EDAN M8 Series User manual

EDAN Agile PLM Electronic Signature Information
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文件名称(Document Name)：iM8 M8 系列 说明书_英文 中性
文件编号(Number)：01.54.456009
版本(Version)：1.5
产品型号(Product Model)：iM8;iM8A;iM8B;M8;M8A;M8B
项目编码(Project Code)：2705I000
签批信息(Signature):
作者(Originator) : 陈 艳娟 (chenyanjuan) 2018-09-21 10:51:26
审核人(Reviewers) : 史 洪华 (shihonghua) 2018-09-25 09:43:23
审核人(Reviewers) : 韩 吉灯 (hanjideng) 2018-09-25 10:07:12
审核人(Reviewers) : 韦 华彪 (weihuabiao) 2018-09-25 16:26:06
审核人(Reviewers) : 王 敏 (wangmin) 2018-09-25 09:21:33
审核人(Reviewers) : 明 镭 (minglei) 2018-09-26 13:31:31
批准人(Approvers) : 夏 欢欢 (xiahuanhuan) 2018-09-29 15:24:05
批准人(Approvers) : 陈 浩杰 (chenhaojie) 2018-09-29 21:50:28
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

I
About this Manual
P/N: 01.54.456009
MPN: 01.54.456009015
Release Date: September, 2018
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User’s operation
failing to comply with this manual may result in malfunction or accident for which the
manufacturer can not be held liable.
The manufacturer owns the copyrights of this manual. Without prior written consent of the
manufacturer, any materials contained in this manual shall not be photocopied, reproduced or
translated into other languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of the manufacturer.
The manufacturer holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
The manufacturer only considers itself responsible for any effect on safety, reliability and
performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by the manufacturer, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.

II
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure

III
Table of Contents
Chapter 1 Intended Use and Safety Guidance ................................................................................1
1.1 Intended Use/Indications for Use...........................................................................................1
1.2 Safety Guidance.....................................................................................................................1
1.2.1 Environment................................................................................................................1
1.2.2 Power Source Requirements.......................................................................................1
1.2.3 Grounding the Monitor ...............................................................................................1
1.2.4 Equipotential Grounding.............................................................................................2
1.2.5 Condensation...............................................................................................................2
1.2.6 Safety Precautions.......................................................................................................2
1.2.7 Protecting Personal Information .................................................................................7
1.2.8 Explanation of Symbols on the Monitor.....................................................................9
Chapter 2 Installation of Monitor ..................................................................................................12
2.1 Opening the Package and Checking.....................................................................................12
2.2 Connecting the Power Cable................................................................................................12
2.3 Powering on the Monitor .....................................................................................................13
2.4 Connecting Patient Sensors..................................................................................................13
2.5 Checking the Recorder.........................................................................................................13
Chapter 3 Introduction....................................................................................................................14
3.1 General Information.............................................................................................................14
3.2 Screen Display .....................................................................................................................17
3.3 Button Functions..................................................................................................................21
3.4 Interfaces..............................................................................................................................22
3.5 Built-in Rechargeable Battery..............................................................................................24
3.5.1 Battery Safety Information........................................................................................24
3.5.2 Battery Status on the Main Screen............................................................................24
3.5.3 Checking Battery Performance .................................................................................25
3.5.4 Replacing the Battery................................................................................................25
3.5.5 Recycling the Battery................................................................................................26
3.5.6 Maintaining the Battery.............................................................................................26
3.5.7 Battery Alarm Information........................................................................................26
Chapter 4 System Menu ..................................................................................................................27
4.1 Patient Setup ........................................................................................................................28
4.2 Default Setup........................................................................................................................29
4.3 Mark Event...........................................................................................................................30
4.4 Face Select ...........................................................................................................................31
4.5 Time Setup ...........................................................................................................................32
4.6 Record Setup........................................................................................................................32

IV
4.7 Module Setup.......................................................................................................................34
4.8 Tracing Waveforms Selection ..............................................................................................34
4.9 Monitor Version ...................................................................................................................34
4.10 Alarm Volume ....................................................................................................................35
4.11 Key Volume........................................................................................................................35
4.12 Drug Calculation................................................................................................................35
4.13 Waveform Demonstration..................................................................................................35
4.14 Maintenance.......................................................................................................................36
4.15 Data Storing .......................................................................................................................39
4.16 Wireless Network with Router (Optional) .........................................................................42
Chapter 5 Face Select.......................................................................................................................44
5.1 Selecting Operating Screen..................................................................................................44
5.2 Standard Screen....................................................................................................................44
5.3 Trend Screen ........................................................................................................................44
5.4 oxyCRG Screen....................................................................................................................45
5.5 Large Font Screen ................................................................................................................45
Chapter 6Alarms.............................................................................................................................48
6.1 Alarm Modes........................................................................................................................48
6.1.1 Alarm Level...............................................................................................................48
6.1.2 Alarm Modes.............................................................................................................48
6.1.3 Alarm Setup...............................................................................................................50
6.2 Alarm Cause.........................................................................................................................52
6.3 Audio Alarm Paused.............................................................................................................52
6.4 Audio Alarm Off ..................................................................................................................53
6.5 Alarm Reset..........................................................................................................................53
6.6 Parameter Alarm...................................................................................................................53
6.7 When an Alarm Occurs........................................................................................................54
6.8 Testing Alarms......................................................................................................................54
Chapter 7Alarm Information.........................................................................................................55
7.1 PhysiologicalAlarm Information.........................................................................................55
7.2 Technical Alarm Information ...............................................................................................59
7.3 Prompts ................................................................................................................................66
7.4 Adjustable Range of Alarm Limits.......................................................................................67
Chapter 8 Freeze ..............................................................................................................................70
8.1 General.................................................................................................................................70
8.2 Entering/Exiting Freeze Status.............................................................................................70
8.3 FROZEN Menu....................................................................................................................70
8.4 Reviewing Frozen Waveform...............................................................................................71
Chapter 9 Recording (Optional).....................................................................................................72

V
9.1 General Information on Recording ......................................................................................72
9.2 Recording Type....................................................................................................................72
9.3 Recording Startup.................................................................................................................74
9.4 Recorder Operations and Status Messages ..........................................................................75
9.5 Recorder Alarm Information................................................................................................76
Chapter 10 Trend and Event...........................................................................................................77
10.1 Trend Graph .......................................................................................................................77
10.2 Trend Table.........................................................................................................................78
10.3 NIBP Recall........................................................................................................................80
10.4 Alarm Event Recall............................................................................................................81
Chapter11DrugCalculationandTitrationTable(Optional).................................................................83
11.1 Drug Calculation................................................................................................................83
11.2 Titration Table ....................................................................................................................85
Chapter 12 Maintenance/Cleaning.................................................................................................87
12.1 Inspecting...........................................................................................................................87
12.2 Maintenance Task and Test Schedule.................................................................................87
12.3 Care and Cleaning..............................................................................................................88
12.3.1 General Points.........................................................................................................88
12.3.2 Cleaning ..................................................................................................................88
12.3.3 Disinfection.............................................................................................................92
12.3.4 Cleaning and Disinfecting OtherAccessories.........................................................94
12.4 Replacement of Fuse..........................................................................................................94
12.5 Cleaning Battery and Battery Compartment Cover ...........................................................94
Chapter 13 Monitoring ECG/RESP...............................................................................................95
13.1 Overview............................................................................................................................95
13.2 ECG Safety Information ....................................................................................................95
13.3 Monitoring Procedure ........................................................................................................97
13.3.1 Preparation ..............................................................................................................97
13.3.2 Placing Electrodes for ECG Monitoring.................................................................98
13.4 ECG Screen Hot Keys......................................................................................................102
13.5 ECG Menu .......................................................................................................................103
13.5.1 ECG SETUP .........................................................................................................103
13.6 ST Segment Monitoring (Optional) .................................................................................107
13.7 Arr. Monitoring (Optional)...............................................................................................111
13.8 Measuring RESP..............................................................................................................115
13.8.1 How to Measure RESP .........................................................................................116
13.8.2 Setting up RESP Measurement .............................................................................116
13.8.3 Installing Electrode for RESP Measurement ........................................................117
13.8.4 RESP SETUP........................................................................................................117

VI
Chapter 14 Monitoring SpO2........................................................................................................120
14.1 Overview..........................................................................................................................120
14.2 SpO2Safety Information..................................................................................................120
14.3 Monitoring Procedure ......................................................................................................121
14.4 Measurement Limitations ................................................................................................122
14.5 Assessing the Validity of a SpO2Reading........................................................................123
14.6 SpO2Alarm Delays..........................................................................................................123
14.7 Perfusion Index (PI).........................................................................................................124
14.8 SpO2SETUP....................................................................................................................124
Chapter 15 Monitoring NIBP .......................................................................................................126
15.1 Overview..........................................................................................................................126
15.2 NIBP Safety Information .................................................................................................126
15.3 Measurement Limitations ................................................................................................127
15.4 Measurement Methods.....................................................................................................128
15.5 Measurement Procedures.................................................................................................128
15.6 NIBP SETUP....................................................................................................................131
15.7 Resetting NIBP ................................................................................................................132
15.8 Calibrating NIBP..............................................................................................................132
15.9 Leak Test..........................................................................................................................132
Chapter 16 Monitoring TEMP......................................................................................................134
16.1 TEMP Monitoring............................................................................................................134
16.2 TEMP SETUP..................................................................................................................134
Chapter 17 Monitoring IBP (Optional)........................................................................................136
17.1 Introduction......................................................................................................................136
17.2 IBP Safety Information ....................................................................................................136
17.3 Monitoring Procedure ......................................................................................................137
17.4 IBP Menu .........................................................................................................................138
Chapter 18 Monitoring CO2(Optional).......................................................................................145
18.1 General.............................................................................................................................145
18.2 Monitoring Procedure ......................................................................................................146
18.2.1 Zeroing the sensor.................................................................................................147
18.2.2 Sidestream CO2Module........................................................................................147
18.2.3 Mainstream CO2Module ......................................................................................150
18.3 CO2SETUP......................................................................................................................152
18.4 Setting CO2Corrections...................................................................................................155
Chapter 19 Accessories ..................................................................................................................157
Chapter 20 Warranty and Service................................................................................................164
20.1 Warranty...........................................................................................................................164
20.2 Contact Information.........................................................................................................164

VII
Appendix I Specifications..............................................................................................................165
A1.1 Classification...................................................................................................................165
A1.2 Specifications..................................................................................................................165
A1.2.1 Physical Specifications.........................................................................................165
A1.2.2 Environment.........................................................................................................166
A1.2.3 Function Configuration........................................................................................167
A1.2.4 Display .................................................................................................................167
A1.2.5 Battery..................................................................................................................167
A1.2.6 Recorder (Optional)..............................................................................................168
A1.2.7 Recall....................................................................................................................168
A1.2.8 ECG......................................................................................................................169
A1.2.9 RESP ....................................................................................................................172
A1.2.10 NIBP...................................................................................................................173
A1.2.11 SpO2....................................................................................................................174
A1.2.12 PR.......................................................................................................................175
A1.2.13 TEMP .................................................................................................................175
A1.2.14 IBP (Optional)....................................................................................................176
A1.2.15 CO2(Optional) ...................................................................................................176
A1.2.16 Interfaces............................................................................................................182
Appendix II EMC Information.....................................................................................................183
A2.1 Electromagnetic Emissions.............................................................................................183
A2.2 Electromagnetic Immunity..............................................................................................183
A2.3 Electromagnetic Immunity..............................................................................................185
A2.4 Recommended Separation Distances..............................................................................188
Appendix III Default Settings.......................................................................................................189
A3.1 Patient Information Default Settings...............................................................................189
A3.2 Alarm Default Settings....................................................................................................189
A3.3 ECG Default Settings......................................................................................................189
A3.4 RESP ...............................................................................................................................191
A3.5 SpO2................................................................................................................................191
A3.6 PR....................................................................................................................................191
A3.7 NIBP................................................................................................................................192
A3.8 TEMP ..............................................................................................................................192
A3.9 IBP...................................................................................................................................192
A3.10 CO2................................................................................................................................193
Appendix IVAbbreviations...........................................................................................................194

Patient Monitor User Manual Intended Use and Safety Guidance
- 1 -
Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use/Indications for Use
iM8 Series: The Patient Monitor (hereinafter called monitor) is intended to be used for
continuous monitoring of ECG, RESP, SpO2, NIBP (Non-invasive Blood Pressure), dual-TEMP,
dual-IBP and CO2.
M8 Series: The Patient Monitor (hereinafter called monitor) is intended to be used for continuous
monitoring of ECG, RESP, SpO2, NIBP (Non-invasive Blood Pressure), dual-TEMP, dual-IBP
and CO2.
The monitor is intended to be used only under regular supervision of clinical personnel. It is
applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient
transport inside a healthcare facility.
The monitor is equipped with alarms that indicate system faults (such as loose or defective
electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
1.2 Safety Guidance
1.2.1 Environment
Follow the instructions below to ensure a completely safe electrical installation. The environment
where the monitor will be used should be reasonably free from vibration, dust, corrosive or
explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation,
allow sufficient room at the front for operation and sufficient room at the rear for servicing with
the cabinet access door open.
The monitor operates within specifications at ambient temperatures between 0 C and 40 C.
Ambient temperatures that exceed these limits could affect the accuracy of the instrument and
cause damage to the modules and circuits. Allow at least 2 inches (5cms) clearance around the
instrument for proper air circulation.
1.2.2 Power Source Requirements
Refer to Appendix Ⅰ .
1.2.3 Grounding the Monitor
To protect the patient and hospital personnel, the cabinet of the monitor must be grounded.
Accordingly, the monitor is equipped with a 3-wire cable which grounds the instrument to the
power line ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a
3-wire receptacle is not available, consult the hospital electrician.
Connect the grounding wire to the equipotential grounding terminal in the main system. If it is
not evident from the instrument specifications whether a particular instrument combination is
hazardous or not, for example due to summation of leakage currents, the user should consult the

Patient Monitor User Manual Intended Use and Safety Guidance
- 2 -
manufacturers concerned or an expert in the field, to ensure that the necessary safety of all
instruments concerned will not be impaired by the proposed combination.
1.2.4 Equipotential Grounding
Protection class I instruments are already included in the protective grounding (protective earth)
system of the room by way of grounding contacts in the power plug. For internal examinations on
the heart or the brain, the monitor must have a separate connection to the equipotential grounding
system. One end of the equipotential grounding cable (potential equalization conductor) is
connected to the equipotential grounding terminal on the instrument rear panel and the other end
to one point of the equipotential grounding system. The equipotential grounding system assumes
the safety function of the protective grounding conductor if ever there is a break in the protective
grounding system. Examinations in or on the heart (or brain) should only be carried out in
medically used rooms incorporating an equipotential grounding system. Check each time before
use that the instrument is in perfect working order. The cable connecting the patient to the
instrument must be free of electrolyte.
WARNING
If the protective grounding (protective earth) system is doubtful, the monitor must be
supplied by internal power only.
1.2.5 Condensation
Make sure that during operation, the instrument is free of condensation. Condensation can form
when equipment is moved from one building to another, and thus being exposed to moisture and
differences in temperature.
1.2.6 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
WARNING
1 The monitor is provided for the use of qualified physicians or personnel professionally
trained. They should be familiar with the contents of this user manual before
operation.
2 Only qualified service engineers can install this equipment. And only service
engineers authorized by the manufacturer can open the shell.
3 EXPLOSION HAZARD Do not install the monitor in the presence of flammable
anesthetics.
4 SHOCK HAZARD-The power receptacle must be a three-wire grounded outlet. A
hospital grade outlet is required. Never adapt the three-prong plug from the monitor
to fit a two-slot outlet.

Patient Monitor User Manual Intended Use and Safety Guidance
- 3 -
WARNING
5 SHOCK HAZARD-Do not attempt to connect or disconnect a power cord with wet
hands. Make certain that your hands are clean and dry before touching a power cord.
6 Accessory equipments connected to the analog and digital interfaces must be
certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the standard IEC/EN 60601-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN60601-1. If in doubt,
consult our technical service department or your local distributor.
7 If the monitor is accidentally damped, place it in the dry circumstance, and do not
operate it until it is approved for further use. If liquid is inadvertently spilled on the
monitor, contact the service personnel authorized by the manufacturer.
8 During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off. The settings configured by the user can be stored, and settings
not configured by user keep no change. That is, the last settings used will be
recovered when the power is restored.
9 The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do not dispose them
together with house-hold garbage. At the end of their life hand the batteries over to
the applicable collection points for the recycling of waste batteries. For more detailed
information about recycling of this product or battery, please contact your local Civic
Office, or the shop where you purchased the product.
10 The packaging is to be disposed of according to local or hospital’s regulations;
otherwise, it may cause environmental contamination. Place the packaging at the
place which is inaccessible to children.
11 Only patient cable and other accessories supplied by the manufacturer can be used.
The performance and electric shock protection can not be guaranteed, and the
patient may be injured otherwise. Prior to use, check if the casing of a disposable or
sterilized accessory is intact. Do not use it if its casing is damaged.
12 Before using the device, the equipment, patient cable and electrodes etc. should be
checked. Replacement shall be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
13 Be sure that all electrodes have been connected to the patient correctly before
operation.
14 Do not touch the patient and metal part of the monitor when operating the monitor.
15 Do not touch the patient, bed and instrument during defibrillation.
16 Please set the alarm according to the individual status of patient to avoid delaying
treatment. Ensure there will be alarm audio prompt when alarming.

Patient Monitor User Manual Intended Use and Safety Guidance
- 4 -
WARNING
17 Devices connecting with monitor should be equipotential.
18 When the monitor and electrosurgical device are used together, the user (physician
or nurse) should guarantee the safety of patient.
19 This equipment is not intended for family usage.
20 Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
21 Without use of data store function, all data measured (including trend data, review
data, alarm events and so on) are cleared either when the monitor is turned off or
when the monitor is powered down in the process of monitoring.
22 Additional multiple socket-outlet or extension cord can’t be connected to the system.
23 Only items that have been specified as part of the system or specified as being
compatible with the system can be connected to the system.
24 SHOCK HAZARD - Don't connect electrical equipment, which has been supplied as a
part of the system, directly to the wall outlet when the non-medical equipment is
intended to be supplied by a multiple portable socket-outlet with an isolation
transformer.
25 SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.
26 Do not touch accessible parts of medical or non-medical electrical equipment in the
patient environment and the patient simultaneously, such as USB connector, VGA
connector or other signal input/output connectors.
27 Connecting any accessory (such as external printer) or other device (such as the
computer) to this monitor makes a medical system. In that case, additional safety
measures should be taken during installation of the system, and the system shall
provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
28 All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
29 Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of the monitoring equipment.

Patient Monitor User Manual Intended Use and Safety Guidance
- 5 -
WARNING
30 The monitor should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, you must check that normal operation is
possible in the necessary configuration before you start monitoring patients.
31 Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix A2
EMC Information.
32 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
33 Do not service or maintain the monitor or any accessory which is in use with the
patient.
34 Setting alarm limits to extreme values may cause the alarm system to become
ineffective. It is recommended to use the default settings.
35 The monitors are intended for use by trained healthcare professionals in hospital
environments.
36 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
37 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the monitor in a location where the operator can easily see the screen,
access the operating controls and access the disconnection device.
38 The equipment can provide protective means to prevent the patient from being
burned when used with HF SURGICAL EQUIPMENT. The equipment can protect
against the effects of the discharge of a defibrillator. Use only the accessories
approved by the manufacturer.
39 After defibrillation, the ECG display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers’ instructions.
40 Only recommended batteries can be used for the monitor.
41 When the monitor is used with HF surgical equipment, the transducer and the cables
must be avoided from conductive connection to the HF equipment. This is to protect
against burns to the patient.
42 Extreme care must be exercised when applying medical electrical equipment. Many
parts of the human/machine circuit are conductive, such as the patient, connectors,
electrodes, transducers. It is very important that these conductive parts do not come
into contact with other grounded, conductive parts when connected to the isolated
patient input of the device. Such contact would bridge the patient's isolation and
cancel the protection provided by the isolated input. In particular, there must be no
contact of the neutral electrode and ground.

Patient Monitor User Manual Intended Use and Safety Guidance
- 6 -
WARNING
43 To protect the monitor from damage during defibrillation, for accurate measurement
information and to protect against noise and other interference, use only accessories
specified by the manufacturer.
44 If several items of medical equipment are interconnected, pay attention to the sum of
the leakage currents, otherwise it may cause shock hazard. Consult your service
personnel.
45 No modification of this equipment is allowed without authorization of the
manufacturer. If this equipment is modified, appropriate inspection and testing must
be conducted to ensure continued safe operation.
46 The device must be connected to the ground to avoid signal interference.
47 The monitor is suitable for use in the presence of electrosurgery. When the monitor is
used with HF surgical equipment, user (doctor or nurse) should be cautious about
patient safety.
48 Make sure networking function is used in a secure network environment.
49 Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the monitor, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
CAUTION
1 Federal laws (U.S.) restrict this device to sale, distribution and use by, or on the order
of a physician.
2 Electromagnetic Interference - Ensure that the environment in which the patient
monitor is installed is not subject to any sources of strong electromagnetic
interference, such as radio transmitters, mobile telephones, microwaves, etc.
3 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine,
dust area, high temperature and humid environment.
4 Do not immerse transducers in liquid. When using solutions, use sterile wipes to
avoid pouring fluids directly on the transducer.
5 Do not use autoclave or gas to sterilize the monitor, recorder or any accessories.
6 The device and reusable accessories may be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
7 Remove a battery whose life cycle has expired from the monitor immediately.
8 Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.

Patient Monitor User Manual Intended Use and Safety Guidance
- 7 -
CAUTION
9 Avoid liquid splash and excessive temperature. The temperature must be kept
between 0 C and 40 C while working. And it should be kept between -20 C and 55
C during transportation and storage.
10 A potential hazard may exist if different alarm presets are used for the same or
similar equipment in any single area.
11 Protect the device against mechanical damage resulting from falls, impacts, and
vibration.
12 A ventilated environment is required for monitor installation. Do not block up the
ventilation grille at the back of the device.
13 Poor connection might be caused by frequently plugging and unplugging the power
cord. Check the power cord regularly and replace it in time.
14 Route all cables carefully to avoid possible entanglement, apnea, or electrical
interference. For the device mounted over the patient, sufficient precautionary
measures should be taken to prevent it from falling on the patient.
15 In normal use, the operator shall stand in front of the monitor.
NOTE:
1 The monitor can only be used on one patient at a time.
2 If the monitor gets damp, put it in dry circumstance to dry it until it can work normally.
If liquid pours on the monitor, please contact the service personnel of the
manufacturer.
3 The manufacturer suggests that the lifetime of the monitor is 5 years.
4 This monitor is not a device for treatment purpose.
5 The pictures and interfaces in this manual are for reference only.
6 The materials with which the patient or any other person can come into contact
conform to the standard of EN ISO 10993-1: 2013.
7 If the device is discolored or damaged, then discontinue use of the device.
8 Regular preventive maintenance should be carried out every two years. You are
responsible for any requirements specific to your country.
9 When there's measurement beyond range, invalid measurement or no measurement
value, it will display ---.
10 When deploying the network of the monitor and MFM-CMS, it is recommended to
isolate the network and the Intranet system of the hospital by using VLAN so as to
ensure the network security.
1.2.7 Protecting Personal Information
Protecting personal health information is a major component of security strategy. To protect the
personal information and ensure the proper device performance, the user should take necessary

Patient Monitor User Manual Intended Use and Safety Guidance
- 8 -
precautions in accordance with local laws and regulations and institution’s policies. The
manufacturer recommends health care organizations or medical institutions to implement a
comprehensive and multifaceted strategy to protect the information and systems from internal and
external security threats.
To ensure the patients’ safety and protect their personal health information, the user should
implement practices or measures that include:
1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not
have access to the monitor.
2. Operational safeguards - safety measures during operation.
3. Administrative safeguards - safety measures in management.
4. Technical safeguards - safety measures in technical field.
CAUTION
1 The access/operation of the monitor is restricted to authorized personnel only. Assign
only staff with a specific role the right to use the monitor.
2 Ensure that all device components maintaining personal information (other than
removable media) are physically secure.
3 Ensure that the data are deleted after the patient is discharged (Refer to Section 4.15
Data Storing).
4 Ensure that the monitor is connected only to the device authorized/approved by the
manufacturer. Users should operate the monitors deployed and supported by the
manufacturer within the specifications authorized by the manufacturer, including
these (such as software, software configuration, security configuration, etc.) approved
by the manufacturer.
5 Protect all the passwords to prevent unauthorized changes.
6 Anti-virus measures such as USB device virus scanning should be carried out prior to
using USB flash drive.
7 When connecting the monitor to a shared network, data security issues of the network
topology and configuration must be considered. Since the patient sensitive data might
be transmitted from the monitor to the network, the medical institution should be
responsible for the network security. Firewalls and/or other security devices should be
in place between the medical system and any externally accessible systems.
8 When the monitor is returned for maintenance, disposed of, or removed from the
medical institution for other reasons, it is necessary to ensure that all patient data are
removed from the monitor (Refer to Section 4.15 Data Storing).
NOTE:
Log files generated by the monitor are used for system troubleshooting and do not
contain protected medical data.

Patient Monitor User Manual Intended Use and Safety Guidance
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1.2.8 Explanation of Symbols on the Monitor
1
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
2
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
3
Caution
4
Operating instructions
5
Equipotential grounding
6
USB (Universal Serial Bus) Connection
7
Video output
8
Power Supply switch
9
Gas inlet
10
DO NOT REUSE
11
SERIAL NUMBER
12
CE marking
13
AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY
14
Date of manufacture
15
MANUFACTURER

Patient Monitor User Manual Intended Use and Safety Guidance
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16
Part Number
17
General symbol for recovery/recyclable
18
Disposal method
19
Caution: Federal (U.S.) Law restricts this device to sale by or on
the order of a physician.
20
Ingress Protection IPX1 (Protected against vertically falling water
drops)
21
Refer to User manual
(Background: blue; Symbol :white )
22
Warning
(Background: yellow; Symbol and outline: black )
23
Non-ionizing electromagnetic radiation
24
(This mark is optional.) Conforms to UL Std. 60601-1, IEC Std.
60601-2-27, IEC Std. 60601-2-30, IEC Std. 60601-2-34, IEC Std.
60601-2-49
Certified to CSA Std. C22.2 No 601.1, CSA Std. C22.2 No
60601-2-27, CSA Std. C22.2 No 60601-2-30, CSA Std. C22.2 No
60601-2-34, CSA Std. C22.2 No 60601-2-49
25
Fragile
26
This way up

Patient Monitor User Manual Intended Use and Safety Guidance
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27
Stacking limit by number
28
Keep away from rain
29
Handle with care
30
Do not step on
NOTE:
The user manual is printed in black and white.