Mindray TRIO Operating instructions

Mindray TRIO Operating instructions
Operating Instructions
0070-01-0628-02_revD_Trio ops color.indd 1
3/10/10 5:37:08 PM
Operating Instructions
Trio™ is a U.S. trademark of Mindray DS USA, Inc.
Navigator™ is a U.S. trademark of Mindray DS USA, Inc.
Masimo SET® is a U.S. registered trademark of Masimo Corp.
Nellcor® and OxiMax® are U.S. registered trademarks of Nellcor Puritan Bennett Inc.
SatSeconds™ is a U.S. trademark of Nellcor Puritan Bennett Inc.
Copyright © Mindray DS USA, Inc., 2008. All rights reserved. Contents of this publication may not be
reproduced in any form without permission of Mindray DS USA, Inc.
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Trio™ Operations Manual
Table of Contents
Foreword ....................................................................................................................................................... v
Warnings, Precautions And Notes .................................................................................................................... v
Warnings ...................................................................................................................................................... vi
Precautions .................................................................................................................................................... vii
Notes ............................................................................................................................................................ xi
Indication For Use ........................................................................................................................................... xi
Unpacking ..................................................................................................................................................... xi
Symbols......................................................................................................................................................... xii
General Product Description.............................................................................................. 1 - 1
Front Panel..................................................................................................................................................... 1 - 3
Front Panel Keypad ................................................................................................................................. 1 - 4
Display................................................................................................................................................... 1 - 6
Left Side Panel ................................................................................................................................................ 1 - 10
Right Side Panel ............................................................................................................................................. 1 - 11
Rear Panel ..................................................................................................................................................... 1 - 12
Operations ....................................................................................................................... 2 - 1
Getting Started ............................................................................................................................................... 2 - 1
Setting-up Patients.................................................................................................................................... 2 - 1
Setting the Clock (Date and Time) .............................................................................................................. 2 - 2
Menus ........................................................................................................................................................... 2 - 2
System Menu.................................................................................................................................................. 2 - 3
Patient Setup ........................................................................................................................................... 2 - 3
List Trend ................................................................................................................................................ 2 - 5
Graphic Trend ........................................................................................................................................ 2 - 5
Mark Event ............................................................................................................................................. 2 - 6
Monitor Setup ......................................................................................................................................... 2 - 6
Maintenance........................................................................................................................................... 2 - 13
Normal Screen........................................................................................................................................ 2 - 13
Parameter Menus ............................................................................................................................................ 2 - 14
Electrocardiogram (ECG) Monitoring ......................................................................................................... 2 - 14
Respiration Monitoring ............................................................................................................................. 2 - 29
SpO2 Monitoring .................................................................................................................................... 2 - 32
NIBP Monitoring...................................................................................................................................... 2 - 44
Temperature Monitoring ........................................................................................................................... 2 - 53
IBP Monitoring (Optional) ......................................................................................................................... 2 - 56
Alarms........................................................................................................................................................... 2 - 63
Alarm Categories .................................................................................................................................... 2 - 63
Alarm Priorities........................................................................................................................................ 2 - 64
Alarm Setup Menus ................................................................................................................................. 2 - 64
Alarm Troubleshooting ............................................................................................................................. 2 - 75
Trends ........................................................................................................................................................... 2 - 76
Graphic Trend ........................................................................................................................................ 2 - 76
List Trend ................................................................................................................................................ 2 - 79
Recorder (Optional) ........................................................................................................................................ 2 - 82
Print Functions ......................................................................................................................................... 2 - 82
Recorder Troubleshooting ......................................................................................................................... 2 - 86
Defaults ............................................................................................................................ 3 - 1
Default Configurations ..................................................................................................................................... 3 - 1
Factory Default Configuration.................................................................................................................... 3 - 1
User Default Configuration........................................................................................................................ 3 - 6
Current Configuration .............................................................................................................................. 3 - 6
Non-Volatile Configuration ....................................................................................................................... 3 - 7
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i
Table of Contents
User Maintenance ............................................................................................................. 4 - 1
Introduction .................................................................................................................................................... 4
Decontamination of the Monitor........................................................................................................................ 4
Care and Cleaning of the Monitor .................................................................................................................... 4
Care and Cleaning of Accessories .................................................................................................................... 4
SpO2 Sensors ......................................................................................................................................... 4
-
1
2
2
3
3
Blood Pressure Cuffs ................................................................................................................................ 4 - 4
Temperature Sensor Cleaning and Disinfection (Reusable).................................................................................... 4
Battery Replacement and Maintenance .............................................................................................................. 4
Recorder Maintenance .................................................................................................................................... 4
Recorder Paper Replacement .................................................................................................................... 4
-
6
6
7
8
Care and Storage of Thermal Paper .................................................................................................................. 4 - 9
Care and Cleaning of ECG Cables and Leadwires ............................................................................................. 4 - 9
Accessories ....................................................................................................................... 5 - 1
Optional Accessories ...................................................................................................................................... 5 - 1
NIBP Accessories..................................................................................................................................... 5 - 1
Oximetry Sensors and Accessories............................................................................................................. 5 - 3
Reusable Temperature Probes.................................................................................................................... 5 - 4
Disposable Temperature Probes................................................................................................................. 5 - 4
ECG Accessories ..................................................................................................................................... 5 - 4
IBP Accessories ....................................................................................................................................... 5 - 5
Miscellaneous Accessories........................................................................................................................ 5 - 5
Mounting Kits and Accessories .................................................................................................................. 5 - 6
Replacement Parts, Trio Rolling Stand......................................................................................................... 5 - 6
Appendix ......................................................................................................................... 6 - 1
Specifications ................................................................................................................................................. 6 - 1
Safety Standards ..................................................................................................................................... 6 - 1
Safety Designations ................................................................................................................................. 6 - 2
Performance / Accuracy .......................................................................................................................... 6 - 3
Environmental / EMC .............................................................................................................................. 6 - 4
United States Food and Drug Administration Documents............................................................................... 6 - 4
Patient Parameter Specifications ....................................................................................................................... 6 - 5
ECG ...................................................................................................................................................... 6 - 5
ECG Performance Requirements ................................................................................................................ 6 - 5
ANSI/AAMI EC13-2002 Compliance........................................................................................................ 6 - 7
ECG Systole Detector and Heart Rate Meter ............................................................................................... 6 - 8
ECG Respiration Performance Requirements................................................................................................ 6 - 9
NIBP Sub-System Performance Characteristics ............................................................................................. 6 - 9
IBP Parameter Sub-System Performance Characteristics................................................................................. 6 - 12
IBP Safety Requirements............................................................................................................................ 6 - 12
Temperature Parameter Performance Characteristics .................................................................................... 6 - 13
SpO2 Performance Requirements............................................................................................................... 6 - 13
Physical Specifications..................................................................................................................................... 6 - 17
Information Display and Control ................................................................................................................ 6 - 17
LED Indicators ......................................................................................................................................... 6 - 17
Real Time Clock ...................................................................................................................................... 6 - 18
Input/Output Communications................................................................................................................... 6 - 18
Power Supply.......................................................................................................................................... 6 - 19
AC Mains Power Source .......................................................................................................................... 6 - 19
Battery Power.......................................................................................................................................... 6 - 19
Data Storage .......................................................................................................................................... 6 - 20
Printers ................................................................................................................................................... 6 - 21
Physical Characteristics ............................................................................................................................ 6 - 21
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Table of Contents
Environmental and Safety Characteristics.................................................................................................... 6 - 22
Warranty Statements ....................................................................................................................................... 6 - 28
Phone Numbers and How To Get Assistance...................................................................................................... 6 - 29
Manufacturer’s Responsibility ........................................................................................................................... 6 - 29
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Trio™ Operating Instructions
Foreword
Introduction
Foreword
The Trio Operating Instructions are intended to provide information for proper operation.
General knowledge of monitoring and an understanding of the features and the functions of
the Trio Monitor are prerequisites for proper use.
Do not operate this monitor before reading these instructions.
Information for servicing this instrument is contained in the Trio Monitor Service Manual,
(Part Number 0070-00-0627-03). For additional information or assistance, please contact a
service 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 U.S.
state law to use or order the use of this device.
Patents: This device is covered under one (1) of more of the following U.S. patents and any
foreign equivalents 4,621,643; 4,700,708; 4,770,179; 4,869,254; 4,653,498;
4,928,692; 4,934,372; 4,960,126; 5,078,136; 5,482,036; 5,490,505; 5,632,272;
5,685,299; 5,743,263; 5,758,644; 5,769,785; 6,157,850; 6,206,830; 4,802,486;
5,351,685; 5,421,329; 5,485,847; 5,533,507; 5,577,500; 5,803,910; 5,853,364;
5,865,736; 6,035,223; 6,263,222; 6,298,252; 6,463,310; 6,591,123; 6,675,031;
6,708,049; 6,801,797; 6,083,172 Re. 35,122. Possession or purchase of this device does
not convey any express or implied license to use this device with replacement parts which
would, alone, or in combination with this device, fall within the scope or one (1) or more of
the patents related 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.
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v
Introduction
Warnings
Warnings
WARNING: Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or
with nitrous oxide.
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 Trio, if nonpatient 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: Route cables neatly. Ensure cables, hoses, and wires are
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: This monitor is not intended for use in an MR environment.
WARNING: When using electrosurgery equipment, leads should be
placed equidistant from electrosurgery electrotome and the
grounding plate to avoid cautery. Ensure that wires from
electrosurgery equipment and ECG cables do not become
tangled.
WARNING: The Trio monitor is intended for hospital use under the direct
supervision of a licensed health care practitioner.
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 Appendix section of this manual for disclosure of the
pacemaker pulse rejection capability of this instrument.
WARNING: Do not clean the monitor or sensors while it is on and/or
connected to AC power.
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.
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Trio™ Operating Instructions
Precautions
Introduction
Precautions
CAUTION:
The use of portable and mobile RF communications
equipment, in the proximity of the Trio, can affect the
performance of this monitor.
CAUTION:
The use of unapproved accessories may diminish monitor
performance.
CAUTION:
The Trio should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the
Trio should be observed to verify normal operation in the
configuration in which it will be used.
CAUTION:
Operation of the Trio below the minimum amplitude or
value of PATIENT physiological signal may cause inaccurate
results (see section 6.0, Appendix).
CAUTION:
When using electrosurgery equipment, never place an
electrode near the grounding plate of the electrosurgery
device. This may create interference with the ECG signal.
CAUTION:
The patient size selection should be matched to the actual
patient before monitoring begins.
CAUTION:
To avoid possible damage to the Trio, use only approved
ECG cables and approved accessories.
CAUTION:
Line isolation 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.
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 Trio. It can also cause delayed recovery
after the discharge of a cardiac defibrillator.
CAUTION:
Thoracic respiration measurement may interfere with some
pacemakers. Refer to the pacemaker's manufacturer
supplied manual.
CAUTION:
If a 3 Lead cable is used when a unit is set to 5 lead mode,
no ECG signal will be obtained. If a 5 lead cable is used
when the unit is set to 3 lead mode only Lead I, II and III are
operable.
CAUTION:
Do not place the SpO2 sensor on an extremity with an
invasive catheter or blood pressure cuff in place.
CAUTION:
Tissue damage or inaccurate measurement 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 and all precautionary
information before use.
CAUTION:
Excessive ambient light may cause inaccurate
measurements. In such cases, cover the sensor site with
opaque material.
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Introduction
Precautions
CAUTION:
viii
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:
If the sensor or patient cable are damaged in any way,
discontinue use immediately. To prevent damage, do not
soak or immerse the sensor in any liquid solution. Do not
attempt to sterilize.
CAUTION:
When equipped with Masimo SpO2, use only Masimo
oxygen sensors and cables. Use of other oxygen sensors
may cause improper oximeter performance.
CAUTION:
When equipped with Nellcor SpO2, use only Nellcor oxygen
sensors and cables. Use of other oxygen sensors may cause
improper oximeter performance.
CAUTION:
When using the Trio equipped with SpO2, use only
approved supplied oxygen transducers and Patient Cables.
Use of other oxygen transducers may cause improper
oximeter performance.
CAUTION:
Use only approved blood pressure cuffs and hoses with the
Trio.
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.
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Trio™ Operating Instructions
Precautions
Introduction
CAUTION:
A patient's skin is sometimes fragile (i.e. on pediatric and
geriatric patients or due to physiological conditions). In
these cases, a longer time duration 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.
CAUTION:
Observe caution on all patients (Pediatrics and Adults) when
NIBP is set to the Continuous mode and the 1 minute
Interval. When the NIBP “Continuous” interval is chosen, the
Trio will continually take back to back blood pressure
readings. As a safety precaution, a limit is placed on the
Continuous mode to revert to an interval of every 5 minutes
after 5 minutes of continuous readings.
CAUTION:
Any condition which may affect the regularity and strength
of arterial pressures (such as patient movement, cardiac
arrhythmias, restriction of hose, etc.), will affect the
accuracy and ability to measure the NIBP.
CAUTION:
When cleaning sensors, do not use an excessive amount of
liquid. Wipe the sensor surface with a soft cloth, dampened
with a cleaning solution.
CAUTION:
Do not subject the sensor to autoclaving.
CAUTION:
Do not use sensors or cables that are damaged or have
deteriorated.
CAUTION:
Replace the battery with one of the following part numbers:
0146-00-0043 (for a sealed lead acid battery),
0146-00-0069 (for a Lithium Ion battery).
CAUTION:
Remove the battery if the Trio is not likely to be used for an
extended period of time.
CAUTION:
Remove the battery prior to shipping the Trio.
CAUTION:
To avoid permanent damage, do not expose metal
components (pins, sockets, snaps) to disinfectants, soaps or
chemicals.
CAUTION:
The cuff must be properly applied to the patient's limb
before inflating. If it is inflated without being securely
wrapped, damage to the cuff can result.
CAUTION:
Only connect NIBP Luer fittings to Blood Pressure Cuff or
Monitor.
CAUTION:
During the decontamination process, do not get the LpH SE
Germicidal detergent into any vent openings.
CAUTION:
To ensure continued use of the Factory Defaults when the
unit is powered off and on, save the Factory Defaults as the
User Default Configuration (see section 3.1.2).
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Introduction
Precautions
CAUTION:
x
Prolonged and continuous monitoring may increase the risk
of skin erosion and pressure necrosis at the site of the
sensor. Check the SpO2 sensor site frequently to ensure
proper positioning, alignment and skin integrity at least
every eight (8) hours; with the Adult and Pediatric re-usable
finger sensor, check every four (4) hours; for patients of
poor perfusion or with skin sensitive to light, check every
2 - 3 hours; more frequent examinations may be required
for different patients. Change the sensor site if signs of
circulatory compromise occur.
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Trio™ Operating Instructions
Notes
Introduction
Notes
NOTE:
Potential hazards due to errors in software or hardware
have been minimized by actions taken in accordance with
IEC 60601-1.
NOTE:
Messages are provided to assist in the identification and
correction of problems that may occur with the monitor.
NOTE:
Should the device become accidently saturated with any
liquid, immediately discontinue use and contact Customer
Service.
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 Technical Support (201) 995-8116.
NOTE:
Only operate this device within the specified operating
signal range.
Indication For Use
The Trio™ monitor is intended for use in healthcare settings under the direct supervision of a
licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic
parameter data on adult and pediatric patients. Physiologic data includes:
electrocardiogram, invasive blood pressure, non-invasive blood pressure (NIBP), pulse
oximetry, heart rate (derived from ECG, SpO2, or NIBP), respiration and temperature as
summarized in the operating instructions manual. The information can be displayed, stored,
trended and printed.
The monitor is not intended for home use. The monitor is not intended to be an apnea
monitor. It was not designed or validated for use as an apnea monitor.
Unpacking
Remove the instrument and accessories from the shipping cartons and examine them 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 your Sales Representative or Distributor for assistance in resolving shipping
problems.
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Introduction
Symbols
Symbols
SYMBOL
DESCRIPTION
SYMBOL
DESCRIPTION
Attention, Consult
Accompanying Documents /
Type BF Equipment
Refer to Manual
Dangerous Voltage
Equipotentiality
Alternating Current (AC)
ON/OFF (only for a part
of the equipment)
Defibrillator Proof Type BF
Equipment
Defibrillator Proof Type CF
Equipment
Alarm Off
Alarm Mute
Battery Charging
Full Battery Indicator
Data Output
Low Battery Indicator
Data Input/Output
No Battery in Unit
NIBP Connection
Non-ionizing electromagnetic
radiation
A symbol designating compliance of the Trio monitor with the
Medical Device Directive (MDD) 93/42/EEC, Class II b device.
xii
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Trio™ Operating Instructions
1.0
General Product Description
The Trio is a vital signs monitor intended for intra-hospital use on human patients. It is
adaptable for use with adult and pediatric patients. The Trio is a three (3) to four (4) trace
monitor. The unit has many features and functions, yet is easy to use through an integrated
keypad, Navigator™ Knob (see FIGURE 1-2) and an intuitive menu system. Refer to Front
Panel Keypad for details.
The patient parameters that can be monitored with the Trio are: ECG (3-lead or 5-lead
selectable), SpO2, Non-Invasive Blood Pressure, Respiration and Temperature.
The Trio is equipped with an 8.4" Color High Resolution (800 x 600) TFT LCD. Digital
displays are provided for Heart Rate, Pulse Rate, Pulse Oximetry (SpO2), Non-Invasive Blood
Pressure (NIBP), Respiration Rate and Temperature (T1). Waveform displays are provided for
ECG, Pleth and Respiration. An optional digital and waveform display for Invasive Blood
Pressure (IBP) is available. The optional built-in thermal recorder provides hard copies of all
digital data and waveforms, as well as Tabular and Graphic Trend information.
The Trio monitor can be mounted on a rolling stand, a wall mount bracket, a bed rail or
operated as a tabletop device.
The Trio is powered by an AC connection or an optional internal battery.
NOTE:
The Trio is suitable for use in the presence of the discharge
of a defibrillator.
NOTE:
The Trio is suitable for use in the presence of electrosurgery.
NOTE:
The Trio may not meet performance specifications if stored
or used outside of the specified environmental conditions
(see section 6.0).
Trio™ Operating Instructions
0070-10-0666-01
1-1
General Product Description
Key Features
The Trio offers several new features that enhance the capabilities of the monitor. The main
improvements of this release are as follows:
• Support for the full line of adult and pediatric NIBP Cuffs, see Section 5.
• Determination of heart rate from an NIBP measurement, see Section 2.
• An enhancement to SpO2 monitoring that enables audible distinction of oxygen
saturation changes, see Section 2.
• A serial port that offers connectivity to various medical devices, see Section 1.
FEATURES
STANDARD
Display
8.4 inch color TFT LCD
ECG
3 or 5 Lead (I, II, III, aVR, aVL, aVF, V)
OPTIONAL
4-trace erase bar refresh
ECG Cascade
ESIS Capability (3 or 5 Lead)
Blood Pressure
Non-Invasive Blood Pressure
SpO2
Masimo SET® SpO2
Respiration
Impedance
Temperature
One YSI 400 channel
Trend
Tabular and Graphic Trends up to 24 hours*
Power
Internal isolated power module
Printing
Nellcor® OxiMax® SpO2
Sealed lead acid battery or
Lithium Ion battery
Two-trace recorder
Communication
Ethernet,
Serial Communication Port (DIAP),**
Analog Output
Other
Handle with bedrail hook
Navigator™
Knob
Wall mount and rolling stand
kits
Dedicated keys
*
**
1-2
When the monitor is powered OFF, the tabular and graphic trend data is maintained for 2 hours. If the
monitor remains OFF for more than 2 hours, the tabular and graphic trend data is deleted.
Model number 0998-00-0600-4XXXX only
0070-10-0666-01
Trio™ Operating Instructions
General Product Description
1.1
Front Panel
Front Panel
1
2
3
FIGURE 1-1 Front View of Monitor
1. Alarm Light
Illuminates when an alarm is triggered.
2. Display
8.4” color TFT LCD (800 x 600 resolution).
3. Front Panel Keypad
Navigator™ Knob and dedicated quick-action keys.
Trio™ Operating Instructions
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1-3
Front Panel
1.1.1
General Product Description
Front Panel Keypad
The front panel keypad is used to access many main functions quickly and easily (see
FIGURE 1-2).
1
2
3
5
4
6
7
8
FIGURE 1-2 Keypad
1.
POWER
Press this key to power the Trio ON or OFF.
NOTE:
2.
The power supply and battery
charger are active any time AC
power is supplied, regardless of
whether the monitor is ON or
OFF.
BATTERY
A green LED that is illuminated when AC power is present and
CHARGING
the battery is installed and charging. When the monitor is
INDICATOR
running on battery power, this LED does not illuminate. When
a “low battery” condition exists, this LED flashes at a constant
rate.
3.
AC POWER
A green LED that is illuminated when AC power is present.
INDICATOR
4.
NIBP
Press this key to begin a NIBP measurement. During a
measurement, press this key to cancel the measurement and
deflate the cuff.
5.
PRINT
Press this key to initiate a real-time printout of numeric data
and selected waveforms. Results are output via the optional
internal printer. During a printing, press this key to cancel the
print job. Various print settings (such as speed and duration of
printout) are adjustable and may be set by accessing the
PRINTER SETUP menu in the MONITOR SETUP menu.
(Refer to section 2.3.5.3 for details).
1-4
0070-10-0666-01
Trio™ Operating Instructions
General Product Description
6.
Front Panel
ALARM 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 ALARM 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 in the
message bar. When in ALARM MUTE mode, press this key
again to re-enable the audio alarm.
7.
8.
NORMAL
Press the key to close all open menus and return the normal
SCREEN
real-time display.
NAVIGATOR™
Rotate this knob to highlight the various menus on the display.
KNOB
When highlighted, the menu target will display as black text
on a white background. Available menu targets on the main
display include the MENU icon, ECG lead, ECG size, ECG
filter, IBP label, ECG, NIBP, SpO2, IBP, RESP and TEMP. Press
the knob to display the highlighted menu. Once a menu is
displayed, rotate the knob to highlight one of the items listed.
Press the knob to select the highlighted item.
• When it is not highlighted, the MENU icon will display as
white text on the footer background with a white outline.
When all other menu targets are not highlighted, they will
be displayed in the colors that are defined in the
PARAMETER COLORS menu.
• When navigating within a menu, the menu target will
display as black text on a white background. When the
menu target is selected by pressing the knob, it will display
as follows:
• If the menu target is a Drop-Down Box, it will open with
the current selection displayed in black text on a white
background. Rotate and press the knob as necessary to
make a selection.
• If the menu target is a Text Edit Box, a cursor will be
inserted in the menu target and the letter “A” in the
onscreen keypad will display in black text on a white
background. Rotate and press the knob as necessary to
input the desired text. Select “OK” in the onscreen
keypad to accept the text and return the cursor to the
Text Edit Box.
• If the menu target is a Spin Edit Box, it will display as
white text on a black background. Rotate and press the
knob as necessary to make a selection.
Trio™ Operating Instructions
0070-10-0666-01
1-5
Front Panel
1.1.2
General Product Description
Display
The Trio display provides menus, waveforms, parameter information, patient information,
and messages. The Trio includes various features that enable the user to customize the
display. Additionally, the user default feature enables the user to save the customized
settings. The display is divided into the following areas (see FIGURE 1-3):
1. Demographics
2. Technical Alarms
3. Waveform Data/Menus
4. Parameter Tiles
5. Status Bar
1
2
4
3
5
FIGURE 1-3 Main Display
1. Demographics
The demographics area displays the following information:
1-6
Bed #
Bed number (6 characters maximum)
First Name
First name of the patient (10 characters maximum)
Last Name
Last name of the patient (10 characters maximum)
Patient Size
Size of the patient: ADU (Adult), PED (Pediatric)
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General Product Description
Front Panel
Gender
Gender of the patient: M (Male), F (Female)
Current Date
XX-XX-XXXX (month-day-year)
Current Time
XX:XX:XX (hours:minutes:seconds)
(24-hour format)
Indicates that all alarm tones have been manually disabled. It is
displayed when the ALARM MUTE button is pressed.
2. Technical Alarms
Technical Alarms are failures or errors that require resolution or attention to continue patient
monitoring (also called System Error Messages).
3. Waveform Data/Menus
The waveform data/menus area is used to display parameter waveforms and system menus.
Waveform Data
Up to four (4) waveforms may be displayed. When all waveforms are selected in the
TRACE SETUP menu, the waveforms will be displayed, from top to bottom, as follows:
ECG, SpO2 (Pleth), IBP (optional), Respiration (RESP). (Refer to Trace Setup for details.)
Up to four (4) waveforms may be displayed on this monitor.
• If the parameter waveforms only include ECG, SpO2 (PLETH), and Respiration (RESP),
and the ECG cascade is set to OFF, then only three (3) waveforms will be displayed. If
the ECG cascade is set to ON, then four (4) waveforms will be displayed. The first two
(2) will be ECG.
• For those monitors in which IBP is ordered as an option, and the cascade is set to OFF,
the display will show four (4) waveforms: ECG, SpO2 (PLETH), IBP, and Respiration
(RESP). If the ECG cascade is set to ON, then the cascaded ECG will replace the
SpO2 (PLETH) waveform.
ECG Lead, Gain and Filter are displayed in the upper left corner of the main display. The
IBP waveform label is displayed in the upper left corner of the IBP waveform window.
The waveforms are refreshed according to the rate designated by the user. (Refer to
specific parameter sections for details of sweep speed.)
Menus
When performing menu functions, a menu will be displayed, potentially obstructing the
view of select waveforms. Select NORMAL SCREEN in the menu (or on the Front Panel
Keypad) to exit all menus and return to the normal screen. If the user does not perform
any screen operation for 30 seconds, the menu will be removed automatically and the
screen will return to the normal display mode. Trend displays do not time out.
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0070-10-0666-01
1-7
Front Panel
General Product Description
4. Parameter Tiles
The numeric data in each parameter tile refreshes continuously, except for the NIBP value,
which refreshes each time a measurement is completed (see section 6). Using the MODULE
SETUP menu, parameters can be turned ON or OFF, and the screen display will adjust
accordingly. The numeric data is displayed at fixed positions within each parameter tile. (see
FIGURE 1-4).
A
B
C
D
E
F
FIGURE 1-4 Parameter Tiles
A. ECG
• PACER Display (ON or OFF)
• Heart Rate (HR)/Pulse Rate (PR) (Unit: bpm)
B. NIBP
• Systolic, Diastolic, Mean (Units: mmHg or kPa)
• Interval Display (CONT, 1min, 2min, 3min, 4min, 5min, 10min, 15min, 30min, 1HR,
2HRS, 4HRS, OFF)
• Elapsed Time Display (ET)
C. SpO2
• Pulse Rate (PR) (Unit: bpm)
• SpO2 (Unit: %)
• Pulse Amplitude Indicator
D. IBP
• Systolic, Diastolic, Mean (Units: mmHg or kPa)
E.
RESP
• Respiration Rate (Units: rpm)
F.
TEMP
• Temperature (Units: °C or °F)
1-8
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General Product Description
Front Panel
5. Status Bar
The status bar is located at the bottom of the screen. It displays the DEMO MODE status, the
battery icons and the MENU icon.
• The DEMO MODE status message indicates that the monitor is in demo mode and is
displaying simulated patient data.
• The battery icons indicate the relative charge status of the optional battery.
• Battery (Full)
The battery full icon appears in the lower right portion of the display when the unit is
operated by battery power. When the batteries are fully charged, the color will be
filled in as shown.
• Battery (Low)
The battery low icon appears in the lower right portion of the display when the unit is
operating on battery power. When the batteries are running low, color appears only
on the right portion of the indicator.
• No Battery in Unit
The no battery icon appears in the lower right portion of the display when a battery is
not installed in the monitor.
• The MENU icon is used to access the SYSTEM MENU. It is a rectangular icon
positioned below the parameter tiles and is the same width as that area.
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1-9
Left Side Panel
1.2
General Product Description
Left Side Panel
The optional, two-trace thermal strip chart recorder and the battery compartment are located
on the left side panel (see FIGURE 1-5).
1
2
3
4
FIGURE 1-5 Left Side Panel
1. Handle/bedrail hook
Handle with integrated bedrail hook
2. Recorder (Optional)
Two-trace thermal strip chart recorder
3. Recorder Power LED
A green LED that indicates that the recorder is receiving power
4. Battery compartment
The housing for the optional, user-replaceable, rechargeable battery (sealed lead acid or
Lithium Ion)
1 - 10
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Trio™ Operating Instructions
General Product Description
1.3
Right Side Panel
Right Side Panel
The connectors for patient cables and sensors are located on the right side panel
(see FIGURE 1-6).
1
SpO
2
¨
4
2
IBP 1
T1
ECG
3
5
FIGURE 1-6 Right Side Panel
1. SpO2 Receptacle
This receptacle is used to attach the SpO2 sensor to the monitor.
2. Optional IBP
A six-pin male receptacle used for an IBP connection.
3. ECG Receptacle
A six position female receptacle used to attach a 3 or 5 Lead ECG cable.
4. T1 Receptacle
A standard 1/4” phone jack is used to mate with the YSI series 400 temperature probe.
5. NIBP Quick-Connect Rectus* Pneumatic Fitting
This pneumatic fitting is used to attach the NIBP hose to the unit.
*
Trio™ Operating Instructions
Quick Connect Pneumatic Fittings available from Rectus-TEMA Corporation.
0070-10-0666-01
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Rear Panel
1.4
General Product Description
Rear Panel
The following connectors are located on the rear panel (see FIGURE 1-7).
1
CS1
2
4
AO1
SP1
XXXX - XX - XXXX - XXXXX
3
XXXX - XX - XXXX - XXXXX
5
FIGURE 1-7 Rear Panel
1. Ethernet Port (CS1)
The ethernet port is an RJ45 jack that is used for software upgrades.
NOTE:
This port should not be used while monitoring a patient.
2. Analog Output (AO1)
The analog signal output connector may be used with a oscillometer, pen recorder or other
external devices (see section 4). The connector is a BNC jack.
NOTE:
1 - 12
After connecting any external device to the Analog Output,
verify that leakage currents do not exceed accepted limits.
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Trio™ Operating Instructions
General Product Description
Rear Panel
3. Serial Port (SP1) or VGA Output (RD1)
Trio monitors bearing a model number of 0998-00-0600-4XXXX are equipped with a
9-position D-shell serial port connector. Trio monitors bearing a model number of 0998-000600-0XXXX or 0998-00-0600-2XXXX are equipped with a 15-position D-Shell VGA output
connector.
The proprietary serial port is a 9-position D-shell plug connector with interface based on TIA/
EIA-232-F signal compliance. Information is transferred via DIAP protocol. (For additional
information see P/N 0070-00-0307).
The VGA output connector provides connectivity to a medical grade remote display. The
connector is a 15-position D-Shell connector. Connection to this port should be made with the
monitor power OFF. Power ON the monitor after powering ON the remote display.
NOTE:
After connecting any external device to the Serial Port or the
VGA Output, verify that leakage currents do not exceed
accepted limits.
4. Equipotential Lug
The equipotential lug provides equipotential grounding for hospital equipment.
NOTE:
Ensure that when connecting external devices to the unit all
equipotential terminals are connected.
5. AC Receptacle
Insert the AC power cord into this receptacle.
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Rear Panel
General Product Description
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Trio™ Operating Instructions
2.0
Operations
2.1
Getting Started
The Trio features default factory settings that enable monitoring to begin without setting
waveforms, parameters, alarms, or functions. Each of these settings can be changed based
on specific patient or departmental needs. Certain operating characteristics (e.g. NIBP start
pressure) are based on the selected patient size.
CAUTION:
The patient size selection should be matched to the actual
patient before monitoring begins.
Before using the monitor, complete the following steps:
1. Examine the device, all external cables, inserted modules and accessories for damage
2. Check all monitor functions for proper operation.
NOTE:
2.1.1
If the monitor is damaged, contact the biomedical engineer
of the hospital or Customer Service immediately.
Setting-up Patients
1. Turn the monitor ON using the POWER key on the front panel.
2. Remove all of the previous patient data (except BED # and SIZE) as follows:
a. Use the Navigator™ Knob to select the MENU icon located in the bottom right
corner of the screen. The SYSTEM MENU (FIGURE 2-1) is displayed.
b. From the SYSTEM MENU, select PATIENT SETUP. The PATIENT SETUP menu
(FIGURE 2-2) is displayed.
c. Select PATIENT DISCHARGE. A confirmation dialog is displayed with the prompt,
Discharge patient from monitor?.
d. Select YES to remove the previous patient data from the monitor.
3. Connect the patient to the monitor, apply appropriate accessories such as ECG
electrodes, NIBP cuff, SpO2 probe, etc.
Trio™ Operating Instructions
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2-1
Menus
Operations
4. Enter the desired patient information into the Trio via the PATIENT SETUP menu.
Select appropriate patient SIZE.
5. If desired, press the NIBP key to initiate a non-invasive blood pressure measurement.
6. When monitoring has concluded, clear the patient's data by selecting PATIENT
DISCHARGE from the PATIENT SETUP menu.
2.1.2
Setting the Clock (Date and Time)
From the MONITOR SETUP menu the date and time can be set.
1. Using the Navigator Knob, select the MENU icon located in the bottom right corner of
the display.
2. From the SYSTEM MENU select MONITOR SETUP.
3. Select TIME SETUP.
4. Select YEAR, MONTH, DAY, HOUR, MINUTE or SECOND and adjust accordingly.
5. Select PREVIOUS MENU to return to the previous menu or select NORMAL SCREEN
(from the menu or the Front Panel Keypad) to exit the menu and return to the normal
screen.
2.2
Menus
The Trio menu system is accessed using the Navigator™ Knob. The flexibility of the menu
system enables the configuration of various features including the monitored parameters,
waveform sweep speed, audio volume, and parameter colors.
The MENU icon located in the bottom right corner of the display provides access to the
SYSTEM MENU. The parameter menu label in each parameter tile provides access to its
user-definable settings. Parameter menus include: ECG, NIBP, SpO2, IBP (optional), RESP
and TEMP.
The menu system restricts the overlap of settings that adjust upper and lower alarm limits. The
menu targets for these limits will be Spin Edit Boxes. See the following example for further
explanation.
Example: if a lower limit is set to 82, the menu system will restrict the upper limit choices
from being 82 or less.
NOTE:
2-2
All menus time-out after 30 seconds of inactivity with the
exception of the List Trend and Graphic Trend menus, which
display indefinitely until closed manually.
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Trio™ Operating Instructions
Operations
2.3
System Menu
System Menu
The SYSTEM MENU provides the following submenu choices: PATIENT SETUP, LIST
TREND, GRAPHIC TREND, MARK EVENT, MONITOR SETUP, MAINTENANCE, and
NORMAL SCREEN. For the default settings of all menu selections, refer to section 3.0,
“Defaults”.
Use the Navigator Knob to select the MENU icon in the lower right corner of the screen. The
SYSTEM MENU (FIGURE 2-1) is displayed. From the SYSTEM MENU, select a submenu.
FIGURE 2-1 System Menu
2.3.1
Patient Setup
Select PATIENT SETUP from the SYSTEM MENU. The PATIENT SETUP menu (FIGURE 22) is displayed.
FIGURE 2-2 Patient Setup Menu
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2-3
System Menu
Operations
The PATIENT SETUP menu provides the following choices for entering patient demographic
information and for patient discharge.
NOTE:
The ID #, BED#, FIRST NAME and LAST NAME use the onscreen keypad to enter demographic information. The
remaining demographic information is chosen from DropDown or Spin Edit Boxes.
ID #
Select to enter the patient ID number (only appears on recorder printouts)
BED#
Select to enter the patient bed number
FIRST NAME
Select to enter the patient's first name
LAST NAME
Select to enter the patient's last name
GENDER
Select to enter the patient gender (choices are: F for Female, M for Male)
SIZE
Select to enter the patient size (choices are: ADU for Adult and PED
for Pediatric)
BIRTH
Select to enter the patient date of birth (format: year/month/day)
HT. (cm)
Select to enter the patient height
WT. (kg)
Select to enter the patient weight
PATIENT
Select to discharge the current patient and admit a new patient. Selecting
DISCHARGE
PATIENT DISCHARGE opens the confirmation dialog box (FIGURE 2-3).
The user is prompted to answer YES or NO to the question: Discharge
patient from monitor?
Select YES to discharge the current patient from the monitor, erase the
stored record of the current patient (except BED # and SIZE) and exit the
menu. Select NO to continue monitoring the current patient, maintain the
stored record of the current patient and exit the menu.
NOTE:
Selecting YES will delete all information
related to the currently monitored patient.
FIGURE 2-3 Confirmation Dialog Box
2-4
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Trio™ Operating Instructions
Operations
System Menu
Entering the ID #, BED#, FIRST NAME and LAST NAME
Use the onscreen keypad to enter the ID #, BED#, FIRST NAME and LAST NAME
information, proceed as follows:
1. Select the PATIENT SETUP menu and use the Navigator™ Knob to scroll to the item
that will be entered or changed.
2. Press the Navigator Knob and the cursor will automatically move to the on-screen
keypad.
3. Move the cursor to the appropriate character and press the knob so that the character
appears in the box above. Continue this technique until the information for that item is
complete.
NOTE:
Select DEL to delete incorrect characters.
4. When finished entering the data for a particular item, select OK. The patient
information will be displayed in the box for that menu item and the cursor will return
to the starting position.
5. Select PREVIOUS MENU to return to the previous menu. Select NORMAL
SCREEN (from the menu or the Front Panel Keypad) to exit the menu and return to the
normal screen.
Entering the GENDER, SIZE, BIRTH DATE, HEIGHT and WEIGHT.
Use the Drop-Down and Spin Edit Boxes to enter the GENDER, SIZE, BIRTH, HT. and WT.
information, proceed as follows:
NOTE:
Setting the SIZE will automatically select all user defined
defaults for that patient size.
1. Select the PATIENT SETUP menu and use the Navigator™ Knob to scroll to the item
that will be entered or changed.
2. Press the Navigator Knob to access the Drop-Down or Spin Edit box for that selection.
3. Scroll to the desired setting and press the knob to accept the selection.
4. Select PREVIOUS MENU to return to the previous menu. Select NORMAL
SCREEN (from the menu or the Front Panel Keypad) to exit the menu and return to the
normal screen.
2.3.2
List Trend
To access the LIST TREND menu/display, select LIST TREND from the SYSTEM MENU.
Refer to "Trends" on page 2-76 for details on List Trend functions.
2.3.3
Graphic Trend
To access the GRAPHIC TREND menu/display, select GRAPHIC TREND from the
SYSTEM MENU. Refer to "Trends" on page 2-76 for details on Graphic Trend functions.
Trio™ Operating Instructions
0070-10-0666-01
2-5
System Menu
2.3.4
Operations
Mark Event
The Mark Event function places a time stamp event marker (A, B, C or D) in the trend
memory. This function may be used to identify medication delivery, change in patient status,
etc. There may be a time delay between the time at which the event is marked and the point
in time at which it displays on the trend screen.
Select MARK EVENT from the SYSTEM MENU (see FIGURE 2-4).
FIGURE 2-4 Mark Event Menu
To mark an event, use the Navigator™ Knob to select EVENT A, B, C or D. Once an event
is marked, the @ symbol appears in the event box. To cancel the selection, move the cursor to
the event and press the knob again. Select PREVIOUS MENU to save the marked event,
exit the MARK EVENT menu and return to the previous menu. Select NORMAL SCREEN
(from the menu or the Front Panel Keypad) to save the marked event, to exit the menu and
return to the normal screen.
NOTE:
2.3.5
Marked Events will not be saved if the menu times out.
Monitor Setup
1. Select MONITOR SETUP from the SYSTEM MENU. The MONITOR SETUP menu,
containing various submenus (FIGURE 2-5), is displayed.
FIGURE 2-5 Monitor Setup Menu
2-6
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Trio™ Operating Instructions
Operations
2.3.5.1
System Menu
Alarm Setup
Select ALARM SETUP from the MONITOR SETUP menu (see FIGURE 2-5).
The ALARM SETUP menu allows the user to adjust various alarm functions. Refer to section
2.5, “Alarms” for details on Alarm functions.
2.3.5.2
Time Setup
From the MONITOR SETUP menu, select the TIME SETUP menu to modify the time and
date settings displayed on the monitor (see FIGURE 2-6). The TIME SETUP menu allows the
user to set the YEAR, MONTH, DAY, HOUR, MINUTE and SECOND. Use the
Navigator™ Knob to adjust settings accordingly. Select PREVIOUS MENU to exit the TIME
SETUP menu and return to the previous menu. Select NORMAL SCREEN (from the menu or
the Front Panel Keypad) to exit the menu and return to the normal screen.
FIGURE 2-6 Time Setup Menu
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0070-10-0666-01
2-7
System Menu
2.3.5.3
Operations
Printer Setup
Select PRINTER SETUP from the MONITOR SETUP (see FIGURE 2-7).
FIGURE 2-7 Printer Setup Menu
Printer Setup Menu Selections
WAVEFORM 1 or
The PRINTER SETUP menu allows the user to designate which two
WAVEFORM 2
(2) parameter waveforms are displayed on the printout as
WAVEFORM 1 and WAVEFORM 2. Only waveforms that are
displayed on screen are available for selection.
Available parameter waveform selections include:
ECG: ECG waveform
SpO2: SpO2 Plethysmogram
IBP: IBP waveform (optional)
RESP: Respiration waveform
OFF: No display for this waveform
NOTE:
2-8
Two (2) waveforms can not be set to
the same parameter. Attempting to
set a duplicate parameter will cause
the previous selection to default to
the next available parameter
waveform.
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Trio™ Operating Instructions
Operations
System Menu
TIME
TIME represents the length of recording time. There are two (2)
selections available: CONTINUAL and 8s. CONTINUAL means
once the user presses the PRINT key on the front panel, the
recorder will continuously print out the selected waveform(s) until the
button is pressed again. 8s indicates a waveform recording time
length of 8 seconds.
INTERVAL
INTERVAL represents the time interval between the start of recorder
activations. The following 10 selections are available: OFF,
10min, 20min, 30min, 40min, 50min, 1HR, 2HRS, 3HRS
and 4HRS. The system will initiate the print operation according to
the selected time interval. All interval waveform printouts are 8
seconds in length.
NOTE:
SPEED
A real-time printout (based on TIME
as described in the previous menu)
takes priority over a printout based
on INTERVAL.
SPEED is used to select the speed at which the paper advances in
the printer. There are two (2) options: 25.0 and 50.0 mm/s.
GRID
GRID is used to select output format: OFF produces a printout
without a background grid, and ON produces a printout with a
background grid.
CLEAR PRINT
CLEAR PRINT TASK is used to clear all print tasks from the
TASK
recorder. This can be used, for example, when multiple alarm print
tasks are triggered simultaneously.
NOTE:
The recorder is optional.
Select PREVIOUS MENU to return to the previous menu. Select NORMAL SCREEN (from
the menu or the Front Panel Keypad) to exit the menu and return to the normal screen.
Trio™ Operating Instructions
0070-10-0666-01
2-9
System Menu
2.3.5.4
Operations
Analog Setup
The monitor can output an analog waveform from the analog output connector (AO1) on the
rear panel.
Select ANALOG SETUP from the MONITOR SETUP menu (see FIGURE 2-8). Select
ANALOG OUT, to set analog out to ON or OFF. Select ANALOG WAVE to select the
parameter waveform output. Choices are ECG and IBP (optional).
Select PREVIOUS MENU to return to the previous menu. Select NORMAL SCREEN (from
the menu or the Front Panel Keypad) to exit the menu and return to the normal screen.
FIGURE 2-8 Analog Setup Menu
2.3.5.5
Module Setup
MODULE SETUP allows the user to customize the display by selecting the parameters to be
monitored. Select MODULE SETUP from the MONITOR SETUP menu (see FIGURE 2-9).
FIGURE 2-9 Module Setup Menu
Select the parameters to monitor by using the Navigator™ Knob to select the item to be
displayed. A check mark will be displayed in the box next to each parameter selected. To
deselect a parameter, press the knob again (the check mark will be removed). Select
PREVIOUS MENU to return to the previous menu. Select NORMAL SCREEN (from the
menu or the Front Panel Keypad) to exit the menu and return to the normal screen.
NOTE:
2 - 10
If the optional IBP is not installed, it will not be displayed in
the MODULE SETUP menu.
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Trio™ Operating Instructions
Operations
2.3.5.6
System Menu
Trace Setup
TRACE SETUP allows the user to choose the traces that will be displayed in the waveform
area and to choose the viewing mode. The viewing modes improve the viewability of the
display depending on how the Trio is positioned for use. There are two viewing modes that
can be selected from the WAVE DISPLAY pull-down menu.
• MODE 1 – provides an enhanced view angle and a less smooth wave. This mode should
be used when the Trio is being viewed from an angle. In most instances, this mode will
provide optimal viewing of waveform data. (MODE 1 is the factory default setting.)
• MODE 2 – provides a basic view angle and a smooth wave. This mode should be used
when the Trio is wall-mounted and being viewed from below.
1. Select TRACE SETUP from the MONITOR SETUP menu. The TRACE SETUP menu
(FIGURE 2-10) is displayed.
FIGURE 2-10 Trace Setup Menu
2. Use the Navigator™ Knob to select each parameter waveform (a check mark in the box
next to a parameter indicates that it has been selected). To deselect a parameter
waveform, press the knob again.
3. Choose the desired viewing mode from the WAVE DISPLAY pull-down menu.
4. Select PREVIOUS MENU to return to the previous menu. Select NORMAL SCREEN
(from the menu or the Front Panel Keypad) to exit the menu and return to the normal
screen.
NOTE:
Trio™ Operating Instructions
If the optional IBP is not installed, it will not be provided as
a choice in the TRACE SETUP menu.
0070-10-0666-01
2 - 11
System Menu
2.3.5.7
Operations
Parameter Colors
1. Select PARAMETER COLORS from the MONITOR SETUP menu. The PARAMETER
COLORS menu (FIGURE 2-11) is displayed. From this menu, the colors for displayed
parameters can be selected. The numeric and waveform data for each parameter
displays in the same color, as selected by the user. The color choices are: GREEN, RED,
YELLOW, BLUE, and WHITE.
FIGURE 2-11 Parameter Colors Menu
2. Select PREVIOUS MENU to return to the previous menu. Select NORMAL SCREEN
(from the menu or the Front Panel Keypad) to exit the menu and return to the normal
screen.
2.3.5.8
Restore Defaults
1. Select RESTORE DEFAULTS from the MONITOR SETUP menu. The RESTORE
DEFAULTS menu (FIGURE 2-12) is displayed.
FIGURE 2-12 Restore Defaults Menu
The RESTORE DEFAULTS menu allows the user to perform the following two (2) functions:
• The RESTORE USER DEFAULTS function allows the user to revert back to a previously
saved group of monitor settings for the selected patient size.
• The RESTORE FACTORY DEFAULTS function allows the user to revert back to the group
of monitor settings initially set by the manufacturer. Factory alarm defaults for each
parameter are indicated in the parameter sections to follow. (See section 3.0 “Defaults”
for a complete list of Factory Default Settings.)
2. Select PREVIOUS MENU to return to the previous menu. Select NORMAL SCREEN
(from the menu or the Front Panel Keypad) to exit the menu and return to the normal
screen.
2 - 12
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Trio™ Operating Instructions
Operations
2.3.5.9
System Menu
Save Current
SAVE CURRENT allows the user to save the current customized settings as the default
settings (or the “User Default Configuration”), replacing the existing user-defined
configuration for the current patient size.
1. Select SAVE CURRENT from the MONITOR SETUP menu. The confirmation dialog
box in FIGURE 2-13 is displayed.
2. Select YES to replace the existing user-defined configuration with the current customized
settings. Select NO to cancel the task.
FIGURE 2-13 Confirmation Dialog Box
2.3.6
Maintenance
Refer to the Trio Service Manual (Part Number 0070-00-0627-03) for details on
maintenance functions.
2.3.7
Normal Screen
Select NORMAL SCREEN to exit the SYSTEM MENU and return to the normal screen.
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2 - 13
Parameter Menus
Operations
2.4
Parameter Menus
2.4.1
Electrocardiogram (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 Trio.
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 Trio, ECG can be obtained by using either a 3 Lead or 5 Lead ECG cable in
conjunction with a lead set and skin electrodes. For best performance and safety, inspect the
ECG cables and electrodes daily.
WARNING: Ensure that the conductive parts of ECG electrodes do not
contact other conductive parts, including earth ground.
2.4.1.1
CAUTION:
To avoid possible damage to the Trio, use only approved
ECG cables and approved accessories.
CAUTION:
Line isolation 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.
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 Trio. It can also cause delayed recovery
after the discharge of a cardiac defibrillator.
NOTE:
This device is not intended for direct cardiac application.
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 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.
2 - 14
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
NOTE:
2.4.1.2
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 2.4.1.3, “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.
NOTE:
Trio™ Operating Instructions
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.
0070-10-0666-01
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Parameter Menus
2.4.1.3
Operations
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
Standard 3-wire lead sets include 3 ECG leads (I, II and III). Only 1 lead is monitored.
Red
White
Yellow
Black
R
L
Green
Red
F
2 - 16
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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Trio™ Operating Instructions
Operations
Parameter Menus
Standard 5-wire Lead Sets
Standard 5-wire lead sets monitor 7 ECG leads: I, II, III, aVR, aVL, aVF and V.
White
Black
RA
LA
Red
Yellow
R
Brown
V Lead
(any V position)
L
White
C Lead
(any C position)
C
V
Green
Black
Red
RL
LL
Green
N
F
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.
Trio™ Operating Instructions
0070-10-0666-01
2 - 17
Parameter Menus
Operations
V-Lead and C-Lead Electrode Positions
2 - 18
FIGURE 2-18 V-Lead Electrode Placement
(AHA)
FIGURE 2-19 C-Lead Electrode Placement
(IEC)
• V1 - Place the electrode at the
fourth intercostal space, on the right
sternal border
• C1 - Place the electrode at the
fourth intercostal space, on the right
sternal border
• V2 - Place the electrode at the
fourth intercostal space, on the left
sternal border
• C2 - Place the electrode at the
fourth intercostal space, on the left
sternal border
• V3 - Place the electrode midway
between V2 and V4 on a line joining
these 2 locations
• C3 - Place the electrode midway
between C2 and C4 on a line joining
these 2 locations
• V4 - Place the electrode at the
fifth intercostal space on the midclavicular line
• C4 - Place the electrode at the
fifth intercostal space on the midclavicular line
• V5 - Place the electrode at the fifth
intercostal space on the anterior
axillary line
• C5 - Place the electrode at the fifth
intercostal space on the anterior
axillary line
• V6 - Place the electrode at the fifth
intercostal space on the mid-axillary line
• C6 - Place the electrode at the fifth
intercostal space on the mid-axillary line
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Trio™ Operating Instructions
Operations
Parameter Menus
Lead II Monitoring
Red
White
Yellow
Black
R
L
Red
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.
Trio™ Operating Instructions
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2 - 19
Parameter Menus
Operations
Modified Chest Lead (MCL) Monitoring
W hite
Red
RA
R
Red
Black
LA
Yellow
F
LL
FIGURE 2-22 MCL Monitoring with a
3-wire Lead Set (AHA)
• Place the RA (white) 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 LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
Select ECG Lead I for MCL1 monitoring.
Lead I is the direct electrical line between
the RA (white) electrode and the LA (black)
electrode.
Select ECG Lead II for MCL6 monitoring.
Lead II is the direct electrical line between
the RA (white) electrode and the LL (red)
electrode.
2 - 20
Green
L
0070-10-0666-01
FIGURE 2-23 MCL Monitoring with a
3-wire Lead Set (IEC)
• Place the R (red) electrode under the
patient’s left clavicle, at the midclavicular line 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 F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
Select ECG Lead I for MCL1 monitoring.
Lead I is the direct electrical line between
the R (red) electrode and the L (yellow)
electrode.
Select ECG Lead II for MCL6 monitoring.
Lead II is the direct electrical line between
the L (red) electrode and the F (green)
electrode.
Trio™ Operating Instructions
Operations
Parameter Menus
Monitoring a Pacemaker Patient
Pacer
White
White
Pacer
Black
V
Brown
Black
Red
Green
FIGURE 2-24 3-wire Lead Placement for
a Pacemaker Patient (AHA)
Red
FIGURE 2-25 5-wire Lead Placement for
a Pacemaker Patient (AHA)
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 (white)
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 Appendix section of this manual for disclosure of the
pacemaker pulse rejection capability of this instrument.
CAUTION:
Thoracic respiration measurement may interfere with some
pacemakers. Refer to the pacemaker's manufacturer
supplied manual.
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.
Trio™ Operating Instructions
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Parameter Menus
2.4.1.4
Operations
ECG Monitoring
NOTE:
If an electro-surgical device is to be used on the patient, use
the ESIS cable. Respiration from ECG is not available if the
ESIS cable is used.
• Plug the patient cable firmly into the ECG connector on the Trio. An ECG waveform will
begin to display in the ECG waveform tile and the heart rate will be displayed in the
ECG parameter tile to the right (see FIGURE 2-26).
• Select the desired ECG lead by turning the Navigator™ Knob to highlight the lead label,
located in the upper left corner of the ECG waveform tile. Press the knob to enable
scrolling through available leads. Lead II is the default setting.
• Select the desired ECG size by turning the Navigator™ Knob to highlight the current
waveform size, located in the upper left corner of the ECG waveform tile. Press the knob
to enable scrolling through available sizes. The default setting is 2 cm/mV.
NOTE:
2 - 22
Check ECG electrode sites every day for skin irritation.
Replace electrodes as necessary.
0070-10-0666-01
Trio™ Operating Instructions
Operations
2.4.1.5
Parameter Menus
ECG Lead, Size and Filter Settings
1
2
3
FIGURE 2-26 ECG settings on the Main Display
Use the Navigator™ Knob to select the following ECG settings (located in the upper left
corner of the ECG waveform tile): ECG Lead, ECG Size, and ECG Filter.
1. ECG Lead
• The selectable leads when in 3 Lead mode are I, II and III
• The selectable leads when in 5 Lead mode are I, II, III, aVR, aVL, aVF and V
CAUTION:
If a 3 Lead cable is used when a unit is set to 5 lead mode,
no ECG signal will be obtained. If a 5 lead cable is used
when the unit is set to 3 lead mode only Lead I, II and III are
operable.
2. ECG Size
The selectable waveform sizes are: 0.25, 0.5, 1 and 2.
• A waveform scale bar displays on the right side of each ECG channel. The height of
the waveform bar is directly proportional to the waveform amplitude
3. ECG Filter
The available filter modes are: MONITOR, EXTENDED and SURGERY. These modes offer
different frequency ranges over which the ECG signal is measured and displayed along with
varying amounts of noise suppression.
• MONITOR Mode
MONITOR mode should be used for typical monitoring conditions. Its frequency range
of 0.50 Hz to 40 Hz filters out most low frequency noise that can be generated by patient
motion, muscle artifact, etc.
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Parameter Menus
Operations
• EXTENDED Mode
EXTENDED mode should be used for diagnostic purposes. It has the widest frequency
range and least noise suppression of the 3 modes. Its extended frequency range of
0.05 Hz to 100 Hz can provide a more accurate view of the waveform, but as a result
can also be more susceptible to low frequency noise generated by patient motion, muscle
artifact, etc.
• SURGERY Mode
SURGERY mode is recommended for use in OR situations or where the ability to
measure a heart rate is more important than the fidelity of the waveform. It has the
narrowest frequency range (1 Hz to 20 Hz) and hence the most noise suppression. It
filters out more low frequency noise as well as the extreme amount of high frequency
noise generated by an Electro-Surgical Device. However, the resultant waveform lacks
detail. SURGERY mode is not recommended for Paced patients. The Pacer pulse can
become sufficiently distorted so that it could be mistaken for a QRS complex, whereby a
heart rate would continue to be counted even though the patient could be in cardiac
arrest.
2.4.1.6
NOTE:
During surgery or procedures which may introduce
electrosurgical interference, the SURGERY mode should be
used.
NOTE:
There will be a delay in the heart rate and systole beep,
reappearing after a change of lead or scale.
ECG Setup
FIGURE 2-27 ECG Setup Menu
Accessing the ECG Setup Menu
To access the ECG SETUP menu, select ECG from the ECG parameter tile using the
Navigator™ Knob. Once in the ECG SETUP menu, use the Navigator Knob to adjust
settings. To close the menu, select NORMAL SCREEN (from the menu or the Front Panel
Keypad).
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0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
ECG Setup Menu Selections
ALM
NOTE:
In the French configuration, the HR
(Heart Rate) alarm is always ON. It
cannot be disabled by turning it OFF.
Allows the user to turn the HR (Heart Rate) alarm ON or OFF. Choose
ON to enable the alarm; choose OFF to disable the alarm. If the
alarm is set to OFF, the alarm OFF symbol
will display to the right
of ECG on the screen. The HR alarm is activated when the heart rate
is equal to or exceeds set high or low HR values.
ALM PRIORITY
Allows the user to select the priority of the ECG alarm. Choices are 1,
2 and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Enables or disables automatic printing during a HR alarm condition.
Choose ON to enable printing upon HR alarm. Choose OFF to
disable printing upon HR alarm.
HR ALM HI
Allows the user to set the upper limit of the HR alarm. (See “Heart
Rate Alarm Limits” on page 2-27.)
HR ALM LO
Allows the user to set the lower limit of the HR alarm. (See “Heart
Rate Alarm Limits” on page 2-27.)
SOURCE
Determines the source of heart rate. An audible tone is generated
when a heart beat is detected from the selected source. The selections
are ECG, SpO2 and AUTO.
NOTE:
When heart rate is being measured, a
heart rate source label
(“SOURCE:XXXX”) is displayed in the
ECG parameter tile. This label indicates
from where the heart rate parameter
is derived and is displayed in the same
color as the ECG waveform.
ECG: When ECG is selected as the heart rate source, the label HR
(heart rate) is displayed in the ECG parameter tile. This label and its
associated numeric value are displayed in the same color as the ECG
waveform. The audible tone sounds with each R wave.
SpO2: When SpO2 is selected as the heart rate source, the label PR
(pulse rate) is displayed in the ECG and SpO2 parameter tiles. This
label and its associated numeric value are displayed in the same color
as the SpO2 numeric value. The audible tone sounds at the peak of
each pulse wave.
Trio™ Operating Instructions
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Parameter Menus
Operations
AUTO: When AUTO is selected as the heart rate source, the label
and associated numeric value in the ECG parameter tile will be
displayed based on the following hierarchy:
1. ECG will be the heart rate source as previously described if ECG
is currently being monitored.
2. SpO2 will be the heart rate source as previously described if
SpO2 is currently being monitored and ECG is not currently
being monitored.
3. NIBP will be the heart rate source if NIBP is currently being
monitored, ECG and SpO2 are not currently being monitored,
and the ECG ALM (alarm) is set to OFF. The label HR (heart rate)
will be displayed in the ECG parameter tile. This label and its
associated numeric value are displayed in the same color as the
NIBP numeric/waveform data.
NOTE:
PACER
Heart rate that is sourced through
NIBP will time-out according to the
NIBP “DISPLAY TIMEOUT” rules
described on page 2-49.
To be used when a patient has a pacemaker. This should be used
whether the pacemaker is active or is in standby mode.
The ON selection will mark each detected pacemaker signal on the
ECG waveform.
CASCADE
ECG cascade extends the ECG waveform into the second waveform
tile. The selections are ON or OFF.
LEAD TYPE
Set the lead type on the monitor to match the type of ECG cable used.
The selections are 3 Lead or 5 Lead ECG cables.
SWEEP
Adjusts the speed of the ECG waveform on the display. The selections
are 12.5, 25.0 and 50.0 mm/sec.
BEEP VOL
Beep volume is the volume of the audible tone for the Heart Rate. The
selections are OFF, LOW, MED and HIGH.
RESTORE
Allows the user to restore the ECG user default configuration.
DEFAULTS
FIGURE 2-28 Confirmation Dialog Box
2 - 26
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
Heart Rate Alarm Limits*
PATIENT SIZE
HIGH ALARM (bpm)
LOW ALARM (bpm)
Adult (ADU)
60 – 250 [150]
30 – 120 [45]
Pediatric (PED)
100 – 300 [175]
30 – 150 [70]
*
Factory default values shown in brackets.
Alarms occurring during the process of ECG measurement include two (2) types:
physiological alarms and technical alarms. Physiological alarms occur when the patient’s
heart rate value is equal to or exceeds set alarm limits. Technical alarms are any ECG-related
alarms, which are not physiological, such as functional failures.
2.4.1.7
ECG Troubleshooting
MESSAGE/
PROBLEM
REASON
SOLUTION
ECG LEAD OFF, or
ECG XX LEAD OFF
ECG electrodes are detached from the
skin, ECG cables are disconnected
from the monitor or ECG lead wires
are disconnected from ECG cable
Check all patient connections. Prep
chest, change electrodes, check
and replace leads.
ECG INIT ERR
ECG module failure
Notify hospital technician or
Customer Support
ECG COMM STOP
Intermittent communication failure
Notify hospital technician or
Customer Support
ECG COMM ERR
Intermittent communication failure
Notify hospital technician or
Customer Support
HR ALM LMT ERR
Functional failure
Notify hospital technician or
Customer Support
ECG NOISE
ECG signal interference
Apply fresh, moist electrodes.
Replace cable or lead wires as
necessary.
Eliminate 60 Hz interference. Use
ECG cable with internal filter block.
Noisy ECG trace
Loose or dry electrodes
Apply fresh, moist electrodes.
Defective cable or lead wires
Replace cable or lead wires as
necessary
Patient cable or leads are routed too
close to other electrical devices.
Eliminate 60 Hz interference. Use
ECG cable with internal filter block.
Excessive Electrosurgical
Interference
Inadequate skin preparation prior to
application of electrode
Repeat skin preparation and
electrode placement procedures.
Intermittent Signal
Connections not tight and/or properly
secured
Ensure proper connection. (cable to
monitor, cable to lead, lead to
electrode).
Electrodes dry or loose
Repeat skin preparation and apply
fresh, moist electrodes.
Cable or leadwires damaged
Check with a continuity tester.
Trio™ Operating Instructions
Apply fresh, moist electrodes.
0070-10-0666-01
2 - 27
Parameter Menus
Operations
MESSAGE/
PROBLEM
Excessive alarms:
Heart rate, lead
fault
Low Amplitude
ECG Signal
No ECG waveform
Base Line Wander
2 - 28
REASON
SOLUTION
Electrodes dry
Repeat skin preparation and apply
fresh, moist electrodes.
Alarm limits set too close to patient's
normal heart rate
Readjust alarm limits.
R-wave wrong size
Readjust the waveform size or
move ECG electrodes to optimize
R-wave.
Excessive patient movement or muscle
tremor
Reposition electrodes and secure
with tape if necessary.
Gain set too low
Readjust the ECG wave gain as
required. Refer to "ECG Lead, Size
and Filter Settings" on page 2-23
for instructions on adjusting the
wave gain setting.
Electrodes dry/old
Apply fresh, moist electrodes.
Skin improperly prepped
Abrade the skin and repeat skin
preparation.
This could be the patient's normal
QRS complex.
Verify with a 12-lead electrocardiogram.
Electrode positioned over a bone or
muscle mass
Reposition electrodes.
Size not set properly
Readjust the ECG wave gain as
required. Refer to "ECG Lead, Size
and Filter Settings" on page 2-23
for instructions on adjusting the
wave gain setting.
Lead wires and/or patient cable not
fully inserted into proper receptacle
Check cables for proper connection
Cables or lead wires damaged
Check with a continuity tester.
Patient moving excessively.
Secure lead wires and cable to
patient.
Patient respiration variance.
Reposition electrodes
Electrodes dry or loose
Repeat skin preparation and apply
fresh, moist electrodes.
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Trio™ Operating Instructions
Operations
2.4.2
Parameter Menus
Respiration Monitoring
The Trio utilizes thoracic impedance to measure respiration. This is accomplished by passing
a small electrical signal across the RA and LL (R and F) ECG limb leads. This signal changes
as the patient's chest wall rises and falls during the breath cycle. The change of impedance
between the two (2) electrodes, (due to the thoracic movement), produces a respiratory
waveform on the screen.
2.4.2.1
Setting Up Respiration Measurement
For Respiration monitoring, it is not necessary to use additional electrodes. However, the
proper placement of electrodes is important. Depending upon the medical condition of the
patient it may be necessary to reposition the ECG electrodes to optimize respiratory signal.
Prep the patient’s skin for electrode placement as described in the ECG section of this manual
(See section 2.4.1).
2.4.2.2
Respiration Setup Menu
Accessing the Respiration Menu
To access the RESP SETUP menu, select RESP from the RESP parameter tile using the
Navigator™ Knob. The RESP SETUP menu (FIGURE 2-29) is displayed. Use the Navigator
Knob to adjust settings. To close the menu, select NORMAL SCREEN (from the menu or the
Front Panel Keypad).
FIGURE 2-29 Respiration Setup Menu
Respiration Setup Menu Selections
ALM
Allows the user to turn the RESP (Respiration) alarm ON or OFF.
Choose ON to enable the alarm; choose OFF to disable the alarm. If
the alarm is set to OFF, the alarm OFF symbol
will display to the
right of RESP on the screen. The RESP alarm is activated when the
respiration rate exceeds set high or low RESP values.
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2 - 29
Parameter Menus
Operations
ALM PRIORITY
Allows the user to select the priority of the RESP alarm. Choices are
1, 2 and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Enables or disables automatic printing during a RESP alarm
condition. Choose ON to enable printing upon RESP alarm. Choose
OFF to disable printing upon RESP alarm.
ALM HI
Allows the user to set the upper limit of the RESP alarm. (See
“Respiration Rate Alarm Limits” on page 2-30.)
ALM LO
Allows the user to set the lower limit of the RESP alarm. (See
“Respiration Rate Alarm Limits” on page 2-30.)
SWEEP
Adjusts the speed of the RESP waveform on the display. The
selections are 6.25, 12.5 and 25.0 mm/sec.
SCALE
Changes the size of the RESP waveform. The selections are 0.25,
0.5, 1, 2, 3, 4 and 5.
RESTORE
Allows the user to restore the RESP user default configuration.
DEFAULTS
FIGURE 2-30 Confirmation Dialog Box
Respiration Rate Alarm Limits*
PATIENT SIZE
HIGH ALARM (rpm)
LOW ALARM (rpm)
Adult (ADU)
10 – 100 [30]
6 – 30 [6]
Pediatric (PED)
15 – 150 [30]
6 – 40 [6]
*
Factory default values shown in brackets.
Alarms occurring during the process of Respiration measurement include two (2) types:
physiological alarms and technical alarms. Physiological alarms occur when the patient’s
respiration rate is equal to or exceeds set alarm limits. Technical alarms are any Respiratoryrelated alarms, which are not physiological, such as functional failures.
2 - 30
0070-10-0666-01
Trio™ Operating Instructions
Operations
2.4.2.3
Parameter Menus
Respiration Troubleshooting
MESSAGE/
PROBLEM
REASON
SOLUTION
RESP ALM LMT ERR
Functional failure
Notify hospital technician or
Customer Support
RR EXCEED
Respiration value exceeds the
measurement range
Check patient, notify physician
Respiration
Waveform too
Large
Scales set inappropriately
Change lead selection
Respiration
Waveform too
Small
Patient breathing shallow or turned on
side
Scale set inappropriately
Change Respiration scale
ARTIFACT
Respiration value equals the heart rate
Check patient, notify physician
Shallow breathing
Change Respiration scale, Adjust
leads
No Respiration
Waveform
No Respiration rate
displayed
Change Respiration scale
Change lead selection
Cessation of breathing
Check patient, notify physician
Cable not connected
Check cable connections
ESIS cable in use
Use non-ESIS cable only for
Respiration detection
Cable not connected
Check cable
ESIS cable in use
Use non-ESIS cable only for
respiration detection
Cardiovascular Artifact Detected
Check patient, notify physician
Change Respiration scale
Adjust leads
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Parameter Menus
2.4.3
Operations
SpO2 Monitoring
Each of the following terms are associated with blood oxygenation: oxygen saturation, pulse
oximetry, SpO2 and plethysmography.
Oxygen saturation in capillary blood is measured by a method called pulse oximetry. Pulse
oximetry is a continuous and non-invasive measurement of oxyhemoglobin saturation (the
amount of oxygen attached to the hemoglobin in red blood cells). SpO2 is the estimation of
arterial oxygen saturation. This term is used interchangeably with SaO2. This value is
displayed in the SpO2 parameter tile (FIGURE 2-31) along with the Pulse Rate and the Pulse
Amplitude Indicator. The indicator provides a graphic depiction of the relative pulse volume.
When the Trio is equipped with Nellcor® OxiMax® SpO2, the SpO2 parameter tile
displays a SatSeconds™ Indicator when the SatSeconds function is enabled as described in
section 2.4.3.2.
SatSeconds Indicator
(Nellcor® only)
Pulse Rate
SpO2
84
Alarm OFF Symbol
(SpO2 alarm high only)
PR
bpm
25
SatSeconds Setting
(Nellcor® only)
98
%
Pulse Amplitude Indicator
SpO2
FIGURE 2-31 SpO2 Parameter Tile
The corresponding plethysmogram is a waveform representation of the arterial oxygenation
and pulse detection. The pleth waveform is automatically scaled and no adjustment can be
made to its size. The SpO2 results are updated once every second.
Traditional pulse oximetry determines SpO2 by passing red and infrared light into a capillary
bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared
light-emitting diodes (LEDs) in oximetry sensors serve as the light sources, a photodiode
serves as the photo detector.
Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are
caused by oscillations in the arterial blood volume. This also assumes that the blood flow in
the region of the sensor passes entirely through the capillary bed rather than through any
arterio-venous shunts.
2 - 32
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
Performance Considerations
To ensure optimal SpO2 measurement, use an appropriate sensor, apply it as directed, and
observe all warnings and cautions. 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, available sensor sites and the sterility requirement.
If excessive ambient light is present, cover the sensor site with opaque material. Failure to do
so may cause 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.
If a reading is unobtainable or inaccurate, consider the following:
• If the patient is poorly perfused, apply the sensor to a different finger or toe.
• Ensure that the sensor is properly aligned and securely applied.
• Use a new sensor.
• Move the sensor to a less active site.
• Use a type of sensor that tolerates some patient motion.
• Ensure that the sensor and site are clean/non-greasy. Remove nail polish and fungus.
Calibration
The oximetry sub-system incorporates automatic calibration mechanisms. No other
calibration is required.
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.
CAUTION:
Trio™ Operating Instructions
Prolonged and continuous monitoring may increase the risk
of skin erosion and pressure necrosis at the site of the
sensor. Check the SpO2 sensor site frequently to ensure
proper positioning, alignment and skin integrity at least
every eight (8) hours; with the Adult and Pediatric re-usable
finger sensor, check every four (4) hours; for patients of
poor perfusion or with skin sensitive to light, check every 2
- 3 hours; more frequent examinations may be required for
different patients. Change the sensor site if signs of
circulatory compromise occur.
0070-10-0666-01
2 - 33
Parameter Menus
2 - 34
Operations
CAUTION:
Do not place the SpO2 sensor on an extremity with an
invasive catheter or blood pressure cuff in place.
CAUTION:
Tissue damage or inaccurate measurement 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 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:
If the sensor or patient cable are damaged in any way,
discontinue use immediately. To prevent damage, do not
soak or immerse the sensor in any liquid solution. Do not
attempt to sterilize.
CAUTION:
Excessive ambient light may cause inaccurate
measurements. In such cases, cover the sensor site with
opaque material.
0070-10-0666-01
Trio™ Operating Instructions
Operations
2.4.3.1
Parameter Menus
Masimo SET® SpO2
The Masimo pulse oximeter determines SpO2 in the traditional manner of passing red and
infrared light into a capillary bed and measuring changes in light absorption during the
pulsatile cycle. It assumes that arterio-venous shunting is highly variable and that fluctuating
absorbance by venous blood is the major component of noise during the pulse. The Masimo
pulse oximeter calculates the ratio of the arterial signals without the noise.
Masimo SET provides a family of sensors suitable for a wide variety of clinical settings and
patient sizes. All sensors are:
• Indicated for continuous non-invasive monitoring of arterial oxygen saturation (SpO2)
and Pulse Rate
• Non-sterile
• Usable during patient movement
The LNOP®•DCI Adult Reusable Finger Sensor can be used for “spot check” applications if
needed. Adhesive-type sensors are also available. Refer to "Accessories" on page 5-1 for
approved sensors. All sensors are intended for “single-patient use only” unless indicated as
“reusable”.
CAUTION:
When equipped with Masimo SpO2, use only Masimo
oxygen sensors and cables. Use of other oxygen sensors
may cause improper oximeter performance.
NOTE:
Refer to instructions included with each SpO2 sensor and
cable for proper placement and use.
1. Select an SpO2 sensor that is appropriate for the size of the patient.
2. Attach the connector of the SpO2 sensor to the SpO2 extension cable.
3. Attach the SpO2 sensor to the patient’s finger (or other appropriate site).
4. Orient the connector on the end of the SpO2 extension cable so that the Masimo SET
logo is facing upward. Plug the connector into the SpO2 receptacle on the right side
panel of the Trio. The SpO2 measurement will display when the Trio detects that the
sensor is connected to the patient. A plethysmogram will be displayed to the left of the
SpO2 parameter tile (if SpO2 is selected in the TRACE SETUP menu).
NOTE:
To disconnect the cable from the Trio, squeeze the tabs on
the sides of the connector and then pull it straight out.
CAUTION:
Prolonged and continuous monitoring may increase the risk
of skin erosion and pressure necrosis at the site of the
sensor. Check the SpO2 sensor site frequently to ensure
proper positioning, alignment and skin integrity at least
every eight (8) hours; with the Adult and Pediatric re-usable
finger sensor, check every four (4) hours; for patients of
poor perfusion or with skin sensitive to light, check every 2
- 3 hours; more frequent examinations may be required for
different patients. Change the sensor site if signs of
circulatory compromise occur.
Trio™ Operating Instructions
0070-10-0666-01
2 - 35
Parameter Menus
2.4.3.1.1
Operations
Masimo SET® SpO2 Setup Menu
FIGURE 2-32 Masimo SET SpO2 Setup Menu
Accessing the Masimo SET SpO2 Setup Menu
To access the MASIMO SPO2 SETUP menu, select SpO2 from the SpO2 parameter tile
using the Navigator™ Knob. Once in the MASIMO SPO2 SETUP menu, use the Navigator
Knob to adjust settings. To close the menu, select NORMAL SCREEN (from the menu or the
Front Panel Keypad).
Masimo SET SpO2 Setup Menu Selections
ALM PRIORITY
Enables the user to select the priority of the SpO2 alarm. Choices are:
1, 2 and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Enables or disables automatic printing during an SpO2 alarm
condition. Choose ON to enable printing upon SpO2 alarm. Choose
OFF to disable printing upon SpO2 alarm.
SPO2 ALM HI
Allows the user to set the upper limit of the SpO2 alarm. (See
“Masimo SET SpO2 Alarm Limits” on page 2-38.)
SPO2 ALM LO
Allows the user to set the lower limit of the SpO2 alarm. (See “Masimo
SET SpO2 Alarm Limits” on page 2-38.)
PR ALM HI
Allows the user to set the upper limit of the Pulse Rate alarm. (See
“Masimo SET SpO2 Alarm Limits” on page 2-38.)
PR ALM LO
Allows the user to set the lower limit of the Pulse Rate alarm. (See
“Masimo SET SpO2 Alarm Limits” on page 2-38.)
SWEEP
2 - 36
Adjusts the speed of the SpO2 waveform on the display. The
selections are 12.5 and 25.0 mm/sec.
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
BEEP VOL
Beep volume is the volume of the audible pulse rate tone when SpO2
is selected as the HR Source. The selections are OFF, LOW, MED
and HIGH.
AVG TIME
Averaging time is the length of time during which the SpO2 value is
calculated. The selections are 2-4, 4-6, 8, 10, 12, 14, and 16
seconds. When 2-4 or 4-6 are selected, the FastSAT mode is
enabled. In this mode, shorter averaging times are achieved under
low noise conditions. Under high noise conditions, a longer
averaging time is utilized.
SENSITIVITY
Sensitivity mode should be selected based on signal quality and
MODE
patient motion. In most cases where there is some level of patient
motion present, the normal sensitivity setting is appropriate. If patient
motion is limited, the high sensitivity setting can be used. High
sensitivity should be used when it is difficult to get a reading on a
patient with low perfusion. This mode will compromise the probe off
detection. Selections are Normal and High.
SENSOR OFF
Controls the onset of the audio beep alarm for the “SpO2 Sensor
AUDIO
OFF” condition. The selections are ON and OFF.
If ON is selected, then the audio beep alarm will sound when an
“SpO2 Sensor OFF” condition occurs. If OFF is selected, then the
audio beep alarm will not sound when an “SpO2 Sensor OFF”
condition occurs.
RESTORE
Allows the user to restore the SpO2 user default configuration.
DEFAULTS
FIGURE 2-33 Confirmation Dialog Box
Trio™ Operating Instructions
0070-10-0666-01
2 - 37
Parameter Menus
Operations
Masimo SET SpO2 Alarm Limits*
PATIENT SIZE
SpO2 HIGH
ALARM (%)
SpO2 LOW
ALARM (%)
PR HIGH
ALARM (bpm)
PR LOW
ALARM (bpm)
Adult (ADU)
80 – 100 [OFF]
50 – 99 [85]
60 – 240 [150]
25 – 120 [45]
Pediatric (PED)
80 – 100 [OFF]
50 – 99 [85]
100 – 240 [175]
25 – 150 [70]
*
Factory default values shown in brackets.
NOTE:
If the SpO2 alarm high is set to OFF, the alarm OFF
symbol
will display in the SpO2 parameter tile.
Alarms occurring during the process of SpO2 measurement include two (2) types:
physiological alarms and technical alarms. Physiological alarms occur when the patient’s
pulse rate or oxygen saturation level is equal to or exceeds set alarm limits. Technical alarms
are any SpO2-related alarms, which are not physiological, such as functional failures.
2.4.3.1.2
2 - 38
Masimo SET® SpO2 Troubleshooting
MESSAGE
REASON
ACTION
SpO2: Sensor Off
SpO2 sensor may be
disconnected from the patient
Place the sensor on the patient.
SpO2: No Sensor
SpO2 sensor may be
disconnected from the monitor
or the extension cable
Plug the sensor into the monitor or the
extension cable.
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
Wait several seconds for saturation
value to be displayed. If it does not
display, do one of the following:
•
Change to site where pulse is
stronger if patient is
vasoconstricted.
•
Change or readjust sensor if loose.
SpO2: Low Perfusion
Patient perfusion is low
Check patient connection and patient
status
SpO2: Too Much Light
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
The sensor is not recognized by
the monitor
Replace the sensor with a
recommended authorized sensor
SpO2:
Communication Error
The monitor and the SpO2
modules are not communicating
properly
Power the unit OFF/ON. If problem
persists, notify hospital technician or
Customer Support.
SpO2: Board Fault
Masimo SET board failed to
operate properly
Notify hospital technician or Customer
Support
SpO2: Sensor Fault
Defective Sensor
Replace sensor
0070-10-0666-01
Trio™ Operating Instructions
Operations
2.4.3.2
Parameter Menus
Nellcor® SpO2
Nellcor provides a family of sensors suitable for a wide variety of clinical settings and
patients. Specific sensors have been developed for a variety of patient sizes.
Nellcor’s SatSeconds™ Alarm Management feature in their OxiMax® SpO2 sensor offers an
effective means of managing nuisance alarms without sacrificing patient safety. Nuisance
alarms are often triggered by minor and brief desaturation events that are clinically
insignificant and are often managed by widening alarm limits, turning OFF the alarm or
monitor, or simply ignoring the alarm. The SatSeconds feature distinguishes clinically
insignificant events from events of consequence.
When an SpO2 measurement exceeds the alarm limit, the SatSeconds indicator begins to fill
clockwise. The difference between the measurement and the limit multiplied by the time the
measurement remains outside the limit determines if or when the SatSeconds alarm occurs.
For example:
The low SpO2 alarm is set at 90% and the SatSeconds “clock” is set to 25.
• If the measurement is 85% for 4 seconds (i.e., 5% below the limit for 4 seconds), then
5% X 4 seconds = 20 SatSeconds. This is less than the 25 SatSeconds setting,
therefore no alarm will occur.
• If the measurement is 85% for 7 seconds (i.e., 5% below the limit for 7 seconds), then
5% X 7 seconds = 35 SatSeconds. This is greater than the 25 SatSeconds setting,
therefore an alarm occurs at 5 seconds because 5% X 5 seconds = 25 SatSeconds.
The alarm continues for another 2 seconds.
When the SpO2 measurement returns to within the alarm limits, the SatSeconds indicator
clears (empties) counter-clockwise in the same amount of time that it took for the SatSeconds
alarm condition to be acquired. The “clear” time is equivalent to the acquire time.
Nellcor’s SatSeconds™ Alarm Management technology also features a safety precaution.
When three (3) SpO2 alarm violations occur within 60 seconds, a priority 2 alarm will
trigger even if the SatSeconds limit has not been reached.
CAUTION:
When equipped with Nellcor SpO2, use only Nellcor oxygen
sensors and cables. Use of other oxygen sensors may cause
improper oximeter performance.
NOTE:
Refer to instructions included with each SpO2 sensor and
cable for proper placement and use. If the sensor LED does
not illuminate within 3 seconds after being connected, then
the sensor is probably defective and should be replaced.
1. Select an SpO2 sensor that is appropriate for the size of the patient.
2. Attach the connector of the SpO2 sensor to the SpO2 extension cable.
3. Attach the SpO2 sensor to the patient’s finger (or other appropriate site).
4. Plug the connector on the end of the SpO2 extension cable into the SpO2 receptacle on
the right side panel of the Trio. The SpO2 measurement will display when the Trio
detects that the sensor is connected to the patient. A plethysmogram will be displayed to
the left of the SpO2 parameter tile (if SpO2 is selected in the TRACE SETUP menu).
NOTE:
Trio™ Operating Instructions
To disconnect the cable from the Trio, squeeze the tabs on
the sides of the connector and then pull it straight out.
0070-10-0666-01
2 - 39
Parameter Menus
Operations
CAUTION:
2.4.3.2.1
Prolonged and continuous monitoring may increase the risk
of skin erosion and pressure necrosis at the site of the
sensor. Check the SpO2 sensor site frequently to ensure
proper positioning, alignment and skin integrity at least
every eight (8) hours; with the Adult and Pediatric re-usable
finger sensor, check every four (4) hours; for patients of
poor perfusion or with skin sensitive to light, check every 2
- 3 hours; more frequent examinations may be required for
different patients. Change the sensor site if signs of
circulatory compromise occur.
Nellcor® SpO2 Setup Menu
FIGURE 2-34 Nellcor SpO2 Setup Menu
Accessing the Nellcor SpO2 Setup Menu
To access the NELLCOR SPO2 SETUP menu, select SpO2 from the SpO2 parameter tile
using the Navigator™ Knob. Once in the NELLCOR SPO2 SETUP menu, use the
Navigator Knob to adjust settings. To close the menu, select NORMAL SCREEN (from the
menu or the Front Panel Keypad).
Nellcor SpO2 Setup Menu Selections
ALM PRIORITY
Enables the user to select the priority of the SpO2 alarm. Choices are:
1, 2 and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Enables or disables automatic printing during an SpO2 alarm
condition. Choose ON to enable printing upon SpO2 alarm. Choose
OFF to disable printing upon SpO2 alarm.
SPO2 ALM HI
Allows the user to set the upper limit of the SpO2 alarm.
(See “Nellcor SpO2 Alarm Limits” on page 2-42.)
SPO2 ALM LO
Allows the user to set the lower limit of the SpO2 alarm.
(See “Nellcor SpO2 Alarm Limits” on page 2-42.)
2 - 40
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
PR ALM HI
Allows the user to set the upper limit of the Pulse Rate alarm.
(See “Nellcor SpO2 Alarm Limits” on page 2-42.)
PR ALM LO
Allows the user to set the lower limit of the Pulse Rate alarm.
(See “Nellcor SpO2 Alarm Limits” on page 2-42.)
SWEEP
Adjusts the speed of the SpO2 waveform on the display. The
selections are 12.5 and 25.0 mm/sec.
BEEP VOL
Beep volume is the volume of the audible pulse rate tone when SpO2
is selected as the HR Source. The selections are OFF, LOW, MED
and HIGH.
SENSOR OFF
Controls the onset of the audio beep alarm for the “SpO2 Sensor
AUDIO
OFF” condition. The selections are ON and OFF.
If ON is selected, then the audio beep alarm will sound when an
“SpO2 Sensor OFF” condition occurs. If OFF is selected, then the
audio beep alarm will not sound when an “SpO2 Sensor OFF”
condition occurs.
SAT SECONDS
Controls pulse oximetry nuisance alarms (see section 2.4.3.2 for
details on SatSeconds™ features). The selections are OFF, 10, 25,
50 or 100.
When SatSeconds is enabled, the SpO2 Low and High Alarm
functions are automatically disabled. As a safety precaution, if three
(3) SpO2 alarm violations occur within 60 seconds, a priority 2 alarm
will trigger even if the SatSeconds limit has not been reached.
RESTORE
Allows the user to restore the SpO2 user default configuration.
DEFAULTS
FIGURE 2-35 Confirmation Dialog Box
Trio™ Operating Instructions
0070-10-0666-01
2 - 41
Parameter Menus
Operations
Nellcor SpO2 Alarm Limits*
PATIENT SIZE
SpO2 HIGH
ALARM (%)
SpO2 LOW
ALARM (%)
PR HIGH
ALARM (bpm)
PR LOW
ALARM (bpm)
Adult (ADU)
80 – 100 [OFF]
50 – 99 [85]
60 – 250 [150]
20 – 120 [45]
Pediatric (PED)
80 – 100 [OFF]
50 – 99 [85]
100 – 250 [175]
20 – 150 [70]
*
Factory default values shown in brackets.
NOTE:
If the SpO2 alarm high is set to OFF, the alarm OFF
symbol
will display in the SpO2 parameter tile.
Alarms occurring during the process of SpO2 measurement include two (2) types:
physiological alarms and technical alarms. Physiological alarms occur when the patient’s
pulse rate or oxygen saturation level is equal to or exceeds set alarm limits. Technical alarms
are any SpO2-related alarms, which are not physiological, such as functional failures.
2.4.3.2.2
2 - 42
Nellcor SpO2 Troubleshooting
MESSAGE
REASON
ACTION
SPO2 SENSOR OFF
SpO2 sensor may be
disconnected from the patient
Place the sensor on the patient.
SPO2 NO SENSOR
SpO2 sensor may be
disconnected from the monitor
or the extension cable
Plug the sensor into the monitor or the
extension cable.
SPO2 PULSE SEARCH
Hardware settings are being
adjusted in order to
discriminate a pulse waveform
Wait several seconds for saturation
value to be displayed. If it does not
display, do one of the following:
•
Change to site where pulse is
stronger if patient is
vasoconstricted.
•
Change or readjust sensor if loose.
SPO2 CHECK
SENSOR
SpO2 sensor may be defective,
incompatible, or improperly
connected.
Reconnect the same sensor or replace
the sensor.
SPO2
COMMUNICATION
ERROR
The monitor and the SpO2
modules are not communicating
properly
Power the unit OFF/ON. If problem
persists, notify hospital technician or
Customer Support.
SPO2 BOARD FAULT
SpO2 board is not producing
measurement values.
Power the unit OFF/ON. If problem
persists, notify hospital technician or
Customer Support.
SPO2 MOTION
Motion is detected.
Decrease patient motion.
SPO2 INIT ERR
SpO2 module failure.
Notify hospital technician or Customer
Support
SPO2 COMM STOP
SpO2 module failure or
communication error.
Notify hospital technician or Customer
Support
SPO2 ALM LMT ERR
Functional failure.
Notify hospital technician or Customer
Support
PR ALM LMT ERR
Functional failure.
Notify hospital technician or Customer
Support
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
MESSAGE
REASON
ACTION
SPO2 EXCEED
SpO2 value exceeds the
measurement range.
Check patient, notify physician
PR EXCEED
PR value exceeds the
measurement range.
Check patient, notify physician
Trio™ Operating Instructions
0070-10-0666-01
2 - 43
Parameter Menus
2.4.4
Operations
NIBP Monitoring
The Trio utilizes the oscillometric method of measuring Non-Invasive Blood Pressure (NIBP).
The measurement includes Systolic (SYS), Diastolic (DIA) and Mean Arterial Pressures (MAP).
Two (2) frequency modes of obtaining measurements are available: MANUAL and
INTERVAL. Each mode will display the Systolic (SYS), Diastolic (DIA) and Mean Arterial
Pressure (MAP) values in the NIBP tile.
MANUAL MODE Each time a measurement is desired, press the NIBP key on the Trio
keypad to initiate a measurement. Press the NIBP key a second time
to stop a measurement already in progress.
INTERVAL MODE Measurements are taken automatically at selected time intervals. The
selections are: CONT (continuous), 1min, 2min, 3min, 4min,
5min, 10min, 15min, 30min, 1HR, 2HRS, 4HRS or OFF. The
NIBP key on the Trio keypad must be pressed to initiate the first
measurement of the interval measurement cycle. If the patient is
discharged from the monitor while in interval mode, the interval
setting will revert to the User Default and the next measurement will be
delayed until the NIBP key is pressed. During the delay period, the
interval setting will remain displayed in the NIBP numeric tile and the
Elapsed Time (ET) will display as “0min”.
2 - 44
CAUTION:
Use only approved blood pressure cuffs and hoses with the
Trio.
CAUTION:
A patient's skin is sometimes fragile (i.e. on pediatric and
geriatric patients or due to physiological conditions). In
these cases, a longer time duration 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.
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:
Any condition which may affect the regularity and strength
of arterial pressures (such as patient movement, cardiac
arrhythmias, restriction of hose, etc.), will affect the
accuracy and ability to measure the NIBP.
CAUTION:
Observe caution on all patients (Pediatrics and Adults) when
NIBP is set to the Continuous mode and the 1 minute
Interval. When the NIBP “Continuous” interval is chosen, the
Trio will continually take back to back blood pressure
readings. As a safety precaution, a limit is placed on the
Continuous mode to revert to an interval of every 5 minutes
after 5 minutes of continuous readings.
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
The initial default cuff inflation pressure is dependent on the patient size setting as follows:
PATIENT SIZE SETTING
DEFAULT CUFF INFLATION PRESSURE
Adult
178 ± 5 mmHg
Pediatric
133 ± 5 mmHg
After the first successful measurement, the subsequent inflation pressure for the same patient
will be 50 ±10 mmHg above the previous systolic pressure measurement.
Upon power ON of the Trio, the NIBP unit of measure defaults to the most recent setting
made in the NIBP SETUP menu.
2.4.4.1
Cuff Application
1. Select a blood pressure cuff that is appropriate for the size of the patient. Measure the
circumference of the patient's limb for the best results.
NOTE:
Using a correctly sized cuff, among other considerations,
has a direct bearing on the accuracy of the obtained NIBP
measurements. A cuff that is too narrow for the limb will
result in erroneously high readings. Selection of the cuff size
should be based on the circumference of the patient’s limb.
The design dimensions of the cuffs and their intended use
are based on recommendations made by the American
Heart Association.
NOTE:
Use only the authorized blood pressure cuffs and hoses
listed in section 5.0, “Accessories” with the Trio.
2. Attach the NIBP cuff to the NIBP extension hose.
3. Attach the NIBP extension hose to the NIBP pneumatic fitting on the Trio.
4. Apply the cuff to the patient as shown in FIGURE 2-36. To reduce errors, ensure that the
cuff is deflated and lies directly against the patient's skin. The cuff should fit snugly.
There should be no clothing between the patient’s skin and the cuff
CAUTION:
The cuff must be properly applied to the patient's limb
before inflating. If it is inflated without being securely
wrapped, damage to the cuff can result.
FIGURE 2-36 Application of the Blood Pressure Cuff
Trio™ Operating Instructions
0070-10-0666-01
2 - 45
Parameter Menus
2.4.4.2
Operations
Measurement
1. Ensure that the appropriate PATIENT SIZE (Adult or Pediatric) has been selected from
the PATIENT SETUP menu accessible from the SYSTEM MENU.
2. Depending on the desired measurement frequency mode, proceed as follows:
Manual Mode
Press the NIBP key, located on the front panel keypad, to begin the NIBP measurement.
Interval Mode
a. Open the NIBP SETUP menu by selecting NIBP from the main display using the
Navigator™ Knob. Once in the NIBP SETUP menu, select the INTERVAL DropDown menu and choose the desired setting.
b. Press the NIBP key, located on the front panel keypad, to initiate the first
measurement of the interval measurement cycle.
• To initiate a STAT blood pressure at any time between intervals, press the NIBP
key on the front panel keypad.
• To exit the Interval Mode, choose OFF from the INTERVAL Drop-Down menu.
NOTE:
If CONT (Continuous) is chosen as the interval, the
monitor will take continuous blood pressure
readings for five (5) minutes. After 5 minutes, the
Trio will automatically revert to an Interval Mode of
5 minutes. The NIBP key on the front panel keypad
must be pressed to initiate the new interval.
The cuff begins to inflate. After reaching the default pressure for the selected patient size, the
cuff gradually deflates and the Trio collects oscillometric pulsations. During this inflation and
deflation portion of the measurement, the current pressure in the cuff is displayed in the lower
right corner of the NIBP parameter tile as “CUFF:XXX”.
If a measurement cannot be obtained, the Trio automatically reinflates the cuff to 30 – 60
mmHg higher than the initial inflation pressure, but will not exceed the maximum cuff
pressure listed in the “NIBP Sub-System Functional Requirements”, section 6.2.6.5.
The patient should remain still to avoid the introduction of unnecessary motion artifact. After
the cuff pressure drops below the diastolic pressure, the measurements are displayed in the
NIBP parameter tile. These results will remain displayed in the NIBP parameter tile until the
user-definable DISPLAY TIMEOUT interval has been reached or until a new NIBP
measurement is obtained. The default DISPLAY TIMEOUT interval is 15 minutes.
NOTE:
2 - 46
Pressing the NIBP key while the NIBP measurement is in
progress will stop the measurement and deflate the cuff.
0070-10-0666-01
Trio™ Operating Instructions
Operations
2.4.4.3
Parameter Menus
NIBP Display Tile
If ECG and NIBP are selected in the MODULE SETUP menu, NIBP will be displayed in the
second parameter tile, beneath the ECG parameter tile. If ECG is not selected in the
MODULE SETUP menu, NIBP will be displayed in the first parameter tile. The following
data is displayed:
Systolic Value
Unit of Measure
NIBP
Diastolic Value
Alarm OFF Symbol
mmHg
108 (84)
70
Interval:OFF
Cont measuring...
ET:5min
CUFF:
Mean Value
Elapsed Time
(since the last
measurement)
100
Interval
Current Cuff Pressure
Status Message
FIGURE 2-37 NIBP Parameter Tile
The following status messages may be displayed during the measurement of NIBP:
MESSAGE
CAUSE
Cont measuring…
Displayed during Continuous measuring
Auto measuring…
Displayed during Automatic / Interval measuring
Please start
Displayed after selecting an INTERVAL in the NIBP SETUP menu
Measurement over
Displayed after an NIBP measurement has been manually stopped by
pressing the NIBP key during the measurement.
Trio™ Operating Instructions
0070-10-0666-01
2 - 47
Parameter Menus
2.4.4.4
Operations
NIBP Setup Menu
FIGURE 2-38 NIBP Setup Menu
Accessing the NIBP Setup Menu
To access the NIBP SETUP menu, select NIBP from the NIBP parameter tile using the
Navigator™ Knob. Once in the NIBP SETUP menu, use the Navigator Knob to adjust
settings. To close the menu, select NORMAL SCREEN (from the menu or the Front Panel
Keypad).
NIBP Setup Menu Selections
ALM
Allows the user to turn the NIBP alarm ON or OFF. Choose ON to
enable the alarm; choose OFF to disable the alarm. If the alarm is set
to OFF, the alarm OFF symbol
will display to the right of NIBP on
the screen. The NIBP alarm is activated when the blood pressure
value exceeds set high or low NIBP values.
ALM PRIORITY
Allows the user to select the priority of the NIBP alarm. Choices are 1,
2 and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Enables or disables automatic printing during a NIBP alarm condition.
Choose ON to enable printing upon NIBP alarm. Choose OFF to
disable printing upon NIBP alarm.
SYS ALM HI
Allows the user to set the upper limit of the Systolic NIBP alarm. (See
“NIBP Alarm Limits” on page 2-50.)
SYS ALM LO
Allows the user to set the lower limit of the Systolic NIBP alarm. (See
“NIBP Alarm Limits” on page 2-50.)
2 - 48
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
MEAN ALM HI
Allows the user to set the upper limit of the Mean NIBP alarm. (See
“NIBP Alarm Limits” on page 2-50.)
MEAN ALM LO
Allows the user to set the lower limit of the Mean NIBP alarm. (See
“NIBP Alarm Limits” on page 2-50.)
DIA ALM HI
Allows the user to set the upper limit of the Diastolic NIBP alarm. (See
“NIBP Alarm Limits” on page 2-50.)
DIA ALM LO
Allows the user to set the lower limit of the Diastolic NIBP alarm. (See
“NIBP Alarm Limits” on page 2-50.)
UNITS
Allows the user to select the unit of measurement for NIBP. The
selections are mmHg or kPa.
INTERVAL
Allows the user to select the interval at which NIBP measurement will
automatically initiate. It also allows the user to turn the automatic
measurement OFF. The selections are: CONT (continuous), 1min,
2min, 3min, 4min, 5min, 10min, 15min, 30min, 1HR,
2HRS, 4HRS and OFF.
DISPLAY
Allows the user to select the interval at which the NIBP measurement
TIMEOUT
will time-out from the display. The selections are: 15min, 30min,
45min, and 1HR.
NIBP measurement will time-out from the display when the elapsed
time exceeds the chosen interval, except during an NIBP alarm
condition. The time-out will be suspended until the alarm condition is
resolved and will then resume. When the time-out interval has been
exceeded, the NIBP measurement is replaced by dashes.
RESTORE
Allows the user to restore the NIBP user default configuration.
DEFAULTS
FIGURE 2-39 Confirmation Dialog Box
Trio™ Operating Instructions
0070-10-0666-01
2 - 49
Parameter Menus
Operations
NIBP Alarm Limits*
SYS
HIGH
(mmHg)
SYS
LOW
(mmHg)
MEAN
HIGH
(mmHg)
MEAN
LOW
(mmHg)
DIA
HIGH
(mmHg)
DIA
LOW
(mmHg)
Adult (ADU)
70 – 240
[180]
50 – 150
[80]
60 – 200
[100]
40 – 140
[40]
40 – 130
[100]
30 – 120
[50]
Pediatric (PED)
40 – 180
[150]
15 – 130
[70]
50 – 180
[80]
10 – 100
[30]
50 – 100
[80]
10 – 50
[40]
PATIENT SIZE
*
Factory default values shown in brackets.
Alarms occurring during the process of NIBP measurement include two (2) types:
physiological alarms and technical alarms. Physiological alarms occur when the patient’s
pressure values are equal to or exceed set alarm limits. Technical alarms are any NIBPrelated alarms, which are not physiological, such as functional failures.
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 0.75 mmHg (0.10 kPa) for every inch
above heart level, and increased by 0.75 mmHg (0.10 kPa) for every inch below heart level.
This is due to changes in hydrostatic pressure.
Precautions While Making Automatically Cycled Blood Pressure
Measurements
Reports have been made of nerve injury occurring from automatically cycled 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 affected nerves,
as well as, 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
When applying the NIBP cuffs use the range markings as a guide to ensure proper fit and
cuff size. Use of a narrow cuff may give erroneous pressure readings. If a standard cuff is
applied to an obese patient or a patient with large biceps, the excess tissue will dissipate the
applied pressure, requiring additional attempts to collapse the artery. This may result in high
pressure readings. Over-wrapping a slender arm may also give erroneous pressure readings
due to excessive force exerted on the arm.
2 - 50
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
Other Factors
An accurate determination of blood pressure can be difficult to obtain if a patient's 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 to complete a measurement cycle.
Newborn NIBP Technique
Newborn patients present unique obstacles to NIBP measurement. Their vital signs can
change frequently and their physiological signals are prone to noise interference. The
following suggestions will help to obtain the best possible NIBP measurement.
1. Try to measure infants when they are calm. A kicking/crying baby may disturb or
dislodge the cuff causing noise within the system and as a result, yielding unstable blood
pressure readings. If necessary, hold the cuffed limb steady, but do not impede
circulation; do not hold onto the cuff and do not pat the cuffed limb to comfort the child.
2. Try placement on the baby's calf. Irritable newborns will react to cuff pressure on the
arm, but may better tolerate placement on the calf. Place the cuff just above the ankle.
3. Use the correct size Newborn and Infant size cuffs. When applying, verify the cuff’s
Index line falls between the Range lines.
4. Use disposable cuffs. Disposable cuffs are more pliant than the reusable ones. They
generally fit smaller infants better.
5. Gently place the cuff on the patient. If the cuff is too snug, it won't work properly. On
infants, the cuff should easily move over the limb.
Trio™ Operating Instructions
0070-10-0666-01
2 - 51
Parameter Menus
2.4.4.5
Operations
NIBP Troubleshooting
MESSAGE/
PROBLEM
REASON
SOLUTION
NS ALM LMT ERR
Functional failure
Notify hospital technician or
Customer Support
NM ALM LMT ERR
Functional failure
Notify hospital technician or
Customer Support
ND ALM LMT ERR
Functional failure
Notify hospital technician or
Customer Support
NIBP SELF TEST ERR
NIBP module hardware failure
Notify hospital technician or
Customer Support
NIBP COMM ERR
Communication with NIBP module has
failed
Notify hospital technician or
Customer Support
LOOSE CUFF
Cuff is not properly wrapped or no
cuff exists
Check cuff, reapply if necessary
AIR LEAK
Cuff, hose or connector is damaged
Check cuff and hose connections,
replace as necessary. If problem
persists, notify hospital technician
or Customer Support.
Internal Leak
2 - 52
AIR PRESSURE
ERROR
Stable pressure value is not available.
e.g. hoses are pinched or occluded
Check hoses. If failure persists,
notify hospital technician or
Customer Support.
WEAK SIGNAL
Cuff is too loose or patient pulse is too
weak
Check patient, reapply hose. Notify
physician.
RANGE EXCEEDED
NIBP value exceeds the upper
measurement limit
Check patient, notify physician
EXCESSIVE
MOTION and/or
SIGNAL
SATURATED
Monitor is detecting too much motion
and/or noise to obtain a reading
Instruct patient to remain still during
the NIBP cuff reading. If patient is
agitated, consider trying to take the
pressure at a later time when
patient is calm.
OVER PRESSURE
Pressure has exceeded the specified
upper safety limit
Try again. If failure persists, notify
hospital technician or Customer
Support.
PNEUMATIC LEAK
During pneumatic test, leak is
detected
Notify hospital technician or
Customer Support
NIBP SYSTEM
FAILURE
Operation of blood pressure pump
system failed
Notify hospital technician or
Customer Support
NIBP TIME OUT
Measuring time has exceeded 120
seconds
Check patient, restart NIBP
measurement
MEASURE FAIL
The system cannot perform
measurement, analysis or calculation
Check patient, restart NIBP
measurement
Unable to obtain a
BP reading
Patient movement
Wait until patient is calm or gently
hold patient’s limb
Cuff or hose not attached or leaking
Check all connections
HR irregular / arrhythmia present
Check patient, notify physician
Blood pressure is out of range
Check patient, verify BP with
manual method, notify physician
Incorrect cuff size / brand
Measure patient’s limb, verify cuff
size. Use only approved
accessories.
0070-10-0666-01
Trio™ Operating Instructions
Operations
2.4.5
Parameter Menus
Temperature Monitoring
The temperature (TEMP) measurement function of the Trio is designed to take continuous
temperature readings from the YSI 400 series probes. One (1) temperature channel is
standard on the Trio.
1. If using a disposable temperature probe:
Connect the preferred disposable temperature probe into the reusable temperature
cable. Plug the cable into the monitor.
2. If using a reusable temperature probe:
Plug the reusable probe directly into the monitor
3. Follow probe manufacturer's suggested temperature monitoring sites and suggested
procedures for site checks, reapplication and moving of the probes.
4. Check the probe site frequently for position, ensuring good contact with the site chosen.
For example, check the skin probe frequently to ensure good skin contact.
NOTE:
2.4.5.1
A self-test of the temperature measurement is performed
automatically once per hour during the monitoring period.
The test procedure lasts approximately 2 seconds and does
not affect the normal measurement of the temperature
monitoring.
Temperature Setup
FIGURE 2-40 Temperature Setup Menu
Accessing the Temperature Setup Menu
To access the TEMP SETUP menu, select TEMP from the TEMP parameter tile using the
Navigator™ Knob. Once in the TEMP SETUP menu, use the Navigator Knob to adjust
settings. To close the menu, select NORMAL SCREEN (from the menu or the Front Panel
Keypad).
Trio™ Operating Instructions
0070-10-0666-01
2 - 53
Parameter Menus
Operations
Temperature Setup Menu Selections
ALM
Allows the user to turn the TEMP alarm ON or OFF. Choose ON to
enable the alarm; choose OFF to disable the alarm. If the alarm is set
to OFF, the alarm OFF symbol
will display to the right of TEMP
on the screen. The TEMP alarm is activated when the temperature
value exceeds set high or low TEMP values.
ALM PRIORITY
Enables priority selection for the TEMP alarm. Choices are 1, 2 and
3. Priority 1 alarms are considered the most serious.
ALM PRINT
Enables or disables automatic printing during a TEMP alarm
condition. Choose ON to enable printing upon TEMP alarm. Choose
OFF to disable printing upon TEMP alarm.
TEMP ALM HI
Allows the user to set the upper limit of Temperature 1 alarm. (See
“Temperature Alarm Limits” on page 2-54.)
TEMP ALM LO
Allows the user to set the lower limit of Temperature 1 alarm. (See
“Temperature Alarm Limits” on page 2-54.)
TEMP UNIT
Allows the user to select the unit of measure for temperature. The
selections are degrees Celsius (°C) or degrees Fahrenheit (°F).
RESTORE
Allows the user to restore the TEMP user default configuration.
DEFAULTS
FIGURE 2-41 Confirmation Dialog Box
Temperature Alarm Limits*
Temperature (T1)
*
HIGH
ALARM (ºC)
LOW
ALARM (ºC)
HIGH
ALARM (ºF)
LOW
ALARM (ºF)
35 – 43 [40]
26 – 38 [30]
95 – 109.4 [104]
78.8 – 100.4 [86]
Factory default values shown in brackets.
Alarms occurring during the process of temperature measurement include two (2) types:
physiological alarms and technical alarms. Physiological alarms occur when the patient’s
temperature values are equal to or exceed set alarm limits. Technical alarms are any
temperature-related alarms, which are not physiological, such as functional failures.
2 - 54
0070-10-0666-01
Trio™ Operating Instructions
Operations
2.4.5.2
Parameter Menus
Temperature Troubleshooting
MESSAGE/
PROBLEM
REASON
SOLUTION
T1 SENSOR OFF
Temperature cable of channel 1 may
be disconnected from the monitor
Make sure that the temperature
cable is properly connected, check
connection between probe and
cable
TEMP SENSOR
OFF
Temperature cable of channel 1 may
be disconnected from the monitor
Make sure that the temperature
cable is properly connected, check
connection between probe and
cable
T1 ALM LMT ERR
Functional failure
Notify hospital technician or
Customer Support
TEMP ALM LMT ERR
Functional failure
Notify hospital technician or
Customer Support
T1 EXCEED
Temperature value of channel exceeds
measurement range
Check patient, notify physician
TEMP EXCEED
Temperature value of channel exceeds
measurement range
Check patient, notify physician
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
Trio™ Operating Instructions
Cable not plugged in
0070-10-0666-01
Check cable and probe
2 - 55
Parameter Menus
2.4.6
Operations
IBP Monitoring (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 or artery and is connected
to a transducer for interpretation of Systolic (Sys), Diastolic (Dia) and/or Mean Arterial
Pressures (MAP).
The user may label the IBP channel according to the insertion site of the catheter or according
to the vessel being monitored. To do this select the IBP label, located in the upper left corner
of the IBP waveform tile, using the Navigator™ Knob. The labels are: ART, PA, CVP, RAP,
LAP and ICP. The selection of IBP labels will alter the IBP waveform default scale.
2 - 56
LABEL
DEFINITION
DEFAULT SCALE (mmHg)
ART
Arterial Blood Pressure
0 – 150
PA
Pulmonary Artery Pressure
0 – 100
CVP
Central Venous Pressure
0 – 40
RAP
Right Atrial Pressure
0 – 40
LAP
Left Atrial Pressure
0 – 40
ICP
Intracranial Pressure
0 – 40
NOTE:
For CVP, RAP, LAP and ICP only the Mean Arterial Pressure is
measured.
NOTE:
An 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 measurement or SpO2
readings.
NOTE:
Please refer to pressure transducer manufacturer's
instructions for suggested procedures and maintenance.
Follow hospital policy regarding catheter insertion, insertion
site checks and cleaning.
NOTE:
Pressure transducers are protected against the effects of
defibrillation and electrocautery.
NOTE:
Please refer to the local hospital policy for requirements for
routine zeroing and calibration of invasive pressure lines.
0070-10-0666-01
Trio™ Operating Instructions
Operations
2.4.6.1
Parameter Menus
IBP Select Menu
The IBP Select menu allows the user to access two sub-menus: IBP ZERO or IBP SETUP
(see FIGURE 2-42).
FIGURE 2-42 IBP Select Menu
Accessing the IBP Select Menu
To access the IBP SELECT menu, select IBP from the IBP parameter tile using the
Navigator™ Knob. Once in the IBP SELECT menu, use the Navigator Knob to open the IBP
ZERO menu (to zero the invasive pressure) or IBP SETUP menu. To close the menu, select
NORMAL SCREEN (from the menu or the Front Panel Keypad).
Invasive Blood Pressure Monitoring
1. Plug the pressure transducer cable into the IBP connector on the side panel.
2. Connect the catheter line with flushing device to a pressure transducer, making sure the
tubing is free of air bubbles.
3. Zero the pressure transducer:
• Adjust the transducer to the mid-axillary line of the patient's chest (heart level)
• Turn the transducer stopcock to open the transducer vent to atmosphere
• Open the IBP SELECT menu by using the Navigator™ Knob to select IBP on the
display
• Select IBP ZERO from the IBP SELECT menu
• Once in the IBP ZERO menu, select IBP ZERO to zero the invasive line
• A successful message will be displayed in the IBP ZERO menu when the invasive line
has been zeroed successfully
• A failure message will be displayed if the transducer fails to zero
Trio™ Operating Instructions
0070-10-0666-01
2 - 57
Parameter Menus
Operations
FIGURE 2-43 IBP Zero Menu
4. Label the Invasive Pressure line
• Use the Navigator™ Knob to select the IBP label located in the upper left corner of the
IBP waveform tile
• Turn the Navigator Knob to scroll through the various labels. Choices are: ART, PA,
CVP, RAP, LAP, and ICP
• Press the Navigator Knob to select the desired label
2.4.6.2
IBP Setup Menu
FIGURE 2-44 IBP Setup Menu
Accessing the IBP Setup Menu
To access the IBP SELECT menu, select IBP from the IBP parameter tile using the
Navigator™ Knob. Once in the IBP SELECT menu, use the Navigator Knob to open the IBP
SETUP menu. To close the menu, select NORMAL SCREEN (from the menu or the Front
Panel Keypad).
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0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
IBP Setup Menu Selections
ALM
Allows the user to turn the IBP alarm ON or OFF. Choose ON to
enable the alarm; choose OFF to disable the alarm. If the alarm is set
to OFF, the alarm OFF symbol
will display to the right of IBP on
the screen. The IBP alarm is activated when the blood pressure value
exceeds set high or low IBP values.
ALM PRIORITY
Enables priority selection for the IBP alarm. Choices are 1, 2 and 3.
Priority 1 alarms are considered the most serious.
ALM PRINT
Enables or disables automatic printing during an IBP alarm condition.
Choose ON to enable report printing upon IBP alarm. Choose OFF
to disable printing upon IBP alarm.
SYS ALM HI
Allows the user to set the upper limit of the Systolic IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
SYS ALM LO
Allows the user to set the lower limit of the Systolic IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
MEAN ALM HI
Allows the user to set the upper limit of the Mean Arterial Pressure IBP
alarm. (See “IBP Alarm Limits” on page 2-61.)
MEAN ALM LO
Allows the user to set the lower limit of the Mean Arterial Pressure IBP
alarm. (See “IBP Alarm Limits” on page 2-61.)
DIA ALM HI
Allows the user to set the upper limit of the Diastolic IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
DIA ALM LO
Allows the user to set the lower limit of the Diastolic IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
SWEEP
Adjusts the speed of the IBP waveform on the display. The selections
are 12.5 and 25.0 mm/sec.
UNITS
Allows the user to select the units of measurement for IBP. The
selections are mmHg or kPa.
Trio™ Operating Instructions
0070-10-0666-01
2 - 59
Parameter Menus
Operations
SCALE ADJUST
Opens the IBP SCALE ADJUST menu and is used to change the
scale at which the invasive pressure is displayed. Scale should be
adjusted to make the waveform as large as possible on the display
without clipping or cutting off any part.
To adjust the scale, use the Navigator™ Knob to scroll to the desired
area of the scale and select the desired limit. Three (3) scale choices
are available: HI, LO and MID. MID allows the user to establish a
reference line between the HI and LO set limits of the scale.
FIGURE 2-45 IBP Scale Adjust Menu
RESTORE
Allows the user to restore the IBP user default configuration.
DEFAULTS
FIGURE 2-46 Confirmation Dialog Box
2 - 60
0070-10-0666-01
Trio™ Operating Instructions
Operations
Parameter Menus
IBP Alarm Limits*
SYS
HIGH
(mmHg)
SYS
LOW
(mmHg)
MEAN
HIGH
(mmHg)
MEAN
LOW
(mmHg)
DIA
HIGH
(mmHg)
DIA
LOW
(mmHg)
Adult
5 – 300
[180]
0 – 150
[80]
5 – 150
[100]
- 5 – 100
[40]
5 – 140
[100]
0 – 120
[50]
Ped
5 – 240
[150]
0 – 130
[70]
5 – 100
[80]
- 5 – 50
[30]
5 – 100
[80]
0 – 95
[40]
Adult
5 – 300
[180]
0 – 150
[80]
5 – 150
[100]
- 5 – 100
[40]
5 – 140
[100]
0 – 120
[50]
Ped
5 – 240
[150]
0 – 130
[70]
5 – 100
[80]
- 5 – 50
[30]
5 – 100
[80]
0 – 98
[40]
n/a
n/a
5 – 150
[10]
- 5 – 100
[0]
n/a
n/a
n/a
n/a
5 – 100
[10]
- 5 – 50
[0]
n/a
n/a
n/a
n/a
5 – 150
[10]
- 5 – 100
[0]
n/a
n/a
n/a
n/a
5 – 100
[10]
- 5 – 50
[0]
n/a
n/a
n/a
n/a
5 – 150
[10]
- 5 – 100
[0]
n/a
n/a
n/a
n/a
5 – 100
[10]
- 5 – 50
[0]
n/a
n/a
n/a
n/a
5 – 150
[10]
- 5 – 100
[0]
n/a
n/a
n/a
n/a
5 – 100
[10]
- 5 – 50
[0]
n/a
n/a
IBP
LABEL
ART
PA
Adult
CVP
Ped
Adult
RAP
Ped
Adult
LAP
Ped
Adult
ICP
Ped
*
Factory default values shown in brackets.
Alarms occurring during the process of IBP measurement include two (2) types: physiological
alarms and technical alarms. Physiological alarms occur when the patient’s pressure values
are equal to or exceed set alarm limits. Technical alarms are any IBP-related alarms, which
are not physiological, such as functional failures.
Trio™ Operating Instructions
0070-10-0666-01
2 - 61
Parameter Menus
2.4.6.3
Operations
IBP Troubleshooting
MESSAGE/
PROBLEM
REASON
SOLUTION
SENSOR OFF, FAIL
Transducer may be disconnected
during attempt to zero
Check transducer and cables for
connection. If problem persists,
notify hospital technician or
Customer Support
IN DEMO FAIL
Monitor is in DEMO mode during
attempt to zero
Turn monitor OFF. Turn ON to
return to normal monitoring mode
PRESSURE OVER
RANGE, FAIL
Stopcock not open to atmosphere
Turn stopcock to atmosphere prior
to zero attempt. If problem persists,
notify hospital technician or
Customer Support
PULSATILE
PRESSURE, FAIL
Stopcock is not open to atmosphere
and a pulsatile pressure has been
detected
Turn stopcock to atmosphere prior
to zero attempt. If problem persists,
notify hospital technician or
Customer Support
IBP SENSOR OFF
IBP cable may be disconnected from
monitor
Make sure that cable is properly
connected
IBP INIT ERR1
Module failure
Notify hospital technician or
Customer Support
IBP COMM STOP
Module failure or communication
failure
Notify hospital technician or
Customer Support
IBP COMM ERR
Communication error
Notify hospital technician or
Customer Support
IBP ALM LMT ERR
Functional failure
Notify hospital technician or
Customer Support
IBP SYS EXCEED
Systolic pressure value exceeds
measurement range
Check patient, notify physician
IBP DIA EXCEED
Diastolic pressure value exceeds
measurement range
Check patient, notify physician
IBP MAP EXCEED
Mean arterial pressure value exceeds
measurement range
Check patient, notify physician
IBP NEED ZEROCAL
Zero calibration must be performed
before measuring IBP
Zero calibration must be
performed. Notify hospital
technician or Customer Support.
Dampened Invasive
Waveform
Air bubbles in tubing
Eliminate air from tubing
Kinked invasive 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
Consult physician
IBP not Displayed /
No Waveform
Abnormally high or
low readings
2 - 62
Cable not plugged in
Check cable connections
Transducer not connected
Check transducer connections
Stopcock turned improperly
Check transducer for proper
alignment
Transducer not zeroed
Check and zero the transducer
Transducer too HIGH or too LOW in
relation to patient's heart
Check patient, adjust transducer,
re-zero
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Trio™ Operating Instructions
Operations
2.5
Alarms
Alarms
The Trio provides audio and visual alarms to indicate:
• The functional status of the monitor
• That the measured parameter values are equal to or exceed the alarm limits
These alarms are divided into three categories: Physiological, Technical and General. Alarms
in each category are classified in one of three levels based on their degree of severity. These
levels are Priority 1, 2 or 3.
When the Trio is turned ON, an audible tone and the alarm light will indicate that the audio
and visual alarm functions of the monitor are working properly. If the tone is not heard and/
or the alarm light does not flash when the unit is turned ON, contact the hospital biomedical
technician or a Customer Service representative.
Technical and General alarm messages will display in the message area located in the upper
right portion of the Trio display, with the exception of the NIBP technical alarms. NIBP
technical alarms will display at the bottom of the NIBP parameter tile.
2.5.1
Alarm Categories
Physiological Alarms
Physiological alarms are alarms prompted by changes in the patient's medical condition.
These alarms occur when the patient’s vital signs are equal to or exceed set alarm limits.
Alarm limits are available for Heart Rate (HR), Systolic (SYS) blood pressure, Diastolic (DIA)
blood pressure, Mean Arterial Pressure (MEAN), Respiration (RESP), SpO2 and Temperature
(TEMP). All of these alarm limits have an OFF selection with the exception of SpO2 alarm
low. Each of these parameters has default alarm limits. However, parameter alarm limits can
be customized based on the individual patient's needs.
NOTE:
In the French configuration, the HR (Heart Rate) alarm is
always ON. It cannot be disabled by turning it OFF.
A physiological alarm will occur when the parameter alarm is set to ON and the measured value
is equal to or exceeds the set alarm limit. Alarms will not activate if the alarm is set to OFF.
If ALARM PRINT is set to ON for a given parameter, a printed record will automatically be
generated when the parameter value is equal to or exceeds the set alarm limits.
Technical Alarms
Technical alarms refer to a communication error or functional failure, which require resolution
or attention to continue patient monitoring. Technical alarms are also called System Errors.
Upon detecting a system error, the monitor alarms immediately. If more than one (1) technical
alarm occurs, each alarm will cycle until the associated error is resolved.
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Alarms
Operations
General Alarms
General alarms are alerts that cannot be classified as physiological or technical, but that
require attention. General alarms are not related to patient medical condition.
2.5.2
Alarm Priorities
Alarms in each category (Physiological, Technical or General) are classified based on their
degree of severity. The priority determines the frequency of audio and visual alerts. There are
two (2) visual alerts: the alarm light and the alarm-related message on the display. For an
ECG Lead Off alarm, the alarm will sound according to the ECG priority setting.
1. Priority One (1) Alarm: This alarm requires an urgent and immediate response from
the clinician. The numeric value of the alarming parameter will flash at a constant rate in
black text on a red background. The alarm light will flash red with high frequency. The
audio alert cycles once every ten (10) seconds.
2. Priority Two (2) Alarm: This alarm requires a serious response and consideration by
the clinician. The numeric value of the alarming parameter will flash at a constant rate in
black text on a yellow background. The alarm light flashes amber with a slow frequency.
The audio alert cycles once every 25 seconds.
3. Priority Three (3) Alarm: This alert should be attended to as soon as possible by the
clinician. The numeric value of the alarming parameter displays in black text on a yellow
background and does not flash. The alarm light will be amber and does not flash. The
audio alert cycles once every 25 seconds.
All physiological alarms can be changed by the clinician. Technical alarm priorities are
preset in the system and can not be changed. The alert message for technical alarms displays
on a yellow background. To change the parameter alarm priorities, open the individual
PARAMETER SETUP menus and select the priority desired. Parameter alarm priorities may
also be adjusted in the ALARM SETUP menu.
NOTE:
2.5.3
When alarms of different priorities occur simultaneously, the
monitor will display the alarm with the highest priority.
Alarm Setup Menus
The Alarm Setup Menus enable the customization of the COMMON ALARM SETUP as
well as the ALARM SETUPs for the following individual parameters: HR, SPO2, NIBP,
IBP, RESP, and TEMP.
2.5.3.1
Accessing the Alarm Setup Menus
1. Using the Navigator™ Knob, select ALARM SETUP from the MONITOR SETUP
menu. The default ALARM SETUP menu is the COMMON ALARM SETUP as shown
in FIGURE 2-47.
2. Use the ALM SEL Drop-Down menu to access the ALARM SETUP menu for a specific
parameter. The choices are: HR ALARM SETUP, SPO2 ALARM SETUP, NIBP
ALARM SETUP, IBP ALARM SETUP, RESP ALARM SETUP, and TEMP ALARM
SETUP. The selected ALARM SETUP menu will determine the other available menu
selections.
NOTE:
2 - 64
For more information on parameter alarms and instructions
for setting these alarms, refer to the parameter-specific
section of this Operator's Manual.
0070-10-0666-01
Trio™ Operating Instructions
Operations
Alarms
COMMON ALARM SETUP Menu Selections
FIGURE 2-47 Common Alarm Setup Menu
ALM SEL
Choose COMMON ALARM SETUP.
(Alarm Selection)
ALARM VOL
Volume of the audio alert. Selections are: LOW, MED, and HIGH.
ALM PRINT TIME Length of the printed waveform. Selections are: 8s, 16s, or 32s.
ALM MUTE TIME Length of time for the alarm to be silenced. Selections are:1min,
2min, 5min, 10min, and PERMANENT.
When ALM MUTE TIME is set to PERMANENT and Alarm Mute
is active, the message “Alarms Permanently Muted” displays at a
constant rate in the technical alarms area.
• If another technical alarm occurs at the same time, both
messages will display alternately.
• If the ALM MUTE TIME is changed to something other than
PERMANENT, the following conditions will exist:
• The elapsed time is defined as the time from which ALM
MUTE TIME had been set to PERMANENT to the time at
which it was changed to something other than
PERMANENT.
• If the elapsed time exceeds the newly selected ALM MUTE
TIME, then the Alarm Mute will immediately deactivate.
Example: Elapsed time = 5min, New ALM MUTE TIME =
2min, Alarm Mute immediately deactivates.
• If the elapsed time is less than the newly selected ALM
MUTE TIME, then the Alarm Mute will continue to be active
for the remainder of the newly selected time period.
Example: Elapsed time = 2min, New ALM MUTE TIME =
10min, Alarm Mute continues to be active for 8 minutes and
then deactivates.
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Alarms
Operations
HR ALARM SETUP Menu Selections
FIGURE 2-48 HR Alarm Setup Menu
ALM SEL
Choose HR ALARM SETUP.
(Alarm Selection)
ALM
NOTE:
In the French configuration, the HR
(Heart Rate) alarm is always ON. It
cannot be disabled by turning it
OFF.
Allows the user to turn the HR (Heart Rate) alarm ON or OFF.
Choose ON to enable the alarm; choose OFF to disable the
alarm. If the alarm is set to OFF, the alarm OFF symbol
will
display to the right of ECG on the screen. The HR alarm is
activated when the heart rate is equal to or exceeds set high or
low HR values.
ALM PRIORITY
Allows the user to select the priority of the alarm. Choices are 1,
2 and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Allows the user to enable or disable automatic printing during a
physiological alarm condition. Choose ON to enable printing
upon alarm. Choose OFF to disable printing upon alarm. See
“Recorder (Optional)” on page 2-82 for details.
HR ALM HI
Allows the user to set the upper limit of the HR alarm. (See “Heart
Rate Alarm Limits” on page 2-27.)
HR ALM LO
Allows the user to set the lower limit of the HR alarm. (See “Heart
Rate Alarm Limits” on page 2-27.)
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Trio™ Operating Instructions
Operations
Alarms
SPO2 ALARM SETUP Menu Selections
FIGURE 2-49 SPO2 Alarm Setup Menu (Masimo® only)
FIGURE 2-50 SPO2 Alarm Setup Menu (Nellcor® only)
NOTE:
See the appropriate subsection of the “SpO2 Monitoring”
section for the alarm limits
ALM SEL
Choose SPO2 ALARM SETUP.
(Alarm Selection)
ALM PRIORITY
Allows the user to select the priority of the alarm. Choices are 1,
2 and 3. Priority 1 alarms are considered the most serious.
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Alarms
Operations
ALM PRINT
Allows the user to enable or disable automatic printing during a
physiological alarm condition. Choose ON to enable printing
upon alarm. Choose OFF to disable printing upon alarm. See
“Recorder (Optional)” on page 2-82 for details.
SPO2 ALM HI
Allows the user to set the upper limit of the SPO2 alarm. Choices
are 80 – 100% and OFF. Choose OFF to disable the alarm. If the
alarm is set to OFF, the alarm OFF symbol
will display within
the parameter tile. The alarm is activated when the measurement
equals or exceeds the high limit.
SPO2 ALM LO
Allows the user to set the lower limit of SPO2 alarm.
PR ALM HI
Allows the user to set the upper limit of the Pulse Rate alarm.
PR ALM LO
Allows the user to set the lower limit of the Pulse Rate alarm.
SENSOR OFF
Controls the onset of the audio beep alarm for the “SpO2 Sensor
AUDIO
OFF” condition. The choices are ON and OFF.
If ON is selected, then the audio beep alarm will sound when an
“SpO2 Sensor OFF” condition occurs. If OFF is selected, then the
audio beep alarm will not sound when an “SpO2 Sensor OFF”
condition occurs.
SAT SECONDS
Controls pulse oximetry nuisance alarms (see section 2.4.3.2 for
(Nellcor® only)
details on SatSeconds™ features). The selections are OFF, 10,
25, 50 or 100.
When SatSeconds is enabled, the SPO2 Low and High Alarm
functions are automatically disabled. As a safety precaution, if
three (3) SPO2 alarm violations occur within 60 seconds, a
priority 2 alarm will trigger even if the SatSeconds limit has not
been reached.
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Trio™ Operating Instructions
Operations
Alarms
NIBP ALARM SETUP Menu Selections
FIGURE 2-51 NIBP Alarm Setup Menu
ALM SEL
Choose NIBP ALARM SETUP.
(Alarm Selection)
ALM
Allows the user to turn the alarm ON or OFF. Choose ON to
enable the alarm; choose OFF to disable the alarm. If the alarm is
set to OFF, the alarm OFF symbol
will display within the
parameter tile. The alarm is activated when the measurement
exceeds the high or low limits.
ALM PRIORITY
Allows the user to select the priority of the alarm. Choices are 1,
2 and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Allows the user to enable or disable automatic printing during a
physiological alarm condition. Choose ON to enable printing
upon alarm. Choose OFF to disable printing upon alarm. See
“Recorder (Optional)” on page 2-82 for details.
SYS ALM HI
Allows the user to set the upper limit of the Systolic NIBP alarm.
(See “NIBP Alarm Limits” on page 2-50.)
SYS ALM LO
Allows the user to set the lower limit of the Systolic NIBP alarm.
(See “NIBP Alarm Limits” on page 2-50.)
MEAN ALM HI
Allows the user to set the upper limit of the Mean NIBP alarm.
(See “NIBP Alarm Limits” on page 2-50.)
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Alarms
Operations
MEAN ALM LO
Allows the user to set the lower limit of the Mean NIBP alarm.
(See “NIBP Alarm Limits” on page 2-50.)
DIA ALM HI
Allows the user to set the upper limit of the Diastolic NIBP alarm.
(See “NIBP Alarm Limits” on page 2-50.)
DIA ALM LO
Allows the user to set the lower limit of the Diastolic NIBP alarm.
(See “NIBP Alarm Limits” on page 2-50.)
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Trio™ Operating Instructions
Operations
Alarms
IBP ALARM SETUP Menu Selections
FIGURE 2-52 IBP Alarm Setup Menu
ALM SEL
Choose IBP ALARM SETUP.
(Alarm Selection)
ALM
Allows the user to turn the alarm ON or OFF. Choose ON to
enable the alarm; choose OFF to disable the alarm. If the alarm is
set to OFF, the alarm OFF symbol
will display within the
parameter tile. The alarm is activated when the measurement
exceeds the high or low limits.
ALM PRIORITY
Allows the user to select the priority of the alarm. Choices are 1,
2 and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Allows the user to enable or disable automatic printing during a
physiological alarm condition. Choose ON to enable printing
upon alarm. Choose OFF to disable printing upon alarm. See
“Recorder (Optional)” on page 2-82 for details.
SYS ALM HI
Allows the user to set the upper limit of the Systolic IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
SYS ALM LO
Allows the user to set the lower limit of the Systolic IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
MEAN ALM HI
Allows the user to set the upper limit of the Mean IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
Trio™ Operating Instructions
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Alarms
Operations
MEAN ALM LO
Allows the user to set the lower limit of the Mean IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
DIA ALM HI
Allows the user to set the upper limit of the Diastolic IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
DIA ALM LO
Allows the user to set the lower limit of the Diastolic IBP alarm.
(See “IBP Alarm Limits” on page 2-61.)
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Trio™ Operating Instructions
Operations
Alarms
RESP ALARM SETUP Menu Selections
FIGURE 2-53 RESP Alarm Setup Menu
ALM SEL
Choose RESP ALARM SETUP.
(Alarm Selection)
ALM
Allows the user to turn the alarm ON or OFF. Choose ON to
enable the alarm; choose OFF to disable the alarm. If the alarm is
set to OFF, the alarm OFF symbol
will display within the
parameter tile. The alarm is activated when the measurement
exceeds the high or low limits.
ALM PRIORITY
Allows the user to select the priority of the alarm. Choices are 1,
2, and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Allows the user to enable or disable automatic printing during a
physiological alarm condition. Choose ON to enable printing
upon alarm. Choose OFF to disable printing upon alarm. See
“Recorder (Optional)” on page 2-82 for details.
ALM HI
Allows the user to set the upper limit of the RESP alarm. (See
“Respiration Rate Alarm Limits” on page 2-30.)
ALM LO
Allows the user to set the lower limit of the RESP alarm. (See
“Respiration Rate Alarm Limits” on page 2-30.)
Trio™ Operating Instructions
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Alarms
Operations
TEMP ALARM SETUP Menu Selections
FIGURE 2-54 TEMP Alarm Setup Menu
ALM SEL
Choose TEMP ALARM SETUP.
(Alarm Selection)
ALM
Allows the user to turn the alarm ON or OFF. Choose ON to
enable the alarm; choose OFF to disable the alarm. If the alarm is
set to OFF, the alarm OFF symbol
will display within the
parameter tile. The alarm is activated when the measurement
exceeds the high or low limits.
ALM PRIORITY
Allows the user to select the priority of the alarm. Choices are 1,
2, and 3. Priority 1 alarms are considered the most serious.
ALM PRINT
Allows the user to enable or disable automatic printing during a
physiological alarm condition. Choose ON to enable printing
upon alarm. Choose OFF to disable printing upon alarm. See
“Recorder (Optional)” on page 2-82 for details.
TEMP ALM HI
Allows the user to set the upper limit of the TEMP alarm. (See
“Temperature Alarm Limits” on page 2-54.)
TEMP ALM LO
Allows the user to set the lower limit of the TEMP alarm. (See
“Temperature Alarm Limits” on page 2-54.)
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Trio™ Operating Instructions
Operations
Alarms
Alarm Mute
The ALARM MUTE function is used to silence parameter alarms that have been triggered.
Press the ALARM MUTE key on the Front Panel Keypad to activate the ALARM MUTE
function. When ALARM MUTE is active, press the key a second time to deactivate the
function. The amount of time the alarm is silenced is programmable through the ALARM
SETUP menu. Any new alarms that occur during the silenced period will disable the
ALARM MUTE function in order for the new alarm to sound.
An ALARM MUTE icon
will be displayed in the message bar when the ALARM MUTE
function is active.
When an Alarm Occurs
Always check the patient to verify the alarm and identify the cause of the alarm. Artifact,
patient movement and other non-physiological conditions may cause false alarms. Verify the
nature and cause of the alarm, mute the alarm as necessary. Check all patient connections
for sensor connections and cable integrity. Change physiological alarm limits if necessary.
Notify physician if change in patient condition occurs.
2.5.4
Alarm Troubleshooting
MESSAGE/
PROBLEM
REASON
SOLUTION
REAL CLOCK NEED
SET
System displays 2000-1-1, the clock has
not been set
Reset system time. After
modifying the time, restart the
monitor to display correct time
REAL CLOCK NOT
EXIST
The system has no battery or the battery
is depleted
Notify hospital biomedical
technician or Customer Support
KEYBOARD COMM
ERR and/or
KEYBOARD ERROR
and/or KEYBOARD
ERR X
The system has detected a keypad error
or failure.
Restart the system. If alert
persists, notify hospital
biomedical technician or
Customer Support
CELL BAT TOO
HIGH
Cell battery is defective or incorrect cell
battery is installed
Check the battery, replace if
necessary. If the failure still
exists, notify hospital technician
or Customer Support
CELL BAT TOO LOW
The cell battery has low capacity, the cell
battery is not installed or the connection
is loose
Check the battery, replace if
necessary. If the failure still
exists, notify hospital technician
or Customer Support
Trio™ Operating Instructions
NOTE: X = 1 or 2.
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Trends
Operations
2.6
Trends
2.6.1
Graphic Trend
The Graphic Trend display allows the user to view a graphic summary of stored vital sign
data. The most recent 1-hour of graphic trend data can be displayed in intervals of 1 or 5
seconds. The most recent 24-hours of graphic trend data can be displayed in intervals of 1,
2, 3 or 4 minutes. Select GRAPHIC TREND from the SYSTEM MENU to access this
menu/display (see FIGURE 2-55).
FIGURE 2-55 Graphic Trend Menu/Display
In the Graphic Trend display, time stamps are plotted horizontally along the x-axis, with the
most recent data appearing on the far right. The values of the trended parameter, and the
corresponding units of measurement are plotted vertically, along the y-axis. The down arrow
symbol
indicates that the value of the parameter which it points to, falls below the x-axis.
All trends, except NIBP trend, are displayed as continuous waveforms. When viewing the
NIBP graphic trend, the W symbol indicates systolic value, the V symbol indicates diastolic
value, and * indicates mean value.
NOTE:
2 - 76
When the monitor is powered OFF, graphic trend data is
maintained for 2 hours. If the monitor remains OFF for more
than 2 hours, the graphic trend data is deleted.
0070-10-0666-01
Trio™ Operating Instructions
Operations
Trends
Graphic Trend Menu Selections
1. PARAMETER
• To change the parameter of data being displayed, select PARAMETER from the
GRAPHIC TREND menu. Using the Navigator™ Knob, scroll to the desired
parameter and press the knob.
• The selections are: HR, NIBP, SpO2, PR, IBP, RR, and TEMP.
2. INTERVAL
• To change the displayed INTERVAL, select INTERVAL from the GRAPHIC TREND
menu. (The chosen interval can be saved as part of the “User Default
Configuration” by using the SAVE CURRENT function as described in section
2.3.5.9.)
• To view the latest hour of trended data, select either the 1s or 5s interval.
• To view the latest 24-hours of trended data, select the 1min, 2min, 3min or 4min
interval.
3. SCROLL
• To view other segments of a graphic trend, select SCROLL from the GRAPHIC
TREND menu.
• When the right arrow key
appears on the right side of the menu display, select
SCROLL
and turn the Navigator™ Knob clockwise to view older trend waveform
data.
• When the left arrow key
appears on the left side of the menu display, select
SCROLL
and turn the Navigator Knob counterclockwise to view more recent trend
data.
4. SCALE
• To modify the scale upon which the graphic trend is displayed, select SCALE from the
GRAPHIC TREND menu. The y-axis scale is adjustable based on the minimum and
maximum values for the particular parameter.
5. CURSOR
To view trend data at a specific point in time, select CURSOR from the GRAPHIC TREND
menu:
• Turn the knob to move the cursor to particular data points. The data to which the cursor
points will correspond to the time displayed. The parameter data corresponding to the
particular point in time is displayed below the x-axis.
• When
appears in the upper right portion of the menu, the user can scroll right to
view more recent trend data.
• When
appears in the upper left portion of the menu, the user can scroll left to view
older trend data.
6. PRINT
• To print the graphic trend data for the currently selected parameter, select PRINT from
the GRAPHIC TREND menu.
• To stop the print job currently in progress, select PRINT on the front panel keypad.
Trio™ Operating Instructions
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Trends
Operations
Mark Event
If, during the trended period of time, an event was marked, the corresponding event type (A,
B, C or D) will display along the x-axis of the graphic trend. The event (A, B, C or D) will
appear in a box, at the corresponding point in time that the event was marked.
Remove Graphic Trend Display
The GRAPHIC TREND menu/display does not automatically time-out. The user must
manually exit this menu. To exit the GRAPHIC TREND menu/display and return to the
SYSTEM MENU, select PREVIOUS MENU. To exit the GRAPHIC TREND menu/display
and return to the normal screen, select NORMAL SCREEN (from the menu or the Front
Panel Keypad).
Delete Graphic Trend Data
To permanently delete all graphic trend data, the user must discharge the currently monitored
patient from the monitor. To discharge a patient, open the SYSTEM MENU. Once in the
SYSTEM MENU, select PATIENT DISCHARGE from the PATIENT SETUP menu. When
given the prompt, Discharge patient from monitor?, select YES to confirm.
Example: View the NIBP Graphic Trend for the Last Hour
1. Select the MENU icon in the bottom right corner of the screen.
2. Once in the SYSTEM MENU, select GRAPHIC TREND.
3. Once in the GRAPHIC TREND menu select PARAMETER then select NIBP.
4. Select INTERVAL and select either the 1s (1 second) or 5s (5 second) interval.
5. Select SCROLL and turn the knob to view different points along the graphic trend (xaxis).
6. Stop scrolling at the desired trend time segment for closer analysis. Select the SCALE
button to adjust the display scale, on the y-axis, if desired.
7. For a measurement result of a specific point in time, select CURSOR to move the cursor
to the desired point. The corresponding time and measurement value will display above
and below the waveform respectively.
8. To print out the NIBP graphic trend displayed, select PRINT from the GRAPHIC
TREND menu.
9. Select PREVIOUS MENU to return to the SYSTEM MENU. Select NORMAL
SCREEN (from the menu or the Front Panel Keypad) to exit the menu and return to the
normal screen.
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Trio™ Operating Instructions
Operations
2.6.2
Trends
List Trend
The List Trend display allows the user to view a tabular list of stored vital sign data. Select
LIST TREND from the SYSTEM MENU to access this menu/display (see FIGURE 2-56). A
maximum of 24 hours of data may be stored. When List Trend reaches the maximum number
of data entries, the oldest entry will be deleted from the trend record in order to allow
storage of a new entry. The List Trend data can be set to display in 1min, 2min, 3min,
4min, 5min, 10min, 15min, 30min, or 1HR intervals.
FIGURE 2-56 List Trend Menu/Display
In the List Trend display, time stamps are displayed in the far left column, with the most recent
data appearing at the top. Any alarm violations appearing in the list trend view are
indicated by inverse video. The LIST TREND displays several parameters of data at a time.
Parameter data displays from left to right, in the following order: HR, NIBP, SpO2, PR,
IBP, RESP and TEMP. Use the SCROLL key to view additional parameter data.
NOTE:
Trio™ Operating Instructions
When the monitor is powered OFF, list trend data is
maintained for 2 hours. If the monitor remains OFF for more
than 2 hours, the list trend data is deleted.
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Trends
Operations
List Trend Menu Selections
1. INTERVAL
• To change the INTERVAL, select INTERVAL from the LIST TREND menu. (The
chosen interval can be saved as part of the “User Default Configuration” by
using the SAVE CURRENT function as described in section 2.3.5.9.)
• Select from intervals of in 1min, 2min, 3min, 4min, 5min, 10min, 15min,
30min, or 1HR.
2. SCROLL
• When an upward facing arrow
appears on the upper portion of the menu, select
SCROLL and turn the knob clockwise to view more recent trend data.
• When a downward facing arrow
appears on the lower portion of the menu, select
SCROLL and turn the knob counterclockwise to view older trend data.
3. SCROLL
Select SCROLL
to select the parameter group for which a view of trend data is desired.
Trend data for each parameter is displayed as follows:
• HR (bpm)
• NIBP (Sys/Dia/Mean) (mmHg or kPa)
• SpO2 (%), PR (bpm)
• IBP (Sys/Dia/Mean) (mmHg or kPa)
• RESP (rpm)
• TEMP (°C or °F)
• When a
is displayed in the lower right corner of the menu, the user can scroll right
to view additional parameter data.
• When a
is displayed in the lower left corner of the menu, the user can scroll left to
view additional parameter data.
4. PRINT
• To print the list trend data for all parameters, select PRINT from the LIST TREND
menu.
• To stop the print job currently in progress, select PRINT on the front panel keypad.
Mark Event
The EVENT column of the LIST TREND menu displays time stamp event markers (A, B, C, or
D) that have been entered in the trend memory from the MARK EVENT menu (see section
2.3.4). The time stamp event markers are displayed in the EVENT column at the
corresponding trend entry time.
Remove List Trend Display
The LIST TREND menu/display does not automatically time-out. The user must manually exit
this menu. To exit the LIST TREND menu/display and return to the SYSTEM MENU, select
PREVIOUS MENU. To exit the LIST TREND menu/display and return to the normal screen,
select NORMAL SCREEN (from the menu or the Front Panel Keypad).
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Trio™ Operating Instructions
Operations
Trends
Delete List Trend Data
To permanently delete all list trend data, the user must discharge the currently monitored
patient from the monitor. To discharge a patient, open the SYSTEM MENU. Once in the
SYSTEM MENU, select PATIENT DISCHARGE from the PATIENT SETUP menu. When
given the prompt, Discharge patient from monitor?, select YES to confirm.
Example: View NIBP List Trend Data
1. Select the MENU icon in the lower right corner of the display to access the SYSTEM
MENU.
2. Select LIST TREND.
3. Select SCROLL
and select NIBP by turning the knob clockwise.
4. Select INTERVAL and scroll to the desired time interval.
5. Select SCROLL and turn the knob to view NIBP trend data for a different time
segment.
6. Select PRINT to initiate a printout of all trend data of this time segment, including NIBP.
7. Select PREVIOUS MENU to return to the SYSTEM menu. Select NORMAL SCREEN
(from the menu or the Front Panel Keypad) to exit the menu and return to normal screen.
Trio™ Operating Instructions
0070-10-0666-01
2 - 81
Recorder (Optional)
2.7
Operations
Recorder (Optional)
The optional Trio Recorder provides a printed record of all patient monitored parameters,
including numeric and waveform data. It is a two-trace thermal strip chart recorder. The Trio
recorder uses plain white thermal paper, 50mm wide (part number 0683-00-0505-02.) See
section 4.7 for Paper Replacement Instructions.
2.7.1
Print Functions
The Trio performs the following print functions:
• Continuous, real-time print
• 8 second, real-time print
• Interval, real-time print
• Alarm print
• Graphic/List Trend print
• Error log print
• Clear print tasks
Accessing the Printer Setup Menu
1. Select the MENU icon from the main screen. The SYSTEM MENU is displayed.
2. Select MONITOR SETUP. The MONITOR SETUP menu is displayed.
3. Select PRINTER SETUP. The PRINTER SETUP menu (FIGURE 2-57) is displayed.
FIGURE 2-57 Printer Setup Menu
2 - 82
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Trio™ Operating Instructions
Operations
Recorder (Optional)
Printer Setup Menu Selections
WAVEFORM 1:
Allows the user to designate the first of two (2) waveforms to print. If
the user selects OFF, no waveform will print as WAVEFORM 1.
Selections are: Any waveforms currently displayed and OFF.
WAVEFORM 2:
Allows the user to designate the second of two (2) waveforms to print.
If the user selects OFF, no waveform will print as WAVEFORM 2.
Selections are: Any waveforms currently displayed and OFF.
TIME:
Allows the user to select the duration of the waveform print. Selections
are: CONTINUAL and 8s (8 second).
INTERVAL:
Allows the user to select the interval at which real-time printouts will
automatically occur. Selections are: OFF, 10min, 20min, 30min,
40min, 50min, 1HR, 2HRS, 3HRS, and 4HRS.
SPEED:
Allows the user to select the speed at which the waveform section of
the printout is output. Selections are: 25.0 mm/s and 50.0 mm/s.
GRID:
Allows the user to select a print format either with or without a
background grid. Selections are: OFF and ON.
CLEAR PRINT
Allows the user to clear a print task already in progress or to clear
TASK:
multiple print tasks from the system.
Real-Time Print
1. Using the PRINTER SETUP menu, select the waveforms to print on the recorder strip.
The user can designate a maximum of two (2) waveforms to print, WAVEFORM 1 and
WAVEFORM 2. The user may opt to set one (1) waveform to OFF, in which case one
(1) waveform and the numeric data will print. If both waveforms are set to OFF, the
monitor will print only the numeric data for available parameters. If no waveforms are
displayed on the screen both waveforms will automatically default to OFF and only the
numeric data for available parameters will print.
2. If the user does not designate which waveforms to print in Printer Setup, pressing the
PRINT key will automatically default to printing the first two (2) waveforms displayed on
the screen.
3. Select TIME in the PRINTER SETUP menu to designate the time length of the waveform
printout. Select CONTINUAL for a continuous waveform printout. Select 8s for an 8
second waveform printout.
4. When the print settings have been selected in the PRINTER SETUP menu, press the
PRINT key on the front panel keypad to initiate a real-time printout.
5. Press the PRINT key again to stop a printout that is already in progress.
NOTE:
Trio™ Operating Instructions
If a printout has started, and a parameter alarm prompts an
additional printout, the alarm printout will not begin until
the current printout is complete.
0070-10-0666-01
2 - 83
Recorder (Optional)
Operations
Interval Real-Time Printout
The Trio can be set to print automatically at regular intervals, as designated by the user. To
activate the interval print feature:
1. Select INTERVAL from the PRINTER SETUP menu.
2. Use the Navigator™ Knob to choose the interval at which an automatic printout will
occur. The following time intervals are available: 10min, 20min, 30min, 40min,
50min, 1HR, 2HRS, 3HRS, and 4HRS.
3. Select OFF to disable the automatic print function.
FIGURE 2-58 Example, Interval Real-Time Printout
Alarm Printout
When a parameter alarm is activated, and ALM PRINT is set to ON for the alarming
parameter, a printout is automatically generated for that parameter. In the ALARM SETUP
menu, the user can designate the length of the waveform on the alarm printout as either 8,
16 or 32 seconds.
To set the length of the alarm printout:
1. Access the SYSTEM MENU using the MENU icon on the main display.
2. Select MONITOR SETUP.
3. Select ALARM SETUP.
4. Scroll to ALM PRINT TIME and select a recording time length.
FIGURE 2-59 Example, Alarm Printout
Depending on the alarm print time selected, the print recording will display the waveform, 4,
8, or 16 seconds respectively, prior to and after the alarm event. For example, for an eight
(8) second alarm printout four (4) seconds of pre-alarm, and four (4) seconds of post alarm
data will appear on the printout. Alarm times of 16 or 32 seconds will print alarm data in a
similar manner. All numeric data displayed during the alarm event will also be included on
the printout and will print before the waveform data.
2 - 84
0070-10-0666-01
Trio™ Operating Instructions
Operations
Recorder (Optional)
When parameter alarms occur, a maximum of two (2) waveforms can print simultaneously. If
more than two (2) parameter alarms are activated simultaneously, the recorder will print out
those of the highest priority level. If the alarm events are of the same priority level, the most
recent alarm event will be printed. If an alarm event occurs when another alarm printout is
already in progress, the more recent alarm printout will not begin until the current alarm
printout is complete.
Graphic/List Trend Print
To print the graphic trend of the currently selected parameter, select PRINT from the
GRAPHIC TREND menu. To stop the print job currently in progress, select PRINT on the
front panel keypad.
FIGURE 2-60 Example, Graphic Trend Printout
To print the list trend of all parameters, select PRINT from the LIST TREND menu. To stop the
print job currently in progress, select PRINT on the front panel keypad.
FIGURE 2-61 Example, List Trend Printout
Error Log Print
To print information displayed in the ERROR LOG menu, select MAINTENANCE from the
SYSTEM MENU. From the MAINTENANCE menu, select ERROR LOG. Select PRINT
from the ERROR LOG menu. To stop the print job currently in progress, select the PRINT
key on the front panel keypad.
FIGURE 2-62 Example, Error Log Printout
Trio™ Operating Instructions
0070-10-0666-01
2 - 85
Recorder (Optional)
Operations
Clear Print Tasks
To cancel all printouts in the print queue, select CLEAR PRINT TASK from the PRINTER
SETUP menu.
2.7.2
Recorder Troubleshooting
MESSAGE/
PROBLEM
2 - 86
REASON
SOLUTION
PRINTER HEAD
HOT
The thermal terminal is too hot
Discontinue print operation. Notify
hospital technician or Customer Support.
PRINT HEAD IN
WRONG POS.
The thermal head is not in the
proper position
Push down the lever on the left side of
the internal recorder
PRINTER OUT
OF PAPER
Recorder paper has been consumed
or is not installed
Install a new roll of paper
PRINTER
COMM ERR
Functional failure
Reset the recorder. Notify hospital
technician or Customer Support
PRINTER PAPER
JAM
Paper is misaligned or installed
incorrectly
Remove the roll of paper and re-install
PRINTER
INITIALIZING
The recorder is in the initialization
process
Wait for the completion of initialization
TOO MANY
PRINT TASKS
Printer has received multiple alarm
print requests at one time
Check patient. Verify alarm status. Clear
print tasks. Notify hospital technician or
Customer Support.
PRINTER PAPER
W.P.
The printer paper is in the wrong
position
Remove the roll of paper and re-install
PRINTER BUSY
Printer has received multiple print
requests at one time
Wait until the printer is not busy
PRINTER NOT
AVAILABLE
Printer inoperable or not installed
Check printer. Notify hospital technician
or Customer Support.
PRINTER VLT
HIGH
The voltage of the recorder is too
high
Stop recording until the recorder restores
normal status. If message reappears,
notify hospital technician or Customer
Support.
PRINTER VLT
LOW
The voltage of the recorder is too
low
Stop recording until the recorder restores
normal status. If message reappears,
notify hospital technician or Customer
Support.
PRINTER S.
COMM ERR
Functional failure
Power cycle unit. If message reappears,
notify hospital technician or call
Customer Support.
PRINTER
SELFTEST ERR
Functional failure
Power cycle unit. If message reappears,
notify hospital technician or call
Customer Support.
PRINTER INIT
ERR1
Functional failure
Power cycle unit. If message reappears,
contact hospital technician or Customer
Support.
0070-10-0666-01
Trio™ Operating Instructions
3.0
Defaults
3.1
Default Configurations
Trio has four default configurations.
• Factory Default Configuration
• User Default Configuration
• Current Configuration
• Non-Volatile Configuration
3.1.1
Factory Default Configuration
The Factory Default Configuration is initially set by the manufacturer. These settings
cannot be changed by the user. If the user changes settings to be different from the Factory
Default settings, the Factory Default Configuration can be restored as follows:
1. Select RESTORE DEFAULTS from the MONITOR SETUP menu. The RESTORE
DEFAULTS menu is displayed as shown in FIGURE 3-1.
FIGURE 3-1 Restore Defaults Menu
Trio™ Operating Instructions
0070-10-0666-01
3-1
Default Configurations
Defaults
2. Choose RESTORE FACTORY DEFAULTS. The confirmation dialog box in FIGURE 3-2
is displayed.
3. Select YES to restore the Factory Default Configuration. Select NO to cancel the
task.
FIGURE 3-2 Confirmation Dialog Box
CAUTION:
To ensure continued use of the Factory Defaults when the
unit is powered off and on, save the Factory Defaults as the
User Default Configuration (see section 3.1.2).
The following table provides the Factory Default Configuration for all of the listed
items.
NOTE:
The Common Factory Defaults column lists items that have
the same Factory Default setting for each patient size.
NOTE:
The Factory Defaults by Patient Size columns list items that
have different Factory Default settings for each patient size.
CONFIGURATION ITEM
FACTORY
DEFAULTS
ADULT
(Patient size)
FACTORY
DEFAULTS
PEDIATRIC
FACTORY
DEFAULTS
COMMON
(Patient size)
GRAPHIC and LIST TREND
Interval
1min
MONITOR SETUP
COMMON ALARM SETUP
Alarm Volume
Medium
Alarm Print Time
8 Second
Alarm Mute Time
2 Minutes
PRINTER SETUP
3-2
Print Waveform 1
ECG
Print Waveform 2
IBP (if the IBP module is
installed)
SpO2 (if no IBP module is
installed)
Print Time (waveform length)
8 Seconds
Print Interval
OFF
Print Speed
25 mm/s
0070-10-0666-01
Trio™ Operating Instructions
Defaults
Default Configurations
CONFIGURATION ITEM
FACTORY
DEFAULTS
ADULT
(Patient size)
FACTORY
DEFAULTS
PEDIATRIC
FACTORY
DEFAULTS
COMMON
(Patient size)
Print Grid
ON
ANALOG SETUP
Analog Output Enable
OFF
Analog Wave
ECG
PARAMETER COLORS
ECG - green
PLETH - blue
RESP - yellow
NIBP/TEMP - white
MODULE SETUP in
MONITOR SETUP
Will be the same as
MODULE SETUP submenu
of the FACTORY menu.
TRACE SETUP
ECG, SpO2, RESP, IBP (if
IBP is set to display from
the MODULE SETUP
submenu of the FACTORY
menu)
Wave Display
Mode 1
ECG SETUP
ECG HR alarm
Standard configuration
French configuration
OFF
ON
ECG HR Alarm Print
OFF
ECG HR Alarm Priority
1
HR Source
ECG
HR Cascade
ON
ECG Lead Type
5 Lead
ECG Sweep Speed
25 mm/s
ECG Beep Volume
Medium
ECG Pacer
OFF
ECG Filter Mode
Extended
ECG Ch1 Lead Mode
II
ECG Ch1 Gain
x2
ECG HR Alarm Limit Hi
150
175
ECG HR Alarm Limit Lo
45
70
RESP SETUP
Resp Rate Alarm
OFF
Resp Rate Alarm Print
OFF
Resp Rate Alarm Priority
2
Resp Sweep Speed
12.5 mm/s
Resp Wave Scale
1
Resp Rate Alarm Limit Hi
30
Resp Rate Alarm Limit Lo
6
SPO2 SETUP
SpO2 Alarm Print
OFF
SpO2 Alarm Priority
2
Trio™ Operating Instructions
0070-10-0666-01
3-3
Default Configurations
CONFIGURATION ITEM
Defaults
FACTORY
DEFAULTS
ADULT
(Patient size)
FACTORY
DEFAULTS
PEDIATRIC
FACTORY
DEFAULTS
COMMON
(Patient size)
SpO2 Sweep Speed
25 mm/s
SpO2 Beep Volume
Medium
SPO2 SENSOR OFF AUDIO
ON
SpO2 Average Time (Masimo
only)
8 second
SpO2 Sensitivity Mode
Normal
Sat Seconds (Nellcor only)
OFF
SpO2 Alarm Limit Hi
OFF (for all languages)
SpO2 Alarm Limit Lo
85
Pulse Alarm Limit Hi
150
175
Pulse Alarm Limit Lo
45
70
NIBP SETUP
NIBP Alarm
OFF
NIBP Alarm Print
OFF
NIBP Alarm Priority
2
NIBP Units
mmHg (for all languages)
NIBP Interval
OFF
NIBP Display Time-out
15 minutes
NIBP Sys Alarm Limit Hi
180
150
NIBP Sys Alarm Limit Lo
80
70
NIBP Mean Alarm Limit Hi
100
80
NIBP Mean Alarm Limit Lo
40
30
NIBP Dia Alarm Limit Hi
100
80
NIBP Dia Alarm Limit Lo
50
40
TEMP SETUP
Temp Alarm
OFF
Temp Alarm Print
OFF
Temp Alarm Level
2
Temp Unit
°C (for all languages)
Temp T1 Alarm Limit Hi
40 °C or 104 °F
Temp T1 Alarm Limit Lo
30 °C or 86 °F
IBP SETUP
IBP Alarm
OFF
IBP Alarm Print
OFF
IBP Alarm Priority
2
IBP Units
mmHg (for all languages)
IBP Sweep Speed
25 mm/s
IBP SCALE ADJUST
3-4
IBP Scale ART High
150
IBP Scale PA High
100
IBP Scale CVP High
40
0070-10-0666-01
Trio™ Operating Instructions
Defaults
Default Configurations
CONFIGURATION ITEM
FACTORY
DEFAULTS
ADULT
(Patient size)
FACTORY
DEFAULTS
PEDIATRIC
FACTORY
DEFAULTS
COMMON
(Patient size)
IBP Scale RAP High
40
IBP Scale LAP High
40
IBP Scale ICP High
40
IBP Scale ART Low
0
IBP Scale PA Low
0
IBP Scale CVP Low
0
IBP Scale RAP Low
0
IBP Scale LAP Low
0
IBP Scale ICP Low
0
IBP Scale ART Value
75
IBP Scale PA Value
50
IBP Scale CVP Value
20
IBP Scale RAP Value
20
IBP Scale LAP Value
20
IBP Scale ICP Value
20
IBP Ch1 Name
ART
IBP ART_Sys Alarm Limit Hi
180
150
IBP ART_Sys Alarm Limit Lo
80
70
IBP ART_Mean Alarm Limit Hi
100
80
IBP ART_Mean Alarm Limit Lo
40
30
IBP ART_Dia Alarm Limit Hi
100
80
IBP ART_Dia Alarm Limit Lo
50
40
IBP PA_Sys Alarm Limit Hi
180
150
IBP PA_Sys Alarm Limit Lo
80
70
IBP PA_Mean Alarm Limit Hi
100
80
IBP PA_Mean Alarm Limit Lo
40
30
IBP PA_Dia Alarm Limit Hi
100
80
IBP PA_Dia Alarm Limit Lo
50
40
IBP CVP_Mean Alarm Limit Hi
10
IBP CVP_Mean Alarm Limit Lo
0
IBP RAP_Mean Alarm Limit Hi
10
IBP RAP_Mean Alarm Limit Lo
0
IBP LAP_Mean Alarm Limit Hi
10
IBP LAP_Mean Alarm Limit Lo
0
IBP ICP_Mean Alarm Limit Hi
10
IBP ICP_Mean Alarm Limit Lo
0
Trio™ Operating Instructions
0070-10-0666-01
3-5
Default Configurations
3.1.2
Defaults
User Default Configuration
All items listed in the preceding table can be customized by the user and saved as a unique
User Default Configuration as follows:
1. Select SAVE CURRENT from the MONITOR SETUP menu. The confirmation dialog
box in FIGURE 3-3 is displayed.
2. Select YES to save the new user-defined configuration, replacing the existing userdefined configuration for the current patient size. Select NO to cancel the task.
FIGURE 3-3 Confirmation Dialog Box
3.1.3
NOTE:
At initial startup of the Trio, the User Default Configuration is
identical to the Factory Default Configuration.
NOTE:
Selecting a new patient size automatically activates the User
Default Configuration for that patient size.
Current Configuration
The Current Configuration consists of the current settings of the items listed in the
preceding table. When the monitor is powered OFF, these settings (and any trend data) are
maintained for 2 hours. When the monitor remains OFF for more than 2 hours (or when a
patient is discharged), any trend data is deleted. When the monitor is powered back ON (or
after a patient is discharged), the Current Configuration is replaced by one of two
configurations in the following hierarchical order:
1. The User Default Configuration (if it has been saved).
2. The Factory Default Configuration (if no User Default Configuration has been
saved).
3-6
0070-10-0666-01
Trio™ Operating Instructions
Defaults
3.1.4
Default Configurations
Non-Volatile Configuration
The Non-Volatile Configuration consists of a group of user-customizable settings that
are not controlled by the Factory or User Defaults. (See the following table.) These settings
are maintained when the monitor is powered OFF for any duration of time. When a patient
is discharged, the items marked with an asterisk (*) in the following table are automatically
cleared and will remain blank until the user re-enters information for each.
CONFIGURATION ITEM
FIRST BURN-IN VALUE
* ID #
blank/empty field
BED#
blank/empty field
* FIRST NAME
blank/empty field
* LAST NAME
blank/empty field
* GENDER
blank/empty field
SIZE
Adult
* HT. (Height)
blank/empty field
* WT. (Weight)
blank/empty field
* BIRTH (day, month, year)
Trio™ Operating Instructions
blank/empty field
MODULE SETUP submenu in
FACTORY menu
ECG/RESP/TEMP/SpO2/IBP/NIBP
System Time
2001-12-31 23:59:59
0070-10-0666-01
3-7
Default Configurations
Defaults
This page intentionally left blank.
3-8
0070-10-0666-01
Trio™ Operating Instructions
4.0
User Maintenance
4.1
Introduction
This section of the manual outlines routine maintenance to be performed by the user and/or
biomedical technician.
The Trio Monitor is designed for stable operation over long periods of time and under
normal circumstances should not require technical maintenance beyond circumstances
described in this section. In general, routine maintenance, calibration and safety checks are
recommended annually, or more often as required by local statutory or hospital
administration practice.
General Maintenance Checks
Before using the monitor, do the following:
1. Check if there is any mechanical damage;
2. Check all external cables, inserted modules and accessories for damage;
3. Check all the functions of the monitor to make sure that the monitor is in good working
condition.
Scheduled Maintenance Checks
1. Frequently check the device, cables, sensors and wires for damage.
2. Clean the device as needed.
3. Perform safety test annually; or once after each disassembly or repair of unit.
4. Perform all parameter checks and calibration annually or once after each repair of unit.
5. Test overall function of the device annually.
NOTE:
Trio™ Operating Instructions
If any damage is found on the monitor, contact the
biomedical engineer of the hospital or Customer Service
immediately.
0070-10-0666-01
4-1
Decontamination of the Monitor
4.2
User Maintenance
Decontamination of the 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:
4.3
During the decontamination process, do not get the LpH SE
Germicidal detergent into any vent openings.
Care and Cleaning of the Monitor
The monitor housing 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 or sensors while it is on and/or
connected to AC power.
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. Fingerprints and stains may be
removed by using a liquid lens cleaner and a soft cloth. DO NOT wipe a dry screen or use
alcohol or a solvent containing chlorinated hydrocarbon.
4-2
0070-10-0666-01
Trio™ Operating Instructions
User Maintenance
Care and Cleaning of Accessories
4.4
Care and Cleaning of Accessories
4.4.1
SpO2 Sensors
NOTE:
Refer to the individual instruction sheets that are packaged
with each sensor.
• Check the sensors and cables for signs of damage on a daily basis. Replace as required.
• The reusable sensors should be cleaned before and after each patient's use
• Wipe the patient contact area using a soft cloth with a mild soap and water solution or
isopropyl alcohol. Hydrogen peroxide can be used to remove dried blood from all
accessible surfaces
• The cable can be cleaned with a 3% hydrogen dioxide solution, isopropanol solution, or
other active reagent. However, the connector of the sensor is not to be subjected to such
a solution
• Allow the sensor to completely dry before using
CAUTION:
When cleaning sensors, do not use an excessive amount of
liquid. Wipe the sensor surface with a soft cloth, dampened
with a cleaning solution.
CAUTION:
Do not subject the sensor to autoclaving.
CAUTION:
If the sensor or patient cable are damaged in any way,
discontinue use immediately. To prevent damage, do not
soak or immerse the sensor in any liquid solution. Do not
attempt to sterilize.
CAUTION:
Do not use sensors or cables that are damaged or have
deteriorated.
Trio™ Operating Instructions
0070-10-0666-01
4-3
Care and Cleaning of Accessories
User Maintenance
4.4.2
Blood Pressure Cuffs
4.4.2.1
Reusable Cuffs with Bladders
Take out the bladder before cleaning and disinfecting the cuff.
Cleaning
The cuff can be hand washed or machine washed in warm water or with mild detergent. The
bladder can be cleaned with a damp cloth. Air dry the cuff thoroughly after washing.
NOTE:
Machine washing may shorten the service life of the cuff.
Disinfection
The cuff may be disinfected with a damp cloth with 70% ethanol or 70% isopropanol. It may
also be disinfected with ultraviolet. The bladder can only be disinfected with ultraviolet.
NOTE:
Prolonged use of disinfectant may cause discoloration of the
cuff.
Replace the bladder after cleaning and disinfecting the cuff, as follows:
1. Place the bladder on the top of the cuff, as the figure shows.
2. Roll the bladder lengthwise and insert it into the large opening. See the figures below.
3. Hold the hose and the cuff and shake the complete cuff until the bladder is in position.
4. Thread the hose from inside the cuff, and out through the small hole under the internal
flap.
FIGURE 4-1 Cuffs with Bladders
CAUTION:
4.4.2.2
Do not dry clean the cuff.
Do not press the cuff with a hot iron.
Do not use detergent and disinfectant other than fresh
water, 70% ethanol or 70% isopropanol.
Clean and disinfect the cuff according to the instructions.
Reusable Bladderless Cuffs
Clean cuffs with warm water and a mild detergent. Do not use a detergent containing hard
conditioners, softeners, or fragrances.
4-4
0070-10-0666-01
Trio™ Operating Instructions
User Maintenance
Care and Cleaning of Accessories
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 Coating
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.
4.4.2.3
Disposable Blood Pressure Cuffs
Disposable cuffs are intended for single patient use only. Once a cuff is used on a patient it
should be discarded. Do not use the same cuff on any other patient. Do not sterilize or use an
autoclave on disposable cuffs.
NOTE:
Trio™ Operating Instructions
Disposable cuffs can be cleaned using a mild soap solution
and dried with a clean cloth. For cuffs with bladders,
remove bladder before cleaning.
0070-10-0666-01
4-5
Temperature Sensor Cleaning and Disinfection (Reusable)
4.5
User Maintenance
Temperature Sensor Cleaning and Disinfection
(Reusable)
• The temperature probe should not be heated above 100 ºC (212 ºF). It should only be
subjected briefly to temperatures between 80 ºC (176 ºF) and 100 ºC (212 ºF)
• The probe must not be sterilized in steam
• Only detergents containing no alcohol can be used for disinfectant
• The rectal probes should be used, if possible, in conjunction with a protective rubber
cover
• To clean the probe, hold the tip with one hand. With the other hand rub the probe down
in the direction of the connector using a moist lint-free cloth
NOTE:
4.6
Disposable temperature probe must not be re-sterilized or
reused.
Battery Replacement and Maintenance
Battery Replacement
1. Open the battery compartment door located on the left side panel of the monitor by
using the finger grip area and sliding the door backward.
2. Lift the release latch in the upper right corner of the battery compartment. This will
release the battery. Remove the battery.
3. Insert the replacement battery, contact end first, with the positive (+) contact facing
downward. Slide in the replacement battery until it latches.
4. Close battery compartment door by sliding the door forward until it firmly locks into
place.
CAUTION:
Replace the battery with one of the following part numbers:
0146-00-0043 (for a sealed lead acid battery), 0146-000069 (for a Lithium Ion battery).
Battery Maintenance
The batteries used in the Trio monitor are of sealed lead acid construction and Lithium Ion
construction. These types of batteries may be subject to local regulations regarding disposal.
At the end of battery life, dispose of the batteries in accordance with any local regulations.
4-6
CAUTION:
Remove the battery if the Trio is not likely to be used for an
extended period of time.
CAUTION:
Remove the battery prior to shipping the Trio.
0070-10-0666-01
Trio™ Operating Instructions
User Maintenance
4.7
Recorder Maintenance
Recorder Maintenance
2
1
FIGURE 4-2 Two-trace, integral recorder
1. Recorder door
Open this door to access the recorder.
2. Recorder door latch
Gently pull down on this latch to open the recorder door.
Trio™ Operating Instructions
0070-10-0666-01
4-7
Recorder Maintenance
4.7.1
User Maintenance
Recorder Paper Replacement
The instructions below describe the replacement of recorder paper. Use only recommended
recorder paper (Part Number 0683-00-0505-02.) This ensures that the print quality is
acceptable and reduces printer head wear.
1. Open the recorder door, located on the left side panel, by pulling down on the recorder
door latch, located on the upper right side of the recorder door.
NOTE:
If the recorder door does not open completely, carefully pull
the door until it is completely open.
2. Remove empty paper spool.
3. Lift the roller lever, located on the left side of the roller head.
FIGURE 4-3 Paper Loading
4. Place the paper roll in the holder with the sensitive (shiny) side of the paper facing
upward.
5. Unroll approximately six (6) inches of paper and fold the end of the paper to make a
triangle.
6. Feed the paper behind the roller head, from below, and push paper in until the paper
feeds through the roller head.
7. Pull the paper out approximately four (4) inches.
8. Roller lever must be returned to the down position before closing the recorder door.
Holding the paper, close the recorder door.
4-8
0070-10-0666-01
Trio™ Operating Instructions
User Maintenance
4.8
Care and Storage of Thermal Paper
Care and Storage of Thermal Paper
Thermal chart paper is chemically treated and the permanency of the printout can be
affected by storage and handling conditions.
Conditions which may affect the integrity of the paper and printouts are:
• Ultraviolet Light
We recommend storing the printouts in a filing cabinet within a few days of printing. Long
term exposure to natural or artificial UV sources may be detrimental
• Storage Temperature and Humidity
Keep the printouts 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 printouts 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 printouts. The reaction between 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
printouts as a back-up. Under normal office filing conditions the printouts should retain
acceptable image quality for about five (5) years
4.9
Care and Cleaning of ECG Cables and Leadwires
The recommended cleaning method for ECG cables and leadwires is as follows:
• Wipe using a cloth and 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 using a clean, damp
cloth. Dry the ECG cables and leadwires using a clean, dry cloth.
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.
Trio™ Operating Instructions
0070-10-0666-01
4-9
Care and Cleaning of ECG Cables and Leadwires
User Maintenance
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4 - 10
0070-10-0666-01
Trio™ Operating Instructions
5.0
Accessories
5.1
Optional Accessories
5.1.1
NIBP Accessories
Hoses
DESCRIPTION
PART NUMBERS
NIBP Hose, 5’ (1.5 m), Female Rectus/Female Rectus
0683-04-0003
NIBP Hose, 10’ (3.5 m), Female Rectus/Female Rectus
0683-04-0004
Color Coded Reusable Bladderless Cuffs - Quick-Connect
DESCRIPTION
PART NUMBERS
Kit, 6 cuffs, (1) small adult, (2) adult, (2) large adult, (1) thigh
latex-free
0020-00-0082-33
Kit, 6 cuffs, (1) small child, (2) child, (3) small adult, latex-free
0020-00-0082-32
Large Adult, Burgundy
(35.5 – 46 cm arm circumference), latex-free
0998-00-0003-55
Large Adult long, Burgundy
(35.5 – 46 cm arm circumference), latex-free
0998-00-0003-58
Adult Long, Navy Blue
(27.5 – 36.5 cm arm circumference), latex-free
0998-00-0003-57
Child, Green
(13.8 – 21.5 cm arm circumference), latex-free
0998-00-0003-52
Small Child, Orange
(9 – 14.8 cm arm circumference), latex-free
0998-00-0003-51 or
0683-15-0001-01
Trio™ Operating Instructions
0070-10-0666-01
5-1
Optional Accessories
Accessories
Color Coded Disposable Bladderless Cuffs - Quick-Connect
DESCRIPTION
PART NUMBERS
Adult Thigh, Brown (Print) (box of 5)
(45 – 56.5 cm circumference), latex-free
0683-07-0036-01
Large Adult, Burgundy (Print) (box of 10)
(35.5 – 46 cm arm circumference), latex-free
0683-07-0035-01
Large Adult Long, Burgundy (Print) (box of 10)
(35.5 – 46 cm arm circumference), latex-free
0683-07-0038-01
Adult, Navy Blue (Print) (box of 10)
(27.5 – 36.5 cm arm circumference), latex-free
0683-07-0034-01
Adult Long, Navy Blue (Print) (box of 10)
(27.5 – 36.5 cm arm circumference), latex-free
0683-07-0037-01
Small Adult, Light Blue (Print) (box of 10)
(20.5 – 28.5 cm arm circumference), latex-free
0683-07-0033-01
Child, Green (Print) (box of 10)
(13.8 – 21.5 cm arm circumference), latex-free
0683-07-0032-01
Small Child, Orange (Print) (box of 10)
(9 – 14.8 cm arm circumference), latex-free
0683-07-0031-01
Reusable Cuffs - Quick-Connect
DESCRIPTION
PART NUMBERS
Starter Kit: (1) child, (1) small adult, (1) adult, (1) large adult,
(1) thigh)
0020-00-0184-01
Child, 10 – 19 cm (arm circumference), latex free
0683-15-0001-01
Small Adult, 18 – 26 cm (arm circumference), latex free
0683-15-0002-01
Adult, 25 – 35 cm (arm circumference), latex free
0683-15-0003-01
Large Adult, 33 – 47 cm (arm circumference), latex free
0683-15-0004-01
Thigh, 46 – 66 cm (arm circumference), latex free
0683-15-0005-01
Disposable Cuffs - Quick-Connect
DESCRIPTION
5-2
PART NUMBERS
Child, 10 – 19 cm (arm circumference), latex free, box of 10
0683-14-0001-01
Small Adult, 18 – 26 cm (arm circumference), latex free,
box of 10
0683-14-0002-01
Adult, 25 – 35 cm (arm circumference), latex free, box of 10
0683-14-0003-01
Large Adult, 33 – 47 cm (arm circumference), latex free,
box of 10
0683-14-0004-01
Thigh, 46 – 66 cm (arm circumference), latex free, box of 5
0683-14-0005-01
0070-10-0666-01
Trio™ Operating Instructions
Accessories
Optional Accessories
5.1.2
Oximetry Sensors and Accessories
5.1.2.1
Pulse Oximetry-Masimo SET® LNOP® SpO2
DESCRIPTION
PART NUMBER
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® DCIP-Pediatric/slender digit reusable finger sensor
0600-00-0063
®
5.1.2.2
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®
0600-00-0077
DCSC-Adult spot check reusable sensor
PC08-SpO2 cable (2.44 m./8’)
0012-00-1099-01
PC12-SpO2 cable (3.66 m./12’)
0012-00-1099-02
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
Adult/Pediatric starter kit (two adult and two pediatric single patient
adhesive sensors and one 3.66 m./12’ cable)
0020-00-0123-01
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® Adult/Pediatric single patient adhesive sensor starter kit (one adult
and one pediatric single patient adhesive sensor, and one 3.04m/10’
cable)
0020-00-0156
LNCS® Adult/Pediatric reusable/single patient adhesive sensor starter kit
(one adult reusable sensor, one adult and one pediatric single patient
adhesive sensor, and one 3.04m/10’ cable)
0020-00-0154
LNCS® DC-I Adult finger reusable sensor
0600-00-0126
®
LNCS DC-IP Pediatric finger reusable sensor
0600-00-0127
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
LNC-4 SpO2 Patient cable, 4'
0012-00-1652
Trio™ Operating Instructions
0070-10-0666-01
5-3
Optional Accessories
Accessories
DESCRIPTION
PART NUMBER
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 MAC-1 LNCS adapter cable
5.1.2.3
0012-00-1656
Nellcor® OxiMax® Cables and Accessories*
DESCRIPTION
PART NUMBER
Durasensor DS100A Adult Reusable Sensor
0600-00-0051
DOC-10 OxiMax® SpO2 cable
0012-00-1464
* Sensors must be reordered through Nellcor.
5.1.3
Reusable Temperature Probes
YSI 400
5.1.4
DESCRIPTION
PART NUMBERS
Adult Rectal / Esophageal
0206-02-0001
Pediatric Rectal / Esophageal
0206-02-0002
Skin Surface
0206-02-0003
Disposable Temperature Probes
400 Series Probes (boxes of 20)
5-4
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
5.1.5
ECG Accessories
5.1.5.1
ECG Cables
DESCRIPTION
PART NUMBERS
Straight, 10’ (3.1 m)
0012-00-1255-01
Straight, 20’ (6.1 m)
0012-00-1255-02
0070-10-0666-01
Trio™ Operating Instructions
Accessories
5.1.5.2
Optional Accessories
ECG Leadwires
ECG Lead Wires - 3 Lead
DESCRIPTION
PART NUMBERS
3 Lead, Snap 18", AAMI (45.7 cm)
0012-00-1261-07
3 Lead, Snap 24", AAMI (61.0 cm)
0012-00-1261-08
3 Lead, Snap 40", AAMI (101.6 cm)
0012-00-1261-09
3 Lead, Pinch Clip 18", AAMI (45.7 cm)
0012-00-1262-07
3 Lead, Pinch Clip 24", AAMI (61.0 cm)
0012-00-1262-08
3 Lead, Pinch Clip 40", AAMI (101.6 cm)
0012-00-1262-09
ECG Lead Wires - 5 Lead
5.1.5.3
5.1.6
DESCRIPTION
PART NUMBERS
5 Lead, Snap 18", AAMI (45.7 cm)
0012-00-1261-01
5 Lead, Snap 24", AAMI (61.0 cm)
0012-00-1261-02
5 Lead, Snap 40", AAMI (101.6 cm)
0012-00-1261-03
Snap, Extended Leg, 3/40", 2/60", AAMI,
(3/101.6 cm, 2/152.4 cm)
0012-00-1261-13
5 Lead, Pinch Clip 18", AAMI (45.7 cm)
0012-00-1262-01
5 Lead, Pinch Clip 24", AAMI (61.0 cm)
0012-00-1262-02
5 Lead, Pinch Clip 40", AAMI (101.6 cm)
0012-00-1262-03
Electrodes
DESCRIPTION
PART NUMBERS
Electrodes (1 box of 60)
0681-00-0100-02
Electrodes (case of 600/10 boxes of 60)
0681-00-0100-01
IBP Accessories
IBP
5.1.7
DESCRIPTIONS
PART NUMBERS
P10EZ-1 Miniature (Reusable)
0682-00-0085
P23XL-1 Transducer (Reusable)
0682-00-0084
Cable, Interface, Transducer
0012-00-1245
Miscellaneous Accessories
DESCRIPTIONS
PART NUMBER
DIAP Cable Assembly 10’
0012-00-1275-01
Recorder Chart Paper (12 Rolls)
0683-00-0505-02
Battery, Sealed Lead Acid
0146-00-0043
Trio™ Operating Instructions
0070-10-0666-01
5-5
Optional Accessories
5.1.8
5.1.9
5-6
Accessories
DESCRIPTIONS
PART NUMBER
Battery, Lithium Ion
0146-00-0069
AC Power Cord, (110 Volt)
0012-25-0001
Mounting Kits and Accessories
DESCRIPTIONS
PART NUMBER
Trio Rolling Stand Kit
(includes Rolling Stand and Mounting Bracket)
TRIOROLLSTD
Trio Value Rolling Stand
0436-00-0224-01
Trio Value Rolling Stand Mounting Bracket
0406-00-0856-01
Trio Standard Wall Mount Kit
0040-00-0337-01
Trio VHM (Variable Height Mount) Wall Mount Kit
0040-00-0337-02
Trio Mounting Bracket Kit
0040-00-0338
Replacement Parts, Trio Rolling Stand
DESCRIPTIONS
PART NUMBER
Trio Monitor Mounting Kit
0406-00-0856-01
Casters, Non Locking
0401-00-0045
Casters, Locking
0401-00-0046
Utility Basket
0202-00-0166
0070-10-0666-01
Trio™ Operating Instructions
6.0
Appendix
6.1
Specifications
6.1.1
Safety Standards
IEC 60601-1:1988
Medical Electrical Equipment - Part 2,
(+ A1:1991, A2:1995)/
General Requirements for Safety
EN 60601-1:1990
(+ A1:1993, A2:1995, A13:1995)
UL 2601-1:1997
Medical Electrical Equipment General Requirements for Safety
CSA Standard C22.2 No. 601.1M90
Medical Electrical Equipment General Requirements for Safety
IEC 60601-1-4:2000/
Collateral Standard: Programmable
EN60601-1-4:1996 (+A1:1999)
Electrical Medical Systems
IEC 60601-2-30:1999/
Particular requirements for the Safety of
EN 60601-2-30:2000
Automatic Cycling Indirect Blood Pressure
Measuring Equipment
IEC 60601-2-34:2000/
Particular Requirements for the Safety of
EN 60601-2-34:2000
Direct Blood Pressure Monitoring Equipment
IEC 60601-2-27:1994/
Particular Requirements for the Safety of
EN 60601-2-27:1994
Electrocardiograph Monitoring Equipment
Trio™ Operating Instructions
0070-10-0666-01
6-1
Specifications
Appendix
EN 12470-4:2000
Clinical thermometers - Part 4: Performance
of Electrical Thermometers for Continuous
Measurement
EN 1441:1997
Medical Devices - Risk Analysis
EN ISO14971:2000
Medical Devices-Application of Risk
Management Analysis to Medical Devices
6.1.2
Safety Designations
Type of protection against electric shock
-Class 1 with internal electric power source.
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 electric shock:
- ECG and IBP - Type CF defibrillation
protected
- NIBP - Type BF defibrillation protected
- SpO2 and Temperature - Type BF
- Monitor - Type B
Supply Connection:
100 – 240 Volt
50 or 60 Hz
0.8 – 0.4 Amps
12 VDC Sealed Lead Acid Internal Battery or
11.1 VDC Lithium Ion Internal Battery
6-2
Mode of Operation:
Continuous
Protection Against Hazards of Explosion:
Not protected (Ordinary)
Protection Against Ingress of Liquid's
Not protected (Ordinary) - IPX0 per IEC 529
Degree of electrical connection between
Equipment designed for direct electrical and
equipment and patient -
non-electrical connection to the patient
Degree of Mobility:
Transportable
0070-10-0666-01
Trio™ Operating Instructions
Appendix
6.1.3
Specifications
Performance / Accuracy
EN 865:1997
Pulse Oximeters - Particular Requirements
EN 1060-1:1995
Specification for Non-invasive
Sphygmomanometers
EN 1060-3:1997
Non-invasive Sphygmomanometers,
Supplementary Requirements for
Electromechanical Blood Pressure Measuring
Systems
ANSI/AAMI EC13:2002
Cardiac Monitors, Heart rate Meters, and
Alarms
ISO 3744:1994
Acoustics - Determination of Sound Power
Levels of Noise Sources Using Sound
Pressure
ANSI/AAMI/ISO 10993-1:1997
Biological evaluation of medical devices Part 1: Evaluation and Testing
ANSI/AAMI SP-10:1992
Electronic or Automated
Sphygmomanometers
EN475:1995
Medical Devices, Electrically-generated
Alarm Signals
EN 1041:1998
Information Supplied by the Manufacturer
with Medical Systems
EN 980:1996 + A1:1999 + A2:2001
Graphical Symbols for Use in Labeling of
Medical Devices
IEC 878:1998
Graphical Symbols for Electrical Equipment
in Medical Practice
ISO 1000:1992 + A1:1998
SI units and recommendations for the use of
their multiples and of certain other units
Trio™ Operating Instructions
0070-10-0666-01
6-3
Specifications
6.1.4
Appendix
Environmental / EMC
IEC 60601-1-2:2001/
Medical Electrical Equipment - Part 1-2: EN
60601-1-2:2001 General Requirements for
Safety: EMC Requirements and Tests
IEC 68-2-6:(1982) and A1(1983) and
Basic Environmental Test Procedures Part 2:
A2(1985)
Vibration
IEC 68-2-27:1987
Basic Environmental Test Procedures Part 2:
Shock
IEC 68-2-37:1973 & A1:1983
Basic Environmental Test Procedures Part 2:
Random Vibration - Wide Band
IEC 529:1989
Degrees of Protection Provided by
Enclosures (IP Code)
ISTA: 1998 Procedure 1A
Pre-Shipment Test Procedures
ECRI PB-296892:1979 (for Drop and Impact Development of Environmental Test Methods
requirements)
for Non-Implantable Devices (Class 3
device)
6.1.5
United States Food and Drug Administration Documents
Reviewer Guidance for Pre-market Notification Submission, November 1993 - draft
Guidance
Non-Invasive Blood Pressure (NIBP) Monitor Guidance, March 10, 1997
Non-Invasive Pulse Oximeter General Guidance, draft, September 7, 1992
Cardiac Monitor Guidance (Including Cardiotachometer and Rate Alarm), November 5,
1998
6-4
0070-10-0666-01
Trio™ Operating Instructions
Appendix
Patient Parameter Specifications
6.2
Patient Parameter Specifications
6.2.1
ECG
6.2.1.1
ECG Safety Requirements
The 3/5 Lead ECG function is in accordance with the applicable requirements of EN 606012-27.
6.2.2
ECG Performance Requirements
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) (one vector at a time)
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 Selection:
Manually Selected.
Gain selection:
x0.25, x0.5, x1, x2 (mm/mV)
Sweep Speed:
12.5 mm/s, 25 mm/s, 50 mm/s
Input Bias Current:
<1 μA
Frequency Response:
BANDWIDTH (-3 dB)
MONITOR MODE
EXTENDED MODE
SURGICAL MODE
0.5 to 40 Hz
0.05 to 100 Hz
1 to 20 Hz
Common Mode Rejection:
MONITOR MODE
EXTENDED MODE
SURGICAL MODE
>105 dB
>90 dB
>105 dB
Trio™ Operating Instructions
0070-10-0666-01
6-5
Patient Parameter Specifications
Appendix
Electrical Surgical Unit (ESU) Use:
Protection:
3 and 5 Lead ECG meets ANSI/AAMI EC13
requirements 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.
Withstand:
3 and 5-Lead ECG will withstand ESU stress
from a High Frequency Surgical Unit
operating at 300 Watts in cut mode and
100 Watts on coagulate mode.
Noise Suppression:
3 and 5-Lead ECG peak noise is less than +
2 mV from ECG baseline when used with
AAMI compatible cables.
ECG Filters:
ESU Interference Filtering:
An ESU Interference filter will provide
greater than 90 dB attenuation at 500 kHz.
The ESU Filter is turned ON by selecting
SURGICAL mode and OFF by selecting
either MONITOR or EXTENDED modes.
50/60 Hz Notch Filtering:
A Notch Filter is provided from 50 to 60 Hz.
The Notch Filter is ON when in MONITOR
or SURGICAL modes and OFF when in
EXTENDED mode.
Pacemaker Pulse Display:
Pacer rejection/enhancement is able to be
turned ON or OFF.
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 ±6 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 are enhanced on the
display when the Pacer Enhancement Mode
is turned ON.
6-6
0070-10-0666-01
Trio™ Operating Instructions
Appendix
6.2.3
Patient Parameter Specifications
ANSI/AAMI EC13-2002 Compliance
The ECG meets the section 4.2 Performance Requirements of ANSI/AAMI EC13-2002
except for paragraph 4.2.9.13, Synchronizing Pulse for Cardioversion, which is not
applicable.
6.2.3.1
Disclosed Performance Specifications
Tall T-Wave Rejection:
When tested in accordance with ANSI/
AAMI EC13-2002 section 4.1.2.1 c), the
heart rate meter will reject all T-waves with
amplitudes less than 120% of a 1 mV, 100
ms QRS, and a T wave duration of 180 ms
and a Q-T interval of 350 ms.
Heart Rate Averaging:
ANSI/AAMI EC13-2002 section 4.1.2.1 d).
The Heart Rate Averaging computation is as
follows: The average of the last 4 R-to-R
intervals, when last 3 R-to-R intervals > 1200
ms. Otherwise, the average of the last 12 Rto-R intervals, minus the maximum and
minimum values. The update rate of the
Heart Rate on the display is once per
second.
Heart Rate Meter Accuracy and Response to When tested in accordance with ANSI/
Irregular Rhythm:
AAMI EC13-2002 section 4.1.2.1 e), the
indicated heart rate after a 20 second
stabilization period is:
Figure 3a (Ventricular Bigeminy) - 80 bpm
Figure 3b (Slow Alternating Ventricular
Bigeminy) - 60 bpm
Figure 3c (Rapid Alternating Ventricular
Bigeminy) - 120 bpm
Figure 3d (Bi-directional Systoles) - 90 bpm
Trio™ Operating Instructions
0070-10-0666-01
6-7
Patient Parameter Specifications
Appendix
Step Change Response Time:
When tested in accordance with ANSI/
AAMI EC13-2002 section 4.1.2.1f), the
response time of the heart rate meter to
changes in heart rate is:
Less then 7 sec for step increase from 80 to
120 bpm
Less then 8 sec for step decrease from 80 to
40 bpm
Time to Alarm for Tachycardia:
When tested in accordance with ANSI/
AAMI EC13-2002 section 4.1.2.1g), the
time to alarm is:
For Figure 4a - < 8 seconds
For Figure 4b - < 8 seconds
Pacer Rejection:
When tested in accordance with ANSI/
AAMI EC13-2002 section 4.1.4.1, the heart
rate meter will reject all pulses of amplitude
±2 mV to ± 700 mV and duration 0.1 ms to
2 ms with no tail.
When tested in accordance with ANSI/
AAMI EC13-2002 section 4.1.4.2, the heart
rate meter will reject all pulses of amplitude
± 2 mV to ± 700 mV and duration 0.1 ms to
2 ms with 100 ms time constant tail of less
than 2.0 mV, or 4 ms time constant tail of
less than 2.0 mV.
When tested in accordance with ANSI/
AAMI EC13-2002 section 4.1.4.3, the
minimum input slew rate that will cause
approximately 50% of Figure 5d's pulses to
trigger the Trio's pacer pulse detector is 10
V/s RTI.
6.2.4
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.
6.2.4.1
ECG Derived Heart Rate Meter Performance Requirements
Range:
6-8
ECG SOURCE
PEDIATRIC RANGE (bpm)
ADULT RANGE (bpm)
3/5 Lead ECG
15 to 350
15 to 300
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Patient Parameter Specifications
Resolution:
1 bpm
Accuracy:
± 1 bpm or ± 1% whichever is greater.
Trigger Threshold Level:
200 μV (Lead II)
Trigger Indication:
There is an audible beep on every beat
captured
6.2.5
ECG Respiration Performance Requirements
Sensing Leads:
Lead II
Source:
3-lead or 5-lead ECG Cable.
Range:
Adult: 6 to 120 breaths per minute
Pediatric: 6 to 150 breaths per minute
Accuracy:
± 2% or ± 2 breaths per minute, whichever
is greater
Excitation:
≤ 300 μA RMS max.
Bandwidth:
0.2 Hz to 2 Hz (-3 dB) for all patient sizes
Baseline Impedance Range:
200 Ω to 2500 Ω at patient with 1 kΩ
resistor in the ECG cable.
Linear Signal Range:
3 Ωp-p minimum
Noise:
less than 0.05 Ω at 500 Ω patient
impedance, using a standard ECG cable
Min. Breath Height Detected:
Function of respiration scale. Waveform
needs to be greater than 0.3 Ω in order for
breaths to be accurately detected.
6.2.6
Cardiovascular Artifact Rejection:
Detected by algorithm
Sweep speed:
6.25 mm/s, 12.5 mm/s, 25 mm/s
NIBP Sub-System Performance Characteristics
The NIBP function is capable of providing systolic, diastolic, and mean blood pressure
measurements in Pediatric and Adult modes non-invasively, using a blood pressure cuff. It
operates over the pulse rate range of 40 to 240 bpm.
The NIBP function is in accordance with the requirements of EN 60601-2-30, EN 1060-1,
EN 1060-3 and ANSI/AAMI SP-10:1992.
Trio™ Operating Instructions
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Patient Parameter Specifications
6.2.6.1
Appendix
Systolic Pressure Measurement
Accuracy*:
Mean error is less than ± 5 mmHg, Standard
Deviation is less than ± 8 mmHg
Range:
6.2.6.2
ADULT MODE
PEDIATRIC MODE
40 to 255 mmHg
40 to 200 mmHg
Diastolic Pressure Measurement
Accuracy*:
Mean error is less than ± 5 mmHg, Standard
Deviation is less than ± 8 mmHg
Range:
ADULT MODE
PEDIATRIC MODE
10 to 210 mmHg
10 to 150 mmHg
*Adult and Pediatric
Blood pressure measurements determined with this device are equivalent to those obtained
by a trained observer using the cuff/stethoscope auscultation method, within the limits
prescribed by ANSI/AAMI SP-10:1992, Electronic or automated sphygmomanometers.
NOTE:
6.2.6.3
6.2.6.4
Static Pressure Measurement
Range:
0 – 325 mmHg
Static Accuracy:
±3 mmHg over the entire range.
Heart Rate from NIBP
Accuracy:
± 2 bpm or 2%, whichever is greater
Resolution:
1 bpm
Range:
6 - 10
Mean Arterial Pressure (MAP) is defined as:
Mean Pressure 1 = Mean Pressure determined from the
oscillometric profile
Mean Pressure 2 = (2*diastolic + systolic) / 3
Mean Pressure Displayed = (Mean Pressure 1 + Mean
Pressure 2) / 2
ADULT MODE
PEDIATRIC MODE
40 to 240 bpm
40 to 240 bpm
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Appendix
6.2.6.5
Patient Parameter Specifications
NIBP Sub-System Functional Requirements
Maximum Cuff Pressure
The software controlled over pressure monitor will vent to atmosphere if the following cuff
pressures are detected:
ADULT MODE
PEDIATRIC MODE
≥ 300 mmHg
≥ 243 mmHg
Under single-fault conditions, the hardware controlled over pressure mechanism will vent the
cuff to atmosphere so that the pressure in the cuff does not exceed the following:
ADULT MODE
PEDIATRIC MODE
300 (+10%) mmHg
300 (+10%) 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 20 seconds.
If the cuff is not inflated 5 mmHg within 18 seconds then the cuff is vented and the
measurement is stopped.
Maximum Leakage
The maximum allowed pressure drop with the bleed valves closed is 6 mmHg in 60 seconds
as measured with a 500 cc volume at differential pressures of 250 mmHg, 150 mmHg and
50 mmHg.
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.
Initial Conditions
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 5 seconds in
order to allow time for the Zero.
NIBP Start Pressure Settings and Ranges
The Start Pressure is automatically adjusted based on the selected patient size and is set to
the following defaults:
PATIENT SIZE
PRESSURE INCREMENT
(DEPENDING ON ALGORITHM)
DEFAULT START PRESSURE
Adult Mode
30 – 60 mmHg
178 ±5 mmHg
Pediatric Mode
30 – 60 mmHg
133 ±5 mmHg
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Patient Parameter Specifications
Appendix
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 seconds for Adult and Pediatric patients.
In interval mode and manual mode, the unit adjusts the inflation pressure according to the
previous systolic pressure. After the first successful measurement is made, the subsequent
inflation pressure becomes +50 ±10 mmHg above the previous systolic pressure
measurement.
6.2.7
IBP Parameter Sub-System Performance Characteristics
The Trio monitor is capable of providing invasive blood pressure (IBP) measurements from a
maximum of 1 IBP channel.
The IBP channel will provide three pressure readings: systolic, diastolic, and mean pressures.
6.2.8
IBP Safety Requirements
The IBP function meets the safety requirements of EN 60601-2-34.
6.2.8.1
IBP Performance Requirements
Accuracy:
± 1 mmHg or 2% which ever is greater
(excluding transducer error)
Excitation:
5 Volts DC, +/-2% Minimum load resistance
is 300 ohms per transducer.
Is compatible with 5 μV/mmHg/Volt
Transfer Function:
nominal excitation transducers. Impedance
range 300 – 3000 Ω.
Zero Offset Range:
The transducer zero offset range is ± 200
mmHg.
Zero Accuracy:
The zero accuracy is ± 1 mmHg.
Linear Input Range:
-50 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. ± 1
mmHg over 24 hours.
6 - 12
Frequency Response:
DC to 16 Hz +/- 1 Hz, -3 dB
Resolution:
1 mmHg
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Appendix
6.2.9
Patient Parameter Specifications
Temperature Parameter Performance Characteristics
The Trio monitor is capable of providing temperature measurements from a single
temperature channel as measured from a YSI 400 probe and meets the requirements of
EN12470-4:2000.
6.2.9.1
Temperature Performance Requirements
Scale:
selectable Celsius or Fahrenheit
Range:
0 °C to 50 °C
32 °F to 122 °F
Resolution:
0.1 °C
0.1 °F
Accuracy:
± 0.1 °C (0 °C to 50 °C), exclusive of probe
errors
± 0.2 °F (32 °F to 122 °F), exclusive of
probe errors
Accuracy inclusive of 400 Series probes:
± 0.2 °C (32 °C – 42 °C)
± 0.3 °C (otherwise)
± 0.4 °F (90 °F – 108 °F)
± 0.6 °F (otherwise)
<100 μA, tip to sleeve.
Probe Excitation: 400 Series:
6.2.10
SpO2 Performance Requirements
The Trio monitor is capable of providing SpO2 functional saturation level measurements via
a Masimo SET® MS-7 pulse oximeter, a Nellcor® MP506 or a Nellcor® Nell-3 pulse
oximeter.
6.2.10.1
Agency Requirements:
The SpO2 function is in accordance with the requirements of EN 865: 1997.
6.2.10.2
Masimo SET® SpO2 Performance Requirements
The Masimo SET MS-7 pulse-oximeter with SET technology is implemented.
LNOP® or LNCS® Series
Sensor Compatibility:
SpO2 Display Range: 1 – 100%
SpO2 Resolution: 1%
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Patient Parameter Specifications
Appendix
SpO2 Accuracy
No motion conditions1,4:
PATIENT SIZE
SATURATION RANGE
70% to 100%
0 – 69%
Adult Mode
± 2 digits
unspecified
Pediatric Mode
± 2 digits
unspecified
During motion conditions2,5:
PATIENT SIZE
SATURATION RANGE
70% to 100%
0 – 69%
Adult Mode
± 3 digits
unspecified
Pediatric Mode
± 3 digits
unspecified
SpO2 Response Time
20 seconds maximum 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 Performance3
LOW PERFUSION CONDITIONS
PULSE
AMPLITUDE
% TRANSMISSION
SATURATION
ACCURACY
PULSE RATE
ACCURACY
> 0.02%
> 5%
± 2 DIGITS
± 3 DIGITS
LNOP TC-I
± 4 digits
± 3 digits
LNOP Y-I
N/A
N/A
Masimo SET SpO2 Pulse Rate Performance Requirements
Pulse Rate Resolution: 1 bpm
Pulse Rate Range and Accuracy
PATIENT SIZE
Adult/Pediatric
PULSE RATE RANGE
25 to 240 bpm
ACCURACY
NO MOTION
CONDITIONS1
DURING MOTION
CONDITIONS2
± 3 digits
± 5 digits
Update Rate
Update rate is 1 Hz.
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Appendix
Patient Parameter Specifications
Masimo SET® Reference Footnotes
1
The Masimo SET MS-7 pulse oximeter with LNOP or LNCS 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.
2
The Masimo SET MS-7 pulse oximeter with LNOP or LNCS 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.
3The
Masimo SET MS-7 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 saturations
ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus
or minus one standard deviation encompasses 68% of the population.
4The
LNOP Ear sensor has an SpO2 accuracy (including low perfusion) of 70% to 100%
±3.5% for adults during no motion conditions, however, since the monitor can not display
1/2 digits, the accuracy is rounded to ±4 digits.
5The
SpO2 accuracy during motion conditions is not specified for the LNOP Ear sensor.
NOTE:
Trio™ Operating Instructions
The sensor measurement wavelengths are nominally
660 nm for the red LED and 940 nm for the infrared LED.
Maximum optical power output for LED is 4 mW.
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Patient Parameter Specifications
6.2.10.3
Appendix
Nellcor® SpO2 Performance Requirements
Sensor Compatibility:
OxiMax series MAX-A, MAX-AL, MAX-N,
MAX-P, MAX-I, MAX-FAST, MAX-R, OxiCliq
A, OxiCliq N, OxiCliq P, OxiCliq I, D-YS, DYSE, D-YSPD, DS-100A, OXI-A/N and OXIP/I.
SpO2 Display Range:
1 – 100%
SpO2 Resolution:
1%
Saturation Accuracy
SENSOR
ACCURACY
MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and
MAX-FAST
70% to 100% ± 2 digits
Below 70% unspecified
OxiCliq A, OxiCliq N, OxiCliq P and OxiCliq I
70% to 100% ± 2.5 digits
Below 70% unspecified
D-YS, DS-100A, OXI-A/N and OXI-P/I
70% to 100% ± 3 digits
Below 70% unspecified
MAX-R, D-YSE and D-YSPD
70% to 100% ± 3.5 digits
Below 70% unspecified
Nellcor® SpO2 Pulse Rate Performance Requirements
Pulse Rate Range and Accuracy
RANGE
ACCURACY
20 to 250 bpm
±3 bpm
251 to 300 bpm
Unspecified
Update Rate
Update rate is 1 Hz.
NOTE:
6 - 16
The sensor measurement wavelengths are nominally
660 nm for the red LED and 890 nm for the infrared LED.
Maximum optical power output for LED is 4 mW.
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Appendix
Physical Specifications
6.3
Physical Specifications
6.3.1
Information Display and Control
6.3.1.1
Front Panel Display
6.3.1.2
DISPLAY TYPE
SIZE
MINIMUM RESOLUTION
Color active matrix TFT liquid crystal
8.4-inch diagonal
800 x 600 pixels
Rotary Knob (Navigator™)
The rotary knob is a 16-position per revolution encoder with an integral push button switch
6.3.2
LED Indicators
6.3.2.1
Alarm Indicators
Visual alarm indicators are in accordance with EN475: 1995
The Alarm Indicator is a top mounted, bi-color LED with a clear, frosted lens.
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 that is illuminated when AC power is present and the
battery is installed and charging. When the monitor is running on battery power, this LED
does not illuminate. When a “low battery” condition exists, this LED flashes at a constant
rate.
6.3.2.2
Keypad
A micro-switch keypad with provisions for 5 keys is provided. Key functions include: power
ON/standby key, NIBP start/stop key, PRINT start/stop key, ALARM MUTE key and
NORMAL SCREEN key.
6.3.2.3
Audio Indicators
An audio speaker is provided to annunciate alarms, message tones and systole beep tones.
Audio alarms are in accordance with EN475: 1995
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Physical Specifications
6.3.3
Appendix
Real Time Clock
The Display Resolution for the Real Time
1 second
Clock is:
The Accuracy of the Real Time Clock is:
±1 minute/month (30 days) @ 21 °C ±3 °C
Clock display format:
12 hr or 24 hr (user selectable)
The Real Time Clock has a dedicated independent power source that allows it to keep time
whether or not the Trio monitor has power provided.
6.3.4
6.3.4.1
Input/Output Communications
Analog Output
Meets the requirements of EN60601-1 for short-circuit protection and leakage current.
6.3.4.2
ECG Analog Output Specification
Bandwidth (-3 dB referenced to 10 Hz):
Same as ECG Filter Setting
Maximum Propagation Delay (Delay of QRS 25 ms
complex):
Sensitivity (referenced to 10 Hz):
1 V/mV of input, ±10%
Pacer Rejection/Enhancement:
There is no pacer rejection or enhancement
in the ECG analog output.
Arterial Blood Pressure Analog Output Specification
Bandwidth (-3 dB referenced to 10 Hz):
DC to 15 Hz minimum
Maximum Propagation Delay:
25 ms (without sensor, measured using a
simulator as the input)
Sensitivity:
6.3.4.3
1 V/100 mmHg, ±10%
DIAP Communication Protocol
(model number 0998-00-0600-4XXXX)
Trio Monitors bearing a model number of 0998-00-0600-4XXXX support the proprietary
communication protocol DIAP (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.
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Appendix
6.3.4.4
Physical Specifications
VGA Output
(model numbers 0998-00-0600-0XXXX and 0998-00-0600-2XXXX)
Trio Monitors bearing model numbers 0998-00-0600-0XXXX or 0998-00-0600-2XXXX are
equipped with a a 15-position D-Shell VGA output connector. The VGA output connector
provides connectivity to a medical grade remote repeater display. Connection to this port
shall be made with the monitor power OFF. The monitor shall be powered ON after
powering ON the remote display.
Working mode: 640X480 resolution, 16-color, APA mode
Signal: Analog RGB - 0.7 Vpp/750 ohm, Horizontal/Vertical - TTL Positive/Negative
Connector type: 15-position D-subminiature receptacle
6.3.4.5
Ethernet
The Trio monitor has a standard Ethernet port for downloading software upgrades.
Connector type:
6.3.5
6.3.5.1
RJ-45
Power Supply
Power Source
The Trio monitor will auto-select its power source from those available. The monitor uses 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 battery installed.
6.3.6
6.3.7
AC Mains Power Source
Input Voltage:
100 – 240 VAC (+/-10%)
Line Frequency:
50 or 60 Hz (+/-3 Hz)
Current:
0.8 – 0.4 Amps
Battery Power
The maximum number of installed batteries:
1
Time to Shutdown from Low Battery:
>10 minutes but < 20 minutes after
indication, with 1 new, fully charged battery.
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Physical Specifications
6.3.7.1
Appendix
Sealed Lead Acid Battery: P/N 0146-00-0043
The minimum Battery Run Time is:
75 minutes from one fully charged new
battery at 25 °C for the following conditions,
which represent the most likely transportable
configuration: ECG, SpO2, and NIBP
running at the 15 minute interval.
The Battery Recharge Time is:
6.3.7.2
8 hours maximum
Lithium Ion Battery: P/N 0146-00-0069
The minimum Battery Run Time is:
3.25 hours from one fully charged new
battery at 25 °C for the following conditions,
which represent the most likely transportable
configuration: ECG, SpO2, and NIBP
running at the 15 minute interval.
The Battery Recharge Time is:
6.5 hours maximum
6.3.8
Data Storage
6.3.8.1
Monitor Configuration Data Storage
The monitor has the ability to store, in non-volatile memory, the user selectable configuration.
In addition to the factory default configuration for each patient size, there is 1 user
configurable 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
6.3.8.2
Patient Data Storage
The current patient information and demographics are stored in non-volatile memory.
6.3.8.3
Patient Trend Data
The monitor is capable of storing a maximum of 24 hours of list and/or graphic trend values
for each active parameter. The minimum time interval for list trends is one minute. The
minimum interval for graphic trends is 1 second. When the monitor is powered OFF, the list
and graphic trend data is maintained for 2 hours. If the monitor remains OFF for more than 2
hours, the list and graphic trend data is deleted.
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Appendix
Physical Specifications
6.3.9
Printers
6.3.9.1
Integrated Thermal Printer
The integrated printer is a maximum 2- trace thermal array strip chart printer.
The printer uses plain white thermal paper 50.0 ± 0.1 mm wide.
The printer supports 2 paper speeds: 25 and 50 mm/sec.
The printer scaling is ± 5% of the scale set on the display for a single trace, and 50% of scale
set on the display for dual trace, ± 5%.
The printer has 6 modes: manual, on alarm, on interval, frozen waveforms, List Trend and
Graphic Trend.
6.3.10
Physical Characteristics
6.3.10.1
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, or 1.61" (41 mm) maximum diameter bed rail.
6.3.10.2
Maximum Size
241 mm (9.49 inches) wide (including printer)
228 mm (8.98 inches) high (including handle)
174 mm (6.85 inches) deep (including knob & folded handle)
6.3.10.3
Maximum Weight
4 kg (8.8 lbs), without optional accessories
4.81 kg (10.61 lbs), with 1 Sealed lead acid battery, without optional accessories
4.33 kg (9.52 lbs), with 1 Lithium Ion battery, without optional accessories
6.3.10.4
Cooling Fan
Fan Control
When the unit is powered from an external source (AC), the cooling fan is ON.
The cooling fan is OFF when the unit is powered from the internal battery.
6.3.10.5
Normal Operating Noise
The SPL produced by the unit during normal operating conditions is less than 60 dBA
maximum 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.
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Physical Specifications
6.3.11
Appendix
Environmental and Safety Characteristics
Storage Temperature
-20 ºC to +60 ºC
Operating Temperature
+5 ºC to +40 ºC
Storage Humidity
10% to 95%, non-condensing
Operating Humidity
15% to 95%, non-condensing
Storage Altitude
(-1000 to 20,000 feet ASL)
1050 hPa to 466 hPa
(788 mmHg to 349 mmHg)
Operating Altitude
(-1000 to 9,889 feet ASL)
1050 hPa to 700 hPa
(788 mmHg to 525 mmHg)
Shipping:
The monitor meets the requirements of ISTA
shipping procedure 1A for containerized
product, when packed in designated
packaging. The shipping carton is marked
with the permissible storage conditions for
temperature, altitude, and humidity.
Shock:
Remains operational within specification
after exposure to100 g, 6 ms, half sine,
shock pulse tested per IEC 68-2-27.
Vibration:
Remains operational within specification
after exposure to the following Sinusoidal
and Random Vibration
Sinusoidal Vibration Per IEC 68-2-6
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 68-2-34
0.02 g2/Hz
20 – 500 Hz
Low degree of reproducibility 9 minutes per
axis
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Physical Specifications
Drop:
Meets the requirements specified by ECRI PB296 892 section AIII 3.3 for Class 3
devices.
Impact
Meets the requirements specified by ECRI PB296 892, section AIII 3.2 for Class 3
devices.
Electromagnetic Compatibility
The Trio meets the requirements of IEC 60601-1-2:2001/EN 60601-1-2:2001.
NOTE:
The Trio 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 Trio. See tables 6-1 through 6-4 that follow.
TABLE 6-1
GUIDANCE AND DECLARATION - ELECTROMAGNETIC EMISSIONS
The Trio is intended for use in the electromagnetic environment specified below. The customer or the
user of the Trio should assure that it is used in such an environment.
EMISSIONS
TEST
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions
CISPR 11
Group 1
The Trio 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 Trio 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
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Physical Specifications
Appendix
TABLE 6-2
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The Trio is intended for use in the electromagnetic environment specified below. The customer or the
user of the Trio 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
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the Trio
requires continued operation during
power mains interruptions, it is
recommended that the Trio be
powered from an uninterruptible power
supply or a battery.
70% UT (30%
dip in UT) for
25 cycles
70% UT (30%
dip in UT) for
25 cycles
<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.
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Physical Specifications
TABLE 6-3
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The Trio is intended for use in the electromagnetic environment specified below. The customer or the
user of the Trio 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 Trio, 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
Trio™ Operating Instructions
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 Trio is
used exceeds the applicable RF compliance level above, the Trio should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the Trio.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
0070-10-0666-01
6 - 25
Physical Specifications
Appendix
TABLE 6-4
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE TRIO
The Trio is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Trio can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Trio 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 ACCORDING TO FREQUENCY
OF TRANSMITTER M (METERS)
150 kHz to
80 MHz
80 MHz to
800 MHz
800 MHz to
2.5 GHz
d = 1.2 x
d = 1.2 x
d = 1.2 x
P
P
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.
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.
NOTE:
The Trio is intended for use in the electromagnetic
environment specified below. The customer or the user of
the Trio should assure that it is used in such an environment.
The Trio meets the additional FDA electromagnetic compatibility requirements of the FDA
Reviewer Guidance for Premarket Notification Submission (November 1993) listed below:
AC Voltage Dropout: < 10 ms
NOTE:
Mains power quality should be that of a typical commercial or hospital
environment. If the user of the Trio requires continued operation during
power mains interruptions, it is recommended that the Trio be powered
from an uninterruptible power supply or a battery.
AC Slow Sags and Surge: 90 V to 150 V for 500 ms
AC Steady State Voltage: 95 – 132 V, AC/battery switching below 95 V
Quasi-static Fields: 500 – 2000 V/m sweep at 0.5 Hz sine
Magnetic Emissions: MIL-STD-461D, RE101, 30 Hz to 100 kHz @ 7 cm
6 - 26
0070-10-0666-01
Trio™ Operating Instructions
Appendix
Physical Specifications
Isolation:
Risk (Leakage) Currents:
Meets the requirements of IEC 60601-1/
EN 60601-1
Enclosure Risk Current:
Normal operating conditions
<= 100 μA
Single fault condition
<= 300 μA for 120 VAC
Single fault condition
<= 500 μA for 230 VAC
Patient Source Current:
Normal operating conditions
<= 10 μA
Single fault condition
<= 50 μA
Patient Sink Current:
Normal operating conditions
not applicable
Single fault condition
<= 50 μA
Dielectric Withstand
Per IEC 60601-1/EN 60601-1
Trio™ Operating Instructions
0070-10-0666-01
6 - 27
Warranty Statements
6.4
Appendix
Warranty Statements
Mindray DS USA, Inc. warrants that components within the monitor unit will be free from
defects in workmanship and materials for the number of years shown on the invoice. Under
this extended warranty, Mindray DS USA, Inc. 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, Inc.’s standard warranty will remain in effect.
USA, Canada, Mexico, and Puerto Rico
Mindray DS USA, Inc. 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, Inc. 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, Inc.’s option at the factory or at an authorized Distributor, any
product which will 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, Inc. has any authority to bind
Mindray DS USA, Inc. to any affirmation, representation, or warranty concerning its
products, and any affirmation, representation or warranty made by any agent, employee, or
representative will 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.
6 - 28
0070-10-0666-01
Trio™ Operating Instructions
Appendix
Phone Numbers and How To Get Assistance
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, Inc. 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 DS USA, Inc., freight prepaid to
Mindray DS USA, Inc., Mahwah, New Jersey 07430. Mindray DS USA, Inc. will 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.
6.5
Phone Numbers and How To Get Assistance
Mindray DS USA, Inc. maintains a network of service representative 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 Customer Service Department at (201) 995-8116 for assistance.
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 closest Mindray DS USA,
Inc. location. A list of international offices, along with their phone numbers, is provided at the
end of this manual.
6.6
Manufacturer’s Responsibility
Mindray DS USA, Inc. 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 DS USA, Inc.; 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.
Trio™ Operating Instructions
0070-10-0666-01
6 - 29
.
0070-10-0666-01
Revision E
June 12, 2010
Mindray DS USA, Inc. • 800 MacArthur Boulevard • Mahwah, NJ 07430 • USA •
Dom. Customer Service: 1.800.288.2121 • Intl. Customer Service: +1.201.995.8000 •
Dom. Fax: 1.800.926.4275 • Intl. Fax: +1.201.995.8680 • www.mindray.com
Mindray Medical Netherlands B.V.• P.O. Box 26 • 3870 CA Hoevelaken • The Netherlands •
Tel: +31 33 25 44 911 • Fax: +31 33 25 37 621
Mindray (UK) Limited • 3 Percy Road • St. John’s Park • Huntingdon • Cambridgeshire PE29 6SZ •
United Kingdom • Tel: 01480 416840 • Fax: 01480 436588
Mindray Medical France SARL • Europarc Créteil •123, Chemin des Bassins •
94035 Créteil Cedex • France • Tel: (0)1.45.13.91.50 • Fax: (0)1.45.13.91.51
Mindray Medical German GmbH • Zwischen den Bächen 4 • 64625 Bensheim • Germany •
Tel: +49.6251.17524-0 • Fax: +49.6251.17524-20
Mindray Medical International Ltd. • 2813 Office Tower, Convention Plaza • No 1 Harbour Road •
Wanchai • Hong Kong • Tel: +852 2793 5596 • Fax: +852 2344 8824
0002-08-8918
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