Mindray DPM 1 Operator`s manual

Mindray DPM 1 Operator`s manual
DPM 5 Patient Monitor
Operator’s Manual
Revision History
This manual has a revision number. This revision number changes whenever the manual is
updated due to software or technical specification change. Contents of this manual are subject to
change without prior notice.
„ Revision number: 9.0
„ Release time:
2012-02
© Copyright 2008-2012 Mindray DS USA, Inc. All rights reserved.
WARNING
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Federal Law (USA) restricts this device to sale by or on the order of a physician.
I
Intellectual Property Statement
Mindray DS USA, Inc. (hereinafter called Mindray DS) owns the intellectual property rights to
this product and this manual. This manual may refer to information protected by copyrights or
patents and does not convey any license under the copyright and patent rights of Mindray DS, nor
the rights of others.
Mindray DS intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray DS is strictly forbidden. Release, amendment, reproduction, distribution,
rental, adaptation and translation of this manual in any manner whatsoever without the written
permission of Mindray DS is strictly forbidden.
is a trademark or a registered trademark of Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. All third-party trademarks that appear in this manual are used solely for
editorial purposes and are the property of their respective owners.
Contents of this manual are subject to changes without prior notice.
II
Manufacturer’s Responsibility
All information contained in this manual is believed to be correct. Mindray DS shall not be liable
for errors contained herein nor for incidental or consequential damages in connection with the
furnishing or use of this manual.
Mindray will not be liable for the effects on safety, reliability and performance of this product if:
„ any installation operations, expansions, changes, modifications and repairs of this product
are not conducted by Mindray DS authorized personnel; and
„ the electrical installation of the relevant room does not comply with the applicable national
and local requirements; and
„ the product is not used in accordance with the instructions for use.
Warranty
This warranty is exclusive and is in lieu of all other warranties, expressed or implied, including
warranties of merchantability or fitness for any particular purpose.
Exemptions
Mindray DS 's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from the
improper use or application of the product or the use of parts or accessories not approved by
Mindray DS or repairs by people other than Mindray DS authorized personnel.
This warranty shall not extend to
„ Any Mindray DS product which has been subjected to misuse, negligence or accident; or
„ Any Mindray DS product from which Mindray DS 's original serial number tag or product
identification markings have been altered or removed; or
„ Any product of any other manufacturer.
III
Return Policy
In the event that it becomes necessary to return a unit to Mindray DS, follow the instructions
below.
1. Return authorization.
Contact the Customer Service Department and obtain a Customer Service Authorization number.
This number must appear on the outside of the shipping container. Returned shipments will not
be accepted if the number is not clearly visible. Please provide the model number, serial number,
and a brief description of the reason for return.
2. Freight policy
The customer is responsible for freight charges when this product is shipped to Mindray DS for
service (this includes customs charges).
3. Return address
Please send the part(s) or equipment to the address offered by the Customer Service Department.
IV
Contact Information
Manufacturer:
Mindray DS USA, Inc.
Address:
800 MacArthur Blvd.Mahwah, New Jersey 07430 USA
Tel:
1.800.288.2121
Website:
www. mindray.com
1.201.995.8000
V
Preface
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in accordance
with its function and intended use. Observance of this manual is a prerequisite for proper product
performance and correct operation and ensures patient and operator safety.
This manual is based on the maximum configuration and therefore some contents may not apply
to your product. If you have any question, please contact us.
This manual is an integral part of the product. It should always be kept close to the equipment so
that it can be obtained conveniently when needed.
Intended Audience
This manual is geared for clinical professionals who are expected to have a working knowledge
of medical procedures, practices and terminology as required for monitoring of critically ill
patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup
or data displayed on your patient monitor.
Conventions
„
Italic text is used in this manual to quote the referenced chapters or sections.
VI
Contents
1 Safety................................................................................................................................. 1-1
1.1 Safety Information .......................................................................................................... 1-1
1.1.1 Dangers .............................................................................................................. 1-2
1.1.2 Warnings ............................................................................................................ 1-2
1.1.3 Cautions ............................................................................................................. 1-3
1.1.4 Notes .................................................................................................................. 1-4
1.2 Equipment Symbols ........................................................................................................ 1-5
2 The Basics ......................................................................................................................... 2-1
2.1 Monitor Description ........................................................................................................ 2-1
2.1.1 Intended Use ...................................................................................................... 2-1
2.1.2 Contraindications ............................................................................................... 2-1
2.1.3 Components ....................................................................................................... 2-1
2.1.4 Functions............................................................................................................ 2-2
2.2 External Appearance ....................................................................................................... 2-3
2.2.1 Front Panel ......................................................................................................... 2-3
2.2.2 Left Side Panel ................................................................................................... 2-4
2.2.3 Right Side Panel................................................................................................. 2-5
2.2.4 Rear Panel .......................................................................................................... 2-6
2.3 Control Panel................................................................................................................... 2-7
2.4 Display ............................................................................................................................ 2-8
2.5 Batteries ........................................................................................................................ 2-10
2.5.1 Battery Guidelines.............................................................................................2-11
2.5.2 Battery Maintenance ........................................................................................ 2-12
2.5.3 Battery Recycling............................................................................................. 2-13
2.6 Wireless Network Card ................................................................................................. 2-13
3 Installation ........................................................................................................................ 3-1
3.1 Unpacking and Checking ................................................................................................ 3-2
3.2 Environmental Requirements.......................................................................................... 3-2
3.3 Power Source Requirements ........................................................................................... 3-3
3.4 Installation Method ......................................................................................................... 3-3
3.4.1 Bracket Mounting............................................................................................... 3-3
3.4.2 Connecting to AC Power Supply ....................................................................... 3-3
3.4.3 Installing the Battery .......................................................................................... 3-4
3.4.4 Connecting Patient Sensors and Probes ............................................................. 3-4
3.4.5 Connecting the Network Cable .......................................................................... 3-4
3.4.6 Auxiliary Output Port......................................................................................... 3-5
3.4.7 Connecting to VGA Monitor.............................................................................. 3-5
3.4.8 Equipotential Grounding.................................................................................... 3-6
3.5 Powering on the Monitor ................................................................................................ 3-6
3.6 Powering off the Monitor................................................................................................ 3-6
1
4 System Menu .................................................................................................................... 4-1
4.1 Overview......................................................................................................................... 4-1
4.2 Patient Setup ................................................................................................................... 4-2
4.2.1 Admit Patient...................................................................................................... 4-3
4.2.2 Quick Admit Patient........................................................................................... 4-5
4.2.3 Modify Patient.................................................................................................... 4-5
4.2.4 Clear Patient Data .............................................................................................. 4-5
4.2.5 Discharge Patient ............................................................................................... 4-5
4.3 Configuration Setup ........................................................................................................ 4-6
4.4 System Setup................................................................................................................... 4-7
4.4.1 Face Select ......................................................................................................... 4-8
4.4.2 Alarm Setup........................................................................................................ 4-8
4.4.3 Time Setup ....................................................................................................... 4-10
4.4.4 Recorder Setup ..................................................................................................4-11
4.4.5 Data Output ...................................................................................................... 4-12
4.4.6 Analog Output .................................................................................................. 4-13
4.4.7 Module Setup ................................................................................................... 4-14
4.4.8 Trace Setup....................................................................................................... 4-15
4.4.9 Mark Event....................................................................................................... 4-16
4.5 Selection Setup.............................................................................................................. 4-17
4.6 Monitor Version ............................................................................................................ 4-18
4.7 Maintenance .................................................................................................................. 4-19
4.7.1 Alarm Setup...................................................................................................... 4-22
4.7.2 IP Address Setup .............................................................................................. 4-23
4.7.3 Self Definition of Color ................................................................................... 4-24
4.7.4 Nurse Call Setup .............................................................................................. 4-25
4.7.5 IBP Pressure Calibration .................................................................................. 4-26
4.7.6 CO2 User Maintain........................................................................................... 4-26
4.7.7 Gas Calibrate.................................................................................................... 4-26
4.7.8 Monitor Status.................................................................................................. 4-27
4.8 DEMO Function............................................................................................................ 4-28
5 Face Selection ................................................................................................................... 5-1
5.1 Standard Screen............................................................................................................... 5-1
5.2 Trend Screen ................................................................................................................... 5-2
5.3 OxyCRG Screen.............................................................................................................. 5-3
5.4 Viewbed Screen............................................................................................................... 5-4
5.5 Large Font Screen ........................................................................................................... 5-6
5.6 Standby Mode ................................................................................................................. 5-7
6 Alarms ............................................................................................................................... 6-1
6.1 Overview......................................................................................................................... 6-1
6.1.1 Alarm Categories................................................................................................ 6-1
6.1.2 Alarm Levels ...................................................................................................... 6-2
6.2 Alarm Modes................................................................................................................... 6-2
2
6.2.1 Visual Alarms ..................................................................................................... 6-2
6.2.2 Audible alarms ................................................................................................... 6-3
6.2.3 Alarm Messages ................................................................................................. 6-3
6.2.4 Parameter Flashes............................................................................................... 6-4
6.2.5 Reminder Tones.................................................................................................. 6-4
6.3 Alarm Statuses................................................................................................................. 6-4
6.3.1 Alarms Disabled ................................................................................................. 6-4
6.3.2 Alarms Paused.................................................................................................... 6-5
6.3.3 System Silenced ................................................................................................. 6-5
6.3.4 Alarm Sound Off ................................................................................................ 6-5
6.3.5 Status Switchover............................................................................................... 6-6
6.4 Latching Alarms.............................................................................................................. 6-6
6.5 Clearing Alarms .............................................................................................................. 6-7
6.6 Testing Alarms ................................................................................................................ 6-8
6.7 When an Alarm Occurs ................................................................................................... 6-8
7 Freezing Waveforms ........................................................................................................ 7-1
7.1 Overview......................................................................................................................... 7-1
7.2 Freezing and Unfreezing ................................................................................................. 7-1
7.3 FROZEN Menu............................................................................................................... 7-2
7.4 Waveform Recall............................................................................................................. 7-3
7.5 Recording Frozen Waveforms......................................................................................... 7-3
8 Recording.......................................................................................................................... 8-1
8.1 Overview......................................................................................................................... 8-1
8.2 Recording Types.............................................................................................................. 8-1
8.3 Recorder Operations ....................................................................................................... 8-3
8.4 Installing Recorder Paper................................................................................................ 8-5
9 Recall................................................................................................................................. 9-1
9.1 Overview......................................................................................................................... 9-1
9.2 Trend Graph Recall ......................................................................................................... 9-2
9.3 Trend Table Recall .......................................................................................................... 9-4
9.4 NIBP Recall .................................................................................................................... 9-6
9.5 Alarm Event Recall ......................................................................................................... 9-7
9.6 Non-Volatile Data Storage .............................................................................................. 9-9
10 ECG/RESP Monitoring ............................................................................................... 10-1
10.1 Overview..................................................................................................................... 10-1
10.2 ECG Monitoring Procedure ........................................................................................ 10-1
10.2.1 Preparation ..................................................................................................... 10-1
10.2.2 Electrode Placement....................................................................................... 10-2
10.2.3 Characteristics of Quality ECG Signal........................................................... 10-7
10.3 ECG Display ............................................................................................................... 10-8
10.3.1 ECG Waveform .............................................................................................. 10-8
10.3.2 ECG Parameters ............................................................................................. 10-9
3
10.4 ECG Setup Menu ...................................................................................................... 10-10
10.5 ST Analysis ............................................................................................................... 10-18
10.5.1 Overview...................................................................................................... 10-18
10.5.2 3/5-Lead ST Analysis Menu......................................................................... 10-18
10.5.3 Adjusting ST Measurement Point................................................................. 10-20
10.6 Arrhythmia Analysis ................................................................................................. 10-22
10.6.1 Overview...................................................................................................... 10-22
10.6.2 Arrhythimia Options..................................................................................... 10-23
10.6.3 Arrhythmia Analysis Menu .......................................................................... 10-24
10.6.4 Arrhythimia Relearn..................................................................................... 10-25
10.6.5 Arrhythmia Alarm Setup .............................................................................. 10-25
10.6.6 Arr Threshold ............................................................................................... 10-27
10.6.7 Arrhythmia Recall ........................................................................................ 10-28
10.7 12-Lead ..................................................................................................................... 10-30
10.7.1 12-Lead Monitoring Display........................................................................ 10-30
10.7.2 12-lead ST Analysis Menu ........................................................................... 10-31
10.8 RESP Monitoring ...................................................................................................... 10-33
10.8.1 Overview...................................................................................................... 10-33
10.8.2 Electrode Placement..................................................................................... 10-34
10.8.3 Respiration Setup ......................................................................................... 10-35
10.9 Maintenance and Cleaning........................................................................................ 10-37
11 SpO2 Monitoring ...........................................................................................................11-1
11.1 Overview ......................................................................................................................11-1
11.2 Mindray DS SpO2 Module ...........................................................................................11-2
11.2.1 Principles of Operation....................................................................................11-2
11.2.2 Precautions ......................................................................................................11-3
11.2.3 Monitoring Procedure .....................................................................................11-3
11.2.4 Measurement Limitations................................................................................11-6
11.2.5 SpO2 Setup Menu ............................................................................................11-7
11.3 Nellcor SpO2 Module ...................................................................................................11-9
11.3.1 Principles of Operation....................................................................................11-9
11.3.2 Precautions ....................................................................................................11-11
11.3.3 Monitoring Procedure ...................................................................................11-11
11.3.4 Measurement Limitations..............................................................................11-12
11.3.5 SpO2 Setup Menu ..........................................................................................11-13
11.3.6 Accessories ....................................................................................................11-15
11.3.7 Nellcor Information.......................................................................................11-15
12 NIBP Monitoring.......................................................................................................... 12-1
12.1 Overview..................................................................................................................... 12-1
12.2 Monitoring Procedure ................................................................................................. 12-2
12.2.1 Cuff Selection and Placement ........................................................................ 12-2
12.2.2 Operation Guides ........................................................................................... 12-3
12.3 Measurement Limitations............................................................................................ 12-4
4
12.4 NIBP Setup Menu ....................................................................................................... 12-5
12.4.1 Calibration...................................................................................................... 12-7
12.4.2 Testing for Air Leakage.................................................................................. 12-8
12.5 Maintenance and Cleaning.......................................................................................... 12-9
13 TEMP Monitoring........................................................................................................ 13-1
13.1 Overview..................................................................................................................... 13-1
13.2 Measurement Procedure.............................................................................................. 13-2
13.3 TEMP Setup Menu...................................................................................................... 13-3
13.4 Maintenance and Cleaning.......................................................................................... 13-4
14 IBP Monitoring............................................................................................................. 14-5
14.1 Overview..................................................................................................................... 14-5
14.2 Precautions .................................................................................................................. 14-6
14.3 Monitoring Procedure ................................................................................................. 14-7
14.4 IBP Menu .................................................................................................................... 14-8
14.4.1 IBP Setup Menu ............................................................................................. 14-8
14.4.2 IBP Pressure Zero Menu .............................................................................. 14-12
14.5 Maintenance and Cleaning........................................................................................ 14-14
15 CO2 Monitoring............................................................................................................ 15-1
15.1 Overview..................................................................................................................... 15-1
15.2 Mindray DS CO2 Module............................................................................................ 15-2
15.2.1 Principles of Operation .................................................................................. 15-2
15.2.2 Preparations for CO2 Measurement................................................................ 15-3
15.2.3 CO2 Setup Menu ............................................................................................ 15-4
15.2.4 CO2 User Maintain Menu............................................................................... 15-9
15.2.5 Maintenance and Cleaning ........................................................................... 15-10
15.3 Oridion CO2 Module..................................................................................................15-11
15.3.1 Principles of Operation .................................................................................15-11
15.3.2 Preparations for CO2 Measurement.............................................................. 15-12
15.3.3 CO2 Setup Menu .......................................................................................... 15-13
15.3.4 CO2 User Maintain Menu............................................................................. 15-16
15.3.5 Maintenance and Cleaning ........................................................................... 15-17
15.3.6 Oridion Information ..................................................................................... 15-18
15.4 Removing Exhaust Gases from the System .............................................................. 15-18
16 Anesthesia Gas Monitoring ......................................................................................... 16-1
16.1 Overview..................................................................................................................... 16-1
16.2 Measurement Principles and Procedure ...................................................................... 16-3
16.3 MAC ........................................................................................................................... 16-5
16.4 AG Setup Menu........................................................................................................... 16-6
16.5 Calibrating AG .......................................................................................................... 16-10
16.6 Maintenance and Cleaning.........................................................................................16-11
16.6.1 Occlusion handling........................................................................................16-11
16.6.2 Removing Exhaust Gases from the System ..................................................16-11
5
17 Maintenance ................................................................................................................. 17-1
17.1 Inspection and Maintenance........................................................................................ 17-1
17.2 Cleaning ...................................................................................................................... 17-2
17.3 Disinfection and Sterilization...................................................................................... 17-3
18 Accessories .................................................................................................................... 18-1
18.1 ECG Accessories......................................................................................................... 18-2
18.2 SpO2 Accessories ........................................................................................................ 18-3
18.3 NIBP Accessories........................................................................................................ 18-4
18.4 TEMP Accessories ...................................................................................................... 18-5
18.5 IBP Accessories........................................................................................................... 18-5
18.6 CO2 Accessories.......................................................................................................... 18-7
18.6.1 Mindray DS CO2 Accessories ........................................................................ 18-7
18.6.2 Oridion CO2 Accessories................................................................................ 18-7
18.7 AG Accessories ........................................................................................................... 18-7
18.8 Others.......................................................................................................................... 18-8
A Product Specifications.....................................................................................................A-1
A.1 Safety Classifications .....................................................................................................A-1
A.2 Environmental Specifications ........................................................................................A-1
A.3 Power Source Specifications..........................................................................................A-2
A.4 Hardware Specifications ................................................................................................A-3
A.5 Data Storage ...................................................................................................................A-4
A.6 Wireless Network ...........................................................................................................A-4
A.7 Signal Output Specifications..........................................................................................A-4
A.8 ECG Specifications ........................................................................................................A-5
A.9 RESP Specifications.....................................................................................................A-10
A.10 SpO2 Specifications....................................................................................................A-11
A.11 NIBP Specifications ...................................................................................................A-13
A.12 TEMP Specifications..................................................................................................A-14
A.13 IBP Specifications ......................................................................................................A-14
A.14 CO2 Specifications .....................................................................................................A-15
A.15 AG Specifications.......................................................................................................A-17
B EMC..................................................................................................................................B-1
C Alarm Messages and Prompt Information....................................................................C-1
C.1 Physiological Alarm Messages.......................................................................................C-1
C.2 Technical Alarm Messages .............................................................................................C-2
C.3 Prompt Messages..........................................................................................................C-14
D Symbols and Abbreviations ............................................................................................D-1
D.1 Symbols..........................................................................................................................D-1
D.2 Abbreviations .................................................................................................................D-3
6
1 Safety
1.1 Safety Information
The safety statements presented in this chapter refer to the basic safety information that the
operator of the patient monitor shall pay attention to and abide by. There are additional safety
statements in other chapters or sections, which may be the same as or similar to the followings, or
specific to the operations.
DANGER
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Indicates an imminent hazard situation that, if not avoided, will result in death
or serious injury.
WARNING
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Indicates a potential hazard situation or unsafe practice that, if not avoided,
could result in death or serious injury.
CAUTION
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Indicates a potential hazard or unsafe practice that, if not avoided, could result
in minor personal injury or product/property damage.
NOTE
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Provides application tips or other useful information to ensure that you get the
most from your product.
1-1
1.1.1 Dangers
There are no dangers that refer to the product in general. Specific “Danger” statements may be
given in the respective sections of this operation manual.
1.1.2 Warnings
WARNING
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The device is intended for use by qualified clinical physicians or well-trained
nurses in the specified places.
To ensure patient safety, verify the device and accessories can function safely
and normally before use.
EXPLOSION HAZARD: Do not use this device in the presence of flammable
anesthetics, explosive substances, vapors or liquids.
You must customize the alarm settings according to the individual patient
situation, and make sure the alarm sound is activated when an alarm occurs.
ELECTRIC SHOCK: Do not open the monitor housing. All servicing and future
upgrades to this device must be carried out by personnel trained and authorized
by our company only.
DEFIBRILLATION: Do not come into contact with the patient during
defibrillation. Otherwise serious injury or death could result.
When used in conjunction with electro-surgery equipment, you must give top
priority to the patient safety. To prevent unwanted skin burns caused by leakage
current, applying the electrode ,transducer and the cable as far as possible from
the high frequency surgical equipment, a distance of least 15cm/6in. is
recommended.
DISPOSE: Dispose of the package material, observing the applicable waste
control regulations and keeping it out of children’s reach.
The device must be connected to a properly installed power outlet with
protective earth contacts only. If the installation does not provide for a
protective earth conductor, disconnect the monitor from the power line and
operate it on battery power, if possible.
The aging of the test equipment and the change of environment may have effects
on the measuring results of the monitor.
1-2
1.1.3 Cautions
CAUTION
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To ensure patient safety, use only parts and accessories specified in this manual.
Remove the battery from the patient monitor if it will not be used or not be
connected to the power line for a long period.
Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
At the end of its service life, the product described in this manual, as well as its
accessories, must be disposed of in compliance with the guidelines regulating the
disposal of such products. If you have any questions concerning disposal of the
products, please contact with us.
Magnetic and electrical fields are capable of interfering with the proper
performance of the device. For this reason make sure that all external devices
operated in the vicinity of the monitor comply with the relevant EMC
requirements. Mobile phone, X-ray equipment or MRI devices are a possible
source of interference as they may emit higher levels of electromagnetic
radiation.
Before connecting the patient monitor to the power line, check that the voltage
and frequency ratings of the power line are the same as those indicated on the
label or in this manual.
Install or carry the patient monitor properly to avoid damages caused by drop,
impact, strong vibration or other mechanical force.
1-3
1.1.4 Notes
NOTE
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Keep this manual close to the patient monitor so that it can be obtained
conveniently when necessary.
This patient monitor complies with the requirements of CISPR11 (EN55011)
class A.
The software was developed per IEC601-1-4. The possibility of hazards arising
from errors in software program is minimized.
Put the patient monitor in a location where you can easily see the screen and
access the operating controls.
The instructions of this manual are based on the maximum configuration. Some
of them may not apply to your patient monitor.
1-4
1.2 Equipment Symbols
NOTE
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Some symbols may not appear on your equipment.
Attention: Consult accompanying documents (this manual).
Power ON/OFF
Power ON/OFF
Alternating current (AC)
Battery indicator
Type CF applied part. The unit displaying this symbol contains an
F-type isolated (floating) patient part providing a high degree of
protection against shock, and is suitable for use during defibrillation.
TYPE BF applied part. Defibrillator-proof protection against
electrical shock.
Equipotentiality
Auxiliary output
Network connector
VGA connector
AG module connector
Gas inlet
1-5
Gas outlet
ESD sensitivity
Manufacture date
Serial number
European community representative
This mark means that this device is fully in conformance with the
Council Directive Concerning Medical Devices 93/42/EEC. The
number adjacent to the CE marking (0123) is the number of the
EU-notified body that certified meeting the requirements of Annex
II of the Directive.
The following definition of the WEEE label applies to EU member
states only.
This symbol indicates that this product should not be treated as
household waste. By ensuring that this product is disposed of
correctly, you will help prevent bringing potential negative
consequences to the environment and human health. For more
detailed information with regard to returning and recycling this
product, please consult the distributor from whom you purchased it.
* For system products, this label may be attached to the main unit
only.
Classified by Underwriters Laboratories Inc. with respect to electric
shock, fire and mechanical hazards, only in accordance with UL
60601-1, CAN/CSA C22.2 NO.601-1, IEC 60601-1-1, IEC
60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-49.
1-6
2 The Basics
2.1 Monitor Description
This monitor integrates the functions of parameter measurement, waveform monitoring, freezing,
and recording, etc. Its color TFT liquid crystal display is able to show patient parameters and
waveforms clearly. The monitor also features compact size, lightweight, easy-to-carry handle and
built-in battery, which make it portable, especially in hospital transport. The compact control
panel and control knob, and the easy-to-use menu system enable you to freeze, record, or perform
other operations conveniently. Besides, this monitor can be connected with the central monitoring
system whereby a monitoring network will be formed.
2.1.1 Intended Use
This monitor is intended to be used for monitoring, recording, and alarming of multiple
physiological parameters (see 2.1.4 Functions) on single adult, pediatric and neonate patient. For
arrhythmia detection and ST Segment analysis, the target populations are adult and pediatric only.
This monitor is to be used in healthcare facilities by trained clinical physicians or appropriate
medical staff under the direction of physicians. It is not intended for out-of-hospital transfer or
home use.
WARNING
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The operator of the monitor must be well trained. Any operation by unauthorized
or non-trained personnel is forbidden.
The physiological waveforms and parameters and the alarm information displayed
by the monitor are only for the reference of physicians, but cannot be used directly
to determine the clinical treatment.
2.1.2 Contraindications
None.
2.1.3 Components
This monitor consists of parameter measuring modules, blood pressure cuff, ECG, IBP cables,
SpO2 sensors, CO2 and AG measuring components. Some of the components are optional and
may not apply to your patient monitor.
2-1
2.1.4 Functions
This monitor is capable of monitoring the following parameters.
„ ECG
‹ Heart rate (HR)
‹ ECG waveform(s)
‹ ST segment analysis
‹ Arrhythmia analysis
„ RESP
‹ Respiration rate (RR)
‹ Respiration waveform
„ SpO2
‹ Pulse oxygen saturation (SpO2)
‹ Pulse rate (PR)
‹ SpO2 plethysmogram
„ NIBP
‹ Systolic pressure (NS), diastolic pressure (ND), mean pressure (NM)
‹ Pulse rate (PR)
„ TEMP
‹ Temperature of channel 1 (T1), temperature of channel 2 (T2)
‹ Temperature differential between two channels (TD)
„ IBP
‹ 2 channels of IBP waveforms
‹ Systolic (SYS), diastolic (DIA), and mean (MEAN) pressure
‹ Pulse rate (PR).
„ CO2
‹ End-tidal carbon dioxide (EtCO2)
‹ Fractional inspiratory carbon dioxide (FiCO2)
‹ Air-way Respiration Rate (AwRR)
„ AG
‹ Fraction of inspired carbon dioxide, nitrous oxide, oxygen or anesthetic gas (FiCO2,
FiN2O, FiO2, FiAA), and End-tidal carbon dioxide, nitrous oxide or oxygen (EtCO2,
EtN2O, EtO2, EtAA)
AA refers to one of the following anesthetic agents:
HAL (Halothame)
ISO (Isoflurane)
ENF (Enflurane)
SEV (Sevoflurane)
DES (esflurane)
‹ Airway respiration rate (AwRR)
‹ Minimum alveolar concentration (MAC)
‹ 4 channels of AG waveforms (CO2, N2O, O2 and AA)
2-2
2.2 External Appearance
2.2.1 Front Panel
Handle
Alarm indicator
Display
Control knob
Control panel
Figure 2-1 Front Panel
This monitor is designed to comply with the requirements of relative international safety
standards (IEC60601-1, EN60601-2-27 and EN60601-2-30) for medical electrical equipment.
This monitor has floating inputs and is protected against the effects of defibrillation and
electrosurgery. When proper electrodes are used and applied according to the manufacturer
instructions, the screen display will recover within 10 seconds after defibrillation.
The alarm indicator of this monitor complies with the requirement of EN60825-1 A11 Class 1 for
LED. The LED indicator varies its flash color and frequency to indicate different alarm levels.
WARNING
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Move or lift the monitor by the handle only. Do not use the patient cable or the
power cord to move or lift the monitor. It might cause the monitor to fall, which
might damage the monitor or injure the patient.
2-3
2.2.2 Left Side Panel
Your monitor may not have all connectors as shown below.
1
2
4
6
3
5
7
8
9
Figure 2-2 Left Side Panel
1.
2.
3.
4.
5.
6.
7.
8.
9.
T1:
Temperature probe connector (channel 1)
T2:
Temperature probe connector (channel 2)
IBP1:
IBP transducer connector (channel 1)
IBP2:
IBP transducer connector (channel 2)
ECG:
ECG cable connector
CO:
CO cable connector (not available in USA)
NIBP: NIBP cuff hose connector
SpO2: SpO2 sensor connector
Battery door
2-4
2.2.3 Right Side Panel
The right side panel differs with different configurations as shown below.
2
1
3
4
Figure 2-3 Right Side Panel
1.
2.
3.
4.
CO2 sensor connector (Oridion CO2 module)
Water trap connector (Mindray DS CO2 or AG module)
Exhaust outlet
Recorder
NOTE
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Some modules are optional. Their connectors may not be available on your patient
monitor.
If your monitor is equipped with CO2 module, then it can’t be equipped with AG
module, vice versa.
2-5
2.2.4 Rear Panel
1
2
3
4
5
6
7
1.
2.
3.
4.
5.
6.
7.
8.
9.
8
Figure 2-4 Rear Panel
9
Fan Vent
Speaker holes
Mounting holes for support bracket.
Network Connector: Standard RJ45 connector.
Through network connector, this monitor can be connected with the central monitoring
system, another monitor, or a PC. It enables the functions of viewbed monitoring, data
output and on-line software upgrading.
Fuse: Standard T3.0A
VGA Monitor Connector
A standard color VGA monitor can be connected to the patient monitor through this
connector.
Equipotential grounding connector
Auxiliary Output Port: A standard BNC connector.
It is the common interface of analog output signals, nurse call output signals or defibrillator
synchronization signals. You can manually select the function of this port in the USER
MAINTAIN menu.
AC Power Input Connector
A three-wire power cord can be connected to this receptacle to provide AC power supply to
the patient monitor.
2-6
WARNING
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Accessory equipments connected to this patient monitor must be certified
according to the respective IEC standards (e.g. IEC 60950 for information
technology equipment and IEC 60601-1 for medical electrical equipment).
Furthermore all configurations shall comply with the valid version of the system
standard IEC 60601-1-1. Any person who connects additional equipment to the
signal input or signal output is responsible to ensure the system complies with the
requirements of the valid version of the system standard IEC 60601-1-1. If in
doubt, contact our company or customer service.
2.3 Control Panel
1
23
4
5
6
7
8
9
10
Figure 2-5 Control Panel
1.
2.
3.
4.
5.
6.
7.
8.
9.
Power switch
This key turns the monitor ON and OFF. A built-in indicator is located inside this key, and it
lights ON or OFF when the monitor is turned ON or OFF. To turn OFF the monitor, please
press this key and hold for more than 2 seconds.
AC power indicator
‹ ON: AC power is applied to the monitor.
‹ OFF: AC power is not applied to the monitor.
Battery indicator
The battery indicator tells the battery status. See 2.5 Batteries for more information.
MAIN
Press this key to exit the menu currently displayed, and return to the main screen.
FREEZE
This key is pressed to freeze and unfreeze waveforms.
SILENCE
You can press this key to pause alarms, silence the monitor or clear alarms. You can also
switch between different alarm statuses through this key.
RECORD
Press this key to start or stop recording.
NIBP
Press this key to start or stop the non-invasive blood pressure measurement.
MENU
Press this key to display the SYSTEM MENU.
2-7
10. Control Knob
The main operator control is the control knob. The control knob rotates in either direction to
highlight parameter labels and menu options. After highlighting the desired selection, press
the control knob to execute an operation, make a selection, view a new menu or a small
drop-down list. This procedure is referred to as “select ” through out the manual. Remember
rotate to highlight, and then press to select.
2.4 Display
This monitor has a color TFT LCD display of high resolution. It is able to display patient
parameters and waveforms clearly. The following is the standard interface when the monitor is
operating normally.
4
1
3
5
2
6
7
9
8
Figure 2-6 Main Screen
1.
Patient information area
It displays patient bed number and patient type. If no patient is admitted, it displays “NO
PATIENT ADMITTED”. If the patient’s information is incomplete, corresponding symbols
will be displayed.
2-8
2.
System time
The system time of the monitor is displayed in two lines. The time format can be set in the
TIME SETUP menu.
3.
Technical alarms area
Technical alarm messages or prompt information are displayed in this area. In case of
multiple messages, they will be displayed alternately. This area shows the patient name and
sex when no message is to be displayed.
Sound icon
4.
5.
6.
7.
8.
9.
Alarms Paused;
System Silenced;
Alarm Sound Off. No icon is displayed
under normal status.
Physiological alarms area
Physiological alarm messages are displayed in this area. In case of multiple messages, they
will be displayed alternately.
Waveforms area
This area shows the waveforms of physiological parameters. The label of a waveform is
displayed on the upper left.
Parameter windows
The parameter windows are located on the right of the waveform area, and are divided by
white lines. Each window is identified by a parameter label on the upper left. You may
select a parameter label to open the setup menu of this parameter. Each of the parameter is
described in more detail in the following chapters.
Prompt information area
This area shows the prompt messages, network status icons, battery status icons, etc. Upon
turning ON the monitor, prompt information, for example “NIBP alarm disabled”, will
cover the network and battery icons.
STANDBY label
You may select this label to enter the standby mode.
2-9
2.5 Batteries
This monitor is designed to operate on battery (sealed lead-acid or Lithium Ion battery) power
during intra-hospital patient transfer or whenever the power supply is interrupted. The battery is
charged automatically when the monitor is connected to AC power, no matter the monitor is
powered on or not. Whenever the AC power is interrupted during patient monitoring, the patient
monitor will automatically run power from the internal batteries.
Sealed acid batteries and Lithium Ion batteries are differentiated by their contacts, as shown
below.
The battery symbol displayed on the main screen tells the status of the battery.
„
The battery is installed in the battery slot.
The solid part indicates its capacity.
„
No battery is installed in the battery slot.
Besides, the battery indicator also indicates the status of the battery.
„ ON:
The battery is being charged or the battery is fully charged.
„ OFF:
No battery is installed. If the battery is installed but the monitor is not
connected to AC power and not turned on, the indicator will also be off.
„ Flashes: The monitor is powered by the internal battery.
The capacity of the internal battery is limited. When the battery capacity is too low, a high level
alarm is triggered and the “Battery too low” message is given in the technical alarms area. At this
moment, the AC power shall be applied to the monitor.
2-10
2.5.1 Battery Guidelines
Life expectancy of a battery depends on how frequent and how long it is used. For a properly
maintained and stored lead-acid or lithium ion battery, its life expectancy is about 2 or 3 years
respectively. For more aggressive use models, life expectancy can be less. We recommend
replacing lead acid batteries every 2 years and lithium ion batteries every 3 years.
To get the most out of the battery, observe the following guidelines:
„ The battery performance test must be performed every two years, before monitor repairs, or
whenever the battery is suspected as being the source of the problems.
„ Condition a battery once when it is used or stored for 3 months, or when its operating time
becomes noticeably shorter.
„ Take out the battery before the monitor is transported or will not be used for more than 3
months.
„ Remove the battery from the monitor if it is not being used regularly. (Leaving the battery in
a monitor that is not in regular use will shorten the life of the battery).
„ The shelf-life of a fully charged sealed lead acid battery is about 6 months and in 6 months
the battery must be fully charged for storage. The shelf life of a Lithium Ion battery is about
6 months when the battery is stored with the battery power being 50% (represented by the
battery symbol
) of the total power. In 6 months the battery power must be depleted
before the Lithium Ion battery is fully charged. Then run the monitor on this fully charged
battery .When its battery power becomes 50% of the total power, take out the battery from
the monitor and store it.
WARNING
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Keep the battery out of the reach of children.
Use only the battery specified by the manufacturer.
If the battery shows signs of damage or signs of leakage, replace it immediately. Do
not use a faulty battery in the monitor.
2-11
2.5.2 Battery Maintenance
Conditioning a Battery
A battery should be conditioned before it is used for the first time. A battery conditioning cycle is
one uninterrupted charge of the battery, followed by an uninterrupted battery discharge and
charge. . Batteries should be conditioned regularly to maintain their useful life.
NOTE
z
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Condition a battery once when it is used or stored for 3 months, or when its
operating time becomes noticeably shorter.
The actual battery capacity will decrease over time with use of batteries. When a
monitor operates on batteries that have been used before, the full capacity battery
symbol does not indicate the capacity and operating time of this battery can still
fulfill battery specifications in the operator’s manual. When conditioning a
battery, please replace the battery if its operating time is significantly lower than
the specified time.
To condition a battery, follow this procedure:
1. Disconnect the monitor from the patient and stop all monitoring or measuring.
2. Insert the battery in need of conditioning in the battery slot of the monitor, and leave the
other slot empty if your monitor has two slots.
3. Apply AC power to the monitor and allow the battery to charge uninterrupted for 10 hours.
4. Remove AC power and allow the monitor to run from the battery until it shuts off.
5. Apply AC power again to the monitor and allow the battery to charge uninterrupted for 10
hours.
6. This battery is now conditioned and the monitor can be returned to service.
Checking a Battery
The battery performance test must be performed every two years, before monitor repairs, or
whenever the battery is suspected as being the source of the problems.The performance of a
rechargeable battery may deteriorate over time. To check the performance of a battery, follow this
procedure:
1. Disconnect the monitor from the patient and stop all monitoring or measuring.
2. Apply AC power to the monitor and allow the battery to charge uninterrupted for 10 hours.
3. Remove AC power and allow the monitor to run from the battery until it shuts off.
4. The operating time of battery reflects its performance directly.
If your monitor has two battery slots, you can check two batteries at the same time. Please
replace the battery or contact with the maintenance personnel if its operating time is significantly
lower than the specified time.
2-12
NOTE
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The battery might be damaged or malfunctioned if its operating time is too short
after being fully charged. The operating time depends on the configuration and
operation. For example, measuring NIBP more frequently will also shorten the
operating time.
When a battery has visual signs of damage, or no longer holds a charge, it should
be replaced. Remove the old battery from the monitor and recycle it properly.
2.5.3 Battery Recycling
When a battery has visual signs of damage, or no longer holds a charge, it should be replaced.
Remove the old battery from the monitor and recycle it properly. To dispose of the batteries,
follow local laws for proper disposal.
WARNING
z
Do not disassemble batteries, or dispose of them in fire, or cause them to short
circuit. They may ignite, explode, leak or heat up, causing personal injury.
2.6 Wireless Network Card
This monitor can be configured with a wireless network card, which is connected to the CMS
(Central Monitoring System) in the wireless mode and constructs with the CMS the monitoring
network.
Yon only need to insert the network cable into the network connector. The following figure shows
the wireless network card correctly installed.
Power cord
Network cable
2-13
In front of the wireless network card are three indicators that indicating its working status:
„ POWER indicator
‹ OFF:
The wireless network card is off or the patient monitor is off.
‹ Flashing: The wireless network card is resetting to the default.
‹ ON:
The wireless network card is on and ready.
„ WIRELESS/WLAN indicator
‹ OFF:
The wireless network card is off or not associated with any access point.
‹ Flashing: The wireless network card is associating or transmitting wireless data.
‹ ON:
The wireless network card is associated with an access point.
„ ETHERNET/LAN indicator
‹ OFF:
The wireless network card is off or not connected to an Ethernet network.
‹ ON:
The wireless network card is connected to an Ethernet network.
The radio device used in the monitor is in compliance with the essential requirements and
other relevant provisions of Directive 1999/5/EC(Radio Equipment and Telecommunications
Terminal Equipment Directive).
NOTE
z
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z
z
The wireless network card is connected to the patient monitor via 5V power
supply and a network port in the monitor. The 5V power supply is the only way
for powering the wireless card, and the network port is used to get clinical data
for wireless transmission. Please verify the connections before using the wireless
network.
The design, installation, restruction and maintenance of the wireless network’s
distribution shall be performed by authorized service personnel of our company.
The existence of obstacles (such as wall) will exert impact on data transferring
or even cause network interruption.
The Central Monitoring System is capable of connecting up to 16 bedside
monitors via the wireless network.
2-14
3 Installation
WARNING
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z
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The installation of the monitor must be carried out by personnel authorized by us.
The software copyright of the monitor is solely owned by our company. Any action
to change, copy or exchange the software copyright by any organization or person
is regarded as copyright infringement and is not allowed.
Accessory equipments connected to this patient monitor must be certified
according to the respective IEC standards (e.g. IEC 60950 for information
technology equipment and IEC 60601-1 for medical electrical equipment).
Furthermore all configurations shall comply with the valid version of the system
standard IEC 60601-1-1. Any person who connects additional equipment to the
signal input or signal output is responsible to ensure the system complies with the
requirements of the valid version of the system standard IEC 60601-1-1. If in
doubt, contact our company or customer service.
If the monitor is connected to another electrical instrument and the instrument
specifications cannot tell whether the instrument combination is hazardous (e.g.
due to summation of leakage currents), you should consult us or experts in the field
to ensure the required safety of all instruments concerned.
NOTE
z
The operations in this section are not all required. User-customized installation by
authorized personnel is provided.
3-1
3.1 Unpacking and Checking
Before unpacking, examine the packing case carefully for signs of damage. If any damage is
detected, contact the carrier or our company.
If the packing case is intact, open the package and remove the instrument and accessories
carefully. Check all materials against the packing list and check for any mechanical damage.
Contact our Customer Service Department in case of any problem.
NOTE
z
Please save the packing case and packaging material for future transport and
storage.
WARNING
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Be sure to keep the packaging materials from children’s reach.
Disposal of the packaging materials shall comply with your local requirements.
The equipment might be contaminated in storage, transport or when used. Verify
the package and the single use accessories are intact. In case of any damage, do not
apply it to patients.
3.2 Environmental Requirements
The operating environment of the monitor must meet the requirements specified in this manual.
The environment where this monitor is to be used should be free from noise, vibration, dust, and
corrosive or explosive and inflammable substances. For a cabinet mounted installation, allow
sufficient room at the front and the rear of the cabinet for operation, maintenance and servicing.
Besides, allow at least 2 inches clearance around the instrument for proper air circulation.
Condensation can form when the monitor is moved from one location to another, and being
exposed to differences in humidity or temperature. Make sure that during operation the
instrument is free from condensation.
3-2
3.3 Power Source Requirements
The power applied to the monitor must meet the requirements specified in this manual.
WARNING
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Make sure that the operating environment and the power applied to the patient
monitor complies with the specified requirements. Otherwise its performance
might not meet the specifications claimed in this manual, and unexpected results,
such as damages to the patient monitor, may be incurred.
The monitor shall be powered according to the requirement for the system power
voltage. Otherwise, serious damage might be caused to the system.
3.4 Installation Method
3.4.1 Bracket Mounting
For details, please refer to the corresponding instructions for use of bracket mounting.
3.4.2 Connecting to AC Power Supply
1.
2.
Use the original three-wire AC power cord.
Connect the power cord to the receptacle for AC power cord on the rear panel of the
monitor.
3. Connect the other end of the power cord to a compatible 3-prong hospital grade AC power
outlet.
The 3-prong power outlet must be ground. If it is doubted, contact related personnel of the
hospital.
WARNING
z
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Do not use three-wire to two-wire adapter with this instrument.
To avoid unexpected power interruption, do no use power outlet with a
wall-mounted switch control.
3-3
3.4.3 Installing the Battery
If the monitor is to be powered by the internal battery, install the battery following the steps as
below:
1. Open the door in the direction as marked on the battery door.
2. Move the battery catch above to one side using one finger.
3. Insert the battery into the battery slot per the “+” and “-” indications.
4. Move the battery catch to another side, and then insert the other one in the same way, if your
monitor is equipped with two batteries.
5. Release the battery catch, and it will fix the battery.
6. Close the battery door.
WARNING
z
Make sure the battery door is securely latched. Falling batteries could seriously or
fatally injure a patient.
3.4.4 Connecting Patient Sensors and Probes
Connect the necessary patient sensors or probes to the monitor. For details, see the chapters for
specific parameter monitoring in the following pages, or corresponding instructions for sensors
and probes.
3.4.5 Connecting the Network Cable
The network connector of the monitor is a standard RJ45 connector. It connects the monitor with
the central monitoring system, or with a PC for online upgrading or data output. It can also
connect with another patient monitor for viewbed monitoring.
1. Connect one end of the network cable with the network connector of the monitor.
2. Connect the other end of the network cable with the hub or switch of the central monitoring
system, or with the network connector of a PC, or with the network connector of another
patient monitor.
NOTE
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Different network cable may be used for different connections. Please consult our
customer service personnel for details.
The system upgrading through the network connector is to be executed by our
authorized personnel only.
3-4
3.4.6 Auxiliary Output Port
The auxiliary output port can be used to generate analog signals, nurse call signals or defibrillator
synchronization signals.
„ Analog output signals can be generated when the monitor is connected to an oscilloscope or
a pen recorder.
„ If the monitor is connected with the Nurse Call System of a hospital through a special nurse
call cable, the monitor can generate nurse call signals when alarms occur.
„ If the monitor is connected with a defibrillation equipment, the monitor can generate
defibrillator synchronization signals to the defibrillation equipment.
NOTE
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For detailed connection methods of different uses, please consult the specialist in
your hospital, or our Customer Service.
The nurse call cable has two non-polarized conducers at the output end. The
installation should be performed by our servicing engineers or engineers of the
hospital according to the specific nurse call system of the hospital.
WARNING
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Before defibrillating the patient, the user should ensure the defibrillator and the
monitor have been tested as a system and the two devices can work together safely
and effectively.
3.4.7 Connecting to VGA Monitor
This monitor can be connected with a standard color VGA monitor. The VGA monitor will
display the patient waveforms and parameters measured by the patient monitor. To connect the
patient monitor with the VGA monitor, follow the steps as below.
1. Power off the patient monitor.
2. Connect the signal cable of the VGA monitor to the VGA connector on the rear panel of the
patient monitor.
3. Power on the VGA monitor and then the patient monitor.
NOTE
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The VGA monitor should be installed at a distance of more than 1.5 m from the
patient.
3-5
3.4.8 Equipotential Grounding
When other equipments are used together with the monitor, a grounding cable should be used to
connect the equipotential grounding connectors of the monitor and of other equipments. This
helps to reduce the potential differences between different pieces of equipment, and ensure the
safety of the operator and patient.
WARNING
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If the grounding system is in doubt, the monitor must be supplied from its internal
battery.
3.5 Powering on the Monitor
After installing the monitor, please follow the procedures described below to power on the
monitor:
1. Before using the monitor, please carry out corresponding safety inspection as given in 17.1
Inspection.
2. Press the Power Switch on the control panel. The alarm indicator will flash once in yellow
and red. Then, a beep will be heard.
3. The system begins self-testing and the product model will be displayed on the screen.
4. Several seconds later, the system finishes the self-test and displays the main screen.
5. The system will initiate every module, and display “XX alarm disabled!” information in the
lower left part of the screen. “XX” represents the name of every module, such as NIBP,
RESP etc.
6. At this time, you can operate the monitor using the control panel. “XX alarm disabled!”
information will disappear a few seconds later.
NOTE
z
During initialization process, alarms of every module detected by the system are
useless, and thereby are disabled.
3.6 Powering off the Monitor
To power off the monitor, please follow the procedures below:
1. Confirm the patient monitoring is to be finished.
2. Disconnect the cables and sensors between the monitor and the patient.
3. Confirm whether to store or clear the patient monitoring data.
4. Press the Power switch for more than 2 seconds, and the monitor will be powered off.
3-6
4 System Menu
4.1 Overview
This chapter only gives introduction to the system menu. Other menus will be described in the
following chapters.
1
2
3
4
Figure 4-1 System Menu
Most menus displayed by the monitor share the same structure. As shown above, a menu is made
up of four parts:
1. Menu title: Summarizes the content of the current menu.
2. Main display area: Displays options, keys or prompt information, etc. “>>“ means a
submenu will pop up if the option is selected.
3. Online help: The help information changes with the highlighted selection.
4. Exit key: Exits from the current menu.
Some menus do not have the EXIT key. Instead, a YES and a NO key or a CONFIRM and a
CANCEL key are provided. You can confirm the operations with these keys.
NOTE
z
Your monitor may not include all options described in this chapter.
4-1
4.2 Patient Setup
Select PATIENT SETUP>> in SYSTEM MENU. The following menu appears.
Figure 4-2 Patient Setup Menu
This menu displays the patient’s information, as well as four buttons located below. If no patient
is admitted, the buttons are:
„ CLEAR PATIENT DATA
„ QUICK ADMIT PATIENT
„ ADMIT PATIENT
„ MODIFY PATIENT
If a patient is admitted, the CLEAR PATIENT DATA button turns to be DISCHARGE PATIENT.
4-2
4.2.1 Admit Patient
To admit a new patient, please follow this procedure:
1. Select ADMIT PATIENT in PATIENT SETUP menu.
2. Select YES in the pop-up CONFIRM TO CLEAR THE DATA menu. The menu as shown
below appears.
Figure 4-3 Patient Information Setup
3.
Enter the patient’s information details. If the patient’s information is entered incompletely,
corresponding symbols
will appear in the upper left hand of the monitor screen.
„
PAT NO
Patient identification number;
„
DOCTOR
Name of the doctor;
„
NAME
Patient name;
„
SEX
Patient gender: “F” for female; “M” for male;
„
PAT TYPE
Patient type:
ADU, PED and NEO (short for adult, pediatric and neonate);
„
PACE
Turn ON or OFF the pace analysis function;
„
ADMIT
The time when the patient is admitted: year-month-day;
„
BIRTH
Patient date of birth: year-month-day;
„
HEIGHT
Patient height (unit: cm or inch);
„
WEIGHT
Patient weight (unit: kg or Ib);
„
BLOOD
Patient blood type:
A, B, O, AB or N (N represents unknown)
4-3
NOTE
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If the PAT NO or NAME has not been input, “PATI. INFO. IMCMP” will be
displayed in the patient information area.
4.
5.
Select OK button, and the patient is admitted.
If the monitor is connected with the central monitoring system, you can monitor the patient
through the central monitoring system.
Setting Patient Information
To enter information in a field containing no mark, follow this procedure (take PAT NO as an
example):
1. Rotate the control knob and highlight the field after PAT NO.
2. Press the control knob, and the cursor jumps to the soft keypad below.
3. Rotate the control knob and move the cursor to the desired letter, number or space, and press
the control knob to enter the character. Select DEL button to delete the unwanted entered
character.
4. Repeat step 3 until you finish the information entering.
5. Select OK on the soft keypad. The information setting finishes.
To enter information in a field containing the mark “ “, follow this procedure (take SEX as an
example):
1. Rotate the control knob and highlight the field after SEX.
2. Press the control knob. A pop-up menu opens.
3. Rotate the control knob and select the desired option.
To set a feild containing the mark “ “, follow this procedure (take HEIGHT as an example):
1. Rotate the control knob and highlight the field after HEIGHT.
2. Press the control knob.
3. Rotate the control knob and select the desired height. The height increases or decreases by
one as the control knob rotates.
4-4
4.2.2 Quick Admit Patient
1.
2.
3.
Select QUICK ADMIT PATIENT in PATIENT SETUP menu.
Select YES in the pop-up CONFIRM TO CLEAR THE DATA menu.
The following menu appears. You can set the PAT TYPE and status of PACE.
Figure 4-4 Quick Admit Patient
4.
5.
Select OK button, and the patient is admitted.
If the monitor is connected with the central monitoring system, you can monitor the patient
through the central monitoring system.
4.2.3 Modify Patient
To modify the information of the patient being monitored, please follow this procedure:
1. Select MODIFY PATIENT button in PATIENT SETUP menu.
2. The menu as shown in Figure 4-3 opens.
3. Modify the patient’s information as described above, and select OK button.
4. Prompt information will be displayed on the central monitoring system if the monitor is
connected with it.
4.2.4 Clear Patient Data
If a patient is monitored but not admit, before monitoring another patient, the data stored in the
patient monitor should be cleared.
1. Click the CLEAR PATIENT DATA button in the PATIENT SETUP menu.
2. Select YES in the pop-up menu.
4.2.5 Discharge Patient
To discharge the patient being monitored, please follow this procedure:
1. Select DISCHARGE PATIENT in PATIENT SETUP menu.
2. Select YES in the pop-up menu.
3. Prompt information will be displayed on the central monitoring system if the monitor is
connected with it.
4-5
4.3 Configuration Setup
Select CONFIG >> in the SYSTEM MENU. The following menu appears.
Figure 4-5 Configuration menu
If you have changed some settings during monitoring a patient and the changed settings are not
proper, especially when a new patient is admitted, you can restore the factory configuration.
According to the patient category, the monitor provides 3 kinds of factory configurations: factory
adult configuration, factory pediatric configuration and factory neonatal configuration.
Restoring Factory Configuration
1.
2.
3.
Rotate the control knob and select the desired configuration.
Select EXIT, and a CONFIRM CONFIG dialog box pops up.
Select YES to restore the monitor to the selected configuration, or select NO to cancel the
operation.
4-6
4.4 System Setup
Select SYSTEM SETUP>> in SYSTEM MENU. The following menu appears.
Figure 4-6 System Setup
SYSTEM SETUP menu contains the following submenus:
„ FACE SELECT>>
„ ALARM SETUP>>
„ TIME SETUP>>
„ RECORD>>
„ DATA OUTPUT>>
„ ANALOG>>
„ MODULE SETUP>>
„ TRACE SETUP>>
„ MARK EVENT>>
4-7
4.4.1 Face Select
Select FACE SELECT>> in SYSTEM SETUP menu. The following menu appears.
Figure 4-7 Face Select
In the FACE SELECT menu, options are available as shown above. For detailed information, see
chapter Face Selection.
4.4.2 Alarm Setup
Select ALARM SETUP>> in SYSTEM SETUP menu. The following menu appears.
Figure 4-8 Alarm Setup
4-8
You can perform the following settings in the menu above:
„
ALM SEL
Alarm selection
Options: COMMON ALM SETUP, XX ALM SETUP;
(XX refers to physiological parameters such as HR,
SPO2, etc.).
If a parameter alarm setup is selected the corresponding
alarm setup items will be displayed in the ALARM
SETUP menu
„
ALARM VOL
Alarm volume
The volume can be set between 0 and 10. 0 means off
and 10 is the maximum volume.
The volume can not be set to 0 unless the ALARM
SOUND OFF is set to ENABLE (Refer to 4.7
Maintenance). When the ALARM VOL is set to 0, it
will not be saved upon power failure. After the monitor
restarts, the ALARM VOL restores the default. It will
also restore its default if you silence or pause alarms.
„
REMINDER VOL
Options: HIGH, MED, LOW.
„
ALM REC TIME
Alarm recording time
Options: 8S,16S and 32S.
When an alarm occurs, the recorder records according
to the alarm recording time.
„
ALM PAUSED TIME
Options: 1MIN, 2MIN and 3MIN.
4-9
4.4.3 Time Setup
Select TIME SETUP>> in SYSTEM SETUP menu. The following menu appears.
Figure 4-9 Time Setup
With the control knob, you can change the year, month, day, hour, minute and second as well as
select the displayed format of the time. YYYY, MM, and DD refer to year, month and day
respectively.
If the monitor is connected with the central monitoring system, the system time of the monitor
will be updated in accordance with the central monitoring system, and the TIME SETUP option
in SYSTEM SETUP menu will become disabled.
4-10
4.4.4 Recorder Setup
Select RECORD>> in SYSTEM SETUP menu. The following menu appears.
Figure 4-10 Recorder Setup
In this menu, you can adjust the following items:
„
REC WAVE1
Select the first waveform to be recorded. The setting of this item
should be different with those of REC WAVE 2 and REC WAVE3;
otherwise, the system will adjust the setting automatically. When
OFF is selected, the first waveform will not be recorded.
„
REC WAVE2
Select the second waveform to be recorded. The setting of this item
should be different with those of REC WAVE1 and REC WAVE3;
otherwise, the system will adjust the setting automatically. When
OFF is selected, the second waveform will not be recorded.
„
REC WAVE3
Select the third waveform to be recorded. The setting of this item
should be different with those of REC WAVE1 and REC WAVE2;
otherwise, the system will adjust the setting automatically. When
OFF is selected, the third waveform will not be recorded.
NOTE
z
If a parameter is not displayed on the screen, this parameter will not be an option
of REC WAVE 1, REC WAVE 2 and RECORD WAVE3..
4-11
„
RT REC TIME
Real-time recording time
Options: CONTINUAL and 8s.
„
TIMING REC TIME
Timing recording time
The interval between automatic recordings.
Options: OFF, 10MIN, 20MIN, 30MIN, 40MIN, 50MIN,
1HOUR, 2HOURS, 3HOURS and 4HOURS. The monitor will
start recording at the selected interval, record for 8s and stop
automatically.
NOTE
z
TIMING REC TIME cannot be saved after the monitor is turned off. But it can be
saved as the user default configuration.
RT REC TIME has priority over TIMING REC TIME.
„
REC RATE
Recording rate
Options: 25.0 and 50.0; unit: mm/s;
„
REC GRID
Recording grid
ON: You can select ON to print a grid on the recorder paper;
OFF: You can select OFF to print without grid on the recorder
paper.
„
CLEAR REC TASK
Clear recording task
This key allows you to clear all current recording tasks.
z
4.4.5 Data Output
Select DATA OUTPUT>> in SYSTEM SETUP menu. The following menu appears.
Figure 4-11 Data Output
4-12
Output Procedure
1.
2.
3.
4.
5.
Disconnect all patient cables connected to the monitor.
Verify the monitor is connected to the PC and the PC is running the Patient Information
Recall System software.
Select from the data source options.
Select OUTPUT in the menu and the prompt “CONNECTING…” is shown aside. If you
exit the DATA OUTPUT menu at this time, the prompt will be displayed in prompt
information area at the lower left corner of the screen.
If the connection is available, the data will be output to the PC. For more information, please
refer to the help information of the Patient Information Recall System software.
NOTE
z
If no data source is selected or the previous data output has not finished, the
OUTPUT option in the DATA OUTPUT menu will be inactive.
4.4.6 Analog Output
Select ANALOG >> in SYSTEM SETUP menu. The following menu appears.
Figure 4-12 Analog Output
You can perform the following settings in the menu above:
„
ANALOG OUT
Analog output
Options: ON and OFF.
When ON is selected, analog signals can be output from
the auxiliary output port on the rear panel of the monitor.
„
ANALOG WAVE
Options: ECG1, ECG2, IBP1 and IBP2;
In the MULTI-LEADS DISPLAY mode, the ECG3,
ECG4, ECG5 and ECG6 options are also available.
4-13
NOTE
z
If DEFIB. SYN or NURSE CALL is selected from the AUX OUTPTU options in
the USER MAINTAIN menu, the ANALOG>> option in the SYSTEM SETUP
menu will be inactive, and the monitor will be unable to output analog signals. For
details, please refer to 4.7 Maintenance.
4.4.7 Module Setup
Select MODULE SETUP>> in SYSTEM SETUP menu. The following menu appears.
Figure 4-13 Module Setup
This menu allows you to enable or disable a parameter module to determine the information
displayed on the main screen. As shown in the figure above, “√” indicates an enabled module. A
module without the “√” mark is disabled and the related waveform and parameter data disappear
from the display.
4-14
4.4.8 Trace Setup
Select TRACE SETUP>> in SYSTEM SETUP menu. The following menu appears.
Figure 4-14 Trace Setup
This menu allows you to select the parameter waveform(s) to be displayed. The mark “√”
indicates the parameter waveform will be displayed, and that without the mark will not be
displayed. The TRACE SETUP menu merely contains the parameter modules enabled in the
MODULE SETUP menu. Besides, in the MULTI-LEADS DISPLAY mode or the
HALF-SCREEN MULTI-LEADS display mode, the ECG1 waveform and the ECG2 waveform
are inactive.
In addition, the WAVE SEQUENCE >> option allows you choose in which sequence the
parameter waveforms are displayed from the upper to the lower.
Figure 4-15 Wave Sequence
4-15
4.4.9 Mark Event
Select MARK EVENT>> in SYSTEM SETUP menu. The following menu appears.
Figure 4-16 Mark Event
This menu allows you to mark four different events, namely event A, B, C and D. The “@”
symbol will appear in the frame of the event being selected. If you attempt to unmark an event,
press the control knob again on the marked selection.
The purpose of event marking is to define the records, such as dose taking, injections or therapy,
which have influence on patients and parameter monitoring. A mark will be displayed on the
trend graph/table indicating the time the mark was initiated in relation to the event it represents.
4-16
4.5 Selection Setup
Select SELECTION>> in SYSTEM MENU. The following menu appears.
Figure 4-17 Selection Setup
You can perform the following settings in this menu:
„
KEY VOL
Key volume
The volume can be set between 0 and 10. 0 indicates the
volume is off and 10 indicates the maximum volume.
„
HELP
Online help
ON: Indicates the online help is enabled and the help
information will be displayed;
OFF: Indicates the online help function is disabled and the
help information will not be displayed.
„
SCAN TYPE
Scan type
REFRESH: The waveform keeps stationary, with real-time
refreshing from the left to the right by a moving "erase bar";
SCROLL: The waveform moves from the right to the left with
time passing by.
„
ALM LIMIT
Alarm limit
ON: The alarm limits of parameters are displayed aside the
parameter value;
OFF: The alarm limits of parameters are not displayed aside.
„
BRIGHTNESS
The brightness can be set between 1 and 10. 1 indicates the
lowest brightness and 10 indicates the highest brightness.
4-17
4.6 Monitor Version
You can select VERSION>> in the SYSTEM MENU to check the version information as shown
below.. However, the VERSION menu of you monitor may be different.
Figure 4-18 Version
You can see the monitor’s configuration by selecting DEVICE CONFIG LIST>> as shown below.
However, the DEVICE CONFIG LIST menu of you monitor may be different.
Figure 4-19 Device Configuration List
4-18
You can also see the device version by selecting DEVICE VERSION LIST>> as shown below.
However, the DEVICE VERSION LIST menu of you monitor may be different.
Figure 4-20 Device Version List
4.7 Maintenance
Select MAINTAIN>> in SYSTEM MENU. The following menu appears.
Figure 4-21 Enter Maintain Password
4-19
Enter USER KEY, then select CONFIRM button. The following menu appears.
Figure 4-22 User Maintain
You can perform the following settings:
„
MONI NAME
Monitor’s name.
„
DEPT.
The department where the monitor is located.
„
BED NO
The bed number where the monitor is located.
„
NET TYPE
Network type
Options: CMS and CMS+.
„
LOCAL NET NO
It indicates the bed number of a monitor in the monitoring
network. If the NET TYPE is CMS, the LOCAL NET NO can
be set between 1 and 64.
„
NOTCH FREQ.
Options: 50Hz and 60Hz;
If NOTCH is turned ON, the monitor filters the ECG signals
with the selected notch frequency.
„
LANGUAGE
Select the required language of the displayed texts.
„
AUX OUTPUT
Three options are available:
4-20
1.
ANALOG OUT (analog output)
‹ If this option is selected, the auxiliary output port will be able to output analog signals,
and you can perform the settings in the ANALOG menu. For details, see 4.4.6 Analog
Output.
‹ If this option is not selected, the analog output function will be disabled and the
ANALOG >> option in the SYSTEM SETUP menu will become inactive. In this
situation, you cannot set the information in the ANALOG menu.
2.
NURSE CALL
‹ If this option is selected, the auxiliary output port will be able to output nurse call
signals, and you can perform the settings in the NURSE CALL SETUP submenu of the
USER MAINTAIN menu. For details, see 4.7.4 Nurse Call Setup.
‹ If not selected, the nurse call function will be disabled and the NURSE CALL
SETUP>> option in USER MAINTAIN will become inactive. In this situation, you
cannot set the information in the NURSE CALL SETUP submenu.
3.
DEFIB. SYN (defibrillator synchronization signals)
‹ If this option is selected, the auxiliary output port will be able to output defibrillator
synchronization signals. In this situation, you can turn on DEFIB SYNC in the ECG
SETUP menu to enable the defibrillator synchronization. For details, see 10.4 ECG
Setup Menu.
‹ If not selected, the defibrillator synchronization function will be disabled and the
DEFIB SYNC option in the ECG SETUP menu will set to OFF (it will not be
user-adjustable).
„
LEAD NAMING
Options: AHA and EURO;
„
POWERON CONFI
It indicates the configuration to be loaded when the monitor is
powered on. The options are LAST CONF, USER ADU
CONF, USER PED CONF and USER NEO CONF.
LAST CONF is the real-time configuration that is selected
before the monitor is last turn off. If the user configuration of
a patient type is not saved, the factory configuration of this
type will be loaded.
If the time interval between turnoff and turnon is less than 60
seconds, LAST CONF is automatically restored when the
monitor is restarted. If this time interval is greater than 120
seconds, the setting of POWERON CONF will be loaded
when the monitor is restarted.
„
SAVE AS USER
CONFIG
You can change the monitor’s settings and save the changed
settings as user configuration of this patient type so that you
can load the user configuration when a new patient is
admitted.
You can restore the saved user configuration in the CONFIG
menu or set it as POWERON CONFI.
4-21
NOTE
z
z
z
If you changed the net type and language, the settings take effect only after you
restart the monitor.
The setting of the notch frequency can neither be saved as the user configuration
nor changed when the factory configuration is selected. Once set by a user, no
operation except for manual adjustment can change it. The setting keeps the same
even when the monitor is restarted.
Do not change the BED NO when your monitor is using the wireless network
feature.
4.7.1 Alarm Setup
Select ALARM SETUP>> to enter the following menu:
Figure 4-23 Alarm Setup
„
ALARM SOUND OFF
ENABLE: ALARM VOL can be set to 0.
DISABLE: ALARM VOL cannot be set to 0.
„
AUDIO OFF
MODE 1: the alarm sound interval of high level alarm is
8s and that of medium level alarm is 24s.
MODE 2: the alarm sound interval of high level alarm is
3s and that of medium level alarm is 14s.
„
PARA ALM TYPE
LATCH, UNLATCH
„
REMINDER TONE
Options: ON,OFF.
„
REMINDER INTERVAL
Options: 1MIN, 2MIN and 3MIN.
„
ECG LEAD OFF
Alarm level: HIGH, MED, LOW.
„
SpO2 SENSOR OFF
Alarm level: HIGH, MED, LOW.
4-22
NOTE
z
In the case that alarm volume is set to 0, if you set ALARM SOUND OFF to
DISABLE, alarm volume change to the default.
WARNING
z
Select the setting of ALARM SOUND OFF with caution.
4.7.2 IP Address Setup
When the monitor is connected with the central monitoring system, and the NET TYPE is CMS+,
you need to set the IP address of your monitor. Select IP ADDRESS SETUP in USER
MAINTAIN menu. The following menu appears. For details, please contact with the technician
responsible for the central monitoring system in your hospital.
Figure 4-24 IP Address Setup
4-23
4.7.3 Self Definition of Color
Select COLOR SELF-DEFINE >> in USER MAINTAIN menu. The following menu appears.
Figure 4-25 Self-definition of color
This menu allows you to choose in which color the waveform(s) and parameter(s) of a parameter
module are to be displayed.
„
„
„
„
OTHER PARA refers to the parameters, NIBP and TEMP, which do not have waveform.
CO2 refers to the parameters measured by CO2 module or AG module.
AG O2, AG N2O and AG AA refer to corresponding parameters measured by AG module.
AA refers to the used anesthetic agent. If the anesthetic agent is available before opening the
COLOR SELF-DEFINE menu, the name of the anesthetic agent will be displayed instead of
AA.
NOTE
z
Your monitor may not include all parameters.
4-24
4.7.4 Nurse Call Setup
Select NURSE CALL SETUP >> in USER MAINTAIN menu. The following menu appears.
Figure 4-26 Nurse Call Setup
You can perform the following settings:
„ SIGNAL DURATION
Two options are available: PULSE, and CONTINUUM.
1. PULSE
When pulse is selected, a nurse call signal is a pulse signal lasting 1s. When multiple alarms
occur simultaneously, only one pulse signal will be output. If an alarm comes out before the
previous alarm is cleared, another pulse signal will be output.
2. CONTINUUM
When continuum is selected, the duration of a nurse call signal is the same with the alarm,
namely, from the time that the alarm occurs to the time it disappears.
„ SIGNAL TYPE
1. NORMAL OPEN: Select this option when the hospital’s call system is set to NORMAL
OPEN.
2. NORMAL CLOSE: Select this option when the hospital’s call system is set to NORMAL
CLOSE.
„
ALM LEV
Alarm level
Options: HIGH, MED (medium) and LOW.
More than one option can be selected at one time.
„
ALM TYPE
Alarm type
Options: TECH. (technical) and PHYS. (physiological).
Both options can be selected at one time.
4-25
Trigger Conditions
A nurse call signal will be triggered only if all the following conditions are met:
1. The nurse call function is enabled.
2. An alarm of the preset alarm level and alarm type comes out.
3. The monitor is not in the Alarms Paused or the System Silenced status.
NOTE
z
z
z
If no option in ALM LEV or ALM TYPE is selected, the nurse call signal will not
be triggered in whatever condition.
The nurse call function can’t be used as the main alarm notice method. Medical
staff must combine the audible and visual alarms, the clinical vital signs of the
patient to determine the patient’s situation.
In the Alarms Paused or the System Silenced status, the nurse call function of the
monitor will be disabled automatically.
4.7.5 IBP Pressure Calibration
The monitor provides the function of IBP pressure calibration.
4.7.6 CO2 User Maintain
Selecting CO2 USER MAINTAIN >> in USER MAINTAIN menu opens the CO2 USER
MAINTAIN menu. The options contained in this menu are relative with the CO2 module that you
monitor is equipped with. For details, please refer to chapter CO2 Monitoring.
4.7.7 Gas Calibrate
Selecting GAS CALIBRATE >> in USER MAINTAIN menu opens the GAS CALIBRATE
menu. The options contained in this menu are relative with the AG module that you monitor is
equipped with. For details, please refer to chapter Anesthesia Gas Monitoring.
4-26
4.7.8 Monitor Status
Select STATUS >> in ENTER MAINTAIN PASSWORD menu. The following menu appears.
Figure 4-27 Monitor Status
„
UP-DOWN
This menu can display a maximum of ten status messages. In
case of more than ten, you can select UP-DOWN to learn
other status messages.
„
REC
Recording
You can select the REC option to record the status message
displayed.
4-27
4.8 DEMO Function
Select DEMO >> in SYSTEM MENU. The following menu appears.
Figure 4-28 Input Demo Key
The monitor enters the demonstration mode when the correct password is input in the menu
above. The word DEMO will be displayed on the main screen. The purpose of the demonstration
display is to demonstrate the performance of the monitor, and for training purposes.
WARNING
z
In clinical applications, this function is forbidden because the DEMO display
can mislead the medical staff to treat the DEMO waveforms and parameters as
the actual data of the patient. This may result in serious injury to the patient, or
a delay of treatment or improper treatment.
4-28
5 Face Selection
5.1 Standard Screen
You can open the FACE SELECT menu by selecting FACE SELECT >> in SYSTEM SETUP
menu.
Figure 5-1 Face Select
The standard screen is the default screen. If the current screen is not the standard screen, you may
enter the standard screen by selecting STANDARD SCREEN and then selecting EXIT in FACE
SELECT menu. For more information about the standard screen, see 2.4 Display.
Figure 5-2 Standard Screen
5-1
5.2 Trend Screen
To enter the following screen, select TREND SCREEN in FACE SELECT menu and then select
EXIT.
Figure 5-3 Trend Screen
„ Trend graph
Trend graphs locate to the right of the corresponding waveform in the waveform area, and
display the trends of one parameter of each module. The parameter labels, as well as their scales,
are displayed to the left of the trend graph.
„ Trend length
The dynamic trend length, located below the trend graph, is 2 hours. On the trend graph, the scale
of the right end of the X-axis is 0 hour while the left end is -2 hour.
„ Selecting a trend parameter
If a module has multiple trend parameters, you can select one from the parameter label options of
the corresponding trend graph. The trend graph of the selected parameter will be displayed.
5-2
5.3 OxyCRG Screen
To enter the following screen, select oxyCRG SCREEN in FACE SELECT menu and then select
EXIT.
1
2
3
Figure 5-4 OxyCRG Screen
Oxy CRG screen is located at the lower part of the waveform area, consisting of the HR trend,
the SpO2 trend, and the RR (respiration rate) trend or the compressed respiration waveform.
Below the RR trend or the compressed respiration waveform is the scale of the trend time. In
addition, three labels are displayed beneath the time scale (see 1, 2 and 3 in the figure above).
The labels are detailed as below.
1. Trend length
This label allows you to select the time duration of the trend graphs displayed. You can
select either 1 MIN, 2 MIN or 4 MIN.
2. Compressed respiration waveform/RR trend
With this lable, you can select to display the compressed respiration waveform or the RR
trend beneath the SpO2 trend.
3. Recording
You can select the REC label to print out the the trends or the waveform displayed in the
oxyCRG screen using the recorder.
5-3
5.4 Viewbed Screen
This monitor can view one parameter waveform and measured data from another patient monitor
(viewbed monitor) on the same monitoring network. To enter the following screen, open FACE
SELECT menu, select VIEWBED SCREEN, and then select EXIT. When connecting by wireless
network (if your monitor has this feature), viewbed function is disabled.
1
3
6
4
2
5
Figure 5-5 Viewbed Screen
The monitor you are viewing from is called “host monitor”. The monitor being viewed is called
“viewbed monitor”. The viewbed screen is always displayed at the lower part of the host
monitor’s waveform area. As shown in Figure 5-5, it consists of the following parts.
5-4
1.
2.
3.
4.
5.
6.
Viewbed monitor label
The viewbed monitor lable allows you to select the viewbed monitor you want to view. It
displays the bed number and patient name of the viewbed monitor. If they are not entered,
the label displays blank. If the host monitor is not connected with any other monitor on the
same network, the label displays N/A.
Viewbed waveform label
The viewbed waveform label allows you to select a waveform of the viewbed monitor. If the
viewbed monitor does not dispaly any waveform, this label displays N/A.
Viewbed alarm indicator
The viewbed alarm indicator in the viewbed screen is used to indicate the alarm status of the
viewbed monitor. Its color is identical with that of the viewbed monitor.
Viewbed parameter area
All parameter data of the viewbed monitor is displayed in this area.
Viewbed waveform area
The viewbed waveform area is located beneath the viewbed waveform label. It displays the
waveform selected through the viewbed waveform label. The scan type (either refresh or
scroll) and the sweep speed of the viewbed waveform follow the host monitor. Besides,
information relating to the viewbed waveform is shown above the waveform.
Technical information area
On the right of the viewbed monitor label is the technical information area. It shows the
technical information about viewing of other patient, such as the prompt information
indicating failure in viewing other patient due to network problems.
Automatic Selection
When the viewbed screen is opened, the host monitor automatically selects a viewbed monitor on
the same network and a waveform of this monitor to view. In case the monitor being viewed is
disconnected, the host monitor automatically closes the display of alarms, parameters and the
waveform of the viewbed monitor. However, the host monitor will not automatically select to
view other monitor. You must make the selection using the viewbed monitor label manually.
If a parameter module of the viewbed patient monitor is turned off or disassembled, the
corresponding waveform displayed on the host monitor disappears, and the viewbed waveform
area becomes blank. At this time, you can use the viewbed waveform label to view other
waveform.
5-5
5.5 Large Font Screen
To enter the following screen, open FACE SELECT menu, select LARGE FONT SCREEN, and
then select EXIT.
Figure 5-6 Large Font Screen
As shown above, the HR, SpO2 and NIBP values (diastolic pressure, mean pressure and systolic
pressure) are displayed in large font. The ECG and SpO2 waveforms are displayed on the upper
left of the screen. In case the ECG, SpO2 or NIBP parameter module is turned off, the
corresponding parameters and waveform disappear. If all the three modules are closed, no
waveform or parameter is displayed on the screen.
NOTE
z
z
When you open a menu in the large font screen mode, the monitor will enter the
standard screen automatically. When you exit the menu, the monitor will return
to the large font screen.
If MULTI-LEADS DISPLAY is selected in the ECG SETUP menu, the monitor
cannot enter the large font screen.
5-6
5.6 Standby Mode
During patient transport or temporary departure of a patient, the monitor can be set to STANDBY
mode. In this mode, the monitor suspends the monitoring and measurement on the patient and
shields all alarm indications. Besides the WORK MODE of CO2 and AG module (if available),
which will also be changed to STANDBY, the previous menu settings and patient information
keep unchanged.
Entering the STANDBY mode
1.
2.
3.
4.
Disconnect all leads and sensors between the patient and the monitor.
Select the STANDBY label at the lower right corner of the main screen. A dialog box pops
up, and you can choose to enter the standby mode or not.
Select YES, and the monitor will enter the standby mode as shown below.
Select NO, and the monitor will return to the previous screen.
Figure 5-7 Standby Mode
Exiting the STANDBY mode
Press any key other than the power switch on the control panel or turn the control knob in the
STANDBY mode, and a dialog box will pop up. Select YES in the dialog box, and you will exit
the STANDBY mode and return to the previous screen.
5-7
FOR YOUR NOTES
5-8
6 Alarms
6.1 Overview
The monitor gives audible or visual alarms to indicate the medical staff, when a vital sign of the
patient appears abnormal, or mechanical or electrical problems occur to the monitor.
Upon turning on the monitor, the alarm indicator will flash once in yellow and red. Then, a beep
will be heard. This is used to verify the audible and visual alarm function of the monitor. If no
beep is heard, or the alarm indicator doesn’t flash normally, please do not use the monitor, and
contact our customer service.
For details about alarm setup of this monitor, please refer to 4.4.2 Alarm Setup.
6.1.1 Alarm Categories
The alarms are divided into three categories: physiological alarms, technical alarms and prompt
information.
1. Physiological alarms
A physiological alarm either indicates that a monitored physiological parameter is out of
specified limits or indicates an abnormal patient condition. For example: HR TOO LOW,
ECG LOST or RESP ARTIFACT, etc. Physiological alarm messages are displayed in the
physiological alarms area of the main screen.
2. Technical alarms
Technical alarms are also referred to as system error messages. A technical alarm indicates
that the monitor or parts of the monitor is not capable of accurately monitoring the patient’s
condition due to improper operation or system failure. For example: ECG INIT ERR or
TEMP SELFTEST ERROR, etc. Technical alarm messages are usually displayed in the
technical alarms area of the main screen. But the technical alarms related to NIBP are
displayed in the lower part of the NIBP parameter window.
3. Prompt information
Strictly speaking, prompt information cannot be counted in alarms. It is usually information
relating to the system, but not concerning vital signs of patients. For example, the monitor
prompts “NIBP alarm disabled!” at the time the monitor is powered on. Besides, if a
parameter module is turned on but the required leads or sensor are not connected, the
monitor will prompt accordingly, such as “ECG LEAD OFF” or “SPO2 SENSOR OFF”, etc.
Prompt information is usually displayed in the technical alarms area. But the prompt
information relating to NIBP is displayed in the lower part of the NIBP paramter window.
NOTE
z
To distinguish from the prompt information, the alarm message is displayed
with yellow or red background.
6-1
6.1.2 Alarm Levels
The alarms are divided into three priority levels: high level alarms, medium level alarms and low
level alarms.
1.
„
„
2.
„
„
3.
„
High level alarms
The patient ‘s life is in danger and requires emergency treatment, or
Serious technical problem occurs to the monitor, such as error in ECG module initialization.
Medium level alarms
Vital signs of the patient become abnormal, and patient requires immediate treatment, or
Certain technical problem occurs to the monitor, such as error in temperature calibration.
Low level alarms
Certain technical alarm occurs to the monitor, such as ECG lead off in measurement.
The levels of all technical alarms and some physiological alarms are not user-adjustable, because
they have been fixed when the monitor is produced. However, you can change the levels of some
physiological alarms in the corresponding parameter setup menus.
All physiological alarms, technical alarms and prompt information are given in chapter Alarm
Messages and Prompt Information.
6.2 Alarm Modes
When an alarm occurs, the monitor raises the user’s attention by the following audible or visual
indications.
„ Visual alarms
„ Audible alarms
„ Alarm messages
„ Parameter flashes
„ Reminder Tones
Besides, the visual alarms, audible alarms and alarm messages are given in different ways to
identify different alarm levels.
6.2.1 Visual Alarms
The alarm indicator on the front panel of the monitor varies its flash color and frequency to
indicate different alarm levels.
„ High level alarm:
red and quick flash;
„ Medium level alarm:
yellow and slow flash;
„ Low level alarm:
yellow light without flash.
6-2
6.2.2 Audible alarms
The monitor uses different alarm tones to indicate different alarm levels.
„ High level alarm:
“DO-DO-DO--DO-DO---DO-DO-DO--DO-DO”.
„ Medium level alarm:
“DO-DO-DO”.
„ Low level alarm:
“DO”.
Different intervals correspond to different alarm levels: High level alarm phonates once every 3
or 8 seconds. Medium level alarm phonates once every 14 or 24 seconds. Low level alarm
phonates once every 24 seconds. For details, please refer to 4.7 Maintenance.
NOTE
z
When multiple alarms of different levels occur simultaneously, the monitor
selects the alarm of the highest level and gives alarm tone accordingly.
6.2.3 Alarm Messages
Alarm messages are given when alarms occur. The alarm messages are displayed in the
physiological alarms area or the technical alarms area in black. For physiological alarms,
asterisks are displayed before the alarm messages to identify the alarm level.
„ High level alarms:
triple asterisks “***”
„ Medium level alarms: dual asterisks “**”
„ Low level alarms:
single asterisk “*”
The monitor varies the background color of the technical and physiological alarm messages to
indicate the alarm level.
„ High level alarms:
red background color
„ Medium level alarms: yellow background color
„ Low level alarms:
yellow background color
NOTE
z
z
Comparing with an alarm message, the background color of prompt
information is the same as that of the position where it appears.
The NIBP technical alarm messages appear in the NIBP parameter window. For
high level alarms, the text color is red; for medium and low level alarms, the text
color is yellow. The background color is the same as the parameter window.
6-3
6.2.4 Parameter Flashes
An alarm is triggered when a patient parameter exceeds the parameter limit. At the same time, the
measured parameter value in the parameter window flashes every second. If the ALM LIMIT in
the SELECTION menu is turned ON, the exceeded upper or lower alarm limit also flashes every
second.
6.2.5 Reminder Tones
When system sounds are silenced or alarm tones are turned off, the patient monitor will give a
single beep in case of an active alarm condition. You can set the REMINDER VOL to HIGH,
MED or LOW. For details, please refer to 4.4.2. Alarm Setup The REMINDER TONE can be
turned on or off , and you can set REMINDER INTERVAL as required. For details, please refer
to 4.7.1 Alarm Setup.
6.3 Alarm Statuses
When an alarm occurs, normally the monitor gives indications in the modes mentioned above as
per the alarm level. If necessary, you can the set the monitor to the following alarm statuses.
„
Alarms Disabled
„
Alarms Paused
„
System Silenced
„
Alarm Sound Off
6.3.1 Alarms Disabled
If the alarm switch of a parameter is turned off, the monitor does not generate alarms even if the
measured parameter value exceeds the alarm limit. This status is called Alarms Disabled.
To disable the alarms of a parameter, you should open the setup menu of the parameter. Take
heart rate (HR) as an example.
1. Rotate the control knob and highlight the ECG parameter label.
2. Press the control knob. The ECG SETUP menu pops up.
3. Rotate the control knob and highlight the field on the right of HR ALM.
4. Press the control knob, and then select OFF from the pull-down list.
5.
The HR alarms are disabled. The
parameter label.
icon will be displayed on the right of the ECG
6-4
NOTE
z
When a new parameter module is installed or when a parameter module is
turned ON, all the parameter alarms and technical alarms related to this
module are disabled in the first 30-second operating time. The other module
alarms are not influenced.
6.3.2 Alarms Paused
To pause all alarms of the monitor for 1, 2 or 3 minutes, press the SILENCE key on the control
panel once (for less than 2 seconds). In Alarms Paused status,
„ Visual alarms and audible alarms are both paused.
„ The parameters generating physiological alarms and their upper or lower limits stop
flashing.
„ Alarm messages are not displayed.
„ The physiological alarms area shows the rest time of alarms paused status.
„
The
icon will be displayed in the sound icon area.
The monitor will not terminate the Alarm Paused status even if a new technical or physiological
alarm occurs during the alarms paused time.
6.3.3 System Silenced
To silence the system, press the SILENCE key for no less than 2 seconds. In the System Silenced
icon is displayed in the sound icon area.
status, all system sounds are shielded and the
However, other modes of alarms (excluding audible alarms) are given as normal. If a new alarm
occurs, the System Silenced status will be terminated.
The system sounds include the audible alarms, key tones, heart beat tones and pulse tones.
Among them, key tones refer to the sounds produced when the control knob is rotated and
pressed.
6.3.4 Alarm Sound Off
In Alarm Sound Off status, all audible alarms are suppressed, but other modes of alarms and
icon will be displayed in the sound icon area. To turn
other sounds are not influenced. The
off the audible alarms, first access the USER MAINTAIN menu, and then set the ALARM
SOUND OFF to DISABLE. For details, please refer to 4.7 Maintenance.
6-5
6.3.5 Status Switchover
1.
„
„
In the Normal status,
Press the SILENCE key for less than 2 seconds to switch to the Alarms Paused status, or
Press the SILENCE key for 2 seconds or more to switch to the System Silenced status.
2.
„
„
In the Alarms Paused status,
Press the SILENCE key for less than 2 seconds to switch to the Normal status, or
Press the SILENCE key for 2 seconds or more to switch to the System Silenced status.
3.
„
„
In the System Silenced status,
Press the SILENCE key for less than 2 seconds to switch to the Alarms Paused status, or
Press the SILENCE key for 2 seconds or more to switch to the Normal status.
4.
„
In the Alarm Sound Off status,
Enter the ALARM SETUP menu and set ALARM VOL to any setting other than 0. The
alarm sound is restored.
Enter the USER MAINTAIN menu and set ALARM SOUND OFF to DISABLE. The
system restores the default alarm volume.
„
6.4 Latching Alarms
As described in 4.7 Maintenance, the parameter alarm type can be set to either LATCH or
UNLATCH.
If the parameter alarm type is set to LATCH, before or during the occurence of a parameter alarm,
the alarm message will be latched even if the initial alarm condition has ceased. The alarm
messsage continues to be displayed, but the alarming modes change as follows:
„ The measured parameter value and the upper or lower parameter limit stop flashing.
„ The generated time of the alarm is displayed behind the alarm message in the physiological
alarms area.
If the parameter alarm type is set to UNLATCH, the monitor stops giving any indication for this
alarm when the initial alarm condition has ceased.
6-6
6.5 Clearing Alarms
Generally the alarm indications of an alarm will automatically be cleared when the alarm
condition that triggered the alarm ceases. However, you can also clear the alarm indications or
the latched alarms by the following ways.
1. Clearing audible and visual alarm indications
For some technical alarms, the audible and visual alarm indications will be cleared if the monitor
is set to the Alarms Paused status (by pressing the SILENCE key for less than 2 seconds), and the
alarm message will be changed to prompt information during and after the alarms paused time. If
the technical alarm is triggered again after the monitor restores to the normal status, the monitor
will give alarming indications as normal.
Please refer to chapter Alarm Messages and Prompt Information to see for which technical
alarms that the audible and visual indications can be cleared.
2. Clearing all alarm indications
For some technical alarms, if the monitor is set to the Alarms Paused status (by pressing the
SILENCE key for less than 2 seconds), all alarm indications will be cleared during and after the
alarms paused time. If the technical alarm is triggered again after the monitor restores to the
normal status, the monitor gives alarming indications as normal.
Please refer to chapter Alarm Messages and Prompt Information to see for which technical
alarms that all alarm indications can be cleared.
3. Clearing latched alarms
Clearing latched alarms is also referred to as resetting alarms. It refers to clear the latched alarms
by setting the monitor to the Alarms Paused status (by pressing the SILENCE key for less than 2
seconds).
6-7
6.6 Testing Alarms
When the monitor starts up, a selftest will be performed automatically. The alarm indicator will
flash once in yellow and red. Then, the system gives a beep indicating that the visible and audible
alarm indicators are functioning correctly. The start-up screen is displayed.
For further testing of individual measurement alarms, perform the measurement on yourself (for
example SpO2 or CO2) or use a simulator. Adjust alarm limits and check if alarms behave
correctly.
6.7 When an Alarm Occurs
WARNING
z
When an alarm occurs, always check the patient’s condition first.
When an alarm occurs to the monitor, refer to the following steps and take action properly.
1. Check the patient’s condition.
2. Identify the alarming parameter and the alarm category.
3. Identify the cause of the alarm.
4. Take action to remedy the alarm cause.
5. Check if the alarm is cleared.
For details about how to deal with specific alarms, see chapter Alarm Messages and Prompt
Information.
6-8
7 Freezing Waveforms
7.1 Overview
You can freeze the monitored waveforms of a patient as desired and view the waveforms of 40
seconds to gain a clear observation. Besides, the monitor can print three frozen waveforms using
the recorder.
The freezing function of the monitor has the following features.
„ When the monitor enters the frozen mode, it exits all other menus automatically.
„ The system freezes all waveforms displayed in the waveforms area.
„ The frozen waveforms can be reviewed and recorded.
7.2 Freezing and Unfreezing
Entering the Frozen Mode
1.
2.
Press the FREEZE key on the control panel when the monitor is not in frozen mode.
The system exits all displayed menus (if displayed), and the FROZEN menu pops up.
Figure 7-1 Frozen Menu
3.
All displayed waveforms are frozen. In other words, the waveforms stop being refreshed or
scrolling.
Exiting the Frozen Mode
To exit the frozen mode,
„ Select EXIT in the FROZEN menu, or
„ Press the FREEZE key on the control panel again.
After exiting the frozen mode, all waveforms on the screen are cleared and new real-time
waveforms are displayed. If the scan type of the monitor is set to REFRESH, the waveforms are
refreshed from the left of the waveforms area to the right ; if the scan type is set to SCROLL, the
waveforms are displayed from the right of the waveforms area to the left and are scrolling.
7-1
7.3 FROZEN Menu
The FROZEN menu is displayed at the lower left corner. You can perform the following settings
in this menu.
„
WAVE 1
Waveform 1
It determines the first frozen waveform to be printed on the recorder
paper. The options of waveform 1 include all waveforms displayed on the
screen and OFF. The waveform 1 will not be recorded when OFF is
selected.
„
WAVE 2
Waveform 2
It determines the second frozen waveform to be printed on the recorder
paper. The options of waveform 2 include all waveforms displayed on the
screen and OFF. The waveform 2 will not be recorded when OFF is
selected.
„
WAVE 3
Waveform 3
It determines the third frozen waveform to be printed on the recorder
paper. The options of waveform 3 include all waveforms displayed on the
screen and OFF. The waveform 3 will not be recorded when OFF is
selected.
„
RECALL
Waveform recall
It changes to L-RIGHT when selected. At this time, you can rotate the
control knob to view the frozen waveform.
„
REC
Record
When selected, the recorder starts printing out the selected waveform 1,
waveform 2 and waveform 3.
„
EXIT
This option allows you to exit the FROZEN menu and unfreeze the
waveforms.
7-2
7.4 Waveform Recall
1.
2.
3.
4.
5.
In the frozen mode, select the RECALL option in the FROZEN menu, and the option name
changes to L-RIGHT.
Rotate the control knob clockwise, and the frozen waveforms move to the right. At the
lower right corner of the first waveform is an arrow pointing upward. The time is indicated
below the arrow. The indication "0S" is used to mark the moment when the waveforms were
frozen.
With the waveforms move to the right, the time mark, in turn, changes to -1S, -2S, -3S…
The time mark is applied to all waveforms displayed on the screen.
Rotate the control knob anticlockwise, and the waveforms move to the left.
7.5 Recording Frozen Waveforms
1.
2.
3.
4.
5.
6.
7.
8.
Select WAVE 1, WAVE 2 and WAVE 3.
Select the REC option, and the recorder prints out the selected frozen waveforms and the
parameters measured at the moment when the waveforms were frozen.
If you set one or two waveforms to OFF, only the waveforms set to ON and corresponding
parameter values measured at the moment when the waveforms were frozen will be printed
out.
If WAVE 1, WAVE 2 and WAVE 3 are all set to OFF, the recorder will not print out any
waveform and will merely print out the parameters measured at the moment when the
waveforms were frozen.
The recording time length is identical to that of the waveforms displayed on the screen. If a
waveform is of faster sweep speed, its recording time is shorter.
During waveform recording, the monitor is still in frozen mode.
When the recording completes, you can select to record other waveforms.
If the recorder is not installed, selecting the REC option or pressing the RECORD key
triggers the "Recorder does not exit" message, which is displayed in the prompt information
area.
7-3
FOR YOUR NOTES
7-4
8 Recording
8.1 Overview
A thermal recorder can be equipped with the monitor. The performance of the recorder is
described as below.
„ Records patient information and parameters.
„ Records a maximum of three waveforms.
„ The optional recording rates: 25mm/s and 50mm/s.
„ The recording grid is optional.
„ Multiple recording types are supported.
For details about the recorder setup, please refer to 4.4.4 Recorder Setup.
8.2 Recording Types
The monitor supports the following types of recordings:
„ Real-time recording: continuous real-time recording or 8-second real-time recording.
„ Automatic recording.
„ Alarm recording: measured parameter alarm recording.
„ Frozen waveform recording.
„ Trend graph/table recording: trend graph, trend table, NIBP measurement or alarm event.
„ OxyCRG recording.
„ Monitor status information recording.
Real-time recording
Pressing the RECORD key on the control panel, the real-time recording starts and the current
parameters and waveforms are recorded. As described in 4.4.4 Recorder Setup, you can set the
RT REC TIME to 8S or CONTINUUM in the RECORD menu. You can also select the three
waveforms (REC WAVE 1, REC WAVE 2 and REC WAVE 3) to be recorded. If one or two of the
three waveforms is set to OFF, the recorder will merely print out the waveforms set to ON and all
the measured parameters; if all the three waveforms are set to OFF, the recorder will only print all
the measured parameters.
Automatic recording
The monitor starts recording at the selected interval (TIMING REC TIME) and record for 8s
waveforms automatically. For details, see 4.4.4 Recorder Setup.
8-1
Alarm recording
Alarm recording is measured parameter recording.
When a parameter alarm occurs, the recorder automatically records two waveforms of 8, 16 or 32
seconds (respectively 4, 8 or 16 seconds before and after the alarm. See 4.4.2 Alarm Setup) and
some measured parameters.
NOTE
z
For a parameter alarm recording, you must first set the ALM and ALM REC
options to ON.
Frozen waveform recording
In the frozen mode, the monitor can print the frozen waveforms displayed on the screen and the
parameters measured at the moment when the waveforms were frozen. For details, see 7.5
Recording Frozen Waveforms.
Trend graph/table recording
When the trend graph/trend table or a recall window is opened, you can select the REC option to
print out the trend graph, trend table, NIBP measurement or alarm event.
OxyCRG recording
In the oxyCRG screen, you can press the RECORD key on the control panel to print the three
trend graphs or waveforms from the recorder.
Monitor status information recording
The REC option in the STATUS menu allows you to print the status information of the monitor.
8-2
8.3 Recorder Operations
Continuous real-time recording
1.
2.
Press the RECORD key to start recording.
Press the RECORD key again to stop the recording.
8-second real-time recording
1.
2.
Press the RECORD key to start recording.
The recording stops automatically in 8 seconds.
Automatic recording
1.
2.
The recorder starts recording automatically at the preset interval (RT REC TIME).
The recording stops automatically in 8 seconds.
Alarm recording
1.
2.
When an alarm occurs, the recorder starts recording automatically.
The recording stops automatically when the preset alarm recording time (ALM REC TIME)
is over.
Frozen waveform recording
1.
2.
3.
4.
Press the FREEZE key to open the FROZEN menu.
Select WAVE 1, WAVE 2 and WAVE 3.
Select the REC option to record.
When the recording completes, the recorder stops automatically.
Trend graph recording
1.
2.
3.
Select TREND GRAPH>> in SYSTEM MENU to open the TREND GRAPH window.
Select the REC option to start recording.
When the recording completes, the recorder stops automatically.
8-3
Trend table recording
1.
2.
3.
Select TREND TABLE>> in SYSTEM MENU to open the TREND TABLE window.
Select the REC option to start recording.
When the recording completes, the recorder stops automatically.
NIBP measurement recording
1.
2.
3.
Select NIBP RECALL>> in SYSTEM MENU to open the NIBP RECALL window.
Select the REC option to start recording.
When the recording completes, the recorder stops automatically.
Alarm event recording
1.
2.
3.
4.
5.
Select ALARM RECALL>> in SYSTEM MENU to open the ALARM RECALL window.
Select the alarm recall time in the START and END fields.
Select the ALARM RECALL>> option and open the ALARM RECALL window.
Select the REC option to start recording.
When the recording completes, the recorder stops automatically.
OxyCRG recording
1.
2.
3.
Enter the OxyCRG screen.
Select the RECORD key when the OxyCRG screen is displayed, and the recorder starts
recording.
When the recording completes, the recorder stops automatically.
Monitor status information recording
1.
2.
3.
4.
Select MAINTAIN >> in SYSTEM MENU, and a popup menu is opened.
Select STATUS >> in the popup menu.
Select the REC option in the STATUS menu to start recording.
When the recording completes, the recorder stops automatically.
8-4
8.4 Installing Recorder Paper
Installing Procedure
1.
2.
3.
4.
5.
6.
Press the latch at the upper right of the paper compartment door to releases the door.
Lift the roller lever located at the upper left of the paper compartment as shown in the
following figure.
Insert a new roll of recorder paper into the compartment as shown below.
The roller of the recorder scrolls automatically, and the paper comes out of the
compartment.
Push down the roller lever.
Close the recorder door.
Roller
Figure 8-1 Installing Recorder Paper
CAUTION
z
z
z
Use the specified recorder paper only. Other recorder paper may cause the
recorder to print with poor quality, function improperly or not at all, or bring
damage to the thermal print head.
Do not pull the recorder paper with force when the printing is in process.
Otherwise, damages to the recorder may be incurred.
Do not leave the recorder door open except you are replacing the recorder paper
or removing a fault.
8-5
Removing the Paper Jam
If the recorder does not function properly or produces unusual sound, open the recorder door to
check for a paper jam. You can follow the operations below to remove the paper jam.
1. Open the recorder door.
2. Tear the paper off from the leading edge at the paper outlet.
3. Lift the lever on the upper left of the recorder.
4. Pull the paper from the paper inlet.
5. Re-insert the paper.
8-6
9 Recall
9.1 Overview
The monitor is able to store important patient data so that the user can review and record the data
as desired.
„ Trend Graph Recall
You can review the latest 1-hour trend graph of a measured parameter displayed every 1 or 5
seconds, or the latest 96-hour trend graph displayed every 1, 5 or 10 minutes.
„ Trend Table Recall
You can review the latest 96-hour trend table data of a measured parameter.
„ NIBP Recall
You can review 800 NIBP measurement results, each of which includes a systolic pressure, a
mean pressure, a diastolic pressure, a pulse rate and a measurement time.
„ Alarm Event Recall
You can review the latest 70 parameter alarm events, as well as the 8, 16, or 32-second
waveforms stored at the time of the alarm.
NOTE
z
When your monitor is powered off or the power is interrupted accidentally, all
the stored data is lost, if the monitor is not equipped with the function of
“Power-off Data Storage”.
9-1
9.2 Trend Graph Recall
Select TREND GRAPH >> in SYSTEM MENU. The following window appears.
4
1
2
3
5
6
1.
4.
Trend cursor 2.
Y-axis
5.
Cursor time
X-axis
3.
6.
Trend graph
Parameters area
Figure 9-1 Trend Graph
As shown above, PARA1, PARA2 and PARA3 allow you to select a parameter from the options.
The trend graph of the selected parameter is displayed. If NIBP is selected, no trend graph is to
be displayed. Instead, the u mark indicates the systolic pressure, the t mark indicates the
diastolic pressure and the * mark indicates the mean pressure. The x-axis shows the time scale
while the y-axis shows the value scale of a parameter. The trend cursor
is used to identify a
specific time in the whole trend time, and it is displayed below the title “TREND GRAPH”. All
the parameter values measured at the time of the cursor are displayed in the parameters area.
„
1.
2.
3.
PARA SELECT (Parameter Selection)
Rotate the control knob and highlight the field at the right side of PARA1, PARA2 or
PARA3.
Press the control knob, and a popup menu with all parameter options is opened.
Rotate the control knob and highlight your desired parameter, and then select it. The trend
graph of the selected parameter is displayed in the TREND GRAPH window.
9-2
„
1.
2.
3.
4.
„
1.
2.
3.
„
1.
2.
3.
When “OFF” is selected for “PARA1”, “PARA2” or “PARA3”, its trend graph will
disappear, and then the trend graphs of other parameters will increase in amplitude and
evenly occupy Parameters area. You can not select the same option for “PARA1”,
“PARA2” and “PARA3” simultaneously other than “OFF”.
RESOLUTION
Rotate the control knob and highlight the field at the right of RESOLUTION.
Press the control knob, and a menu pops up.
Select 1S or 5S to review a 1-hour trend graph, or
Select 1MIN, 5MIN or 10 MIN to review a 96-hour trend graph.
L-RIGHT
Rotate the control knob to highlight the L-RIGHT option, and then press.
If the
mark is displayed at the upper left corner of the trend graph, you can rotate the
control knob anticlockwise to review the earlier trend graph.
is displayed at the upper right of the trend graph, you can rotate the control
If the mark
knob clockwise to review the later trend graph.
CURSOR
Rotate the control knob to highlight the CURSOR option, and then press.
Rotate the control knob, and the trend cursor moves as per the preset resolution.
The cursor time and the values displayed in the parameters area change accordingly.
„ REC (Recording)
The REC option allows you to print the currently displayed parameters and trend graph from the
recorder.
„
Mark Event
If an event is marked A, B, C or D, the mark ( A, B, C or D )will be displayed at the mark time
on the trend graph.
NOTE
z
The chapter uses "earlier" or "later" to indicate the time that an event
happened. For example, May 28 is earlier than May 29, and 8:00 on May 29 is
earlier than 9:00 on May 29.
9-3
9.3 Trend Table Recall
Select TREND TABLE >> in SYSTEM MENU. The following window appears.
Figure 9-2 Trend Table
The TIME is displayed on the left of the trend table. On the top is the latest time. From the upper
to the lower, the interval between two adjacent times depends on the preset resolution. And the
date is contained in the brackets. On the right of the TIME is the EVENT. If a marked event
happened at a specific time, the mark will be displayed aside that time in the EVENT field. On
the right of the trend table are parameter names and the trend data. The symbol "――" means the
parameter is not measured at the corresponding time. Besides, the L-RIGHT option allows
change of the parameter name and the trend data.
If you select to review the NIBP trend data, the measurement results as well as the specific
measurement time (in the TEST AT filed) are displayed. If more than one measurement results
are obtained in a time interval, only one result is to be displayed in the measurement result field.
„
1.
2.
3.
RESOLUTION
Rotate the control knob to highlight the field at the right of RESOLUTION.
Press the control knob, and a popup value with the options, 1MIN, 5 MIN, 10MIN, 30MIN
and 60MIN, is opened.
The time displayed in the TIME filed changes with the resolution.
9-4
„
1.
UP-DOWN
Rotate the control knob to highlight the UP-DOWN option, and press.
2.
If the
mark is displayed at the lower right of the TIME field, you can rotate the control
knob anticlockwise to page down and review the trend data of earlier time.
3.
If the
mark is displayed at the upper right of the TIME field, you can rotate the control
knob clockwise to page up and review the trend data of later time.
„ L-RIGHT
1. Rotate the control knob to highlight the L-RIGHT option, and then press.
2. Rotate the control knob to select a parameters set.
The “>” mark on the right of the parameter names indicates the following page is available, and
the “<” mark on the left of the parameter names indicates the previous page is available.
3. The parameter names and the trend data changes with the selected parameter set.
„ REC
The REC option allows you to print out the trend data of the currently displayed parameter(s).
„
Mark Event
If an event is marked A, B, C or D, the mark ( A, B, C or D ) will be displayed aside the mark
time on the trend table.
9-5
9.4 NIBP Recall
Select NIBP RECALL >> in SYSTEM MENU. The following window appears.
Figure 9-3 NIBP Recall
The NIBP RECALL window shows the non-invasive systolic pressure (NS), non-invasive mean
pressure (NM), non-invasive diastolic pressure (ND), puse rate (PR) and the measurement time
(TIME). The optional pressure units (UNIT) are mmHg and kPa. NUM indicates the current
measurement times. PR is derived from NIBP measurements. A maximum of ten measurements
can be displayed on the screen once. If there are more, you may use the UP-DOWN option to
review the
data of a later or earlier time. If the measurement times surpass 800, only the latest 800
measurements are to be displayed. The REC option allows you to print out all measurement data
of NIBP RECALL.
9-6
9.5 Alarm Event Recall
Select ALARM RECALL >> in SYSTEM MENU. The following menu appears.
Figure 9-4 Alarm Recall Condition Selections
In this menu, you may select the conditions of alarm review:
„ ALARM RECALL TIME
You can select the desired start time and end time for review. The end time can be set to either
CURRENT TIME or SELF-DEFINE.
„ ALARM RECALL EVENT
The drop-down menu of ALARM RECALL EVENT provides a list of parameter options to be
reviewed. Among them, ALL indicates all parameter alarm events are to be reviewed, H refers to
the upper parameter limit and L refers to the lower parameter limit.
„ ALARM RECALL>>
If the ALARM RECALL TIME and the ALARM RECALL EVENT are both selected, you can
select the ALARM RECALL >> option to open the ALARM RECALL window as shown in
Figure 9-5.
This window contains the following information:
1. Time span (the start time and end time of alarm recall).
2. Alarm event type.
3. The alarming parameter, parameter value, alarm level and the alarm time.
4.
The alarm event number (format: NO: n of N). N indicates the amount of alarm events and n
indicates the sequence number of the currently displayed alarm event.
9-7
5.
6.
Parameter values at the time of the alarm event.
Two waveforms at the time of the alarm event. You can set the waveform length by
selecting from the ALM REC TIME options in the ALARM SETUP menu. Please refer to
4.4.2 Alarm Setup.
1
2
3
4
5
6
Figure 9-5 Alarm Event Recall
„ UP-DOWN
The monitor is able to store a maximum of 70 alarm events. But only one alarm event can be
displayed in the ALARM RECALL window once. You can select the UP-DOWN option and then
rotate the control knob to view an earlier or later alarm event.
„ L-RIGHT
You may select the L-RIGHT option and then rotate the control knob to review the 8,16,or
32-second waveforms stored.
„ REC
This option allows you to print out all parameter data and waveforms displayed in the current
window using the recorder.
9-8
9.6 Non-Volatile Data Storage
To avoid losing patient’s data when the monitor is powered off intentionally or accidentally, this
monitor can realize the non-volatile data storage function (optional). During monitoring, the
patient’s data, including trend data, NIBP measurement results, alarm events, and relative
waveforms, will be saved into the monitor. When the monitor is powered on again, you can
review the saved data using the TREND GRAPH, the TREND TABLE or the NIBP RECALL
menu, etc.
9-9
FOR YOUR NOTES
9-10
10 ECG/RESP Monitoring
10.1 Overview
Two algorithm packages are optional for ECG monitoring:
1. Mindray DS algorithm package
This package provides 3/5-lead monitoring.
2. Mortara algorithm package
This package provides 3/5/12-lead monitoring, ST-segment analysis and extended ARR
analysis.
10.2 ECG Monitoring Procedure
10.2.1 Preparation
1. Skin preparation
The quality of ECG information displayed on the monitor is a direct result of the quality of the
electrical signal received at the electrode. Proper skin preparation is necessary for good signal
quality at the electrode. A good signal at the electrode provides the monitor with valid
information for processing the ECG data. Choose flat area to place electrodes. Following is a
suggested guideline for skin preparation:
„ Shave hair from skin at chosen sites.
„ Gently rub skin surfaces at sites to remove dead skin cells.
„ Thoroughly cleanse the site with a mild soap and water solution (do not use ether or pure
alcohol because they will increase skin impedance).
„ Dry the skin completely before applying the electrodes.
2. Attach the ECG leadwire to the electrodes prior to placement.
3. Place the electrodes on the patient. If the conductive ointment is not applied to the electrodes,
apply it before the placement.
4. Connect the electrode lead to the patient cable.
5. Make sure the monitor is turned on and is ready for monitoring.
10-1
10.2.2 Electrode Placement
WARNING
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Use only the specified ECG cable for monitoring.
When applying electrodes or connecting cables, make sure they are not
connected to any conductive part or the ground. Verify that all ECG electrodes,
including neutral electrodes, are securely attached to the patient.
Skin irritation may result from the continuous application of the ECG
electrodes. These should be checked each day. If there is an indication of excess
skin irritation, replace the electrodes or change the location of the electrodes
every 24 hours.
Do not touch the patient, bed or instrument during defibrillation.
When applying the ECG cable with no resistance to our patient monitor or
other patient monitor that has no current limit resistance in it, the monitor
cannot be applied to defibrillation.
Interference from a non-grounded instrument near the patient and ESU
interference can cause inaccuracy of the ECG waveform.
Always dispose of, or recycle electrodes properly to prevent from environment
contamination.
Verify the lead fault detection prior to the start of monitoring. Unplug the ECG
cable from the ECG connector and the screen should display the error message
“ECG LEAD OFF” and an audible alarm should be activated.
NOTE
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The conductive ointment coatings should be isolated, and the chest electrodes
should have no contact with each other to avoid short-circuit.
Do not use the physiological saline to replace the electrode gel to avoid the
electrodes being eroded.
Using 3M electrodes is recommended during defibrillation.
10-2
3-Leadwire Electrode Placement
Following is the configuration per European standard when using three leadwires:
„ R (right arm) electrode: near the right shoulder, directly below the clavicle.
„ L (left arm) electrode: near the left shoulder, directly below the clavicle.
„ F (left leg) electrode: on the left hypogastrium.
Figure 10-1 Positions of 3-Leadwire Electrode Placement
The chart below shows the label used to identify each leadwire. Included also is its associated
color code per American (AHA) and European (IEC) standards.
American Standard
European Standard
Label
Color
Label
Color
RA
White
R
Red
LA
Black
L
Yellow
LL
Red
F
Green
10-3
5-Leadwire Electrode Placement
Following is the configuration per American standard when using five leadwires:
Figure 10-2 5-Leadwire Electrode Placement
„
„
„
„
„
RA (right arm) electrode: near the right shoulder, directly below the clavicle.
LA (left arm) electrode: near the left shoulder, directly below the clavicle.
RL (right leg) electrode: on the right hypogastrium.
LL (left leg) electrode: on the left hypogastrium.
V (precordial) electrode: on the chest.
Attach the chest (V) electrode to one of the following positions indicated in Figure 10-3:
„ V1: On the 4th intercostal space at the right sterna margin.
„ V2: On the 4th intercostal space at the left sterna margin.
„ V3: Midway between V2 and V4 electrodes.
„ V4: On the 5th intercostal space at the left clavicular line.
„ V5: On the left anterior axillary line, horizontal with V4 electrode.
„ V6: On the left middle axillary line, horizontal with V4 electrode.
„ V3R-V7R: On the right side of the chest in positions corresponding to those on the left.
„ VE: Over the xiphoid.
10-4
When attaching the chest electrode to the back of a patient, place it at one the following sites:
„ V7: On the 5th intercostal space at the left posterior axillary line of the back.
„ V7R: On the 5th intercostal space at the right posterior axillary line of the back.
Figure 10-3 Positions of Chest Electrode
The chart below shows the label used to identify each leadwire. Included also is its associated
color code per American (AHA) and European (IEC) standards.
American Standard
European Standard
Label
Color
Label
Color
RA
White
R
Red
LA
Black
L
Yellow
LL
Red
F
Green
RL
Green
N
Black
V
Brown
C
White
10-5
10-Leadwire Electrode Placement
Figure 10-4 10-Leadwire Electrode Placement
12-lead ECG monitoring uses 10 electrodes which are placed on the patient’s four limbs and
chest. The limb electrodes should be placed on the soft skin and the chest electrodes placed
according to the physician’s preference.
Electrode Placement for Surgical Patients
Electrode placement during surgery is dependent on the type of surgery being performed. For
example, with open chest surgery, the electrodes might be placed laterally on the chest or on the
back. In the operating room, artifact can sometimes affect the ECG waveform due to the use of
electrosurgery equipment. To help reduce this, place the electrodes on the right and left shoulders,
the right and left sides near the stomach, and place the chest lead on the left side at mid-chest.
Avoid placing the electrodes on the upper arms. This will cause the ECG waveform to be too
small.
10-6
WARNING
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When using Electrosurgery equipment, patient leads should be placed in a
position that is equal distance from the Electrosurgery electrotome and the
grounding plate to avoid burns to the patient. The Electrosurgery equipment
wire and the ECG cable must be kept separated and not allowed to tangle.
When using Electrosurgery equipment, never place the ECG electrodes near the
grounding plate of the Electrosurgery device. This will cause a great deal of
interference with the ECG signal.
10.2.3 Characteristics of Quality ECG Signal
As shown in Figure 10-5, the normal QRS complex should exhibit the following characteristics.
„ Tall and narrow with no notches.
„ With a tall R-wave completely above or below the baseline.
„ With a pacer spike no higher than the height of the R-wave.
„ With the T-wave less than one-third of the height of the R-wave.
„ With the P-wave much smaller than the T-wave.
Figure 10-5 Standard ECG Waveform
To display a 1-millivolt calibration pulse on the ECG wave, select the ECG CAL option in the
ECG SETUP menu. A message "when CAL, can't monitor!" is displayed on the screen.
NOTE
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If the ECG waveform is too small, or not accurate, and the electrodes are secure
and firmly attached to the patient, change the display to a different lead.
10-7
10.3 ECG Display
10.3.1 ECG Waveform
In the standard screen, one or two ECG waveform(s) is (are) displayed at the top of the display
when LEAD TYPE is set to 3 LEADS or 5LEADS respectively in the ECG SETUP menu.
1
2
4
5
3
Figure 10-6 ECG Waveforms
As shown above, when 5 LEADS is selected, five labels are located above the ECG waveforms:
1. ECG lead of channel 1 (Primary lead)
You can select the lead of channel 1 from the label options.
‹ When you use a 3-lead set, the monitor gives three lead options: I, II and III;
‹ When you use a 5-lead set, the monitor gives seven lead options: II, III, aVR, aVL,
aVF, V and I.
2.
Gain of the channel-1 waveform
You may use this label to adjust the amplitude of the channel-1 ECG waveform. The gain
options include ×0.125, ×0.25, ×0.5, ×1, ×2 and AUTO. When AUTO is selected, the
monitor adjusts the gain automatically. Besides, a 1mV scale is displayed at the right side of
each ECG waveform. The height of the 1mV bar is directly proportional to the ECG
waveform amplitude.
3.
Filter Method
The filtering enables clearer and more detailed waveforms. There are three filter methods for
selection.
‹ DIAGNOSTIC: The monitor displays the ECG waveforms without filter;
‹ MONITOR: It effectively filters the artifacts that might cause false alarms;
SURGERY: This filter is used to reduce the artifacts and interference from
electrosurgery equipment.
The selected filter is applied to both channels, but the filter label is merely displayed above the
first ECG waveform.
‹
10-8
WARNING
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Only in the DIAGNOSTIC mode will the monitor provide non-processed real
signal waveforms. In the MONITOR or SURGERY mode, the ECG waveforms
may have slight distortions and the result of the ST segment analysis may be
affected greatly. In the SURGERY mode, the ARR analysis result may be affected
to some extent. Hence, the DIAGNOSTIC mode is recommended when monitoring
a patient in an environment with slight interference.
4.
ECG lead of channel 2 (Secondary lead)
You can select the lead of channel 2 in the same method used to select the channel-1 lead.
5.
Gain of the channel-2 waveform
You can adjust the gain of the channel-2 ECG waveform in the same method used for
channel 1.
Besides, pace pulse marks “|” are shown above the ECG wave if the PACE is set to ON and the
patient has a paced signal. If a defibrillator is connected, the synchronization marks are shown on
the ECG wave.
NOTE
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If the amplitude of an ECG waveform is too large, the peak of the waveform
might not be displayed. In this case, you should change the waveform gain
properly.
The selected leads of channel 1 and channel 2 should not be identical. Otherwise,
the system will change one of them automatically. In the MULTI-LEADS
DISPLAY mode or the HALF-SCN MUTLI-LEADS display mode, the leads of
both channels cannot be set.
10.3.2 ECG Parameters
Heartbeat icon
ECG label
HR/PR
Alarms Disabled icon
Figure 10-7 ECG Parameters
The parameters related to ECG are displayed to the right of the ECG waveforms as shown above.
The heartbeat indicator flashes in the same rate with the patient’s heartbeat or pulse. The status of
PACE, ST1, ST2, PVCs and NOTCH is shown at the right side of HR/PR reading.
If your monitor is not configured with ST and ARR features, the numerics of ST1, ST2 and PVCs
will not be displayed.
10-9
10.4 ECG Setup Menu
To display the ECG SETUP menu, use the knob to select the ECG label in the parameter
windows. The options available in the menu vary with each algorithm package
Figure 10-8 ECG SETUP Menu (Mindray DS Algorithm Package)
Figure 10-9 ECG SETUP Menu (Mortara Algorithm Package)
10-10
The options of ECG SETUP menu are listed below. However, your algorithm package may not
include some of these options.
„
HR ALM
Heart rate alarm on/off status
ON: When a heart rate alarm occurs, the monitor gives alarm
indications and stores the alarm;
OFF: When a heart rate alarm occurs, the monitor neither gives
alarm indications nor stores the alarm;
When OFF is selected, the
the ECG label.
icon is displayed on the right of
„
ALM LEV
Alarm level
Options: HIGH, MED and LOW.
„
ALM REC
Alarm recording
ON: When a heart rate alarm occurs, the monitor enables the
recording;
OFF: When a heart rate alarm occurs, the monitor does not
enable the recording.
„
ALM HI
Upper alarm limit
Determines the upper ECG alarm limit.
„
ALM LO
Lower alarm limit
Determines the lower ECG alarm limit.
For different patient types, the upper/lower limits of the heart rate alarm may vary in the
following range.
Patient type
Upper Limit
Lower Limit
Increment (beat/min)
Adult
(lower limit+2)~300
15~(upper limit-2)
1
Pediatric
(lower limit+2)~350
15~(upper limit-2)
1
Neonate
(lower limit+2)~350
15~(upper limit-2)
1
NOTE
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Always set the alarm limits according to the clinical condition of the individual
patient.
In many cases, the upper limit of heart rate alarms should not exceed 20 beats per
minute higher than the patient's heart rate.
HR FROM
Heart rate source
Options: ECG, SPO2, IBP, AUTO and ALL
10-11
1.
2.
3.
4.
5.
„
ECG: HR is always calculated from ECG.
SpO2: If the ECG signal is seriously interfered, you can select SPO2, which means PR will
be derived from PLETH waveform. In this case, PULSE is displayed to the right of the ECG
label while the PR reading is displayed below. The monitor activates pulse beeps instead of
heartbeat beeps.
IBP: If the ECG signal is seriously interfered, you can select IBP which means PR will be
calculated by IBP module. In this case, PULSE is displayed to the right of the ECG label
while the PR reading is displayed below. The monitor activates pulse beeps from IBP
module.
AUTO: The monitor determines the heart rate source depending on the signal quality. The
priorities for heart rate calculation are: ECG, SpO2, IBP.
ALL: The monitor displays both the HR and the PR values. PR value is displayed at the
right of SpO2 label or IBP label, SpO2 takes priority of IBP. The monitor will alarm for both
abnormal HR and PR. HR is given priority in determining the source of the beep tone. If HR
is not available, the sound will be from the PR.
HR CHANNEL
CH1: The heart rate is determined by the first ECG
waveform;
CH2: The heart rate is determined by the second ECG
waveform;
AUTO: The monitor automatically selects an optimal
channel to calculate the heart rate.
This option is available in Mindray DS algorithm package only. For Mortara algorithm package,
the monitor uses both channels to calculate the heart rate simultaneously.
„
LEAD TYPE
Options: 3 LEADS, 5 LEADS and 12LEADS;
„
SWEEP
Options: 12.5, 25.0 and 50.0 mm/s;
„ ECG DISPLAY
When LEAD TYPE is set to 5 LEADS, you can select one of the following options:
1. NORMAL DISPLAY: The monitor displays two ECG waveforms.
2. MULTI-LEADS DISPLAY: The monitor displays six ECG waveforms, which occupies the
whole waveforms area.
3. HALF-SCN MULTI-LEADS: The monitor displays six ECG waveforms, which only
occupies four waveform positions.
When LEAD TYPE is set to 3 LEADS, only NORMAL DISPLAY can be selected for the ECG
DISPLAY. When LEAD TYPE is set to 12LEADS, you can select 12-LEAD DISPLAY to enter
the 12-lead monitoring display.
10-12
Other Setup
Select OTHER SETUP >> in the ECG SETUP menu. The following menu appears. The options
available in the menu vary with each algorithm package.
Figure 10-10 Other ECG Setup (Mindray DS Algorithm Package)
Figure 10-11 Other ECG Setup (Mortara Algorithm Package)
In this menu, you can select any of the displayed option. All options are listed below. Your
algorithm package may not include some of these options.
„
SMART LEAD
OFF
ON: If there is a LEAD OFF in the HR-derived channel, the
system will automatically switch to another lead to restore the
display of the ECG waveform in the HR-derived channel.
OFF: The SMART LEAD OFF is turned off.
10-13
When ECG is in NORMAL DISPLAY mode, if the SMART LEAD OFF is configured ON and
there is a LEAD OFF in the HR-derived channel, the system will automatically switch to another
lead to restore the display of the ECG waveform in the HR-derived channel. When the LEAD
OFF condition is corrected, the leads are automatically switched back. However, if you manually
switch the HR-derived channel, change the ECG display mode, or turn off SMART LEAD OFF
before the LEAD OFF condition is corrected, the leads will not be switched back.
Switching rules for SMART LEAD OFF:
LEAD OFF condition
HR-derived channel automatically switches to
RA OFF
III
LL OFF
I
LA OFF
II
V OFF
II
RL OFF
None
Any two out of LL, RA and LA fall off.
None
LL, RA or LA, and V fall off together
Same as LL, RA or LA falls off.
NOTE
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The SMART LEAD OFF function is available only when the LEAD TYPE is 5
LEADS or 12 LEADS.
When the HR CHANNEL is set to AUTO, SMART LEAD OFF does not work as
long as there is ECG waveform displayed in either channel 1 or 2.
When you perform ECG calibration, SMART LEAD OFF does not work.
„
BEAT VOL
Beat volume
Range: 0-10. 0 indicates disabled and 10 indicates the
maximum volume.
„
PACE
ON: When ON is selected, a detected pacemaker signal is
indicated by a "|" symbol above the ECG waveform.
OFF: When OFF is selected, the pacemaker analysis is
disabled.
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10-14
NOTE
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„
When monitoring a patient with a pacemaker, PACE must be turned ON.
Otherwise, the system will count the pacemaker pulse as QRS complex. Do not
completely depend on the alarms of heart rate. The patient with a pacemaker must
be nearly monitored.
When PACE is turned ON, the system will neither detect the arrhythmia relating
to premature ventricular beats (including PVCs counting) nor perform the ST
analysis. When monitoring a patient without a pacemaker, PACE should be
turned OFF.
The PACE tag can be printed in the real-time recording when PACE is turned
ON.
PACE LEAD
Set PACE LEAD as required.
NOTE
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You can switch the leads by setting LEAD TYPE in the ECG SETUP menu. At the
time of switching between 5 LEADS and 3 LEADS, PACE LEAD in the ECG
SETUP menu will be II.
„
PACER RATE
Some pace pulses may be difficult to suppress. When this
happens, the pace pulse may be counted as a QRS complex,
and could result in incorrect HR measurements and failure to
detect some arrhythmias. This option allows you to input the
heart rate of pacemaker, so that the software can calculate the
HR and detect the arrhythmias more accurately. When PACE
is set to OFF, this option is disabled.
„
NOTCH
Determines whether filter or not.
ON: The monitor protects the signals from the noise
generated by the power line.
OFF: No filtering.
10-15
NOTE
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If the filter method of the ECG waveform is set to a non-diagnostic mode, only the
NOTCH option ON is active and the monitor filters the signals of the power line
frequency.
„
CASCADE
ECG cascade
ON: The monitor displays the waveform of each channel in
two lines.
OFF: The monitor displays the waveform of each channel in
one line.
The CASCADE can be turned ON only if the monitor is set
to NORMAL DISPLAY mode and the SCAN TYPE is set
to REFRESH.
„
DEFIB SYNC
Defibrillator synchronization
ON: The function of defibrillation is enabled;
OFF: The function of defibrillation is disabled.
If the function of defibrillator synchronization is enabled and the ventricular defibrillation is
applied, 100ms/+5V defibrillator synchronization signals will be output through the auxiliary
output connector to the defibrillation equipment.
When the defibrillator synchronization is enabled, the “Defib Sync ON!” message is displayed in
the prompt information area, at the lower left corner of the screen. This message disappears after
10 seconds. Besides, the technical alarms area also shows the “DEFIB SYNC ON” message.
NOTE
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Defibrillator synchronization can be enabled only if the AUX OUTPUT in the
USER MAINTAIN menu is set to DEFIB. SYN. Otherwise, this function is
disabled.
When the monitor is started, DEFIB SYNC is set to OFF as a default.
WARNING
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Improper defibrillation will endanger the patient’s safety. You user should decide
whether to defibrillate the patient based on the patient’s actual condition.
Before defibrillating the patient, the user should ensure the defibrillator and the
monitor have been tested as a system and the two devices can work together safely
and effectively.
Before defibrillating the patient, the user should ensure the defibrillator has been
connected to the auxiliary output port of the monitor, the defibrillation
synchronization function is enabled, and the filter mode is set to DIAGNOSTIC.
When the defibrillation is done, sure to disable the defibrillation function and
select the filter method as needed.
10-16
„
ECG CAL
Select this option to begin calibrating the ECG. To stop
calibration, select this option again, or change the ECG lead
selection on the screen.
„
ADJUST WAVE POS
>>
This is used to adjust the position of the ECG waveform on
the screen. Select this option to access the ADJUST WAVE
POS menu. Open the CH NAME popup menu and select the
channel to be adjusted. Afterwards, select the UP-DOWN
option and rotate the control knob to adjust the position of
the selected channel on the screen. The BACK TO
DEFAULT option allows you to restore the waveform to the
default position on the screen.
Figure 10-12 ADJUST WAVE POS Menu
„
CONFIG >>
You can use this option to access the ECG CONFIG menu.
You may choose the FACTORY CONFIG or the USER
CONFIG. After finishing the selection, a dialog pops up
asking for confirmation of your selection.
10-17
10.5 ST Analysis
10.5.1 Overview
„
„
„
„
„
„
„
„
The function of ST analysis is optional.
In the factory configuration, ST analysis is disabled.
When turning ST ANALYSIS on, the monitor selects DIAGNOSTIC mode automatically.
You can set the monitor to MONITOR or SURGERY mode as required. However, ST
analysis will turn off automatically.
With the ST analysis, the variance of the ST segment at the waveform tracks of the selected
lead can be measured. The ST measurement result is displayed numerically in the ST1 and
ST2 positions in the parameter window.
You can review the ST trend graph and trend data in the TREND GRAPH and the TREND
TABLE menus.
Measurement unit of the ST segment: mV (millivolt).
Measurement symbols of the ST segment: “+” means positive elevation, “-” means negative
elevation.
Measurement range of the ST segment: -2.0 mV to +2.0 mV.
WARNING
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ST analysis is not intended for neonatal patients.
The ST algorithm has been tested for accuracy of the ST segment data. The
significance of the ST segment changes need to be determined by a clinician.
10.5.2 3/5-Lead ST Analysis Menu
Select ST ANALYSIS >> in ECG SETUP menu. The following menu appears.
Figure 10-13 ST Analysis
In this menu, you can perform the following settings:
10-18
„
ST ANAL
ST analysis
ON: Enables the ST analysis;
OFF: Disables the ST analysis.
NOTE
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„
ST analysis can be carried out only when the filter method is set to DIAGNOSTIC.
When ST analysis is switched on, the filter method will automatically switch to
DIAGNOSTIC if it is not in the diagnostic mode. However, if you switch the filter
method to MONITOR or SURGERY, ST analysis will turn off automatically. In
case that you change MONITOR or SURGERY to DIAGNOSTIC and ST analysis
keeps off, you can turn it on manually.
When ST analysis is switched on, the notch filter is switched on automatically.
However, you can manually switch NOTCH off as necessary.
ST ALM
ST segment alarm
ON: If the measured ST numerics exceed the alarm limit,
the monitor gives alarm indications and saves the alarm;
OFF: If the measured ST numerics exceed the alarm limit,
the monitor does not give alarm indications or saves the
alarm.
icon is displayed on the
When OFF is selected, the
right of ST1 in the parameter window.
„
ST ALM
ST alarm level
Options: HIGH, MED and LOW;
„
ALM REC
ST alarm recording
ON: The monitor starts recording when an ST alarm occurs;
OFF: The monitor does not record when an ST alarm
occurs.
„
ALM HI
Determines the upper limit of the ST alarm; 2.0mV is the
highest.
„
ALM LO
Determines the lower limit of the ST alarm; -2.0 mV is the
lowest.
NOTE
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The alarm limits for two ST segment numerics are identical. You cannot set the
alarm limit of one channel separately.
10-19
10.5.3 Adjusting ST Measurement Point
The ST measurement for each beat complex is the ventical difference between two measurement
points. The isoelectric point provides the baseline for the measurement and the ST point provides
the other measurement point.
R wave
T wave
P wave
Base point ISO
ST measurement point
ST measurement value
Figure 10-14 ST Measurement Point
The ST measurement points need to be adjusted when you start monitoring, and if the patient’s
heart rate or ECG morphology changes siginificantly. Artifactual ST segment depression or
elevation may occur if the ISO or the ST point is incorrectly set.
NOTE
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Abnormal QRS complex is not considered in ST analysis.
10-20
Mortara algorithm package
To adjust the points:
1. Select DEF POINT >> in the ST ANALYSIS menu to open the following window. Three
vertical cursors indicate the positions of the ISO, J and ST points.
Figure 10-15 ST Measurement Point
2.
3.
Select VIEW LEADS option, and then rotate the knob to select a suitable ECG lead for ST
measurement, with a visible J-point and a visible P wave.
Select ISO, J or ST option, and then rotate the knob to adjust the position of each point
respectively.
‹ The ISO-point cursor positions the isoelectric point relative to the R-wave peak.
Position the ISO-point in the middle of the flattest part of the baseline (between the P
and Q waves or in front of the P wave).
‹ The J-point cursor postions the J-point relative to the R-wave peak. It helps to correctly
position the ST-point. Position the J-point at the end of the QRS complex and the
beginning of the ST segment.
‹ The ST-point is positioned a fixed distance from the J-point, either J+60 or J+80. Move
the J-point cursor to position the ST-point at the midpoint of the ST segment.
10-21
10.6 Arrhythmia Analysis
10.6.1 Overview
The monitor uses the user-selected primary or secondary ECG lead for arrhythmia analysis. In
clinical application, the medical professionals can use the arrhythmia analysis to evaluate
patients’ condition (such as heart rate, PVCs rate, rhythm and ectopic beat) and give proper
treatment.
The arrhythmia analysis of the monitor has the following characteristics:
„ Applicable to the monitoring of a patient either with a pacemaker or without a pacemaker.
„ Disabled in the factory configuration.
„ Capability of raising the doctor’s attention to the patient’s heart rate, by measuring and
classifying the arrhythmia and the abnormal heartbeat and triggering the alarm.
„ Capability of storing the latest 80 alarm events (including the ECG waveform respectively 4
seconds before and after the alarm), when performing the arrhythmia analysis. You can
review the arrhythmia events through the menu below.
WARNING
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The arrhythmia analysis program is intended to detect ventricular arrhythmias. It
is not intended to dectect atrial or supraventricular arrhythimias. Occasionally it
may incorrectly identify the presence or absence of an arrhythmia. Therefore a
physician must analyze the arrhythmia information in conjunction with more
clinical findings.
The arrhythmia detection is not intended for neonatal patients.
10-22
10.6.2 Arrhythimia Options
Mortara algorithm package
When Mortara algorithm package is configured, your monitor has the following extended
arrhythmia analysis option.
Arrhythmia Message
Description
ASYSTOLE
No QRS complex within the defined time in absence of ventricular
fibrillation or chaotic signals.
VFIB
Ventricular fibrillation occurs and persists for 6 seconds.
VTAC
Ventricular HR is greater or equal to the defined limit and the number
of consecutive PVCs is greater than the defined value.
PNP
No pace pulse within (60*1000/pace rate +90) milliseconds following a
QRS complex or a pacer pulse (for paced patient only).
PNC
No QRS complex within 300 milliseconds following a pace pulse (for
paced patient only).
V RHYTHM
Ventricular HR is less than the defined limit and the number of PVCs is
greater than 3.
COUPLET
Pair PVCs are detected.
VT > 2
Ventricular HR is greater than or equal to the defined limit and the
number of PVCs is greater than or equal to 3 but less than the defined
limit.
BIGEMINY
A dominant rhythm of N, V,N, V, N, V.
TRIGEMINY
A dominant rhythm of N, N, V,N, N, V, N, N, V.
R ON T
R on T is detected.
MULTIF. PVC
More than two forms of PVCs are detected within the defined search
window (3 to 31).
IRR. RHYTHM
Consistently irregular rhythm
MISSED BEATS
No beat detected for 1.75x average R-R interval for HR <120, or No
beat for 1 second with HR >120 (non-paced patient only), or No beat
detected for more than the set pause threshold.
BRADY
The HR is less than or equal to the defined bradycardia low limit.
TACHY
The HR is greater than or equal to the defined tachycardia high limit.
10-23
10.6.3 Arrhythmia Analysis Menu
Select ARR ANALYSIS >> in ECG SETUP menu. The following menu appears. The menu items
vary with the algorithm packages.
Figure 10-16 Arrhythmia Analysis (Mortara algorithm package)
In this menu, you can perform the following settings:
„
ARR ANAL
Arrhythmia analysis
ON: Enables the arrhythmia analysis;
OFF: Disables the arrhythmia analysis.
„
PVCs ALM
PVCs alarm
ON: When the PVCs alarm occurs, the monitor gives alarm
indications and saves the alarm;
OFF: When the PVCs alarm occurs, the monitor neither gives
alarm indications nor saves the alarm;
When OFF is selected, the
icon is displayed on the right of
PVCs in the parameter window.
„
ALM LEV
Alarm level
Options: HIGH, MED and LOW.
„
ALM REC
Alarm recording
ON: The monitor starts recording when the PVCs alarm occurs.
OFF: The monitor does not record when the PVCs alarm
occurs.
„
ALM HI
Upper alarm limit
Determines the upper limit of the PVCs alarm. Range: 1–10.
An alarm is triggered when the PVCs exceeds the upper limit.
10-24
10.6.4 Arrhythimia Relearn
During ECG monitoring, you may need to start an arrhythmia relearn when a dramatic change in
the patient’s ECG pattern has occurred. A change in the ECG pattern could result in:
„ Incorrect arrhythmia alarms,
„ Loss of ST measurements, and/or
„ Inaccurate heart rate.
Arrhythmia relearn allows the monitor to learn the new ECG pattern to correct arrhythmia alarms
and heart rate value, and to restore ST measurements. To manually start an arrhythmia relearn,
select the ARR RELEARN option in the ARR ANALYSIS menu. The “ARR LEARNING”
message will be displayed in the information area.
10.6.5 Arrhythmia Alarm Setup
Select ARR ALARM >> in the ECG SETUP menu. The following menu appears.
10-25
Figure 10-17 Arrhythmia Alarm Setup (Mortara algorithm package)
In the menu, the ALM field indicates the alarm on/off status, REC indicates the alarm recording
on/off status and LEV indicates the alarm level. You can change the settings as described below.
„
ALL ALM ON
All alarms on
Enables all arrhythmia alarms;
„
ALL ALM OFF
All alarms off
Disables all arrhythmia alarms that can be disabled;
„
ALL REC ON
All recording on
Enables the recording of all arrhythmia alarms;
„
ALL REC OFF
All recording off
Disables the recording of all arrhythmia alarms;
„
ALM LEV
Options: HIGH, MED and LOW.
Sets the level of all arrhythmia alarms that can be set to the
same value.
„
UP-DOWN
Page up or down
10-26
10.6.6 Arr Threshold
Select ARR THRESHOLD >> in the ECG SETUP menu and the following menu appears. You
can change the threshold settings in this menu. An alarm will be triggered when a rate exceeds a
threshold.
Figure 10-18 ARR Threshold Setup
ARR Event
Range
Default
Step
Unit
ASYS DELAY
3 to 10
5
1
s
VTAC RATE
100 to 200
130
5
bpm
VTAC PVC
3 to 12
6
1
Beats
MULTIF. PVC
3 to 31
15
1
Beats
TACHY HI
Adult: 100 to 300
Pediatric: 160 to 300
Adult: 100
Pediatric: 160
5
bpm
BRADY LO
Adult: 15 to 60
Pediatric: 15 to 80
Adult: 60
Pediatric: 80
5
bpm
10-27
10.6.7 Arrhythmia Recall
Select ARR RECALL >> in the ARR ANALYSIS menu. The following menu appears. You can
review any stored arrhythmia event in this menu.
Figure 10-19 Arrhythmia Recall
You can perform the following operations:
„
UP-DOWN
A maximum of 10 arrhythmia events can be displayed in the
window each time. In case of more than 10 events, you can
use the UP-DOWN option to review more. At most 8 pages
can be reviewed.
„
CURSOR
This option allows you to select an arrhythmia event
displayed in the window.
„
DELETE
This option allows you to delete a selected arrhythmia event.
„
RENAME
This option allows you to change the name of a selected
arrhythmia event.
Select this option, and rotate the control knob till the desired
name appears. Then, press the control knob to select the
name.
„
WAVE >>
Selecting this option opens the following window. In the
window, the waveform and the time of a selected arrhythmia
event as well as the parameter values at the event time are
displayed.
10-28
Figure 10-20 Arrhythmia waveform Review
You can perform the following operations:
„
UP-DOWN
This option allows you to page up and down to review the
waveform and the parameters of other arrhythmia events.
„
L-RIGHT
This option allows you to review 8-second waveform of the
currently displayed arrhythmia event.
„
REC
Selecting this option starts the recording of the waveform
and the parameters of the currently displayed arrhythmia
event.
„
EXIT
This option allows you to return to the ARR RECALL
window.
10-29
10.7 12-Lead
10.7.1 12-Lead Monitoring Display
You can enter the 12-lead monitoring display if your monitor is configured with the 12-lead
monitoring. To enter the ECG 12-Lead monitoring screen:
1. Place the 10 electrodes on the patient.
2. Select the ECG label to enter the ECG SETUP menu.
3. Set LEAD TYPE to 12 LEADS.
4. Set the ECG DISPLAY to 12-LEAD DISPLAY.
Rhythm lead label
Figure 10-21 12-Lead Display
A total of 12 ECG waves and 1 rhythm wave will be displayed on the screen. The ST numerics
are displayed in three groups:
„ ANT (anterior):
V1, V2, V3, V4
„ INF(inferior):
II, III, aVF, (aVR)
„ LAT (lateral):
I, aVL, V5, V6
Although aVR is displayed in the INF group, it is not an inferior lead.
10-30
In the 12-Lead Monitoring Display:
„ Labels except the ECG-related ones (ECG, ST, GAIN, RHYTHM) are all disabled.
„ The REC button on the control panel is disabled.
„ You can press the MAIN and MENU buttons on the control panel to exit the 12-Lead
Monitoring Display and return to the normal monitoring display.
10.7.2 12-lead ST Analysis Menu
Select the ST label in the parameter area, or select ST ANALYSIS >> in the ECG SETUP menu.
The following menu appears.
Figure 10-22 ST ANALYSIS menu
In the ST ANALYSIS menu, you can perform the following settings:
„
ST ANAL
ST analysis
ON: Enables the ST analysis;
OFF: Disables the ST analysis.
NOTE
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When ST ANAL is set to ON, the monitor selects DIAGNOSTIC mode
automatically. You can set the monitor to MONITOR or SURGERY mode as
required. However, ST analysis will turn off automatically.
10-31
„
ST ALM
ST segment alarm
ON: If the measured ST numerics exceed the alarm limit, the
monitor gives alarm indications and saves the alarm;
OFF: If the measured ST numerics exceed the alarm limit, the
monitor does not give alarm indications or save the alarm.
When OFF is selected, the
right of the ST data area.
icon is displayed on the upper
„
ALM LEV
ST alarm level
Options: HIGH, MED and LOW;
„
ALM REC
ST alarm recording
ON: The monitor starts recording when an ST alarm occurs;
OFF: The monitor does not record when an ST alarm occurs.
„
ANT ALM HI
Determines the upper limit of the ST alarm in the ANT group;
2.0mV is the highest.
„
ANT ALM LO
Determines the lower limit of the ST alarm in the ANT group;
-2.0 mV is the lowest.
„
INF ALM HI
Determines the upper limit of the ST alarm in the INF group;
2.0mV is the highest.
„
INF ALM LO
Determines the lower limit of the ST alarm in the INF group; -2.0
mV is the lowest.
„
LAT ALM HI
Determines the upper limit of the ST alarm in the LAT group;
2.0mV is the highest.
„
LAT ALM LO
Determines the lower limit of the ST alarm in the LAT group;
-2.0 mV is the lowest.
10-32
10.8 RESP Monitoring
10.8.1 Overview
Respiration is detected by measuring thoracic impedance. The monitor measures the change of
the impedanec between the RA and LA electrodes of the ECG lead I, or the RA and LL electrodes
of the ECG lead II, and produces a respiration waveform as shown below.
4
1
2
3
5
Figure 10-23 Respiration Waveform and Parameter
1.
2.
3.
4.
5.
Waveform name.
RESP lead: I or II
Waveform gain: 7 options are available: ×0.25, ×0.5, ×1, ×2, ×3, ×4, ×5. If the gain is too
large, the upper part of the waveform may not be normally displayed.
RESP label: Selecting this label, you can open the RESP SETUP menu.
RR: Respiration rate numerics.
NOTE
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Respiration monitoring is not recommended on patients who are very active, as
this will cause false alarms.
It is recommended to set Waveform gain to 1 when external electromagnetic
interference is great.
10-33
10.8.2 Electrode Placement
Since the same electrodes are used for ECG and respiration monitoring, the electrode placement
is very important. Some patients, due to their clinical condition, expand their chest laterally,
causing a negative intrathoracic pressure. In these cases it is better to place the two electrodes
used for respiration monitoring laterally in the right axillary and left lateral chest areas, at the
maximum point of the breathing movement, to optimize the respiratory waveform.
NOTE
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To optimize the respiration waveform, place the RA and LA electrodes
horizontally when the ECG Lead I is selected, and place the RA and LL
electrodes diagonally when the ECG lead II is selected.
Try to avoid placing the electrodes so the liver area and the ventricles of the
heart are in path between the electrodes used for respiration, to avoid cardiac
artifact to overlay on the ECG. This is particularly important when monitoring
neonate patients.
Electrode Placement of ECG Lead I
Electrode Placement of ECG Lead II
Figure 10-24 Electrode Placement
10-34
10.8.3 Respiration Setup
Selecting the RESP label on the screen opens the following menu.
Figure 10-25 RESP Setup Menu
In this menu, you can perform the following settings.
„
ALM
Alarm on/off
ON: When a respiration rate alarm occurs, the monitor gives
alarm indications and stores the alarm;
OFF: When a respiration rate alarm occurs, the monitor
neither gives alarm indications nor stores the alarm;
When OFF is selected, the
of the RESP label.
icon is displayed on the right
„
ALM LEV
Alarm level
Options: HIGH, MED and LOW.
„
ALM REC
Alarm recording
ON: When a respiration rate alarm occurs, the monitor
enables the recording;
OFF: When a respiration rate alarm occurs, the monitor does
not enable the recording
„
ALM HI
Upper alarm limit
Determines the upper limit of respiration rate alarm.
„
ALM LO
Lower alarm limit
Determines the lower limit of respiration rate alarm.
10-35
For different patient types, the upper/lower limits of the respiration rate alarm may vary in the
following range.
Patient type
Upper Limit
Lower Limit
Increment (breath/min)
Adult
(lower limit+2) ~120
0~(upper limit-2)
1
Neonate/pediatric
(lower limit+2) ~150
0~(upper limit-2)
1
„
APNEA ALM
Apnea alarm
Determines whether the patient’s cessation of breath is an
apnea event. Range: 10–40 seconds.
„
SWEEP
Waveform speed
Options: 6.25, 12.5 and 25.0 mm/s.
„
HOLD TYPE
Calculation type
Options: AUTO and MANUAL
1.
AUTO: When AUTO is selected, the monitor automatically determines the detection
threshold for respiration and calculates the respiration rate. The HOLD HI and HOLD LO
options are inactive.
MANUAL: When MANUAL is selected, the user determines the detection threshold for
respiration and the monitor calculates the respiration rate depending on the user-selected
criteria.
2.
„
CONFIG >>
Select CONFIG >> to access the RESP CONFIG menu. You
can select either FACTORY CONF or USER CONF. After
finishing the selection and exiting the menu, a dialog box
pops up asking for confirmation of your selection.
10-36
10.9 Maintenance and Cleaning
WARNING
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Before cleaning the ECG cable, be sure to disconnect the monitor from the ECG
cable, or shut down the system and disconnect all power cords from the outlet.
If the ECG cable is damaged or aged, replace with a new one.
„ Cleaning
The exterior surfaces of the ECG cable may be cleaned with a soft cloth, dampened with the
alcohol, and then be air-dried or dried with a clean dry cloth.
„ Disinfection
Disinfection may cause damage to the equipment. We recommend the disinfection be contained
in the hospital’s servicing schedule only when necessary. The equipment should be cleaned prior
to disinfection.
„ Sterilization
Sterilization may cause damage to the equipment. We recommend the sterilization be contained
in the hospital’s servicing schedule only when necessary. The equipment should be cleaned prior
to sterilization.
10-37
FOR YOUR NOTES
10-38
11 SpO Monitoring
2
11.1 Overview
The monitor measures the patients’ SpO2 (oxygen saturation) and displays:
1. Pulse rate (PR) value in the ECG or SpO2 parameter window.
2. PLETH waveform in the waveforms area.
3. Oxygen saturation (SpO2%) value in the SpO2 parameter window.
The PR value is displayed in the ECG parameter window only if:
1. SpO2 is selected from the HR FROM options in the ECG SETUP menu; or
2. AUTO is selected from the HR FROM options in the ECG SETUP menu and no ECG signal
is received.
As the following figure shows, the PLETH waveform is located on the left while the SpO2
parameter window on the right. The SpO2 value is displayed by percentage and is followed by a
perfusion indicator (pro rata with the pulse intensity). Besides, the SpO2 label at the upper left
corner of the parameter window allows you to access the SpO2 SETUP menu.
1
5
2
3
4
Figure 11-1 SpO2 Waveform and Parameter
1.
2.
3.
4.
5.
PLETH waveform
SPO2 label
SpO2 value
Perfusion indicator
Pulse rate
11-1
PITCH TONE
The PITCH TONE function refers to the monitor’s capability to vary the pitch of the heart rate
tone or pulse rate tone with the change of the SpO2 reading. This monitor provides 22 pitch levels.
The pitch rises as the SpO2 reading increases toward 100% and falls as it decreases. Although the
tone pitch cannot be adjusted manually, the tone volume can be adjusted by one of the following
two ways, depending on the setting of the HR FROM item in the ECG SETUP menu:
„ If the HR FROM is set to SPO2 or IBP, you can adjust the PITCH TONE volume by
changing the setting of the PR SOUND item in the SPO2 SETUP or IBP (1,2) SETUP
menu;
„ In case of other settings, you can adjust the PITCH TONE volume by changing the setting
of the BEAT VOL item in the ECG SETUP menu.
If the PR SOUND or BEAT VOL is set to 0, the PITCH TONE function will be muted; if the
SpO2 module is disabled, the PITCH TONE function will be disabled as well.
NOTE
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SpO2 and SPO2 are used interchangeably in this chapter.
11.2 Mindray DS SpO2 Module
NOTE
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This section is only applicable to the monitor equipped with a Mindray DS SpO2
module.
11.2.1 Principles of Operation
SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated
hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The
light generated in the probe passes through the tissue and is converted into electrical signals by
the photodetector in the probe. The SpO2 module processes the electrical signal and displays on
the screen a waveform and digital values for SpO2 and pulse rate.
The sensor measurement wavelengths are nominally 660nm for the red LED and 940nm for
infrared LED. The maximum optical power output for LED is 4mW.
11-2
11.2.2 Precautions
WARNING
z
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The SpO2 value might be overestimated in the presence of Hb-CO, Met-Hb or
dye dilution chemicals.
Check if the sensor cable is in normal condition before monitoring. Do not use
the SpO2 sensor once the package or the sensor is found damaged.
Verify sensor cable fault detection before beginning monitoring. Unplug the
SpO2 sensor cable from the connector. The screen will display the prompt
information “SPO2 SENSOR OFF” and the audible alarm is activated.
ES (Electrosurgery) equipment wire and SpO2 cable must not be tangled up.
Do not put the SpO2 sensor on the limb with arterial catheter or venous syringe.
Do not perform SpO2 and NIBP measurements on the same limb
simultaneously. Obstruction of blood flow during NIBP measurements may
adversely affect the reading of the SpO2 value.
Prolonged continuous monitoring may increase the risk of undesirable changes
in skin characteristics, such as irritation, reddening, blistering or burns. Inspect
the sensor site every two hours and move the sensor if the skin quality changes.
Change the application site every four hours. For neonates or patients with poor
peripheral blood circulation or sensitive skin, inspect the sensor site more
frequently.
11.2.3 Monitoring Procedure
Sensor selection for SpO2 measurement depends on the patient type. For an adult patient, you can
choose a finger SpO2 sensor; for an infant patient, you can choose a hand or toe sensor. Refer to
the following procedure.
1. Power on the monitor.
2. Attach the sensor to the proper site on the patient.
3. Plug the connector of the sensor extension cable into the SpO2 connector on monitor.
Finger Sensor Placement
You can easily place the finger sensor as shown below.
Figure 11-2 Finger Sensor Placement
11-3
NOTE
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Place the SpO2 sensor cable at the backside of the patient hand. Make sure the
fingernail is just opposite to the light emitted from the sensor.
Neonate Sensor Placement
Neonate SpO2 sensor consists of a Y-shape SpO2 sensor and its sheath. Insert the LED and PD
ends of the Y-shape SpO2 sensor respectively into the upper and lower grooves on the sheath
(Figure 11-3). The Figure 11-4 shows us the neonate SpO2 sensor after insertion.
Y-shape sensor
Neonate sensor sheath
Figure 11-3 Neonate Sensor Placement (1)
Figure 11-4 Neonate Sensor Placement (2)
Wind the SpO2 sensor around a hand or foot of a neonate patient. Hold the sensor, pull the belt
and fit one of its sides with “V” edge into the “V” groove on the corresponding side of the sheath.
Appropriately elongate the belt to about 20mm, and fit the “V” edge of the other side of the belt
into the “V” groove of the other side of the sheath. Then, loosen the belt. After the “V” edges of
the two sides of the belt fit well into the “V” grooves on the two sides of the sheath, put the belt
into the first lock bar to fasten the belt. SeeFigure 11-5. If the belt is too long, you may put it into
the second lock bar. You must position the SpO2 sensor in this way so as to make the
photoelectric component face the correct position. Besides, note not to elongate the belt too much,
which may lead to inaccurate measurement and block the blood circulation severely.
11-4
Figure 11-5 Neonate Sensor Placement (3)
NOTE
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If the sensor cannot be positioned accurately to the part to be measured, it may
result in inaccurate SpO2 reading, or the SpO2 even cannot be measured because
no pulse is detected. In this case, you must position the sensor again.
The excessive patient movement may result in inaccurate reading. In this situation,
you must keep the patient quiet or change the measured position to reduce the
adverse influence of excessive movement.
WARNING
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In the process of extended and continuous monitoring, you should check the
peripheral circulation and the skin every 2 hours. If any unfavorable change takes
place, you should change the measured position in time.
In the process of extended and continuous monitoring, you should periodically
check the position of the sensor. In case that the position of the sensor moves
during monitoring, the measurement accuracy may be affected.
11-5
11.2.4 Measurement Limitations
If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs
by an alternate method. Then check the instrument for proper function. Inaccurate measurements
may be caused by:
„ Improper SpO2 sensor;
„ High-frequency electrical noise, including noise created by the host system, or noise from
external sources, such as electrosurgical apparatus connected to the system;
„ Oximeters and oximetry sensors used during magnetic resonance imaging (MRI) scanning.
Induced current could potentially cause burns;
„ Intravascular dye injections;
„ Excessive patient motion;
„ Excessive ambient light;
„ Improper sensor installation or incorrect sensor placement on the patient
„
Sensor temperature (optimal temperature is between 28℃ and 40℃);
„
The sensor is placed on a limb that is attached to a blood pressure cuff, arterial catheter, or
intravascular line;
Concentration of dysfunctional hemoglobin, such as carboxyhemoglobin and
methemoglobin;
SpO2 too low;
Low circular perfusion of the applied part;
Shock, anemia, low temperature and application of vasomotor all reduce the arterial blood
flow and may affect the pulse oximetry measurement.
„
„
„
„
The absorption of oxyhemoglobin (HbO2) and deoxyhemoglobin to the light of special
wavelength may also affect SpO2 measurement. If there exist other substances (like carbon
hemoglobin, methemoglobin, methylene blue and indigo carmine) absorbing the light of the same
wavelength, they may result in false or low SpO2 reading.
11-6
11.2.5 SpO2 Setup Menu
Selecting the SPO2 label in the parameter window opens the following menu.
Figure 11-6 SpO2 Setup Menu
You can perform the following settings in this menu.
„
ALM
SpO2 alarm on/off status
ON: When a SpO2 alarm occurs, the monitor gives alarm
indications and stores the alarm;
OFF: When a SpO2 alarm occurs, the monitor neither gives
alarm indications nor stores the alarm;
When OFF is selected, the
of the SPO2 label.
icon is displayed on the right
„
ALM LEV
Alarm level
Options: HIGH and MED.
„
ALM REC
Alarm recording
ON: When a SpO2 alarm occurs, the monitor enables the
recording;
OFF: When a SpO2 alarm occurs, the monitor does not
enable the recording.
„
SPO2 ALM HI
SpO2 upper alarm limit
„
SPO2 ALM LO
SpO2 lower alarm limit
„
PR ALM HI
PR upper alarm limit
„
PR ALM LO
PR lower alarm limit
11-7
SpO2 and PR alarm limits:
Parameter
Upper Limit
Lower Limit
Step
SpO2
(lower limit+1) ~100
0~(upper limit-1)
1
PR
(lower limit+2) ~254
0~(upper limit-2)
1
The SpO2 and PR alarm limits in factory configuration:
Parameter
SpO2
PR
Patient type
Upper limit
Lower limit
Adult
100
90
Pediatric
100
90
Neonate
95
90
Adult
120
50
Pediatric
160
75
Neonate
200
100
WARNING
z
Setting the SpO2 upper alarm limit to 100% will disable the upper alarm limit.
High oxygen levels may predispose a premature infant to retrolental fibroplasia.
Therefore, the upper alarm limit for oxygen saturation must be carefully selected
in accordance with the commonly accepted clinical practices.
„
SWEEP
Waveform speed
Options: 12.5 and 25.0 mm/s.
„
PR SOUND
Pulse volume
Range: 0–10. 0 indicates the volume is closed and 10
indicates the maximum volume.
„
SENSITIVE
Sensitivity of SpO2 calculation
Options: HIGH, MED and LOW.
When HIGH is selected, the monitor gives quick response to
the change of the oxygen saturation but the measurement
accuracy might be compromised.
When LOW is selected, the monitor gives slow response to
the change of the oxygen saturation but the accuracy is
relatively high.
„
NIBP SIMUL
ON: When measuring NIBP and SpO2 at the same side, the
SpO2 alarm status remains unchanged until the NIBP
measurement is finished;
OFF: The function of NIBP SIMUL is disabled.
11-8
„
CONFIG >>
You can select this option to access the SPO2 CONFIG
menu, in which you may select FACTORY CONFIG or
USER CONFIG. After finishing your selection and exiting
the menu, the system pops up a dialog box asking for your
confirmation.
11.3 Nellcor SpO2 Module
NOTE
z
This section is only applicable to the monitor equipped with a Nellcor SpO2
module.
11.3.1 Principles of Operation
Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over
time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the
pulsations. The Nellcor SpO2 module uses pulse oximetry to measure functional oxygen
saturation in the blood. Pulse oximetry works by applying a sensor to a pulsating arteriolar
vascular bed, such as a finger or toe. The sensor contains a dual light source and a photodetector.
The ratio of light absorbed is translated into a measurement of functional oxygen saturation
(SpO2).
„ Oximetry Overview
Pulse oximetry is based on two principles:
1. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light
(i.e., spectrophotometry).
2. The volume of arterial blood in tissue (and hence, light absorption by that blood) changes
during the pulse (i.e., plethysmography).
A monitor determines SpO2 by passing red and infrared light into an arteriolar bed and measuring
changes in light absorption during the pulsatile cycle. Red and infrared low-voltage light-emitting
diodes (LEDs) in the oximetry sensor serve as light sources; a photodiode serves as the photo
detector.
Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and
infrared light absorbed by blood is related to hemoglobin oxygen saturation. To identify the
oxygen saturation of arterial hemoglobin, the monitor uses the pulsatile nature of arterial flow.
During systole, a new pulse of arterial blood enters the vascular bed, and blood volume and light
absorption increase. During diastole, blood volume and light absorption reach their lowest point.
The monitor bases its SpO2 measurements on the difference between maximum and minimum
absorption (i.e., measurements at systole and diastole). By doing so, it focuses on light absorption
by pulsatile arterial blood, eliminating the effects of nonpulsatile absorbers such as tissue, bone,
and venous blood.
11-9
„ Automatic Calibration
Because light absorption by hemoglobin is wavelength dependent and because the mean
wavelength of LEDs varies, a monitor must know the mean wavelength of the sensor’s red LED
to accurately measure SpO2. During manufacturing, the mean wavelength of the red LED is
encoded in a resistor in the sensor. During monitoring, the monitor reads this resistor and selects
coefficients that are appropriate for the wavelength of that sensor’s red LED; these coefficients
are then used to determine SpO2.
This resistor is read when the monitor is turned on, periodically thereafter, and each time a new
sensor is connected. Additionally, to compensate for differences in tissue thickness, the intensity
of the sensor’s LEDs is adjusted automatically.
„ Functional versus Fractional Saturation
This monitor measures functional saturation — oxygenated hemoglobin expressed as a
percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of
dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast, some
instruments report fractional saturation — oxygenated hemoglobin expressed as a percentage of
all measured hemoglobin, including measured dysfunctional hemoglobins. To compare functional
saturation measurements to those from an instrument that measures fractional saturation,
fractional measurements must be converted as follows:
Functional saturation =
Fractional saturation
100 - (%carboxyhemoglobin + %methemoglobin)
×100
„ Measured versus Calculated Saturation
When saturation is calculated from a blood gas partial pressure of oxygen (PO2), the calculated
value may differ from the SpO2 measurement of a monitor. This usually occurs because the
calculated saturation was not appropriately corrected for the effects of variables that shift the
relationship between PO2 and saturation (Figure 11-7): pH, temperature, the partial pressure of
carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin.
SpO2%
Temperature
PCO2
2,3-DPG
Fetal Hb
Saturation (%)
PH
Temperature
PCO2
2,3-DPG
Figure 11-7 Oxyhemoglobin Dissociation Curve
11-10
11.3.2 Precautions
WARNING
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z
z
Pulse oximeter can overestimate the SpO2 value in the presence of Hb-CO,
Met-Hb or dye dilution chemicals.
ES (Electrosurgery) equipment wire and SpO2 cable must not be tangled up.
Carefully route patient cabling to reduce the possibility of patient entanglement
or strangulation.
Do not use this instrument and the sensors during magnetic resonance imaging
(MRI). Induced current could potentially cause burns. The monitor may affect
the MRI image, and the MRI unit may affect the accuracy of the oximetry
measurements.
Do not put the SpO2 sensor on the limb with arterial catheter or venous syringe.
Do not use the supplied sterile SpO2 sensors if the packaging or the sensor is
damaged. Return them to the distributor or manufacturer.
Do not perform SpO2 monitoring and NIBP measurements on the same arm
simultaneously. Obstruction of blood flow during NIBP measurements may
adversely affect the reading of the SpO2 value.
Before performing the testing, check the sensor cable. After unplugging the
SpO2 sensor cable from the socket, the system shall display the prompt
information "SPO2 SENSOR OFF" and give the audible alarm.
Prolonged continuous monitoring may increase the risk of undesirable changes
in skin characteristics, such as irritation, reddening, blistering or burns. Inspect
the sensor site every two hours and move the sensor if the skin quality changes.
Change the application site every four hours. For neonates or patients with poor
peripheral blood circulation or sensitive skin, inspect the sensor site more
frequently.
NOTE
z
z
Place the SpO2 sensor cable at the backside of the patient hand. Make sure the
fingernail is just opposite to the light emitted from the sensor.
SpO2 waveform is not proportional to the pulse volume.
11.3.3 Monitoring Procedure
Follow the procedure as below:
1. Power on the monitor.
2. Attach the sensor to the proper site on the patient.
3. Plug the connector of the sensor extension cable into the SpO2 connector on monitor.
The process of SpO2 plethysmogram measurement is generally the same. But the SpO2 sensor
selection and placement depend on the patient type. When choosing a site for a sensor, refer to
the directions for that sensor.
11-11
11.3.4 Measurement Limitations
If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs
by an alternate method. Then check the instrument for proper function.
Inaccurate measurements may be caused by:
„ Incorrect sensor application or use;
„ Placement of a sensor on the same extremity with a blood pressure cuff, arterial catheter, or
intravascular line;
„ Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon
light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight
(exposure to excessive illumination can be corrected by covering the sensor with a dark
material);
„ Excessive patient motion;
„ Venous pulsations;
„ Intravascular dyes such as indocyanine green or methylene blue;
„ Defibrillation;
Other physiological conditions or medical procedures that may interfere with the monitor’s
measurements include significant levels of dysfunctional hemoglobin, low perfusion, and dark
pigment.
Loss of pulse signal can occur in the following situations:
„ The sensor is too tight;
„ A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor
attached;
„ There is arterial occlusion proximal to the sensor.
Select an appropriate sensor, apply it as directed, and observe all warnings and cautions presented
in the directions for use accompanying the sensor. Clean and remove any substances such as nail
polish from the application site. Periodically check to ensure that the sensor remains properly
positioned on the patient.
If patient movement presents a problem, try one or more of the following remedies to correct the
problem.
„ Verify that the sensor is properly and securely applied.
„ Move the sensor to a less active site.
„ Use an adhesive sensor that tolerates some patient motion.
„ Use a new sensor with fresh adhesive backing.
If poor perfusion affects performance, consider using the Oxisensor R-15 sensor; it obtains
measurements from the nasal septal anterior ethmoid artery, an artery supplied by the internal
carotid. This sensor may obtain measurements when peripheral perfusion is relatively poor. For
low peripheral perfusion, consider using the Nellcor RS-10 sensor, which is applied to the
forehead or temple. These are sites that may be spared during peripheral vasoconstriction.
11-12
11.3.5 SpO2 Setup Menu
Selecting the SPO2 label in the parameter window opens the following menu.
Figure 11-8 SpO2 Setup Menu
You can perform the following settings in this menu.
„
ALM
SpO2 alarm on/off status
ON: When a SpO2 alarm occurs, the monitor gives alarm
indications and stores the alarm;
OFF: When a SpO2 alarm occurs, the monitor neither
gives alarm indications nor stores the alarm;
When OFF is selected, the
right of the SPO2 label.
„
ALM LEV
„
ALM REC
icon is displayed on the
Alarm level
Options: HIGH and MED.
‹
‹
‹
Alarm recording
ON: When a SpO2 alarm occurs, the
monitor enables the recording;
OFF: When a SpO2 alarm occurs, the
monitor does not enable the recording.
„
SPO2 ALM HI
SpO2 upper alarm limit
„
SPO2 ALM LOW
SpO2 lower alarm limit
„
PR ALM HI
PR upper alarm limit
„
PR ALM LO
PR lower alarm limit
11-13
SpO2 and PR alarm limits:
Parameter
Upper Limit
Lower Limit
Step
SpO2
(lower limit+1) ~100
0~(upper limit-1)
1
PR
(lower limit+2) ~254
0~(upper limit-2)
1
The SpO2 and PR alarm limits in factory configuration:
Parameter
SpO2
PR
Patient type
Upper limit
Lower limit
Adult
100
90
Pediatric
100
90
Neonate
95
80
Adult
120
50
Pediatric
160
75
Neonate
200
100
WARNING
z
Setting the SpO2 upper alarm limit to 100% will disable the upper alarm limit.
High oxygen levels may predispose a premature infant to retrolental fibroplasia.
Therefore, the upper alarm limit for oxygen saturation must be carefully
selected in accordance with the commonly accepted clinical practices.
„
SWEEP
Waveform speed
Options: 12.5 and 25.0 mm/s.
„
PR SOUND
Pulse volume
Range: 0–10. 0 indicates the volume is closed and 10
indicates the maximum volume.
„
AVG TIME
Average time
Determines the average SpO2 calculation time.
Options: 4S, 8S and 16S.
„
NIBP SIMUL
ON: When measuring NIBP and SpO2 at the same side, the
SpO2 alarm status remains unchanged until the NIBP
measurement is finished;
OFF: The function of NIBP SIMUL is disabled.
„
CONFIG >>
You can select this option to access the SPO2 CONFIG
menu, in which you may select FACTORY CONFIG or
USER CONFIG. After finishing your selection and exiting
the menu, the system pops up a dialog box asking for your
confirmation.
11-14
11.3.6 Accessories
If your monitor is equipped with a Nellcor SpO2 module, use only Nellcor oximetry sensors for
SpO2 measurements. Other sensors may cause improper pulse oximeter performance. Before use,
carefully read the directions for the sensor. When selecting a sensor, consider, the patient’s weight
and motion, the adequacy of perfusion, the available sensor sites, and the required disinfection.
Biocompatibility testing has been conducted on Nellcor sensors in compliance with ISO 10993-1,
Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. The sensors have
passed the recommended biocompatibility testing and are therefore in compliance with ISO
10993-1.
Before attempting to clean a SpO2 sensor, read the directions for use enclosed with the sensor.
Each sensor model has cleaning instructions specific to that sensor.
WARNING
z
Incorrect use of an oximetry sensor may cause damage to the patient’s muscle.
Verify the sensor site carefully according to the directions for use.
11.3.7 Nellcor Information
Nellcor Patents
This device is covered under one or more the following U.S. Patents: 4,802,486; 4,869,254;
4,928,692; 4,934,372; 5,078,136; 5,351,685; 5,485,847; 5,533,507; 5,577,500; 5,803,910;
5,853,364; 5,865,736; 6,083,172; 6,463,310; 6,591,123; 6,708,049; Re.35,122 and international
equivalents. U.S.A and international patents pending.
No Implied License
Possession or purchase of this device does not convey any express or implied license to use the
device with replacement parts which would, alone, or in combination with this device, fall within
the scope of one or more of the patents relating to this device.
11-15
FORYOURNOTES
11-16
12 NIBP Monitoring
12.1 Overview
The Non-invasive Blood Pressure (NIBP) module measures blood pressure using the
oscillometric method. This monitor can be applied to adult, pediatric, and neonatal patients.
Three modes of measurement are available: manual, automatic and continuous.
„ Manual: Pressing the NIBP key on the control panel starts a NIBP measurement.
„ Auto: The NIBP measurement is conducted automatically at a preset interval.
„ Continuous: The NIBP measurement is performed as many times as possible in five
minutes.
NOTE
z
Blood pressure measurements determined with this device are equivalent to
those obtained by a trained observer using the cuff/stethoscope auscultatory
method, within the limits prescribed by the American National Standard,
Manual, electronic, or automated sphygmomanometers.
The NIBP measurement does not produce any waveform. Instead, it displays the measurement
result in the NIBP parameter window as shown below.
1
2
3
4
5
6
7
Figure 12-1 NIBP Parameter Window
1.
2.
3.
4.
5.
6.
7.
NIBP label: Selecting this label to access the NIBP SETUP menu.
Time of last measurement.
NIBP unit: mmHg or kPa.
Prompt information area: Shows the NIBP measurement mode and other information.
Systolic pressure value (NS)
Mean pressure value (NM)
Diastolic pressure value (ND)
12-1
If a set of measured results appears in grey, it indicates this measurement is performed at least 1
hour ago.
12.2 Monitoring Procedure
WARNING
z
z
z
z
You must not perform NIBP measurements on patients with sickle-cell disease
or under any condition in which the skin is damaged or expected to be damaged.
For a thrombasthemia patient, it is important to determine whether
measurement of the blood pressure shall be done automatically.
This monitor is suitable for use in the presence of electrosurgery.
Ensure that the setting is correctly made when performing measurements on
children. Incorrect patient type setting may cause a danger to the patient
because adult blood pressure level is higher than children.
To perform NIBP measurement on a patient, follow the procedure as below
1. Power on the monitor.
2. Check the patient information area on the screen. If the patient type is incorrect, select a
correct patient type in PATIENT SETUP menu.
3. Plug the air hose in the NIBP cuff connector of the monitor.
4. Apply a cuff of proper size to the upper arm or the leg of the patient.
5. Connect the cuff with the air hose.
6. Press the NIBP key on the control panel to start the NIBP measurement.
12.2.1 Cuff Selection and Placement
1.
2.
3.
Identify the patient limb circumference.
Select appropriate cuff; limb circumference is identified on each cuff.
Verify the cuff is completely deflated; place cuff around extremity being used and make
sure the marking φ matches artery location.
4.
Verify the cuff is not wrapped too tightly around the limb. Excessive tightness may cause
discoloration or ischemia of the extremities.
12-2
5.
6.
„
„
Make sure that the cuff edge falls within the range of the <-> mark. If it does not, use a
larger or smaller cuff that will fit better.
The limb chosen for taking the measurement should be placed at the same level as the
patient's heart. If this is not possible, use the following method to correct the measurement
result:
If the cuff is placed higher than the heart level, add 0.75 mmHg (0.10 kPa) for each
centimeter of difference.
If it is placed lower than the heart level, deduct 0.75 mmHg (0.10 kPa) for each centimeter
of difference.
WARNING
z
z
z
The width of the cuff should be either 40% of the limb circumference (50% for
neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should
be long enough to circle 50-80% of the limb. The wrong size cuff can cause
erroneous readings. If the cuff size is in question, use a larger cuff.
Do not apply the cuff to a limb that has an intravenous infusion or catheter in
place. This could cause tissue damage around the catheter when infusion is
slowed or blocked during cuff inflation.
Make sure the air tubing connecting the blood pressure monitor is not blocked,
twisted, or tangled.
12.2.2 Operation Guides
1.
„
„
To start a manual NIBP measurement
Access the NIBP SETUP menu and select MANUAL from the INTERVAL option; then,
press the NIBP key on the control panel to start a manual NIBP measurement; or
During the interval between two auto NIBP measurements, press the NIBP key on the
control panel to start a manual NIBP measurement.
2. To start auto NIBP measurement
Access the NIBP SETUP menu and select a time (e.g. 5MIN) from the INTERVAL options; press
the NIBP key on the control panel to start the auto NIBP measurment. When this measurment
finishes, the system will perform the NIBP measurment automatically as per the preset interval.
WARNING
z
Auto non-invasive blood pressure measurements performed in long intervals
may incur ischemia and neuropathy in the limb wearing the cuff. When
monitoring a patient, examine the extremities of the limb frequently for normal
color, warmth and sensitivity. If any abnormality is observed, change the
position of the cuff on the patient or stop the blood pressure measurements
immediately.
12-3
3. To start a continuous NIBP measurement
Selecting CONTINUAL in NIBP SETUP menu starts a continuous NIBP measurement. The
monitor continues measuring NIBP for five minutes.
4. To stop a NIBP measurement
During an auto, manual or continuous measurement, pressing the NIBP key on the control panel
stops the ongoing measurement.
NOTE
z
If you are in doubt about the accuracy of any reading(s), check the patient's
vital signs by an alternative method before checking the function of the monitor.
12.3 Measurement Limitations
Non-invasive blood pressure measurement uses the oscillometric method of measurement. The
monitor detects the regular arterial pressure pulse. In some circumstances when the patient's
condition makes it difficult to detect this pulse, the measurement becomes unreliable and the
measurement time increases. You should be aware that the following conditions could interfere
with the measurement, make the measurement unreliable, prolong the measurement, or even
make a measurement impossible.
„ Patient Movement
E.g.The patient is moving, shivering, or having convulsions.
„ Cardiac Arrhythmia’s
E.g.The patient's cardiac arrhythmia has caused an irregular heartbeat.
„ Heart-lung Machine
E.g. Measurements will be impossible if the patient is connected to a heart-lung machine.
„ Pressure Changes
E.g.The patient's blood pressure is changing rapidly over the period of time during which the
arterial pressure pulses are being analyzed to obtain the measurement.
„ Severe Shock
E.g.If the patient is in severe shock or hypothermia, reduced blood flow to the peripheries will
cause reduced pulsation of the arteries.
„ Heart Rate Extremes
The monitor is unable to perform pressure measurements at a heart rate of less than 40 bpm and
greater than 240 bpm.
12-4
12.4 NIBP Setup Menu
Selecting the NIBP label in the parameter area opens the following menu.
Figure 12-2 NIBP Setup Menu
You can perform the following settings in this menu.
„
ALM
NIBP alarm on/off status
ON: When a NIBP alarm occurs, the monitor gives alarm
indications and stores the alarm;
OFF: When a NIBP alarm occurs, the monitor neither
gives alarm indications nor stores the alarm;
When OFF is selected, the
right of the NIBP label.
icon is displayed on the
„
ALM LEV
Alarm level
Options: HIGH and MED.
„
ALM REC
Alarm recording
ON: When an NIBP alarm occurs, the monitor enables the
recording;
OFF: When a NIBP alarm occurs, the monitor does not
enable the recording.
12-5
„
SYS ALM HI
Determines the upper limit of the systolic pressure.
„
SYS ALM LO
Determines the lower limit of the systolic pressure.
„
MEAN ALM HI
Determines the upper limit of the mean pressure.
„
MEAN ALM LO
Determines the lower limit of the mean pressure.
„
DIA ALM HI
Determines the upper limit of the diastolic pressure.
„
DIA ALM LO
Determines the lower limit of the diastolic pressure.
If a measured pressure crosses a preset upper or lower alarm limit, an alarm will be triggered.
The NIBP alarm limits are as follows:
Adult
Patient type
Pediatric
Neonate
Upper
Limit
Lower
Limit
Upper
Limit
Lower
Limit
Upper
Limit
Lower
Limit
Systolic pressure
(mmHg)
(lower
limit+2)
~270
40~(upper
limit-2)
(lower
limit+2)
~200
40~(upper
limit-2)
(lower
limit+2)
~135
40~(upper
limit-2)
Mean pressure
(mmHg)
(lower
limit+2)
~230
20~(upper
limit-2)
(lower
limit+2)
~165
20~(upper
limit-2)
(lower
limit+2)
~110
20~(upper
limit-2)
Diastolic pressure
(mmHg)
(lower
limit+2)
~210
10~(upper
limit-2)
(lower
limit+2)
~150
10~(upper
limit-2)
(lower
limit+2)
~100
10~(upper
limit-2)
The alarm limits in factory configuration (Unit: mmHg):
Patient type
Adult
Pediatric
Neonate
Sys alarm high
160
120
90
Sys alarm low
90
70
40
Mean alarm high
110
90
70
Mean alarm low
60
50
25
Dia alarm high
90
70
60
Dia alarm low
50
40
20
„
DISPLAY WAY
1 GROUP: The NIBP parameter area only displays a group
of NIBP values obtained in the latest measurement.
GROUPS: Multiple groups of measurement values are
displayed at the lower left corner of the screen as shown
below.
12-6
NS
NM
ND
PR
DATE
TIME
108
84
70
68
2006-6-12
16:06:00
108
80
70
67
2006-6-12
16:11:00
108
80
70
72
2006-6-12
16:16:00
„
UNIT
Options: mmHg, kPa;
„
INTERVAL
Select MANUAL to set the monitor to manual NIBP
measurement mode, or select from the time options to
determine the interval between automatic measurements.
Optional intervals: 1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 180,
240, and 480MIN.
„
RESET
Select this option to restore the initial settings of the
pressure pump. If the monitor fails to give a visual
indication when the pressure pump is working improperly,
selecting this option activates a self-test procedure, and
restores the monitor to normal performance.
„
CONTINUAL
Select this option to start a continuous measurement for five
minutes.
„
CONFIG >>
You can select this option to access the NIBP CONFIG
menu, in which you may select FACTORY CONFIG or
USER CONFIG. After finishing your selection and exiting
the menu, the system pops up a dialog box asking for your
confirmation.
12.4.1 Calibration
If you select the CALIBRATE option, the monitor starts the NIBP calibration and the
CALIBRATE option changes to STOP CAL. Selecting the option again stops the calibration.
Calibrate the cuff pressure reading with a calibrated reference manometer (or mercury
manometer) with accuracy higher than 1mmHg. To perform the calibration, follow the procedure
shown below:
1. Remove the blood pressure cuff from the monitor and replace it with a rigid metal container
or vessel with a capacity of 500 ml ± 5%.
2. Connect a calibrated reference manometer (with an error less than 1mmHg) and a ball pump
using “T” connectors as shown below.
3. Select the CALIBRATE option.
4. Inflate the metal container using the ball pump until the reference manometer reads 0, then
50, and finally 200 mmHg.
5. The difference between the indicated pressure of the reference manometer and the indicated
pressure of the monitor will not exceed 3 mmHg. Contact our Customer Service if these
values are not met.
12-7
Monitor
NIBP cuff
connector
Reference
manometer
Hose
Ball pump
Metal vessel
Figure 12-3 NIBP Calibration
NOTE
z
The calibration of the NIBP measurement should be performed every two years
or performed according to the Hospital Procedure.
12.4.2 Testing for Air Leakage
The PNEUMATIC option is used to test air leakage. When the NIBP cuff is connected, select this
option to start the NIBP inflation and test whether the air leakage occurs in the airway. If the test
is passed, no prompt information will be displayed; if the test is not passed, corresponding
prompt information will be displayed in the NIBP parameter window.
To test air leakage, use the following procedure:
1. Set PAT TYPE to ADU.
2. Connect a rigid metal container or vessel with a capacity of 500 ml ± 5% to the NIBP cuff
connector of the monitor.
Monitor
Air tubing
Connector for
NIBP cuff
Metal
vessel
Figure 12-4 NIBP Leakage Test
3.
4.
Select the PNEUMATIC option, and the information “Pneum testing…” is displayed at the
lower left corner of the NIBP parameter window.
After approximately 20 seconds, the monitor will automatically open the deflate valve,
ending the test.
12-8
5.
If no information appears on the bottom of the NIBP parameter area, it indicates the airway
is in good condition and an air leak does not exist. However if the information
“PNEUMATIC LEAK” appears, it indicates the airway may have an air leak. In this case,
check for loose connections. After confirming all connections are secure, perform the test
again.
If there is still a failure, contact our Customer Service.
NOTE
z
z
Set PAT TYPE to ADU in the PATIENT SETUP menu before leakage test.
The pneumatic test, other than being specified in the EN 1060-1 standard, is to
be used to simply determine whether there are air leaks in the NIBP airway.
12.5 Maintenance and Cleaning
WARNING
z
z
Do not press the rubber tube on the cuff with excessive strength.
When a reusable cuff is not connected to the monitor or is being cleaned, always
cover the rubber tube with a lid. Avoid splashing liquid into the rubber tube or
the monitor inadvertently.
Reusable Blood Pressure Cuffs
The cuff is not suitable for dry-cleaned. Instead, it should be machine or hand washed. Hand
washing, may prolong the service life of the cuff. Before washing, remove the latex rubber
bladder. Allow the cuff to dry thoroughly after washing, and then reinsert the rubber bladder. The
cuff can be disinfected by means of conventional autoclaving, gas, or radiation disinfection in hot
air ovens, or sterilized by immersion in decontamination solutions. Remember to remove the
rubber bladder if you use this method
12-9
Figure 12-5 Replacing the Rubber Bladder
To replace the rubber bladder in the cuff:
1. Place the bladder on top of the cuff so the rubber tubes line up with the large opening on the
long side of the cuff.
2. Roll the bladder lengthwise and insert it into the opening on the long side of the cuff.
3. Hold the tubes and the cuff and shake the complete cuff until the bladder is in position.
4. Thread the rubber tubes from inside the cuff, and out through the small hole under the
internal flap.
CAUTION
z
Some disinfectants may cause skin irritation. Please rinse cuff thoroughly with
water to remove any residual disinfectants. Using dark colored disinfectants
may stain the cuffs. Test a single cuff to ensure that no damage will occur.
Disposable Blood Pressure Cuffs
Disposable cuffs are intended for single patient use only. Do not sterilize or use autoclave
sterilization for disposable cuffs.
NOTE
z
Disposable blood pressure cuffs must be recycled or disposed of properly.
12-10
13 TEMP Monitoring
13.1 Overview
The monitor is able to use two temperature probes simultaneously, to obtain two temperature
values and the difference between them. The measurement values are displayed in the TEMP
parameter window as shown below.
1
2
3
4
5
Figure 13-1 TEMP Parameter Window
1.
TEMP label: Selecting this label opens the TEMP SETUP menu.
2.
Temperature unit: ℃ or ℉.
3.
4.
5.
T1: Temperature channel 1. Displays the temperature measured at temperature channel 1.
T2: Temperature channel 2. Displays the temperature measured at temperature channel 2.
TD: Temperature difference, namely the difference between temperature 1 and temperature
2.
13-1
13.2 Measurement Procedure
To measure the temperature of a patient,
1. If a disposable temperature probe is used, plug the temperature probe cable in the
temperature probe connector on the side panel of the monitor, and then connect the
temperature probe with the cable; if a reusable temperature probe is used, connect the
temperature probe with the temperature probe connector directly.
2. Attach the temperature probe to the patient properly.
3. Power on the monitor.
NOTE
z
z
Disposable temperature probes are for single patient use only.
The self-test of the temperature measurement is performed once per hour
during monitoring. This self-test lasts about 2 seconds and does not affect the
normal measurement of temperature.
WARNING
z
z
z
Verify probe cable fault detection before beginning monitoring. Unplug the
temperature probe cable of channel 1 or channel 2 from the connector on the
monitor. The monitor will display the prompt information “T1 SENSOR OFF”
or “T2 SENSOR OFF” and an audible alarm is activated. The other channel is
the same.
Be careful to avoid damaging the temperature probe and cable. When the
temperature probe and cable are not in use, shape them into a loose round. If
the cable is tangled too tightly or over-bent, mechanical damage may occur.
The calibration of the temperature measurement function is required every two
years (or as dictated by your Hospital Procedures Policy). If you need to
calibrate the temperature measurement function, contact our Customer Service.
13-2
13.3 TEMP Setup Menu
Selecting the TEMP label in the parameter window opens the following menu.
Figure 13-2 TEMP Setup Menu
You can perform the following settings in this menu.
„
ALM
Temperature alarm on/off status
ON: When a temperature alarm occurs, the monitor gives
alarm indications and stores the alarm;
OFF: When a temperature alarm occurs, the monitor neither
gives alarm indications nor stores the alarm;
When OFF is selected, the
of the TEMP label.
icon is displayed on the right
„
ALM LEV
Alarm level
Options: HIGH, MED and LOW.
„
ALM REC
Alarm recording
ON: When a TEMP alarm occurs, the monitor enables the
recording;
OFF: When a TEMP alarm occurs, the monitor does not
enable the recording.
„
T1 ALM HI
Determines the upper alarm limit of temperature channel 1.
„
T1 ALM LO
Determines the lower alarm limit of temperature channel 1.
„
T2 ALM HI
Determines the upper alarm limit of temperature channel 2.
„
T2 ALM LO
Determines the lower alarm limit of temperature channel 2.
„
TD ALM HI
Determines the upper limit of the temperature difference
13-3
between channel 1 and channel 2.
„
TEMP UNIT
Options: ℃ and ℉
„
CONFIG >>
You can select this option to access the TEMP CONFIG
menu, in which you may select FACTORY CONFIG or
USER CONFIG. After finishing your selection and exiting
the menu, the system pops up a dialog box asking for your
confirmation.
Temperature alarm limits:
Parameter
Upper Limit
Lower Limit
Step
T1 and T2
(lower limit+1) ~50
0~(upper limit-1)
0.1
TD
(lower limit+1) ~50
0~(upper limit-1)
0.1
Temperature alarm limits in factory configuration:
T1/T2 alarm high limit: 39℃
T1/T2 alarm low limit: 36℃
TD alarm limit: 2.0℃
13.4 Maintenance and Cleaning
WARNING
z
Before cleaning the monitor or the probe, make sure the equipment is turned off
and disconnected from AC power.
Reusable Temperature Probes
„
The temperature probe should not be heated to a temperature over 100℃ (212℉). It is only
able to bear the temperature between 80 and 100℃ (176 to 212℉) for a short time.
„
„
„
„
The probe must not be disinfected in steam.
Only detergents containing alcohol can be used for disinfection.
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 and with the other hand rub the probe down
in the direction of the connector using a moist lint-free cloth.
NOTE
z
z
Disposable temperature probes must not be re-sterilized or reused.
Disposable temperature probes must be recycled or disposed of properly.
13-4
14 IBP Monitoring
14.1 Overview
The monitor provides two channels to measure the invasive blood pressure (IBP, including
diastolic, systolic and mean pressures), and displays two waveforms.
1
2
Figure 14-1 IBP Waveform
1. CH1 label:
select the waveform of channel 1 to be displayed.
2. CH2 label:
select the waveform of channel 2 to be displayed.
Options for CH1 and CH2: ART (Arterial Blood Pressure), PA (Pulmonary Arterial Pressure),
CVP (Center Venous Pressure), RAP (Right Atrial Pressure), LAP (Left Atrial Pressure), ICP
(Intracranial Pressure) and P1-P2 (Expand Pressure).
Besides, each waveform is followed by three scale lines, among which the upper and the lower
ones are marked by scales on the left.
The parameter window locates to the right of the IBP waveforms as shown below.
5
1
2
3
2
4
Figure 14-2 IBP Parameter Window
1.
2.
3.
4.
5.
IBP (1,2) label: This label allows you to access the IBP (1,2) SELECT menu.
Pressure unit: mmHg, kPa or cmH2O.
Parameter values of channel 1: Systolic pressure, mean pressure and diastolic pressure (from
the left to the right).
Parameter values of channel 2: Systolic pressure, mean pressure and diastolic pressure (from
the left to the right). When ART or ICP is selected for CH1 and CH2 respectively, the ICP
and CPP values will be displayed, where CPP is equal to the mean pressure of ART minus
ICP.
PR numeric
14-5
14.2 Precautions
WARNING
z
z
z
z
z
Use only the IBP transducer specified in this operation manual. Disposable IBP
transducers or domes should not be reused.
Parts and accessories used must meet the safety requirements of the medical
electrical equipment standards.
The need for the operator to avoid conductive connection to the applied part
likely to degrade safety. (For example, by not contacting metal cocks, if used.)
When the monitor is used with high frequency surgical equipment, do not allow
the transducer and the cable contact the high frequency surgical equipment to
prevent the patient from burning caused by leakage current.
Verify transducer cable fault detection before beginning to monitor. Unplug the
transducer cable from the IBP connector on the monitor. The screen will display
the error message “IBP SENSOR OFF” and an audible alarm will be heard.
The transducer (except for the ICT/B transducer) specified in this operation manual is able to
protect against electrical shock, especially the leakage current, and the interference of cardiac
defibrillation. It can be used in surgical operation. During defibrillation, the pressure waveform
might become temporarily distorted. However, the monitor returns to normal operation after the
defibrillation, with the operation mode and the user configuration being unaffected.
NOTE
z
Periodically calibrate the transducer according to the Hospital Regulation.
14-6
14.3 Monitoring Procedure
1.
2.
Plug the pressure cable into the IBP connector on the monitor and power on the monitor.
Prepare the pressure line and transducer by flushing the system with normal saline solution.
Make sure the tubing and transducer system is free of air bubbles.
NOTE
z
3.
4.
5.
6.
In case of any entrapped air in the pressure system, re-fill the system with
normal saline.
Connect the catheter to the pressure line, making sure there is no air present in the catheter
or pressure line.
Position the transducer so it is at the same level with the patient’s heart, approximately
mid-axillary line.
Verify the correct label is selected.
Zero the transducer.
Normal
saline with
heparin
Pressure
Transducer
Valve
3-way
stopcock
Drip
chamber
Pressure transducer
interface cable
Pressure
line
Monitor
Figure 14-3 IBP Monitoring
14-7
14.4 IBP Menu
Selecting the IBP (1,2) label in the parameter window opens the following menu.
Figure 14-4 IBP (1,2) Select Menu
14.4.1 IBP Setup Menu
The IBP SETUP in IBP (1,2) SELECT menu allows you to access the following menu.
Figure 14-5 IBP (1,2) Setup Menu
14-8
You can perform the following settings in this menu.
„
ALM
IBP alarm on/off status
ON: When a IBP alarm occurs, the monitor gives alarm
indications and stores the alarm;
OFF: When a IBP alarm occurs, the monitor neither gives
alarm indications nor stores the alarm;
When OFF is selected, the
of the IBP (1,2) label.
icon is displayed on the right
„
ALM LEV
Alarm level
Options: HIGH, MED and LOW.
„
AMP ADJUST
Amplitude adjustment
This option allows you to adjust the waveform amplitude.
Options: MANUAL and AUTO.
1.
MANUAL: If MANUAL is selected, you can select an IBP channel manually from the
options, including ART, PA, CVP, RAP, LAP, ICP, P1 and P2, and then adjust the IBP
scale in the SCALE ADJUST >> menu.
AUTO: If AUTO is selected, the waveform labels of IBP channels become P1 and P2 and
the IBP scale is adjusted by the system automatically.
2.
„
SWEEP
Waveform speed
Options: 12.5 and 25.0 mm/s.
„
PR SOUND
Pulse volume
Range: 0–10. 0 indicates the volume is closed and 10
indicates the maximum volume.
„
RESPONSE
Options: HIGH, MED and LOW.
The corresponding averaging time is about 1 s, 8 s and 12 s
respectively.
The IBP value displayed on the monitor screen is the average of data collected within a specific
time. The shorter the averaging time is, the quicker the patient monitor responds to changes in the
patient’s blood pressure. Contrarily, the longer the averaging time is, the slower the patient
monitor responds to changes in the patient’s blood pressure, but the measurement accuracy will
be improved. For critically ill patients, selecting shorter averaging time will help understanding
the patient’s state.
„
IBP1 UNIT
Options: mmHg, kPa and cmH2O.
„
IBP2 UNIT
Options: mmHg, kPa and cmH2O.
„
ALM LIMIT SETUP >>
This option allows you to access the following menu,
whereby you can set the upper and lower alarm limits.
14-9
Figure 14-6 IBP Alarm Setup Menu
IBP alarm limits
Pressure Label
Upper Limit (mmHg)
Lower Limit (mmHg)
Step (mmHg)
ART
(lower limit+2) ~300
0~(upper limit-2)
1
PA
(lower limit+2) ~120
-6~(upper limit-2)
1
CVP
(lower limit+2) ~40
-10~(upper limit-2)
1
RAP
(lower limit+2) ~40
-10~(upper limit-2)
1
LAP
(lower limit+2) ~40
-10~(upper limit-2)
1
ICP
(lower limit+2) ~40
-10~(upper limit-2)
1
P1
(lower limit+2) ~300
-50~(upper limit-2)
1
P2
(lower limit+2) ~300
-50~(upper limit-2)
1
The PR alarm limits are the same as those of the corresponding SpO2 module.
„
SCALE ADJUST >>
This option allows you to open the following menu and set
the positions of the high, reference and low scales for the
two waveforms.
Figure 14-7 IBP Scale Adjust Menu
14-10
1.
2.
3.
HI: Determines the high scale. The reference scale changes when the high scale is changed.
LO: Determines the low scale. The reference scale changes when the low scale is changed.
VAL: Determines the reference scale and position. The high and low scales remain
unchanged when the reference scale is changed.
NOTE
z
z
„
The high scale should not be smaller than the low scale; the low scale should not
be larger than the high scale.
The waveform amplitude changes when the high and low scales are adjusted.
EXPAND PRESSURE
Selecting this option opens the following menu. You can
select the pressure to be measured by P1 and P2.
Options: SYS, MEAN, DIA (three pressures are all
measured); MEAN (only the mean pressure is measured).
Figure 14-8 IBP Pressure Setup Menu
„
CONFIG >>
You can select this option to access the IBP (1,2) CONFIG
menu, in which you may select FACTORY CONFIG or
USER CONFIG. After finishing your selection and exiting
the menu, the system pops up a dialog box asking for your
confirmation.
14-11
14.4.2 IBP Pressure Zero Menu
You can select IBP PRESURE ZERO in IBP (1,2) SELECT menu to open the following menu.
Figure 14-9 IBP Pressure Zero Menu
Pressure Transducer Zeroing Procedure
1.
Disconnect the transducer from the patient.
Pressure
transducer
3-way
stopcock
Pressure transducer
interface cable
Monitor
Figure 14-10 Pressure Transducer Zeroing
2.
3.
Adjust the 3-way stopcock to close the channel leading to the patient. The transducer is open
to the atmosphere through the stopcock.
Select CH1 ZERO or CH2 ZERO in IBP PRESSURE ZERO menu to start zeroing.
14-12
NOTE
z
z
z
To ensure correct measurement, zero the transducer before it is used to zero the
monitor.
Position the transducer at the same level with the patient’s heart, approximately
mid-axillary line.
Perform the pressure zeroing before monitoring, and at intervals during
monitoring (at least once per day). The zeroing should also be conducted once
the transducer cable is disconnected and then connected.
Prompt Information Related to Zeroing
Take channel 1 as an example. The monitor may give the following prompt information after the
pressure transducer zeroing has been finished.
„ CH1 SUCCESSFUL ZERO
The zeroing procedure is over. The transducer port opening to the atmosphere is to be closed and
the port connecting to the patient opened.
„ CH1 SENSOR OFF, FAIL
Verify the transducer of channel 1 is connected to the monitor, and then perform zeroing again. If
the monitor continues to give this prompt information, contact our Customer Service.
„ IN DEMO, FAIL
Make sure the monitor is not in DEMO mode, and perform pressure transducer zeroing again. If
the monitor continues to give this prompt information, contact our Customer Service.
„ PRESSURE OVER RANGE, FAIL
Verify the 3-way stopcock is open to the atmosphere, and perform the pressure transducer zeroing
again. If the prompt information is still displayed, change with a new transducer and contact our
Customer Service.
„ PULSATILE PRESSURE, FAIL
Make sure the transducer is not connected to the patient and the stopcock is open to the
atmosphere. Then, perform the pressure transducer zeroing once again. If the prompt is still
displayed, contact our Customer Service.
14-13
14.5 Maintenance and Cleaning
WARNING
z
Before cleaning the transducer, make sure the transducer is disconnected from
the monitor, or the monitor is powered off and disconnected from AC power.
Cleaning of IBP Transducer
After the IBP monitoring operation is completed, remove the tubing and the dome from the
transducer and wipe the transducer diaphragm with water. To clean the transducer and the cable,
wipe them using soap or the detergents listed below:
„ Cetylcide
„ Wavicide-01
„ Wescodyne
„ Cidex
„ Lysol
„ Vesphene
Do not immerse the connector in any liquid. After cleaning, dry the transducer thoroughly before
storing. Slight discoloration or temporary increase of surface stickiness of the cable should not be
considered abnormal. If it is necessary to remove the adhesive tape residue from the transducer
cable, the double seal tape remover is recommended; use the remover with special caution to
minimize the damage to the cable. Acetone, Alcohol, Ammonia and Chloroform, or other strong
solvents are not recommended because they are harmful to the vinyl cabling if used for a long
time.
NOTE
z
z
The disposable transducers or domes must not be reused.
To avoid contamination, the disposable transducers or domes must be reclaimed
or disposed of properly.
14-14
Sterilization
„ Chemical Solution Sterilization
After finishing the cleaning, select an effective sterilant for chemical solution sterilization of the
operating room equipment. Buffered glutaraldehyde (e.g. Cidex or Hospisept) is recommended.
Do not use quaternary cationic detergents such as zephiran chloride. If the whole unit is to be
sterilized, immerse the transducer but not the electrical connector into the sterilant for the
recommended sterilizing period. Ensure that the dome has been removed. Then rinse all
transducer parts except the electrical connector with sterilized water or saline. The transducer
must be thoroughly dried before storing.
„ Gas Sterilization
For more complete asepsis, use gas sterilization. The transducer should be completely dry after
cleaning. When ethylene oxide gas is used as the gas disinfectant, follow the operating
instructions provided by the manufacturer of the gas disinfectant.
NOTE
z
The disinfectant temperature must not exceed 70°C (158°F). Plastics in the
pressure transducer may deform or melt above this temperature.
14-15
FORYOURNOTES
14-16
15 CO Monitoring
2
15.1 Overview
The monitor is able to measure the CO2 pressure of the patient airway, and displays the CO2
waveform in the waveforms area of the monitor screen. The CO2 parameter window shows the
following parameters:
„ End-tidal CO2 concentration (EtCO2)
„ Inspired Minimum CO2 (InsCO2)
„ Air Way Respiration Rate (AwRR)
2
1
Waveform Name
3
4
Figure 15-1 CO2 Waveform and Parameters
1.
2.
3.
4.
5.
CO2 label:
Pressure unit:
EtCO2:
InsCO2:
AwRR:
This option allows you to access the CO2 SETUP menu.
mmHg or kPa.
The measured value of EtCO2.
The measured value of InsCO2.
The measured value of AwRR.
Adverse effects on stated perfomance may occur as a result of the following:
„ Leaks or internal venting of sampled gas;
„ Mechanical shock;
„ Cyclic pressure up to 10 kPa (100 cmH2O);
„ Other sources of interference, if any.
NOTE
z
z
CO2 and CO2 are used interchangeably in this chapter.
The sidestream and microstream CO2 module is equipped with automatic
barometric pressure compensation.
15-1
5
15.2 Mindray DS CO2 Module
NOTE
z
This section is only applicable to a monitor equipped with a Mindray DS CO2
module.
15.2.1 Principles of Operation
WARNING
z
z
z
The CO2 module should be protected against crash and vibration.
This CO2 module is applicable to neonate, pediatric as well as adult patients.
Inaccurate measurement may occur when the monitor is operating in an
environment of excessively high CO2 content (>0.5%).
The monitor adopts sidestream CO2 module. The measurement of this module is based on the
feature that the CO2 molecule absorbs infrared ray. The measurement procedure is as follows :
send the CO2 to a measurement chamber inside the module through the airway system, and then
irradiate 4.26um infrared ray at one side of the chamber and use the sensor to measure the
attenuation degree of the received infrared ray at the other side. Since the attenuation degree of
the infrared ray is proportional to the concentration of CO2, the CO2 concentration is calculated.
The measured CO2 concentration is thereafter converted into the partial pressure under the same
temperature and pressure, and then displayed.
The relation between the partial pressure and the CO2 concentration is given below:
CO2 partial pressure (mmHg)=
CO2 concentration (%)×Pamp (ambient pressure, mmHg)/100
CO2 partial pressure (kPa)= CO2 partial pressure (mmHg)/7.5
15-2
15.2.2 Preparations for CO2 Measurement
1.
2.
3.
4.
Plug the water trap into its receptacle before the measurement.
Open the CO2 SETUP menu and set WORK MODE to MEASURE. The “CO2 START
UP” prompt information is displayed on the screen until the startup is finished.
After the module start-up, the “CO2 WARM UP” prompt information is displayed on the
screen. At this time, the module is in the Warming–up status.
After the module warm-up, the module enters the Ready-to-measure status.
When the monitor is powered on for the first time, the CO2 module enters the STANDBY mode
by default. To activate the CO2 module, you must change the work mode to MEASURE. The
work mode of the CO2 module keeps unchanged when the monitor is restarted. For instance, if
the monitor is power off when the CO2 module is working in the MEASURE mode, the CO2
module will automatically enter the MEASURE mode after the monitor is restarted. For details
about WORK MODE, please refer to the section Other Setup in 15.2.3CO2 .
Figure 15-2 CO2 Module Airway Connections
The measure CO2 concentration can be compensated in two ways:
„ ATPD (Ambient Temperature and Pressure, Dry Gas);
„ BTPS (Body temperature and pressure, Saturated);
ATPD means the CO2 value is measured in ambient temperature and pressure and dry gas, while
BTPS means the CO2 is measured at a temperature of 37℃, a relative humidity of 95% and a
47mmHg (pH2O) partial pressure of moisture.
15-3
The calculation formulas in the above two compensations are as follows:
ATPD: PCO2 (mmHg)= CO2 (vol%)× Pamp/100
BTPS: PCO2 (mmHg)= CO2 (vol%)×(Pamp-47)/100
In the above formulas, PCO2 refers to the CO2 partial pressure, vol% is the percentage of the gas
concentration, and Pamp is the ambient pressure in the unit of mmHg.
WARNING
z
z
z
z
z
Do not use the accessory if the packaging or the internal accessory is damaged.
Return it to the manufacturer.
“CO2 START UP” and “CO2 WARM UP” displayed on the screen indicate that
the sensor is starting up and warming up. During the warming up, the module
can measure CO2, but the measurement is not standard. After the above
information disappears, the standard measurement can be performed.
The sidestream sampling line is disposable. It should not be disinfected for reuse
or cross-used by different patients.
The water trap is used to collect water drops condensed in the sampling airway
and prevent water drops from entering the module. When the collected water
reaches to a certain amount, remove the water to avoid blocking the airway.
In the long-term use, dust or other substances may lower the air permeability of
the filter material in the water trap and may block the airway. In this situation,
the water trap must be replaced.
15.2.3 CO2 Setup Menu
Selecting the CO2 label in the parameter window opens the following menu.
Figure 15-3 CO2 Setup Menu
15-4
You can perform the following settings in this menu.
„
ALM
Alarm on/off status
ON: When a CO2 alarm occurs, the monitor gives alarm
indications and stores the alarm;
OFF: When a CO2 alarm occurs, the monitor neither gives
alarm indications nor stores the alarm;
When OFF is selected, the
right of the CO2 label.
icon is displayed on the
„
ALM LEV
Alarm level
Options: HIGH and MED.
„
ALM REC
Alarm recording
ON: When a CO2 alarm occurs, the monitor enables the
recording;
OFF: When a CO2 alarm occurs, the monitor does not
enable the recording.
„
CO2 ALM HI
Upper alarm limit of EtCO2
„
CO2 ALM LO
Lower alarm limit of EtCO2
„
INS ALM HI
Upper alarm limit of InsCO2
„
AWRR ALM HI
Upper alarm limit of AwRR
„
AWRR ALM LO
Lower alarm limit of AwRR
„
APNEA ALM
Determines the apnea alarm delay.
If the apnea of the patient exceeds the preset apnea alarm
delay, the monitor triggers an alarm and gives the " CO2
APNEA " alarm message.
Options: 10S, 15S, 20S, 25S, 30S, 35S and 40S.
„
SWEEP
Waveform speed
Options: 6.25, 12.5 and 25.0.
Unit: mm/s.
„
UNIT
Options: mmHg, kPa and %.
„
WAVE SCALE
Options: HIGH and LOW.
This option allows you to adjust the amplitude of the CO2
waveform.
„
WORK MODE
Options: MEASURE and STANDBY.
To start the CO2 monitoring, select the MEASURE mode.
In the STANDBY mode, the air pump and infrared ray
source of the CO2 module are disabled. Hence, decreases
the power consumption and prolongs the operating life of
infrared ray source and the whole CO2 module.
15-5
Alarm limits:
Parameter
Upper Limit
Lower Limit
Step
CO2
(lower limit+2) ~100
0~(upper limit-2)
1
INS
0~100
/
1
AwRR
(lower limit+2) ~150
0~(upper limit-2)
1
Patient type
Upper limit
Lower limit
Adult
50
15
Pediatric
50
20
Neonate
45
30
Adult
4
/
Pediatric
4
/
Neonate
4
/
Adult
30
8
Pediatric
30
8
Neonate
100
30
Default alarm limits:
Parameter
CO2
INS
AwRR
NOTE
z
z
The apnea alarm cannot be disabled.
When the CO2 monitoring is not required, it is recommended the water trap not
be connected and the work mode be set to STANDBY.
15-6
Other Setup
Selecting OTHER SETUP option opens the following menu.
Figure 15-4 CO2 Other Setup Menu
You can perform the following settings in this menu.
„
PUMP RATE
Determines the sampling rate of the CO2 module pump.
„
N2O COMPEN
N2O compensation
The presence of nitrous oxide causes the CO2 value to be
higher than the actual value. Use this option to compensate
for the presence of N2O.
„
O2 COMPEN
O2 compensation
The presence of a large concentration of oxygen causes the
CO2 value to be lower than the actual value. Use this option
to compensate for the presence of O2.
„
Des COMPEN
Desflurane compensation
The presence of desflurane causes the CO2 value to be
higher than the actual value. Use this option to compensate
for the presence of desflurane.
NOTE
z
z
„
The unit of N2O COMPEN, O2 COMPEN and Des COMPEN is “%”. The
concentration of N2O, O2 and Desflurane can be obtained from the anesthesia
machine.
Set the N2O COMPEN, O2 COMPEN and Des COMPEN according to the
practical situation. Incorrect setting might incur errors from the actual value and
cause misdiagnosis.
BTPS
Body Temperature and Pressure, Saturated
Options: ON and OFF.
15-7
When BTPS is turned ON, the system performs BTPS compensation automatically; when BTPS
is turned OFF, the BTPS compensation is disabled.
When measuring the CO2 content inside the patient’s lung, turn ON BTPS. Normally, the lung
temperature of the patient is 37℃ and the water vapor is sufficient or regarded as saturated. But
the temperature and water vapor content of the sampling line are different from the patient’s
exhalation. Thus, when the patient’s exhalation passes the sampling line, the accuracy of the CO2
concentration measured by the sensor will be adversely affected. To ensure an accurate
measurement, you should turn ON the BTPS. In this mode, the system adjusts the calculation
coefficient automatically, so that the measured value is just the actual CO2 content in the patient’s
lung.
When measuring the CO2 content of the environment or a certain vessel, turn OFF BTPS. In the
standard ambient pressure and dry gas, the accuracy of the sensor measurement is not affected.
NOTE
z
When measuring a moist gas of saturated water vapor at the body temperature
and the ambient pressure, turn ON BTPS; when measuring a dry gas at the
ambient temperature and pressure, turn OFF BTPS.
„
ZERO CAL
This option allows you to zero manually so as to eliminate
the adverse affect of baseline drift in the process of
measurement.
„
CONFIG >>
Select CONFIG >> to access the CO2 CONFIG menu. You
can select either FACTORY CONF or USER CONF. After
finishing the selection and exiting the menu, a dialog pops
up asking for confirmation of your selection.
15-8
15.2.4 CO2 User Maintain Menu
Select CO2 USER MAINTAIN >> in USER MAINTAIN menu. The following menu appears.
Figure 15-5 CO2 User Maintain Menu
The following information is displayed in the menu above.
„
CO2
The currently measured CO2 content.
Unit: %.
In the field at the right of the CO2 value, you can select a standard gas containing a certain
amount of CO2 for calibration.
Options: 3%, 4%, 5%, 6% and 7%.
„
BAROMETRIC
The currently measured barometric pressure.
Unit: mmHg.
„
SENSOR TEMP
The currently measured temperature around the infrared
sensor.
Unit: ℃.
„
CUR PUMP RATE
The currently measured pumping rate.
Unit: ml/min.
„
SET PUMP RATE
The sampling flow rate set by the user.
„
ZERO CAL
This option allows you to zero the CO2 module, so as to
eliminate the adverse affect of the baseline drift in the
process of measurement. Perform zeroing prior to
concentration calibration.
15-9
„
CONFIRM CAL
This option allows you to confirm the calibration of the CO2
module.
Calibration Procedure
1.
2.
Verify the module enters the ready-to-measure status.
Connect a gas bottle with the CO2 sensor connector on the monitor as shown below.
Tube
Decompression
valve
T-shape connector opening
to the atmosphere
Monitor
Gas bottle
Figure 15-6 Connections for Calibration
3.
4.
5.
6.
7.
Fill the gas bottle with a standard gas of certain CO2 content (3%, 4%, 5%, 6% and 7%),
and input the gas to the monitor.
Open the CO2 USER MAINTAIN menu, and set the CO2 field to a value, which is the same
with the CO2 content of the gas bottle.
When the CO2 USER MAINTAIN menu displays the currently measured CO2 content, wait
until a stable reading is indicated, and then select the CONFIRM CAL option to start
calibrating the CO2 module.
If the calibration succeeds, “CALIBRATE SUCCESS!” will be displayed in the CO2 USER
MAINTAIN menu. If fails, “CAL FAIL, TRY AGAIN!” will be displayed, and
re-calibration is required.
Select the EXIT option to exit the CO2 USER MAINTAIN menu.
15.2.5 Maintenance and Cleaning
„
„
„
The sampling line of the sidestream CO2 module is disposable and cannot be disinfected for
reuse.
In case of an exception in the sampling system of the CO2 module, check for entanglement
of the sampling line. If the sampling line is not entangled, remove it from the water trap. In
this situation, if the screen displays a prompt information indicating the CO2 sampling line
is abnormal, the water trap must have been blocked, and you must replace it with a new one.
If no prompt information is given, the sampling line must have been blocked, and you
should replace with a new sampling line.
Routine calibration of the sidestream CO2 module is not required. But the calibration must
be performed every year, or when great inaccuracy of measurement is found.
15-10
15.3 Oridion CO2 Module
NOTE
z
z
This section is applicable to a monitor equipped with the Oridion CO2 module
only.
When the sample flow is lower than 42.5 ml/min, alarm message will be displayed,
and the CO2 module will stop work.
15.3.1 Principles of Operation
WARNING
z
z
z
The CO2 module should be protected against crash and vibration.
This CO2 module is applicable to neonate, pediatric as well as adult patients.
Inaccurate measurement may occur when the monitor is operating in an
environment of excessively high CO2 content (>0.5%).
The monitor adopts Oridion (microstream) CO2 module. The measurement of this module is
based on the feature that the CO2 molecule absorbs infrared ray. The measurement procedure is
as follows : send the CO2 to a measurement chamber inside the module through the airway
system, and then irradiate 4.26um infrared ray at one side of the chamber and use the sensor to
measure the attenuation degree of the received infrared ray at the other side. Since the attenuation
degree of the infrared ray is proportional to the concentration of CO2, the CO2 concentration is
calculated. The measured CO2 concentration is thereafter converted into the partial pressure
under the same temperature and pressure, and then displayed.
The relation between the partial pressure and the CO2 concentration is given below:
CO2 partial pressure (mmHg)=
CO2 concentration (%)×Pamp (ambient pressure, mmHg)/100
CO2 partial pressure (kPa)= CO2 partial pressure (mmHg)/7.5
15-11
15.3.2 Preparations for CO2 Measurement
1.
2.
3.
Plug the sampling line into its receptacle before the measurement.
Open the CO2 SETUP menu and set WORK MODE to MEASURE.
The “CO2 START UP” prompt information is displayed on the screen until the startup is
finished.
Figure 15-7 CO2 Module Airway Connections
When the monitor is powered on for the first time, the CO2 module enters the STANDBY mode
by default. To activat the CO2 module, you must change the work mode to MEASURE. The work
mode of the CO2 module keeps unchanged when the monitor is restarted. For instance, if the
monitor is power off when the CO2 module is working in the MEASURE mode, the CO2 module
will automatically enter the MEASURE mode after the monitor is restarted. For details about
WORK MODE, please refer to the section 15.3.3CO2 .
WARNING
z
z
Do not use the accessory if the packaging or the internal accessory is damaged.
Return it to the manufacturer.
The sidestream sampling line is disposable. It should not be disinfected for reuse or
cross-used by different patients.
15-12
15.3.3 CO2 Setup Menu
Selecting the CO2 label in the parameter window opens the following menu.
Figure 15-8 CO2 Setup Menu
You can perform the following settings in this menu.
„
ALM
Alarm on/off status
ON: When a CO2 alarm occurs, the monitor gives alarm
indications and stores the alarm;
OFF: When a CO2 alarm occurs, the monitor neither gives
alarm indications nor stores the alarm;
When OFF is selected, the
right of the CO2 label.
icon is displayed on the
„
ALM LEV
Alarm level
Options: HIGH and MED.
„
ALM REC
Alarm recording
ON: When a CO2 alarm occurs, the monitor enables the
recording;
OFF: When a CO2 alarm occurs, the monitor does not
enable the recording.
„
CO2 ALM HI
Upper alarm limit of EtCO2
„
CO2 ALM LO
Lower alarm limit of EtCO2
„
INS ALM HI
Upper alarm limit of InsCO2
„
AWRR ALM HI
Upper alarm limit of AwRR
15-13
„
AWRR ALM LO
Lower alarm limit of AwRR
„
APNEA ALM
Determines the apnea alarm delay.
If the apnea of the patient exceeds the preset apnea alarm
delay, the monitor triggers an alarm and gives the “CO2
APNEA” alarm message.
Options: 10S, 15S, 20S, 25S, 30S, 35S and 40S.
„
SWEEP
Waveform speed
Options: 6.25, 12.5 and 25.0.
Unit: mm/s.
„
UNIT
Options: mmHg, kPa And %.
„
WAVE SCALE
Options: HIGH and LOW.
This option allows you to adjust the amplitude of the CO2
waveform.
„
WORK MODE
Options: MEASURE and STANDBY.
To start the CO2 monitoring, select the MEASURE mode.
In the STANDBY mode, the air pump and infrared ray
source of the CO2 module are disabled. Hence, decreases
the power consumption and prolongs the operating life of
infrared ray source and the whole CO2 module.
NOTE
z
When the CO2 monitoring is not required, it is recommended the work mode be set
to STANDBY.
Other Setup
Selecting the OTHER SETUP option opens the following menu.
Figure 15-9 CO2 Other Setup Menu
15-14
You can perform the following settings in this menu.
„
MAX HOLD
If Max Hold is configured to 10 sec or 20 sec, the etCO2
numeric shows the highest CO2 value measured within the
previous 10 or 20 seconds. If set to Off the etCO2 numeric
shows breath-to-breath value.
„
BTPS
Body temperature and pressure, Saturated
Options: ON and OFF.
When BTPS is turned ON, the system performs BTPS compensation automatically; when BTPS
is turned OFF, the BTPS compensation is disabled.
When measuring the CO2 content inside the patient’s lung, turn ON BTPS. Normally, the lung
temperature of the patient is 37℃ and the water vapor is sufficient or regarded as saturated. But
the temperature and water vapor content of the sampling line are different from the patient’s
exhalation. Thus, when the patient’s exhalation passes the sampling line, the accuracy of the CO2
concentration measured by the sensor will be adversely affected. To ensure an accurate
measurement, you should turn ON the BTPS. In this mode, the system adjusts the calculation
coefficient automatically, so that the measured value is just the actual CO2 content in the patient’s
lung.
When measuring the CO2 content of the environment or a certain vessel, turn OFF BTPS. In the
standard ambient pressure and dry gas, the accuracy of the sensor measurement is not affected.
NOTE
z
When measuring a moist gas of saturated water vapor at the body temperature
and the ambient pressure, turn ON BTPS; when measuring a dry gas at the
ambient temperature and pressure, turn OFF BTPS.
„
AUTO STANDBY
Range: 0 to 60min.
If no respiration waveform is detected in the selected time,
the CO2 module enters the standby mode automatically.
When AUTO STANDBY is set to 0min, it means the CO2
module is in MEASURE state. If the sampling line is not
connected, the CO2 module enters the standby mode
automatically 3 minutes later.
„
ZERO CAL
This option allows you to zero manually so as to eliminate
the adverse affect of baseline drift in the process of
measurement.
„
CONFIG >>
Select CONFIG >> to access the CO2 CONFIG menu.
You can select either FACTORY CONF or USER CONF.
After finishing the selection and exiting the menu, a dialog
pops up asking for confirmation of your selection.
15-15
15.3.4 CO2 User Maintain Menu
Select CO2 USER MAINTAIN >> in USER MAINTAIN menu. The following menu appears.
Figure 15-10 CO2 User Maintain Menu
The following information is displayed in the menu above.
„
CO2
The currently measured CO2 content.
Unit: %.
In the field at the right of the CO2 value, you can select a standard gas containing a certain
amount of CO2 for calibration.
„
BAROMETRIC
The currently measured barometric pressure.
Unit: mmHg.
„
CONFIRM CAL
This option allows you to confirm the calibration of the CO2
module.
15-16
Calibration Procedure
1.
2.
Verify the module enters the Full Accuracy Mode.
Connect a gas bottle with the CO2 sensor connector on the monitor as shown below.
Tube
Decompres
sion valve
T-shape connector opening
to the atmosphere
Monitor
Gas bottle
Figure 15-11 Connections for Calibration
3.
4.
5.
6.
7.
Fill the gas bottle with a standard gas of certain CO2 content (4% to 6%), and input the gas
to the monitor.
Open the CO2 USER MAINTAIN menu, and set the CO2 field to a value, which is the same
with the CO2 content of the gas bottle.
When the CO2 USER MAINTAIN menu displays the currently measured CO2 content, wait
until a stable reading is indicated, and then select the CONFIRM CAL option to start
calibrating the CO2 module.
If the calibration succeeds, “CALIBRATE SUCCESS!” will be displayed in the CO2 USER
MAINTAIN menu. If fails, “CAL FAIL, TRY AGAIN!” will be displayed, and
re-calibration is required.
Select the EXIT option to exit the CO2 USER MAINTAIN menu.
15.3.5 Maintenance and Cleaning
„
„
The sampling line of the micorstream CO2 module is disposable and cannot be disinfected
for reuse.
Routine calibration of the microstream CO2 module is not required. But the calibration must
be performed if it is prompted in the CO2 USER MATINTAIN menu, or great inaccuracy of
measurement is found.
15-17
15.3.6 Oridion Information
This trademark is registered in Israel, Japan, Germany and US.
Oridion Patents
This device and the CO2 sampling consumable designed for use herewith is covered by one or
more of the following USA patents: 4,755,675; 5,300,859; 5,657,750; 5,857,461 and international
equivalents. USA and international patents pending.
No Implied Licence
Possession or purchase of this device does not convey any express or implied license to use the
device with unauthorized consumable CO2 sampling consumable products which would, alone,
or in combination with this device, fall within the scope of one or more of the patents relating to
this device and/or CO2 sampling consumable products.
15.4 Removing Exhaust Gases from the System
WARNING
z
Anesthetics: When using the Sidestream or Microstream CO2 measurement on
patients who are receiving or have recently received anesthetics, connect the
outlet to a scavenging system, or to the anesthesia machine/ventilator, to avoid
exposing medical staff to anesthetics.
To remove the sample gas to a scavenging system, connect an exhaust tube to the gas outlet
connector of the module.
15-18
16 Anesthesia Gas Monitoring
16.1 Overview
The anesthesia gas (AG) monitoring can be used for measuring the anesthesia gas and respiration
gas of the patient in the anesthetic status. This monitor can configure AION 02 AG module or
AION 03 AG module. AG module provides the end-tidal numerics and inhaling numerics of the
gases mentioned below.
„
„
„
„
„
Carbon dioxide (CO2): The measured numeric is EtCO2 (Max. exhaling value: Max.
exhaling numeric detected during the respiration).
Nitrous oxide (N2O): Laughing gas.
Oxygen (O2): Optional function.
Anesthetic (AA): Refers to the monitored anesthetic (DES, ISO, ENF, SEV or HAL).
Airway respiration rate (AwRR): respiration per minute (BrPM).
The patient monitor can display simultaneously a maximum of 4 waveforms, including the CO2
waveform (default waveform), N2O waveform, O2 waveform and the anesthetic (ENF:
Enflurane) waveform.
Figure 16-1 AG waveform
In addition, the patient monitor can display parameters, including CO2, N2O, O2 and AA (Which
refers to the monitored anesthetic: DES, ISO, ENF, SEV or HAL). It also displays the inhaling
and exhaling numerics as well as MAC (Minimum Alveolar Concentration)/MAL (balance gas)
and AwRR.
When the O2 module is not connected, no O2 waveform will be displayed. After the O2 module
is connected, whether the O2 waveform is displayed depends on whether the O2 waveform is
switched on in the configuration. If there are too many waveforms to be displayed, the O2
waveform will probably not be displayed.
16-1
Parameters:
„ CO2:
„ N2O:
„ O2:
„ AwRR:
„ HAL:
„ ISO:
„ ENF:
„ SEV:
„ DES:
Carbon dioxide
Nitrous oxide (laughing gas)
Oxygen
Airway respiration rate (respiration per minute, BrPM)
Halothame
Isoflurane
Enflurane
Sevoflurane
Desflurane
Measured numerics of AGs
MAC numeric
Figure 16-2 AG parameters
AG label
AwRR numeric
NOTE
z
z
The AG module is not intended to monitor multiple halogenated anaesthetic
gases.
To avoid explosion hazard, do not use flammable anesthetic agent such as ether
and cyclopropane for this equipment.
16-2
16.2 Measurement Principles and Procedure
Measurement principle of AGs
The AG concentration is measured based on the rationale that the AGs have the property of
absorbing the infrared.
The AG module can measure gases that have various properties of absorbing the infrared. To
measure the concentration of a gas, send it to the sampling room, select the infrared of a specific
wavelength with an optical infrared filter, and transmit it through the gas. For a given volume of
gas, the higher its concentration is, the more the infrared that will be absorbed by the gas is, and
the less the infrared that will be transmitted through the gas is. The concentration of the measured
gas is in inverse proportion to the volume of the infrared that is transmitted through the gas.
Therefore, the AG concentration can be obtained by calculating the infrared. For the AG module
that implements the measurements of multiple gases, multiple infrared filters are necessary.
Measurement principle of O2
The oxygen (O2) does not absorb the infrared within the above-mentioned wavebands, so the
oxygen is measured based on its paramagnetism. Inside the sensor of the O2 module, there are
two crystal balls full of nitrogen. They are suspended in the symmetrical magnetic field, and they
are designed to point to the strongest outgoing part of the magnetic field. Outside the balls is the
paramagnetic oxygen. Therefore, the balls are forced, by the relatively stronger paramagnetic
oxygen, out of the magnetic field. The moment of the force acting on the balls is proportional to
the paramagnetic strength as well as to the concentration of the oxygen.
AG module
Patient Monitor
Airway adapter
Exhaust line to
scavenging system
Patient sample line
Endotracheal tube
Figure 16-3 Connections for AG measurements
16-3
WARNING
z
z
z
z
z
z
z
Ensure the compactness of the connection when performing gas measurements.
Any leakage in the system will lead to incorrect readings because this leakage
will make the surrounding environmental air mix up with the patient gas.
The water trap is used for collecting water condensates to protect the module
from the ingress of water; when the collected water in the water trap reaches a
specific volume, it must be removed, thus to avoid clogging in the gas system.
The water trap has filter materials inside, which protect the module from being
contaminated by bacterium, liquid, or patient secretion. When the water trap
works for a long time, dusts or other foreign bodies may block the filter
materials, or even result in system clogging. In this case, replace the water trap.
The recommended replacement period is 2 months.
Only gas sampling hoses recommended for the patient monitor are permitted.
Otherwise, the performance and reliability of the AG module may be decreased.
In case a gas sampling hose is knotted, disuse it. Because the knot may cause
clogging or leakage.
When an inspiratory anesthetic is used, use an exhaust hose to connect the outlet
of the AG module to the exhaust disposal system of the hospital or to the
anesthetic/respiration machine.
Use of high frequency electrosurgical equipment may increase the risk of burns.
Do not use antistatic or conductive masks or breathing tubes.
16-4
16.3 MAC
Minimum alveolar concentration (MAC) is the minimum concentration of the agent in the alveoli.
It is a basic index to indicate the depth of anesthesia. The standard ISO 21647 defines MAC as
this: alveolar concentration of an inhaled anesthetic agent that, in the absence of other anesthetic
agents and at equilibrium, prevents 50% of patients from moving in response to a standard
surgical stimulus.
Minimum alveolar concentration (MAC) values are listed below:
Agent
Des
Iso
Enf
Sev
Hal
N2O
1 MAC
7.3%
1.15%
1.7%
2.1%
0.77%
105%*
* indicates 1 MAC nitrous oxide can only be reached in hyperbaric chamber.
NOTE
z
z
The MAC values shown in the table above are those published by the U.S. Food
and Drug Administration for a healthy 40-year-old adult male patient.
In actual applications, the MAC value may be affected by age, weight and other
factors.
The formula to calculate the MAC value is as follows:
N −1
MAC = ∑
i =0
EtAgent i
AgentVoli
Where N is the number of all agents (including N2O) that the AG module can measure, EtAgenti
is the concentration of each agent and AgentVoli is the concentration of each agent at 1 MAC.
For example, the AG module measures there are 4% of Des, 0.5% of Hal and 50% of N2O in the
patient’s end-tidal gas:
MAC =
4.0% 0.5% 50%
+
+
= 1.67
7.3% 0.77% 105%
NOTE
z
The formula mentioned above is intended for adult patients only.
16-5
16.4 AG Setup Menu
Select the GAS label in the parameter window. The AG SETUP menu appears.
Figure 16-4 AG SETUP menu
In this menu, you can set the following items.
„
Agent
Used to select the name of the anesthetic to be monitored,
including AA, HAL, ENF, ISO, SEV and DES.
If you select the AION 02 AG module, the patient monitor cannot identify the anesthetic type.
Therefore, you have to select the used anesthetic before using the AG module so that the AG
module can conduct measurements normally.
If you select the AION 03 AG module, the used anesthetic will be automatically displayed here,
so you need not set this item.
„
CO2 UNIT
Options: mmHg, kPa and %.
„
O2 UNIT
Options: mmHg, kPa and %.
„
N2O UNIT
%
„
AA UNIT
%
„
PUMP RATE
Used to select the appropriate pump rate
3 options: HIGH, MED, LOW
HIGH: 200 ml/min for adult and pediatric, 120 ml/min for neonate.
MED: 150 ml/min for adult and pediatric, 100 ml/min for neonate.
LOW: 120 ml/min for adult and pediatric, 70 ml/min for neonate.
16-6
„
O2 COMPEN
The options include: OFF, 30%, 40%, 50%, 60%, 70%,
80%, 90%, and 100%.
When the O2 concentration exceeds 60% and it is not being monitored, turn on this switch.
„
SWEEP
Used to select the speed to scan the screen waveforms.
Options: 6.25mm/s and 12.5mm/s.
„
WORK MODE
Options: MEASURE and STANDBY.
To monitor the anesthetic gas, select the MEASURE option. Otherwise, select the STANDBY
option.
Alarm Setup Menu
Select ALARM SETUP >> in AG SETUP menu. The following menu appears.
Figure 16-5 Alarm Setup Menu
In the ALARM SETUP menu-1, you can set the following items.
„
ALM
Alarm on/off status
ON: When the AG has an alarm, the system will give alarm
indications and save the alarm information.
OFF: The system will not give alarm indications when an
on the right of
AG alarm occurs. Instead it will display
the GAS label in the parameter window.
„
ALM LEV
Options: HIGH and MED.
„
ALM REC
ON: The recorder outputs the alarm information in case an
AG alarm occurs.
OFF: The recorder does not output the alarm information in
case an AG alarm occurs.
„
EtCO2 ALM HI
Set the upper limit of EtCO2 which triggers the alarm
16-7
„
EtCO2 ALM LO
Set the lower limit of EtCO2 which triggers the alarm
„
FiCO2 ALM HI
Set the upper limit of FiCO2 which triggers the alarm
„
FiCO2 ALM LO
Set the lower limit of FiCO2 which triggers the alarm
„
EtO2 ALM HI
Set the upper limit of EtO2 which triggers the alarm
„
EtO2 ALM LO
Set the lower limit of EtO2 which triggers the alarm
„
FiO2 ALM HI
Set the upper limit of FiO2 which triggers the alarm
„
FiO2 ALM LO
Set the lower limit of FiO2 which triggers the alarm If FiO2
is lower than 18%, a high level alarm will be triggered.
„
AWRR ALM HI
Set the upper limit of AwRR which triggers the alarm
„
AWRR ALM LO
Set the lower limit of AwRR which triggers the alarm
Select OTHER SETUP >> in ALARM SETUP menu. The following menu appears.
Figure 16-6 ALARM SETUP menu
In the ALARM SETUP menu-2, you can set the following items.
„
EtN2O ALM HI
Set the upper limit of EtN2O which triggers the alarm
„
EtN2O ALM LO
Set the lower limit of EtN2O which triggers the alarm
„
FiN2O ALM HI
Set the upper limit of FiN2O which triggers the alarm
„
FiN2O ALM LO
Set the lower limit of FiN2O which triggers the alarm
„
EtAA ALM HI
Set the upper limit of EtAA which triggers the alarm
„
EtAA ALM LO
Set the lower limit of EtAA which triggers the alarm
„
FiAA ALM HI
Set the upper limit of FiAA which triggers the alarm
„
FiAA ALM LO
Set the lower limit of FiAA which triggers the alarm
„
APNEA ALM
Used to set up the apnea alarm time.
Options: 20s, 25s, 30s, 35s and 40s.
16-8
Adjust Wave Amplitude Menu
Select ADJUST WAVE AMP>> in AG SETUP menu. The following menu appears.
Figure 16-7 ADJUST WAVE AMP menu
In the ADJUST WAVE AMP menu, you can set the following items.
„
CO2 WAVE AMP
Used to adjust the display amplitude of CO2 waveform.
„
N2O WAVE AMP
Used to adjust the display amplitude of N2O waveform.
„
O2 WAVE AMP
Used to adjust the display amplitude of O2 waveform.
„
AA WAVE AMP
Used to adjust the display amplitude of AA waveform.
Where, 1 indicates the minimum amplitude, and 5 indicates the maximum.
Configuration Menu
Select CONFIG >> in AG SETUP menu. The AG CONFIG menu appears. In this menu, you can
select FACTORY CONFIG or USER CONFIG.
16-9
16.5 Calibrating AG
Calibrate the AG module every year or when the measured value has a great deviation.
Tools required:
„ Gas bottle, with a certain standard gas or mixture gas. Gas concentration should meet the
following requirements: AA>1.5%, CO2>1.5%, N2O>40%, O2>40%, of which AA
represents an anesthetic agent.
„ T-shape connector
„ Tubing
„ Reservoir bag
Follow this procedure to perform a calibration:
1. Select MAINTAIN>> in SYSTEM MENU, enter USER KEY, then select CONFIRM
button. Then selecting GAS CALIBRATE >> in USER MAINTAIN menu opens the GAS
CALIBRATE menu.
2. Select VERIFY ACCURACY to check the airway and make sure that there are no
occlusions or leaks.
‹ Vent the tubing to the air and check if the CUR RATE and SET RATE are
approximately the same. If the deviation is great, it indicates that there is an occlusion
in the tubing. Check the tubing for an occlusion.
‹ The CUR RATE shall fall rapidly and the system prompt that the tubing is blocked.
Otherwise, it indicates that there are leakages in the tubing. Check the tubing for
leakages.
3. Connect the gas bottle, reservoir bag and the tubing using a T-shape connector as shown in
the figure below. Check the airway and make sure there are no leaks.
4. Open the gas valve and vent a certain standard gas or mixture gas into the tubing.
Gas valve
Tubing
AG module
Reservoir bag
Gas bottle
5.
6.
7.
In the CALIBRATE menu, the concentration and flowrate of each measured gas are
displayed
‹ If the difference between the measured gas concentration and the actual one is very
small, a calibration is not needed.
‹ If the difference is great, you should perform a calibration. Select START CAL>> to
enter the calibrate menu.
Enter the vented gas concentration. If you use only one gas for calibration, set other gases’
concentration to 0.
Select CALIBRATE to start calibration.
16-10
8.
9.
If the calibration is finished successfully, the message CALIBRATION COMPLETED! is
displayed. If the calibration failed, the message AG CAL. FAILED is displayed. Perform
another calibration.
Select EXIT to exit the current menu.
16.6 Maintenance and Cleaning
16.6.1 Occlusion handling
If the AG module passage is occluded, the screen will prompt “AG OCCLUSION”. Following
are a few examples of occlusion, which you may remove one by one until this message
disappears.
Entrance occlusion
If the part at the entrance such as the filter, sample line or airway adapter is occluded by the
condensed water, the system will prompt on the screen that the airway is occluded.
The optimal method to remove clogs of this kind is:
„ Check the filter for clogs. If it is clogged, replace the bacteria filter at the entrance.
„ Check the sample pipe for clogs or knots. Replace it if necessary.
„ Check the airway adapter for water. If necessary, drain the water and install the adapter
again.
Internal Occlusion
If the interior of the AG module is contaminated by the condensed water, the system will prompt
on the screen that the airway is occluded.
The optimal method to remove clogs of this kind is:
1. Check, as usual, the entrance or the exit for clogs, and remove them if any.
2. If the occlusion still exists after step 1, check for the existence of interior occlusion. In this
case, contact our Customer Service.
16.6.2 Removing Exhaust Gases from the System
WARNING
z
Anesthetics: When using the AG measurement on patients who are receiving or
have recently received anesthetics, connect the outlet to a scavenging system, or
to the anesthesia machine/ventilator, to avoid exposing medical staff to
anesthetics.
To remove the sample gas to a scavenging system, connect an exhaust tube to the gas outlet
connector of the module.
16-11
FOR YOUR NOTES
16-12
17 Maintenance
WARNING
z
z
Failure on the part of the responsible hospital or institution employing the use of
the monitoring equipment to implement a satisfactory maintenance schedule
may cause undue equipment failure and possible health hazard.
The safety inspection or maintenance, which requires opening the monitor
housing, must be performed by trained and authorize personnel only.
Otherwise, equipment failure and possible health hazard may be caused.
17.1 Inspection and Maintenance
Make sure the qualified service personnel have implemented a complete inspection before
putting the monitor into operation, after monitor servicing or system upgrading, or after the
monitor has been used for 6-12 consecutive months. This is to ensure the normal operation of the
system.
Follow these guidelines when inspecting the equipment:
„ The environment and the power supply meet the specified requirements.
„ Inspect the keys, control knob, connectors and accessories for damage.
„ Inspect the power cords for fraying or other damage and check the insulation.
„ The grounding cables are correctly connected.
„ Only specified accessories like electrodes, sensors and probes are applied.
„ The monitor clock is correct.
„ The audible and visual alarms functions normally.
„ The recorder functions normally and the recorder paper meets the requirement.
„ Batteries are in good status and can operate normally.
The defibrillator synchronization function must be verified according to your hospital regulations,
and be checked by a qualified technician once every 3 months.
In case of any damage or exception, do not use the monitor. Contact the technician in your
hospital or our Customer Service immediately.
CAUTION
z
Be sure to check and maintain batteries regularly. For detailed battery check
and maintenance procedures and battery guidelines, see Section 2.5 Batteries.
17-1
17.2 Cleaning
WARNING
z
Be sure to shut down the system and disconnect all power cords from the outlet
before cleaning the equipment.
Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots of dust
and sand in your place, the equipment should be cleaned more frequently. Before cleaning the
equipment, consult your hospital’s regulations for cleaning, disinfecting and sterilizing
equipment.
The exterior surfaces of the equipment may be cleaned with a clean and soft cloth, sponge or
cotton ball, dampened with a non-erosive cleaning solution. Drying off excess cleaning solution
before cleaning the equipment is recommended. Following are examples of cleaning solutions:
„ Diluted soap water
„ Diluted ammonia water
„ Diluted sodium hyoichlo (bleaching agent)
„ Diluted formaldehyde (35 to 37%)
„ Hydrogen peroxide (3%)
„ Ethanol (70%), or Isopropanol (70%)
To avoid damage to the equipment, follow these rules:
„ ALWAYS dilute the solutions according to the manufacturer’s suggestions.
„ ALWAYS wipe off all the cleaning solution with a dry cloth after cleaning.
„ NEVER submerge the equipment into water or any cleaning solution, or pour or spray water
or any cleaning solution on the equipment.
„ NEVER permit fluids run into the casing, switches, connectors, or any ventilation openings
in the equipment.
„ NEVER use abrasive, erosive cleaners, or cleaners containing acetone.
Failure to follow these rules may erode or fray the casing, or blur lettering on the labels, or cause
equipment failures.
For cleaning information of accessories, please refer to the chapters for specific patient
parameters and the instructions for use of the accessories.
17-2
17.3 Disinfection and Sterilization
Sterilization or disinfection may cause damage to the equipment. We recommend the sterilization
and disinfection are contained in the hospital’s servicing schedule only when necessary. The
equipment should be cleaned prior to sterilization and disinfection.
Recommended sterilization material: Alcohol based (Ethanol 70%, Isopropanol 70%), and
aldehyde based.
WARNING
z
z
Disinfection or sterilization may cause damage to the equipment; therefore,
when preparing to disinfect or sterilize the equipment, consult your hospital’s
infection controllers or professionals.
The cleaning solutions above can only be used for general cleaning. If you use
them to control infections, we shall assume no responsible for the effectiveness.
NOTE
z
z
z
z
z
ALWAYS dilute the solutions according to the manufacturer’s suggestions and
adopt lower concentration if possible.
NEVER submerge the equipment into water or any solution, or pour water or
any solution on the equipment;
ALWAYS wipe off all the excess liquids on the equipment surface and accessory
surface with a dry cloth;
Never use EtO and formaldehyde to disinfect.
Never permit high-pressure and high-temperature disinfection of the equipment
and accessories.
17-3
FOR YOUR NOTES
17-4
18 Accessories
WARNING
z
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z
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Use accessories specified in this chapter. Using other accessories may cause
damage to the patient monitor or not meet the claimed specifications.
The operating and storage conditions of the patient monitor should meet the
specifications claimed by respective accessories. For environmental
specifications of each accessory, refer to instructions for use of respective
accessories.
Single-use accessories are not designed to be reused. Reuse may cause a risk of
contamination and affect the measurement accuracy.
Check the accessories and their packages for any sign of damage. Do not use
them if any damage is detected.
18-1
18.1 ECG Accessories
ECG Electrodes
Model
Quantity
Patient Category
Part No.
210
10 pieces
Adult
0010-10-12304
2258-3
3 pieces
Neonate
900E-10-04880
Separate Trunk Cable
Leadwire
supported
Compatible
with
3-leadwire
3-leadwire
Model
EV 6122
AHA
3/5-leadwire
EV 6102
EV 6101
Type
Defibrillator
-proof
Patient Category
Part No.
Neonate, Infant
040-000753-00
Neonate
0010-30-12377
Adult, pediatric
0010-30-42782
Note: The cables listed in the table above must be used together with leadwires.
Cable Sets
3-Electrode Cable Sets
Type
Compatible with
Model
EL6301A
EL6303A
Clip
AHA
EL6305A
EL6311A
EL6301B
Snap
AHA
EL6311B
Patient Category
Part No.
Remark
0010-30-42726
/
0010-30-42731
Long
Neonate
0010-30-42896
/
Neonate, Infant
040-000148-00
DIN
Connector
Adult, pediatric
0010-30-42734
/
Neonate, Infant
040-000146-00
DIN
Connector
Adult, pediatric
5-Electrode Cable Sets
Type
Compatible with
Clip
AHA
Snap
AHA
Model
Patient Category
EL6501A
EL6503A
Adult, pediatric
EL6501B
Part No.
Remark
0010-30-42727
/
0010-30-42729
Long
0010-30-42735
/
Note: The leadwires listed in the table above must be used with separate trunk cables. And the
leadsets with DIN connector should be used only with the cable EV6122.
18-2
18.2 SpO2 Accessories
Extension Cable
Module type
Part No.
Mindray DS SpO2 Module
0010-20-42594
SpO2 Sensors
The SpO2 sensor material that patients or other staff will come into contact with have undertaken
the bio-compatibility test and is verified to be in compliance with ISO 10993-1.
Mindray SpO2 Module
Type
Single
patient use
Model
Patient Category
Part No.
520A
Adult (>30Kg)
520A-30-64101
520P
Pediatric (10 to 50Kg)
520P-30-64201
520I
Infant (3 to 20Kg)
520I-30-64301
520N
Neonate(<3Kg)
520N-30-64401
518B
Adult, pediatric, neonate (multi-sites)
518B-30-72107
512E
Reusable
512F
512G
512H
„
„
„
„
512E-30-90390
Adult (Finger type)
512F-30-28263
Pediatric (Finger type)
512G-30-90607
512H-30-79061
The main cable must be used with the matching SpO2 sensor.
Wavelength emiited by the sensors intended for Mindray SpO2 module: red light: 660 nm,
infrared light: 905 nm.
Wavelength emitted by the sensors intended for Nellcor SpO2 module: red light: 660 nm,
infrared light: 890 nm.
The maximum photic output consumption of the sensor is less than 18 mW.
The information about the wavelength range and maximum photic output consumption can be
especially useful to clinicians, for example, clinicians performing photodynamic therapy.
18-3
18.3 NIBP Accessories
Tubing
Type
Reusable
Patient Category
Part No.
Adult, pediatric
509B-30-06259
Neonate
509B-30-06260
Reusable Cuff
Model
/
Patient Category
Measurement Site
Blood Pressure Cuff Starter Kit
Limb Circumference
(cm)
Part No.
/
0020-00-018401
Limb Circumference
(cm)
Part No.
3.1 to 5.7
001B-30-70692
4.3 to 8.0
001B-30-70693
5.8 to 10.9
001B-30-70694
7.1 to 13.1
001B-30-70695
Single-Patient Cuff
Model
Patient Category
Measurement Site
CM1500A
CM1500B
CM1500C
Neonate
Arm
CM1500D
18-4
18.4 TEMP Accessories
Extension Cable
Type
Model
Temp probe
Part No.
Reusable
MR420
MR411, MR412
0011-30-90444
Temp Probes
Type
Model
Patient Category
MR401
Reusable
MR403
MR402
MR404
Disposable
MR411
MR412
Adult
Pediatric, neonate
/
Measurement Site
Part No.
Esophageal/Rectal
0011-30-90440
Skin
0011-30-90442
Esophageal/Rectal
0011-30-90441
Skin
0011-30-90443
Esophageal/Rectal
0011-30-90446
Skin
0011-30-90447
Note: The disposable Temp probes listed in the table above must be used with the matching
extension cables.
18.5 IBP Accessories
Accessories Kit No.
Model
Components
Part No.
/
IM 2101
IM2201 6Pin IBP Cable (for Hospira)
001C-30-70760
/
IM 2102
IM2102 6Pin IBP Cable (for BD)
001C-30-70758
/
6 Pin IBP Cable for Memscap (SP844
transducer)
0010-21-43081
/
6 Pin IBP Cable for Edwards
0010-21-43094
/
/
It is proved through tests that the following accessories are compatible with the patient monitor.
Only the accessories proceeded by “*” are available from our company. If you want to purchase
other accessories, contact respective manufacturers and make sure if these accessories are
approved for sale in local.
18-5
Manufacturer
Accessory
Smith Medical (Medex)
MX961Z14 trunk cable
MX960 transducer
MX9605A monitoring kit
MX960E6441 transducer seat
MX261 single channel transducer holder
MX262 dual-channel transducerr holder
(More transducer holders are available. refer to Medex for detail)
Braun
Trunk cable (REF: 5203511)
Combitrans series minitoring kit (Refer to Braun for detail)
Transducer holder (REF: 5215800)
Transducer seat (Refer to Braun for detail)
Memscap
*Trunk cable (0010-21-43081)
SP844 transducer
844-26 monitoring kit
84X-49 transducer rest
Utah
Trunk cable (REF: 650-201)
Deltran series transducers
(Multiple types of Deltran series transducers are available, refer to
Utah for detail)
transducer holder (ERF:650-150)
3-hole Deltran rest (REF: 650-100)
4-hole Deltran rest (REF: 650-105)
Edwards
*Trunk cable (0010-21-43094)
Truwave series transducers
(Multiple types of Truwave series transducers are available, refer
to Edwards for detail)
DTSC transducer holder
DTH4 transducer rest
18-6
18.6 CO2 Accessories
18.6.1 Mindray DS CO2 Accessories
Material
Patient Category
Remark
DRYLINE Watertrap
Adult, pediatric
DRYLINE Watertrap
Neonate
Sampling Line, Adult 2.5m
Adult, pediatric
9200-10-10533
Sampling Line, Neonate, 2.5m
Neonate
9200-10-10555
Adult Nasal CO2 Sample Cannula
Adult
Pediatric Nasal CO2 Sample Cannula
Pediatric
M02A-10-25938
Infant Nasal CO2 Sample Cannula
Infant
M02B-10-64509
DRYLINE Airway Adapter
/
Reusable
Disposable
Straight
Part No.
9200-10-10530
9200-10-10574
M02A-10-25937
9000-10-07486
18.6.2 Oridion CO2 Accessories
Model
Patient Category
Remark
Part No.
Starter kit
/
/
9201-30-36019
18.7 AG Accessories
Material
Watertrap
Sampling line
Airway adapter
Patient Category
Adult, pediatric
Neonate
Adult, pediatric
Neonate
Remark
Reusable
Disposable
Part No.
9200-10-10530
9200-10-10574
9200-10-10533
9200-10-10555
Adult, pediatric, neonate
Disposable, straight
9000-10-07486
Adult, pediatric, neonate
Disposable, elbow
9000-10-07487
18-7
18.8 Others
Model
Lithium battery
CF storage card
Part No.
M05-010001-06 (black)
0146-00-0099
023-000034-00
0000-10-10798
Data output software package
7000-30-24590
U.S. power cord
DA8K-10-14452
Grounding cable
1000-21-00122
Nurse call cable
8000-21-10361
Roll Stand bracket
0010-30-42942
Wall Mount bracket
0010-30-42951
Bedrail Hook
8000-30-90169
Bedrail Clamp
8000-30-90170
9201 Transition plate kit
115-003477-00
-
18-8
(gray)
A Product Specifications
A.1 Safety Classifications
Type of protection against
electric shock
Class I with internal electric power supply.
Where the integrity of the external protective earth (ground) in
the installation or its conductors is in doubt, the equipment shall
be operated from its internal electric power supply (batteries)
Degree of protection against
electric shock
CO2/AG:
ECG/RESP/TEMP/SpO2/NIBP/IBP:
Degree of protection against
hazards of ignition of
flammable anesthetic
mixtures
Not protected (ordinary)
Degree of protection against
harmful ingress of water
Not protected (ordinary)
Mode of operation
Continuous
Equipment type
Portable
BF (defibrillation proof)
CF (defibrillation proof)
A.2 Environmental Specifications
0 to 40℃
Operating temperature
5 to 35℃
(With CO2 module)
10 to 35℃
(With AION AG module)
Operating humidity
15 to 95%, noncondensing
Operating altitude
-500 to 4600 m (-1640 to 15092 feet)
-305 to 3014 m (-1000 to 9889 feet) (with CO2, AG or Nellcor
SpO2 module)
Storage temperature
-20 to 60℃
Storage humidity
10 to 95%, noncondensing
Storage and transportation
altitude
-500 to 13100 m (-1640 to 42979 feet)
-305 to 6096 m (-1000 to 20000 feet) (with CO2, AG or Nellcor
SpO2 module)
A-1
A.3 Power Source Specifications
AC Power Supply Specifications
Input voltage
100 to 240 V~
Current
1.4A to 0.6A
Frequency
50/60 Hz
Fuse
T 3 A, 250 V
Internal battery
Number of batteries
2
Type
Sealed lead-acid battery or lithium-ion battery
Time to shutdown
>5 min (after the first low-power alarm)
Sealed lead-acid battery
Nominal voltage
12 VDC
Capacity
2.3 Ah
Operating time
48 minutes or 120 minutes typical when powered by one or two
new fully-charged batteries respectively (25℃, ECG, SpO2,
NIBP measurement per 15 minutes).
Charge time
A maximum of 6 h for each battery, and a maximum of 12h for
both (in the running status or standby mode)
Lithium battery
Rated voltage
11.1 VDC
Capacity
4.4 Ah
Operating time
120 minutes or 300 minutes typical when powered by one or two
new fully-charged batteries respectively (25℃, ECG, SpO2,
NIBP measurement per 15 minutes).
Charge time
A maximum of 6.5h (in the running status or standby mode)
A-2
A.4 Hardware Specifications
Physical
Size
318 × 270 × 137mm (width×height×depth)
Weight
Different due to different configurations
Standard configuration: 4.7kg
Maximum weight: ≤ 7.5kg
Display
Type
Color TFT LCD
Size
12.1 inches (diagonal)
Resolution
800×600 pixels
Recorder
Type
Thermal dot array
Horizontal resolution
160 dots/cm (at 25 mm/s recording rate)
Vertical resolution
80 dots/cm
Width of the recorder paper
50 mm
Length of the recorder paper
20 m
Recording rate
25 mm/s, 50 mm/s
Recorded waveforms
3
LED indicator
Alarm indicator
1 (yellow and red)
Running status indicator
1 (green)
AC power indicator
1 (green)
Battery indicator
1 (green)
Audio indicator
Speaker
Giving audio alarms (45 to 85 dB), keypad tones, and
heartbeat/pulse tone.
Supporting PITCH TONE and multi-level volume.
Audio alarms comply with EN 60601-1-8 and IEC60601-1-8.
Connectors
Power supply
1 AC power connector
Network
1 standard RJ45 network connector, 100 BASE-TX
VGA
1 standard color VGA monitor connector, 15-PIN D-sub
Auxiliary output
1 BNC connector
Equipotentiality
1 equipotential grounding connector
A-3
A.5 Data Storage
Trend data
Long trend: 96 hours, resolution 1min, 5 min or 10 min.
Short trend: 1 hour, resolution 1 s or 5 s.
Alarm events
70 alarm events and associated waveforms (with user
selectable waveform length 8s, 16 or 32).
NIBP measurements
800 NIBP groups, including systolic pressures, mean pressures,
diastolic pressures and measurement time.
A.6 Wireless Network
Standards
IEEE 802.11g, Wi-Fi compatible
Frequenct range
2.412 to 2.462GHz
China
Operating channel
America
Canada
Europe
1 to 11
Spain
France
10, 11
For other country, please refer to your local law.
Safe distance
10 m (a circle centering AP with the diameter of 10 m)
A.7 Signal Output Specifications
Standards
Meets the requirements of EC60601-1 for short-circuit
protection and leakage current
Output impedance
50Ω
ECG analog output
Diagnostic mode:
Bandwidth (-3dB; reference
frequency: 10Hz)
Monitor mode:
Surgery mode:
0.05 to 100 Hz (812A module)
0.05 to 150 Hz (M08A module)
0.5 to 40 Hz
1 to 20 Hz
Maximum propagation delay
25 ms (In DIAGNOSTIC mode, NOTCH is OFF)
Sensitivity
1 V/mV± 5%
PACE rejection/enhancement
No pace rejection or enhancement
IBP analog output
Bandwidth
0 to 12.5 Hz (-3 dB, reference frequency: 1 Hz)
Maximum propagation Delay
55 ms (the filter function is disabled)
Sensitivity
1 V/100 mmHg ±5%
Nurse call output
Driver
Relay
Electrical specifications
≤60W, ≤2A, ≤36VDC, ≤25VAC
A-4
Japan
2
Conducting resistance
< 1Ω
Isolation voltage
> 1500 VAC
Signal type
Normally open or normally closed, selectable
Defibrillator synchronization pulse
Maximum time delay
35 ms (R-wave peak to leading edge of the pulse)
Amplitude
3.5 V (min) at 3 mA sourcing; 0.8 V (max) at 1 mA sinking
Pulse width
100 ms ±10%
Rising and falling time
< 3 ms
VGA
Connector type
15-PIN D-sub socket
Signal
RGB: 0.7 Vp-p/75Ω;
Horizontal/vertical synchronization: TTL level
A.8 ECG Specifications
A.8.1 Mindray DS Software Package
Lead naming style
AHA, EURO
Lead fault
The lead resistance is no greater than 51 kΩ and it is in parallel
with a 0.047 µF capacitor, it will not cause a lead fault condition.
For 3/5-lead, differential offsets ≤ ±300 mV, it will not cause a
lead fault condition.
Sensitivity selection
1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5),
10 mm/mV (×1), 20 mm/mV (×2) and AUTO
Sweep speed
12.5 mm/s, 25 mm/s, 50 mm/s
Diagnostic mode:
Bandwidth (-3 dB)
Common mode rejection
Monitor mode:
Surgery mode:
0.05 to 100 Hz (812A module)
0.05 to 150 Hz (M08A module)
0.5 to 40 Hz
1 to 20 Hz
Diagnostic mode:
Monitor mode:
Surgery mode:
≥90 dB
≥105 dB
≥105 dB
(The notch filter is turned off.)
50/60Hz Notch Filtering
The monitor provides software filtering against the 50/60HZ
industrial frequency.
In monitor and surgery modes, the 50/60HZ filter will be turned
on automatically.
In diagnostic mode, the 50/60HZ filter will be turned off.
Input offset current
≤0.1μA (except currents to drive leads)
Differential input
impedance
≥ 5MΩ
A-5
Input signal range
±8mV (peak-to-peak value)
Accuracy of input signal
reproduction
Methods A and D were used to establish overall system error and
frequency response according to EC11.
Auxiliary current (Leads
off detection)
Active electrode: < 0.1 μA
Reference electrode: < 1 μA
Patient leakage current
< 10uA
Recovery time after
defibrillation
< 5s
Calibration signal
1 mV (peak-to-peak value), precision: ±5%
ESU protection
Incision mode: 300W
Congelation mode: 100W
Restore time: ≤10s
The monitor complies with the requirements of ANSI/AAMI
EC13 Section 4.2.9.14.
ESU noise control
The monitor uses the ECG leads meeting the requirements of
AAMI; based on the ECG baseline, the peak noise ≤ 2mV
The monitor complies with the test method in EC13 Section
5.2.9.14.
HR
Measurement range
Neonate:
Pediatric:
Adult:
Resolution
1 bpm
Precision
±1 bpm or ±1%, whichever is greater.
Trigger threshold level
200 μV (lead II)
Trigger indication
There will be an audible beep on every beat captured.
Heart Rate Averaging
The average Heart Rate is computed in line with the ANSI/AAMI
EC13 Section 4.1.2.1 d) as follows:
When the last 3 R-to-R intervals > 1200 ms, compute the average
of the last 4 R-to-R intervals; otherwise, compute the average of
the last 12 R-to-R intervals minus the longest and shortest
intervals.
The displayed Heart Rate is updated once per second.
Heart Rate Meter
Accuracy and Response to
Irregular Rhythm
When tested in accordance with the ANSI/AAMI EC13 Section
4.1.2.1 e), the indicated heart rate after a 20 second stabilization
period is:
Figure 3a (Ventricular Bigeminy) -80±1 bpm
Figure 3b (Slow Alternating Ventricular Bigeminy) -60±1 bpm
Figure 3c (Rapid Alternating Ventricular Bigeminy) -120±1bpm
Figure 3d (Bi-directional Systoles) -90±2 bpm
Response time to heart rate
changes
15 to 350 bpm
15 to 350 bpm
15 to 300 bpm
Meets the requirement of ANSI/AAMI EC13: Section 4.1.2.1 f).
Less than 11 sec for a step increase from 80 to 120 BPM
Less than 11 sec for a step decrease from 80 to 40 BPM
A-6
Response time of
tachycardia alarm
Tall T-Wave Rejection
When tested in accordance with ANSI/AAMI EC13 Section
4.1.2.1 g, the response time is as follows:
Figure 4ah – range: 15.7 to 19.2s, average: 17.4s
4a – range: 5.7 to 8.5s, average: 7.5s
4ad – range: 3.6 to 5.1s, average: 4.2s
Figure 4bh – range: 11.5 to 14.7s, average: 12.9s
4b – range: 4 to 14s, average: 7.2s
4bd – range: 6.6 to 14.5s, average: 10.5s
When tested in accordance with the ANSI/AAMI EC13 Section
4.1.2.1 c), the heart rate meter will reject all T-waves with
amplitudes less than 1.2 mV, 100 ms QRS, a T wave duration of
180ms and a Q-T interval of 350 ms.
Pace pulse
Pace pulses meeting the following conditions are marked by the
PACE indicator.
Pulse indicator
Amplitude:
Width:
Rise time:
±4 to ±700 mV (3/5-lead)
0.1 to 2 ms
10 to 100 µs
When tested in accordance with the ANSI/AAMI EC13: Sections
4.1.4.1 and 4.1.4.3, the heart rate meter rejects all pulses meeting
the following conditions.
Pulse rejection
Amplitude:
Width:
Rise time:
Min. input slew rate:
A-7
±2 to ±700 mV
0.1 to 2 ms
10 to 100 µs
20V/s RTI
A.8.2 Mortara Software Package
Lead naming style
AHA, EURO
Lead fault
The lead resistance is no greater than 51 kΩ and it is in parallel
with a 0.047 µF capacitor, it will not cause a lead fault condition.
For 3/5-lead, differential offsets ≤ ±300 mV, it will not cause a
lead fault condition.
For 12-lead, differential offsets ≤ ±500 mV, it will not cause a
lead fault condition.
Sensitivity selection
1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5),
10 mm/mV (×1), 20 mm/mV (×2) and AUTO
Sweep speed
12.5 mm/s, 25 mm/s, 50 mm/s
Bandwidth (-3 dB)
Diagnostic mode:
Monitor mode:
Surgery mode:
0.05 to 150 Hz (M08A module)
0.5 to 40 Hz
1 to 20 Hz
Diagnostic mode:
Monitor mode:
Surgery mode:
≥90 dB
≥105 dB
≥105 dB
Common mode rejection
(The notch filter is turned off.)
50/60Hz Notch Filtering
The monitor provides software filtering against the 50/60HZ
industrial frequency.
In monitor and surgery modes, the 50/60HZ filter will be turned
on automatically.
In diagnostic mode, the 50/60HZ filter will be turned off.
Input offset current
≤0.1μA (except currents to drive leads)
Differential input impedance
≥ 5MΩ
Input signal range
±8mV (peak-to-peak value)
Accuracy of input signal
reproduction
Methods A and D were used to establish overall system error and
frequency response according to EC11.
Auxiliary current (Leads off
detection)
Active electrode: < 0.1 μA
Reference electrode: < 1 μA
Patient leakage current
< 10uA
Recovery time after
defibrillation
< 5s
Calibration signal
1 mV (peak-to-peak value), precision: ±5%
ESU protection
Incision mode: 300W
Congelation mode: 100W
Restore time: ≤10s
The monitor complies with the requirements of ANSI/AAMI
EC13 Section 4.2.9.14.
ESU noise control
The monitor uses the ECG leads meeting the requirements of
AAMI; based on the ECG baseline, the peak noise ≤ 2 mV
A-8
The monitor complies with the test method in EC13 Section
5.2.9.14.
HR
Measurement range
Neonate:
Pediatric:
Adult:
Resolution
1 bpm
Precision
±1 bpm or ±1%, whichever is greater.
Trigger threshold level
200 μV (lead II)
Trigger indication
There will be an audible beep on every beat captured.
Heart Rate Averaging
The average Heart Rate is computed in line with the ANSI/AAMI
EC13 Section 4.1.2.1 d) as follows:
The average heart rate is calculated on the basis of the mean
RR-interval of the last 16 beats, unless the heart rate calculated
using the last 4 beats is less than or equal to 48, then this rate is
used.
The displayed Heart Rate is updated once per second.
Heart Rate Meter Accuracy
and Response to Irregular
Rhythm
When tested in accordance with the ANSI/AAMI EC13 Section
4.1.2.1 e), the indicated heart rate after a 20 second stabilization
period is:
Figure 3a (Ventricular Bigeminy) -80±1 bpm
Figure 3b (Slow Alternating Ventricular Bigeminy) -60±1 bpm
Figure 3c (Rapid Alternating Ventricular Bigeminy) -120±1 bpm
Figure 3d (Bi-directional Systoles) -90±2 bpm
Response time to heart rate
changes
15 to 350 bpm
15 to 350 bpm
15 to 300 bpm
Meets the requirement of ANSI/AAMI EC13: Section 4.1.2.1 f).
Less than 11 sec for a step increase from 80 to 120 BPM
Less than 11 sec for a step decrease from 80 to 40 BPM
When tested in accordance with ANSI/AAMI EC13 Section
4.1.2.1 g, the response time is as follows.
Response time of tachycardia
alarm
Tall T-Wave Rejection
Figure 4ah – range:
4a – range:
4ad – range:
Figure 4bh – range:
4b – range:
4bd – range:
4.30 to 5.34s, average: 4.75s
3.94 to 5.92s, average: 4.69s
4.28 to 5.18s, average: 4.78s
3.57 to 8.22s, average: 4.83s
3.09 to 4.11s, average: 3.64s
3.20 to 4.52s, average: 4.09s
When tested in accordance with the ANSI/AAMI EC13 Section
4.1.2.1 c), the heart rate meter will reject all T-waves with
amplitudes less than 1.2 mV, 100 ms QRS, a T wave duration of
180ms and a Q-T interval of 350 ms.
Pace pulse
Pulse indicator
Pace pulses meeting the following conditions are marked by the
PACE indicator.
A-9
Amplitude:
±4 to ±700 mV (3/5-lead)
±2 to ±700 mV (12-lead)
0.1 to 2 ms
10 to 100 µs
Width:
Rise time:
When tested in accordance with the ANSI/AAMI EC13: Sections
4.1.4.1 and 4.1.4.3, the heart rate meter rejects all pulses meeting
the following conditions.
Pulse rejection
Amplitude:
Width:
Rise time:
Min. input slew rate:
±2 to ±700 mV
0.1 to 2 ms
10 to 100 µs
20 V/s RTI
ST segment measurement
Measurement range
-2.0 to +2.0 mV
Precision
-0.8 to +0.8 mV: ±0.02 mV or ±10%, whichever is greater
Beyond this range: Undefined
Update period
Updated every 16 valid beats
A.9 RESP Specifications
Measurement technique
Thoracic impedance
Lead
Optional: lead I and lead II; default lead II
Respiration excitation
waveform
< 300 µA, sinusoid, 62.8 kHz (±10%)
Respiration impedance test
range
0.3 to 3 Ω
Baseline impedance range
200 to 2500 Ω (using an ECG cable with 1kΩ resistance)
Differential input
impedance
> 2.5 MΩ
Linear Signal Range
3 Ω p-p minimum
Bandwidth
0.2 to 2 Hz (-3 dB)
Sweep speed
6.25 mm/s, 12.5 mm/s, 25 mm/s
RR
Measurement range
Adult:
Pediatric/neonate:
Resolution
1 BrPM
Precision
7 to 150 BrPM:
0 to 6 BrPM:
Apnea alarm delay
10 to 40 s
0 to 120 BrPM
0 to 150 BrPM
±2 BrPM or ±2%, whichever is greater.
Undefined.
A-10
A.10 SpO2 Specifications
A.10.1 Mindray DS SpO2 Module
All SpO2 sensors specified in the section Mindray DS SpO2 Accessories meets the following
specifications when used with Mindray DS SpO2 module.
SpO2
Measurement range
0 to 100%
Resolution
1%
Precision
70 to 100%:
70 to 100%:
0% to 69%:
Refreshing rate
1s
Averaging time
7 s (When the sensitivity is set to High)
9 s (When the sensitivity is set to Medium)
11 s (When the sensitivity is set to Low)
±2 % (adult/pediatric, non-motion conditions)
±3% (neonate, non-motion conditions)*
Undefined.
PR
Measurement range
20 to 254 bpm
Resolution
1 bpm
Precision
±3 bpm (non-motion conditions)
Refreshing rate
1s
* A study was performed to validate the accuracy of this monitor with 520N SpO2 sensor.
Totally 122 neonates (65 male & 57 female) aged from 1 day to 30 days with a gestation
age of 22 weeks to full term were involved in this study. The statistical analysis of the 200
pairs of data over the range of 72% to 100% SaO2 of this study shows that the accuracy
(Arms) is 2.47 digits, which is within the stated accuracy specification. Another study
performed on adult subjects also shows the effectiveness.
This monitor with 520N SpO2 sensor was validated on adult subjects (1.62% Arms) and
that actual performance in the neonatal population was observed.
A-11
A.10.2 Nellcor SpO2 Module
All SpO2 sensors specified in the section Nellcor SpO2 Accessories meets the following
specifications when used with Nellcor SpO2 module.
SpO2 measurement range
and precision
Sensor
Range
Precision*
MAX-A, MAX-AL, MAX-N,
MAX-P, MAX-I and MAX-FAST
70 to 100%
0% to 69%
±2%
Undefined
OxiCliq A, OxiCliq N, OxiCliq P,
OxiCliq I
70 to 100%
0% to 69%
±2.5%
Undefined
D-YS, DS-100A, OXI-A/N and
OXI-P/I
70 to 100%
0% to 69%
±3%
Undefined
MAX-R, D-YSE and D-YSPD
70 to 100%
0% to 69%
±3.5%
Undefined
PR measurement range and
precision
20 to 250 bpm: ±3 bpm
251 to 300 bpm: Undefined
Refreshing rate
1s
Averaging time
8 s, 16 s
*: When sensors are used on neonatal subjects as recommended, the specified precision range is
increased by ±1%, to account for the theoretical effect on oximeter measurements of fetal
hemoglobin in neonatal blood.
A-12
A.11 NIBP Specifications
Measurement technique
Auto oscillation
Displayed parameters
Systolic pressure, diastolic pressure, mean pressure and PR
Mode of operation
Manual, auto and continuous
Measurement interval in
auto mode
1/2/3/4/5/10/15/30/60/90/120/180/240/480 minutes
Measurement time in
continuous mode
5 minutes
Measurement range in
normal mode
mmHg
Adult
Pediatric
Neonate
Systolic pressure
40 to 270
40 to 200
40 to 135
Diastolic pressure
10 to 210
10 to 150
10 to 100
Mean pressure
20 to 230
20 to 165
20 to 110
Measurement precision
Maximum average error: ±5mmHg
Maximum standard deviation: 8mmHg
Resolution
1mmHg
Static pressure
measurement range
0 to 300mmHg
Static accuracy
± 3 mmHg
Over-pressure protection
by software
Adult:
Pediatric:
Neonate:
297±3 mmHg
240±3 mmHg
147±3 mmHg
Over-pressure protection
by hardware
Adult:
Pediatric:
Neonate:
330 mmHg
330 mmHg
165 mmHg
Default start pressure
Adult:
Pediatric:
Neonate:
178±5 mmHg
133±10 mmHg
67±5 mmHg
PR from NIBP
Measurement range
40 to 240 bpm
Precision
±3 bpm or ±3%, whichever is greater
Resolution
1 bpm
A-13
A.12 TEMP Specifications
Number of channels
2
Displayed parameters
T1, T2 and TD
Measurement range
0 to 50°C (32 to 122°F)
Resolution
0.1°C
Precision
±0.1°C (excluding the sensor)
±0.2°C (including the YSI 400 series sensor)
Update period
1s
Minimum time for
accurate measurement
Body surface: < 100s
Body cavity: < 80s
(YSI 400 series sensor)
A.13 IBP Specifications
Number of channels
2
Pressure readings
Systolic, diastolic, mean pressures and PR
Pressure labels
ART, PA, CVP, RAP, LAP, ICP, P1 and P2
Linear input range
will be -50 to﹢300 mmHg, after zeroing.
Measurement range
ART
0 to 300 mmHg
PA
-6 to 120 mmHg
CVP/RAP/LAP/ICP
-10 to 40 mmHg
P1/P2
-50 to 300 mmHg
Resolution
1 mmHg
Precision
±2% or ±1mmHg, whichever is greater
Excitation
will be 5 Volts DC, ± 2%
Minimum load resistance will be 300Ω per transducer.
Update period
1s
Zero offset range
± 200 mmHg
Zero accuracy
± 1 mmHg
Noise
<0.5 mmHg RTI, DC to 12.5 Hz, 300Ω source impedance.
Drift
<0.15 mmHg/℃; will not exceed ± 1 mmHg in 24 hours.
Frequency Response
DC-12.5Hz ±1 Hz, -3db
PR from IBP
Measurement range
25 to 350 bpm
Precision
±1 or ±1%, whichever is greater.
A-14
Resolution
1 bpm
Pressure transducer
Excitement voltage
5 VDC, ±2%
Sensitivity
5 uV/V/mmHg
Impedance range
300 to 3000Ω
Volume displacement
(ABBOTT)
<0.04 mm3 /100 mmHg
A.14 CO2 Specifications
Measurement technique
Infrared absorption technique
Displayed parameter
EtCO2, FiCO2, Respiration Rate
CO2 function
Meet the requirements of EN ISO21647/ISO 21647 and
ISO9918.
A.14.1 Mindray DS CO2 Specifications
CO2 measurement range
0 to 99mmHg
Precision*
0 to 40 mmHg:
41 to 76 mmHg:
77 to 99 mmHg:
Resolution
1 mmHg
Drift
meet the requirement of accurancy in 6 hours
Sample flow rate
70, 100 ml/min
Precision of deflation rate
±15% or 15 ml/min, whichever is great
Start-up time of CO2
module
< 1min, the module enters the warming up status after the startup.
One minute later, it enters the ready-to-measure status.
AwRR measurement range
0 to 120 BrPM
Precision
0 to 70 BrPM:
> 70 BrPM:
Response time
When measured with a neonatal watertrap and a 2.5 m-long
neonatal sampling line:
<3.5 s @ 100 ml/min
<4 s @ 70 ml/min
When measured with an adult watertrap and a 2.5 m-long adult
sampling line:
<5.5 s @ 100 ml/min
<7 s @ 70 ml/min
Delay time
When measured with a neonatal watertrap and a 2.5m-long
neonatal sampling line:
±2 mmHg
±5%
±10%
±2 BrPM
±5 BrPM
A-15
<3 s @ 100 ml/min
<3.5 s @ 70 ml/min
When measured with an adult watertrap and a 2.5m-long adult
sampling line:
<5 s @ 100 ml/min
<6.5 s @ 70 ml/min
Apnea alarm delay
AwRR: 10 to 40 s
* Conditions for measurements in typical precision:
The measurement is started after the preheating mode of the module;
Ambient pressure: 750 mmHg to 760 mmHg; room temperature: 22℃ to 28℃;
The gas under test is dry, and the balance gas is N2;
The deflation rate is 100 ml/min, the respiration rate is no greater than 50 BrPM, with a
fluctuation less than ±3 BrPM, and the inhale interval/exhale interval is 1:2;
When the working temperature is from 15 to 25 degree, or from 50 to 55 degree, or when the
breath rate is greater than 50Brpm, the measurement precision should meet the requirements of
ISO21647: ±4mmHg (0 to 40mmHg) or ±12% of the reading (41 to 99 mmHg)
A.14.2 Oridion CO2 Specifications
CO2 measurement range
0 to 99mmHg
Precision*
0 to 38 mmHg:
39 to 99 mmHg:
Drift
meet the requirement of accurancy in 6 hours
Resolution
Waveform:
Value:
Sample flow rate
50−+7.5
15 ml/min
Initialization time
30 s (typical)
Response time
2.9 s (typical)
Delay time
2.7 s (typical)
AwRR measurement range
0 to 150 BrPM
AwRR measurement
precision
0 to 70 BrPM:
70 to 120 BrPM:
121 to 150 BrPM:
Apnea alarm delay
AwRR: 10 to 40 s
±2 mmHg
±5% + 0.08% × (reading - 38 mmHg)
0.1 mmHg
1 mmHg
±1 BrPM
±2 BrPM
±3 BrPM
* Precision applies for breath rates of up to 80 bpm. For breath rates above 80 bpm, accuracy
complies with EN ISO 21647/ISO 21647/ISO 9918 (4 mmHg or ±12% of reading whichever is
greater) for EtCO2 values exceeding 18 mmHg. To achieve the specified accuracies for breath
rates above 60 breaths/minute, the Microstream® FilterLine H Set for Infant/Neonatal (p/n
006324) must be used.The accuracy specification is maintained to within 4% of the values
indicated in the above table in the presence of interfering gases according to EN ISO
21647/ISO 21647 Section Eleven, Part 101.
A-16
A.15 AG Specifications
Measurement technique
Infrared absorption
Measurement mode
Sidestream
AG functions
Meets requirements of ISO9918, ISO11196, EN12598 and
ISO7767
Warm-up time
45 seconds (warming-up status)
10 minutes (ready-to-measure status)
Sampling flow
(sidestream)
Adult/Pediatric
120, 150, 200 ml/minute (user-selectable)
Neonatal
70, 90, 120 ml/minute (user-selectable)
Gas type
CO2, N2O, O2 (optional), Des, Iso, Enf, Sev, Hal
Measurement range
CO2:
N2O:
Des:
Sev:
Enf, Iso, Hal:
O2:
AwRR:
0 to 30%
0 to 100%
0 to 30%
0 to 30%
0 to 30%
0 to 100%
2 to 100 BrPM
Resolution
CO2:
AwRR:
1 mmHg
1 BrPM
Precision
Gas
Range (%REL)
Precision (%ABS)
0 to 1
±0.1
1 to 5
±0.2
5 to 7
±0.3
7 to 10
±0.5
> 10
Not specified
0 to 20
±2
20 to 100
±3
0 to 1
±0.15
1to 5
±0.2
5 to 10
±0.4
10 to 15
±0.6
15 to 18
±1
>18
Not specified
0 to 1
±0.15
1 to 5
±0.2
5 to 8
±0.4
CO2
N2O
Des
Sev
A-17
Enf, Iso, Hal
O2 (Optional)
AwRR
>8
Not specified
0 to 1
±0.15
1 to 5
±0.2
>5
Not specified
0 to 25
±1
25 to 80
±2
80 to 100
±3
2 to 60 BrPM
±1 BrPM
> 60 BrPM
Not specified
Drift
meet the requirement of accurancy in 6 hours
Alarm range
CO2:
AwRR:
0 to 10 % (0 to 76 mmHg)
2 to 100 BrPM
Apnea alarm delay
AwRR:
20 to 40 s
Refreshing rate
1s
Calibration
Yearly calibration requested.
Calibration stability
After module being used for 12 consective months, the error is <
1%
Rise time (10 % to 90 %)
Sampling flow 120ml/min,
using the DRYLINE™
water trap and neonatal
DRYLINE™ sampling
line (2.5m)
CO2
250 ms (fall time 200 ms)
N2O
250 ms
O2
600ms
HAL, ISO, SEV, DES
300 ms
ENF
350 ms
Rise time (10 % to 90 %)
Sampling flow 200ml/min,
using the DRYLINE™
water trap and adult
DRYLINE™ sampling
line (2.5m)
CO2
250 ms (fall time 200 ms)
N2O
250 ms
O2
500ms
HAL, ISO, SEV, DES
300 ms
ENF
350 ms
Delay time
< 4s
* Accuracy applies for the following conditions:
1. Measurements begin after the module warms up;
2. Ambient pressure is from 750 to 760 mmHg, and ambient temperature from 22 to 28ºC;
3. The measured gas is a dry gas and the balance gas N2;
4.Gas sample flow rate is 120 ml/min, respiration rate is 20 rpm with a fluctuation between ±3
rpm, and I:E is 1:2.
A-18
Effect of interference gases on AG measurements
Gas
Concentration(%)
CO2
N2O
Agent 1) 2)
/
/
/
Nitrogen
Xenon
Quantitive effect(%ABS)3)
CO2
N2O
Agent 1)
O2
0.1
/
0.15)
0
0
0.1
0.14)
0.2
0.2
1
≤78%
/
0.1
0.15)
0
0
0
<100%
0.1
0
0
0.5
Helium
<50%
0.1
0
0
0.5
Ethanol
<0.1%
0
0
0
0.5
Acetone
<1%
0.1
0.1
0
0.5
Methane
Saturated Isopropanol
vapour
Metered dose inhaler
propellants,
Methoxyflurane
<1%
0.1
0.1
0
0.5
/
0.1
0
0
0.5
/
Unspecified
Unspecified
Unspecified
0.5
/
Unspecified
Unspecified
Unspecified
Unspecified
1) Agent represents one of Des, Iso, Enf, Sev, and Hal.
2) Multiple agent interference on CO2, N2O and O2 is typically the same as single agent interference.
3) For CO2, N2O and Agents, maximum interference from each gas at concentrations within specified
accuracy ranges for each gas. The total interference of all gases is never larger than 5%REL.
4) Only applicable for AION 03-type module, meaning the secondary agent interference on the
primary one.
5) For AION 02-type module, it is the interference provided that input of used anaesthetic agent has
been done.
A-19
FOR YOUR NOTES
A-20
B EMC
The equipment meets the requirements of EN 60601-1-2.
NOTE
z
z
z
z
z
Use of accessories, transducers, and cables other than those specified may result
in increased emission and/or decreased immunity of the equipment.
The equipment should not be used adjacent to or stacked with other equipment,
and if adjacent or stacked use is necessary, the equipment should be observed to
verify normal operation in the configuration in which it will be used.
The equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided
below.
The equipment may be interfered with by other equipment, even if that other
equipment complies with CISPR emission requirements.
Operation of the device, in the case that the patient physiological signal is lower
than the minimum amplitude and/or value specified in the product
specifications, may cause inaccurate results.
TABLE 1
Guidance and declaration — electromagnetic emissions
The equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the equipment should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment — guidance
RF emissions
CISPR 11
Group1
The equipment 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
IEC61000-3-2
Class A
The equipment is suitable for use in all establishments
other than domestic 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
Compliance
Pst ,Tdt (ms)
Dmax(%)
Dc (%)
B-1
TABLE 2
Guidance and declaration — electromagnetic immunity
The equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the equipment 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
(>3m).
±2 kV for power
supply lines
±1 kV for
input/output
lines (>3m)
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 different
mode
±2 kV common
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
Short
interruptions and
voltage variation
on power supply
input lines IEC
61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycle
70% UT
(30% dip in UT)
for 25 cycle
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycle
70% UT
(30% dip in UT)
for 25 cycle
<5% UT
(>95% dip in UT)
for 5 sec
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of our product requires continued
operation during power mains
interruptions, it is recommended
that our product be powered from
an uninterruptible power supply or
a battery.
Power frequency
(50/60 HZ)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
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.
B-2
TABLE 3
Guidance and declaration — electromagnetic immunity
The equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the equipment should assure that it is used in such an environment
Immunity
test
Conduced
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
IEC 60601
Test level
3 Vrms
150kHz to
80MHz
3 V/m
80MHz to
2.5GHz
Compliance
level
Electromagnetic environment — guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
equipment, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
3 Vrms
d = 1.2 x P
d = 1.2 x P 80 MHz to 800 MHz
3V/m
d = 2.3 x P 800 MHz to 2.5GHz
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
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 equipment is used exceeds the
applicable RF compliance level above, the equipment should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the equipment.
b
Over the frequency ranges 150kHz to 80MHz, field strengths should be less than 3V/m.
B-3
TABLE 4
Recommended separation distances between portable and mobile RF communication and
the equipment
The equipment is intended for use in an electromagnetic environment in which radiated RF
disturbance are controlled. The customer or the user of the equipment can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communication equipment (transmitters) and the equipment as recommended below,
according to the maximum output power of the communication equipment.
Rated Maximum
Output power of
Transmitter W
(Watts)
Separation Distance According to Frequency of Transmitter
M (Meters)
80MHz -800MHz
800MHz -2.5GHz
150kHz -80MHz
d = 1.2 P
d = 1.2 P
d = 2.3 P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.34
10
3.69
3.69
7.38
100
11.67
11.67
23.34
For transmitters at a maximum output power not listed above, the recommended separation
distanced 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.
B-4
C Alarm Messages and Prompt Information
NOTE
z
Your patient monitor may not include all the information listed in this section.
C.1 Physiological Alarm Messages
Note: XX represents the parameters being monitored, such as HR, RR, SpO2, etc. The “L” field
indicates the alarm level, and 1 means high, 2 means medium, 3 mean low, * means the level is
user-adjustable.
Alarm
messages
L
Cause
Measure
XX TOO HIGH
2*
XX value exceeds the upper alarm limit.
XX TOO LOW
2*
XX value exceeds the lower alarm limit.
Make sure the alarm
limits are appropriate
for the patient, and
check the patient’s
condition.
ECG LOST
1
The ECG signal is so weak that the monitor
can’t perform ECG analysis.
RESP
ARTIFACT
1
The patient’s heartbeat interferes with his
respiration. The respiration rate cannot be
measured correctly.
NO PULSE
1
The pulse signal of the patient is so weak that
the monitor cannot perform pulse analysis.
CO2 APNEA
1
RESP APNEA
1
No respiration signal is detect or the
respiration signal of the patient is so weak that
the monitor cannot perform respiration
analysis.
ASYSTOLE
1*
The asystole arrhythmia event occurs to the
patient.
VFIB/VTAC
1*
The ventricular tachycardia or ventricular
fibrillation arrhythmia event occurs to the
patient.
R ON T
2*
The R ON T arrhythmia event occurs to the
patient.
VT > 2
2*
The VT>2 arrhythmia event occurs to the
patient.
COUPLET
2*
The couplet arrhythmia event occurs to the
patient.
C-1
Check the
connection of the
patient cable and
lead wires, and then
check the patient’s
condition.
PVC
2*
The PVC arrhythmia event occurs to the
patient.
BIGEMINY
2*
The bigeminy arrhythmia event occurs to the
patient.
TRIGEMINY
2*
The trigeminy arrhythmia event occurs to the
patient.
TACHY
2*
The patient is suffering from tachycardia.
BRADY
2*
The patient is suffering from bradycardia.
PNC
2*
No pacer signal is captured.
PNP
2*
The pacemaker is not paced.
MISSED
BEATS
2*
The arrhythmia event of missed beats occurs
to the patient.
IRREG
RHYTHM
2*
Irregular rhythm occurs to the patient.
VENT
RHYTHM
2*
Ventricular rhythm occurs to the patient.
MULTIF. PVC
2*
Multiform PVCs occur to the patient.
C.2 Technical Alarm Messages
Note: XX represents the parameter modules like ECG, NIBP and SpO2, or the parameters being
monitored like HR, PR and SpO2.
The A field indicates whether an alarm can be completely cleared; the B field indicates whether
only visual and audible indications of an alarm can be cleared; the “L” field indicates the alarm
level, and 1 means high, 2 means medium, 3 mean low, * means the level is user-adjustable.
C.2.1 General Alarm Messages of Parameter Modules
Alarm message
A
B
L
Cause
Measure
XX INIT ERR N
Yes
No
1
XX module initialization error N
Restart the
monitor. If the
error remains,
contact our
company for
repair.
Note: N stands for the error number.
XX COMM
STOP
No
No
1
Failure in communication between
XX module and the main board.
XX COMM ERR
Yes
No
1
Error in communication between XX
module and the main board.
XX COMM
ABNORMAL
No
No
1
The communication between XX
module and the main board is
abnormal.
XX ALM LMT
ERR
No
No
1
The alarm limit of the XX parameter
is changed inadvertently.
XX EXCEED
No
No
1
The measured XX parameter value
exceeds the measurement range.
C-2
If the error
remains, contact
our company for
repair.
C.2.2 ECG Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
ECG LEAD OFF
No
Yes
3
ECG X LEAD
OFF
No
Yes
3
The ECG lead is not
connected correctly.
Check for correct
connection of the
leadwires.
Note: X represents the leadwires, V, LL, RL, LA and RA, as per
AHA standard, or C, L, F, R and N as per IEC standard.
ECG NOISE
No
No
3
Large interference signals
appear on the ECG signal.
Make sure the leadwires
are correctly connected.
Check the patient for
severe motion.
ECG CH1
SELFTEST ERR
Yes
No
1
An error occurs in the ECG
initialization.
Restart the monitor. If
the error remains,
contact our company for
repair.
ARTIFACT
Yes
No
1
Artifacts are detected on
analysis lead, resulting in HR
unable to be calculated,
asystole, missed beats and
ventricular fibrillation unable
to be analyzed.
Check the connection
between the electrode
and the lead wire; check
if there is an
interference source near
the electrode and the
lead wire; check if the
patient makes excessive
motion.
HIGH
FREQUENCY
NOISE
Yes
No
1
Check if other radio
equipment is located
nearby.
LOW
FREQUENCY
NOISE
Yes
No
1
The monitor is interfered by
electromagnetic signals
emitted by other radio
equipment
ECG Signal Too
Weak
No
No
1
The ECG signal is too weak
to be detected.
Select a lead with better
ECG signal output.
Check the placement of
the electrode or replace
the leadwire.
C.2.3 RESP Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
RESP
DISTURBED
No
No
3
The module circuit is
disturbed.
RR EXCEED
No
No
1
The circuit is disturbed and
the measurement is
inaccurate.
If the problem occurs
continuously, restart the
monitor. If it still exits,
contact our company for
repair.
C-3
C.2.4 TEMP Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
TEMP1
SENSOR OFF
No
Yes
3
The T1 sensor is not
connected correctly to the
patient or the monitor.
Check for correct
connection of the T1
sensor.
TEMP2
SENSOR OFF
No
Yes
3
The T2 sensor is not
connected correctly to the
patient or the monitor.
Check for correct
connection of the T2
sensor.
TEMP
SELFTEST
ERROR
No
No
1
Circuit fault of the
temperature channel.
Contact our company for
repair.
TEMP
CALIBRATION
ERR
No
No
2
Error in temperature channel
calibration.
Restart the monitor. If the
error remains, contact our
company for repair.
C.2.5 NIBP Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
NIBP
SELFTEST ERR
Yes
Yes
1
Error in NIBP
initialization.
Select RESET from the
NIBP SETUP menu. If the
error remains, contact our
company for repair.
LOOSE CUFF
No
Yes
3
The NIBP cuff is not
properly connected.
AIR LEAK
No
Yes
3
Leak in the airway.
PNEUMATIC
LEAK
No
Yes
3
CUFF TYPE
ERR
No
Yes
2
The cuff applied is not
appropriate to the patient
type.
Check the patient’s
condition, and check if the
patient type is correct.
Replace with a proper cuff
and connect it correctly. If
the problem still exists,
contact our company for
repair.
AIR PRESSURE
ERROR
No
Yes
3
WEAK SIGNAL
No
Yes
3
SIGNAL
SATUATED
No
Yes
3
Failure occurs in the pulse
measurement. The monitor
cannot perform
measurement, analysis, or
calculation.
RANGE
EXCEEDED
No
Yes
3
EXCESSIVE
MOTION
No
Yes
3
Excessive motion of the
patient’s arms.
OVER
PRESSURE
No
Yes
2
The airway might be
blocked.
C-4
Check the patient’s
condition, and check if the
patient type is correct.
Replace with a proper cuff
and connect it correctly. If
the problem still exists,
contact our company for
Alarm message
A
B
L
Cause
NIBP SYSTEM
FAILURE
No
Yes
2
NIBP TIME
OUT
No
Yes
2
MEASURE
FAIL
No
Yes
2
Failure occurs in the pulse
measurement. The monitor
cannot perform
measurement, analysis, or
calculation.
NIBP
ILLEGALLY
RESET
No
Yes
2
Illegal reset comes out
during the NIBP
measurement.
Measure
repair.
Check if the airway is
blocked. Deal with the
blocking and perform the
measurement again. If the
problem still exists, contact
our company for repair.
C.2.6 Mindray DS SpO2 Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
SPO2 SENSOR
OFF
No
Yes
3
The sensor is disconnected
from the patient or the
monitor.
Make sure the sensor is
placed on the patient’s
finger or other parts, and
the monitor is connected to
cables correctly.
SPO2 NO
SENSOR
Yes
Yes
3
The sensor is disconnected
from the patient or the
monitor, or it is not
properly connected.
Disconnect and reconnect
the sensor as directed by
the instructions. If the
alarm remains, the sensor
or the cable might have
been damaged.
The SpO2 is connected
upside down.
Disconnect and reconnect
the sensor as directed by
the instructions. Pay
attention to the mark on the
probe.
The pulse signal is too
weak.
Move the sensor to a site
with better perfusion.
SPO2 LOW
PERFUSION
No
No
3
C-5
C.2.7 Nellcor SpO2 Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
SPO2 SENSOR
OFF
No
Yes
3
The sensor is
disconnected from the
patient or the monitor.
Make sure the sensor is placed
on the patient’s finger or other
parts, and the monitor is
connected to cables correctly.
SPO2 NO
SENSOR
Yes
Yes
3
The sensor is
disconnected from the
patient or the monitor,
or the sensor is not
connected properly.
Disconnect and reconnect the
sensor as directed by the
instructions. If the alarm
remains, the sensor or the cable
might have been damaged.
The SpO2 probe is
inserted upside down.
Disconnect and reconnect the
sensor as directed by the
instructions. Pay attention to the
mark on the probe.
SPO2
INTERFERENC
E
No
No
3
The pulse signals are
subject to great external
interference.
Reduce or remove external
interference.
SPO2 BOARD
FAULT
No
No
1
The SpO2 set board
malfunctions and might
be unable to measure
the pulse signals
correctly.
Stop using the SpO2module,
and contact biomedical
engineers or our company for
maintenance.
SPO2 MOTION
No
No
3
The patient is moving.
Reduce patient motion.
SPO2 SENSOR
FAULT
No
No
1
The probe is damaged.
Stop using the sensor.
SPO2 WEAK
SIGNAL
No
No
3
The SpO2 signal is
weak.
Change the sensor site for better
signals.
SPO2 WEAK
PULSE
No
No
3
The detected pulse
signal is too weak.
C-6
C.2.8 IBP Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
IBP1 SENSOR
OFF
No
Yes
3
The invasive blood
pressure cable of channel 1
is disconnected from the
monitor.
Check if the IBP 1 sensor is
properly connected.
IBP2 SENSOR
OFF
No
Yes
3
The invasive blood
pressure cable of channel 2
is disconnected from the
monitor.
Check if the IBP 2 sensor is
properly connected.
IBP1 NEED
ZERO-CAL
No
No
3
The IBP transducer of
channel 1 has not been
zeroed.
Zero the IBP transducer of
channel 1.
IBP2 NEED
ZERO-CAL
No
No
3
The IBP transducer of
channel 2 has not been
zeroed.
Zero the IBP transducer of
channel 2.
C.2.9 CO Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
TB SENSOR
OFF
No
Yes
3
The cable for blood pressure
measurement is disconnected
from the monitor.
Check for proper
connection of TB cable.
C.2.10 Mindray DS CO2 Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
CO2 NO
WATERTRAP
No
No
2
The water trap is not
properly connected or is
disconnected.
Make sure the sidestream
CO2 water trap is firmly
connected.
CO2 SENSOR
TEMP HIGH
No
No
1
The temperature of the
sensor assembly is too
high.
CO2 SENSOR
TEMP LOW
No
No
1
The temperature of the
sensor assembly is too
low.
Restart the monitor if
necessary. If the problem
remains, contact our
company for repair.
CO2 AIRWAY
PRES TOO
HIGH
No
No
2
The pressure inside the
airway is too high.
CO2 AIRWAY
PRES TOO
LOW
No
No
2
The pressure inside the
airway is too low.
C-7
Alarm message
A
B
L
Cause
Measure
CO2
BAROMETRIC
TOO HIGH
No
No
2
The barometric pressure is
too high.
CO2
BAROMETRIC
TOO LOW
No
No
2
The barometric pressure is
too low.
CO2
HARDWARE
ERROR
No
No
1
AD sampling 2.5V error
CO2
HARDWARE
ERROR
No
No
1
The pump malfunctions.
CO2
HARDWARE
ERROR
No
No
1
The 3-way stopcock
malfunctions.
CO2 SAMPLE
LINE
ABNORMAL
No
No
2
The sample line is
abnormal or blocked.
Make sure the airway is not
blocked. If the problem still
exists, contact our company
for repair.
CO2
CALIBRATE
ZERO ERROR
No
No
1
Zeroing failure.
Restart the monitor. If the
problem still exists, contact
our company for repair.
CO2 USER
CALIBRATE
FAIL
No
No
2
User calibration failure.
Make sure the preset
calibration gas concentration
consists with the input
calibration gas. If the
problem remains, contact our
company for repair.
CO2 SYSTEM
ERROR
No
No
1
EEPROM reading address
error.
Contact our company for
repair.
CO2 SYSTEM
ERROR
No
No
1
EEPROM reading length
error.
CO2 SYSTEM
ERROR
No
No
1
EEPROM response to
component error.
CO2 SYSTEM
ERROR
No
No
1
EEPROM checksum error.
CO2 SYSTEM
ERROR
No
No
1
External AD sample line
error.
CO2 SYSTEM
ERROR
No
No
1
Internal AD sample line
error.
CO2 SYSTEM
ERROR
No
No
1
Self-test error
CO2 COMM
ERROR
Yes
No
1
CO2 module
communication fault.
C-8
Restart the monitor. If the
problem still exists, contact
Alarm message
A
B
L
Cause
CO2 INIT ERR
Yes
No
1
The CO2 module is not
properly installed, or
malfunctions.
CO2 COMM
STOP
No
No
1
CO2 module fault or
communication fault.
Measure
our company for repair.
C.2.11 Oridion CO2 Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
CO2 CHECK
CALIBRATION
No
No
2
Calibration error
Make sure the calibration gas
is proper.
CO2 CHECK
FLOW
No
No
2
Airway error
Check for leaks in the airway.
CO2 OCCLU. IN
GAS LINE
No
No
2
The sampling airway has
been occluded for a
period of time.
CO2
FILTERLINE
OFF
No
No
2
The filter Line cannot be
detected.
Check if the filter line is
properly connected.
CO2 OVER
RANGE
No
No
2
The CO2 concentration
value exceeds the
measurement range.
Check the input gas.
CO2 REPLACE
MAIN BOARD
No
No
1
CO2 module fault.
Contact our company.
CO2 CHECK
SENSOR OR
PCB
No
No
1
CO2 REPL
SCRUBBER+PU
MP
No
No
1
CO2 CHANGE
SENSOR
No
No
1
CO2 15VOLT
OUT OF
RANGE
No
No
1
CO2 TEMP
OVERRANGE
No
No
1
The temperature of CO2
module overranges.
Restart the monitor if
necessary. If the problem
remains, contact our company
for repair.
C-9
Alarm message
A
B
L
Cause
Measure
CO2 CALIB
ERROR
No
No
2
Including the error
messages displayed at the
lower part of the menu
(like gas error,
measurement error,
zeroing failure, etc.)
Take measures specific to the
errors. For instance, in case
of a gas error, check if the gas
concentration is wrong. A
measurement error indicates
the module is removing the
occlusion or the filter line is
not connected properly.
CO2 INIT ERR
Yes
No
1
An error occurs during the
CO2 initialization.
CO2 COMM
STOP
No
No
1
Failure in communication
between the CO2 module
and the main board.
Restart the monitor. If the
error remains, contact our
company for repair.
CO2 COMM
ERR
Yes
No
1
Error in communication
between the CO2 module
and the main board.
C.2.12 AG Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
AG SENSOR OFF
No
Yes
3
The AG sensor is not
properly connected or
is disconnected.
Make sure the AG sensor
is properly connected.
AG NO WATERTRAP
No
Yes
3
The AG water trap is
disconnected from the
monitor.
Make sure the water trap
is properly connected.
CHANGE AG
WATERTRAP
Yes
No
2
The AG water trap is
replaced.
Wait until the water trap
has been changed.
AG WATERTRAP TYPE
WRONG
Yes
No
2
The AG water trap is
of a wrong type.
Replace with a water trap
of a correct type.
AG USA ERROR
Yes
No
2
AG module fault.
Contact us to get rid of
the fault.
AG PARAMAGNETIC O2
ERR
Yes
No
2
O2 module fault.
Contact us to get rid of
the fault.
AG GALVANIC O2
ERROR
Yes
No
1
AG OXIMA DEPLETION
WARN
Yes
No
2
AG OXIMA DEPLETION
ERR
Yes
No
2
AG OCCLUSION
Yes
No
1
The actual pump rate
of the AG module is
<20ml/min, which
Remove the block of the
airway.
C-10
exceeds 1 second.
AG SELF-TEST ERR
Yes
No
1
AG module fails or
fails to communicate
with the host.
Unplug and re-plug the
module and then restart
the monitor, or plug the
AG module in another
monitor to check if it
operates properly.
AG HARDWARE MALF
No
No
1
AG module hardware
failure. The module
enters the standby
mode or stop AG
monitoring.
Remove the AG module
from the monitor and
send for authorized
maintenance personnel.
AG HARDWARE ERROR
Yes
No
2
AG module hardware
fault. The module
remains AG
monitoring.
Unplug and re-plug the
module and then restart
the monitor.
AG DATA LIMIT ERROR
Yes
No
2
AG module fault.
AG ZREF FAIL
Yes
No
3
Failure in AG module
zeroing.
AG CAL FAIL
Yes
No
1
Failure in AG module
calibration.
CO2 ACCURACY
UNSEPCIFIED
Yes
No
3
N2O ACCURACY
UNSEPCIFIED
Yes
No
3
The measurement is
out of specified range
at specified accuracy.
O2 ACCURACY
UNSEPCIFIED
Yes
No
3
HAL ACCURACY
UNSEPCIFIED
Yes
No
3
ENF ACCURACY
UNSEPCIFIED
Yes
No
1
ISO ACCURACY
UNSEPCIFIED
Yes
No
3
SEV ACCURACY
UNSEPCIFIED
Yes
No
3
DES ACCURACY
UNSEPCIFIED
Yes
No
3
AwRR ACCURACY
UNSEPCIFIED
Yes
No
3
C-11
Check that appropriate
gas is used and the
clinical environment is
stable. If the problem
persists, send for
authorized maintenance
personnel.
C.2.13 Recorder Module Alarm Messages
Alarm message
A
B
L
Cause
Measure
RECORDER
INIT ERR N
Yes
No
2
An error occurs during the
recorder initialization.
Contact the hospital’s
engineers or our customer
Service.
Note: N represents the error number.
RECORDER
SELFTEST ERR
Yes
No
2
An error might occur to the
RAM, ROM and CPU
watchdog.
Open the RECORD menu and
select the CLEAR REC TASK
option. If the problem remains,
contact our company for repair.
RECORDER
VLT HIGH
No
No
1
A problem occurs to the
system power.
RECORDER
VLT LOW
No
No
1
If this alarm message is given
for many times, contact our
company for repair.
RECORDER
HEAD HOT
No
No
1
The thermal head of the
recorder is too hot.
Resume the recording till the
recorder cools down
completely. If the problem still
exists, contact our company for
repair.
REC HEAD IN
WRONG POS.
Yes
Yes
3
The thermal head of the
recorder is in wrong
position.
Restore the control lever of the
recorder to its previous
position.
RECORDER
OUT OF PAPER
Yes
Yes
3
The recorder paper is used
up.
Replace with a new paper roll.
RECORDER
PAPER JAM
No
No
2
The recording continues for
more than 30 minutes.
Place the recorder correctly and
try again.
RECORDER
COMM ERR
Yes
No
2
Error in recorder
communication.
Open the RECORD menu and
select the CLEAR REC TASK
option. If the problem remains,
contact our company for repair.
TOO MANY
REC TASKS
No
No
2
Quite a few alarm events
occur at the same time.
Check the patient’s condition
and the alarms. Open the
RECORD menu and select the
CLEAR REC TASK option. If
the problem remains, contact
our company for repair.
RECORDER
PAPER W.P.
Yes
Yes
2
The paper roll of the
recorder is not placed in the
correct position.
Place the paper roll correctly.
RECORDER S.
COMM ERR
Yes
No
2
Error in recorder
communication.
REC NOT
AVAILABLE
No
No
2
Error in the recorder work
mode.
Open the RECORD menu and
select the CLEAR REC TASK
option. If the problem remains,
contact our company for repair.
C-12
C.2.14 System Alarm Messages
Alarm message
A
B
L
Cause
Measure
REAL CLOCK
NEED SET
No
No
1
The system time is incorrect.
Reset the system time and then
restart the monitor.
REAL CLOCK
NOT EXIST
No
No
1
No button battery, or the
battery power is depleted.
Add, or replace with a new
button battery.
KEYBOARD
INIT ERR N
No
No
1
Keyboard error. The
keyboard cannot be used.
Contact our company for repair.
Note: N represents the error
number.
KEYBOARD
ERROR
No
No
2
NET INIT ERR
(G.)
No
No
2
NET INIT ERR
(Ram)
No
No
2
NET INIT ERR
(Reg)
No
No
2
NET ERR (Run
1)
No
No
2
NET ERR (Run
2)
No
No
2
12V TOO HIGH
No
No
1
12V TOO LOW
No
No
1
BATTERY TOO
LOW
No
No
1
The system cannot be
connected to the network
due to problems in the
monitor’s network part.
A problem occurs to the
system power.
If this alarm message is given
for many times, contact our
company for repair.
The battery voltage is too
low.
Connect the monitor with AC
power to recharge the battery.
C-13
C.3 Prompt Messages
Prompt messages
Cause
Measure
ECG1 SIGNAL
SATURATION
Signals of abrupt change interfere with
the ECG signal.
Check whether the electrodes
and leads are well connected.
SEARCH PULSE
The SpO2 module is searching the pulse.
Wait till the end of the
searching.
DOMINANT
RHYTHM CHANGE
A change happens to the patient’s
dominant rhythm.
None.
ECG2 SIGNAL
SATURATION
Mindray DS CO2 module
CO2 STANDBY
The CO2 module enters the energy-saving
status when switching from the Normal
mode to the Standby mode.
None
CO2 START UP
The CO2 module is starting.
Wait for the CO2 module to
finish the startup.
CO2 CALIBRATE
ZERO
The CO2 module is in the zeroing status.
Wait for the CO2 module to
finish the zeroing.
CO2 WARM UP
The CO2 module is warming itself up
after startup.
Wait for the CO2 module to
finish warming itself up.
CO2 STANDBY
The CO2 module enters the energy-saving
status when switching from the Normal
mode to the Standby mode.
None
CO2 START UP
The CO2 module is starting.
Wait for the CO2 module to
finish the startup.
CO2 CALIBRATE
ZERO
The CO2 module is in the zeroing status.
Wait for the CO2 module to
finish the zeroing.
CO2 SENSOR
START UP
The CO2 sensor is warming itself up after
startup.
Wait for the CO2 module to
finish warming itself up.
CO2 CALIBRATE
The CO2 module is in the calibrating
status.
Wait for the CO2 module to
finish the calibration.
CO2 PURGING
The CO2 module is in the purging status.
Wait for the CO2 module to
finish the purging.
RECORDER
INITIALIZING
The recorder is in the initializing status.
Wait for the recorder to finish
the initialization.
RECORDER BUSY
The recorder is recording.
Wait for the recorder to finish
the recording.
The AG module is in the standby mode.
None
Oridion CO2 module
Recorder
AG module
AG STANDBY
C-14
Prompt messages
Cause
Measure
AG IS STARTING
The AG module is starting.
Wait for the AG module to
finish the startup.
AG WARM UP
The AG module is warming itself up.
Wait for the AG module to
finish warming itself up.
Manual measure...
The NIBP module is performing the
manual measurement.
Wait for the NIBP module to
finish the measurement.
CONTINUAL...
The NIBP module is performing the
continuous measurement.
Auto measuring...
The NIBP module is performing the auto
measurement.
Resetting...
The NIBP module is being reset.
Wait the NIBP module to finish
the resetting.
Please start
This message appears after the auto
measurement interval is selected.
Press the NIBP button to start
the measurement.
CALIBRATE...
The NIBP module is performing the
calibration.
Wait for the NIBP module to
finish the calibration.
Calibration over
The calibration is finished.
None
PNEUMATIC...
The NIBP module is checking the
pneumatic system for leakage.
Wait for the NIBP module to
finish checking the pneumatic
system.
Pneum test over
The NIBP finishes checking the
pneumatic system for leakage.
None
Measurement over
The NIBP button is pressed during the
measurement.
None
Reset failed
The reset fails.
None
ST LEARNING
The QRS complex template for the ARR
analysis is forming.
Wait till the end of the ARR
learning.
The DEFIB. SYNC. switch is turned on.
It indicates that the auxiliary
output port is outputting
DEFIB. SYNC. signals.
NIBP module
Resetting...
ARR LEARNING
DEFIB. SYNC.ON
C-15
FOR YOUR NOTES
C-16
D Symbols and Abbreviations
Symbols and abbreviations that you may encounter while reading this manual or using the
monitor are listed below with their meanings.
D.1 Symbols
A
ampere
Ah
ampere hour
bpm
beats per minute
BrPM
breaths per minute
℃
centigrade
cc
cubic centimeter
cm
centimeter
dB
decibel
DS
dyne second
℉
fahrenheit
g
gram
GTT
gutta
hr
hour
hPa
hundred pascal
Hz
hertz
inch
inch
kg
kilogram
kPa
kilopascal
l
litre
lb
pound
m
meter
mcg
micrograms
mEq
milli-equivalents
mg
milligrams
min
minute
ml
milliliter
mm
millimeters
D-1
mmHg
millimeters of mercury
ms
millisecond
mV
millivolt
mW
milliwatt
nm
nanometer
ppm
part per million
s
second
V
volt
VA
volt ampere
Ω
ohm
µA
microampere
µm
micron
µV
microvolt
W
watt
-
minus
%
percent
/
per; divide; or
^
power
+
plus
=
equal to
<
less than
>
greater than
≤
less than or equal to
≥
greater than or equal to
±
plus or minus
×
multiply
©
copyright
D-2
D.2 Abbreviations
AAMI
Association for Advancement of Medical Instrumentation
AC
alternating current
ADT
adult
AG
anaesthesia gas
AHA
American Heart Association
ANSI
American National Standard Institute
AP
access point
ARR
arrhythmia
ART
arterial
aVF
left foot augmented lead
aVL
left arm augmented lead
aVR
right arm augmented lead
AwRR
Air way respiratory rate
BSA
body surface area
BTPS
body temperature and pressure, saturated
CCU
critical care unit
CH
channel
CI
cardiac index
CISPR
International Special Committee on Radio Interference
CMS
central monitoring system
cmos
Complementary Metal Oxide Semiconductor
CO
cardiac output
CO2
carbon dioxide
COHb
carboxyhemoglobin
CPU
central processing unit
CVP
central venous pressure
D
diastolic
DC
direct current
DES
desflurane
DIA
diastolic
e.g.
for example
ECG
electrocardiograph
EEC
European Economic Community
EMC
electromagnetic compatibility
ENF
enflurane
D-3
ERR
error
ES
electrosuigical
ESU
electrosuigical unit
Et
end-tidal
EtCO2
end-tidal carbon dioxide
EtN2O
end-tidal nitrous oxide
EtO
Ethylene Oxide
EtO2
end-tidal oxygen
EURO
European
Fi
fraction of inspired
FiCO2
fraction of inspired carbon oxygen
FiN2O
fraction of inspired nitrous oxide
FiO2
fraction of inspired oxygen
fpga
Field Programmable Gate Array
HAL
halothane
Hb-CO
Carbon mono-oxide hemoglobin
HR
heart rate
HT
height
IBP
invasive brood pressure
ICP
intracranial pressure
ICT/B
intracranial catheter tip pressure transducer
IEC
International Electrotechnical Commission
ID
IM
IS
invasive diastolic brood pressure
invasive mean brood pressure
invasive systolic brood pressure
Ins, INS
Inspired Minimum
InsCO2
Inspired Minimum carbon dioxide
ISO
isoflurane
ISO
International organization for standardization
LA (L)
left arm
LAP
left artrial pressure
LCD
liquid crystal display
LED
light emitting diode
LL (F)
left leg
Loop
loop read-write test fail
M
mean
D-4
MAC
minimal alveolar concentration
MAP
mean arterial pressure
MDD
Medical Device Directive
MEAN
mean pressure
MetHb
methemoglobin
Mii
initialize MII registers fail
MRI
magnetic resonance imaging
N2O
nitrous oxide
N/A
not applied
NEO
neonate, neonatal
NIBP
noninvasive blood pressure
ND
NM
NS
non-invasive diastolic brood pressure
non-invasive mean brood pressure
non-invasive systolic brood pressure
O2
oxygen
oxyCRG
Oxygen Cardio-respirogram
P
power
PA
pulmonary artery
PD
photodetector
PED
pediatric
PLETH
plethysmogram
PM
Patient Monitor
PR
pulse rate
PVC
premature ventricular complex
QRS
interval of ventricular depolarization
RA (R)
right arm
RAM
random access memory
RAP
right atrial pressure
Reg
test NE2000 registers fail
RESP
respiration
RL (N)
right leg
ROM
read-only memory
RR
respiration rate
S
systolic
SEV
sevoflurane
SpO2
arterial oxygen saturation from pulse oximetry
D-5
SYNC
synchronization
SYS
systolic
T1
temperature of channel 1
T2
temperature of channel 2
TB
temperature of blood
TD
temperature difference
TEMP
temperature
TFT
Thin-Film Technology
TI
Temperature of Injectate
VGA
Video Graphic Array
WT
weight
D-6
Mindray DS USA, Inc.
800 MacArthur Blvd.
Mahwah, New Jersey 07430
USA
Tel:1.800.288.2121
Tel:1.201.995.8000
www.mindray.com
P/N: 046-000182-00(9.0)
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