Mindray PM-7000 User Manual
PM-7000
Patient Monitor
Operation Manual
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) 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 patent rights of Mindray, nor the rights of others. Mindray does not assume any
liability arising out of any infringements of patents or other rights of third parties.
Mindray 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 is strictly forbidden. Release, amendment, reproduction, distribution,
rent, adaption and translation of this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
and are the registered trademarks or trademarks owned by Mindray in
China and other countries. All other trademarks that appear in this manual are used only for
editorial purposes without the intention of improperly using them. They are the property of
their respective owners.
Contents of this manual are subject to changes without prior notice.
© 2006 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
I
Manufacturer’s Responsibility
All information contained in this manual is believed to be correct. Mindray shall not be
liable for errors contained herein nor for incidental or consequential damages in connection
with the furnishing, performance, or use of this manual.
Mindray is responsible for safety, reliability and performance of this product only in the
condition that:
All installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel; and
The electrical installation of the relevant room complies with the applicable national
and local requirements; and
This product is operated under strict observance of this manual.
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'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 or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to
Any Mindray product which has been subjected to misuse, negligence or accident; or
Any Mindray product from which Mindray's original serial number tag or product
identification markings have been altered or removed; or
Any product of any other manufacturer.
II
Return Policy
In the event that it becomes necessary to return a unit to Mindray, follow the instructions
below.
1. Obtain a return authorization.
Contact the Mindray Service Department and obtain a Mindray Customer Service
Authorization Number. The Mindray Customer Service Authorization Number must appear
on the outside of the shipping container. Return shipments will not be accepted if the
Mindray Customer Service Authorization 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 for
service (including any relevant customs fees or other freight related charges).
3. Return address
Please send the part(s) or equipment to the address offered by Customer Service
Department.
III
Contact Information
Manufacturer:
Address:
Tel:
Fax:
Website:
EC-Representative:
Address:
Tel:
Fax:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Building, Keji 12th Road South, Hi-tech Industrial
Park, Nanshan, Shenzhen 518057 P.R. China
+86 755 26582479 +86 755 26582888
+86 755 26582934 +86 755 26582500
www.mindray.com
Shanghai International Holding Corp. GmbH (Europe)
Eiffestraße 80, 20537 Hamburg Germany
0049-40-2513175
0049-40-255726
IV
Contents
1 Safety................................................................................................................................. 1-1
1.1 Safety Information ..........................................................................................................1-2
1.1.1 Dangers .............................................................................................................. 1-3
1.1.2 Warnings............................................................................................................. 1-3
1.1.3 Cautions ............................................................................................................. 1-4
1.1.4 Notes .................................................................................................................. 1-5
1.2 Equipment Symbols ........................................................................................................ 1-6
1.3 CE Marking..................................................................................................................... 1-8
1.4 Reference Literature........................................................................................................1-9
2 The Basics ......................................................................................................................... 2-1
2.1 Monitor Description........................................................................................................ 2-2
2.1.1 Intended Use....................................................................................................... 2-2
2.1.2 Contraindications ............................................................................................... 2-3
2.1.3 Components ....................................................................................................... 2-3
2.1.4 Functions............................................................................................................ 2-3
2.2 External Appearance ....................................................................................................... 2-5
2.2.1 Front Panel ......................................................................................................... 2-5
2.2.2 Side Panel........................................................................................................... 2-6
2.2.3 Rear Panel .......................................................................................................... 2-8
2.3 Control Panel................................................................................................................. 2-10
2.4 Display ...........................................................................................................................2-11
2.5 Batteries ........................................................................................................................ 2-14
2.5.1 Battery Maintenance ........................................................................................ 2-15
2.5.2 Battery Recycling............................................................................................. 2-16
3 Installation and Maintenance.......................................................................................... 3-1
3.1 Installation....................................................................................................................... 3-2
3.1.1 Unpacking and Checking ................................................................................... 3-2
3.1.2 Environmental Requirements............................................................................. 3-3
3.1.3 Power Source Requirements .............................................................................. 3-3
3.1.4 Bracket Mounting............................................................................................... 3-3
3.1.5 Installation Method ............................................................................................ 3-4
3.1.6 Powering on the Monitor.................................................................................... 3-9
3.1.7 Powering off the Monitor................................................................................... 3-9
3.2 Maintenance .................................................................................................................. 3-10
3.2.1 Inspection ......................................................................................................... 3-10
3.2.2 Cleaning ............................................................................................................3-11
1
Contents
3.2.3 Disinfection and Sterilization........................................................................... 3-12
4 System Menu .................................................................................................................... 4-1
4.1 Overview......................................................................................................................... 4-2
4.2 Patient Setup ................................................................................................................... 4-4
4.2.1 Admit Patient...................................................................................................... 4-5
4.2.2 Quick Admit Patient........................................................................................... 4-7
4.2.3 Modify Patient.................................................................................................... 4-7
4.2.4 Discharge Patient................................................................................................ 4-7
4.3 Default Setup................................................................................................................... 4-8
4.4 System Setup................................................................................................................... 4-9
4.4.1 Face Select ....................................................................................................... 4-10
4.4.2 Alarm Setup.......................................................................................................4-11
4.4.3 Time Setup ....................................................................................................... 4-12
4.4.4 Recorder Setup................................................................................................. 4-13
4.4.5 Data Output ...................................................................................................... 4-15
4.4.6 Analog Output .................................................................................................. 4-16
4.4.7 Module Setup ................................................................................................... 4-17
4.4.8 Trace Setup....................................................................................................... 4-18
4.4.9 Mark Event....................................................................................................... 4-19
4.5 Selection Setup.............................................................................................................. 4-20
4.6 Monitor Version ............................................................................................................ 4-21
4.7 Maintenance .................................................................................................................. 4-23
4.7.1 IP Address Setup .............................................................................................. 4-26
4.7.2 Wireless Net Setup ........................................................................................... 4-26
4.7.3 Self Definition of Color ................................................................................... 4-27
4.7.4 Nurse Call Setup .............................................................................................. 4-28
4.7.5 CO
User Maintain........................................................................................... 4-30
2
4.7.6 Monitor Status.................................................................................................. 4-30
4.8 DEMO Function............................................................................................................ 4-31
5 Face Selection ................................................................................................................... 5-1
5.1 Standard Screen............................................................................................................... 5-2
5.2 Trend Screen ................................................................................................................... 5-3
5.3 OxyCRG Screen.............................................................................................................. 5-4
5.4 Viewbed Screen............................................................................................................... 5-5
5.5 Large Font Screen ...........................................................................................................5-7
5.6 Standby Mode ................................................................................................................. 5-8
6 Alarms............................................................................................................................... 6-1
6.1 Overview......................................................................................................................... 6-2
6.1.1 Alarm Categories................................................................................................ 6-2
6.1.2 Alarm Levels ...................................................................................................... 6-3
6.2 Alarm Modes................................................................................................................... 6-4
2
Contents
6.2.1 Visual Alarms..................................................................................................... 6-4
6.2.2 Audible alarms ................................................................................................... 6-4
6.2.3 Alarm Messages ................................................................................................. 6-5
6.2.4 Parameter Flashes............................................................................................... 6-5
6.3 Alarm Statuses................................................................................................................. 6-6
6.3.1 Alarms Disabled ................................................................................................. 6-6
6.3.2 Alarms Paused .................................................................................................... 6-7
6.3.3 System Silenced ................................................................................................. 6-7
6.3.4 Alarms Silenced ................................................................................................. 6-7
6.3.5 Status Switchover............................................................................................... 6-8
6.4 Latching Alarms .............................................................................................................. 6-9
6.5 Clearing Alarms ............................................................................................................ 6-10
6.6 When an Alarm Occurs ..................................................................................................6-11
7 Freezing Waveforms ........................................................................................................ 7-1
7.1 Overview......................................................................................................................... 7-2
7.2 Freezing and Unfreezing................................................................................................. 7-2
7.3 FROZEN Menu............................................................................................................... 7-3
7.4 Waveform Recall.............................................................................................................7-4
7.5 Recording Frozen Waveforms......................................................................................... 7-4
8 Recording.......................................................................................................................... 8-1
8.1 Overview......................................................................................................................... 8-2
8.2 Recording Types.............................................................................................................. 8-2
8.3 Recorder Operations........................................................................................................ 8-5
8.4 Installing Recorder Paper................................................................................................ 8-8
9 Recall................................................................................................................................. 9-1
9.1 Overview......................................................................................................................... 9-2
9.2 Trend Graph Recall ......................................................................................................... 9-3
9.3 Trend Table Recall ..........................................................................................................9-5
9.4 NIBP Recall .................................................................................................................... 9-7
9.5 Alarm Event Recall ......................................................................................................... 9-8
9.6 Non-Volatile Data Storage............................................................................................. 9-10
10 Drug Calculation.......................................................................................................... 10-1
10.1 Drug Calculation ......................................................................................................... 10-2
10.1.1 Calculation Formula....................................................................................... 10-2
10.1.2 Operating Method .......................................................................................... 10-2
10.1.3 Units............................................................................................................... 10-3
10.2 Titration Table ............................................................................................................. 10-5
11 ECG/RESP Monitoring.................................................................................................11-1
11.1 Overview......................................................................................................................11-2
3
Contents
11.1.1 ECG Waveform ...............................................................................................11-2
11.1.2 ECG Parameters..............................................................................................11-4
11.2 ECG Monitoring Procedure..........................................................................................11-5
11.2.1 Preparation ......................................................................................................11-5
11.2.2 Electrode Placement ........................................................................................11-6
11.3 ECG Setup Menu .......................................................................................................11-12
11.4 ST Analysis ................................................................................................................11-19
11.4.1 Overview.......................................................................................................11-19
11.4.2 ST Analysis Menu .........................................................................................11-20
11.5 Arrhythmia Analysis...................................................................................................11-23
11.5.1 Overview.......................................................................................................11-23
11.5.2 Arrhythmia Analysis Menu ...........................................................................11-24
11.5.3 Arrhythmia Alarm Setup ...............................................................................11-25
11.5.4 Arrhythmia Recall .........................................................................................11-26
11.6 ECG 12-Lead Monitoring ..........................................................................................11-28
11.6.1 General ..........................................................................................................11-28
11.6.2 Monitoring Procedure....................................................................................11-29
11.6.3 ECG Setup Menu for 12-Lead Monitoring ...................................................11-32
11.6.4 Data Review..................................................................................................11-39
11.7 RESP Monitoring .......................................................................................................11-41
11.7.1 Overview.......................................................................................................11-41
11.7.2 Electrode Placement ......................................................................................11-42
11.7.3 Respiration Setup ..........................................................................................11-43
11.8 Maintenance and Cleaning.........................................................................................11-45
12 SpO
Monitoring.......................................................................................................... 12-1
2
12.1 Overview..................................................................................................................... 12-2
12.2 Mindray SpO2 Module ................................................................................................ 12-4
12.2.1 Principles of Operation................................................................................... 12-4
12.2.2 Precautions..................................................................................................... 12-5
12.2.3 Monitoring Procedure .................................................................................... 12-6
12.2.4 Measurement Limitations............................................................................... 12-8
12.2.5 SpO
12.3 Masimo SpO
Setup Menu........................................................................................... 12-9
2
Module............................................................................................... 12-12
2
12.3.1 Principles of Operation................................................................................. 12-12
12.3.2 Precautions................................................................................................... 12-14
12.3.3 Monitoring Procedure .................................................................................. 12-16
12.3.4 Measurement Limitations............................................................................. 12-16
12.3.5 SpO
Setup Menu......................................................................................... 12-17
2
12.3.6 Sensors and Accessories............................................................................... 12-19
12.3.7 Masimo Information..................................................................................... 12-21
12.4 Nellcor SpO
Module................................................................................................ 12-22
2
12.4.1 Principles of Operation................................................................................. 12-22
12.4.2 Precautions................................................................................................... 12-24
4
Contents
12.4.3 Monitoring Procedure .................................................................................. 12-25
12.4.4 Measurement Limitations............................................................................. 12-26
12.4.5 SpO
Setup Menu......................................................................................... 12-27
2
12.4.6 Accessories................................................................................................... 12-29
12.4.7 Nellcor Information...................................................................................... 12-30
13 NIBP Monitoring.......................................................................................................... 13-1
13.1 Overview..................................................................................................................... 13-2
13.2 Monitoring Procedure ................................................................................................. 13-3
13.2.1 Cuff Selection and Placement ........................................................................ 13-3
13.2.2 Operation Guides ........................................................................................... 13-4
13.3 Measurement Limitations............................................................................................ 13-6
13.4 NIBP Setup Menu ....................................................................................................... 13-7
13.4.1 Calibration...................................................................................................... 13-9
13.4.2 Testing for Air Leakage................................................................................ 13-10
13.5 Maintenance and Cleaning.........................................................................................13-11
14 TEMP Monitoring........................................................................................................ 14-1
14.1 Overview..................................................................................................................... 14-2
14.2 Measurement Procedure.............................................................................................. 14-3
14.3 TEMP Setup Menu...................................................................................................... 14-4
14.4 Maintenance and Cleaning.......................................................................................... 14-6
15 IBP Monitoring............................................................................................................. 15-1
15.1 Overview..................................................................................................................... 15-2
15.2 Precautions.................................................................................................................. 15-3
15.3 Monitoring Procedure ................................................................................................. 15-4
15.4 IBP Menu .................................................................................................................... 15-5
15.4.1 IBP Setup Menu ............................................................................................. 15-5
15.4.2 IBP Pressure Zero Menu ................................................................................ 15-9
15.4.3 IBP Pressure Calibration ...............................................................................15-11
15.5 Maintenance and Cleaning........................................................................................ 15-14
16 CO Monitoring.............................................................................................................16-1
16.1 Overview..................................................................................................................... 16-2
16.2 Measurement Procedure.............................................................................................. 16-3
16.2.1 Window for CO Measurement ....................................................................... 16-5
16.2.2 Blood Temperature Monitoring ...................................................................... 16-8
16.3 CO Setup Menu........................................................................................................... 16-9
16.4 Hemodynamic Calculation.........................................................................................16-11
16.5 Maintenance and Cleaning........................................................................................ 16-13
17 CO
Monitoring............................................................................................................ 17-1
2
17.1 Overview..................................................................................................................... 17-2
5
Contents
17.2 Mindray CO2 Module.................................................................................................. 17-3
17.2.1 Principles of Operation................................................................................... 17-3
17.2.2 Preparations for CO
17.2.3 CO
17.2.4 CO
Setup Menu ............................................................................................ 17-6
2
User Maintain Menu............................................................................. 17-10
2
Measurement................................................................ 17-4
2
17.2.5 Maintenance and Cleaning........................................................................... 17-12
17.3 Oridion CO
Module................................................................................................. 17-12
2
17.3.1 Principles of Operation................................................................................. 17-12
17.3.2 Preparations for CO
17.3.3 CO
17.3.4 CO
Setup Menu .......................................................................................... 17-14
2
User Maintain Menu............................................................................. 17-17
2
Measurement.............................................................. 17-13
2
17.3.5 Maintenance and Cleaning........................................................................... 17-19
17.3.6 Oridion Information ..................................................................................... 17-19
17.4 Welch Allyn CO
Module.......................................................................................... 17-20
2
17.4.1 Principles of Operation................................................................................. 17-20
17.4.2 Preparations for CO
17.4.3 CO
Setup Menu .......................................................................................... 17-22
2
Measurement.............................................................. 17-21
2
17.4.4 Maintenance and Cleaning........................................................................... 17-26
18 Anesthesia Gas Monitoring ......................................................................................... 18-1
18.1 Overview..................................................................................................................... 18-2
18.2 Anesthesia module ...................................................................................................... 18-4
18.2.1 Introduction of anesthesia module ................................................................. 18-4
18.2.2 Connection of anesthesia module................................................................... 18-6
18.3 Measurement Principles and Procedure...................................................................... 18-7
18.4 AG Setup Menu........................................................................................................... 18-9
18.5 Maintenance and Cleaning........................................................................................ 18-13
19 Accessories.................................................................................................................... 19-1
19.1 ECG Accessories......................................................................................................... 19-2
19.2 SpO2 Accessories ........................................................................................................ 19-4
19.2.1 Mindray SpO
19.2.2 Masimo SpO
19.2.3 Nellcor SpO
Accessories............................................................................. 19-4
2
Accessories ............................................................................. 19-5
2
Accessories............................................................................... 19-5
2
19.3 NIBP Accessories........................................................................................................ 19-6
19.4 TEMP Accessories ...................................................................................................... 19-7
19.5 IBP Accessories........................................................................................................... 19-8
19.6 CO Accessories ........................................................................................................... 19-9
19.7 CO
Accessories........................................................................................................ 19-10
2
19.7.1 Mindray CO
19.7.2 Oridion CO
19.7.3 Welch Allyn CO
Accessories ............................................................................ 19-10
2
Accessories.............................................................................. 19-10
2
Accessories .......................................................................19-11
2
19.8 AG Accessories ......................................................................................................... 19-12
6
Contents
20 Appendices.................................................................................................................... 20-1
A Product Specifications................................................................................................... 20-2
A.1 Safety Classifications ................................................................................................... 20-2
A.2 Environmental Specifications....................................................................................... 20-3
A.3 Power Source Specifications........................................................................................ 20-4
A.4 Hardware Specifications .............................................................................................. 20-5
A.5 Wireless network.......................................................................................................... 20-6
A.6 Data Storage................................................................................................................. 20-6
A.7 Signal Output Specifications........................................................................................ 20-7
A.8 ECG Specifications ...................................................................................................... 20-8
A.9 RESP Specifications................................................................................................... 20-10
A.10 SpO
Specifications...................................................................................................20-11
2
A.11 NIBP Specifications ................................................................................................. 20-13
A.12 TEMP Specifications................................................................................................ 20-14
A.13 IBP Specifications.................................................................................................... 20-15
A.14 CO Specifications..................................................................................................... 20-16
A.15 CO
Specifications ................................................................................................... 20-16
2
A.16 AG Specifications..................................................................................................... 20-20
B EMC.............................................................................................................................. 20-22
C Alarm Messages and Prompt Information................................................................ 20-27
C.1 Physiological Alarm Messages................................................................................... 20-27
C.2 Technical Alarm Messages ......................................................................................... 20-28
C.3 Prompt Messages........................................................................................................ 20-40
D Optional Functions...................................................................................................... 20-43
E Symbols and Abbreviations ........................................................................................ 20-45
E.1 Symbols ...................................................................................................................... 20-45
E.2 Abbreviations.............................................................................................................. 20-47
7
FOR YOUR NOTES
Contents
8
Preface
Manual Purpose
This manual provides the instructions necessary to operate the PM-7000 Patient Monitor
(hereinafter called as this monitor) in accordance with its function and intended use.
Observance of this manual is a prerequisite for proper performance and correct operation,
and ensures patient and operator safety.
This manual is written based on the maximum configuration. Part of this manual may not
apply to your monitor. If you have any question about the configuration of your monitor,
please contact our Customer Service.
This manual is an integral part of and should always be kept close to the patient monitor, so
that it can be obtained conveniently when necessary.
Intended Audience
This manual is geared for the clinical medical professionals. Clinical medical professionals
are expected to have working knowledge of medical procedures, practices and terminology
as required for monitoring of critically ill patients.
Version Information
This manual has a version number. This version number changes whenever the manual is
updated due to software or technical specification change. Content of this manual is subject
to change without prior notice. The version information of this manual is as follows.
Version number Release date
1.0 September 2006
1
Preface
Illustrations and Names
All illustrations in this manual are provided as examples only. They may not necessarily
accord with the graph, settings or data displayed on your patient monitor.
All names appeared in this manual and illustrations are fictive. It is a mere coincidence if
the name is the same with yours.
Conventions
Italic text is used in this manual to quote the referenced chapters or sections.
The terms danger, warning, and caution are used throughout this manual to point out
hazards and to designate a degree or level or seriousness.
2
1 Safety
1-1
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
z Indicates an imminent hazard situation that, if not avoided, will result in
death or serious injury.
WARNING
z Indicates a potential hazard situation or unsafe practice that, if not avoided,
could result in death or serious injury.
CAUTION
z Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
NOTE
z Provides application tips or other useful information to ensure that you get
the most from your product.
1-2
Safety
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
z The device is intended for use by qualified clinical physicians or well-trained
nurses in the specified places.
z To ensure patient safety, verify the device and accessories can function
safely and normally before use.
z EXPLOSION HAZARD: Do not use this device in the presence of flammable
anesthetics, explosive substances, vapors or liquids.
z You must customize the alarm settings according to the individual patient
situation, and make sure the alarm sound is activated when an alarm
occurs.
z 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.
z DEFIBRILLATION: Do not come into contact with the patient during
defibrillation. Otherwise serious injury or death could result.
z When used in conjunction with electro-surgery equipment, you must give
top priority to the patient safety.
z DISPOSE: Dispose of the package material, observing the applicable waste
control regulations and keeping it out of children’s reach.
z 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.
1-3
Safety
1.1.3 Cautions
CAUTION
z To ensure patient safety, use only parts and accessories specified in this
manual.
z 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.
z Disposable devices are intended for single use only. They should not be
reused as performance could degrade or contamination could occur.
z 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.
z 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.
z 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.
z Install or carry the patient monitor properly to avoid damages caused by
drop, impact, strong vibration or other mechanical force.
1-4
Safety
1.1.4 Notes
NOTE
z Keep this manual close to the patient monitor so that it can be obtained
conveniently when necessary.
z This patient monitor complies with the requirements of CISPR11 (EN55011)
class A.
z The software was developed per IEC60601-1-4. The possibility of hazards
arising from errors in software program is minimized.
z Put the patient monitor in a location where you can easily see the screen
and access the operating controls.
z The instructions of this manual are based on the maximum configuration.
Some of them may not apply to your patient monitor.
1-5
Safety
1.2 Equipment Symbols
NOTE
z Some symbols may not appear on all equipment.
Attention: Consult accompanying documents (this manual).
Power ON/OFF
Direct current and alternating current (DC&AC)
Alternating current (AC)
Direct current (DC)
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
Electrical Signal Input/Output
Gas inlet
Gas outlet
Auxiliary output
1-6
Safety
Network connector
VGA connector
Manufacture date
Serial number
European community representative
ESD sensitivity
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.
1-7
Safety
1.3 CE Marking
The patient monitor bears CE mark indicating its conformity with the provision of Council
Directive 93/42/EEC concerning medical devices, and fulfills the essential requirement of
Annex I of this directive.
The patient monitor is in radio-interference protection class A in accordance with EN55011.
The product complies with the requirement of standard EN60601-1-2 “Electromagnetic
Compatibility – Medical Electrical Equipment”.
1-8
Safety
1.4 Reference Literature
1. Medical Device Directive 93/42/EEC
2. EN60601-1+A1+A2 or IEC60601-1+A1+A2, Medical Electrical Equipment, Part 1:
General Requirements for Safety
3. EN60601-1-1 or IEC60601-1-1, Medical Electrical Equipment- Part 1-1: General
Requirements for Safety - Collateral Standard: Safety Requirements for Medical
Electrical Systems
4. IEC60601-1-4, Medical Electrical Equipment- Part 1-4: General Requirements for
Safety - Collateral Standard: Programmable Electrical Medical Systems
5. IEC60601-2-49 Medical Electrical Equipment-Part 2-49: Particular Requirements for
the Safety of Multifunction Patient Monitoring Equipment
1-9
FOR YOUR NOTES
Safety
1-10
2 The Basics
2-1
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
The intended use of this monitor is to monitor a fixed set of parameters (see 2.1.4
Functions) for single adult, pediatric and neonatal patient, to display patient data and
waveforms, to store patient data in a trend database, and to generate alarms and recordings.
This monitor is to be used in but not restricted to medical institutions such as ICU, CCU,
cardiopathy ICU, operating room, emergency room and postoperative observation ward etc.
This monitor may also be used during hospital transport or ambulance. This monitor is not
intended for helicopter transport or home use.
WARNING
z This Monitor is to be operated by clinical physicians or appropriate medical
staffs under the direction of physicians. The operator of the monitor must
be well trained. Any operation by unauthorized or non-trained personnel is
forbidden.
z 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.
2-2
The Basics
2.1.2 Contraindications
None.
2.1.3 Components
This monitor consists of parameter measuring modules, blood pressure cuff, ECG, IBP and
CO cables, SpO
sensors, CO2 and AG measuring components. Some of the components are
2
optional and may not apply to your patient monitor.
2.1.4 Functions
This monitor is capable of monitoring the following parameters.
ECG
Heart rate (HR)
2 channels of ECG waveforms
Arrhythmia and ST segment analysis (optional)
Pace analysis (PACE)
RESP
Respiration rate (RR)
Respiration waveform
SpO
2
Oxygen saturation (SpO
)
2
Pulse rate (PR)
SpO
plethysmogram
2
NIBP
Systolic pressure (NS), diastolic pressure (ND), mean pressure (NM)
TEMP
Temperature of channel 1 (T1), temperature of channel 2 (T2),
and temperature differential between two channels (TD)
IBP
CO
2 channels of IBP waveforms
Systolic (SYS), diastolic (DIA), and mean (MEAN) pressure.
Temperature of blood (TB)
Cardiac output (CO)
2-3
The Basics
CO
2
End-tidal carbon dioxide (EtCO
)
2
Fractional inspiratory carbon dioxide (FiCO2)
Air-way Respiration Rate (AwRR)
AG
Fraction of inspired carbon dioxide, nitrous oxide, oxygen or anesthetic
gas (FiCO
oxide or oxygen (EtCO
, FiN2O, FiO2, FiAA), and End-tidal carbon dioxide, nitrous
2
, EtN2O, EtO2, EtAA)
2
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 (CO
, N2O, O2 and AA)
2
This monitor has additional functions including visual & audible alarms, freezing, data
storage and output, recall, recording and drug calculation etc. Please refer to the following
corresponding chapters for details of each specific function.
2-4
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