Mindray BIO Medical electronics WM3000 Mobile Remote ECG Measurement System User Manual

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Wearable ECG Monitor
Operator’s Manual
© Copyright 2014-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights
reserved.
For this Operator’s Manual, the issue date is 2016-4.
II
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this Mindray 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 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, rental, 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.
Responsibility on the Manufacturer
Party
Contents of this manual are subject to changes without prior notice.
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 the effects on safety, reliability and performance of this product, only if:
 all installation operations, expansions, changes, modifications and repairs of this product are
conducted by Mindray authorized personnel;
 the electrical installation of the relevant room complies with the applicable national and local
requirements;
 the product is used in accordance with the instructions for use.
III
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
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or unauthorized
service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
Company Contact
Manufacturer:
Address:
Website:
E-mail
Address:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Building, Keji 12th Road South, Hi-tech industrial park,
Nanshan,Shenzhen 518057,P.R.China
www.mindray.com
service@mindray.com
Tel:
+86 755 81888998
Fax:
+86 755 26582680
EC-Representative:
Shanghai International Holding Corp. GmbH(Europe)
Address:
Eiffestraβe 80, 20537 Hamburg, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
IV
Preface
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in accordance
with its function and intended use. Observance of this manual is a prerequisite for proper product
performance and correct operation and ensures patient and operator safety.
This manual is based on the maximum configuration and therefore some contents may not apply to
your product. If you have any question, please contact us.
This manual is an integral part of the product. It should always be kept close to the equipment so
that it can be obtained conveniently when needed.
Intended Audience
This manual is geared for clinical professionals and common people.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or
data displayed on your product.
Conventions
Italic text is used in this manual to quote the referenced chapters or sections.
Contents
1.1.1 Warnings ............................................................................................................... 2
1.1.2 Cautions ................................................................................................................ 3
1.1.3 Notes ..................................................................................................................... 3
1.2 Equipment Symbols ......................................................................................................... 4
2.1 Product introduction ......................................................................................................... 1
2.1.1 Apply scope .......................................................................................................... 1
1.2.1 Applied Parts .......................................................................................................... 1
2.2 Product appearance......................................................................................................... 2
3.1 Installation ......................................................................................................................... 1
3.1.1 Unpacking and Checking ................................................................................... 1
1.2.2 Environmental Requirements ............................................................................ 2
3.1.2 Power requirements ............................................................................................ 2
3.1.3 Installation method .............................................................................................. 2
3.2 Cleaning and Disinfection ............................................................................................... 2
3.2.1 Cleaning ................................................................................................................ 2
3.2.2 Disinfection ........................................................................................................... 3
4.1 Preparation before use .................................................................................................... 1
4.2 Wear the ECG recorder ................................................................................................... 1
4.3 View ECG data ................................................................................................................. 3
4.4 Take off the ECG recorder .............................................................................................. 3
4.5 Charge the ECG recorder ............................................................................................... 4
4.6 Offline data transimission ................................................................................................ 5
5.1 Frequence Questions Management .............................................................................. 6
7.1 ECG Sensor ...................................................................................................................... 2
7.2 Charger .............................................................................................................................. 3
A Product Specifications ................................................................................................. A‐1
A.1 Safety Specifications ................................................................................................... A‐1
A.2 Environmental Specifications ..................................................................................... A‐1
A.3 Power Supply Specifications...................................................................................... A‐1
A.4 Physical Specifications ............................................................................................... A‐2
A.5 Display, Recorder and Storage Specification .......................................................... A‐2
A.6 ECG Specification ....................................................................................................... A‐2
A.7 Charger Specification .................................................................................................. A‐2
B EMC and Radio Regulatory Compliance.................................................................... B‐1
B.1 EMC ............................................................................................................................... B‐1
B.2 Radio Regulatory Compliance ................................................................................... B‐6
C Symbols and Abbreviations ......................................................................................... C‐1
C.1 Symbols......................................................................................................................... C‐1
C.2 Abbreviations ................................................................................................................ C‐2
1.Safety
1.1 Safety Information
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or
serious injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor
personal injury or product/property damage.
NOTE
Provides application tips or other useful information to ensure that you get the most from
your product.
1.1.1 Warnings
WARNING
 This equipment can not be used for infant whose weight is less than 10 Kg.
 Before putting the system into operation, the operator must verify that the equipment,
connecting cables and accessories are in correct working order and operating
condition.
 This equipment can not be used for the person whose skin is hypersusceptible to the
the accessories.
 To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich
atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).
 There is a battery inside. Do not open the equipment housings. All servicing and
future upgrades must be carried out by the personnel trained and authorized by our
company only.
 Please don’t bend or reverse the ECG recorder. Otherwise the equipment may be
damaged.
 Remove the equipment from patients during defibrillation. Otherwise the equipment
may be damaged.
 Remove the equipment from patients during using the electro-surgery unit. Otherwise
the equipment may be damaged.
 When disposing of the package material, be sure to observe the applicable waste
control regulations and keep it out of children’s reach.
 Keep the equipment and accessories out of children’s reach. Otherwise children may
inadvertently damage the equipment and accessories or swallow the same small
parts casuing apnea or other hazards.
 The equipment is suit for violent sports such as football, basketball and volleyball.
The balls hit the equiepment that may hurt the user.
 The equipment transmit wireless signal via sape. The signal may be interrupted by
serval possible sources of interference. The transmission failure may happen
sometime, although the equipment has some anti- interference capacity.
1.1.2 Cautions
CAUTION
 Make sure that the operating environment of the equipment meets the specific
requirements.
 To prolong the service life of the wquipment, please don’t put it under the sunshine for
a long time.
 To ensure patient safety, use only parts and accessories specified in this manual.
 Single-use accessories are not designed to be reused. Reuse may cause a risk of
contamination and affect the measurement accuracy.
 At the end of its service life, the equipment, 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 equipment, please
contact us.
 Magnetic and electrical fields are capable of interfering with the proper performance
of the equipment. For this reason make sure that all external devices operated in the
vicinity of the equipment 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.
1.1.3 Notes
NOTES
 Keep this manual in the vicinity of the equipment so that it can be obtained
conveniently when needed.
1.2 Equipment Symbols
General warning sign
DATE OF MANUAFACTURE
Serial number
AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
The product bears CE mark indicating its conformity with the provisions of the
Council Directive 93/42/EEC concerning medical devices and fulfils the
essential requirements of Annex I of this directive.
Note: The product complies with the Council Directive 2011/65/EU.
Waterproof level 7
Refer to instruction manual/booklet
Type CF APPLIED PART
Non-ionization radiation symbol
2.Safety
2.1 Product introduction
Wearable ECG monitor contain adhesive ECG recorder，ECG sensor. The adhesive ECG recorder
collect ECG signal via ECG sensor. The data collected is stored in ECG recorder. It can be transmitted
to protocol compatible device or APP.
2.1.1 Apply scope
Can be used for measuring, recording and storing human ECG data, for applications that require long
continuous records of patients ECG data. Can be used in medical departments or in home environment.
WARNING
 This equipment is used for single user at a time.
 The PATIENT is an intended OPERATOR.
 The ECG recorder is suitable for use within the patient environment.
 The waterproof level of the ECG recorder is IPX7. It can be used in the shower or in
water for a short time.
 Prohibit using the equioment in the hyperbaric oxygen chamber.
1.2.1 Applied Parts
The applied parts of the wearable ECG monitor are:
 Shell of ECG recorder,
 ECG electrodes
 ECG sensor
2.2 Product appearance
Picture 错误！文档中没有指定样式的文字。-1 Adhesive ECG recorder front
Picture 错误！文档中没有指定样式的文字。-2 Adhesive ECG recorder back
3.Installation and Maintenance
3.1 Installation
WARNING

The software copyright of the equipment is solely owned by us. No organization or
individual shall resort to juggling, copying, or exchanging it or to any other
infringement on it in any form or by any means without due permission.
3.1.1 Unpacking and Checking
Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected,
contact the carrier or us.
If the packing case is intact, open the package and remove the equipment and accessories carefully.
Check all materials against the packing list and check for any mechanical damage. Contact us in case
of any problem.
NOTE
 Save the packing case and packaging material as they can be used if the equipment must
be reshipped.
WARNING
 When disposing of the packaging material, be sure to observe the applicable waste
control regulations and keep it out of children’s reach.
 The equipment might be contaminated during storage and transport. Before use, please
verify whether the packages are intact, especially the packages of single use
accessories. In case of any damage, do not apply it to patients / users.
1.2.2 Environmental Requirements
The operating environment of the equipment must meet the Environmental Specification in
Appendix B.
3.1.2 Power requirements
The power used for this equipment must meet the Power Specification in Appendix B.
WARNING
 Make sure that the operating environment and power of the equipment meets the
specific requirements. Otherwise unexpected consequences, e.g. damage to the
equipment, could result.
3.1.3 Installation method
Installation methods of adhesive ECG recorder, please refer chapter 4.
3.2 Cleaning and Disinfection
Only adhesive ECG recorder and changer need cleaning and disinfection. The accessories are single
use products. So they need not cleaning and disinfection.
3.2.1 Cleaning
The ECG recorder should be cleaned beroe and after use. The charger should be cleaned beroe use.
Please use clean and soft cloth, sponge or tampon adsorb non-erosive cleaning agent and dry
appropriately to clean the surface of the equipment. Recommended cleaning agents are:

Water

Ethanol (70%)

Isopropyl alcohol (70%)
To clean your equipment, follow these rules:
1.
Clean the exterior surface of the equipment using a soft cloth dampened with the cleaner,
making sure that no cleanser is dripping from the cloth.
2.
Wipe off all the cleaning solution with a dry cloth after cleaning if necessary.
3.
Dry your equipment in a ventilated, cool place.
WARNING
 Please clean the surface under the rules abbove. Otherwise, it may damage the shell
or the print of the equipement
3.2.2 Disinfection
Disinfect the equipment as required in your hospital’s servicing schedule. Cleaning equipment before
disinfecting is recommended.
4.Operations
4.1 Preparation before use
Please shake the ECG recorder and observe the LED light before use.

The green light flicker means the ECG recorder is normal.

The red light flicker every 3 seconds means the ECG recorder is malfunction.

The red light flicker every 9 seconds means the ECG recorder is low power.

No light flicker means the ECG recorder is mal function or its battery uses out.
NOTES

The ECG recorder need be waked up by charger before first use.

The battery will use out when the ECG recorder doesn’t use for a long time. It can not
be waked up by shaking. It needs be charged before use.

It is ready to use when it is waked up and flicker greens light. The time is less than 15
seconds.

The time required for me equipment to warm from the minimum storage temperature
between uses until it is ready for intended use is less than 30 minutes.

The time required for me equipment to cool from the maximum storage temperature
between uses until it is ready for intended use is less than 30 minutes.
4.2 Wear the ECG recorder
Picture 4-1 shows how to install accessory and wear the equipment on human body.
Picture 错误！文档中没有指定样式的文字。‐3 ECG recorder installatiosketch map with one
channel ECG sensor
Installation process shows as below:
1.Tear off the tape marked①.
2.Stick the ECG recorder to the accessory.
3.Tear off the tape marked②.
4.Stick the ECG recorder with accessory nearby to heart such as A, B, C area in the picture.
5.Tear off the tape marked③.
When use two channels ECG sensor, the operation is similar with one channel ECG sensor. The
position shows as picture 4-2.
Picture 错误！文档中没有指定样式的文字。‐4 ECG recorder installatiosketch map with two
channel ECG sensor
NOTES

The ECG recorder can work with one channel ECG sensor or two channel ECG
sensor. Please use of accessories approved by Mindray.
 Check the accessories and their packages for any sign of damage. Do not use them if
any damage is detected.
4.3 View ECG data
The ECG recorder can transmit data by Bluetooth. It can work with mobile equipment that is
android 4.3 upwards, iOS 7.1 upwards, and Bluetooth 4.0 upwards. The ECG data can be read by
protocol compatible APP’s.
4.4 Take off the ECG recorder
1.Take off the ECG recorder with ECG sensor from human body.
2.Tear off the ECG recorder from the ECG sensor
3.Put the ECG recorder to the original box.
Picture 错误！文档中没有指定样式的文字。‐5 Take off the ECG recorder
NOTES

The ECG recorder will enter sleep mode. There is no need to power off it.
4.5 Charge the ECG recorder
Please charge the ECG recorder under following conditions:
First use
There is no light indicator when shake the ECG recorder.
Reuse the ECG recorder over one month between last use.
Please charge it once every month to protect its battery, if it will not be used for a long
time. Store it in a cool and dry place. You can check the battery volume on the APP and
decide to charge or not basing on the intended using time. Recommend charging the
ECG recorder when the battery volume is less than 10%.
Show as picture 4-4, put the ECG recorder on the charger and connect the cable to DC
5V 500mA out put power. The blue light of ECG recorder will be on and the red light will
flicker, when it is charging. The red light will go out when the battery is full.
Picture 错误！文档中没有指定样式的文字。‐6 the indicators of charger
The charger indicator lights
Battery volume indicator: Every light represents 25% volume.
Charge indicator: This light turning on means the ECG recorder is charing.
Data transimission indicator: This light flicker means the ECG recorder is sending data
to the charger.
NOTES

The charger that model is EPC001 has no Battery volume indicator. Only can check
the battery is full or not by ECG recorder’s indicator.
4.6 Offline data transimission
The data stored in ECG recorder can be exported by Bluetooth of charger. A
computer and export software are needed as well. You can get the download link by
scanning the picture below.
Connect the charger to the computer with thw USB cable. Then open the software.
Put the ECG recorder to the charger. Operate the software following the instruction
on the software. The data can be exported to computer by Bluetooth of charger and
upload to cloud by internet.
NOTES

The charger that model is EPC001 can not export data.
5.Frequence Questions Management
5.1 Frequence Questions Management
Malfunction
Possible cause
resolvent
Battery used out
Charge ECG recorder
1.Battery low volume
1.Charge ECG recorder, then use.
2.ECG recorder malfunction
2.Contact Manufacturer to fix it。
1.Battery low volume
1.Charge ECG recorder, then use.
Bluetooth
2.ECG recorder malfunction
2.Contact Manufacturer to fix it。
disconnection
3.Mobile equipement closed
3.Open
phenomena
Battery low volume
Work time is short,
only a couple of hours
or minutes
bluetooth
equipment.
Bluetooth.
of
mobile
6.Battery
Adhesive ECG recorder has a rechargeable Lithium-ion battery as work power.
The battery icon on Mindray health APP shows the volume status:
When the remaining volume of battey is less than 10%, the red light on the ECG recorder will flash.
The ECG recorder should be chargerd at this time.
WARNING

Inside rechargeable Lithium-ion battery can not be replaced.

When charge, keep it out of children’s reach.

Only use the charger approved by Mindray.

To improve the life time of battery, please charge when indicating low volume.

Please charge to 80% upwards before longtime storage. And charge it once a month.

Please don’t expose the battery to high temperature envirenment, such as warmer,
oven, water heater and microwave oven. Battery overheating may explode.

Please don’t disasemble or modify the battery. Otherwise it may cause battery
leakage, overheating, fire or explosion.

Keep skin and eyes from the leakage liquid, if the battery leakage. Please flush the
skin or eyes immediately and go to hospital for treatment, if skin or eyes touch the
leakage liquid.

Please don’t throw the battry into the fire. Otherwise it may cause explosion.

When a battery exceed lifetime , or no longer holds a charge, it should be disposed.
To dispose of the batteries, follow local laws for proper disposal.

Please don’t let children or pets swallow or bite the battrey. Otherwise it may hurt
them or cause explosion.
7.Accessory
7.1 ECG Sensor
The accessories show as the table below. The lifetime of the accessories is 2years.
Part description
MR.Wear sigle channel
ECG sensor
model
Type
EPA001
Manufacturer
Sigle use
Mindray
MR.Wear two channels
ECG sensor
EPA002
Sigle use
WARNING

Use accessories specified in this chapter. Using other accessories may cause
damage to the equipment or not meet the claimed specifications.
 Single-use accessories are not designed to be reused. Reuse may cause a risk of
contamination and affect the measurement accuracy.
 Check the accessories and their packages for any sign of damage. Do not use them if
any damage is detected.

The accessory material that contacts the patients has undertaken the
bio-compatibility test and is verified to be in compliance with ISO 10993-1.

The accessory can not be pasted on the damaged skin. Otherwise it may cause
dermatitis.

Don’t stick the accessory in the same position time by time for a long time. It may
cause dermatitis.
CAUTION
 Please store the ECG sensor in dark shade under the room temperature.

Please use the ECG sensor as soon as possible after the package is open. Otherwise
the water evaporation of ECG sensor will impact its performance.

Check the ECG sensor is not expired before use.

Please close the package after getting ECG sensor.
7.2 Charger
Part description
model
ECG Recorder Charger
EPC001
Type
Manufacturer
Repeat use
Mindray
ECG Recorder Charger
(Professional)
Repeat use
EPC002
WARNING

Please select a computer or adapter that fulfills IEC60950 or related industry safety
standards to supply the charger.

Only use the charger approved by Mindray. The charger complies with the
requirements of IEC60601-1.

The metal material stuff can not be placed on the charger. The charger can not use
for other device except the ECG recorder.

Don’ touch the user when touch the charger and USB cable during the charger
conneting to the power.
A Product Specifications
A.1 Safety Specifications
The ECG recorder is classified, according to IEC60601-1:
Type of protection against electrical
Class I, equipment energized from an internal electrical
shock
power source.
Degree of protection against electrical
shock
Type CF
Continuous
Mode of operation
Degree of protection against harmful
ingress of water
IPX7
A.2 Environmental Specifications
WARNING
 The equipment may not meet the performance specifications if stored or used outside
the specified temperature and humidity ranges.
Item
Operating conditions
Storage conditions
Temperature (°C)
0 to 45
-20 to 45
15% to 95%
10% to 95%
86.0 to 106.0
57.0 to 107.0
Relative
(noncondensing)
Barometric (kPa)
humidity
A.3 Power Supply Specifications
Battery voltage range
3-4.2V
Battery Type
Chargeable Lithium-Ion, 11.1DVC, 4.5 Ah
Run time (type value)
≥ 30 hours
A-1
A.4 Physical Specifications
Size
Length：87±5mm
Width：32±3mm
Height：6±1mm
Weight
≤10g
Interface
Standard interface, include ECG leads signals and Bluetooth signal
A.5 Display, Recorder and Storage Specification
Display
A least one lead ECG wave and equipment status information will
be display on mobile phone or other mobile device.
Recorder mode
Real time record
Storage mode
Chip storage
Storage capacity
Storage 30 hours data
A.6 ECG Specification
ECG
Lead set
3-lead: I, III
Sample rate
125Hz
Input signal range
±8 mV (peak-to-peak value)
Pace pulses meeting the following conditions are labelled with a
PACE marker:
Pace pulse markers
Amplitude: ±2 to ±200 mV
Width:
0.1 to 2 ms
Rise time:
10 to 100 µs
Common mode rejection ratio
≥96dB
Bandwidth (-3dB)
0.05~40Hz
Gain setting
error≤±5%
Display sensitivity
Accuracy: ±5%
Differential input impedance
≥20MΩ@10Hz
A.7 Charger Specification
Interface
Standard interface, micro USB
Input
DC 5V 200mA
Output
DC 5V 40mA
A-2
B EMC and Radio Regulatory
Compliance
B.1 EMC
The device meets the requirements of IEC 60601-1-2.
NOTE
 Using accessories, transducers and cables other than those specified may result in
increased electromagnetic emission or decreased electromagnetic immunity of the
device.
 The device or its components should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the device or its components should
be observed to verify normal operation in the configuration in which it will be used.
 The device needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided below.
 Other devices may interfere with this device even though they meet the requirements of
CISPR.
 When the inputted signal is below the minimum amplitude provided in technical
specifications, erroneous measurements could result.
 Portable and mobile communication equipment may affect the performance of this
monitor.
 Other devices that have RF transmitter or source may affect this device (e.g. cell phones,
PADs, PCs with wireless function).
Guidance and Declaration - Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of
the device should assure that it is used in such an environment.
Emission tests
Compliance
Electromagnetic
guidance
Radio frequency (RF)
Group 1
The device uses RF energy only for its internal
emissions CISPR 11
environment
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
B-1
RF emissions CISPR 11
Class B
The device is suitable for use in all establishments ,
domestic and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes
Harmonic emissions
Not apply
IEC61000-3-2
Voltage Fluctuations/Flicker
Not apply
Emissions IEC 61000-3-3
If the system is operated within the electromagnetic environment listed in Table Guidance and
Declaration —Electromagnetic Immunity, the system will remain safe and provide the following
essential performance,
 Operating mode
 Accuracy
 Function
 Accessories identification
 Data stored
 Alarm
 Detect for connection
Guidance and Declaration - Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of
the device should assure that it is used in such an environment.
Immunity test
IEC60601 test level
Compliance level
Electromagnetic
environment - guidance
Electrostatic
±6 kV contact
±6 kV contact
Floors should be wood,
discharge (ESD)
±8 kV air
±8 kV air
concrete or ceramic tile. If
IEC 61000-4-2
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
±2 kV for power supply
±2 kV for power supply
transient/burst IEC
lines
lines
61000-4-4
±1 kV for input/output
lines
B-2
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge IEC
±1 kV line(s) to line(s)
61000-4-5
±2 kV line(s) to earth
Voltage dips, short
<5 % UT (>95 % dip in
interruptions and
UT) for 0.5 cycle
Not apply
Not apply
voltage variations
on power supply
input lines IEC
61000-4-11
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in
UT) for 5 s
Power frequency
3 A/m
3 A/m
Power frequency magnetic
(50/60 HZ)
fields should be at levels
magnetic field IEC
characteristic of a typical
61000-4-8
location in a typical commercial
or hospital environment.
Note: UT is the AC mains voltage prior to application of the test level.
Guidance and Declaration - Electromagnetic Immunity
The device is intended for use in the specified electromagnetic environment. The customer or the user of the
device should assure that it is used in such an environment as described below.
Immunity test
IEC60601
test level
Compliance
level
Electromagnetic
guidance
environment
Conduced RF
3 Vrms
3 Vrms
Portable and mobile RF communications
IEC61000-4-6
150 kHz to 80
equipment should be used no closer to any part
MHz
of the system, including cables, than the
recommended separation distance calculated
from the equation appropriate for the frequency
of the transmitter. Recommended separation
distances:
d  1 .2 P
Radiated RF
3V/m
3V/m
Recommended separation distances:
IEC61000-4-3
80MHz to
80 MHz～800 MHz
2.5GHz
d  1 .2 P
800MHz-2.5GHz
B-3
d  2 .3
Where, P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
,should be less than the compliance level in
each frequency range b.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note 1: At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Note 3: The device that intentionally receives RF electromagnetic energy at the exclusion band
(2400MHz-2483.5MHz) is exempt from the ESSENTIAL PERFORMANCE requirements, but remains safe.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the [ME EQUIPMENT
or ME SYSTEM] is used exceeds the applicable RF compliance level above, the [ME EQUIPMENT or ME
SYSTEM] should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM].
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than3V/m.
Recommended separation distances between
communications equipment and the device
portable
and
mobile
RF
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the device as recommended below, according to the maximum output power of the communications
equipment.
Rated
Separation distance in meters (m) according to frequency of the
maximum
transmitter
output power
150 kHz ～ 80 MHz
80 MHz ～ 800 MHz
B-4
800 MHz ～ 2.5 GHz
of transmitter d  1 . 2 P
（W）
d  1 .2 P
d  2 .3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.20
1.20
2.30
10
3.80
3.80
7.30
100
12.00
12.00
23.00
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
B-5
B.2 Radio Regulatory Compliance
RF parameters
Item
Operating Frequency
Band (MHz)
Modulation
Transmitter Output
Power (dBm)
Description
Bluetooth low energy 4.1
2402 - 2480
GFSK
≤2.5
The device including Bluetooth module which complies with part 15 of the FCC Rules. Operation
is subject to the condition that this device does not cause harmful interference.
Operation of this equipment requires the prior coordination with a frequency coordinator
designated by the FCC for the Wireless Medical Telemetry Service.
This Bluetooth device complies with Canadian ICES‐001. Cet appareil ISM est conforme a la
norme NMB‐001 du Canada.
The device including Bluetooth module FCC and Industry Canada Radio Compliance: This device
complies with Part 15 of the FCC Rules and RSS‐210 of Industry Canada. Operation is subject to
the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received, including interference
that may cause undesired operation. Any changes or modifications to this equipment not
expressly approved by Mindray may cause harmful radio frequency interference and void your
authority to operate this equipment.
The maximum antenna gain permitted complies with the e.i.r.p. limits as stated in RSS‐210.
The maximum antenna gain permitted complies with the e.i.r.p. limits specified for
point‐to‐point operation, as stated in RSS‐210.
The radio device used in this product is in compliance with the essential requirements and
other relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications
Terminal Equipment Directive).
B-6
C Symbols and Abbreviations
C.1 Symbols
ampere
dB
decibel
gram
Hz
hertz
kilo
kPa
kilopascal
meter
mm
millimeters
ms
millisecond
mV
millivolt
mW
milliwatt
second
volt
Ω
ohm
watt
－
minus
percent
per; divide; or
～
to
power
＋
plus
＝
equal to
＜
less than
＞
greater than
≤
less than or equal to
≥
greater than or equal to
±
plus or minus
×
multiply
©
copyright
C-1
C.2 Abbreviations
ECG
electrocardiograph
MDD
Medical Device Directive
MRI
magnetic resonance imaging
C-2
C-1

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