant changes to the patient QRS complex
• Any significant changes to the patient ECG rhythm
• A clinician has observed clinically questionable arrhythmia calls
A Relearn must be initiated if “Learning” occurred during a “Leads Off” condition.
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Parameter Menus and Monitoring
2.4.2.7
Operations
ST Analysis (Optional)
ST Analysis is available for Adult and Pediatric patients only.
R
ST Point
J Point
P
ISO Point
ST deviation
(Depression or Elevation)
T
Q
S
40 to 80 msec
FIGURE 2-33 ST Monitoring
The depression or elevation of the ST segment is measured as the vertical distance between
the isoelectric (ISO) point which provides the baseline, and the ST point (See figure above).
ST measurements are available on a maximum of three user selected ECG leads at a point
situated 80 ms (heart rate 120 bpm or less) or 60 ms (heart rate more than 120 bpm) from
the algorithmically determined end point of the QRS (J Point). In addition, the user can also
select from three (3) different settings for the ST measurement point (80, 60, or 40 ms) from
the J-point and independent of heart rate. These measurements are valid only on normal
beats. Abnormal beats, like ventricular beats, are excluded from the analysis of the ST
segment. Ventricular paced beats are also rejected from the analysis of the ST segment,
because pacemaker tails distort the shape of the ST segment.
ST segment changes are continuously measured by the monitor, but update of the displayed
ST data is different depending on the ECG cable in use. When using a 3 or 5-lead ECG
cable, the displayed ST data is updated approximately every 10 seconds.
NOTE:
The ST algorithm has been tested for accuracy of the ST
segment data. The significance of the ST segment changes
must be determined by a clinician.
ST Minitrends or Average ST data may be displayed in any of the available waveform
areas.
ST Minitrends are graphical displays of ST deviations. The data can be displayed at
intervals of 15, 30 or 60 minutes, selectable via the ST Setup Menu. The ST scale is also
adjustable with selections of ±2.5 mm, ±5 mm or ±10 mm.
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Parameter Menus and Monitoring
Average ST is an on-screen display of both the learned ST complex and the current ST
complex superimposed to show changes in ECG morphology over time. The learned ST
complex will appear in white, with the current ST complex appearing in the ECG waveform
color. (If the ECG waveform is white, then the learned complex will appear in green).
With a 3-lead cable, ST Minitrends and Average ST will display the ST data from ECG1.
With a 5-lead cable, ST Minitrends and Average ST will display the ST data from ECG1,
ECG2, and ECG3. With a 12-lead ECG cable, ST Minitrends and Average ST will
display the ST data from the 3 ECG leads with the greatest deviation.
2.4.2.7.1
ST Analysis Setup
ST analysis begins when the feature is turned on from the ST Menu. By default, ST data will
appear in the Heart Rate Tile, when using a 3-lead or 5-lead cable.
When using a 3-lead cable, ST Analysis is performed on the lead chosen as ECG1. With a
5-lead cable, ST Analysis is performed on the leads chosen as ECG 1, ECG 2 and ECG 3 on
the ECG Menu.
To display ST data, set a waveform to display any ECG wave (i.e., ECG2, ECG3, etc.), or
set any waveform to display Average ST or Minitrends, then set Combine ST/HR to
OFF.
FIGURE 2-34 ST Menu
When View 12™ ECG Analysis Module is installed, continuous 12-lead ST monitoring will be
enabled when ST Analysis is set to On. 12-lead ST analysis may be viewed in 2 modes:
Delta and Absolute. Delta ST is the ST segment change between the learned ST segment
and the present ST segment. Absolute ST is the ST segment change between the 0 baseline
point of the ST and the present ST segment.
To display 12-lead ST data in a tile, set any waveform to display any ECG wave, ST
Minitrends or Averaged ST.
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Parameter Menus and Monitoring
Operations
Adjusting the ISO and J/ST Point
1. Open the ST Menu by using the Navigator™ Knob to select the ST parameter heading.
ST Menu can also be accessed through the ECG Menu.
2. Insure the ST Analysis selection in the ST Menu is On. The Spectrum will learn the
patient's QRS complexes (one for a 3-lead cable, 3 for a 5-lead or 12-lead cable).
These learned complexes will appear in the ST Menu with the monitor-selected ISO
and J/ST points displayed.
3. Scroll to the ISO selection to adjust the isoelectric point on the learned QRS complex.
The isoelectric point is the area of the QRS complex following the P-wave and before the
start of the Q-wave.
4. Adjust the ISO point by pressing the Navigator™ Knob and turning to adjust the white
ISO reference line. Press the Navigator Knob when the ISO point is satisfactory.
5. Scroll to the J/ST point heading. Adjust the J/ST point by pressing the Navigator Knob
and turning to adjust the orange and green J/ST reference lines. Press the Navigator
Knob when the J/ST points are satisfactory.
6. To adjust the ST-pt, scroll to the ST-pt heading and press the Navigator Knob to display
a list of ST measurement point settings. Select the appropriate setting, then press the
Navigator Knob when the ST-pt choice is satisfactory.
2.4.2.8
Relearning ST or Arrhythmia Analysis
The Spectrum initiates the learning process for ST measurements or Arrhythmia analysis
after one of the following:
• Unit Power-Up
• Return to normal monitoring from Standby mode
• Enabling ST or Arrhythmia analysis
• The lead has been changed in ECG 1 waveform (3 lead only)
• Patient Size is changed
• Whenever the Relearn function is selected from the ST, ECG or Arrhythmia
Menus
A Relearn is recommended after one or more of the following:
• ECG electrodes have been repositioned
• Eight hours have passed since the last Relearn
• After significant changes to the patient QRS complex
• The observed ST measurement mode has been changed (Delta or Absolute - 12-lead
only)
• A clinician has observed clinically questionable arrhythmia calls
A Relearn must be initiated if “Learning” occurred during a “Leads Off” condition.
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Operations
2.4.2.9
Parameter Menus and Monitoring
12-lead ECG (Optional)
This feature is added to the Spectrum by inserting the View 12™ ECG Analysis Module into
one of the two (2) PCM slots on the right side of the monitor.
WARNING: The View 12™ ECG Analysis Module is not intended for use
during electrosurgery. If the electrosurgical ground
connection is not satisfactory, there exists a possibility of
patient burns at the ECG electrode sites.
1. Prep patient’s skin prior to placement of electrodes. See proper electrode placement and
skin prep instructions.
2. Insert View 12 ECG Analysis Module with cable attached into a PCM slot on the right
side of the Spectrum. The monitor will automatically initialize.
3. If 12-lead function is disabled, access the Functions Menu and select Enable 12lead ECG using the Navigator™ Knob.
4. To view multiple leads of ECG, press the VIEW key. Press the VIEW key once to view
the first 6 ECG leads, press again to view another 6 leads. Pressing a third time will
return to normal viewing.
FIGURE 2-35 View ECG Setup Menu
5. Select desired leads to view in the View ECG Setup Menu within the Monitor
Setup Menu.
6. To change size of displayed waveforms, go to the ECG Sizes Menu within the ECG
Menu.
7. To remove the View 12 ECG Analysis Module, turn monitor off or go to the Functions
Menu and select Disable 12-lead ECG, then use the Navigator Knob to select Yes,
or remove when power is off.
CAUTION:
Spectrum® Operating Instructions
Removal of the View 12™ ECG Analysis Module without first
disabling the 12-lead ECG card may cause a temporary
disruption in patient monitoring.
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Parameter Menus and Monitoring
2.4.2.9.1
Operations
12-lead Interpretation
With a View 12™ ECG Analysis Module installed and enabled, the Spectrum is capable of
providing 12-lead interpretive printouts to either the internal thermal printer or an attached
laser printer.
To print this analysis, press the VIEW key (to view multiple ECG leads), then press the STRIP
key. If all conditions for analysis have been met, the recorder will include the results on the
printout. The analysis will consist of an interpretive statement, a condition statement, and a
rhythm statement as specified in the Physician’s Guide to Computerized ECG Analysis.
The conditions for printing the ECG analysis are:
1. The Spectrum patient size must be set to Adult.
2. The patient’s Gender and Date of Birth must be entered via the Patient Menu.
3. The patient must be at least 18 years old. (The monitor calculates the patient age from
the date of birth entered).
WARNING: Computerized ECG Analysis should be reviewed by qualified
medical personnel. It should not be used exclusively for
treatment or non-treatment of patients.
WARNING: ST segment measurements may be affected by one or more
of the following ECG rhythm morphologies: wide complex
QRS such as bundle branch blocks, ventricular pacemaker
rhythm, left ventricular hypertrophy or Wolff-ParkinsonWhite Syndrome. Consult with qualified medical personnel
prior to treatment or non-treatment.
2.4.2.10
ECG Troubleshooting
MESSAGE/PROBLEM
Noisy ECG traces
2 - 46
REASON
SOLUTION
Loose or dry electrodes.
Apply fresh, moist electrodes.
Defective electrode wires.
Replace wires as necessary.
Patient cable or leads are
routed too close to other
electrical devices.
Eliminate 60Hz interference.
Excessive Electro-surgical
Interference
Wrong ECG cable used.
Use ESIS ECG cable with
internal filter block.
NOTE: Respiration monitoring
via the ECG electrodes will not
be available when using the
cable.
Muscle Noise
Inadequate skin preparation
prior to application of
electrode, tremors, tense
subject, and/or poor electrode
placement.
Repeat skin preparation and
electrode location procedures.
Apply fresh, moist electrodes.
Avoid areas of the torso that are
very muscular.
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Parameter Menus and Monitoring
MESSAGE/PROBLEM
REASON
SOLUTION
Intermittent Signal
Connections not tight and/or
properly secured.
Ensure proper connection.
(Electrode to lead, lead to
cable, cable to monitor).
Electrodes dry or loose.
Re-prep skin and apply fresh,
moist electrodes.
Cable or lead wires damaged.
Check with continuity tester.
Electrodes dry
Re-prep skin and apply fresh,
moist electrodes.
Alarm limits set too close to
patient's normal heart rate.
Readjust
R-wave wrong size
Must have a higher amplitude
than the other ECG waves, like
the P and T waves.
Excessive patient movement or
muscle tremor.
Reposition electrodes and
secure with tape, if necessary.
Gain set too low.
Readjust as required (Set via the SIZE key).
Excessive alarms: heart rate,
lead fault
Low Amplitude ECG Signal
No ECG Waveform
Base Line Wander
“Artifact” Message
Electrodes dry / old
Apply fresh, moist electrodes
Skin improperly prepared
Abrade skin
This could be the patient’s
normal QRS complex.
Verify with a 12-lead electrocardiogram.
Electrode could be positioned
over a bone or muscle mass.
Move ECG patches closer
towards each other.
Gain set too low.
Readjust as required (Set via the SIZE key).
Lead wires and patient cable
not fully or properly inserted.
Check for proper insertion.
Cable or lead wires damaged.
Check with lead continuity
tester.
Patient moving excessively.
Secure lead wires and cable to
patient.
Patient's respiration
Reposition electrodes
Electrodes dry or loose
Re-prep skin and apply fresh,
moist electrodes.
Static build up around patient.
Check with local biomedical
personnel.
ECG Filter set to “ST” or
“Extended” mode.
Set ECG Filter to “Monitor”
mode.
The 12-lead ECG is detecting
muscle artifact, or electrical
interference from auxiliary
devices.
Check leads, follow skin
preparation procedure.
Check for electrical
interferences, replace wires as
necessary.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 47
Parameter Menus and Monitoring
2.4.3
Operations
Non-Invasive Blood Pressure Measurements (NIBP)
In the Spectrum, Non-Invasive Blood Pressure monitoring utilizes the oscillometric method
of measurement. The NIBP measurement includes Systolic (Sys), Diastolic (Dia) and Mean
Blood Pressure.
FIGURE 2-36 NIBP Menu
2.4.3.1
Manual NIBP Measurements
1. Select a blood pressure cuff that is appropriate for the size of the patient. Measure limb
for the best results.
2 - 48
NOTE:
A cuff that is too narrow for the limb will result in
erroneously high readings. The correct size of the pressure
cuff for a given patient has, among other considerations, a
direct bearing on the accuracy of the obtained NIBP
measurements. Base selection of the cuff size on the limb
circumference of the patient. The design dimensions of the
cuffs and their intended uses are based on
recommendations of the American Heart Association.
NOTE:
Cuffs become brittle as they age and sometimes develop
permanent folds that can leave temporary marks on the
limb. Any cuffs that exhibit this effect should be replaced.
NOTE:
Ensure that the pressure tubes are not compressed or
restricted.
NOTE:
The pressure on the limb may not fall to zero between
measurements if the cuff is wrapped too tightly. Therefore,
ensure that the cuff is properly applied.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
NOTE:
The skin is sometimes fragile (i.e., on pediatrics, geriatrics,
etc.). In these cases, a longer interval between
measurements should be considered to decrease the
number of cuff inflations over a period of time. In extreme
cases, a thin layer of soft roll or cotton padding may be
applied to the limb in order to cushion the skin when the
cuff is inflated. This measure may affect NIBP performance
and should be used with caution.
2. Attach cuff hose to NIBP Connector.
3. Apply the cuff to the patient. To reduce errors, the cuff should be adjusted for a snug fit.
Little or no air should be present within the cuff. Be sure the cuff lies directly against the
patient’s skin. No clothing should come between the patient and the cuff.
NOTE:
The NIBP cuff should not be placed on a limb that is being
utilized for any other medical procedure. For example, an IV
catheter or an SpO2 sensor.
4. If not already selected, select the Patient Size through the Patient Menu. Choices
are Adult, Pediatric or Neonate.
5. If necessary, change the initial cuff inflation pressure through the NIBP Menu.
Initial cuff inflation pressures depend on the patient size setting. The values for cuff
inflation are identified in the following table:
PATIENT SIZE
SETTING
INITIAL CUFF
INFLATION VALUES
DEFAULT
SETTING
MAXIMUM
INFLATION VALUES
Adult
100 - 280 mmHg
180 mmHg
300 mmHg
Pediatric
60 - 180 mmHg
140 mmHg
195 mmHg
Neonate
40 - 120 mmHg
100 mmHg
150 mmHg
6. Press START to begin an NIBP measurement.
CAUTION:
Cuffs must be used with the correct Mindray hoses.
CAUTION:
Please consult a physician for interpretation of blood
pressure measurements.
CAUTION:
A blood pressure measurement can be affected by the
position of the patient, and his / her physiological condition
as well as other factors, such as patient movement.
NOTE:
Inflate the cuff only after proper application to the patient’s
limb. Cuff damage can result if the cuff is left unwrapped
and then inflated.
7. The cuff begins to inflate to the selected cuff pressure. After reaching the selected value
the cuff begins to slowly deflate and the Spectrum collects oscillometric pulsations.
8. If the initial cuff inflation is found to be inadequate, the unit retries with a higher inflation
pressure (+50 mmHg in adult or pediatric mode; +40 mmHg in neonate mode).
9. The patient should remain still to avoid the introduction of unnecessary motion artifact.
After the cuff pressure drops below the diastolic pressure, the results of the measurement
are displayed.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 49
Parameter Menus and Monitoring
Operations
If NIBP is the only parameter being measured with the Spectrum, a heart rate can be
derived from NIBP. The HR Source Menu selection must be in the Auto Mode (i.e., not
selected for ECG, IBP or SpO2) with no heart rate alarm limits set. If another heart rate
source is available, the NIBP heart rate will be replaced by the heart rate from the available
source.
If NIBP is a selected trend source, then NIBP data will be recorded in the trend with the time
stamp of the reading. If NIBP is not a selected trend source, then NIBP data will be recorded
in the trend with the next entry into the trend caused by another trigger (i.e., ALARM,
INTERVAL, or MARK EVENT key press). The time stamp will be that of the trigger causing
the trend entry. The NIBP measurement and NIBP heart rate will be automatically removed
from the display after a predetermined time interval. The NIBP timeout interval is 15 minutes
by default and can be set to a different value through the Installation Menu.
2.4.3.2
Automatic Interval NIBP Measurements
There are two modes available for automatic NIBP measurements. They are the Interval
Mode and the Timer Mode. The Interval Mode allows you to set the interval between
measurements. For example, if the interval is set to 10 minutes and the START key is pressed
at 10:12, the measurements will be taken at 10:12, 10:22, 10:32, etc. The Timer Mode
allows you to set an interval that is synchronized with the real time clock. For example, if the
timer is set to 30 and the START key is pressed at 10:12, the measurements will be taken at
10:12, 10:30, 11:00, 11:30, etc.
1. Select the Interval Mode or the Timer Mode in the Monitor Setup Menu.
2. Press INTERVAL until the desired time displays. The choices are: OFF, Continuous, 1,
2.5, 3, 5, 10, 15, 20, 30, 60, and 120 minutes and 4 hours.
3. Press START to begin taking interval measurements.
NOTE:
If the monitor is in the interval mode when it is turned ON,
no measurement will be taken until the START key is
pressed.
Automatic Adjustment in the Interval Mode
In the Interval Mode, the unit adjusts the inflation pressure according to the previous
reading of the systolic pressure. After the first measurement in the timer mode, the inflation
pressure is the previous systolic +50 mmHg in the Adult Mode or Pediatric Mode and
+40 mmHg in the Neonate Mode.
Suspension of NIBP Measurements
1. Press STOP to suspend an automatically timed measurement sequence or to end a
measurement cycle already in progress (deflate cuff).
2. Press START to take an immediate measurement and resume a suspended timed
measurement sequence.
NOTE:
2 - 50
You can press STOP at any time to postpone a scheduled
measurement or to terminate a measurement cycle already
in progress.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
CAUTION:
Observe caution on all patients (Neonates, Pediatrics, and
Adults) when NIBP is set to the Continuous Mode and the 1
minute interval. When the NIBP continuous interval is
selected, the Spectrum will continually take back to back
blood pressure readings. As a safety precaution, a limit is
placed on continuous and 1 minute interval measurements.
In continuous mode, after 5 minutes, the NIBP interval will
automatically switch to one measurement taken every 5
minutes. In 1 minute mode, after 10 minutes the NIBP
interval automatically switches to measurements taken once
every 10 minutes. Reports have been made of nerve injury
occurring during use of automatically cycled blood pressure
cuffs.
NIBP Pressure Limit Fail Safe
If the cuff is over-pressurized, the cuff will automatically vent to atmosphere and the NIBP
message window will alternately read Cuff Over Pressure and Unable to
Measure.
Cuff Inflation Time
If the cuff pressure does not attain 20 mmHg within 40 seconds of the start of inflation or if
the target pressure is not reached within another 60 seconds, then the cuff is vented and the
Retry or Unable to Measure message will display in the NIBP message window.
START and STOP Functions
The START and STOP functions have the following effects on the timed measurement
sequence (Interval or Timer Mode).
INTERVAL is set and you press START:
An unscheduled measurement is made. Taking this unscheduled measurement does not affect
the timing of the interval cycle, therefore, the scheduled measurements will be taken as if
there were no interruptions. Only one measurement is taken for each measurement cycle therefore, if the unscheduled measurement coincides with the scheduled measurement, it
counts as the scheduled measurement.
INTERVAL is set and you press STOP during the measurement:
1. The cuff deflates and interval measurements are suspended.
2. INTERVAL is set and you change the interval.
3. The measurement cycle is reset with the new interval. A measurement will be taken after
you press the START key.
NIBP Auto Time Out Functions
The NIBP data will time out on the display under the following conditions:
• When the elapsed time exceeds the pre-set time out in the installation mode
• If a measurement is unsuccessful, the display values are replaced with “XX” and a
tone sounds
Spectrum® Operating Instructions
0070-10-0648-02
2 - 51
Parameter Menus and Monitoring
Operations
Indirect BP Measurements and Associated Errors
Place the patient in a supine position to obtain true physiological pressure. If the cuff is not at
the patient’s heart level, the pressure values obtained will not reflect the true physiological
pressure. Instead, the readings will be decreased by 1.86 mmHg for every inch the cuff is
placed above the heart level and increased by 1.86 mmHg for every inch the cuff is placed
below the heart level. This effect is due to hydrostatic pressure.
Blood weight influences blood pressure readings. The value of the weight of blood depends
on where the measurement is taken with respect to the heart. When the patient is supine, on
a flat surface, the arm is near enough to the heart level that no adjustment of the NIBP
readings is necessary.
Recommendations for Automatic Blood Pressure Measurements
The following practices are recommended when making automatically cycled blood pressure
measurements:
• Position and support the limb in such a way as to minimize stretching of and weight
exertion on affected nerves
• Avoid cuff placement that applies pressure on the ulnar nerve. Cuff tubing should not
exit the cuff over the course of the ulnar nerve at the elbow
• Select a measurement interval that provides adequate venous drainage during cuff
deflation
• Periodically inspect the limb bearing the cuff in order to detect venostasis
• If necessary move cuff to another limb to relieve single-limb stress
Cuff Size
Using a narrow cuff gives erroneously high pressure readings. If a standard cuff is applied to
an obese patient or a patient with large biceps, the extra tissue and fat will dissipate the
applied pressure requiring an additional pressure increase to collapse the artery. On the
other hand, over-wrapping a slender arm gives erroneously low pressure readings because
too much force per unit area is exerted. This requires less pressure to collapse the artery.
Other Factors
An accurate determination of blood pressure by the Spectrum can be difficult if cardiac
rhythm is irregular. Irregular cardiac rhythm changes the stroke volume from beat to beat.
This changing stroke volume may increase the time it takes the Spectrum to take a
measurement. The Spectrum makes up to four successive attempts to obtain a
measurement. If a measurement cannot be taken after four tries, the numeric displays are
zeroed.
User Verification of Spectrum Blood Pressure Measurements
Regular service to blood pressure equipment will help insure accurate measurements. Consult
your Service Manual for appropriate information. If you question the accuracy of the
Spectrum check the blood pressure in the Spectrum with a manometer.
2 - 52
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
Auscultatory verification can be made at the same time the Spectrum is taking a
measurement. Apply a bell stethoscope over the brachial artery. Do not allow the
stethoscope to touch either the patient’s clothing or the pressure cuff.
Newborn NIBP Technique
Newborn patients present unique obstacles to NIBP measurement. Their vital signs can
change from moment to moment, and their tiny physiological signals are very prone to noise
interference. The following suggestions will help you to obtain the best possible NIBP
measurement:
1. Try to measure infants when they are calm. A kicking/crying baby may disturb or jiggle
the cuff, causing noise within the system and resulting in unstable blood pressure
readings. If necessary, hold the cuffed limb steady, without impeding circulation. Do not
hold onto the cuff and do not pat the cuffed limb to comfort the child.
2. Try the calf. Irritable newborns will react to the cuff pressure but may tolerate the calf
better than the arm. Place the cuff just above the ankle.
3. Use the correct size cuff. Mindray offers Newborn and Infant size cuffs. When
applying, verify the cuff’s Index line falls between the Range lines.
4. Try disposable cuffs. Disposable cuffs are more pliant than reusable ones. They
generally fit smaller infants better.
5. Place the cuff lightly. If the cuff is too snug, it won’t work properly. On infants, you should
be able to easily move the cuff over the limb.
NOTE:
2.4.3.3
NIBP cannot be taken under all conditions. Even manual
methods, employing a sphygmomanometer and
stethoscope, will not work on unstable or active patients.
NIBP Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
NIBP: Idle
Displayed while system is idle.
Note: This is not displayed
while in the interval mode.
Press START to take a single
measurement. Select an
interval and start timed
measurements.
NIBP: Deflate
Displayed when a measurement
that is in process is stopped by
pressing the STOP key.
Press START to take an
immediate measurement and
resume timed measurements.
NIBP: Interval
Displayed during the interval
between two timed measurements.
Press STOP to suspend timed
measurements.
Change timer to OFF to stop
timer.
NIBP: Failure
The system has detected an
unrecoverable failure of the NIBP
system.
Power cycle unit. If message
reappears, contact Mindray
Customer Support.
NIBP: Measuring
Displayed during a measurement.
Cuff pressure is also displayed.
Press STOP to suspend a
measurement and deflate the
cuff.
NIBP: Retry Pump Higher
A measurement has been
attempted but no reading was
possible. This results from
inadequate cuff inflation.
Retry will be attempted.
Check that appropriate
patient size is set.
Preset initial inflation
pressure.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 53
Parameter Menus and Monitoring
Operations
MESSAGE/PROBLEM
REASON
SOLUTION
NIBP: Retry
A measurement has been
attempted but no reading was
possible and the retry limit has not
been reached.
Retry will be attempted.
Check for leaks and quality of
peripheral pulses. Decrease
patient movement. Switch cuff
to another limb.
Unable To Measure
An unsuccessful measurement
cycle has been completed.
Switch cuff to another limb.
Decrease patient movement.
Press START to retry. Be
prepared to auscultate BP
manually.
Contact Mindray Customer
Support.
NIBP: Cuff Overpressure
The hardware overpressure limit
has been exceeded.
Power cycle unit.
If message reappears, contact
Mindray Customer Support.
NIBP: Cuff Overpressure/
Press STOP to clear.
The hardware overpressure limit
has been exceeded.
Press STOP to clear the
hardware overpressure.
If message reappears, contact
Mindray Customer Support.
NIBP: Check Calibration
The software has detected that the
overpressure transducer is out of
calibration.
Have the unit calibrated.
If problem persists contact
Mindray Customer Support.
Unable to obtain a BP
Patient movement
Wait until patient is calm or
gently hold limb.
Cuff or hose NOT attached /
leaking
Check all connections.
HR irregular / arrhythmia present
Check Patient and notify
Physician.
Blood pressure is out
of range.
Check Patient and verify BP
with manual method.
Improper cuff size / brand
Measure patient limb. Use
only properly sized Mindray
accessories.
Incorrect cuff size
Measure Patient limb, use
correct cuff.
Patient movement
Wait until patient is calm or
gently hold limb.
Reading too high or too low
2 - 54
NOTE:
Always have an alternate method of BP verification
available.
NOTE:
On vasoconstricted patients, failure to evacuate air from the
cuff can distort BP measurement.
NOTE:
Cuff should be at heart level.
NOTE:
The presence of an arrhythmia may increase the time
required to complete a measurement and may cause
measurement cycle to extend beyond a point where a
measurement can be completed.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
2.4.4
Parameter Menus and Monitoring
SpO2 Pulse Oximetry
Pulse oximetry is a continuous and non-invasive measurement of the amount of oxygen
attached to the hemoglobin in red blood cells. SpO2 is an estimation of arterial oxygen
saturation, SpO2 may be used interchangeably with SaO2. The Spectrum comes standard
with Masimo SET® SpO2. Nellcor® Oxismart® or OxiMax® SpO2 is an option.
SpO2 Measurements
1. Select the appropriate sensor for the patient.
2. Attach the SpO2 patient cable to the sensor and plug the other end of the patient cable
into the SpO2 connector located on the left side panel of the monitor.
NOTE:
Do not place the sensor on an extremity with an IV catheter
or blood pressure cuff in place.
NOTE:
Ensure proper routing of patient cable to avoid
entanglement and/or strangulation.
FIGURE 2-37 SpO2 Menu-Masimo SET®
equipped unit
FIGURE 2-38 SpO2 Menu-Nellcor®
equipped unit
3. The pleth waveform and digital SpO2 value will be displayed by default in the second
waveform and parameter area.
4. Enter the Display Setup Menu to describe Pleth waveform and data in an alternate
location.
5. Set Sensor Off Audio in the SpO2 Menu to the desired setting. When set to Off the
Spectrum will not give an audio beep. When set to On, the Spectrum will sound a
series of 5 triple beeps.
Calibration
The oximetry sub-system incorporates automatic calibration mechanisms. No other
calibration is required.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 55
Parameter Menus and Monitoring
Operations
Auto Scaling
The pleth waveform is automatically scaled and is not proportional to the patient’s pulse
volume. There is no adjustment that can be made to the pleth waveform.
2 - 56
CAUTION:
Tissue damage or inaccurate measurements may be caused
by incorrect sensor application or use, such as wrapping too
tightly, applying supplemental tape, failing to inspect the
sensor site periodically, or failing to position appropriately.
Carefully read the sensor directions for use, the Spectrum
Operating Instructions, and all precautionary information
before use.
CAUTION:
Inaccurate SpO2 measurements may be caused by:
•
Incorrect sensor application or use
•
Significant levels of dysfunctional hemoglobins, (e.g.,
carboxyhemoglobin or methemoglobin)
•
Intra-vascular dyes such as indocyanine green or
methylene blue
•
Exposure to excessive illumination such as surgical
lamps (especially ones with a xenon light source),
bilirubin lamps, fluorescent lights, infrared heating
lamps, or excessive ambient light. In such cases, cover
the sensor site with opaque material.
•
Excessive patient movement
•
Venous pulsations
•
Electro-surgical interference
•
Placement of a sensor on an extremity that has a blood
pressure cuff, arterial catheter, or intra-vascular line.
•
Nail polish or fungus
CAUTION:
In certain situations in which perfusion and signal strength
are low, such as in patients with thick or pigmented skin,
inaccurately low SpO2 readings will result. Verification of
oxygenation should be made, especially in preterm infants
and patients with chronic lung disease, before instituting
any therapy or intervention.
CAUTION:
Many patients suffer from poor peripheral perfusion due to
hypothermia, hypovolemia, severe vasoconstriction,
reduced cardiac output, etc. These symptoms may cause a
loss in vital sign readings.
CAUTION:
The SpO2 sensor site should be checked at least every eight
(8) hours (every four (4) hours with the Adult re-usable
finger sensor). Ensure proper adhesion, skin integrity, and
proper alignment. Exercise extreme caution with poorly
perfused patients. Skin erosion and pressure necrosis can
be caused when sensors are not frequently monitored.
Assess the site every two (2) hours with poorly perfused
patients and neonates.
CAUTION:
When cleaning sensors, do not use excessive amounts of
liquid. Wipe the sensor surface with a soft cloth, dampened
with cleaning solution. Do not attempt to sterilize.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
2.4.4.1
Parameter Menus and Monitoring
Masimo SET® SpO2
Spectrum monitors equipped with Masimo SET SpO2 allow the user to adjust Sensitivity
and Post Averaging Time. The user should choose the sensitivity mode depending upon
signal quality and patient motion. In most cases, the normal setting is appropriate. If patient
motion is limited, high sensitivity can be used.
It is also possible to change the averaging time of the Saturation and Pulse Rate
measurements. The Post Average Time can be changed to 6, 8, 10, 12, 14 or 16
seconds.
CAUTION:
When equipped with Masimo SET® SpO2, use only Masimo
SET Oxygen Transducers including Masimo SET LNOP® and
LNCS™ Patient Dedicated Adhesive, Sensors and Masimo SET
PC Series Patient Cables. Use of other oxygen transducers
may cause improper oximeter performance.
Masimo SET Sensors
Masimo SET provides a family of sensors suitable for a wide variety of clinical settings and
patients. Specific sensors have been developed for neonates, infants, children, and adults.
All sensors are indicated for continuous non-invasive monitoring of arterial oxygen saturation
(SpO2) and pulse rate, all sensors are non-sterile and usable during patient movement.
The Adult Reusable Finger Sensors can also be used for spot check applications if needed.
All sensors are intended for single-patient use only unless indicated as “reusable.”
2.4.4.2
Nellcor® SpO2
CAUTION:
When equipped with Nellcor® SpO2, use only Nellcor
oxygen transducers including Nellcor Oxisensor® and
OxiMax® patient dedicated adhesive sensors. Use of other
oxygen transducers may cause improper oximeter
performance.
Nellcor Sensors
Nellcor provides a family of sensors suitable for a wide variety of clinical settings and
patients. Specific sensors have been developed for neonates, infants, children, and adults.
Oxisensor® and OxiMax® oxygen transducers are sterile adhesive sensors with optical
components mounted on adhesive tape. Oxiband® oxygen transducers and the Duraform®
oxygen transducer system are reusable sensors that are applied with disposable adhesive.
The Durasensor DS-100A Adult Digit Oxygen Transducer is a reusable sensor with its optical
components mounted in a plastic casing. The Nellcor RS-10 and Max-Fast® oxygen
transducers are adhesive sensors for application on the forehead or temples.
To order all Nellcor accessories and sensors call 1-888-744-1414.
Selecting a Nellcor Sensor
Sensors are designed for specific sites on patients with designated weight ranges. To select
the appropriate sensor, consider the patient’s weight, level of activity, adequacy of perfusion,
which sensor sites are available, whether sterility is required, and the anticipated duration of
monitoring.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 57
Parameter Menus and Monitoring
NOTE:
2.4.4.3
Operations
Only Nellcor oxygen transducers should be used with the
Spectrum monitors with Nellcor Oxismart® or OxiMax®
pulse oximetry.
SpO2 Troubleshooting and SpO2 Menu Performance Considerations
To ensure optimal performance, use an appropriate sensor, apply it as directed and observe
all warnings and cautions.
If excessive ambient light is present, cover the sensor site with opaque material. Failure to do
so may result in inaccurate measurements. Light sources that can affect performance include
surgical lights, especially those with a xenon light source, bilirubin lamps, fluorescent lights,
infrared heating lamps, and direct sunlight.
In the event that you are unable to get a reading, or the reading you get is inaccurate,
consider the following:
• If your patient is poorly perfused, try applying the sensor to another site - such as a
different finger or toe
• Check that the sensor is properly aligned
• In electrosurgery, make sure sensor is not too close to ESU devices or cables
• Check to make sure the site area is clean/non-greasy. Clean site and sensor if needed.
2 - 58
MESSAGE/PROBLEM
REASON
SOLUTION
SpO2: No Sensor
Sensor is not plugged in to the
Spectrum.
Plug the sensor into the monitor.
SpO2: Sensor Off
(Masimo SET® Only)
Sensor may not be connected to
the patient.
Check patient connection.
SpO2: Interference
Noise detected on the pulse
signal prevents pulse
discrimination.
Decrease patient motion, check
sensor.
SpO2: Pulse Search
Hardware settings are being
adjusted in order to discriminate
a pulse waveform.
Change to site where pulse is
stronger if patient is
vasoconstricted. Change or
readjust sensor if loose.
SpO2: No Pulse (Nellcor
Only)
No detectable pulse is measured
Check to patient connection and
patient status.
SpO2: Failure
The system has detected an
unrecoverable failure of the
SpO2 system.
Power cycle unit. If message
reappears, contact Mindray
Customer Support.
SpO2: Low Perfusion
(Masimo SET Only)
Patient perfusion is low.
Check to patient connection and
patient status.
SpO2: Too Much Light
(Masimo SET Only)
There is too much ambient room
light for the sensor to function
properly
Minimize the room light around
the patient. Check sensor.
SpO2: Unrecognized
Sensor (Masimo SET Only)
The sensor is not recognized by
the Monitor.
Replace the sensor with a
Mindray recommended sensor.
SpO2: Communication
Error
The monitor and the SpO2
modules are not communicating
properly.
Power cycle unit. If problem
persists, contact Mindray
Customer Support.
SpO2: Board Fault
Masimo SET board failed to
operate properly.
See Proper Service Menu:
Suggestion.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
MESSAGE/PROBLEM
REASON
SOLUTION
SpO2: Sensor Fault
Defective Sensor.
Replace Sensor.
SpO2: Motion (Nellcor
Only)
Motion is detected
Decrease patient motion, check
sensor.
SpO2: Check Sensor
(Nellcor Only)
The SpO2 module has sensed a
poor connection or a bad sensor
Reconnect the same sensor. If
problem persists, replace sensor
Unable to obtain SpO2
reading
Patient has poor perfusion.
Switch limbs / Notify physician.
Sensor not on Patient.
Reapply sensor.
Cables loose / not connected.
Check connections, switch cable.
Ambient light.
Switch limbs and cover sensor
with opaque material.
No SpO2 waveform
Waveform not selected to
Display.
Go to the Display Setup
Menu, choose to display Pleth
in the waveform area.
Cable or sensor not plugged in
Check cable and sensor
Low amplitude SpO2
signal
SpO2 sensor on same limb as
cuff.
Check sensor placement, move
as necessary.
Patient has poor perfusion.
Switch limb / Notify physician.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 59
Parameter Menus and Monitoring
2.4.5
Operations
Temperature Menu
The temperature measurement function of the Spectrum is designed to take a continuous
temperature reading from YSI 400 or YSI 700 or compatible probes. To display the
Temperature Menu, turn the Navigator™ Knob to the Parameters Menu. Press the
Navigator Knob and rotate down to highlight Temperature. Press the Navigator Knob
again and the Temperature Menu will appear.
FIGURE 2-39 Temperature Menu
To display temperature in a parameter tile, go to Display Setup Menu and select a tile in
which to display temperature.
Measuring Temperature
The Spectrum Monitor has three (3) potential temperature measurement sources: the TI
connector on the monitor, the T2 connector on a Mindray External Parameter Module (EPM)
and a PA catheter (T Blood) from an EPM or an Edwards Vigilance® Monitor. Data for up to
two (2) of these sources may be simultaneously displayed.
T1 and T Blood data have display priority over T2 data. If all three (3) temperature sources
are being used, T2 data will not appear on the display, although T2 alarms will still function
and T2 data will appear on printouts and continue to accumulate in the Trend data.
Whenever two (2) temperatures are being displayed, the difference between them (ΔT) may
also be displayed.
To display ΔT in the Temperature Parameter Area:
1. Ensure that two temperature sources are connected.
2. Go to the Temperature Menu and select Display Delta, then select Yes.
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Spectrum® Operating Instructions
Operations
2.4.5.1
Parameter Menus and Monitoring
Temperature Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Temperature Probes not
Working
Poor contact from probes to body
Check the body surface contact
at the probe tip
Reposition or apply
thermoconductive gel
Temperature not displayed
2.4.6
Improper display setup
Check display setup in Monitor
Setup Menu and change as
desired
Cable not plugged in
Check the cable
Respiration Menu
Respirations, or the amount of breaths per minute, are measured by 2 methods in the
Spectrum. The first method is thoracic impedance through the ECG signal. The second is by
CO2 exchange via Microstream® CO2 or via the Gas Module.
FIGURE 2-40 Respiration Menu
2.4.6.1
Thoracic Impedance
The Spectrum Monitor presents a small electrical signal across the RA and LA (or R & L)
ECG limb leads. This signal changes as the patient’s chest wall rises and falls during the
breath cycle. The advantage of the thoracic impedance method is that respiration is obtained
non-invasively. It is important to use cables with internal resistors for thoracic impedance.
ESIS choke block cables have electrical filters that may be used in electro-cautery
environments where ECG interference can be substantial. These filters remove the electrocautery noise, but also block the signal used by the Spectrum Monitor to measure
respiration.
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Parameter Menus and Monitoring
Operations
The filling and emptying of the heart chambers can interfere with the thoracic impedance
signal, so called cardiovascular artifact (CVA), such that the respiratory signal matches the
heart rate. The Spectrum warns the operator when the respiration value equals the heart
rate by displaying “CVA”.
If the patient’s airway is obstructed and the patient attempts to breath, then the chest wall can
move and create a respiratory signal even though no gas flow is occurring in the patient.
CAUTION:
2.4.6.2
Some pacemakers may contain a respiratory sensor that
may produce artifact on an ECG waveform.
Microstream® CO2 Monitoring (Optional)
Microstream CO2 modules provide Expired CO2, Inspired CO2 and Respiration Rate
monitoring utilizing a small lumen FilterLine® Microstream capnography that is acquired via
a nasal cannula (non-intubated) or through an adapter set for use in a breathing circuit
(intubated). Microstream can be used on adult, pediatric and neonatal patients.
To begin monitoring Microstream CO2:
1. Connect one end of an exhaust line to the exhaust port on the Spectrum and the other
end to the hospital gas scavenging system.
2. Select CO2 or AUTO as the Resp. Source in the Resp Menu.
CAUTION:
Vacuum (negative pressure) should not exceed 1 mmHg at
the Spectrum Pump Exhaust fitting. Excessive scavenge
vacuum may result in an Occlusion message or damage to
the Spectrum’s internal pump. The scavenging system must
be on during calibration.
3. Open CO2 input door and connect the proper FilterLine® to the Monitor. Connect the
opposite end to the patient.
WARNING: When monitoring CO2 with a Spectrum, the maximum
sampling rate at the nasal cannula is 58 ml/min. This device
should not be used on patients whose breathing could be
impaired by this vacuum flow rate.
WARNING: When monitoring CO2, connection from the exhaust port of
the Spectrum to the hospital’s waste gas scavenging system
is recommended to prevent exposure of hospital personnel
to the patient’s respiratory sample.
NOTE:
2 - 62
Ensure all tubing connections are secure. Ensure that the
nasal cannula is away from all sources of CO2 (including the
patient’s and your own exhaled breath and ventilator
exhaust valves) during the warm up period.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
2.4.6.3
Parameter Menus and Monitoring
Microstream® CO2 Menu
Accuracy verification of the Microstream CO2 is recommended at one (1) year intervals, or
whenever the readings appear to be in error. The date of the last successful calibration
appears on the CO2 Calibration Menu.
FIGURE 2-41 CO2 Menu
NOTE:
For maximum accuracy during calibration, a 20 minute
warm-up time is recommended.
1. Connect the tubing that comes with the calibration gas to the gas canister and to the
FilterLine. Use calibration gas, part number 0075-00-0033-01 and a Microstream
FilterLine®. Attach the gas / tubing assembly to the CO2 input port on the Spectrum.
2. Select the CO2 Parameter Tile by rotating Navigator™ Knob and pressing the
Navigator Knob after the CO2 Menu is highlighted. The same menu can be accessed
by using the Parameters Tile and selecting CO2.
3. Select the Calibrate and press the button on the gas canister to begin releasing the gas
mixture.
NOTE:
Auto zero occurs at the start of the CO2 monitoring session
and periodically throughout the monitoring session. Auto
zero will last approximately 15 seconds.
4. Select Start from the Calibration Menu. Once the Start option has been selected,
no CO2 waveform data will be displayed.
5. The message Calibrating, continue to apply 5% CO2 will appear in the
Calibration Menu.
NOTE:
Spectrum® Operating Instructions
If no gas is being delivered, or the mixture does not contain
5% CO2, the message “Calibration error. Caused by no gas
or wrong gas concentration” will appear. Obtain a new gas
canister and return step 1.
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Parameter Menus and Monitoring
Operations
6. When the proper gas mixture is applied, the message Calibrating, continue to
apply 5% CO2 will appear in the Calibration Menu window. When the calibration
is complete, the message will change to Calculating, calibration gas can be
removed. Release the button and remove the connector from the canister.
7. After a moment, the message will change to Calibration Completed Successfully.
The date and time of the successful calibration will appear in the Calibration Menu.
-
8. Rotate the Navigator™ Knob to Previous Menu and press to select.
9. Rotate the Navigator Knob to Normal Screen and press to return to the monitor’s
normal display screen.
10. When the Spectrum has detected valid breaths, numbers will display for the CO2,
Inspired CO2 and Respiratory Rate.
11. The CO2 respiration waveform and data will automatically replace the ECG Respiration
waveform and data on the display. If respiration wave or data is not displayed, use the
Display Setup Menu to select RESP or CO2 to be displayed as desired.
12. If desired, the CO2 waveform scale can be changed through the CO2 Menu.
CAUTION:
2.4.6.4
Microstream® CO2 waste and CO2 FilterLine® should be
treated as biohazardous waste.
Respiration and CO2 Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Resp. Waveform Too Large
Scales set inappropriately.
Change lead selection.
Resp. Waveform Too Small
Patient breathing is shallow or
patient is turned on side.
Change lead selection.
Scale set inappropriately.
Change respiration scale.
Apnea delay may be
improperly set.
Choose an.other apnea delay
Patient may be having frequent
episodes of CVA.
Reposition electrodes to better
detect respirations.
Change Respiration scale.
False Apnea Alarm
No Resp. Waveform or Rate
Displayed
Change Respiration scale
Respiration turned Off.
Turn respiration On (Off will be
displayed in Resp. window).
Patient connected using ESIS
choke cable.
Check that proper patient cable
is used. Use Mindray non ESIS
patient cable.
Cable not connected.
Check cable.
CO2: FilterLine® Disconnected
The FilterLine is not connected
to the monitor.
Connect the FilterLine.
CO2: Warming Up
The CO2 sensor has not
reached its operating
temperature.
Wait for the message to go
away.
(The monitor was just turned
on).
It takes typically 30 seconds for
the sensor to warm up.
The CO2 sensor is. performing
an auto-zero
Wait for the auto-zero to
complete.
CO2: Auto-zero In Progress
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Scale size may be too low.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
MESSAGE/PROBLEM
REASON
SOLUTION
CO2: Auto-zero Requested
An Auto-zero was
automatically requested by the
system.
Wait for the auto-zero to
complete.
CO2: Failure
CO2 system failure.
Contact Mindray Technical
Support.
CO2: Occlusion
Sampling pump line is blocked
while the CO2 sidestream
pump is on.
Check sampling line and filter
for blockage, clear sampling
line if possible.
Replace sampling line if
necessary.
Disconnect and reconnect the
FilterLine from the Spectrum in
order to clear this message.
CO2: Purge
The system has detected a
blocked FilterLine® and has
attempted to unblock it by
temporarily increasing the flow
rate.
Check FilterLine and replace if
necessary.
CO2: Check Flow Rate
The system has detected a high
or low flow rate.
Check FilterLine and replace if
necessary.
“CHK Lead” Message
Increased impedance caused
by one of the following:
Chest hair under electrodes.
“CVA” Message
Prep chest.
Dried electrode gel.
Change electrodes.
Electrode off.
Replace electrode.
Lead off.
Replace lead.
Cracked lead wires.
Replace lead wires.
Poor skin prep.
Clean and abrade skin before
applying electrodes.
Can be caused by shallow
breathing or an apnea event.
Check the patient.
Patient HR and respiratory rate
identical.
Adjust scales or leads if
necessary.
Check the patient.
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Parameter Menus and Monitoring
2.4.7
Operations
Gas Monitoring with Gas Module
The Gas Module option allows for the measurement of anesthetic gases, O2, N2O and CO2
levels. Measurement can be acquired via a nasal cannula (non-intubated) for oxygen and
CO2 only or through a sampling line connected to a breathing circuit (intubated).
FIGURE 2-42 Gas Menu
NOTE:
The Spectrum will interface to the Gas Module via the Serial
Port Connector on the Comm-Port mounted onto the
Spectrum.
WARNING: When using the Gas Module, the maximum sampling rate at
the nasal cannula is 200 ml/min (120 ml/min for Gas
Module 3 with a neonatal water trap). This device should
not be used on patients whose breathing could be impaired
by this vacuum flow rate.
2 - 66
NOTE:
The Gas Module 3 is equipped with automatic barometric
pressure compensation.
NOTE:
The Gas Module 3 uses a fixed correction of 11 hPa to
compensate for the influence of water vapor in the gas
sample, when converting the gas readings to ATPD. An
increase in the ambient H20 partial pressure to 30 hPa
(i.e. 28 °C, 80% RH or 33 °C, and 60% RH) will cause a
general error for all gases of only -2% REL.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
Monitoring Anesthetic Gases, O2, N2O and/or CO2
NOTE:
To prevent moisture from entering the pneumatic system,
ensure that the Gas Module is always installed and
operated in the horizontal orientation shown in all graphical
depictions.
1. Turn on the Gas Module and Spectrum, and configure the Spectrum serial port to be
used with the Gas Module. Hold the DISCHARGE key in while powering unit on. Set
alarms as desired.
NOTE:
Sample line must be connected to Gas Module when turned
on to avoid Air Leak message (Gas Module II and SE).
7 Foot Nasal Cannula, CO2/O2
P/N 0683-00-0452-10
or
7 Foot Nasal Cannula, CO2
P/N 0683-00-0424-10
Adapter, Straight Tee ET
P/N 0683-00-0242-22
10 Foot Sample Line, Patient
P/N 0683-00-0451-10
Gas Scavenging Adapter Assy.
P/N 0997-00-0923
or
P/N 0997-00-0984
Adapter, Mask Elbow ET
P/N 0683-00-0242-12
FIGURE 2-43 Gas Module II and SE Airway Adapter
7 Foot Nasal Cannula, CO2/O2
P/N 0683-00-0452-10
or
7 Foot Nasal Cannula, CO2
P/N 0683-00-0424-10
Adapter, Straight Tee ET
P/N 0683-00-0242-22
2.5 Meter Sample Line, Patient
Adult/Pediatric P/N 0683-00-0525-25
Neonate P/N 0683-00-0524-25
Gas Scavenging Adapter Assy.
P/N 0997-00-0923
or
P/N 0997-00-0984
Adapter, Mask Elbow ET
P/N 0683-00-0242-12
FIGURE 2-44 Gas Module 3 Airway Adapter
Spectrum® Operating Instructions
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2 - 67
Parameter Menus and Monitoring
NOTE:
Operations
DRYLINE™ Sample Lines are for use with Gas Module 3 only.
2. For non-intubated patients, apply the nasal cannula to the patient. For intubated patients
connect the sample line to the breathing circuit. Refer to instruction provided in the
sample line packets.
3. Connect the other end of the nasal cannula or sample line to the Gas Module at the
input port. Do not connect anything to the reference port on the rear of the Gas Module
II or SE. This port is used to monitor the room air only. Ensure all tubing connections are
tight.
WARNING: Connection of the Gas Module exhaust port to the hospital’s
waste gas scavenging system is strongly recommended to
prevent exposure of hospital personnel to the patient’s
respiratory sample. Vacuum (negative pressure) should not
exceed 1 mmHg at the Gas Module Pump Exhaust fitting.
Excessive scavenge vacuum may result in damage to the
Gas Modules internal pump.
CAUTION:
Contamination with CO2, N2O or Anesthetic Agent in the air
surrounding the Gas Module 3 may cause significant
measurement errors.
4. Check for a clean water trap.
5. Select CO2 or AUTO as the Resp Source in the Resp Menu.
6. Observe the capnogram on the monitor’s display. On Spectrum powerup, O2, Agent
and N2O numbers will display. CO2 numbers will be displayed when a valid breath is
detected.
NOTE:
The Gas Module II and SE must be warmed up a minimum of
two minutes for accurate CO2, O2 and N2O readings and
five minutes for agent readings.
NOTE:
The Gas Module 3 must be warmed up a minimum of 45
seconds for ISO accurate CO2, O2, N2O, and agent readings.
7. If not already set, use the Display Setup Menu to select the gas waveforms to be
displayed.
8. If desired, the gas waveform speed can be changed via the Monitor Setup Menu
and the scale can be changed in the Gas Menu.
2.4.8
Gas Module 3 Pre-use Test
Prior to each use, perform the following test with the Gas Module 3 to verify that the gas
analyzer and sample system are functioning properly:
1. Verify that the appropriate water trap is properly installed and that the appropriate
sampling line is connected.
• DRYLINE™ Adult/Pediatric water trap used with DRYLINE™ Adult/Pediatric sampling
line (colorless Luer lock nut)
• DRYLINE™ Neonatal water trap used with DRYLINE™ Neonatal sampling line (blue
Luer lock nut)
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Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
2. Verify that the water trap container is less than half full.
3. Occlude the sampling line and verify that the occlusion alarm functions properly.
4. Breathe into the sampling line and verify that a CO2 waveform is correctly displayed on
the monitor.
5. Sample room air for 30 seconds and verify that the monitor oxygen output is 20.95%
(± sensor inaccuracy).
2.4.8.1
Gas Monitor Calibration
Accuracy verification of the Gas Module II and SE is recommended at six (6) month intervals
or whenever gas readings appear to be in error. Accuracy verification of the Gas Module 3
is recommended at one (1) year intervals or whenever gas readings appear to be in error.
The date of the last successful mixture calibration appears at the bottom of the gas
Calibration Menu. During the calibration session gas readings and all other gas functions
are not available. Span calibration is a set of prompted commands that enables the operator
to align the gas display(s) to specific gas concentration(s) in the Calibration Gas canister.
Span calibration can be initiated by the operator any time the gas module’s readings are
suspected to be inaccurate.
Always verify accuracy using a full canister of Mindray approved precision calibration gas,
after calibration is performed. Never use calibration gas that has expired, or has a canister
that is indicating low pressure. The pressure indicator on the Mindray gas regulator must
operate in the green zone during the entire calibration session.
NOTE:
The Gas Module II and SE must be fully warmed up before
performing a gas calibration. For maximum accuracy, a
warm-up time of 30 minutes is recommended.
NOTE:
The Gas Module 3 must be fully warmed up before
performing a gas calibration. For maximum accuracy, a
warm-up time of 10 minutes is recommended.
1. Select Calibrate from the Gas Menu. The Calibration Menu opens.
2. Select Gas Selection from the Calibration Menu and choose the calibration gas
type. Choices are: Mixture, 5% CO2, 55% O2, 33% N2O and 2% Des.
3. Select Start to begin calibration.
4. At the start of the calibration, the Gas Module will zero the gas channels. After
successful zeroing, the Gas Module will request the calibration gas.
Spectrum® Operating Instructions
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Parameter Menus and Monitoring
Operations
FIGURE 2-45 Calibration Menu
NOTE:
If the Gas Module cannot zero, a zeroing error will be
displayed and the previous calibration data will be
restored. Repeat the calibration procedure from step 1. If
problems persist, contact Mindray Customer Support.
5. The message Feed Calibration Gas will appear. At this point, attach the calibration
gas canister to the regulator and turn it on. Increasing gas values will appear in the
window as the Gas Module samples the calibration gas.
FIGURE 2-46 Gas Calibration Menu
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0070-10-0648-02
FIGURE 2-47 Gas Calibration Menu
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
6. When sampling is complete, the Feed Calibration Gas message will disappear and
Adjusting will appear next to each value. An Accept menu item will also appear. If
the values are acceptable, select Accept. To cancel calibration and re-install the
previous calibration values, select Abort.
FIGURE 2-48 Gas Calibration Menu
NOTE:
To avoid premature emptying of the gas canister, always
remove the regulator at the end of the procedure.
NOTE:
For Gas Module II and SE, if any channel cannot be
calibrated due to a sampling error, the “Sampling Error”
message will appear. Selecting the “Accept” button will
calibrate only those channels that do not have a sampling
error. If any channel fails calibration, the gas value will be
“XXX”. These channels will appear as “XXX” in the normal
run mode as well. Repeat procedure from step 1. If
problems persist, contact Mindray Customer Support.
NOTE:
For Gas Module 3, if any input data is corrupt or if there are
other errors, a “Calibration Error” message will appear
after the “Accept” button is selected. The Gas Module 3 will
not accept span calibration with errors in any channel.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 71
Parameter Menus and Monitoring
2.4.8.2
Gas Module Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
GM: Warming Up
Appears when the system has been
turned on, and the sensors have not
reached their stable operating
temperature.
Wait for the message to go
away. It takes up to five
minutes for the device to
warm up.
GM: Agent Warming Up
This message appears after the GM:
Warming Up message disappears.
It indicates that the Agent ID Bench is
warming up and readings will not be
available.
Wait for the message to go
away. It takes up to five
minutes from power-up for the
Agent ID Bench to warm up.
GM: Exhaust Blocked
Appears when the system detects a
blockage at the exhaust gas outlet, as
indicated by an increase in internal
pressure.
Remove waste gas
scavenging assembly, check
if message disappears.
Check exhaust line for
blockage and clear if
possible. If message persists
contact Mindray Customer
Support.
GM: Mixed Agents
Appears when more than one
anesthetic agent is detected by the
system.
Message will disappear
when a single agent is
detected again.
GM: Air Leak
Appears when the system detects a
pneumatic leak.
Turn Gas Module and
Spectrum Off.
Also may appear when the Gas
Module has been turned on without a
sample line attached.
Install/check sample lines,
filters, water trap and
electrical connections.
Gas Module has been on for a long
period of time without the Spectrum
Monitor being on.
Turn off Gas Module.Turn on
Gas Module and Spectrum
Monitor.
GM: Replace Trap
Indicates residue build-up on the
water trap membrane that is
decreasing air flow.
Replace water trap reservoir.
GM: Occlusion
Appears when the system detects an
obstruction in the sampling line or the
water trap bottle is full.
Empty and rinse water trap.
Change water trap if
necessary. Check sampling
line and filter for blockage,
clear sampling line if
possible. Replace sampling
line and/or filter if necessary.
Check exhaust line for
blockage and clear if
possible. If problem persists,
contact Mindray Customer
Support.
GM: Zero In Progress
Appears when the system is zeroing
all of it’s channels. This appears
whether initiated by the user or is
automatic.
This is normal operation.
Wait for message to clear.
GM: CO2 Zero Error
Appears when the system has been
unable to successfully zero the CO2
sensor.
Manually start zeroing the
system again. If problem
persists, contact Mindray
Customer Support.
Does not apply to Gas
Module 3.
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Operations
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
MESSAGE/PROBLEM
REASON
SOLUTION
GM: O2 Zero Error
Appears when the system has been
unable to successfully zero the O2
sensor.
Manually start zeroing the
system again. If problem
persists, contact Mindray
Customer Support.
GM: N2O Zero Error
Appears when the system has been
unable to successfully zero the N2O
sensor.
Manually start zeroing the
system again. If problem
persists, contact Mindray
Customer Support.
GM: Agent Zero Error
Appears when the system has been
unable to successfully zero the
anesthetic agent sensor.
Manually start zeroing the
system again. If problem
persists, contact Mindray
Customer Support.
GM: Pump Off
Appears when the system has turned
off the pump due to a pneumatic
error.
Restart the pump from the
Gas Menu. If problem
persists, contact Mindray
Customer Support.
GM: Agent Mismatch HAL
Appears when the system detects
Halothane as the primary agent and
the manually selected agent is not
Halothane.
Match the Agent
administered with the Agent
selected, or select Agent
Auto ID.
GM: Agent Mismatch ISO
Appears when the system detects
Isoflurane as the primary agent and
the manually selected agent is not
Isoflurane.
Match the Agent
administered with the Agent
selected, or select Agent
Auto ID.
GM: Agent Mismatch ENF
Appears when the system detects
Enflurane as the primary agent and
the manually selected agent is not
Enflurane.
Match the Agent
administered with the Agent
selected, or select Agent
Auto ID
GM: Agent Mismatch SEV
Appears when the system detects
Sevoflurane as the primary agent and
the manually selected agent is not
Sevoflurane.
Match the Agent
administered with the Agent
selected, or select Agent
Auto ID
GM: Agent Mismatch DES
Appears when the system detects
Desflurane as the primary agent and
the manually selected agent is not
Desflurane.
Match the Agent
administered with the Agent
selected, or select Agent
Auto ID
GM: Unknown Agent
Appears when the system detects a
gas that does not match the
spectroscopic signatures of the five
known anesthetic agents
Use recognized agent
GM: Cannot Zero...
RETRYING
Appears when the Spectrum
requests Zeroing (either on the
automatic cycle or by a user request)
and the Gas Module is unable to
initialize the cycle
Allow system to retry without
intervention. If problem
persist, contact Mindray
Customer Support.
GM: CO2 Uncalibrated
Appears after an unsuccessful
calibration attempt of the CO2 sensor.
The numeric data for CO2 will appear
as - - -, and the CO2 waveform will be
a flatline
Ensure proper gas mixture is
attached tightly and regulator
is on. Repeat calibration
procedure. If problem
persists, contact Mindray
Customer Support.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 73
Parameter Menus and Monitoring
2 - 74
Operations
MESSAGE/PROBLEM
REASON
SOLUTION
GM: O2 Uncalibrated
Appears after an unsuccessful
calibration attempt of the O2 sensor.
The numeric data for O2 will appear
as - - -, and the O2 waveform will be a
flatline
Ensure proper gas mixture is
attached tightly and regulator
is on. Repeat calibration
procedure. If problem
persists, contact Mindray
Customer Support.
GM: N2O Uncalibrated
Appears after an unsuccessful
calibration attempt of the N2O
sensor. The numeric data for N2O will
appear as - - -, and the N2O
waveform will be a flatline
Ensure proper gas mixture is
attached tightly and regulator
is on. Repeat calibration
procedure. If problem
persists, contact Mindray
Customer Support.
GM: Agents Uncalibrated
Appears after an unsuccessful
calibration attempt of the agent
sensor. The numeric data for all
agents will appear as - - -, and the
agent waveform will be a flatline
Ensure proper gas mixture is
attached tightly and regulator
is on. Repeat calibration
procedure. If problem
persists, contact Mindray
Customer Support.
GM: Failed
Appears when the Gas Module
detects an unrecoverable error in its
own operation
Contact Mindray Customer
Support.
GM: Disconnected
Appears when the Spectrum cannot
detect signals being sent by the Gas
Module
Ensure Gas Module is turned
on and interface cable is
properly connected. If
problem persists, contact
Mindray Customer Support.
Sampling Error
Appears when a sampling error
occurs on one or more Gas Module
channels during calibration
Repeat calibration
procedure. If problem
persists, contact Mindray
Customer Support.
Not Ready For
Calibration
Appears when the Gas Module is
unable to initialize calibration
Repeat calibration
procedure. If problem
persists, contact Mindray
Customer Support.
Calibration Error,
Sampling Error
Appears when a sampling error
occurs in all four Gas Module
channels during calibration
Repeat calibration
procedure. If problem
persists, contact Mindray
Customer Support.
Calibration Error, Zeroing
Error
Appears when the Gas Module
cannot perform a Zeroing during
calibration
Repeat calibration
procedure. If problem
persists, contact Mindray
Customer Support.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
2.4.9
Parameter Menus and Monitoring
IBP - Invasive Blood Pressure Menu (Optional)
Invasive Blood Pressure (IBP) is a direct measurement of the patient's arterial or venous blood
pressure. IBP utilizes a catheter that is inserted directly into a vein, artery or other pressure
access areas, and is connected to a transducer for interpretation of Systolic (Sys), Diastolic
(Dia), and Mean blood pressures.
Invasive Blood Pressure measurement is an option for the Spectrum.
FIGURE 2-49 IBP Menu
IBP1, IBP2, IBP3, IBP4 waveforms may be labeled according to the site of insertion. The
labels are identified in the following table:
LABEL
DEFINITION
Art
Arterial Blood Pressure
UA
Umbilical Artery Pressure
LV
Left Ventricular Pressure
PA
Pulmonary Artery Pressure
CVP
Central Venous Pressure
ICP
Intracranial Pressure
LA
Left Atrial Pressure
RA
Right Atrial Pressure
Spectrum® Operating Instructions
0070-10-0648-02
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Parameter Menus and Monitoring
2.4.9.1
Operations
Measuring IBP
1. Plug the pressure transducer cable into the IBP port(s) on the left side panel, or into the
IBP port(s) on the External Parameter Module.
2. The IBP1 and IBP2 waveforms will appear by default as the fourth and fifth waveform on
the display with its associated data to the right of the waveform. The waveform may be
moved to another location or turned off by accessing the Display Setup Menu. The
IBP3 and IBP4 waveforms and/or data will not appear unless the External Parameter
Module has been enabled and a location has been designated in the Display Setup
Menu.
NOTE:
The arterial pressure catheter should not be used on a limb
that is being utilized for any other medical procedure. For
example, an IV Catheter, NIBP Cuff or an SpO2 sensor.
3. Connect catheter line with flushing device to a pressure transducer.
4. Zero pressure transducer as follows:
a. Open transducer vent to atmosphere.
b. Press ZERO ALL IBP or individually zero pressure lines by opening individual IBP
menus.
After the automatic zero process is complete, the pressure display should indicate zeros.
NOTE:
If the transducer offset should exceed 120 mmHg, it will not
be possible to automatically zero the transducer. Pressure
values will be xxx and an “Unable to Zero” message will
be displayed.
5. Close the pressure transducer vent from atmosphere.
6. Select the desired pressure scale in the IBP Menu.
7. Zero and flush pressure line at regular intervals per standard hospital procedure.
NOTE:
Pressure transducers are protected against the effects of
defibrillation, electrocautery and cerebral perfusion.
Cerebral Perfusion Pressure (CPP)
The monitor will calculate and display CPP under the following conditions:
1. The Hemodynamic Calculation option has been installed in the monitor.
2. One IBP channel has been labeled Art
3. One IBP channel has been labeled ICP
4. Display CPP, located on the ICP parameter menu, has been set to Yes.
NOTE:
2 - 76
CPP data will be displayed in the same parameter tile as the
ICP data.
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Operations
2.4.9.2
Parameter Menus and Monitoring
IBP Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Damped Invasive
Waveform
Air bubbles in tubing.
Eliminate air from tubing.
Kinked catheter.
Change position of catheter,
check patient.
Catheter against wall of blood
vessel.
Check for leaks at connector, flush
catheter.
Blood in tubing
Pump pressure bag up to 300
mmHg.
Catheter partially occluded with
clot.
Consult physician.
Improper Setup.
Check display setup in monitor
setup.
Cable not plugged in
Check cable.
Transducer not connected.
Check transducer connection.
Stopcock turned improperly.
Check transducer.
IBP not Displayed / No
IBP Waveform
Transducer not zeroed.
Check and zero the transducer.
Abnormally High or Low
readings
Transducer too HIGH or to LOW.
Check patient adjust transducer
rezero.
Unable to Zero
Stopcock not open to
atmosphere.
Check transducer.
Cable/Transducer not
plugged in.
Check cable.
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Parameter Menus and Monitoring
2.4.10
Operations
Pulmonary Artery Wedge Pressure (PAWP)
Pulmonary Artery Wedge Pressure (PAWP) is a pressure measurement derived from a PA
catheter when the PA distal balloon is inflated and the catheter advances and occludes a
distal pulmonary artery. PAWP pressure is a reflection of the pressure in the left ventricle at
end-diastole.
PAWP measurement is available if the Hemodynamic Calculation option has been installed
on the monitor and one of the available invasive pressure channels has been labeled PA.
The Wedge Menu may be opened from the PA Menu or by pressing the PAWP key on
the monitor keypad.
FIGURE 2-50 Wedge Menu
2.4.10.1
Measuring PAWP
NOTE:
To ensure accurate wedge pressure readings, rezero the PA
pressure channel and check the PA catheter for integrity,
kinks and/or leaks prior to measurement.
1. Open the PAWP Menu by pressing the PAWP key or by selecting Wedge Menu
from the PA Menu.
NOTE:
Follow manufacturer’s suggested procedures and hospital
policy for PAWP balloon inflation.
2. Inflate balloon, watch PA waveform for wedge waveform.
3. Once a satisfactory wedge waveform is detected, press Measure to freeze the
waveforms within the PAWP Menu.
4. Use the Navigator™ Knob to adjust the reference line to the estimated Wedge
measurement.
5. Press the Navigator knob to return to PAWP Menu choices.
6. Press Accept to enter the PAWP measurement onto the Hemodynamic Calculations
Menu and post the measurement in the PA parameter tile, or select Measure to further
adjust the reference line.
The Reset Waves menu selection will restart the waves scrolling from the left side of the
display. All waves will be restarted.
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Parameter Menus and Monitoring
The Print Wedge menu selection will begin a continuous printout of the top two waveforms
on the Wedge Menu. By default these waveforms are ECG1 and PA. To stop the Wedge
printout, select Print Wedge again.
The Wedge Setup menu selection opens the Wedge Setup Menu. This menu allows you
to make the following changes to the waveforms displayed on the Wedge Menu:
1. Change the parameters displayed in the upper and lower waveform windows
2. Change the scale of the PA waveform
3. Change the speed of the waveforms displayed
The monitor also allows you to use the PA Diastolic (PAD) reading as PAWP.
NOTE:
Please check hospital policy concerning the use of PAD as a
Wedge
To use the Pulmonary Artery Diastolic reading as PAWP, select Accept PAD as Wedge
from the PA Menu. A confirmation prompt will appear. This menu selection will not be
available if the PA Diastolic value is invalid or the pressure channel in use has not been
zeroed.
2.4.10.2
PAWP Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Unable to Wedge
Improper catheter position
Check PA catheter, notify
physician
Catheter against wall or blood
vessel
Flush catheter, notify physician
PA catheter in
Spontaneous Wedge
Catheter in too far
Notify physician immediately
“Overwedging” or
dampened PAWP
Balloon overinflated
Deflate balloon, reinflate slowly,
notify physician
Spectrum® Operating Instructions
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Parameter Menus and Monitoring
2.4.11
Operations
Cardiac Output (CO) (Optional)
Cardiac Output (CO) is the amount of blood ejected from the left ventricle each minute,
expressed in liters per minute (l/min). Cardiac Index (CI) is the Cardiac Output divided by
the patient's body surface area. The following two optional interfaces can be used to
measure CO:
• the Mindray External Parameter Module (EPM)
(P/N 0998-00-0501-01X and 0998-00-0501-03X)
• the Edwards Vigilance® Monitor (Vigilance)
CO can be monitored when Patient Size is set to either Adult or Pediatric and:
1. When the Hemodynamics Option is installed and the EPM is enabled in
the Installation Menu
and/or
2. When the Vigilance Option is installed and a serial port is set to Vigilance
in the Installation Menu
Cardiac Output cannot be monitored when Patient Size is set to Neonate.
2.4.11.1
External Parameter Module (EPM)
Intermittent (bolus) CO can be monitored through a Mindray EPM. If a tile has been set to
display CO from the Display Setup Menu, when measuring intermittent CO with the EPM,
the CO tile will be displayed as shown in the example of FIGURE 2-51. The “@ 3:06 PM”
label shown in the example is a “time stamp” that indicates the time at which the displayed
measurement occurred. A “Source” label indicates the source of the CO. The units of
measure for each parameter are: CO - l/min, CI - l/min/m2
NOTE:
CO
CI
If the “CO & PAWP Timeout” setting in the Installation
Menu is exceeded, the CO and CI numeric data in the CO
tile will be replaced by dashes and the “time stamp” will be
removed.
5.4 l/min
2.7
l/min/m2
@ 3:06 PM
Source: Module
FIGURE 2-51 Example CO tile with Intermittent Cardiac Output from the EPM
Optimizing EPM CO Measurements
1. From the PA catheter package insert, verify the correct computation constant for the
catheter type, injectate volume, and injectate temperature. If the computation constant is
different than the monitor’s factory default of 0.500, it must be changed.
2. Verify proper PA catheter positioning.
3. Purge system of air.
4. Use correct injectate port.
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Operations
Parameter Menus and Monitoring
5. Inject correct volume in smooth motion.
6. Edit erroneous values from average.
2.4.11.1.1
EPM CO Setup
1. Ensure that the Spectrum is powered OFF.
2. Connect the EPM to the Spectrum as follows:
a. Align the EB1 Module Connector on the EPM with the EM1 External Parameter
Module Port on the rear of the Spectrum.
b. Slide the EPM and the Spectrum together, using the Guide Pins on the EPM to
guide the EB1 connector into the EM1 port. The Module Latches on the EPM will
secure it to the Spectrum.
3. Power ON the Spectrum while holding down the DISCHARGE key to enter into its
Installation Mode.
4. From the Spectrum Installation Menu, set “Enable EPM” to “Yes” and then select “Save
Current”.
5. Restart the Spectrum to enter normal monitoring mode.
6. From the Patient menu of the main screen, set Patient Size to either Adult or Pediatric.
7. Open the Cardiac Output Menu (shown in FIGURE 2-52) in one of the following
three ways:
• by choosing CO from the Parameters Menu
• by pressing the C.O. key on the front panel keypad
• by pressing the C.O. key on the EPM keypad
8. Open the CO Setup Menu by choosing CO Setup Menu from the Cardiac
Output Menu.
FIGURE 2-52 Cardiac Output Menu
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Parameter Menus and Monitoring
2.4.11.1.2
Operations
CO Setup Menu
FIGURE 2-53 CO Setup Menu
Auto Start
With the EPM, there are two modes of operation: Auto Start and Manual. To choose the
desired mode of operation, open the CO Setup Menu (shown in FIGURE 2-53) and set
Auto Start to either On or Off.
In Auto Start Mode (when Auto Start is set to On), the monitor automatically displays the
prompt Inject when Ready upon achieving a baseline blood temperature. When injection
is completed, the Spectrum computes the CO and is ready to start another bolus injection.
In Manual Mode (when Auto Start is set to Off), the monitor will display the message
Ready when a baseline blood temperature is achieved. Manual mode of operation is
similar to Auto Start except that you must press Start CO Run or the C.O. key on the
Monitor or Module prior to each injection.
NOTE:
Refer to the catheter package insert provided with each PA
catheter for the appropriate computation constant, specific
instructions on catheter placement and use, warnings,
cautions, and specifications.
WARNING: Do not use a damaged or broken unit or accessory.
Computation Constant
Computation Constant is used to change the monitor’s factory default of 0.500 with the
appropriate computation constant from the PA catheter package insert.
CO Time
CO Time is used to adjust the time period for the current CO Run window shown in the top of
the Cardiac Output Menu. Choices are 30 sec and 60 sec.
CO Scale
CO Scale is used to adjust the temperature scale for the current CO Run window shown in
the top of the Cardiac Output Menu. Choices are 0.5 ºC, 1 ºC, 2 ºC and 4 ºC.
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Parameter Menus and Monitoring
CO Source
As noted in the introduction to the Cardiac Output section, CO can also be measured
through an Edwards Vigilance® Monitor. If both the EPM and the Vigilance are connected
and the Installation Menu is properly configured, CO Source enables the user to choose
either device as the source for CO. A detailed description of this configuration is provided in
the CO from both Vigilance and EPM section.
2.4.11.1.3
Measuring Cardiac Output with the EPM
WARNING: Inaccurate Cardiac Output measurements may be caused
by:
•
Incorrect placement or position of the catheter
•
Excessive variation in pulmonary artery blood
temperature
•
Clot formation on the thermistor
•
Anatomical abnormalities, (for example, cardiac shunts)
•
Excessive patient movement
•
Repeated intermittent flushes of cold fluid through the
fluid lumens of the catheter
•
Use of a manual pump such as the Abbott® Blood Set
with Pump and CAIR clamp
•
Electrocautery or electrosurgical unit interference
•
Rapid changes in cardiac output
•
Using an incorrect computation constant
Auto Start On (Auto Mode)
1. Connect the proper Cardiac Output cable and PA catheter. Open the CO Setup Menu
and set Auto Start to On. From the PA catheter package insert, verify the correct
computation constant for the catheter type, injectate volume, and injectate temperature.
Set the Computation Constant as necessary if it is different than the monitor’s factory
default of 0.500. Return to the Cardiac Output Menu.
2. When a stable baseline blood temperature is obtained, the Inject when Ready
message will be displayed. Proceed with a bolus injection.
CAUTION:
Sudden changes in blood temperature such as those caused
by bolus drug administration may cause a CO or CI value to
be computed. To avoid falsely triggered curves, inject as
soon as possible after the “Inject when Ready” message is
displayed.
3. Once a bolus is injected, the CO curve appears, the Measuring message is displayed,
and the resultant CO measurement is displayed.
NOTE:
Spectrum® Operating Instructions
If a measurement is compromised, as indicated by an
Irregular Curve or Injectate Temp Error alert message, the
curve will be displayed in Red and an X mark will be
displayed in the box.
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Parameter Menus and Monitoring
Operations
4. Note the injectate temperature and verify that the correct computation constant was set.
5. Subsequent cardiac output runs can be performed as desired when the Inject when
Ready message reappears.
6. When sufficient CO runs are completed, use Edit CO Runs to choose the runs to be
computed in the CO Average. Runs that have green waveform data and a check mark
( ) in the box will be included in the average. Runs that have red waveform data and
an X mark (X) in the box will be excluded from the average.
7. Select the Accept Average key to accept and store the CO Average.
8. To display Cardiac Index (CI), the patient weight and height must be entered via the CO
Setup Menu or the Patient Menu.
Auto Start Off (Manual Mode)
1. Connect the proper Cardiac Output cable and PA catheter. Open the CO Setup Menu
and set Auto Start to Off. From the PA catheter package insert, verify the correct
computation constant for the catheter type, injectate volume, and injectate temperature.
Set the Computation Constant as necessary if it is different than the monitor’s factory
default of 0.500. Return to the Cardiac Output Menu.
2. When a stable baseline blood temperature is obtained, the Ready message will be
displayed. Select Start CO Run or the C.O. key on the Monitor or Module and the
Inject Now message will be displayed. Proceed with a bolus injection.
NOTE:
You have a maximum of 30 seconds in which to inject
following Start CO Run. If no injection is detected within this
time interval, the display returns to Ready until you choose
to resume the measurement sequence.
3. Once a bolus is injected, the CO curve appears, Measuring message is displayed,
and the resultant CO measurement is displayed.
NOTE:
If a measurement is compromised, as indicated by an
Irregular Curve or Injectate Temp Error alert message, the
curve will be displayed in Red and an X mark will be
displayed in the box.
4. Note the injectate temperature and verify that the correct computation constant was set.
5. Subsequent CO runs can be performed as desired when the Ready message
reappears.
6. When sufficient CO runs are completed, use Edit CO Runs to choose the runs to be
computed in the CO Average. Runs that have green waveform data and a check mark
( ) in the box will be included in the average. Runs that have red waveform data and
an X mark (X) in the box will be excluded from the average.
7. Select the Accept Average key to accept and store the CO Average.
8. To display Cardiac Index (CI), the patient weight and height must be entered via the CO
Setup Menu or the Patient Menu.
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Spectrum® Operating Instructions
Operations
2.4.11.1.4
Parameter Menus and Monitoring
EPM Cardiac Output Troubleshooting
MESSAGE/
PROBLEM
CO value higher /
lower than expected
No measurement/
Unable to measure
REASON
SOLUTION
Computation constant incorrect for PA
catheter type, injectate temperature,
and injectate volume.
Check computation constant
and enter correct data.
Catheter may be kinked or not in proper
position.
Notify physician.
Unstable temperature.
Check injectate temperature.
No temperature or temperature out of
range.
Flush PA catheter.
Time elapsed for measurement.
Discard bolus fluid.
Check patient.
Wait for Ready or Inject
when Ready message to
appear. Rebolus when ready.
CO Signal Under
Range
Appears if the CO curve is not sufficient
for a CO calculation or if a curve is not
detected within thirty (30) seconds
Rebolus if necessary
CO Out of Range
Appears if the CO is out of the
measurable range
(0.2 l/min to 20.0 l/min). Computation
constant incorrect for PA catheter type,
injectate temperature, and injectate
volume.
Check computation constant
and enter correct data. Rebolus
when ready.
Irregular curve
Improper injection procedure.
Check hospital policy, inject in
a smooth and fluid bolus.
Catheter may be kinked or not in proper
position.
Notify physician.
Patient movement during injection.
Have patient lay still during
bolus procedure.
Measurement displayed if CO curve
has multiple peaks, failure to return to
baseline or irregularities in curve.
Rebolus when ready
Appears if the time between the start of
the CO measurement and the onset of
the temperature change is more than
fifteen (15) seconds
Rebolus when ready.
Injectate Temp Error
Appears when the temperature of the
injectate is too warm (>27ºC) or the
difference between the injectate and the
blood temperature is <8ºC.
Check injectate fluid, insure
fluid is not under warm lights,
near a warming blanket or
another warm source.
Noisy Baseline
Cardiac Output waveform baseline is
unstable
Rebolus when ready.
Measuring
Appears once an injection is detected
during the process of a CO run.
Injectate Temp. Out
of Range
Appears when the temperature of the
injectate is too warm (>27ºC) or the
difference between the injectate and the
blood temperature is <8ºC.
Delayed Injection
Spectrum® Operating Instructions
0070-10-0648-02
Ensure that the CO bolus is
initiated within 15 seconds
Check the temperature of the
injectate
Check injectate fluid, insure
fluid is not under warm lights,
near a warming blanket or
over-chilled in the ice bath.
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Parameter Menus and Monitoring
Operations
MESSAGE/
PROBLEM
2.4.11.2
REASON
SOLUTION
Inject When Ready
Appears if Auto Start is enabled,
stable temperatures are detected
Bolus when ready
Ready
Appears if Auto Start is not enabled,
and stable temperatures are detected
Press START when ready
Inject Now
Appears once START has been
pressed, before bolus is initiated
Bolus when ready
Please Wait
Appears after fluid bolus is initiated and
Cardiac Output is being calculated
Wait until message disappears
Edwards Vigilance® Monitor (Vigilance)
For questions regarding the use and maintenance of the Edwards Vigilance® Monitor, refer
to its operator’s manual or contact Edwards Lifesciences Corporation for assistance. Within
the USA: (800)-424-3278, Outside the USA: (949)-250-2500.
The standard Edwards Vigilance Monitor measures both intermittent and continuous cardiac
output (CO), as well as T Blood. It can also be optionally configured to measure continuous
mixed venous oxygen saturation (SvO2). Intermittent CO uses the bolus thermodilution
method, while continuous CO uses a pulmonary artery catheter to introduce small pulses of
energy into the blood and then record the blood temperature. SvO2 is measured by a
spectrophotometric technique that uses light emitting diodes to transmit light in the red and
infrared spectra through an optical fiber in a pulmonary artery catheter to the blood.
The Vigilance can be interfaced with the Spectrum. This enables Vigilance CO, T Blood
and SvO2 data to be displayed and trended at the Spectrum, as well as providing alarm
control for these parameters. The Spectrum uses T Blood data from Vigilance to derive ΔT
which can also be displayed and trended, as well as providing alarm control.
At the Spectrum, the CO value is divided by the patient’s BSA (Body Surface Area) to
calculate and display a corresponding cardiac index (CI). The BSA is determined from the
patient’s height and weight as entered in the Spectrum.
When measuring continuous cardiac output, the CO tile on the main screen of the
Spectrum will be displayed as shown in the example of FIGURE 2-54. The “@Cont” label in
the example CO tile indicates that the displayed measurements are continuous. If the
Vigilance is used for intermittent CO measurements, an “@XX:XX” label will be displayed.
This label is a “time stamp” where XX:XX = the time at which the displayed measurements
occurred. A “Source” label indicates the source of the cardiac output. The units of measure
for each attribute are: CO - l/min, CI - l/min/m2, SvO2 - %
NOTE:
2 - 86
If the Edwards Vigilance Monitor is powered off or
disconnected from the Spectrum, the CO tile will
be removed from the display.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Parameter Menus and Monitoring
CO
SvO2
CI
5.4
2.7 85%
@ Cont
l/min
l/min/m2
Source:
Vigilance
FIGURE 2-54 Example CO tile with Continuous Cardiac Output from Vigilance
The setup and patient connections for the Vigilance must be completed as instructed in the
Edwards Vigilance Monitor Operator’s Manual.
To display Vigilance cardiac output measurements at the Spectrum, the two devices must be
physically configured as follows:
• the Spectrum must be equipped with an optional Comm-Port that contains serial port
interface SP1 and/or SP2
• the two devices must be interfaced using the Vigilance/PC Interface cable (serial port to
serial port) (P/N 0012-00-1275-01) as described in step 1 of the following section.
2.4.11.2.1
Vigilance CO Setup
1. Both ends of the Vigilance/PC Interface cable are identical. Before it is connected,
ensure that the Vigilance and the Spectrum are powered OFF. Connect one end of the
cable to the Spectrum at a serial port (SP1 or SP2) that is located on the optional
Comm-Port. Connect the other end of the cable to the Vigilance at the COM 1 port.
2. Power ON the Vigilance and then power ON the Spectrum while holding down the
DISCHARGE key to enter into its Installation Mode.
3. Set a serial port to “Vigilance” and then select “Save Current”.
4. Restart the Spectrum to enter normal monitoring mode.
5. From the Patient menu of the main screen, set Patient Size to either Adult or Pediatric.
6. Open the Vigilance CO Menu by choosing CO from the Parameters Menu or by
pressing the C.O. key on the front panel keypad.
NOTE:
Spectrum® Operating Instructions
The C.O. key on the EPM keypad does not function when the
Spectrum is configured to monitor Vigilance cardiac output
measurements.
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Parameter Menus and Monitoring
2.4.11.2.2
Operations
Vigilance CO Menu
The Vigilance CO Menu enables the user to:
• set the patient height and weight to be used in calculating cardiac index (CI)
NOTE:
Other menus also use patient height and weight data. When
this data is changed in any menu, it is automatically
updated in the other menus.
• choose the source for cardiac output
• access the Hemodynamics Calculations Menu (a description of the Spectrum
Hemodynamics Calculation method is provided in section 2.5.2)
• choose the color of the data that will display in the CO tile
FIGURE 2-55 Vigilance CO Menu
CO Source
As noted in the introduction to the Cardiac Output section, CO can also be measured
through an EPM. If both the EPM and the Vigilance are connected and the Installation Menu
is properly configured, CO Source enables the user to choose between either device as the
source for CO. A detailed description of this configuration is provided in the CO from both
Vigilance and EPM section.
2.4.11.2.3
Vigilance Cardiac Output Troubleshooting
MESSAGE/
PROBLEM
CO: Check Vigilance.
REASON
SOLUTION
This message is displayed when an
alert or alarm status has been sent
from the Vigilance to the Spectrum.
Refer to the Edwards Vigilance®
Monitor Operator’s Manual or
contact Edwards Lifesciences
Corporation for assistance.
Within the USA: (800)-424-3278
Outside the USA: (949)-250-2500
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Spectrum® Operating Instructions
Operations
2.4.11.3
Parameter Menus and Monitoring
CO from both Vigilance and EPM
If switching between Vigilance CO and EPM CO is desired, proceed as follows:
1. Setup the EPM as described in steps 1 and 2 of the EPM CO Setup section.
2. Setup the Vigilance as described in step 1 of the Vigilance CO Setup section.
3. Power ON the Vigilance and then power ON the Spectrum while holding down the
DISCHARGE key to enter into its Installation Mode.
4. Set “Enable EPM” to “Yes”, set a serial port to “Vigilance” and then select “Save
Current”.
5. Restart the Spectrum to enter normal monitoring mode.
6. From the Patient menu of the main screen, set Patient Size to either Adult or Pediatric.
7. Open the Cardiac Output Menu (shown in FIGURE 2-52) in one of the following
three ways:
• by choosing CO from the Parameters Menu
• by pressing the C.O. key on the front panel keypad
• by pressing the C.O. key on the EPM keypad
8. Open the CO Setup Menu by choosing CO Setup Menu from the Cardiac
Output Menu.
EPM CO
Refer to the CO Setup Menu section.
Vigilance CO
a. Choose “CO Source” from the CO Setup Menu, select “Vigilance” and then close
the CO Setup Menu.
b. Open the Vigilance CO Menu by choosing CO from the Parameters Menu or
by pressing the C.O. key on the front panel keypad.
NOTE:
The C.O. key on the EPM keypad does not function when the
Spectrum is configured to monitor Vigilance cardiac output
measurements.
c. Refer to the Vigilance CO Menu section 2.4.11.2.2.
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Calculations
2.5
Operations
Calculations
The Spectrum supports two types of calculation packages: Drug / IV Medications and
Hemodynamics. Calculations are accessible through the Functions Menu.
2.5.1
Drug Calculations
The Spectrum has the ability to calculate and display IV drug infusion rate and
concentration based upon patient weight and/or drug dosage.
Drug calculations may also be accessed through the Patient Menu. Drug calculations are
only available if the Patient Size is set to Adult.
Drug Calculation Formulas
For Drug Concentration, the Spectrum uses the following formula:
( Drug Amount)
------------------------------------------------------- = Concentration
( Solution Volume)
For weight-based Drug Infusion Rate, the Spectrum uses the following formula:
(Dose Ordered) x (Weight in kg) x (Solution Volume)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- = Infusion Rate ( ml/hr )
(Drug Amount)
For non-weight-based Drug Infusion Rate, the Spectrum uses the following formula:
( Dose Ordered) x (Solution Volume)
------------------------------------------------------------------------------------------------------------------------------- = Infusion Rate ( ml/hr )
( Drug Amount)
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Operations
Calculations
Drug Calculator
When “Drug Calculator” is chosen from the Patient Menu or the Functions Menu, the
Drug Calculator is displayed. An example Drug Calculator that is set for a weightbased drug is shown in FIGURE 2-56.
FIGURE 2-56 Drug Calculator set for a weight-based drug
The following table describes the menu structure of the Drug Calculator:
Drug Calculator Menu Structure
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
Normal Screen
ACTIONS/
COMMENTS
Select to return to normal
screen.
Drug Name
See the “GENERIC
NAME” and “BRAND
NAME” columns of the
table in the Adult
Medication Choices
subsection. The Drug A –
D choices are for drugs
that are not listed in the
table.
Unspecified
Select to choose
medication.
Weight
1 to 1100 lbs or
1 to 500 kg
Unspecified
Select to enter or change
patient weight.
*
When any one of the menu items marked with an asterisk (*) is changed, the others are
automatically updated.
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Calculations
Operations
Drug Calculator Menu Structure (Continued)
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
Drug Units
mcg, mg, g, units, mU
mcg for Drug A, B,
C or D. For drugs
listed in the table in
the Adult
Medication
Choices
subsection, see the
“DEFAULT UNITS”
column.
ACTIONS/
COMMENTS
This menu item is only
selectable if Drug A, B, C
or D is chosen.
Otherwise, the default
unit for the specified drug
is used. If Drug Units are
changed for Drug A, B,
C or D, Drug Amount,
Solution Volume, Dose/
min, Dose/hr, Dose/kg/
min and Dose/kg/hr will
be reset to blank fields
and Infusion Rate and
Concentration will be
invalidated.
Select to enter or change
drug units.
Drug Amount
Based on current Drug
Units setting.
Select to enter amount of
drug in IV bag.
Solution Volume
10 to 1000 ml
Select to enter volume of
solution in IV bag.
Dose/min*
0.01 to 10000.00
If the chosen drug is
Vasopressin, the
Default is 0.200
Select to enter dosage of
drug to be infused per
minute.
For all other drugs,
the Default is 1.00
Dose/hr*
0.01 to 10000.00
If the chosen drug is
Vasopressin, the
Default is 12.00
Select to enter dosage of
drug to be infused per
hour.
For all other drugs,
the Default is 60.00
Dose/kg/min*
Dose/kg/hr*
If the chosen drug is
Milrinone, 0.005 to
2.000
If the chosen drug is
Milrinone, the
Default is 0.375
For all other drugs, 0.01
to 10000.00
For all other drugs,
the Default is 1.00
If the chosen drug is
Milrinone, 0.300 to
120.000
If the chosen drug is
Milrinone, the
Default is 22.500
For all other drugs, 0.01
to 10000.00
For all other drugs,
the Default is 60.00
Infusion Rate
*
2 - 92
Select to enter dosage of
drug to be infused per
minute based upon
patient weight. Please
verify patient weight.
Select to enter dosage of
drug to be infused per
hour based upon patient
weight. Please verify
patient weight.
This menu item is
automatically calculated
as previously described
in this section using the
values entered for other
menu items.
When any one of the menu items marked with an asterisk (*) is changed, the others are
automatically updated.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Calculations
Drug Calculator Menu Structure (Continued)
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
Concentration
Print Units
ACTIONS/
COMMENTS
This menu item is
automatically calculated
as previously described
in this section using the
values entered for other
menu items.
Dose/min, Dose/hr,
Dose/kg/min, Dose/kg/
hr
Dose/kg/min
(when the chosen
drug is weightbased)
Dose/min (when the
chosen drug is nonweight-based)
This menu item is
automatically populated
with the appropriate
default when: 1) a Drug
Name is chosen, 2) the
patient Weight is
specified (for a weightbased drug), and
3) Dose/min, Dose/hr,
Dose/kg/min or Dose/
kg/hr is specified.
If the dose is entered as
Dose/min, then the menu
choices will be Dose/min
or Dose/hr.
If the dose is entered as
Dose/kg/min, then the
menu choices will be
Dose/kg/min or Dose/
kg/hr.
If the dose is entered as
Dose/hr, then Dose/hr
will be the only menu
choice for the Print Units.
If the dose is entered as
Dose/kg/hr, then Dose/
kg/hr will be the only
menu choice for the Print
Units.
If the chosen drug is
Milrinone, then Dose/
kg/min will be the only
menu choice for the Print
Units.
Print Table
*
Select to print Drug
Calculation data.
When any one of the menu items marked with an asterisk (*) is changed, the others are
automatically updated.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 93
Calculations
Operations
The following table details adult medication choices:
Adult Medication Choices
GENERIC
NAME
BRAND NAME
1
DEFAULT
UNITS
DEFAULT
SOLUTION
VOLUME
DEFAULT
DRUG
AMOUNT
Theophylline
Y
mg
500 ml
500 mg
Cardizem
N
mg
125 ml
125 mg
Dobutamine
Dobutrex
Y
mcg
250 ml
500 mg
Dopamine1
Inotropin
Y
mcg
250 ml
400 mg
Epinephrine
HCL1
Adrenalin
N
mcg
250 ml
1mg
Esmolol HCL1,2
Brevibloc
Y
mcg
500 ml
5000 mg
Fentanyl Citrate1
Sublimaze
Y
mcg
100 ml
5 mg
Aminophylline
Diltiazem1
1
1
Heparin
N
units
250 ml
12,500 units
Inamrinone
Lactate1
Inocor
Y
mcg
250 ml
500 mg
Insulin, Regular1
Humulin
N
units
100 ml
100 units
Isoproterenol
HCL1
Isuprel HCL
N
mcg
500 ml
2 mg
Labetalol HCL1,2
Normodyne
N
mg
200 ml
200 mg
Lidocaine HCL1,2
Xylocaine HCL
N
mg
500 ml
2000 mg
Lorazepam
Ativan
N
mg
500 ml
40 mg
Midazolam
HCL1,2
Versed
Y
mg
125 ml
125 mg
Milrinone
Lactate1,2
Primacor
Y
mcg
200 ml
20 mg
Nicardipine
HCL1
Cardene
N
mg
250 ml
25 mg
Nitroglycerin1
Tridil
N
mcg
250 ml
50 mg
Nitroprusside
Sodium1
Nipride
Y
mcg
250 ml
50 mg
Norepinephrine1
Levophed
N
mcg
250 ml
4 mg
Phenylephrine1
Neosynephrine
N
mcg
250 ml
10 mg
Procainamide
HCL1
Pronestyl
N
mg
500 ml
2000 mg
Propofol1
Diprivan
Y
mcg
50 ml
500 mg
Vasopressin2
Pitressin
N
units
250 ml
250 units
Heparin Sodium
1
2
2 - 94
IS THE PATIENT’S
WEIGHT USED IN
THE
CALCULATION?
Gahart B and Nazareno A. 2002 Intravenous Medications. St. Louis: Mosby, 2001.
Algozzine G, Algozzine R, and Lilly D. Critical Care Intravenous Infusion Drug Handbook.
St. Louis: Mosby, 2002.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
2.5.2
Calculations
Hemodynamic Calculations
Hemodynamic calculations are a set of values that are used to determine the hemodynamic
status of the patient. The values that are necessary for these calculations are Patient
Height, Patient Weight, Cardiac Output, Heart Rate, Mean Arterial Pressure,
Mean PA, Wedge and Central Venous Pressure.
All manually entered values (such as PAWP) are denoted with an asterisk (*). The following
values are calculated and trended: CI, SV, SVI, SVR, SVRI, PVR, PVRI, LCW, LCWI, RCW,
RCWI, LVSW, LVSWI, RVSW, and RVSWI.
NOTE:
Calculated patient parameters contain more decimal places
of accuracy than are displayed on the screen (e.g., a CO of
2.4 may be a CO of 2.4492). Consequently, attempts to
verify the accuracy of the monitor’s display using the
following equations may produce results that are slightly
different from the data computed by the monitor.
Hemodynamic Calculations
ABBREVIATION /
UNITS
DESCRIPTION
FORMULA
CI (l/min/m2)
Cardiac Index
CO / BSA
BSA (m2)*
Body Surface Area
Ht0.725(cm) x Wt0.425(kg) x 0.007184
SV (ml)
Stroke Volume
(CO / HR) x 1000
2)
Stroke Volume Index
SV / BSA
SVR (dyne-sec/cm5)
Systemic Vascular
Resistance
((ART mean-CVP) / CO) x 79.96
SVRI (dyne-sec/cm5/m2)
Systemic Vascular
Resistance Index
SVR x BSA
PVR (dyne-sec/cm5)
Pulmonary Vascular
Resistance
((PA mean-PAWP) / CO) x 79.96
PVRI (dyne-sec/cm5/m2)
Pulmonary Vascular
Resistance Index
PVR x BSA
LCW (kg-m)
Left Cardiac Work
0.0136 x ART mean x CO
LCWI (kg-m/m
Left Cardiac
Work Index
LCW / BSA
RCW (kg-m)
Right Cardiac Work
0.0136 x PA mean x CO
RCWI (kg-m/m2)
Right Cardiac Work Index
RCW / BSA
LVSW (gm-m)
Left Ventricular Stroke
Work
SV x (ART mean-PAWP) x 0.0136
LVSWI (gm-m/m2)
Left Ventricular Stroke
Work Index
LVSW / BSA
RVSW (gm-m)
Right Ventricular Stroke
Work
SV x (PA mean - CVP) x 0.0136
RVSWI (gm-m/m2)
Right Ventricular Stroke
Work Index
RVSW / BSA
SVI (ml/m
2)
*
Dubois’ equation
Spectrum® Operating Instructions
0070-10-0648-02
2 - 95
Alarms
2.6
Operations
Alarms
The Spectrum monitor provides a broad range of alarm settings. For detailed information
see “Alarm Limits”. Settings for alarm delay times are also available.
FIGURE 2-57 Alarm Limits Menu
2.6.1
Adjusting Alarms
Setting Parameter Alarm Limits
1. To access the Alarms Limits Menu press the ALARMS LIMITS key. The main
Alarm Limits Menu displays.
2. Use the Navigator™ Knob to set alarm limits as desired for currently monitored
parameters.
3. To save alarm limit settings as the default, select Save Current from the Monitor
Setup Menu.
NOTE:
Alarm Limits are not saved when the monitor is turned off,
unless you select Save Current from the Monitor Setup
Menu.
4. To set alarm limits for any parameter not currently monitored or to adjust the priority level
of any alarm select Alarm Setup from the Alarm Limits Menu. The Alarm Setup
menu also provides options for setting alarm delay times and alarm muting features.
FIGURE 2-58 Alarm Setup Menu
2 - 96
0070-10-0648-02
Spectrum® Operating Instructions
Operations
2.6.2
Alarms
Alarm Limits
A separate table of alarm limit settings is maintained for each patient size. When the patient
size is changed, the appropriate selections are automatically used. See table below for
alarm ranges. Default settings appear in bold text.
HIGH
LOW
PARAMETERS
ADULT
PED
NEONATE
ADULT
PED
NEONATE
Heart Rate (bpm)
Except France
Off,
60-250
Off,
100-300
Off,
100-350
Off,
30-120
Off,
30-150
Off,
30-200
Heart Rate (bpm)
France
120,
60-250
150,
100-300
175,
100-350
30,
30-120
50,
30-150
70,
30-200
PVC/min
Off, 1-30
Run
Off, 4-8
ST Single
Lead (mm)
Off, +0.5 to +10.0 (Elevation)
Off, -0.5 to -10.0 (Depression)
ST Dual
Lead (mm)
Off, +0.5 to +10.0 (Elevation)
Off, -0.5 to -10.0 (Depression)
NIBP Sys (mmHg)
Off,
70-240
Off,
40-180
Off,
40-180
Off,
50-150
Off,
15-130
Off,
15-130
NIBP Mean
(mmHg)
Off,
60-200
Off,
50-180
Off,
40-160
Off,
40-140
Off,
10-100
Off,
10-70
NIBP Dia (mmHg)
Off,
40-130
Off,
50-100
Off,
50-100
Off,
30-120
Off,
10-50
Off,
10-50
IBP Sys (mmHg)
Off,
5-300
Off,
5-240
Off,
5-180
Off,
0-150
Off,
0-130
Off,
0-130
IBP Mean (mmHg)
Off,
5-150
Off,
5-100
Off,
5-100
Off,
2-100
Off,
2-50
Off,
2-50
IBP Dia (mmHg)
Off,
0-140
Off,
0-100
Off,
0-70
Off,
0-120
Off,
0-100
Off,
0-50
SpO2 (%)
Off,
80-100
Off,
80-100
Off,
80-100
50-99
85
50-99
85
50-99
85
Temp (ºF)
Off, 95-110
Off, 80-100
Temp (ºC)
Off, 35-43
Off, 26-38
T blood (ºF)
Off, 95-110
Off, 80-100
T blood (ºC)
Off, 35-43
Off, 26-38
Delta Temp (ºF)
Off, 2-10
Off, 2-10
Delta Temp (ºC)
Off, 1-5
Off, 1-5
Resp Rate (rpm)
Off,
10-100
Off,
5-40
Off,
5-50
ET CO2 (mmHg)
Off, 20-80
60
Off, 5-50
ET CO2 (%)
Off, 2.0-10.0
8.0
Off, 1.0-6.0
ET CO2 (kPa)
Off, 2.0-10.0
8.0
Off, 1.0-6.0
Insp CO2 (mmHg)
Off, 5-30
10
Off,
15-150
Insp CO2 (%)
Off, 1.0 - 4.0
Insp CO2 (kPa)
Off, 1.0 - 4.0
Spectrum® Operating Instructions
0070-10-0648-02
Off,
30-200
Off,
5-30
2 - 97
Alarms
Operations
HIGH
LOW
PARAMETERS
ADULT
PED
NEONATE
ADULT
PED
NEONATE
ET O2
Off,
40-100
Off,
40-100
Off,
40-100
Off,
10-60
Off,
10-60
Off,
10-60
Insp O2
Off,
40-100
Off,
40-100
Off,
40-100
18-60
18-60
18-60
ET N2O
Off,
10-80
Off,
10-80
Off,
10-80
Off,
5-70
Off,
5-70
Off,
5-70
Insp N2O
10-80
Off,
5-70
Off,
5-70
Off,
5-70
Apnea Delay
(seconds)
10-60
30
10-20
15
CCO (l/min)
Off,
1.0-20.0
Off,
1.0-20.0
Off,
1.0-20.0
Off,
1.0-20.0
CCI (l/min/m2)
Off,
1.0-20.0
Off,
1.0-20.0
Off,
1.0-20.0
Off,
1.0-20.0
SvO2 (%)
Off,
10-99
Off,
10-99
Off,
10-99
Off,
10-99
10-80
10-80
10-20
15
Alarm Parameters (Gas Module)
PARAMETERS
HIGH
LOW
Insp. Hal
Off, 2-10
Off, 0.5-5
ET Hal
Off, 2-10
Off, 0.5-5
Insp. Iso
Off, 2-10
Off, 0.5-5
ET Iso
Off, 2-10
Off, 0.5-5
Insp. Enfl
Off, 2-10
Off, 0.5-5
ET Enfl
Off, 2-10
Off, 0.5-5
Insp. Sevo
Off, 2-10
Off, 0.5-5
ET Sevo
Off, 2-10
Off, 0.5-5
Insp. Des
Off, 2-20
Off, 0.5-10
ET Des
Off, 2-20
Off, 0.5-10
All Gas Module alarms are in units of % and increment in units of 0.5.
2 - 98
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Alarms
Alarm Violations
Spectrum alarm violations are classified by severity:
For priority 1 or “Warning” alarms,
• The red alarm LED flashes
• The data in violation of the alarm flashes over a red background
• The priority 1 audio alarm sounds. The priority 1 audio alarm is a pattern of 10 tones
repeated every 10 seconds
For priority 2 or “Caution” alarms,
• The amber alarm LED flashes
• The data in violation of the alarm flashes over an amber background
• The priority 2 audio alarm sounds. The priority 2 audio alarm is a pattern of 3 tones
repeated every 30 seconds
For both priority 1 and priority 2 alarms,
• If there is no displayed digital data associated with the alarm, a message will be posted
in Message Area A that identifies the alarm
If the “Print on Alarm” feature has been enabled and an alarm violation occurs,
• The internal recorder will print a 2-wave 16 second strip. The upper wave will be ECG1
and the lower wave will be that of the parameter associated with the alarm violation
• Any other printing in process at the time of the alarm will be aborted
• Data in violation of an alarm will be printed within brackets
• A bar will be printed along the top margin of the waveform area to mark the time the
alarm was triggered.
A. Parameter Alarms
Individual alarm levels are adjustable for most of the parameters Spectrum is capable of
monitoring. In addition, these alarms may be set by the user to either priority level 1 or 2 as
desired.
NOTE:
The Heart Rate Alarm can be triggered only by the source
identified in the Heart Rate data tile. In some circumstances,
the pulse rate displayed in the SPO2 data tile may differ
from the heart rate displayed in the heart rate data tile.
When the Spectrum detects SPO2 pulse rate is in violation of
the set heart rate limits, the pulse rate data will flash over a
red background, but the audio alarm will not sound.
B. Heart Rate Fault Alarm
The Heart Rate Fault Alarm occurs if the selected heart rate source is no longer able to detect
a heart rate. This alarm is only active if a low heart rate limit is set. The Spectrum may
display a message to help identify the cause of the alarm (e.g., “Lead Off”, “Sensor
Off”). The Heart Rate Fault Alarm is a priority 1 alarm.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 99
Alarms
Operations
C. Apnea Alarm
The Apnea Alarm is active when respiration is being monitored. The Apnea Alarm will be
triggered if respiration is not detected for a time period longer than set in the Alarm Setup
menu. The Apnea Alarm can be set as a “Latched” or “Non-latched” alarm via the Advanced
Setup menu.
When “Apnea Latch” is set to “Off”, the Apnea Alarm will silence and cancel itself if patient
breathing is again detected.
When “Apnea Latch” is set to “On” (default), the Apnea Alarm will not be silenced unless the
operator acknowledges the alarm by pressing the MUTE or MUTE ALL keys. The visual
Apnea Alarm indications will not be cancelled unless patient breathing resumes.
The Apnea Alarm is a priority 1 alarm.
D. Arrhythmia Alarms
Arrhythmia Alarms, with the exception of the PVC Rate Alarm, are identified in message
Area A.
“Lethal” Arrhythmia Alarms (“Asystole”, “V-Fib”, and “V-Tach”) are priority 1 alarms and in
addition are latched. Even after the alarming condition is resolved, a latched alarm will
continue until it is acknowledged by pressing the MUTE or MUTE ALL key on the front panel
keypad. If the alarm is acknowledged while the lethal condition still exists, the audio portion
of the alarm will be muted for the duration that is selected from the “Mute For” list in the
“Alarm Setup” menu, but the alarm message will remain in message area A. If a new lethal
condition occurs while the initial lethal alarm is muted, the new lethal alarm will not break
through and will be muted for the remainder of the mute duration. If the lethal condition is
resolved while the alarm is muted, the alarm will be terminated.
“Non-Lethal” Arrhythmia Alarms are priority 2 alarms. These alarms will silence and cancel
automatically if the patient's condition is corrected. The PVC Rate Alarm, although
considered “non-lethal”, may be set to either priority 1 or 2.
E.
ST Alarms
ST alarms can be set for either single lead alarm or dual lead alarm. The ST single lead
alarm will be initiated if one ST lead has exceeded the set alarm parameters. The ST dual
lead alarm will be initiated if two ST leads have exceeded the set alarm parameters.
F.
Indications of Disabled or Silenced Alarms
ALARMS OFF ICON
If both high and low alarms are not set for a parameter, an alarm off icon, resembling a
crossed bell, will be displayed next to the numerical data for that parameter.
VOLUME - The audio level of the alarm can be adjusted through the Monitor
Setup Menu.
2 - 100
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Alarms
ALARM MUTE
One or more alarms can be muted for a programmable length of time. The following is a
description of how to enable the different mute modes.
MUTE - This key silences alarms on parameters for a programmed length of time (default is 2
minutes), or until the alarm condition is no longer present, whichever is shorter. Any new
alarms that occur during the silenced period will disable the silence and the alarm will sound
the tone. An Alarm Mute Icon, resembling a crossed speaker, is displayed next to each
muted parameter. A message and digital timer counts down in the upper message area.
Pressing MUTE again does not re-enable audio alarms.
MUTE ALL- This key suspends alarms on all parameters for a programmed period of time
(default is 2 minutes). An Alarm Mute Icon, resembling a crossed speaker, is displayed
next to each parameter. A message and timer appear in the upper message area showing
the time remaining. Pressing MUTE ALL at any time re-enables audio alarm tones. If MUTE
ALL is set to Permanent the message All alarms muted permanently is displayed.
The time period for MUTE and MUTE ALL is adjustable via the Alarms Setup Menu.
2.6.3
Alarm Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
High or Low or No Alarm
Sound
Alarm limits not set
Go to Alarm Setup and adjust
alarms
Alarm Mute All, On time has
not expired
Press MUTE ALL to reactivate
alarms
Arrhythmia option not installed
Call Sales Rep to purchase option
Arrhythmia Alarms off
Go to Monitor Setup /
Advanced Setup to activate
alarm
Monitor is in learning mode
Wait until learning is concluded
and monitor patient closely
Alarms continue to Sound
despite pressing MUTE
More than one alarm is active
Press MUTE or MUTE ALL key to
silence
No Alarm printout with
Alarm violation
Print on Alarm is set to Off
No Arrhythmia
Alarm Sound
Check Patient
Spectrum® Operating Instructions
0070-10-0648-02
Go to Print Menu and set Print
on Alarm to On
2 - 101
Trends
2.7
Operations
Trends
Three types of trend displays are available with the Spectrum. All trends are accessed via
the trends key and can be printed via the internal recorder.
2.7.1
List Trends
The List Trend display allows the user to view a tabular list of stored patient vital signs and
anesthetic gas data. Press the TRENDS key to access this display. A maximum of 120 timestamped entries may be stored. If the Extended Trend option is installed, a maximum of
500 time-stamped entries may be stored. When the maximum number of entries has been
reached, the oldest entry will be deleted from the trend record in order to allow storage of a
new entry.
FIGURE 2-59 List Trends
The left side of the List Trend display contains menu items for scrolling and access to other
displays. Trend data is listed from newest to oldest. Use the vertical scroll feature to view
older data. Use the horizontal scroll feature to view all the columns of data.
NOTE:
When scrolling horizontally, the first column of data remains
displayed and does not scroll.
Scroll bars along the right and bottom sides of the trend display indicate the position of
viewed data in relation to the rest of the database. Upon reopening of the List Trend
display, the top of the trend screen will display the most recently viewed data.
The leftmost column of the List Trend display contains markers which indicate that the entry
was triggered by an alarm violation or by pressing the MARK EVENT key. These markers
are red for priority 1 alarms, yellow for priority 2 alarms, and green if initiated by pressing
the MARK EVENT key.
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0070-10-0648-02
Spectrum® Operating Instructions
Operations
Trends
Trend data in violation of an alarm is also highlighted according to the priority of the alarm.
On color displays the data is red for priority 1 alarms and yellow for priority 2 alarms.
If data for a parameter is not available at the time of the trend entry, the data field will be
dashed. If an NIBP reading could not be obtained or an invasive pressure channel was not
zeroed at the time of the trend entry, the data field will contain “xxx”.
Modification of Parameters Displayed
The parameters displayed always include the currently active parameters and any others
used since the time the patient was admitted to the monitoring system. The default order of
parameters displayed from left to right is: HR, NIBP, SpO2, Resp, CO2, IBP1, IBP2, IBP3,
IBP4, T1, T2, TBlood, ΔT, O2, Agent, N2O, PVC, CO, CI and SvO2. When CO and CI data
is obtained in continuous mode, the label “@Cont” will display next to the data entry in the
CO and CI columns. When CO and CI data is obtained in intermittent mode, an “@XX:XX”
label will display next to the data entry in the CO and CI columns. This label is a “time
stamp” where XX:XX = the time at which the trended data was recorded. To change the order
of the parameters displayed, select the Setup Menu from the List Trend Menu. Once in
the Setup Menu, change the Format selection from Auto to Manual. Select parameters
to be displayed in each of the first 6 columns.
Modification of Trend Entry Conditions
Trend entry conditions may be modified via the Advanced Setup Menu. The Advanced
Setup Menu is accessed from the Monitor Setup Menu. Any combination of trend input
triggers may be used.
TREND ENTRY TRIGGER
DEFAULT
COMMENT
Interval
Off
Trend entries will occur at the selected time
interval
Alarm
Off
Trend entries will occur when an alarm violation
occurs
NIBP
On
Trend entries will occur whenever an NIBP
measurement is made
Filtering of List Trend Data Displayed
Pressing the MARK EVENT key will cause a Trend Entry.
Data corresponding to MARK EVENT key presses will be included in the displayed data. If
the Trend Entry Triggers for Alarms and/or NIBP have been set to On, this data will
also always be included.
Spectrum® Operating Instructions
0070-10-0648-02
2 - 103
Trends
Operations
Trend entries triggered by the Interval setting above may be filtered out from the displayed
List Trend data. To change the amount of interval entries displayed, select Setup from the
List Trend Menu. From the Setup Menu, select Display Interval and set as desired.
The choices available for the Display Interval depend on the setting of the Trend Entry
Interval setting above. (If the Trend Entry Interval is set to Off, there will be no choices
available for Display Interval.)
NOTE:
If the Display Interval remains set to Off while the Trend
Entry Interval has been set to something other than Off, the
trend may appear to clear itself or to have disappeared.
This is because the trend has reached the maximum number
of entries. New interval data (although not displayed) is
causing older trend entries to be deleted from the database.
Transferring List Trend Data Between Different Spectrum Monitors
List and Graph Trend data, along with patient name and demographics may be
transferred between Spectrum monitors with a Mindray Transfer Card.
1. Insert the Transfer Card into the PCM2 slot on the right side of the source monitor.
2. Access the Functions Menu of the source monitor, and select Copy patient data to
card from the menu. A status message will report completion of the transfer.
3. Remove the card and insert it into the PCM2 slot of the receiving monitor.
4. Access the Functions Menu of the receiving monitor, and select Copy patient data
from card. A status message will report completion of the transfer.
NOTE:
If the source monitor is equipped with the Extended Trend
option and the receiving monitor is not, only the latest 120
trend entries will be transferred from the card.
NOTE:
If the latest trend data stored on the card has a time stamp
newer than the time displayed on the receiving monitor,
data transfer will be prohibited. (This is possible when the
time and date settings on the monitors have not been
correctly set.)
Clearing Trend Data
To manually clear all trend data, including Graph and OxyCRG trends, choose Clear
Trends from the menu. A confirmation prompt will appear. Once cleared, the data cannot
be restored.
• All trend data is automatically cleared when the patient is discharged from the monitor.
• All trend data is also cleared if the monitor’s displayed time or date is changed.
Removing the List Trend Display
The List Trend display does not automatically time-out and must be manually removed to
return to the normal waveform display. To remove the List Trend display, choose Normal
Screen from the menu, or press the NORMAL SCREEN key.
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Spectrum® Operating Instructions
Operations
2.7.2
Trends
Graph Trends
The Graph Trend display allows the user to view a graphic summary of stored patient vital
signs and anesthetic gas data. To access this display from the normal monitoring screen,
press the TRENDS key twice. To access this display from the List Trends display, press the
TRENDS key once. This display may also be accessed from other trend displays via menu
selection.
FIGURE 2-60 Graph Trends
The left side of the Graph Trend display contains menu items for scrolling, setup and
access to other displays. The Graph Trend data window contains up to 4 parameter
displays. Use the vertical Scroll feature to view other parameters.
NOTE:
When scrolling vertically, the topmost parameter remains
displayed and does not scroll.
Time stamps are included at the top of the window, with the most recent data appearing at
the right end. Use the horizontal Scroll feature to move the cursor though time. Scroll bars
along the right and bottom sides of the Graph Trend display indicate the position of
viewed data in relation to the rest of the database. The Event feature may be used to scroll
quickly between events (caused by Alarm entries and MARK EVENT keypresses).
The Rescale Waves feature automatically rescales the viewed parameters’ graphs so all
data is displayed. The Zoom feature may be used to adjust the amount of time shown in the
trend window.
The top line of the Graph Trend display contains markers which indicate if the entry was
triggered by an alarm violation or by pressing the MARK EVENT key. These markers are
red for priority 1 alarms, yellow for priority 2 alarms, and green if initiated by pressing the
MARK EVENT key.
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Trends
Operations
As the cursor is scrolled horizontally, the digital data corresponding to the points in the graph
is shown at the right side of the window. Trend data in violation of an alarm is highlighted
according to the priority of the alarm.
On color displays:
• Priority 1 alarm data is shown in inverse video with red background.
• Priority 2 alarm data is shown in inverse video with yellow background.
If data for a parameter is not available at the time of the trend entry, the data field will be
dashed. If an NIBP reading could not be obtained or an invasive pressure channel was not
zeroed at the time of the trend entry, the data field will contain “xxx”.
Modification of Parameters Displayed
The parameters displayed always include the currently active parameters and any others
used since the time the patient was admitted to the monitoring system. The default order of
parameters displayed from top to bottom is: HR, NIBP, SpO2, Resp, CO2, IBP1, IBP2, IBP3,
IBP4, ST1, ST2, ST3, ST4, ST5, ST6, ST7, ST8, ST9, ST10, ST11, ST12, T1, T2, TBlood, ΔT,
O2, Agent, N2O, PVC/min, CO, CI, and SvO2. To change the order of the parameters
displayed, select the Setup Menu from the Graph Trend Menu. Once in the Setup
Menu, change the Format selection from Auto to Manual. Select parameters to be
displayed in each of the top 5 rows.
Modification of Trend Entry Conditions
The Graph Trend data is the same as that stored for List Trends, arranged graphically. (If
data is not available for time period, it appears as a gap in the Graph Trend.) Refer to the
previous section (List Trend) for modification of trend entry conditions.
Transferring Graph Trend Data Between Different
Spectrum Monitors
Graph Trend data is transferred together with List Trend and patient name and
demographics. Refer to the List Trend section for details.
Clearing Trend Data
To manually clear all trend data, including List and OxyCRG trends, choose Clear Trends
from the menu. A confirmation prompt will appear. Once cleared, the data cannot be
restored.
• All trend data is automatically cleared when the patient is discharged from the
monitor.
• All trend data is also cleared if the monitor’s displayed time or date is changed.
Removing the Graph Trend Display
The Graph Trend display does not automatically time-out and must be manually removed
to return to the normal waveform display. To remove the Graph Trend display, choose
Normal Screen from the menu, or press the NORMAL SCREEN key.
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Spectrum® Operating Instructions
Operations
2.7.3
Trends
OxyCRG Trends
The OxyCRG (Oxygen Cardiorespirogram) display allows the user to view a continuously
updated graphic summary of 5 specific patient vital signs. This display is available for
Neonate and Pediatric patient sizes only. To access this display from the normal monitoring
screen, press the TRENDS key 3 times. To access this display from the List Trends display,
press the TRENDS key twice. To access this display from the Graph Trends display, press the
TRENDS key once. This display may also be accessed from the other trend displays via
menu selection. A maximum of 6 minutes of data may be stored. If the Extended Trend
option is installed, a maximum of 12 hours of data may be stored. When the maximum
storage time has been reached, the oldest data will be deleted from the database in order to
allow storage of new data.
FIGURE 2-61 OxyCRG Display Menu
The general operation and format of the OxyCRG Menu items and display is the same as
for Graph Trend display described previously.
Parameters Displayed
The parameters displayed are Heart Rate (from ECG source only), SpO2, condensed
thoracic impedance respiration wave (with digital rate data), IBP1, and Temperature.
Transferring OxyCRG Data Between Different Spectrum Monitors
OxyCRG data may not be transferred between monitors.
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Trends
Operations
Clearing Trend Data
To manually clear all trend data, including List and Graph trends, choose Clear Trends
from the menu. A confirmation prompt will appear. Once cleared, the data cannot be
restored.
• All trend data is automatically cleared when the patient is discharged from the monitor.
• All trend data is also cleared if the monitor’s displayed time or date is changed.
Removing the OxyCRG Display
The OxyCRG Trend display does not automatically time-out and must be manually
removed to return to the normal waveform display. To remove the OxyCRG Trend display,
choose Normal Screen from the menu, press the NORMAL SCREEN key, or press the
TRENDS key once.
2.7.4
2 - 108
Trends Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
No Trends displayed
No Trend triggers set
Go to the Monitor Setup
Menu and set NIBP Trend,
Trend Interval or Alarm
Trend as desired
Trend page is scrolled
Use scroll button in Trend Menu
to scroll to top of Trend Menu
0070-10-0648-02
Spectrum® Operating Instructions
Operations
2.8
Printing (Optional)
Printing (Optional)
Spectrum data and waveforms may be printed to the following destinations: internal
recorder, remote central station or to a laser printer (12-lead data only).
FIGURE 2-62 Print Setup Menu
2.8.1
Internal Recorder (Optional)
The Spectrum recorder can provide a printed record of all patient parameters. It is a twotrace thermal strip chart recorder with an integral paper spool. The recorder uses plain white
thermal paper, 5 cm wide.
NOTE:
All grid patterns and data are printed by the recorder.
Operation of the Recorder
1. Select the waveforms to print to the recorder via the Print Setup Menu using the
Navigator™ Knob. To change the waveforms that appear, select Waveform 1 or
Waveform 2 and choose from the available parameters.
2. To print to the recorder, select Local from the Print Setup Menu.
3. Press the STRIP key to initiate printing.
4. Press the STRIP key again to abort the printout. Select printouts will also require the use
of alternate menus or keys.
During an ECG waveform printout, tic marks appear every one second, for reference.
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Printing (Optional)
Operations
Printouts from the Recorder
Print Formats
The print format can be changed from Leader to Wave in the Print Setup Menu.
Leader will print all patient demographic data, date / time of printout, waveform speed,
source of the printout and all patient parameter data prior to printing the waveform data.
Wave will print all patient demographic data, date/time of printout, waveform speed and
source of the printout in the space prior to the waveform printing. The patient parameter data
will print above and below the waveform area. Wave format is not available if the speed of
the upper printed waveform is less than 25 mm/sec. The waveform speed can be set via the
Monitor Setup Menu.
Strip Printing
When the STRIP key is pressed a 16-second strip is printed. This strip consists of data 8seconds prior to and 8-seconds after the printout is initiated. The source of the printout is
indicated on the strip as Key.
FIGURE 2-63 Sample Printout, Single Waveform
FIGURE 2-64 Sample Printout, Two Waveforms
Continuous ECG Printing
If a real-time, continuous printing of ECG data is required, press the CONT ECG key. Press
CONT ECG again to abort printing.
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Spectrum® Operating Instructions
Operations
Printing (Optional)
Printing Frozen Waveforms
When waveforms are frozen (by pressing the FREEZE key), the recorder will print an 8second strip of Waveform 1 and Waveform 2 data. The source of the printout is indicated on
the strip as Frozen.
Print on Alarm
If a waveform is initiated by an alarm violation, then the internal recorder will initiate a 16second waveform strip. To activate this feature, go to the Print Setup Menu, highlight the
Print on Alarm selection and select Yes. During an alarm printout, the data for the
parameter which violated the alarm will be printed in brackets and the portion of the
waveform triggering the alarm will have a bar printed above. If the recorder is printing a
strip (or trend data) and an alarm is violated, then the currently printing waveform will be
aborted and the alarm waveform will be printed. The source of the printout is indicated on
the strip as Alarm.
Interval Printing
To print waveform strips at regular intervals, go to the Print Setup Menu, highlight Print
Every and select a time interval to print. The selections are Off, 1, 5, 10, 15, 20, 30
minutes, 1 hour and 2 hours. The source of the printout is indicated on the strip as
Periodic.
Trend Printing
To print any trend data to the recorder, press the PRINT TREND key while the trend is
displayed. To abort trend printing, press the PRINT TREND key during the print. The trends
available for printing are: List Trend, Graph Trend and OxyCRG Trend.
List Trend prints digital data information while Graph Trend and OxyCRG print graphic
representations of the data in the respective menus.
FIGURE 2-65 Sample Printout, List Trend Format
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2 - 111
Printing (Optional)
Operations
FIGURE 2-66 Graph Trend Format
FIGURE 2-67 OxyCRG Trend Format
Calculations
IV Drug and Hemodynamic printouts are initiated in the respective menu by using the
Navigator™ Knob and scrolling to the Print function. The printout data will include patient
demographic data, date / time of printout, data used to calculate the information and the
calculated data. Drug Calculations will include the patient weight, IV fluid infusion rate and
medication concentration.
12-lead ECG
To print 12-lead ECG data and interpretation to internal recorder, View 12™ ECG Analysis
Module must be installed and enabled. Insert the View 12 ECG Analysis Module, press the
VIEW key (to begin the VIEW ALL ECG mode), then press the STRIP key. The printout will
contain patient demographic data, date/time of printout, waveform speed, ECG Filter, and
all patient parameter data prior to the waveform printing. The waveform printing will show a
2 ½ second sample of each of the 12 ECG vector waveforms. The printout waveforms
represent the 2 ½ seconds prior to pressing the STRIP key. The waveforms will then be
followed by ECG measurement data and the 12-lead interpretation. Please see the
Physician's Reference Guide to Computerized ECG Analysis for more information on
interpretive printouts.
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Spectrum® Operating Instructions
Operations
Printing (Optional)
12-lead interpretation data statements will print only if the following conditions are met:
1. The Patient Size must be set to Adult.
2. The patient's Gender and Date of Birth must be entered.
3. The patient must be at least 18 years old.
FIGURE 2-68 12-lead ECG Format
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Printing (Optional)
Operations
Average ST Complex
To print the Average ST Complex, use the Navigator™ Knob to select Average ST
Complex from the Print Setup Menu. This function is only available when the View 12™
ECG Analysis Module is enabled and ST Analysis is occurring. The internal recorder will
print the patient's demographic data, date/time of printout, waveform speed and source of
the printout in the space prior to the waveform printing. The recorder will print the average
ST complex (waveform) for each of the 12 ECG vectors, followed by the digital information
associated with each waveform.
FIGURE 2-69 Average ST Complex Format
Cardiac Output
Printing Cardiac Output waveforms and data is initiated from the Cardiac Output
Menu by selecting Print Runs. Only valid Cardiac Output runs will be printed. The
printout data will include patient demographic data, date of printout and patient parameter
data prior to printing the waveform data. Following the digital information, up to five (5)
Cardiac Output runs with time, Cardiac Output data and Cardiac Index data will be
printed, followed by the Average Cardiac Output / Cardiac Index and catheterspecific data.
NOTE:
2 - 114
Cardiac Output report printing from the recorder is only
available if the CO Source is the EPM.
0070-10-0648-02
Spectrum® Operating Instructions
Operations
Printing (Optional)
PAWP
To print PAWP (Pulmonary Artery Wedge Pressure) waveforms access the PAWP Menu
and select Print Wedge. This printout is continuous and will only be aborted by pressing
the PRINT WEDGE key again or by running out of recorder paper. The printout data will
include patient demographic data, time/date of printout, and waveform speed just prior to
printing the waveform data. Following the digital information, 2 waveforms will print
continuously. These waveforms are the top two (2) waveforms appearing in the Wedge
Menu. The printed strip will be annotated with the waveform names and scales every 18
seconds.
Laser Printing 12-lead
Printing 12-lead data to a laser printer is similar to the printing of the data to the recorder.
The data will print Landscape orientation to the laser printer to pre-grid laser printer paper.
The printout will include, in addition to the data on a recorder strip, a 10-second rhythm strip
of Lead II.
NOTE:
Printing 12-lead to a laser printer is not available when
“WMTS Enabled” is set to “Yes” in the Installation Menu.
FIGURE 2-70 12-lead Laser Format
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Printing (Optional)
2.8.2
Operations
Printing 12-lead to the Laser Printer
1. To select the print destination for 12-lead ECG data, select the Print Setup Menu
and ensure Select Printer is set to Laser, Laser/Local or Laser/Remote.
NOTE:
12-lead ECG data will not print remotely to the Central
Station.
2. To print 12-lead ECG data to the laser printer, the View 12™ ECG Analysis Module
must be installed and enabled.
3. Enter the Patient’s Date of Birth and Gender via the Patient Menu to print the 12lead interpretation.
4. Press the VIEW key to display View All ECG mode.
5. Press the STRIP key to print 12-lead ECG to the destination of choice.
2.8.3
2 - 116
Printer / Recorder Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Recorder Report Appears
Totally Blank
Thermal paper may be installed
incorrectly (up-side down)
Remove paper and re-install with
paper feeding off of the spool
from the bottom
Local Printer Door Open
The printer door is not closed
Close the printer door
Local Printer Out Of Paper
Printer out of paper
Replace with a new roll of paper
Printer Busy
Printer received multiple print
requests at one time
Wait until the printer is not busy
Local Printer Unable To
Print
The system has detected an
unrecoverable printer failure
Power cycle unit. If message
reappears, contact Mindray
Customer Support.
Check Laser Printer
Laser printer is busy,
disconnected, out of paper or has
a fault condition
Check laser printer
No print on Alarm
Alarm printing not active
Go to Print Setup Menu and
set Print on Alarm to On
Trends not printing
Print Trend not pressed
Press PRINT TREND when trend
window is open
No Trends displayed
Use scroll feature to scroll to the
top of the trend then press
PRINT TREND
No paper
Check / Replace paper
0070-10-0648-02
Spectrum® Operating Instructions
Connection to PatientNet® Central Station
Operations
2.9
Connection to PatientNet® Central Station
The Spectrum can be connected to the PatientNet Central Stations via direct hardwire or
telemetry connection using the Comm-Port. Access the Installation Menu and set a Serial
Port to PatientNet to enable PatientNet.
The interface allows the Spectrum waveforms and data to be displayed at the PatientNet
Central Station. The interface also enables the Spectrum to Admit to, Discharge from,
and print at the PatientNet Central Station.
NOTE:
Pressing the VIEW key does not affect the waveforms being
transmitted to the Central Station.
NOTE:
See the PatientNet Operating Instructions for more details
on PatientNet Operation.
NOTE:
See Administrative Guide for the PatientNet Central Station,
for more detail.
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Connection to Panorama™ Central Station
2.10
Operations
Connection to Panorama™ Central Station
The Spectrum will communicate with the Panorama Central Station via direct hardwire to
an appropriate Comm-Port or via a wireless network. The “Enable Network” option in the
System Information menu must be set to “Wired” when using a hardwire Spectrum.
“Enable Network” must be set to “Wireless” for communication between the Spectrum and
the Panorama via the 2.4 GHz wireless Symbol radio card. “WMTS Enabled” must be set to
“Yes” to allow for communication between the Spectrum and the Panorama via the
Panorama Instrument Radio - 608.
Refer to the Panorama Operating Instructions Manual for a list of supported parameters.
The Spectrum is capable of transmitting a discharge command to a Panorama Central
Station. It is also capable of bi-directional transmission of patient demographics and patient
alarm settings with a Panorama Central Station.
When the Panorama Central is selected for operation, the Patient Discharge menu selections
will vary as follows:
• For Main Module Software Versions H.xx and earlier, “Discharge From Central” and
“Discharge From Both” will be displayed.
• For Main Module Software Versions J.xx and later, “Discharge From Both” will be
displayed.
When “Discharge From Central” or “Discharge From Both” are selected from the Patient
Discharge menu, the Panorama will discharge the patient.
If Trend is cleared or the patient is discharged at the Spectrum, the Spectrum time and date
will be synchronized with the Panorama Central Station time and date.
2 - 118
NOTE:
If the Edwards Vigilance® Monitor is the source for CO, CCO,
CI, CCI, SvO2, T Blood and ΔT measurements, this data will
not be available at the Panorama Central Station.
NOTE:
If a Spectrum 608 radio is communicating with a Panorama
Central Station, Gas Module data and alarms, V2 - V6
waveform data and ST templates are not displayed at the
Central Station.
0070-10-0648-02
Spectrum® Operating Instructions
Connection to Panorama™ Gateway
Operations
2.11
Connection to Panorama™ Gateway
The Spectrum can communicate with an EMR system through a Panorama Gateway via a
hardwired network connection to a Comm-Port with a CS1 port or via wireless connection
through a Panorama Central Monitoring System. The “Enable Network” option in the
Spectrum System Information menu must be set to “Wired” when using a hardwire
Spectrum. “Enable Network” must be set to “Wireless” to allow for wireless communication
through a Panorama Central Station via the 2.4 GHz wireless Symbol radio card. “WMTS
Enabled” must be set to “Yes” to allow for wireless communication through a Panorama
Central Station via the Panorama Instrument Radio - 608.
For the Spectrum to be recognized by the EMR system, certain demographics content,
referred to as the “Patient Key”, must be entered from its Patient Menu. Each facility has its
own unique “Patient Key” that must be entered before making a connection to the EMR. The
“Patient Key” consists of the required ID # and, optionally, one or more of the following
Patient Menu demographics fields:
• First name
• Last name
• Bed #
Once the “Patient Key” has been entered, communication with the EMR system must be
verified. Since the Panorama Gateway can be purchased with ADT messaging only, Results
messaging only or ADT messaging with Results messaging, this verification differs as follows:
ADT messaging
For a Panorama Gateway that has ADT messaging, verify that communication with the EMR
system has been established as follows:
• After entering the “Patient Key” in the Patient Menu, select Normal Screen to close the
menu.
• If demographics information corresponding to the following fields was not part of the
“Patient Key” but is entered into the EMR system, these fields in the Patient Menu should
auto-populate upon re-opening the menu:
• First name
• Last name
• Date of Birth
• Gender
• Bed #
• In addition, the First Name and Last Name should populate in the upper right of the
display.
• If the fields do not auto-populate, verify that the “Patient Key” has been correctly entered
and that the patient demographics have been entered in the EMR system. If the fields still
do not auto-populate, contact the EMR administrator.
Results messaging
For facilities with a Panorama Gateway that has Results messaging, verify that
communication with the EMR system has been established by checking the charting system to
ensure that vital signs data has been uploaded. If the charting system is not displaying the
information, contact the EMR administrator.
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Monitor/Display Troubleshooting
2.12
Operations
Monitor/Display Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
No trace for a desired
parameter
Improper attachment of
transducer or cable to monitor
Check transducer / cable
connection.
Faulty transducer or cable.
Try a new transducer or cable.
Trace Not Moving
FREEZE key may have been
pressed.
Press the FREEZE key to
unfreeze the trace.
Display Appears to be Off
Mains power switch may not be
on.
Check mains power switch on
side panel.
Unit may not be plugged into an
AC outlet.
Check power cord (Is it plugged
in?)
If used as a portable, battery
pack may be drained.
If battery pack is drained, plug
into an AC outlet to recharge the
battery. A period of 5 hours is
required for a full charge of
lithium-ion batteries. A period of
16 hours is required for a full
charge of sealed lead acid
batteries.
12-lead card removed without
disabling 12-lead.
Always disable 12-lead card
prior to removal.
Power unit back on.
Contact Mindray Customer
Support.
2 - 120
Disabled Alarm Tone
MUTE key pressed.
Check for alarm mute symbol
and message.
Beep volume low.
Increase beep volume.
Cooling Fan Failure
The unit running on AC power
and the cooling fan is not
operational.
Contact Mindray Customer
Support.
Patient Information did not
appear on display
No data entered.
Enter proper patient data.
Done was not selected from
keypad after entering data.
Go to the proper keypad enter
data, select Done when
finished.
Incorrect Date or Time
Data not entered or entered
incorrectly.
Follow instructions from “How
to Set the Clock / Date and
Time”.
0070-10-0648-02
Spectrum® Operating Instructions
3.0
User Maintenance
3.1
Introduction
This section of the manual outlines routine user maintenance guidelines.
The Spectrum Monitor is designed for stable operation over long periods of time. Under
normal circumstances the monitor should not require technical maintenance beyond that
described in this section. However, routine maintenance, calibration and safety checks are
recommended at least once a year or more often as required by local statutory or hospital
administration practice.
3.2
Care and Cleaning of Monitor
The monitor enclosure may be cleaned with a mild soap and water solution or ammoniated
window cleaner. Apply cleaning solution to the cloth, not directly onto the monitor. DO NOT
apply large amounts of liquid. DO NOT use abrasive cleaning agents or organic solvents.
WARNING: Do not clean the monitor while it is on and/or plugged in.
To prevent scratches on the screen carefully brush dust and dirt particles with a soft sponge
moistened with cleaning solution or a fine, soft-hair brush. DO NOT use abrasive cleaning
materials. Remove fingerprints and stains with a liquid lens cleaner and a soft cloth. DO
NOT wipe a dry screen or use alcohol or solvents containing chlorinated hydrocarbon.
Spectrum® Operating Instructions
0070-10-0648-02
3-1
Decontamination of Monitor
3.3
User Maintenance
Decontamination of Monitor
WARNING: Perform the decontamination process with the unit powered
down and power cord removed.
Decontamination of a unit that has come in contact with a biological material can be
performed using LpH SE Germicidal detergent. Apply a small amount of detergent to a
disposable wipe (paper based) and wipe down the outside of the unit. Discard the wipe
appropriately. After waiting 10 minutes, use a clean dry wipe to dry the unit.
CAUTION:
3.4
During the decontamination process, do not get the LpH SE
Germicidal detergent into any vent openings.
Care and Cleaning of SpO2 Sensors
NOTE:
Refer to the individual instruction sheets that are packaged
with each sensor.
• Check sensors and cables daily for signs of damage. Replace as required.
• Sensors should be cleaned before and after each new patient.
• Wipe the patient contact area using a soft cloth with mild soap and water solution or
isopropyl alcohol. Hydrogen peroxide can be used to remove dried blood.
• Allow the sensor to completely dry before using.
CAUTION:
When cleaning sensors, do not use excessive amounts of
liquid. Wipe the sensor surface with a soft cloth, dampened
with cleaning solution. Do not attempt to sterilize.
Cleaning and Re-use of a Nellcor® Sensor
Sensors may be reattached to the same patient if the emitter and detector windows are clear
and the adhesive still adheres to the skin. The adhesive can be partially rejuvenated by
wiping with an alcohol wipe and allowing the sensor to thoroughly air dry prior to
replacement on the patient.
Do not immerse any Oxisensor®, OxiMax®, Durasensor®, Oxiband®, or Duraform® oxygen
transducers, the Nellcor® RS-10 or Max-Fast® oxygen transducers, or any Nellcor® adhesive
in water or cleaning solution. Clean Durasensor®, Oxiband®, and Duraform® oxygen
transducers, and the Nellcor® RS-10 or Max-Fast® oxygen transducers by wiping with a
disinfectant such as a solution containing 70% alcohol. Do not sterilize by irradiation, steam,
or ethylene oxide. Use a new Oxiband® adhesive wrap or FORM-A adhesive bandage for
each patient. Do not re-sterilize Oxisensor® or OxiMax® oxygen transducers.
3-2
0070-10-0648-02
Spectrum® Operating Instructions
User Maintenance
3.5
Sterilization and Cleaning of Reusable Bladderless Cuffs
Sterilization and Cleaning of Reusable
Bladderless Cuffs
Clean cuffs with warm water and a mild detergent. Do not use a detergent containing hand
conditioners, softeners, or fragrances.
NIBP cuffs can be sterilized with gamma sterilization without effecting the repeated
performance of the cuff. Steam sterilization is not recommended. Use of a washing liquid
containing bleach is not recommended because chlorine will chemically break down the
urethane on the inside of the cuff.
Antimicrobial Definition
Mindray bladderless cuffs are treated with an antimicrobial coating. Antimicrobial
technology effectively controls a broad spectrum of bacteria, fungi, algae and yeasts on a
wide variety of treated substrates.
3.6
Battery Replacement and Maintenance
3.6.1
Battery Replacement
1. Open battery compartment door, on left side of unit, by pressing the finger grip area
and sliding the door to the left.
2. Press the release button, located on the right side of the installed battery. This will eject
the battery. Slide out and remove battery.
3. Slide in replacement battery until it clicks into place.
4. Close battery compartment door by sliding the door to the right until it firmly clicks into
place.
CAUTION:
3.6.2
Replace sealed lead acid batteries with Mindray P/N 014600-0043 ONLY. Replace lithium-ion batteries with Mindray
P/N 0146-00-0069 ONLY.
Battery Maintenance
The batteries may be subject to local regulations regarding disposal. At the end of the
battery life, dispose of the batteries in accordance with any local regulations.
NOTE:
Spectrum batteries may only be charged within a Spectrum
monitor. Do not attempt to use commercial rechargers.
Sealed Lead Acid
Due to the self-discharge characteristics of sealed lead acid batteries, it is imperative that
they are charged after 3 months of storage (or unit not in use). If not, permanent loss of
capacity may occur as a result of sulfation. Charge retention at 20oC is 6 months to 83%.
Lithium-Ion
Storage of the lithium-ion batteries depends on temperature, time period and the degree of
cell charging state. After 6 months of storage at 23oC, fully charged lithium-ion batteries
have a retention capacity of 93%.
Spectrum® Operating Instructions
0070-10-0648-02
3-3
Recorder Paper Replacement
3.7
User Maintenance
Recorder Paper Replacement
The instructions below describe the replacement of recorder paper. Use only recommended
recorder paper, Mindray part number 0683-00-0422-XX. This ensures that the print quality is
acceptable and reduces print head wear.
1. Open recorder door by pressing the paper eject button.
2. Remove empty paper spool.
3. Insert new paper roll between the two rounded tabs of the paper holder with the
sensitive (shiny) side of the paper facing the print head at the top of the recorder (paper
feeding off of the spool from the bottom).
4. Unroll approximately 4 inches of paper.
5. Align the paper across the top of the roller.
6. Holding the paper in place, close recorder door.
7. To ensure that the paper is aligned properly and has not been pinched in the door, pull
the loose edge out a couple of inches. If the paper jams, open the door and return to
step 5.
3.8
Care and Storage of Thermal Chart Paper
Thermal Chart Paper is chemically treated and the permanency of a recording is affected by
storage and handling conditions. These conditions are:
• Ultraviolet Light
We recommend storing the recordings in a filing cabinet within a few days of printing.
Long term exposure to natural or artificial U.V. sources is detrimental.
• Storage Temperature and Humidity
Keep the recordings in a cool and dry area for a longer lasting image. Extreme
temperature and humidity (above 80° F/26° C and 80% Humidity) should be avoided.
• Solvent Reactions
Do not store the recordings in plastic bags, acetate sheet protectors, and similar items
made from petroleum products. These products emit a small amount of vapor which will,
over a period of time, deteriorate the image on the chart paper.
• Adhesive Tape
Never place adhesive tape over recordings. The reaction between the adhesive
compound and the chemical/thermal paper can destroy the image within hours.
• Archives
We recommend that if long term archives are required, make a photocopy of the
recordings as back-up. Under normal office filing conditions the recordings should retain
acceptable image quality for about 5 years.
3-4
0070-10-0648-02
Spectrum® Operating Instructions
User Maintenance
Care and Cleaning of Gas Module
3.9
Care and Cleaning of Gas Module
3.9.1
Gas Module II and Gas Module SE
WARNING: Do not clean the Gas Module while it is on and/or plugged
in.
1. The Gas Module enclosure may be cleaned with a mild soap and water solution or
ammoniated window cleaner. Apply cleaning solution to the cloth, not directly onto the
Gas Module. DO NOT apply large amounts of liquid. DO NOT use abrasive cleaning
agents or organic solvents.
CAUTION:
The internal sampling system of the Gas Module does not
need to be cleaned or sterilized. There is no reverse flow
back to the patient. If the internal sampling system is
suspected to be clogged or dirty, the module should be
serviced by an authorized service person only.
2. The fan dust filter should be checked and cleaned on a regular basis, at least once every
two months.
• Locate fan on front panel.
• Remove the filter by pulling the dust filter cover.
• Remove the dust from the filter.
• Let the filter soak in a mild detergent solution.
• Rinse the filter and let dry completely before re-installing.
CAUTION:
If the dust filter for the fan cannot be cleaned or is
damaged, replace it with part number 0378-00-0040. Use
of another type of filter may decrease the cooling effectivity
and cause damage to the Gas Module.
3. The Water Trap Reservoir must be checked and emptied whenever changing patients or
if it is more than half full.
• To remove the water trap, push the water trap latch to the right. The water trap is
spring loaded and will pop out. An Air Leak message will be displayed. The monitor
will suspend sampling.
• Detach the reservoir from the water trap assembly by pulling it down carefully.
• Empty the reservoir and rinse with water only.
• Re-attach the reservoir to the assembly tightly.
• Re-install the whole unit into the Gas Module making sure the latch is set. Check that
the Air Leak message disappears and monitoring resumes.
NOTE:
Do not disinfect or open the water trap. If an occlusion
message appears, it may be necessary to replace the water
trap assembly (P/N 0202-00-0129).
NOTE:
The Water Trap Assembly must be replaced every two
months.
Spectrum® Operating Instructions
0070-10-0648-02
3-5
Care and Cleaning of Gas Module
3.9.2
User Maintenance
Gas Module 3
WARNING: Do not clean the Gas Module while it is on and/or plugged
in.
1. The Gas Module enclosure may be cleaned with a mild soap and water solution or
ammoniated window cleaner. Apply cleaning solution to the cloth, not directly onto the
Gas Module. DO NOT apply large amounts of liquid. DO NOT use abrasive cleaning
agents or organic solvents.
CAUTION:
The internal sampling system of the Gas Module does not
need to be cleaned or sterilized. There is no reverse flow
back to the patient. If the internal sampling system is
suspected to be clogged or dirty, the module should be
serviced by an authorized service person only.
2. The DRYLINE™ Water Trap Assembly consists of a filter housing and reservoir that must
be checked and emptied whenever changing patients or if it is more than half full.
WARNING: The contents of the water trap should be handled as a
potential infection hazard.
NOTE:
Replace the complete DRYLINE™ Water Trap Assembly every
month or more often if indicated on the monitor.
• To remove the DRYLINE™ Water Trap Assembly from its receptacle, press the lugs on
its sides and pull out. An Air Leak message will be displayed. The monitor will
suspend sampling.
• Detach the reservoir from the filter housing by twisting and separating these two parts.
• Empty the reservoir and rinse with water only.
• Tightly re-attach the reservoir to the filter housing.
• Re-install the DRYLINE™ Water Trap Assembly into the Gas Module, ensuring that it
snaps into place. Check that the Air Leak message disappears and monitoring
resumes.
3-6
NOTE:
Only the reservoir of the DRYLINE™ Water Trap Assembly
may be cleaned and/or disinfected.
NOTE:
If an “Occlusion” message appears, it may be necessary to
replace the DRYLINE™ Water Trap Assembly (Adult/Pediatric
P/N 0202-00-0182-10; Neonate P/N 0202-00-0181-10).
0070-10-0648-02
Spectrum® Operating Instructions
User Maintenance
3.10
Care and Cleaning of 3 and 5-lead ECG Cables and Leadwires
Care and Cleaning of 3 and 5-lead ECG Cables
and Leadwires
Recommended cleaning method of ECG cables and leadwires is a cloth wipe using ordinary
alcohol-free hand soap or USP green soap tincture. When disinfection is required, a cloth
wipe using disinfectants such as isopropyl alcohol, chlorine bleach in water (1:10 mixture) or
2% Glutaraldehyde solution (i.e., Cidex) is recommended. After cleaning, the ECG cables
and leadwires should be wiped with water using a clean damp cloth then dried with a clean
dry cloth.
3.11
CAUTION:
To avoid permanent damage, do not expose metal
components (pins, sockets, snaps) to disinfectants, soaps or
chemicals.
NOTE:
ECG cables and leadwires must never be immersed, soaked
in any fluids, and they should not be cleaned with harsh
chemicals such as acetone or non-diluted bleach.
NOTE:
Do not autoclave, radiation or steam sterilize ECG cables or
leadwires.
NOTE:
Extended exposure to Ethylene Oxide gas may shorten life
of the ECG cables and leadwires, leading to poor signal
quality.
Care and Cleaning of View 12™ ECG
Analysis Module
Clean cables and leadwires using a cloth wipe and warm water. Use a dry, clean cloth to
dry leadwires and cables before placing them on a patient. Do not use alcohol to clean the
View 12 ECG Analysis Module. Alcohol or other harsh chemicals will cause the cables and
leadwires to become brittle or harden, causing damage.
NOTE:
Spectrum® Operating Instructions
The View 12 ECG Analysis Module must never be immersed
or soaked in any fluids.
0070-10-0648-02
3-7
Care and Cleaning of View 12™ ECG Analysis Module
User Maintenance
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3-8
0070-10-0648-02
Spectrum® Operating Instructions
4.0
Accessories
4.1
Optional Accessories
4.1.1
NIBP Accessories
Hoses/Adapters
DESCRIPTION
PART NUMBERS
NIBP Hose, 60” (1.5 m), Female Rectus to Female Rectus
0683-04-0003
NIBP Hose, 138” (3.5 m), Female Rectus to Female Rectus
0683-04-0004
NIBP Hose, Neonate 60” (1.5 m), Female Luer to Female Rectus
(for use with disposable neonate cuffs)
0683-04-0005
Color Coded Reusable Cuffs (with Quick-Connect fittings)
DESCRIPTION
PART NUMBER
Variety Kit I, 6 cuffs [(1) Small Child, (1) Child, (1) Small Adult, (1) Adult,
(1) Large Adult, (1) Adult Thigh]
0020-00-0082-31
Variety Kit II, 6 cuffs [(1) Small Adult, (2) Adult, (2) Large Adult,
(1) Adult Thigh]
0020-00-0082-33
Variety Kit III, 6 cuffs [(1) Small Child, (2) Child, (3) Small Adult]
0020-00-0082-32
Adult Thigh, Brown (45 - 56.5 cm circumference)
0998-00-0003-56
Large Adult Long, Burgundy (35.5 - 46 cm arm circumference)
0998-00-0003-58
Large Adult, Burgundy (35.5 - 46 cm arm circumference)
0998-00-0003-55
Adult Long, Navy Blue (27.5 - 36.5 cm arm circumference)
0998-00-0003-57
Adult, Navy Blue (27.5 - 36.5 cm arm circumference)
0998-00-0003-54
Small Adult, Light Blue (20.5 - 28.5 cm arm circumference)
0998-00-0003-53
Child, Green (13.8 - 21.5 cm arm circumference)
0998-00-0003-52
Small Child, Orange (9 - 14.8 cm arm circumference)
0998-00-0003-51
Spectrum® Operating Instructions
0070-10-0648-02
4-1
Optional Accessories
Accessories
Disposable Cuffs (with Quick-Connect fittings)
DESCRIPTION
PART NUMBER
Adult Thigh, White/Brown (5/box) (45 - 56.5 cm circumference)
0683-07-0036-01
Large Adult Long, White/Burgundy (10/box) (35.5 - 46 cm
arm circumference)
0683-07-0038-01
Large Adult, White/Burgundy (10/box) (35.5 - 46 cm arm circumference)
0683-07-0035-01
Adult Long, White/Navy Blue (10/box) (27.5 - 36.5 cm
arm circumference)
0683-07-0037-01
Adult, White/Navy Blue (10/box) (27.5 - 36.5 cm arm circumference)
0683-07-0034-01
Small Adult, White/Light Blue (10/box) (20.5 - 28.5 cm
arm circumference)
0683-07-0033-01
Child, White/Green (10/box) (13.8 - 21.5 cm arm circumference)
0683-07-0032-01
Small Child, White/Orange (10/box) (9 - 14.8 cm arm circumference)
0683-07-0031-01
Disposable Neonatal NIBP Cuffs - Quick Connect*
DESCRIPTION
PART NUMBERS
Neonatal Size 1: limb circumference 3 – 6 cm, Box of 10
0683-13-0001-01
Neonatal Size 2: limb circumference 5 – 8 cm, Box of 10
0683-13-0002-01
Neonatal Size 3: limb circumference 7 – 10 cm, Box of 10
0683-13-0003-01
Neonatal Size 4: limb circumference 9 – 13 cm, Box of 10
0683-13-0004-01
Neonatal Size 5: limb circumference 12 – 17 cm, Box of 10
0683-13-0005-01
*
Disposable neonatal cuffs require NIBP hose part number 0683-04-0003 (1.5 m).
4.1.2
Oximetry Sensors and Accessories
4.1.2.1
Pulse Oximetry-Masimo SET® LNOP® SpO2
DESCRIPTION
PART NUMBER
®
4-2
LNOP DCI Adult/Pediatric starter kit (one reusable adult sensor, 2 adult
and 1 pediatric single patient adhesive sensors and one 12’ cable)
0020-00-0130
LNOP® DCI-Adult reusable finger sensor (with added “flaps” for ambient
light shielding and 3’ cable)
0600-00-0047
LNOP® DC-12 Adult direct connect reusable finger sensor with attached
12' cable
0600-00-0120
LNOP® DCIP-Pediatric/slender digit reusable finger sensor
0600-00-0063
LNOP® TCI Tip Clip Ear Sensor
0600-00-0110
Ear Clip
0600-00-0086
Ear Hanger (pkg of 5)
0600-00-0087
LNOP® YI-Multisite reusable sensor
0600-00-0078
Multisite wrap (box of 100)
0600-00-0081
Multisite wrap, foam (pkg of 12)
0600-00-0083
LNOP® DCSC-Adult spot check reusable sensor
0600-00-0077
PC08-SpO2 cable (2.44 m./8’)
0012-00-1099-01
PC12-SpO2 cable (3.66 m./12’)
0012-00-1099-02
0070-10-0648-02
Spectrum® Operating Instructions
Accessories
Optional Accessories
DESCRIPTION
PART NUMBER
LNOP® Adt-Adult single patient adhesive sensors for patients more than 30
kgs. (pkg of 20)
0600-00-0043-01
LNOP® Pdt-Pediatric/slender digit single patient sensors for patients more
than 10 kgs. and less than 50 kgs. (pkg of 20)
0600-00-0044-01
LNOP® II Inf-L-Infant L single patient adhesive sensors for patients more
than 3 kgs. and less than 10 kgs. (pkg of 20)
0600-00-0100
Tape, Infant, L-Series (Package of 100)
0600-00-0108
®
4.1.2.2
LNOP Neo-Neonatal Y single patient adhesive sensors for patients more
than 1 kg. and less than 10 kgs. (pkg of 20)
0600-00-0045-01
Adhesive tapes for Neonatal Y single patient adhesive sensors
(pkg of 100)
0600-00-0065
LNOP® II Neo-Neonatal L single patient adhesive sensors for patients more
than 1 kg. and less than 10 kgs. (pkg of 20)
0600-00-0099
Adhesive tapes for Neonatal L single patient adhesive sensors (pkg of 100)
0600-00-0096
LNOP® NeoPt-Preterm neonatal Y single patient adhesive sensors for
patients less than 1 kg. (pkg 20)
0600-00-0046-01
Posey wraps for Preterm neonatal Y single patient adhesive sensors
(pkg of 12)
0600-00-0064
LNOP® II NeoPt-L-Preterm neonatal L single patient adhesive sensors for
patients less than 1 kg. (pkg 20)
0600-00-0098
Posey wraps for Preterm neonatal L single patient adhesive sensors
(pkg of 12)
0600-00-0097
Adult/Pediatric starter kit (two adult and two pediatric single patient
adhesive sensors and one 3.66 m./12’ cable)
0020-00-0123-01
Neonatal Y starter kit (two neonatal and two preterm neonatal Y single
patient adhesive sensors and one 3.66 m./12’ cable)
0020-00-0123-02
Clothing clips (pkg of 5)
0600-00-0084
Adhesive squares (12 cards/12 squares per card)
0600-00-0085
Pulse Oximetry-Masimo Set® LNCS® SpO2
DESCRIPTION
PART NUMBER
LNCS DC-I Adult finger reusable sensor
0600-00-0126
LNCS DC-IP Pediatric finger reusable sensor
0600-00-0127
LNCS TC-I, Reusable Adult Ear Sensor
0600-00-0128
LNCS ADTX Adult single patient adhesive sensors (20/Box)
0600-00-0121
LNCS PDTX Pediatric single patient adhesive sensors (20/Box)
0600-00-0122
LNCS INF-L Infant single patient adhesive sensors (20/Box)
0600-00-0123
LNCS NEO-L Neonatal single patient adhesive sensors (20/Box)
0600-00-0124
LNCS NEO PT-L Neonatal preterm patient adhesive sensors (20/Box)
0600-00-0125
LNC-4 SpO2 Patient cable, 4'
0012-00-1652
LNC-10 SpO2 Patient cable, 10'
0012-00-1599
LNC-14 SpO2 Patient cable, 14'
0012-00-1653
LNCS to LNOP PC series adapter
0012-00-1651
Masimo SET AC-1 LNCS adapter cable
0012-00-1656
LNCS Adult/Pediatric starter kit (one reusable Adult sensor, 2 Adult and 1
Pediatric single patient adhesive sensor and one 3.1 m cable)
0020-00-0154
Spectrum® Operating Instructions
0070-10-0648-02
4-3
Optional Accessories
4.1.2.3
Accessories
DESCRIPTION
PART NUMBER
LNCS Neonatal disposable starter kit (2 Neonate and 2 Neonate PreTerm
single patient adhesive sensors and one 3.1 m cable)
0020-00-0155
LNCS Adult/Pediatric disposable starter kit (2 Adult and 2 Pediatric single
patient adhesive sensors and one 3.1 m cable)
0020-00-0156
Pulse Oximetry-Nellcor® OxiMax® SpO2*
DESCRIPTION
Reusable sensor
0600-00-0051
SpO2 cable, DOC-10, OxiMax
0012-00-1464
Disposable OxiMax Sensor Kit (2 adult/2 neonatal)
0600-00-0103
*
4.1.3
PART NUMBER
Oximetry-Nellcor® OxiMax® SpO2 Replacement sensors are available from Nellcor-Puritan Bennett.
Phone: 1 800 NELLCOR or WWW.NELLCOR.COM
Oridion CO2 Accessories
DESCRIPTION
PART NUMBERS
Filterline Set (short term), Adult/Pediatric (box of 25)
0683-00-0470-25
Filterline Set, High Humidity, Infant/Neonatal (box of 25)
0683-00-0490-25
Filterline Set, High Humidity, Adult/Pediatric (box of 25)
0683-00-0469-25
Smart CapnoLine
™
Oral Nasal Cannula Pediatric (box of 25)
0683-00-0495-25
Smart CapnoLine™ O2/CO2 Oral Nasal Cannula Adult (box of 25)
™
O2/CO2 Oral Nasal Cannula Pediatric (box of 25)
0683-00-0498-25
Smart CapnoLine Plus™ O2/CO2 Oral Nasal Cannula with O2 tubing,
Adult/Intermediate (box of 25)
0683-00-0516-25
Smart CapnoLine Plus™ O2/CO2 Oral Nasal Cannula with O2 connector,
Adult/Intermediate (box of 25)
0683-00-0517-25
NIV Line™ Adult (box of 25)
0683-00-0506-25
Smart CapnoLine
NIV Line
™
Pediatric (box of 25)
CapnoLine™ H Adult (box of 25)
4-4
0683-00-0496-25
0683-00-0507-25
0683-00-0508-25
CapnoLine™ H Pediatric (box of 25)
0683-00-0509-25
CapnoLine™ H Infant/Neonatal (box of 25)
0683-00-0510-25
CapnoLine™ H O2 Adult (box of 25)
0683-00-0511-25
CapnoLine™ H O2 Pediatric (box of 25)
0683-00-0512-25
Calibration Gas
0075-00-0033-01
CO2 Exhaust Connector, Male
0008-00-0332-01
0070-10-0648-02
Spectrum® Operating Instructions
Accessories
Optional Accessories
4.1.4
Gas Module Accessories
4.1.4.1
Gas Module II and Gas Module SE
4.1.4.2
DESCRIPTION
PART NUMBERS
Calibration Gas
0075-00-0028
Calibration Gas Regulator
0119-00-0166
Gas Module Rolling Stand Kit
0040-00-0232-01
Gas Module Wall Mount Kit
0040-00-0232-02
Y-Power Cord, 120V
0012-00-1081-01
Y-Power Cord, 220V
0012-00-1081-02
Y-Power Cord, 240V
0012-00-1081-03
Dust Filter
0378-00-0040
Nasal Cannula, CO2, 7’ (2.1 m) (box of 10)
0683-00-0424-10
Nasal Cannula, CO2/O2, 7’ (2.1 m) (box of 10)
0683-00-0452-10
Adapter, Straight Tee ET (box of 12)
0683-00-0242-22
Adapter, Mask Elbow ET (box of 12)
0683-00-0242-12
Sample Line, Patient, 10’ (3.1 m) (box of 10)
0683-00-0451-10
Water Trap Assembly (box of 10)
0202-00-0129
Gas Scavenging Adapter Assembly, Quick Connect
0997-00-0923
Gas Scavenging Adapter Assembly, Luer
0997-00-0984
Spectrum/Gas Module Mounting Kit
0040-00-0287-03
Gas Module 3
DESCRIPTION
PART NUMBERS
Calibration Gas
0075-00-0028
Calibration Gas Regulator
0119-00-0166
Mounting Bracket, Gas Module to Spectrum
(includes 4 screws, Part Number 0212-17-0606)
0040-00-0299-02
Mounting Plate, Gas Module to Wall Mount
(includes 4 screws, Part Number 0211-03-5008)
0386-00-0344
Mounting Plate, Gas Module to Spectrum
(requires 4 screws, Part Number 0211-04-4010)
0436-00-0160
Y-Power Cord, 120V
0012-00-1081-01
Y-Power Cord, 220V
0012-00-1081-02
Y-Power Cord, 240V
0012-00-1081-03
Cable, Gas Module to Spectrum Serial Port, short (0.3 m)
0012-00-1276-01
Cable, Gas Module to Spectrum Serial Port, long (1.8 m)
0012-00-1276-02
Nasal Cannula, CO2, 7’ (2.1 m) (box of 10)
0683-00-0424-10
Nasal Cannula, CO2/O2, 7’ (2.1 m) (box of 10)
0683-00-0452-10
Adapter, Straight Tee ET (box of 12)
0683-00-0242-22
Adapter, Mask Elbow ET (box of 12)
0683-00-0242-12
DRYLINE™ Neonate Sample Line, Patient, (2.5 m) (box of 25)
0683-00-0524-25
*
For U.S. use only.
Spectrum® Operating Instructions
0070-10-0648-02
4-5
Optional Accessories
Accessories
DESCRIPTION
PART NUMBERS
DRYLINE™ Adult/Pediatric Sample Line, Patient, (2.5 m) (box of 25)
0683-00-0525-25
DRYLINE
™
Neonate Water Trap Assembly (box of 10)
DRYLINE™ Adult/Pediatric Water Trap Assembly (box of 10)
0202-00-0182-10
Gas Scavenging Adapter Assembly, Quick Connect*
0997-00-0923
Gas Scavenging Adapter Assembly, Luer*
0997-00-0984
Spectrum/Gas Module Mounting Kit
0040-00-0287-03
Wall Mount
0436-00-0061-01
*
4.1.5
0202-00-0181-10
For U.S. use only.
Reusable Temperature Probes
YSI 400
DESCRIPTION
PART NUMBERS
Adult Rectal / Esophageal
0206-02-0001
Pediatric Rectal / Esophageal
0206-02-0002
Skin Surface
0206-02-0003
YSI 700
4.1.6
DESCRIPTION
PART NUMBERS
Adult Rectal / Esophageal
0206-00-0701
Skin Surface
0206-00-0709
Disposable Temperature Probes
400 Series Probes (boxes of 20)
4-6
DESCRIPTION
PART NUMBERS
Esophageal Stethoscope, 12 Fr, ES 400-12
0206-03-0112-02
Esophageal Stethoscope, 18 Fr, ES 400-18
0206-03-0118-02
Esophageal/Rectal, 9 Fr, ER 400-9
0206-03-0209-02
Esophageal/Rectal, 12 Fr, ER 400-12
0206-03-0212-02
Skin, SK 400
0206-03-0300-02
Instrument Cable, 400 Series
0012-00-0975
0070-10-0648-02
Spectrum® Operating Instructions
Accessories
Optional Accessories
4.1.7
ECG Accessories
4.1.7.1
ECG Cables
3/5 Lead ECG Cables
DESCRIPTION
PART NUMBER
10’ (3.1 m) Straight
0012-00-1255-01
20’ (6.1 m) Straight
0012-00-1255-02
10’ (3.1 m) Right Angle
0012-00-1255-03
20’ (6.1 m) Right Angle
0012-00-1255-04
10’ (3.1 m) Straight, ESIS
0012-00-1255-05
20’ (6.1 m) Straight, ESIS
0012-00-1255-06
10’ (3.1 m) Right Angle, ESIS
0012-00-1255-07
20’ (6.1 m) Right Angle, ESIS
0012-00-1255-08
10’ (3.1 m) Neonate Cable, AAMI
0012-00-1265-01
10’ (3.1 m) Neonate Cable, IEC
0012-00-1265-02
Panorama Mobility Cable (ESIS and Non ESIS)
4.1.7.2
DESCRIPTION
PART NUMBER
Non-ESIS, 10’ (3.1 m), AAMI
0012-00-1502-01
Non-ESIS, 20’ (6.1 m), AAMI
0012-00-1502-02
ESIS, 10’ (3.1 m), AAMI
0012-00-1502-03
ESIS, 20’ (6.1 m), AAMI
0012-00-1502-04
ECG Leadwires
ECG Lead Wires - 3 Lead
DESCRIPTION
PART NUMBERS
3 Lead, Snap 18" (45.7 cm), AAMI
0012-00-1261-07
3 Lead, Snap 24" (61.0 cm), AAMI
0012-00-1261-08
3 Lead, Snap 40" (101.6 cm), AAMI
0012-00-1261-09
3 Lead, Snap 18" (45.7 cm), IEC
0012-00-1261-10
3 Lead, Snap 24" (61.0 cm), IEC
0012-00-1261-11
3 Lead, Snap 40" (101.6 cm), IEC
0012-00-1261-12
3 Lead, Pinch Clip 18" (45.7 cm), AAMI
0012-00-1262-07
3 Lead, Pinch Clip 24" (61.0 cm), AAMI
0012-00-1262-08
3 Lead, Pinch Clip 40" (101.6 cm), AAMI
0012-00-1262-09
3 Lead, Pinch Clip 18" (45.7 cm), IEC
0012-00-1262-10
3 Lead, Pinch Clip 24" (61.0 cm), IEC
0012-00-1262-11
3 Lead, Pinch Clip 40" (101.6 cm), IEC
0012-00-1262-12
Spectrum® Operating Instructions
0070-10-0648-02
4-7
Optional Accessories
Accessories
ECG Lead Wires - 5 Lead
DESCRIPTION
PART NUMBERS
5 Lead, Snap 18" (45.7 cm), AAMI
0012-00-1261-01
5 Lead, Snap 24" (61.0 cm), AAMI
0012-00-1261-02
5 Lead, Snap 40" (101.6 cm), AAMI
0012-00-1261-03
5 Lead, Snap 18" (45.7 cm), IEC
0012-00-1261-04
5 Lead, Snap 24" (61.0 cm), IEC
0012-00-1261-05
5 Lead, Snap 40" (101.6 cm), IEC
0012-00-1261-06
Snap, Extended Leg, 3/40" (3/101.6 cm), 2/60" (2/152.4 cm), AAMI
0012-00-1261-13
Snap, Extended Leg, 3/40" (3/101.6 cm), 2/60" (2/152.4 cm), IEC
0012-00-1261-14
5 Lead, Pinch Clip 18" (45.7 cm), AAMI
0012-00-1262-01
5 Lead, Pinch Clip 24" (61.0 cm), AAMI
0012-00-1262-02
5 Lead, Pinch Clip 40" (101.6 cm), AAMI
0012-00-1262-03
5 Lead, Pinch Clip 18" (45.7 cm), IEC
0012-00-1262-04
5 Lead, Pinch Clip 24" (61.0 cm), IEC
0012-00-1262-05
5 Lead, Pinch Clip 40" (101.6 cm), IEC
0012-00-1262-06
Pinch, Extended Leg, 3/40" (3/101.6 cm), 2/60" (2/152.4 cm), AAMI
0012-00-1262-13
Pinch, Extended Leg, 3/40" (3/101.6 cm), 2/60" (2/152.4 cm), IEC
0012-00-1262-14
ECG Leadwires - 12 Lead
DESCRIPTION
PART NUMBERS
12 Lead, AAMI
0012-00-1411-02
12 Lead, IEC
0012-00-1411-03
12 Long Lead, AAMI, 63” (160 cm)
0012-00-1588
12 Long Lead, IEC, 63” (160 cm)
0012-00-1587
Panorama Mobility Lead Wires
4.1.7.3
DESCRIPTION
PART NUMBERS
5 Lead, Snap 24" (61.0 cm), AAMI
0012-00-1503-02
3 Lead, Snap 24" (61.0 cm), AAMI
0012-00-1503-05
12 Lead ECG Accessories
DESCRIPTION
4-8
PART NUMBERS
View 12 Domestic Kit
VIEW12DOMP2SP
View 12 International Kit
VIEW12INTP2SP
0070-10-0648-02
Spectrum® Operating Instructions
Accessories
4.1.7.4
4.1.8
Optional Accessories
Electrodes
DESCRIPTION
PART NUMBERS
Neo Pre-wired (3 Lead Combiner Clip) 18", AAMI box of 100 Pks of 3 Ea:
Radio Opaque Set
0681-00-0098-01
Neo Pre-wired (3 Lead Combiner Clip) 18", AAMI box of 100 Pks of 3 Ea:
Radio Translucent Set
0681-00-0098-02
Disposable pre-gelled ECG Electrodes, foam base and Hydrogel
conductive adhesive, 1 case of 600/10 boxes of 60
0681-00-0100-01
Disposable pre-gelled ECG Electrodes, foam base and Hydrogel
conductive adhesive, 1 case of 60
0681-00-0100-02
IBP Accessories
IBP
TRANSDUCERS
4.1.9
PART NUMBERS
P10EZ Miniature (Reusable)
0682-00-0085
P23XL-1 Transducer (Reusable)
0682-00-0084
Cable, Interface, Transducer
0012-00-1245
Comm-Port Accessories
Comm-Port
Comm-Port 2
CS1, MB1, RD1
0998-00-0178-03
Comm-Port 3
RD1, NC1, SP1
0998-00-0178-05
Comm-Port 4
CS1, MB1, SP1
0998-00-0178-04
Comm-Port 5
SP1, NC1, SP2
0998-00-0178-06
CS = Ethernet Port, MB = Module Bus, SP = Serial Port, RD = Remote Display, NC = Nurse Call
Nurse Call (NC1)
DESCRIPTIONS
PART NUMBER
Unterminated Cable, 9’ (2.7 m)
0012-00-1277-02
Remote Display (RD1)
DESCRIPTIONS
PART NUMBERS
Cable, 6’ (1.83 m), VGA Extension, Male D to Female D
0012-00-0852-01
Cable, 25’ (7.62 m), VGA Extension, Female to Unterminated
0012-00-0852-02
Cable, 50’ (15.24 m), VGA Extension, Female to Unterminated
0012-00-0852-03
Cable, 100’ (30.48 m), VGA Extension, Female to Unterminated
0012-00-0852-04
Cable, 10’ (3.05 m), VGA Male to Male
0012-00-0994-01
Cable, 25’ (7.62 m), VGA Male to Male
0012-00-0994-02
Cable, 50’ (15.24 m), VGA Male to Male
0012-00-0994-03
Cable, 75’ (22.86 m), VGA Male to Male
0012-00-0994-04
Display, 19.0” LCD Flat Panel, Medical Grade, Desktop
0160-00-0093-03
Spectrum® Operating Instructions
0070-10-0648-02
4-9
Optional Accessories
Accessories
Remote Display (RD1)
DESCRIPTIONS
PART NUMBERS
Display, 19.0” LCD Flat Panel, Medical Grade, Wall mount
0160-00-0093-04
Wall mount, adjustable, VHM, Flat Panel
0436-00-0210
Wall mount, flush, Flat Panel
0040-00-0368
Serial Port (SP1)
DESCRIPTIONS
PART NUMBERS
Cable, Serial Port to Gas Module, 12” (30.48 cm)
0012-00-1276-01
Cable, Serial Port to Gas Module, 72” (182.88 cm)
0012-00-1276-02
Cable, Interface, Vigilance/PC, Serial Port to Serial Port
0012-00-1275-01
Cable, Serial Port to VISA, 10’ (3.05 m)
0012-00-1299-01
Ethernet (CS1)
4.1.10
4 - 10
DESCRIPTIONS
PART NUMBERS
CAT 5 Ethernet Cable, Patch, STP, 6’ (1.83 m)
0012-00-1274-01
CAT 5 Ethernet Cable, Patch, STP, 25’ (7.62 m)
0012-00-1274-02
CAT 5 Ethernet Cable, Patch, STP, 50’ (15.24 m)
0012-00-1274-03
CAT 5 Ethernet Cable, Patch, STP, 1’ (0.30 m)
0012-00-1274-04
CAT 5 Ethernet Cable, Patch, STP, 2’ (0.61 m)
0012-00-1274-05
CAT 5 Ethernet Cable, Patch, STP, 3’ (0.91 m)
0012-00-1274-06
CAT 5 Ethernet Cable, Patch, STP, 10’ (3.05 m)
0012-00-1274-07
Laser Printer, Laserjet 4200N
0992-00-0091-04
Paper, Laser Printer, View 12
0683-00-0503
ECS, HUB, 12 Port
0992-00-0085-01
CAT 5 Ethernet Cable, Crossover, STP, 3’ (0.91 m)
0012-00-1392-05
CAT 5 Ethernet Cable, Crossover, STP, 6’ (1.83 m)
0012-00-1392-06
CAT 5 Ethernet Cable, Crossover, STP, 10’ (3.05 m)
0012-00-1392-07
CAT 5 Ethernet Cable, Crossover, STP, 20’ (6.10 m)
0012-00-1392-08
Base Station Accessories
DESCRIPTION
PART NUMBERS
Base Station kit with 110V line cord
BASESTATION110
Base Station kit with 220V line cord
BASESTATION220
Base Station kit with 240V line cord
BASESTATION240
Base Station 110V line cord
0012-25-0001
Base Station 220V line cord
0012-25-0002
Base Station 240V line cord
0012-25-0003
Base Station power supply
0014-00-0070
Base Station mounting kit
0386-00-0259
Base Station Operator's manual multilanguage
0073-00-1292
0070-10-0648-02
Spectrum® Operating Instructions
Accessories
4.1.11
4.1.12
Optional Accessories
Miscellaneous Accessories
DESCRIPTIONS
PART NUMBERS
Recorder Chart Paper (10 Rolls)
0683-00-0422-02
Battery, Lithium-Ion
0146-00-0069
Battery, Sealed Lead Acid
0146-00-0043
AC Power Cord, 120V
0012-25-0001
AC Power Cord, 220V
0012-25-0002
AC Power Cord, 240V
0012-25-0003
Cable Assy, DPD Defibrillator, 8” (20.32 cm)
0012-00-1301-01
Cable Assy, DPD Defibrillator, 10’ (3.05 m)
0012-00-1301-02
Cable Assy, Analog Output (ECG only), 15’ (4.57 m)
CABLEANALOGOUT
Cable, ECG/IBP to IABP interface, for Software Version L.04 and above,
6-pin (4.6 m)
0012-00-1650-01
Transfer Card
0996-00-0094-01
Extended Trend Card
0996-00-0052-01
Abbreviated Operator’s Manual
0070-00-0574-02
12 Lead ECG Physician’s Reference Guide, English Version
0070-00-0524-01
12 Lead ECG Physician’s Reference Guide, Multi-Language Version
0070-00-0524-50
Mounting Kits and Accessories
DESCRIPTIONS
PART NUMBERS
Rolling Stand with mounting bracket
TRANSLBRKT
Rolling Stand with quick release plate
TRANSQRMTG
Wall Mount Kit
0040-00-0287-02
VHM Wall Mount
0040-00-0287-04
Bedrail Mount Kit
0040-00-0293
Quick Release Mounting Plate Kit
0040-00-0299-01
Stationary Mounting Bracket Kit
0040-00-0299-02
Gas Module Mounting Kit
0040-00-0287-03
12 Lead ECG Mounting Kit
0040-00-0352
Spectrum® Operating Instructions
0070-10-0648-02
4 - 11
Optional Accessories
4.1.13
Accessories
Upgrade Kits
DESCRIPTION
PART NUMBERS
CO2 Upgrade Kit with Masimo SpO2
0040-00-0353-01
CO2 Upgrade Kit with Nellcor® Oxismart® SpO2
0040-00-0353-02
CO2 Upgrade Kit with
4 - 12
Nellcor®
OxiMax®
SpO2, Nell-3
0040-00-0353-03
CO2 MiniMedi Upgrade - For use in units with serial number prefix MS
only, with Masimo SpO2 (includes installation at Mindray Repair Center)
0040-00-0353-04
CO2 MiniMedi Upgrade - For use in units with serial number prefix MSXXXX-A6 and below only, with Nellcor OxiSmart SpO2 (includes
installation at Mindray Repair Center)
0040-00-0353-05
CO2 MiniMedi Upgrade - For use in units with serial number prefix MSXXXX-B6 and above only, with Nellcor OxiMax SpO2 (includes installation
at Mindray Repair Center)
0040-00-0353-06
IBP Upgrade Kit (Add IBP1 and IBP2)
0040-00-0268-02
ST Software Option Enable Kit - 1 License
0040-00-0300-01
ST Software Option Enable Kit - 5 Licenses
0040-00-0300-02
ST Software Option Enable Kit - 10 Licenses
0040-00-0300-03
Arrhythmia Software Option Enable Kit - 1 License
0040-00-0300-11
Arrhythmia Software Option Enable Kit - 5 Licenses
0040-00-0300-12
Arrhythmia Software Option Enable Kit - 10 Licenses
0040-00-0300-13
ST & Arrhythmia Software Option Enable Kit - 1 License
0040-00-0300-21
ST & Arrhythmia Software Option Enable Kit - 5 Licenses
0040-00-0300-22
ST & Arrhythmia Software Option Enable Kit - 10 Licenses
0040-00-0300-23
Vigilance Software Option Enable Kit - 1 License
0040-00-0300-31
Vigilance Software Option Enable Kit - 5 Licenses
0040-00-0300-32
Vigilance Software Option Enable Kit - 10 Licenses
0040-00-0300-33
Vigilance & ST Software Option Enable Kit - 1 License
0040-00-0300-41
Vigilance & ST Software Option Enable Kit - 5 Licenses
0040-00-0300-42
Vigilance & ST Software Option Enable Kit - 10 Licenses
0040-00-0300-43
Vigilance & Arrhythmia Software Option Enable Kit - 1 License
0040-00-0300-51
Vigilance & Arrhythmia Software Option Enable Kit - 5 Licenses
0040-00-0300-52
Vigilance & Arrhythmia Software Option Enable Kit - 10 Licenses
0040-00-0300-53
Vigilance, ST & Arrhythmia Software Option Enable Kit - 1 License
0040-00-0300-61
Vigilance, ST & Arrhythmia Software Option Enable Kit - 5 Licenses
0040-00-0300-62
Vigilance, ST & Arrhythmia Software Option Enable Kit - 10 Licenses
0040-00-0300-63
0070-10-0648-02
Spectrum® Operating Instructions
Accessories
4.1.14
4.1.15
Optional Accessories
Central Station Accessories
DESCRIPTION
PART NUMBERS
Kit, Telemetry, 2.4 GHz
0040-00-0327-XX
Kit, Instrument Radio, Panorama, 608 MHz
0040-00-0361-01
External Parameter Module Accessories
DESCRIPTION
PART NUMBERS
External Parameter Module with Temperature
0998-00-0501-04X*
External Parameter Module with Temperature and Cardiac Output
0998-00-0501-03X*
External Parameter Module with Temperature and IBP
0998-00-0501-02X*
External Parameter Module with Temperature, Cardiac Output and IBP
0998-00-0501-01X*
Cable, Cardiac Output Y, two Temperature connections
0012-00-1447-01
Cable, Cardiac Output Edwards LifeSciences in-line injectate adapter
0012-00-1520
Cable, Cardiac Output Edwards LifeSciences Bath probe adapter
0012-00-1519
Cable, Cardiac Output Becton Dickinson in-line injectate adapter
0012-00-1532
Cable, Cardiac Output Abbott Labs in-line injectate adapter
0012-00-1533
*
NOTE: Please replace “X” with one of the following letters to designate language required: A-English;
P-Spanish; T-Italian; D-Dutch; F-French; G-German; N-Danish
Spectrum® Operating Instructions
0070-10-0648-02
4 - 13
Optional Accessories
Accessories
This page intentionally left blank.
4 - 14
0070-10-0648-02
Spectrum® Operating Instructions
5.0
Appendix
5.1
Safety Designations
5.1.1
Safety designations per IEC 60601-1 Standard
Type of protection against
Class 1 with internal electric power source.
electric shock:
Where the integrity of the external protective
earth (ground) in the installation or its
conductors is in doubt, the equipment will be
operated from its internal electric power
source (batteries).
Degree of protection against
ECG, IBP and Cardiac Output -
electric shock:
Type CF defibrillation protected
NIBP - Type BF defibrillation protected
SpO2, CO2 and Temperature - Type BF
Supply Connection:
100 - 240 Volt
50 or 60 Hz
1.2 - 0.7 Amps
12 VDC Sealed Lead Acid Internal Battery
or
11.1 VDC Lithium-Ion Internal Battery
Mode of Operation:
Continuous
Protection Against Hazards of Explosion:
Not protected (Ordinary)
Protection Against Ingress of Liquids:
Not protected (Ordinary)
Spectrum® Operating Instructions
0070-10-0648-02
5-1
Safety Designations
5-2
Appendix
Degree of electrical connection
Equipment designed for direct electrical and
between equipment and patient:
non-electrical connection to the patient
Degree of Mobility:
Transportable
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Patient Parameter Specifications
5.2
Patient Parameter Specifications
5.2.1
ECG
ECG Safety Requirements
The 3/5-lead ECG function is in accordance with the applicable requirements of EN 606012-27.
The 12-lead ECG function is in accordance with the applicable requirements of EN 60601-225.
ECG Performance Requirements
The ECG meets the Section 3.2 Performance Requirements of ANSI/AAMI EC11-1991.
The ECG meets the Section 3.2 Performance Requirements of ANSI/AAMI EC13-1992.
Lead Definition
ECG Type
Acquired Leads
Displayable Leads
3-lead ECG
I, II, III
I, II, III (one vector at a time)
5-lead ECG
I, II, and V (n)
I, II, III, aVR, aVL, aVF, V (n)
12-lead ECG
II, III, V1, V2, V3, V4,V5, V6
I, II, III, aVR, aVL, aVF, V1, V2,
V3, V4, V5, V6
Lead resistances ≤ 51 kΩ in parallel with
Lead Fault:
0.047 μF capacitance will not cause a lead
fault condition.
Differential offsets ≤ ±300 mV will not cause a
lead fault condition.
3/5-lead ECG Cable Detection:
Automatically detected using Mindray autodetecting cables.
12-lead ECG Analysis Enabling:
12-lead ECG analysis is automatically
enabled when the 12-lead card is installed, in
the PCM1 or PCM2 slot, prior to power up or
while the Spectrum is in operating mode.
The Spectrum has the ability to enable and
disable the 12-lead ECG function. Once
disabled, the Spectrum will default back to
the 3 or 5-lead ECG.
Spectrum® Operating Instructions
0070-10-0648-02
5-3
Patient Parameter Specifications
Appendix
Frequency Response
Bandwidth (-3db)
ECG Type
Monitor Mode
Extended Mode
ST Mode
3/5-lead ECG
0.5 to 40 Hz
0.05 to 100 Hz
0.05 to 40 Hz
12-lead ECG
0.5 to 40 Hz
0.05 to 150 Hz
0.05 to 40 Hz
3/5-lead ECG
0.55 to 35 Hz
0.05 to 90 Hz
0.05 to 35 Hz
analog output HP
compatible cable
Electrical Surgical Unit (ESU) Use
Protection:
3 and 5-lead ECG meets IEC. 60601-2-25,
clause 36.202.7 for functionality following
ESU energy exposure.
The system is capable of withstanding ESU
stress with no permanent damage and regain
normal function within 10 seconds after
removal of the disturbance. The 12-lead ECG
function does not provide ESU protection or
suppression.
Withstand:
3 and 5-lead ECG can withstand ESU stress
from a High Frequency Surgical Unit
operating at 300 Watts in cut mode and 100
Watts on coagulate mode. The 12-lead ECG
function does not provide ESU protection or
suppression
Noise Suppression:
3 and 5-lead ECG peak noise is less than ± 2
mV from ECG baseline when used with AAMI
compatible cables. Noise level is unspecified
when the monitor is used with HP compatible
cables. The 12-lead ECG function does not
provide ESU protection or suppression.
Noise Detection:
An ESU noise declaration will be asserted if
signals detected as pacers are detected at a
rate greater than 50 Hz. No noise declaration
will be asserted if pacer-like signals are
detected at a rate less than 10 Hz. The 12lead ECG function does not provide ESU
protection or suppression.
5-4
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Patient Parameter Specifications
ECG Filters
ESU Interference Filtering:
An ESU Interference filter provides greater
than 90 dB attenuation at 500 kHz.
The ESU Filter may be turned off.
The 12-lead ECG function does not provide
ESU interference filtering.
50/60 Hz Notch Filtering:
A Notch Filter is provided at 50 or 60 Hz.
The Notch Filter may be turned off.
Pacemaker Pulse Display
Rejection:
Pacer signals from ± 2 mV to ± 700 mV (RTI)
amplitude and 0.1 ms to 2 ms in duration,
and a maximum of 100 μs rise time are
rejected from the display when the Pacer
Rejection Mode is On.
Enhancement:
Pacer signals within the range ± 2 mV and ±
700 mV (RTI) amplitude with a maximum rise
time of 100 μs and with duration in the 0.1
ms to 2.0 ms range will be enhanced on the
display when the Pacer Enhancement Mode is
turned On.
ECG Systole Detector and Heart Rate Meter
The ECG heart rate meter function is derived from the ECG waveform. It provides a count of
the number of R waves per minute that are detected in the ECG waveform.
ECG Derived Heart Rate Meter Performance Requirements
ECG SOURCE
NEONATAL RANGE
(BPM)
PEDIATRIC RANGE
(BPM)
ADULT RANGE:
(BPM)
3/5-lead ECG
30 to 350
30 to 300
30to 300
12-lead ECG
30 to 300
30 to 300
30 to 300
Resolution:
1 bpm
Accuracy:
± 3 bpm or ± 3% at 30 to 250 bpm,
whichever is greater.
± 5% 251 to 350 bpm.
Trigger Indication:
There is an audible beep on every beat
captured.
Spectrum® Operating Instructions
0070-10-0648-02
5-5
Patient Parameter Specifications
Appendix
Tall T-Wave Rejection:
When tested in accordance with ANSI/AAMI
EC13-1992 Section 4.1.2.1c, the heart rate
meter rejects all T-waves with amplitudes less
than 120% of a 1mV, 100 ms QRS, and a T
wave duration of 180ms and a Q-T interval of
350 ms.
Step Change Response Time:
When tested in accordance with ANSI/AAMI
EC13-1992 Section 4.1.2.1f, the response
time of the heart rate meter to changes in
heart rate is:
Less then 10 sec for step increase from 80 to
120 bpm.
Less then 11 sec for step decrease from 80 to
40 bpm.
Pacemaker Pulse Rejection:
When tested in accordance with ANSI/AAMI
EC13-1992 Section 4.1.4, the heart rate
meter rejects tall pulses of amplitude ± 2.0 mV
to ± 700 mV and duration 0.1 ms to 2 ms
with no tail.
When tested in accordance with ANSI/AAMI
EC13-1992 Section 4.1.4, the 3/5 Lead ECG
derived heart rate meter will reject all pacer
pulses ± 2.0 mV to ± 700 mV and duration
0.1 ms to 2 ms with 4 ms time constant tail of
less than 2.0 mV.
NOTE:
12-lead does not reject Pacemaker pulses with tails.
Heart Rate Averaging:
3/5/12 Lead ECG:
The average heart rate is calculated as
follows:
Mean R to R interval in the last 16 R to R
intervals (HR > 48 bpm).
Mean R to R interval in the last 4 R to R
intervals (HR ≤ 48 bpm).
5-6
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.2.2
Patient Parameter Specifications
ECG Respiration Performance Requirements
Sensing Leads:
Lead II or I
Default Sensing Lead:
Lead II
Source:
When 12-lead ECG is enabled, the
Spectrum is capable of acquiring respiration
while using a 3-lead or 5-lead ECG cable.
Range:
4 to 199 breaths per minute.
Accuracy:
± 2% or ± 2 breaths per minute, whichever is
greater from 4 to 150.
± 4%, from 151 to 199.
Excitation:
< 550 μA RMS max.
Bandwidth:
0.1 Hz to 3 Hz (-3 dB) for adults.
0.2 Hz to 3 Hz (-3 dB) for pediatric and
neonatal patients.
200 Ω to 2000 Ω at patient with 1 k resistor
Baseline Impedance Range:
in the ECG cable.
High Impedance Indication:
Greater than 2.2 kΩ at patient.
Linear Signal Range:
8 Ω p-p minimum.
Less than 0.05 Ω at 500 Ω patient
Noise:
impedance, using a standard ECG cable.
User Selectable Scales:
Function of respiration scale. Waveform needs
to be greater than 0.1 Ω in order for breathes
to be accurately detected.
Cardiovascular Artifact Rejection:
5.2.3
Detected by algorithm.
NIBP Performance and Functional Characteristics
The NIBP function is capable of providing systolic, diastolic, and mean blood pressure
measurements in Neonate, Pediatric, and Adult modes non-invasively, using a blood pressure
cuff.
The NIBP function is in accordance with the requirements of EN 60601-2-30, EN 1060-1,
EN 1060-3, and SP 10.
Spectrum® Operating Instructions
0070-10-0648-02
5-7
Patient Parameter Specifications
Appendix
Systolic Pressure Measurement
Accuracy:
Mean error is less than ± 5 mmHg, Standard
Deviation is less than ± 8 mmHg.
Range:
Adult Mode
55 to 235 mmHg
Pediatric Mode
55 to 160 mmHg
Neonatal Mode
45 to 120 mmHg
Diastolic Pressure Measurement
Accuracy:
Mean error is less than ± 5 mmHg, Standard
deviation is less than ± 8 mmHg.
Range:
Adult Mode
30 to 200 mmHg
Pediatric Mode
30 to 150 mmHg
Neonatal Mode
20 to 100 mmHg
Static Pressure Measurement
Range:
0-300 mmHg
Static Accuracy:
± 3 mmHg or 2% whichever is greater in the
range of 20 to 275 mmHg.
Pulse Rate
Range:
5-8
Adult Mode
35 - 245 bpm
Pediatric Mode
35 - 245 bpm
Neonatal Mode
70 - 245 bpm
Resolution:
1 bpm
Accuracy:
The greater of ± 3 bpm or ± 3%
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Patient Parameter Specifications
Maximum Cuff Pressure
The software controlled maximum cuff pressure:
Adult Mode
300 mmHg
Pediatric Mode
195 mmHg
Neonatal Mode
150 mmHg
The hardware controlled maximum cuff pressure:
Adult Mode
330 mmHg
Pediatric Mode
220 mmHg
Neonatal Mode
165 mmHg
Cuff Inflation
The inflation source is capable of supplying sufficient air to bring a volume of 500 cc's to a
pressure of 300 mmHg in no more than 35 seconds (Reference ANSI/AAMI SP10A-1996,
EN60601-2-30:1995 does not have a requirement for this).
If the cuff is not inflated to the desired pressure within 60 seconds then the cuff is vented and
a retry cycle is initiated, up to 3 times.
Maximum Leakage
The maximum allowed pressure drop with the bleed valves closed is 10 mmHg in 10 seconds
as measured with a 500 cc volume at differential pressures of 250 mmHg, 150 mmHg and
50 mmHg (Reference ANSI/AAMI SP10-1992, EN1060-3, 1997).
Vent Rate
A volume of 500 cc, when vented, is reduced from a pressure of 260 mmHg to a pressure of
15 mmHg in a maximum of 10 seconds. For Neonate, from a pressure of 150 mmHg to a
pressure of 5 mmHg in less then 5 seconds (Reference: EN1060-3, 1997).
Initial Conditions
The NIBP will power-up and go into a warm up state.
An NIBP Zero is performed automatically before the NIBP can be initiated.
An NIBP measurement will not initiate until the unit has been powered on for 20 sec. in order
to allow time for the Zero. Afterwards it goes into an idle state.
Spectrum® Operating Instructions
0070-10-0648-02
5-9
Patient Parameter Specifications
Appendix
NIBP Start Pressure Settings and Ranges
The Start Pressure is adjustable throughout the following ranges and is set to the following
defaults:
PATIENT SIZE
USER SELECTABLE START
PRESSURE RANGE
INCREMENT SIZE
DEFAULT
SETTING
Adult Mode
100-280 mmHg
5 mmHg
180 mmHg
Pediatric Mode
60-180 mmHg
5 mmHg
140 mmHg
Neonatal Mode
40-120 mmHg
5 mmHg
100 mmHg
NIBP Measurement Cycle
There are two different modes of measurement operation: manual and interval modes. The
manual mode requires the operator to initiate the measurement cycle. The interval mode
follows a configured plan of automatically initiated measurement cycles.
The Maximum Measurement Cycle Duration is 180 sec for Adult and Pediatric patients
(Reference: EN60601-2-30, 1995).
The Maximum Measurement Cycle Duration is 90 sec for Neonatal patients (Reference:
EN60601-2-30, 1995).
During a measurement, if the initial cuff inflation pressure is found to be inadequate, the unit
will retry with a higher inflation pressure (+ 50 ± 10 mmHg in Adult mode and Pediatric
mode, + 40 ± 10 mmHg in Neonatal mode).
In interval mode only, the unit will adjust the inflation pressure according to the previous
systolic pressure. After the first successful measurement is made, the subsequent inflation
pressure becomes + 50 ± 10 mmHg in the Adult mode and Pediatric Mode and + 40 ±10
mmHg in Neonatal mode.
5.2.4
IBP Performance Characteristics
The Spectrum is capable of providing invasive blood pressure (IBP) measurements from a
maximum of 4 IBP channels that can be used simultaneously.
Each IBP channel provides three pressure readings: systolic, diastolic, and mean pressures.
IBP Safety Requirements
The IBP function meets the safety requirements of EN 60601-2-34.
IBP Performance Requirements
Accuracy:
± 2mm Hg or 2% which ever is greater (excluding
transducer error)
5 - 10
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Patient Parameter Specifications
IBP Transducer Performance
Excitation:
5 Volts DC, ± 2%
Minimum load resistance is 300 ohms per transducer.
Compatible with 5 μV/mmHg/Volt nominal excitation
Transfer Function:
transducers.
Zero Offset Range:
The transducer zero offset range is ± 120 mmHg.
Zero Accuracy:
The zero accuracy is ± 1 mm Hg.
Linear Input Range:
Is -30 to +300 mmHg, after zeroing.
Noise:
< 0.5 mmHg RTI, DC to 15 Hz, 300 Ω source
impedance.
Drift:
< 0.15 mmHg per degree Celsius.
Frequency Response:
DC to 16 Hz ± 1 Hz, -3 dB
IBP Heart Rate Meter
Range:
Neonatal Range (bpm)
30 to 350
Pediatric Range (bpm)
30 to 300
Adult Range (bpm)
30 to 300
Resolution:
1 bpm
Accuracy:
± 3 bpm or ± 3% at 30 to 250 bpm
± 5 bpm or ± 5% from 251 to 350 bpm
Trigger Threshold:
18 mm ± 9 mmHg
Step Change Response Time:
When tested using methods similar to ANSI/AAMI
EC13-1992 Section 4.1.2.1f, the response time of the
heart rate meter to changes in heart rate is:
Less then 10 sec for step increase from 80 to 120 bpm.
Less then 11 sec for step decrease from 80 to 40 bpm.
Spectrum® Operating Instructions
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5 - 11
Patient Parameter Specifications
5.2.5
Appendix
Temperature Parameter Performance Characteristics
The Spectrum is capable of providing temperature measurements from a maximum of 2
temperature channels, used simultaneously, as measured from YSI 400 or YSI 700 probes.
Temperature Performance Requirements
Scale:
Celsius or Fahrenheit
Range:
T1-T2:
15° C to 45° C
59° F to 113° F
Delta T:
0° C to 9.9° C
0° F to 9.9° F
Resolution:
0.1° C
0.1° F
Accuracy:
± 0.1° C (15° C - 45° C), exclusive of
probe errors
± 0.2° F (59° F - 113° F), exclusive of
probe errors
Accuracy inclusive of 400 Series probes:
± 0.1° C (25° C - 42° C)
± 0.2° C (otherwise)
± 0.2° F (77° F - 108° F)
± 0.4° F (otherwise)
Accuracy inclusive of 700 Series probes:
± 0.2° C (15° C - 45° C)
± 0.4° F (59° F - 113° F)
Probe Excitation: 400 Series:
< 200 μA, tip to sleeve.
Probe Excitation: 700 Series:
< 200 μA, tip to sleeve and <30 μA
maximum, ring to sleeve.
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Spectrum® Operating Instructions
Appendix
5.2.6
Patient Parameter Specifications
SpO2 Performance Requirements
The Spectrum is capable of providing SpO2 measurements via an OEM Masimo SET® MS3, OEM Nellcor MP-304 or OEM Nellcor NELL-3 pulse oximeter.
The SpO2 function is in accordance with the requirements of EN 865: 1997.
The SpO2 function is calibrated to display functional saturation.
Update Rate:
5.2.6.1
Every 2 seconds
Masimo SET SpO2 Performance Requirements
Sensor Compatibility: LNOP® and LNCS™ Series
SpO2 Accuracy
No motion conditions:
SATURATION RANGE
PATIENT SIZE
70% TO 100%
0-69%
Adult Mode
± 2 digits
unspecified
Pediatric Mode
± 2 digits
unspecified
Neonatal Mode
± 3 digits
unspecified
During motion conditions:
SATURATION RANGE
PATIENT SIZE
70% TO 100%
0-69%
Adult Mode
± 3 digits
unspecified
Pediatric Mode
± 3 digits
unspecified
Neonatal Mode
± 3 digits
unspecified
SpO2 Response Time:
The response time is 18 seconds to 95% of final step change of % SpO2 value from 60 to
95% at 75 bpm. Post averaging time is set at 8 seconds.
Low Perfusion Performance
LOW PERFUSION CONDITIONS
PULSE
AMPLITUDE
%
TRANSMISSION
SATURATION
ACCURACY
PULSE RATE
ACCURACY
> 0.02%
> 5%
± 2 digits
± 3 digits
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5 - 13
Patient Parameter Specifications
Appendix
Pulse Rate Range and Accuracy
ACCURACY
PATIENT SIZE
PULSE RATE
RANGE
NO MOTION
CONDITIONS
DURING
MOTION
CONDITIONS
Adult / Pediatric / Neonate
30 to 235 bpm
± 3 digits
± 5 digits
Update Rate
Every 2 seconds
Masimo SET® Reference notes
The Masimo SET MS-3 pulse oximeter with LNOP®•Adt sensors has been validated for no
motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia
studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG
monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
The Masimo SET MS-3 pulse oximeter with LNOP®•Adt sensors has been validated for
motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia
studies while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to
2 cm and non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced
hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and
ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
The Masimo SET MS-3 pulse oximeter with LNOP®•Neo and Neo•Pt sensors has been
validated for neonatal motion accuracy in human blood studies on neonates while moving
the neonate's foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co-oximeter
and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus
one standard deviation encompasses 68% of the population.
The Masimo SET MS-3 pulse oximeter has been validated for low perfusion accuracy in
bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal
strengths of greater then 0.02% and a % transmission of greater than 5% for saturation's
ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus
or minus on standard deviation encompasses 68% of the population.
The LNOP ear sensors have an SPO2 accuracy of 70% to 100% ±3.5% for adults during no
motion conditions, however, since the monitor cannot display ½ digits, the accuracy rounded
to ±4 digits. The SPO2 accuracy during motion conditions is not specified for the LNOP ear
or LNCS™ TF-I sensors.
5 - 14
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.2.6.2
Patient Parameter Specifications
Nellcor SpO2 Performance Requirements
Sensor Compatibility
Nellcor types: D-25L, N-25, I-20, D-20, OxiCliq A, OxiCliq N, OxiCliq P, OxiCliq I,
Oxiband A/N, Oxiband P/I, OXI 1-2-3 A/N, OXI 1-2-3 P/I, DS-100A, DY-S, Max-Fast
Saturation Accuracy
Sensor
Accuracy
D-25L, D-20, I-20, N-25
70% to 100% ± 2 digits Below 70%
unspecified
OxiCliq A, OxiCliq N, OxiCliq P, OxiCliq I,
70% to 100% ± 3 digits Below 70%
Oxiband A/N, Oxiband P/I, OXI 1-2-3 A/N,
unspecified
OXI 1-2-3 P/I, DS-100A, DY-S, Max-Fast
Pulse Rate Range and Accuracy
Range
Accuracy
20 to 249 bpm
± 3 bpm
Update Rate
Every 2 seconds
5.2.7
CO2 Performance Characteristics
The Spectrum is capable of providing CO2 measurements from either an Oridion
MediCO2 capnography module, or an Oridion MiniMediCO2 capnography module.
The CO2 performance is in accordance with the requirements of EN 864 (MediCO2) or ISO
21647:2004 (MiniMediCO2).
5.2.7.1
MediCO2 Microstream® (Only in monitors with serial numbers
below MS05000.)
Range:
0 - 99 mmHg
Accuracy specification of the measured CO2 partial pressure is according to the
following table
OPERATING
TIME
CO2
CONCENTRATION*
ACCURACY**
0 - 20 min.
0 - 38 mmHg
± 4 mmHg
39 - 99 mmHg
± 12%
0 - 38 mmHg
± 2 mmHg
20 min. and up
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5 - 15
Patient Parameter Specifications
Appendix
OPERATING
TIME
CO2
CONCENTRATION*
39 - 99 mmHg
*
**
ACCURACY**
± 5% to 39 - 40 mmHg
+ 0.08% for every 1 mmHg above 40 mmHg
At 760 mmHg
Accuracy applies for respiration rates of up to 80 RPM. For breath rates above 80 RPM, accuracy complies
with EN 864/ISO 9918 (4 mmHg or ± 12% of reading whichever is greater) for EtCO2 values exceeding 19
mmHg. To achieve the specified accuracy for respiration rates above 60 respirations/minute, an endotracheal tube adapter with low dead-space must be used in neonatal mode.
The accuracy specification is maintained to within ± 4% for the following gas mixtures (all
values are in Vol. %)
CO2
N2
O2
N2O
H2 O
ANESTHETIC
AGENTS
0 to 13
0 to 97.5
0 to 100
0 to 100
Dry to
According to
saturated
EN864
Above 80% O2, 1 mmHg has to be added to the upper tolerance of the accuracy specs.
Sampling Rate:
Nominally 50 ml/minute, ± 7.5 ml/min
Respiration Rate Range:
0 - 150 RPM
Respiration Rate Accuracy
Respiration Rate
0 to 40 RPM
41 to 70 RPM
71 to 100 RPM
100 to 150 RPM
Accuracy
± 1 RPM
± 2 RPM
± 3%
± 5%
Auto Zero:
The Auto Zero process is performed only during
measurement mode. The MediCO2 PlusMediCO Plus 2001A
updates the ambient pressure that is measured during the
Auto Zero process. The Auto Zero is triggered:
1. During the first hour after entering measurement mode,
periodically for durations of typically 15 seconds at a
rate which limits the total time consumed by Auto Zeros
to less then 2% of the time in which active measurements
are taken. Following the first hour after entering
measurement mode, periodically from or durations of
typically 15 seconds at a rate of at most once per hour.
2. If a change of 8 degree C from the last Auto Zero is
detected.
3. If a pressure change of 20 mmHg relative to the last
Auto Zero (less than the purge threshold) for period of
30 seconds. is detected.
Pump Calibration:
5 - 16
No routine calibration is required
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Patient Parameter Specifications
Rise/Fall Time:
< 190 ms to display 10 to 90% step change with a 5%
CO2/balance air test gas at 10 liters per minute flow through
an airway adapter.
< 190 ms to display 90 to 10% step change with a 5%
CO2/balance air test gas at a 10 liters per minute flow
through an airway adapter.
5.2.7.2
MiniMediCO2 Microstream® (Only in monitors with serial number
MS05000 and higher.)
Range:
0 - 99 mmHg
Accuracy specification of the measured CO2 partial pressure is according to the
following table (This testing is done according to ISO 21647 clauses 51.101.1 and
51.101.2.).
CO2 PARTIAL PRESSURE *
ACCURACY**
0 - 38 mmHg
± 2 mmHg
39 - 99 mmHg
± (5% of reading + 0.08% for every 1 mmHg above 38 mmHg)
*
**
At sea level.
Accuracy applies for respiration rates of up to 80 RPM. For respiration rates above 80 RPM, accuracy is
4 mmHg or ± 12% of the reading, whichever is greater, for EtCO2 values exceeding 18 mmHg. This is
tested according to and is compliant with EN 864 and ISO 21647. To achieve the specified accuracies for
respiration rates above 60 respirations/minute, the Microstream FilterLine H Set for Infant/Neonatal
(p/n 006324) must be used. Above 55 degrees C module temperature, ± 1 mmHg or ± 2.5% (whichever is
greater) has to be added to the tolerance of the accuracy specs.
Accuracy in the presence of interfering gases:
The accuracy specification is maintained to within 4% of the values indicated in the table
above in the presence of interfering gases according to ISO 21647 clauses 51.101.3 and
101.1.
Flow Rate:
50 ml/min -7.5 + 15 ml/min, flow measured by volume.
Respiration Rate Range:
0 - 150 RPM
Respiration Rate Accuracy:
Respiration Rate
0 to 70 RPM
71 to 120 RPM
121 to 150 RPM
Accuracy
± 1 RPM
± 2 RPM
± 3 RPM
Spectrum® Operating Instructions
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5 - 17
Patient Parameter Specifications
Appendix
Self Maintenance (SFM) Interval:
Self-Maintenance (SFM) is performed only during measurement mode. The module performs
one or more of the following:
• Ambient pressure measurement
• Auto zero (AZ)
• Flow test
SFM is triggered under the following conditions:
• During the first hour after entering measurement mode, periodically for durations of
typically 10 seconds at a rate which limits the total time consumed by SFMs to less
than 2% of the time in which active measurements are taken. Following the first hour
after entering measurement mode, periodically for durations of typically 10 seconds at
a rate of at most once per hour.
• If a change of 8 °C from the last AZ is detected.
• If a pressure change of 20 mmHg relative to the last ambient pressure measurement
(less than the purge threshold) for a period of 30 seconds is detected. The module will
be able to detect a real change in the ambient pressure and a pressure change due to
partial blockage of the FilterLine.
The module prevents the triggering of an SFM in the following situations:
• In case of purging until the end of this state.
• During a breath absence period which follows a valid breath.
• While waiting a minimum of 20 seconds for host SFM enable command. (After the 20second opportunity given to the host to schedule the SFM passes, the module
schedules the SFM according to a priority determined by current conditions).
System Response Time:
The system response time (with a standard-length FilterLine)
which includes the delay time and rise time (10% to 90%) in
response to a step change in the CO2 concentration is 2.9
seconds typical.
Rise Time (Adult and
190 msec maximum
Neonatal):
Delay Time:
2.7 seconds typical
Pump Calibration Interval:
No routine calibration is required. The module should initially
be calibrated after 1200 operating hours, then once a year
or after 4,000 operating hours, whichever comes first.
5 - 18
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.2.8
Patient Parameter Specifications
Cardiac Output
The Spectrum is capable of providing thermal dilution Cardiac Output in Adult and
Pediatric modes only.
Performance Requirements:
Cardiac output range:
0.2 - 20.0 liters/minute
Cardiac output resolution:
0.1 liters/minute
Cardiac Output Repeatability:
± 2% or 0.2 liters/minute from the mean
value, whichever is greater, as measured
using electronically generated flow curves.
Accuracy:
± 5% or 0.2 liters/minute, whichever is
greater, as measured using electronically
generated flow curves.
Blood Temperature Measurement:
Range:
17.5 - 43° C (63.5° F - 109.4° F)
Accuracy:
Exclusive of probe errors:
± 0.2° C (± 0.4° F)
Resolution:
0.1° C (0.1° F)
Injected Temperature Measurement:
Range:
0.1 - 30.0° C (30.2° F - 86° F)
Accuracy:
Exclusive of probe errors:
± 0.2° C (± 0.4° F)
Resolution:
0.1° C (0.1° F)
Modes of Operation:
Auto Start, Manual Start
Injectate volume:
3, 5, 10 cc
Spectrum® Operating Instructions
0070-10-0648-02
5 - 19
Special Functions
Appendix
5.3
Special Functions
5.3.1
ST Segment Analysis Performance Requirements
Enabling:
Enabled in Adult and Pediatric modes only
Absolute ST Deviation Range:
3/5-lead ECG:
-9.9 mm to 9.9 mm (-990 μV to 990 μV RTI)
12-lead ECG:
-10.0 mm to + 10.0 mm (-1000 μV to
1000 μV RTI)
Delta ST Deviation Range:
12-lead ECG Only:
-20.0 mm to 20.0 mm (-2000 μV to
2000 μV RTI)
Resolution:
0.1 mm (10 μV)
Default ST Measurement Point:
80 ms after J point for heart rates ≤ 120 bpm
60 ms after the J point for heart rates >
120 bpm
User Selectable ST Measurement Points:
40, 60 and 80 ms after J point (heart rate
independent) or 60/80 (heart rate dependent)
Default ISO Point:
Located between the P and Q waves.
User adjustable ISO Point:
3/5 Lead ECG:
User adjustable from “R peak” - 10 ms to “R
peak” - 200 ms in 8 ms increments.
12 Lead ECG:
User adjustable from “R peak” - 10 ms to “R
peak” - 200 ms in 8 ms increments.
Default J Point:
5 - 20
The end of the QRS complex.
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Special Functions
User Selectable J Point:
3/5 Lead ECG:
User adjustable from “R peak” + 10 ms to “R
peak” + 200 ms in 8 ms increments.
12 lead ECG:
User adjustable from “R peak” + 10 ms to “R
peak” + 200 ms in 8 ms increments.
Excluded Beats:
Ectopic beats and ventricular paced beats are
excluded from ST measurement.
Invalid ST
3 and 5-lead modes: ST data is invalidated
when the paced rhythm, Ventricular Rhythm or
Ventricular Tachycardia persists for more than
45 seconds and/or during detected episodes
of Asystole and Ventricular Fibrillation.
12-lead mode: ST data is invalidated when
the paced rhythm or Ventricular Rhythm
persists for more than 30 seconds, and/or
during detected episodes of Asystole,
Ventricular Fibrillation and Ventricular
Tachycardia.
5.3.2
Arrhythmia Analysis
Arrhythmia analysis can be enabled in Adult and Pediatric modes. Arrhythmia analysis will
identify ventricular arrhythmia only. Non-lethal or all arrhythmia alarms are capable of being
disabled. The Spectrum will have the ability to make the following arrhythmia calls as
applicable per ECG source:
3/5-lead ECG includes the following Arrhythmia Calls: Asystole, Irregular Heart Rate,
Couplet, PVCs per minute, Run, Bigeminy, Trigeminy, Ventricular Tachycardia, Ventricular
Fibrillation, Ventricular Rhythm and Bradycardia.
12-lead ECG includes the following Arrhythmia Calls: Asystole, Pause, Couplet, Ventricular
Rhythm, PVCs per minute, Run, Bigeminy, Trigeminy, Ventricular Tachycardia and Ventricular
Fibrillation.
When the ECG source is 3/5-Lead, PVCs per minute are invalidated and the PVC counter
reset to 0 during periods of Ventricular Rhythm, Ventricular Tachycardia, Ventricular
Fibrillation or Asystole.
When the ECG source is 12-Lead, PVCs per minute are invalidated and the PVC counter is
reset to 0 during periods of Ventricular Rhythm, Ventricular Tachycardia, and Ventricular
Fibrillation. During periods of Asystole, the PVC counter is reset to 0.
Spectrum® Operating Instructions
0070-10-0648-02
5 - 21
Special Functions
5.3.3
Appendix
ECG Interpretation
The Spectrum, equipped with 12-lead ECG and in adult mode only, is capable of providing
interpretive, rhythm, and condition statements in accordance with 0070-00-0524-XX.
Interpretive statements are disabled in adult modes for ages less than 18 years old.
5.3.4
Calculations
The Spectrum has the ability to calculate and display intravenous (IV) drug infusion rate
and concentration based upon patient weight and drug dosage.
Drug Infusion Rate
Units:
ml/hr
Range:
0 to 9999 ml/hr
Resolution:
0.01 ml/hr
Drug Concentration
Units:
mcg/ml, mg/ml, g/ml, units/ml, or mU/ml
Range:
0.1 - 100
Resolution:
0.1
References
Source: Chulay M, Guzzetta C, Dossey B. AACN Pocket Handbook of Critical Care
Nursing. Stamford: Appleton & Lange, 1997.
Source: Vallerand A, and Deglin J. Davis's Guide to IV Medications, 3rd Edition.
Philadelphia: F.A. Davis Company, 1996.
5.3.5
Hemodynamic Calculations
The Spectrum will have the ability to calculate and display the following Hemodynamic
parameters.
Cardiac Index (CI)
Range:
0.1 - 20.0 l/min/m2
Resolution:
0.1 l/min/m2
Stroke Volume (SV)
5 - 22
Range:
1 - 1000 ml
Resolution:
1 ml
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Special Functions
Stroke Volume Index (SVI)
Range:
0.1 - 500.0 ml/m2
Resolution:
0.1 ml/m2
Systemic Vascular Resistance (SVR)
Range:
50 - 9999 dyne-sec/cm5
Resolution:
1 dyne-sec/cm5
Systemic Vascular Resistance Index (SVRI)
Range:
50 - 5000 dyne-sec /cm5/m2
Resolution:
1 dyne-sec /cm5/m2
Pulmonary Vascular Resistance (PVR)
Range:
1 - 1000 dyne-sec/cm5
Resolution:
1 dyne-sec/cm5
Pulmonary Vascular Resistance Index (PVRI)
Range:
1 - 2000 dyne-sec/cm5/m2
Resolution:
1 dyne-sec/cm5/m2
Left Cardiac Work (LCW)
Range:
0.1 - 100.0 kg-m
Resolution:
0.1 kg-m
Left Cardiac Work Index (LCWI)
Range:
0.1 - 50.0 kg-m/m2
Resolution:
0.1 kg-m/m2
Right Cardiac Work (RCW)
Range:
0.1 - 100.0 kg-m
Resolution:
0.1 kg-m
Right Cardiac Work Index (RCWI)
Range:
0.1 - 50.0 kg-m/m2
Resolution:
0.1 kg-m/m2
Spectrum® Operating Instructions
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5 - 23
Special Functions
Appendix
Left Ventricular Stroke Work (LVSW)
Range:
1 - 500 gm-m
Resolution:
1 gm-m
Left Ventricular Stroke Work Index (LVSWI)
Range:
1 - 500 gm-m/m2
Resolution:
1 gm-m/m2
Right Ventricular Stroke Work (RVSW)
Range:
1 - 50 gm-m
Resolution:
1 gm-m
Right Ventricular Stroke Work Index (RVSWI)
Range:
1 - 50 gm-m/m2
Resolution:
1 gm-m/m2
Cerebral Perfusion Pressure (CPP)
Range:
-30 - 300 mmHg
Resolution:
1 mmHg
Reference Sources
Source: Kinney M, Dunbar S, Brooks-Brunn J, Molter N, and Vitello-Cicciu J. AACN's Clinical
Reference for Critical Care Nursing. St. Louis: Mosby, 1996.
Source: DuBois D, Dubois EF. A formula to estimate the approximate surface height and
weight be known. Arch Intern Medicing. 1916; 17:863-71.
Source: Baxter Healthcare Corporation. Model COM-2 Cardiac Output Computer
Operations Manual Software Version 2.2. Santa Ana: 1989.
5 - 24
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.4
Information Display and Control
Information Display and Control
Front Panel Display, Indicators, and Controls
The front of the monitor will provide a keypad, display, rotary/push knob, and four LEDs.
Front Panel Display
DISPLAY TYPE
SIZE
MINIMUM RESOLUTION
Color active matrix TFT liquid crystal
12.1-inch diagonal
800 x 600 pixels
Anti-Glare/ Anti-Reflection Filter
The display is fitted with an anti-glare/anti-reflection filter.
Rotary Knob
The rotary knob is 16 position per revolution optical encoder with an integral push button
switch.
LED Indicators
Alarm Indicators
Visual alarm indicators are in accordance with EN475: 1995.
A red LED will flash at 1.4 - 2.8 Hz (84 times/minute) at 50% duty cycle during a warning
alarm (high priority).
A yellow LED will flash at a rate of 0.4 - 0.8 Hz at a 50% duty cycle during a caution alarm
(medium priority).
If a warning and caution alarm are in force simultaneously, only the red LED is activated.
Power Indicators
A green AC Mains LED is illuminated whenever the unit is connected to AC Power.
A green Battery Charging LED is illuminated constantly when the batteries are charging.
Audio Indicators
An audio speaker is provided in order to annunciate alarms, key depresses, message tones,
and systole beep tones.
Audio alarms are in accordance with EN475: 1995.
Spectrum® Operating Instructions
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5 - 25
Information Display and Control
Appendix
Real Time Clock
The Display Resolution for the Real Time
1 minute
Clock is:
The Accuracy of the Real Time Clock is:
± 1 minute/month (30 days) @ 21± 3ºC
The Real Time Clock has a dedicated independent power source that allows it to keep time
whether or not the Spectrum has power provided.
5 - 26
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Spectrum® Operating Instructions
Appendix
5.5
Input/Output Communications
Input/Output Communications
ECG Analog Output Specification
ECG analog output is disabled when 12-lead ECG analysis is enabled.
Bandwidth (-3 dB referenced to 10 Hz):
Same as ECG Filter Setting
Maximum Propagation Delay
25 ms
(Delay of QRS complex):
± 10%
Sensitivity (referenced to 10 Hz):
1 V/mV of input,
Pacer Enhancement:
Pacer is summed at the output when pacer
enhancement mode is turned ON.
Pacer amplitude signal is a minimum of 2.5 V
Pacer width is 10 ms, with a 5% tolerance.
Pacer rise and fall times is 100 μs, maximum.
The Spectrum supports slaving of an IABP for the ECG analog output only.
Arterial Blood Pressure Analog Output Specification
(Only in monitors with serial number prefix “MS” and software versions L.X and higher.)
Bandwidth (-3 dB referenced to 10 Hz):
DC to 15 Hz minimum
Maximum Propagation Delay:
25 ms
Sensitivity:
1 V/100 mmHg, +10%
The Spectrum supports slaving of an IABP from Arterial Blood Pressure analog output.
Sync Pulse for Cardioversion
Source:
The Sync Pulse is derived from the active ECG
source.
Propagation Delay:
35 ms maximum, between QRS peak and the
rising edge of the Sync Pulse Amplitude: 2 Vp
minimum into a 5 kΩ load
Width:
3/5-LEAD ECG
12-LEAD ECG
2-7 ms
9-11 ms
Spectrum® Operating Instructions
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5 - 27
Communication Protocols
5.6
Appendix
Communication Protocols
DIAP Communication Protocol
The Spectrum supports the Mindray Improved ASCII Protocol (0070-00-0307) with the
following exceptions:
1. The NIBP elapsed time is set to “---” when the elapsed time is greater than 999 minutes.
2. Though not specified in the protocol, the alarm limit values are at the same resolution as
the parameter value. Example, temperature is 10X; therefore, the alarm limit values are
also 10X.
Gas Module
The Spectrum supports the Gas Module Communication Protocol (0084-00-0025).
ELAN Communication Protocol
The Spectrum supports the ELAN Communication Protocol for communication to the
Panorama Central Station (0084-00-0007).
Accutorr Communication Protocol
The Spectrum supports the Accutorr Communication Protocol (0070-00-0304) with the
following exceptions:
1. Baud Rate: 9600 or 1200
2. The following “Show patient data” command fields are not supported:
• “f” Status Byte 0
• “g” Status Byte 1
• “h” Status Byte 2
3. The following bits of Status Byte 1 are not supported:
• Bit 1, SpO2 Uncalibrated
• Bit 2, SpO2 Alarm Overlapped
• Bit 3, SpO2 RAM Test Failure
• Bit 4, SpO2 ROM Test Failure
• Bit 5, SpO2 OFFSET Mismatch
• Bit 6, SpO2 FILTER Mismatch
• Bit 7, SpO2 System Test in Progress
4. The following bits of Status Byte 2 are not supported:
• Bit 1, NIBP indicating Motion Artifact
• Bit 2 through 7 not used
Vigilance Interface
The Spectrum supports the Vigilance IFMout communications protocol in accordance with
Edwards Lifesciences specification ELS 1291.
5 - 28
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Communication Protocols
Module Bus Communication Protocol
The Spectrum supports the Enterprise Module Serial Protocol Specification
(0060-00-0991).
Alarm Delay Time to Remote Equipment
The alarm delay time from the Spectrum to remote equipment is ≤ 2.7 seconds, measured
at the Spectrum signal output connector.
Spectrum® Operating Instructions
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5 - 29
Power Supply
5.7
Appendix
Power Supply
Power Source
The Spectrum will auto-select its power source from those available. The monitor will use
the following priority in choosing the power source:
1. AC Mains Power
2. Internal battery power
The monitor will operate from AC Mains power with or without the internal batteries
installed.
AC Mains Power Source
Input Voltage:
100 - 240 VAC (± 10%)
Line Frequency:
50 or 60 Hz (± 3 Hz)
Current:
1.2 - 0.7 Amps
5.7.1
Battery Power
5.7.1.1
Sealed Lead Acid (P/N0146-00-0043)
Battery Type:
Sealed Lead Acid
Number of Batteries:
2 (the unit is capable of operation with one
battery for the sole purpose of changing
batteries while in the normal operating mode.)
Minimum Battery Run Time:
1 hour and 20 minutes from two fully charged
new batteries at 25º C for the following
conditions: ECG, SpO2, and NIBP running at
the 15 minute interval.
Battery Recharge Time:
16 hours maximum.
Charging Method:
Parallel and independent.
Time to Shutdown from Low Battery:
>10 minutes but < 20 minutes after indication,
with 2 new, fully charged batteries.
5 - 30
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.7.1.2
Power Supply
Lithium-Ion Battery (P/N 0146-00-0069)
Battery Type:
Lithium-ion
Number of Batteries:
2 (the unit is capable of operation with one
battery for the sole purpose of changing
batteries while in the normal operating mode.)
Minimum Battery Run Time:
4 hours and 30 minutes from two fully
charged new batteries at 25°C for the
following conditions: ECG, SpO2, and NIBP
running at the 15 minute interval.
Battery Recharge Time:
5 hours maximum.
Charging Method:
Parallel and independent.
Time to Shutdown from Low Battery:
>10 minutes but < 20 minutes after indication,
with 2 new, fully charged batteries with no
CO2 and printer.
Spectrum® Operating Instructions
0070-10-0648-02
5 - 31
Data Storage
5.8
Appendix
Data Storage
Monitor Configuration Data Storage and Transfer
Storage
The monitor has the ability to store, in non-volatile memory, the user selectable configuration.
There is one (1) configuration available for each patient size and the following information is
saved:
• Alarm Values
• Display Configurations
• NIBP Interval
• Parameter Settings, scaling
• Trace Speed
• Printer Settings
• Trend Configurations
Transfer
Transfer of monitor configuration data to and from the Spectrum using a PCMCIA card
inserted into PCM2 is provided while in installation mode.
The Transfer PCMCIA card has the ability to be write protected
Patient Data Storage and Transfer
Storage
The current patient information and demographics is stored in non-volatile memory.
The monitor is capable of storing, in non-volatile memory, a maximum of 120 trend values
for each active parameter and 6 minutes of OxyCRG data.
Extended Trend
With the addition of a PCMCIA memory card inserted into PCM1, the monitor is capable of
storing 500 list trend records for each active parameter and 12 hours of OxyCRG data.
The extended trend card is expected to be present at power-up and never removed.
All trend data not on the extended trend card when installed is lost and not accessible.
Transfer
Transfer of list trend data and demographics data to and from the Spectrum using a
PCMCIA card inserted into PCM2, is provided while in monitoring mode. Only trended data
for those parameters that are common between the monitors will be transferred.
The Transfer PCMCIA card has the ability to be write protected.
5 - 32
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.9
Printing
Printing
Integrated Thermal Printer
The integrated printer is a maximum 2- trace thermal strip chart printer with integral
paper spool.
The printer uses plain white thermal paper 5 cm wide.
The printer supports 5 paper speeds: 3.125, 6.25, 12.5, 25, and 50 mm/sec., each within
+ 5%.
The printer sensitivity is
± 5% on a single trace, and 50% if scale for dual trace, + 5%.
External Laser Printer
The Spectrum has the ability to print 12-lead data to an external Hewlett-Packard 4100N
laser printer via a wired Ethernet connection.
The laser printer will print on 8.5" x 11" pre-grided paper.
Spectrum® Operating Instructions
0070-10-0648-02
5 - 33
Monitor Physical Characteristics
5.10
Appendix
Monitor Physical Characteristics
Mounting
The monitor has the capability to be carried as a portable unit, placed on a tabletop, or
mounted to a wall mount, rolling stand, bed rail or Gas Module or SE. The monitor is
capable of having a PatientNet instrument transmitter, and an External Parameter Module
mounted to it.
Maximum Size
Without External
With External Parameter
Parameter Module
Module mounted
11.9" wide
11.9" wide
10.5" high
10.7" high
7.4" deep (including knob)
7.5" deep (including knob)
Maximum Weight
11.95 lbs. without optional accessories
15.52 lbs. with 2 Sealed Lead Acid batteries, without optional accessories
13.52 lbs. with 2 Lithium-Ion batteries, without optional accessories
PCMCIA Card Slot
PCMCIA Card Slot Functions
PCM1
PCM2
Extended Trend
Patient Data Transfer
12-lead ECG
Monitor Configuration Transfer
Software Download
12-lead ECG
A tool is needed to eject the card from PCM1.
Blank PCMCIA cards will fill the unused slots.
Cooling Fan Control
The cooling fan is ON when the unit is powered from an external source (AC).
The cooling fan is OFF when the unit is powered from the internal batteries.
5 - 34
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Monitor Physical Characteristics
Normal Operating Noise
The Sound Pressure Level (SPL) produced by the unit during normal operating conditions is
60 dBA at 1 meter when measured in accordance with ISO 3744. Maximum SPL is
measured with no alarms sounding, but all internal mechanical devices (i.e., pumps, fans)
running.
Spectrum® Operating Instructions
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5 - 35
Comm-Port Physical Characteristics
5.11
Appendix
Comm-Port Physical Characteristics
Maximum Weight
0.5 lbs.
The CS1/MB1/RD1 Comm-Port supports the following connections
Ethernet Communication labeled CS1
Module Bus labeled MB1
Remote Display labeled RD1 (Future Use)
The CS1/MB1/SP1 Comm-Port supports the following connections
Ethernet Communication labeled CS1
Module Bus labeled MB1
Serial Communication Channel, labeled SP1
The RD1/NC1/SP1 Comm-Port supports the following connections
Remote Display labeled RD1 (Future Use)
Nurse Call labeled NC1
Serial Communication Channel, labeled SP1
The SP1/NC1/SP2 Comm-Port supports the following connections
Nurse Call labeled NC1
2 Serial Communication Channels, labeled SP1 and SP2
5 - 36
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.12
External Parameter Module Physical Characteristics
External Parameter Module Physical Characteristics
Mounting
The External Parameter Module mounts atop the monitor.
A means of quick disconnect is provided. It does not require a tool, yet requires more than
one action in order to prevent accidental disconnect.
Connecting/disconnecting the external module from the Monitor will not disturb monitor
operation.
Maximum Size
11.0" wide x 2.3" high x 5.0" deep.
Maximum Weight
1.75 lbs.
Power
The module receives power from the monitor.
Spectrum® Operating Instructions
0070-10-0648-02
5 - 37
Environmental and Safety Characteristics
Appendix
5.13
Environmental and Safety Characteristics
5.13.1
Spectrum
Transport and Storage Temperature:
-20º C to 60º C
Transport and Storage Humidity:
10% to 95%, non-condensing
Transport and Storage Altitude:
(-1250 to 9,889 feet ASL)
1060 hPa to700 hPa
(795 mmHg to 525 mmHg)
Operating Temperature:
5º C to 40º C
Operating Humidity:
15% to 95% non-condensing
Operating Altitude:
(-1250 to 9,889 feet ASL)
1060 hPa to 700 hPa
(795 mmHg to 525 mmHg)
Shipping:
ISTA shipping procedure 1A
Shock:
15 g, 11 ms, half sine shock pulse tested per
IEC 60068-2-27.
Vibration:
Sinusoidal Vibration per IEC 60068-2-6
1 g or 0.07 mm, 57 - 62 Hz crossover
frequency
10 to 500 Hz 10 sweep cycles in each axis
Random Vibration per IEC 60068-2-34
0.02 g2/Hz
20 - 500 Hz
low degree of reproducibility 9 minutes per
axis
Drop:
ECRI PB-296 892, section AIII 3.3 for Class III
devices.
Impact:
ECRI PB-296 892, section AIIII 3.2 for Class 3
devices.
Spillage and Ingress of Fluids:
Non Protected Equipment (IPX0) as specified
in IEC 529.
5 - 38
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.13.2
Environmental and Safety Characteristics
Gas Module 3
Transport and Storage Temperature:
-40 °C to +70 °C
Transport and Storage Humidity:
5 to 100%, condensing1
Operating Temperature:
10 °C to 40 °C
Operating Humidity:
10 to 95% RH, non-condensing
(in Airway: 0-100% RH, condensing)
Operating Altitude:
Sea Level to 8,000 feet
Shipping:
ISTA shipping procedure 2A
Shock:
IEC 60068-2-27
peak acceleration: 150 m/s2 (15.3 g);
duration: 11 ms;
pulse shape: half-sine;
number of shocks: 3 shocks per direction per
axis (18 total).
Vibration:
IEC 60068-2-64
Drop:
IEC 60068-2-32
Spillage and Ingress of Fluids:
Non-protected Equipment (IPX0) as specified
in IEC 60529.
1
After storage in a condensing atmosphere, the unit shall, before use, be kept for more than 24 hr. in an
environment equivalent to the operating atmosphere.
CAUTION:
Spectrum® Operating Instructions
Gas Module 3 must be moisture protected whenever
transported. This can be done with a protective plastic bag
in which water-absorbing materials (e.g. silica gel) have
been included.
0070-10-0648-02
5 - 39
Agency Compliance
Appendix
5.14
Agency Compliance
5.14.1
Spectrum
The Spectrum was designed to comply with the following industry standards:
• EN 60601-1
• UL 60601-1
• CSA Standard C22.2 No. 601.1M90
• EN 60601-1-1/IEC 60601-1-1
• EN 60601-1-4/IEC 60601-1-4
• EN 60601-2-27/IEC 60601-2-27
• EN 60601-2-30/IEC 60601-2-30
• EN 60601-2-34/IEC 60601-2-34
• EN 60601-2-25/IEC 60601-2-25
• EN 60601-2-26/IEC 60601-2-26
• EN 60601-2-49/IEC 60601-2-49
The View 12™ ECG Analysis Module complies with AAMI EC 11 for Diagnostic
Electrocardiographic Devices.
The Spectrum has been certified by CSA.
The Spectrum has been tested for functionality following ESU (Electrosurgery Unit
Interference) energy exposure as described in the draft Amendment A1 to
IEC 60601-2-25.
5.14.2
Gas Module II and Gas Module SE
The Gas Module II and Gas Module SE were designed to comply with the following
industry standards:
• EN 60601-1/IEC 60601-1
• UL 60601-1
• CSA Standard C22.2 No. 601.1M90
The Gas Module II and Gas Module SE have been certified by CSA
5 - 40
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.14.3
Electromagnetic Capability
Gas Module 3
The Gas Module 3 was designed to comply with the following industry standards:
• EN 60601-1/IEC 60601-1
• UL 60601-1
• CSA Standard C22.2 No. 601.1M90
• EN 60601-1-1/IEC 60601-1-1
• EN 60601-1-4/IEC 60601-1-4
• ISO 21647
The Gas Module 3 has been certified by CSA.
5.15
Electromagnetic Capability
5.15.1
Spectrum
The Spectrum meets the requirements of IEC 60601-1-2/EN 60601-1-2.
NOTE:
The Spectrum needs special precautions regarding EMC and
needs to be installed and put into service according to the
EMC information provided below.
NOTE:
Portable and mobile RF communications equipment can
affect the Spectrum. See tables 5-1 through 5-4 that follow.
TABLE 5-1
GUIDANCE AND MINDRAY DS USA DECLARATION - ELECTROMAGNETIC EMISSIONS
The Spectrum is intended for use in the electromagnetic environment specified below. The customer
or the user of the Spectrum should assure that it is used in such an environment.
EMISSIONS
TEST
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions
CISPR 11
Group 1
The Spectrum uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class A
Harmonic
emissions IEC
61000-3-2
Class A
The Spectrum is suitable for use in all establishments
other than domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes
Voltage
fluctuations/
Flicker
emissions IEC
61000-3-3
Complies
Spectrum® Operating Instructions
0070-10-0648-02
5 - 41
Electromagnetic Capability
Appendix
TABLE 5-2
GUIDANCE AND MINDRAY DS USA DECLARATION - ELECTROMAGNETIC IMMUNITY
The Spectrum is intended for use in the electromagnetic environment specified below. The customer
or the user of the Spectrum should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines ±1
kV for input/
output lines
±2 kV for power
supply lines ±1
kV for input/
output lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV
differential
mode ±2 kV
common mode
±1 kV differential
mode ±2 kV
common mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines IEC
61000-4-11
<5% UT (>95%
dip in UT) for
0.5 cycle
<5% UT (>95%
dip in UT) for 0.5
cycle
40% UT (60%
dip in UT) for
5 cycles
40% UT (60%
dip in UT) for
5 cycles
70% UT (30%
dip in UT) for
25 cycles
70% UT (30%
dip in UT) for
25 cycles
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
Spectrum requires continued
operation during power mains
interruptions, it is recommended that
the Spectrum be powered from an
uninterruptible power supply or a
battery.
<5% UT (>95%
dip in UT) for 5
sec
<5% UT (>95%
dip in UT) for 5
sec
3 A/m
3 A/m
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
UT is the A.C. mains voltage prior to application of the test level.
5 - 42
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Electromagnetic Capability
TABLE 5-3
GUIDANCE AND MINDRAY DS USA DECLARATION - ELECTROMAGNETIC IMMUNITY
The Spectrum is intended for use in the electromagnetic environment specified below. The customer or
the user of the Spectrum should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601 TEST
LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Portable and mobile RF communications
equipment should be used no closer to
any part of the Spectrum, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation
distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1.2 x
P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.2 x
P
80 MHz to 800 MHz
d = 2.3 x
P
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the
compliance level in each frequency
range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE:
At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE:
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
b
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
Spectrum is used exceeds the applicable RF compliance level above, the Spectrum should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Spectrum.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Spectrum® Operating Instructions
0070-10-0648-02
5 - 43
Electromagnetic Capability
Appendix
TABLE 5-4
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE SPECTRUM
The Spectrum is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Spectrum can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Spectrum as recommended below, according to
the maximum output power of the communications equipment.
RATED MAXIMUM
OUTPUT POWER (P)
OF TRANSMITTER
IN WATTS (W)
SEPARATION DISTANCE (d) IN METERS (m) ACCORDING
TO FREQUENCY OF TRANSMITTER
150 kHz to
80 MHz
d = 1.2 x
P
80 MHz to
800 MHz
d = 1.2 x
P
800 MHz to
2.5 GHz
d = 2.3 x
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
P
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
5 - 44
NOTE:
At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE:
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.15.2
Electromagnetic Capability
Gas Module SE and Gas Module 3
The Gas Module SE and Gas Module 3 meet the requirements of IEC 60601-1-2/EN
60601-1-2.
NOTE:
The Gas Module SE and Gas Module 3 need special
precautions regarding EMC and need to be installed and put
into service according to the EMC information provided
below.
NOTE:
Portable and mobile RF communications equipment can
affect the Gas Module SE and Gas Module 3. See tables 5-5
through 5-8 that follow.
TABLE 5-5
GUIDANCE AND MINDRAY DS USA DECLARATION - ELECTROMAGNETIC EMISSIONS
The Gas Module SE and Gas Module 3 are intended for use in the electromagnetic environment
specified below. The customer or the user of the Gas Module SE or Gas Module 3 should assure
that they are used in such an environment.
EMISSIONS
TEST
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions
CISPR 11
Group 1
The Gas Module SE and Gas Module 3 use RF
energy only for their internal function. Therefore, their RF
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic
emissions IEC
61000-3-2
Class A
The Gas Module SE and Gas Module 3 are suitable
for use in all establishments other than domestic
establishments and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Voltage
fluctuations/
Flicker
emissions IEC
61000-3-3
Complies
Spectrum® Operating Instructions
0070-10-0648-02
5 - 45
Electromagnetic Capability
Appendix
TABLE 5-6
GUIDANCE AND MINDRAY DS USA DECLARATION - ELECTROMAGNETIC IMMUNITY
The Gas Module SE and Gas Module 3 are intended for use in the electromagnetic environment
specified below. The customer or the user of the Gas Module SE or Gas Module 3 should assure
that they are used in such an environment.
IMMUNITY
TEST
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact ±8
kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge IEC
61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines IEC
61000-4-11
<5% UT (>95%
dip in UT) for
0.5 cycle
<5% UT (>95%
dip in UT) for
0.5 cycle
40% UT (60%
dip in UT) for
5 cycles
40% UT (60%
dip in UT) for
5 cycles
70% UT (30%
dip in UT) for
25 cycles
70% UT (30%
dip in UT) for
25 cycles
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the Gas
Module SE or Gas Module 3
requires continued operation during
power mains interruptions, it is
recommended that the Gas Module
SE or Gas Module 3 be powered
from an uninterruptible power supply
or a battery.
<5% UT (>95%
dip in UT) for
5 sec
<5% UT (>95%
dip in UT) for
5 sec
3 A/m
3 A/m
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
UT is the A.C. mains voltage prior to application of the test level.
5 - 46
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
Electromagnetic Capability
TABLE 5-7
GUIDANCE AND MINDRAY DS USA DECLARATION - ELECTROMAGNETIC IMMUNITY
The Gas Module SE and Gas Module 3 are intended for use in the electromagnetic environment
specified below. The customer or the user of the Gas Module SE or Gas Module 3 should assure
that they are used in such an environment.
IMMUNITY
TEST
IEC 60601 TEST
LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Portable and mobile RF
communications equipment should be
used no closer to any part of the Gas
Module SE or Gas Module 3,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1.2 x
P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.2 x
P
80 MHz to 800 MHz
d = 2.3 x P 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should be
less than the compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE:
At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE:
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
b
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
Gas Module SE or Gas Module 3 are used exceeds the applicable RF compliance level above, the Gas Module SE or Gas Module 3 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Gas Module SE or
Gas Module 3.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Spectrum® Operating Instructions
0070-10-0648-02
5 - 47
Electromagnetic Capability
Appendix
TABLE 5-8
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE GAS MODULE SE OR GAS MODULE 3
The Gas Module SE and Gas Module 3 are intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the Gas Module SE
or Gas Module 3 can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Gas
Module SE or Gas Module 3 as recommended below, according to the maximum output power
of the communications equipment.
RATED MAXIMUM OUTPUT
POWER (P) OF
TRANSMITTER IN WATTS
(W)
SEPARATION DISTANCE (d) IN METERS (m)
ACCORDING TO FREQUENCY OF TRANSMITTER
150 kHz to
80 MHz
d = 1.2 x
P
800 MHz to
2.5 GHz
80 MHz to
800 MHz
d = 1.2 x
P
d = 2.3 x
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
P
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
5 - 48
NOTE:
At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE:
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.16
Warranty Statements
Warranty Statements
Mindray DS USA warrants that components within the monitor unit will be free from defects
in workmanship and materials for the number of years shown on the Mindray invoice. Under
this extended warranty, Mindray DS USA will repair or replace any defective component at
no charge for labor and/or materials. This extended warranty does not cover consumable
items such as, but not limited to batteries, displays, external cables and sensors.
Recommended preventative maintenance, as prescribed in the Service Manual, is the
responsibility of the user, and is not covered by this warranty.
Except as otherwise provided herein, the terms, conditions and limitations of Mindray DS
USA’s standard warranty will remain in effect.
USA, Canada, Mexico, and Puerto Rico
Mindray DS USA warrants that its products will be free from defects in workmanship and
materials for a period of one (1) year from the date of purchase except that disposable or
one-time use products are warranted to be free from defects in workmanship and materials
up to a date one year from the date of purchase or the date of first use, whichever is sooner.
This warranty does not cover consumable items such as, but not limited to, batteries, external
cables, sensors, cuffs, hoses, or mounts.
Mindray DS USA will not be liable for any incidental, special, or consequential loss,
damage, or expense directly or indirectly arising from the use of its products, liability under
this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or
replacing at Mindray DS USA’s option at the factory or at an authorized Mindray Distributor,
any product which shall under normal use and service appear to the Company to have been
defective in material or workmanship.
No agent, employee, or representative of Mindary DS USA has any authority to bind
Mindray DS USA to any affirmation, representation, or warranty concerning its products,
and any affirmation, representation or warranty made by any agent, employee, or
representative shall not be enforceable by buyer.
This warranty is expressly in lieu of any other express or implied warranties, including any
implied warranty or merchantability or fitness, and of any other obligation on the part of the
seller.
Damage to any product or parts through misuse, neglect, accident, or by affixing any nonstandard accessory attachments or by any customer modification voids this warranty.
Mindray DS USA makes no warranty whatever in regard to trade accessories, such being
subject to the warranty of their respective manufacturers.
A condition of this warranty is that this equipment or any accessories which are claimed to
be defective be returned when authorized by Mindray, freight prepaid to Mindray DS USA,
Mahwah, New Jersey 07430. Mindray DS USA shall not have any responsibility in the event
of loss or damage in transit.
Spectrum® Operating Instructions
0070-10-0648-02
5 - 49
Warranty Statements
Appendix
Calibration may be performed without the need to disassemble the instrument. It is the
responsibility of the purchaser to perform calibration as necessary, in accordance with the
instructions provided in this manual.
International (excluding North America)
Mindray DS USA warrants that its products will be free from defects in workmanship and
materials for a period of two (2) years from the date of purchase except that disposable or
one-time use products are warranted to be free from defects in workmanship and materials
up to a date one year from the date of purchase or the date of first use, whichever is sooner.
This warranty does not cover consumable items such as, but not limited to, batteries, external
cables, sensors, cuffs, hoses, or mounts.
Mindray DS USA shall not be liable for any incidental, special, or consequential loss,
damage, or expense directly or indirectly arising from the use of its products, liability under
this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or
replacing at Mindray DS USA’s option at the factory or at an authorized Mindray Distributor,
any product which shall under normal use and service appear to the Company to have been
defective in material or workmanship.
No agent, employee, or representative of Mindray DS USA has any authority to bind
Mindray DS USAto any affirmation, representation, or warranty concerning its products, and
any affirmation, representation or warranty made by any agent, employee, or representative
shall not be enforceable by buyer.
This warranty is expressly in lieu of any other express or implied warranties, including any
implied warranty or merchantability or fitness, and of any other obligation on the part of the
seller.
Damage to any product or parts through misuse, neglect, accident, or by affixing any nonstandard accessory attachments or by any customer modification voids this warranty.
Mindray DS USA makes no warranty whatever in regard to trade accessories, such being
subject to the warranty of their respective manufacturers.
A condition of this warranty is that this equipment or any accessories which are claimed to
be defective be returned when authorized by Mindray, freight prepaid to Mindray DS USA,
Mahwah, New Jersey 07430. Mindray DS USA shall not have any responsibility in the event
of loss or damage in transit.
Calibration may be performed without the need to disassemble the instrument. It is the
responsibility of the purchaser to perform calibration as necessary, in accordance with the
instructions provided in this manual.
5 - 50
0070-10-0648-02
Spectrum® Operating Instructions
Appendix
5.17
Phone Numbers and How To Get Assistance
Phone Numbers and How To Get Assistance
Mindray DS USA maintains a network of service representatives and factory-trained
distributors. Prior to requesting service, perform a complete operational check of the
instrument to verify proper control settings. If operational problems continue to exist, contact
the Mindray Service Department at (800) 288-2121 or (201) 995-8116 for assistance in
determining the nearest field service location.
Please include the instrument model number, the serial number, and a description of the
problem with all requests for service.
Any questions regarding the warranty should be directed to the nearest Mindray location. A
list of international offices, along with their phone numbers, is provided at the end of this
manual.
NOTE:
5.18
Upon request, Mindray will provide circuit diagrams,
component part lists, descriptions, calibration instructions,
or other information which will assist the user’s
appropriately qualified technical personnel to repair those
parts of the Mindray equipment which are designated by
Mindray as repairable.
Mindray’s Responsibility
Mindray is responsible for the effects on safety, reliability and performance of the equipment
only if:
a. assembly operations, extensions, readjustments, modifications or repairs are carried
out by persons authorized by Mindray; and
b. the electrical installation of the relevant room complies with the appropriate
requirements; and
c. the equipment is used in accordance with the instructions for use
Spectrum® Operating Instructions
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Mindray’s Responsibility
Appendix
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Spectrum® Operating Instructions
6.0
Glossary
6.1
Glossary of Terms
AaDO2
Alveolar-Arterial Oxygen Difference
ALVENT
Alveolar Ventilation
Art
Arterial - label for invasive blood pressure
AvDO2
Arteriovenous Oxygen Difference
BSA
Body Surface Area
CaO2
Arterial Oxygen Content
CcO2
Pulmonary Capillary Blood Oxygen Content
CI
Cardiac Index
CO
Cardiac Output
CO2
Carbon Dioxide
Comp
Dynamic Compliance
CPP
Cerebral perfusion pressure - this is the calculated difference between
cranial pressure and mean arterial pressure
CVA
Cardiovascular Artifact - this is any artifact in the respiratory waveform
due to heartbeats, also message will occur if heart rate and respiration
rate are the same
CvO2
Venous oxygen content
CVP
Central Venous Pressure - label for invasive blood pressure
ECG
Electrocardiogram
EMR
Electronic Medical Records system. This may include a Hospital
Information System (HIS) and/or a Clinical Information System (CIS).
EPM
External Parameter Module
etCO2
End - tidal CO2 - A patient’s carbon dioxide level measured at endexpiration
Spectrum® Operating Instructions
0070-10-0648-02
6-1
Glossary of Terms
Glossary
FiO2
Fraction of inspired oxygen
Hgb
Hemoglobin
IABP
Intra-aortic balloon pump
ICP
Intracranial pressure - label for invasive blood pressure
IBP
Invasive Blood pressure
ISO
Isoelectric point - reference point on ECG waveform for ST analysis
LA
Left atrium - label for invasive blood pressure
LCW
Left Cardiac Work - feature of hemodynamic calculations
LCWI
Left Cardiac Work Index - feature of hemodynamic calculations
LV
Left ventricle - label for invasive blood pressure
LVSW
Left Ventricular Stroke Work - feature of hemodynamic calculations
LVSWI
Left Ventricular Stroke Work Index - feature of hemodynamic calculations
MAP
Mean arterial pressure
MinVol
Minute Volume
NIBP
Non-invasive Blood Pressure
O2AV
Oxygen Availability
O2AVI
Oxygen Availability Index
O2ER
Oxygen Extraction Ratio
OxyCRG
Oxygen - cardiorespirogram - this trend feature is for pediatric and
neonatal patients. It graphs selected parameters for comparisons and
evaluation.
PA
Pulmonary artery - label for invasive blood pressure
PAD
Pulmonary artery - diastolic
PAO2
Partial pressure of alveolar oxygen
PaO2
Partial pressure of arterial oxygen
PaCO2
Partial pressure of arterial carbon dioxide
PAWP
Pulmonary Artery Wedge Pressure
PB
Atmospheric pressure
PECO2
Partial pressure of end-tidal CO2
PEEP
Positive End-Expiratory Pressure
PIP
Peak Inspiratory Pressure
PVC
Premature Ventricular Contractions
PvO2
Partial pressure of venous oxygen
PVR
Pulmonary Vascular Resistance - feature of hemodynamic calculations
PVRI
Pulmonary Vascular Resistance Index - feature of hemodynamic
calculations
6-2
Qs/Qt
Arteriovenous Shunt percent
RA
Right Atrium - label for invasive blood pressure
RCW
Right Cardiac Work - feature of hemodynamic calculations
RCWI
Right Cardiac Work Index - feature of hemodynamic calculations
RVSW
Right Ventricular Stroke Work - feature of hemodynamic calculations
RVSWI
Right Ventricular Stroke Work Index - feature of hemodynamic calculations
0070-10-0648-02
Spectrum® Operating Instructions
Glossary
Glossary of Terms
SpO2
Oxygen Saturation
SV
Stroke volume - feature of hemodynamic calculations
SVI
Stroke Volume Index - feature of hemodynamic calculations
SvO2
Mixed venous oxygen saturation
SVR
Systemic Vascular Resistance - feature of hemodynamic calculations
SVRI
Systemic Vascular - feature of hemodynamic calculations
TV
Tidal Volume
UA
Umbilical Artery - label for invasive blood pressure
Vd
Dead Space
VO2
Oxygen Consumption
VO2I
Oxygen Consumption Index
Wedge
Pulmonary Artery Wedge Pressure. This term is used interchangeably with
PAWP
Spectrum® Operating Instructions
0070-10-0648-02
6-3
0070-10-0648-02
Rev L
October 14, 2010
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