M33246-GB-Rev.2.03.20
Figure 4.18
Figure 4.19
• Set device parameters: Languages and sample time can be set by user. The
interface for setting success is shown as
Figure 4.20
6) PC management software can be operated in WIN8/WIN 10 operation system,
hereafter list the requirements of hardware of PC to run WIN10/WIN 8 operation
system
Hardware Specications for the WIN 10 operation system
Processor: 1.0 GHz or faster
Screen: above 800×600 resolution
Firmware: UEFI 2.3.1, support safety start
Start memory: 2 GB(64 bit), 1 GB(32 bit)
Hard disk space: no less than 16 GB(32 bit), no less than 20 GB(64 bit)
Graphic card: support Direct X9 tablet
Hardware specication for WIN 8 operation system
Windows 8 PC (32 bit ,64 bit)
32 bit (×86)
64 bit (×64)
Windows 8 tablet computer
Mobile Application Operation and Communication
1) The intended use of mobile application: Mobile application is intended to download
and display case data from PM 10, it will not control PM 10 and will not alter any
setting of PM10
2) Mobile application Download:
Website: http://www.contecmed.com DOWNLOAD Software
PM10SyncSoftwareLite_xxx.apk
3 Software Installation
Run the setup software, and you can see a window as follows, Click the button
“install”.
4) Mobile application can be installed in mobile phone installed Android system, cur-
rently , Mobile applicable is not suitable for mobile phone installed Apple system.
5) Mobile App has the following functions:
• Connect with PM10 via Bluetooth
• Download case data( date, time, measuring duration and average heart rate )
• Display store and review the case data.
Figure 4.21 Figure 4.22
6) Data Communication
• Start the software, turn on the device, then the software starts to search the
device, click “PM10”
Figure 4.23 Figure 4.24
• Click “ALL”, device information will be displayed in “List” form, including: cases
ID, time length, check time, heart rate.
Figure 4.25 Figure 4.26 Figure 4.27
Chapter 5 Trouble Shooting and Solution
If the device has a problem account, please look up the following sheet for solutions
rst, if not included in the following issues and you can not solve either, please
contact with the customer service.
Chapter 6 Maintenance & Transportation & Storage
6.1 Cleaning and Disinfecting
Turn off the device before cleaning. Medical alcohol is available for the device disin-
fection, then air dry. Or just wipe it with a dry and clean cloth for cleaning. Do not allow
any liquid to enter the device.
6.2 Maintenance
1) Non-maintenance personnel designated by our company, do not open the instru-
ment case so as to avoid damage to internal components.
2) Any equipment maintenance and upgrades must be carried by the professionals
who are trained and authorized of the company.
3) Prevent any liquid from seeping into the device as it will affect the safety and per-
formance of the device.
4) The device should avoid the use of violent shaking or impact.
Architecture ARM, x86 and x86-64
Central processor NVIDIA Tegra/Qualcomm/Texas Instructment TI ARM,
AMD x86/x64 and Intel x86/x64
Memory Suggest above 4G
Graphics card Adopt WDDM 1.2 or DirectX10 graphics device
with higher version driver program
Hard disk/NAND
Flash
10 GB Memory capacity or above after installation
of system
Push button "n/off", "rotation lock ", "Windows key",
"increase volume", "decrease volume"
Touch screen at least 5 points touch controlled capacitor screen, the
resolution higher than 1366×768, the screen must be 10
inch or above
Screen resolution Resolution 1280 × 720
USB 2.0 At least one outlets
Connection with
internet
Wi-Fiand bluetooth 4.0
System starting
rmware
UEFI
Others Speaker, microphone ,gyroscope, gravity sensor
5) Do not place objects on the device. This could damage the touch screen.
6) If you do not use the device for a long time, please charge the battery to full every
3 months, otherwise, it will cause permanent damage to the battery.
7) The device should not be maintained during use.
6.3 Transportation and Storage
1) The device transportation adopts general transportation means or follows the con-
tract requirements. Avoid violent shock, vibration, rain and snow splash during the
process of transportation.
2) Store the packaged device in an environment with temperature -40°C~+55°C, rel-
ative humidity no more than 95%, atmospheric pressure 500 hPa~1060 hPa, no
corrosion gas and well-ventilated room.
Chapter 7 The Explanation of Symbols
Chapter 8 Packing List
Chapter 9 Electromagnetic Compatibility and Interference
Guidance and manufacturer’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity
The PM10 is intended for use in the electromagnetic environment specied be-
low. The customer or the user of PM10 should assure that it is used in such an
environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, con-
crete or ceramic tile. If oor are
covered with synthetic materi-
al, the relative humidity should
be at least 30%.
Power
frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m 30 A/m Mains power quality should be
that of a typical commercial or
hospital environment.
Guidance and manufacturer’s declaration – electromagnetic emission
The PM10 is intended for use in the electromagnetic environment specied below.
The customer of the user of the PM10 should assure that it is used in such and
environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The PM10 uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
RF emission
CISPR 11
Class B The PM10 is suitable for use in all establish-
ments, including domestic and those directly
connected to a low voltage power supply net-
work which supplies buildings used for domes-
tic purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity
The PM10 is intended for use in the electromagnetic environment specied be-
low. The customer or the user of PM10 should assure that it is used in such an
environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2.7 GHz
10 V/m Portable and mobile RF communi-
cations equipment should be used
no closer to any part of the PM10,
including cables, than the recom-
mended separation distance calcu-
lated from the equation applicable
to the frequency of the transmitter.
Recommended separation dis-
tance
80 MHz to 800 MHz
800 MHz to 2,7 GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the trans-
mitter manufacturer and d is the
recommended separation distance
in metres (m).
Field strengths from xed RF trans-
mitters, as determined by an elec-
tromagnetic site survey,
a
should be
less than the compliance level in
each frequency range.
b
Interference may occur
in the vicinity of
equipment marked
with the following symbol:
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propa-
gation is affected by absorption and reection from structures, objects and people.
a
Field strengths from xed transmitters, such as base stations for radio (cellu-
lar/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 xed RF transmitters, an electro-
magnetic site survey should be considered. If the measured eld strength in the
location in which the PM10 is used exceeds the applicable RF compliance level
above, the PM10 should be observed to verify normal operation. If abnormal per-
formance is observed, additional measures may be necessary, such as reorienting
or relocating the PM10.
Recommended separation distances between portable and mobile RF commu-
nications equipment and the PM10
The PM10 is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the PM10 can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the PM10
as recommended below, according to the maximum output power of the commu-
nications equipment.
Rated
maximum
output power
of transmitter
(W)
Separation distance according to frequency of transmit-
ter (m)
80 MHz to 800 MHz 800 MHz to 2,7 GHz
0,01 0,12 0,23
0,1 0,37 0,74
1 1,17 2,33
10 3,69 7,38
100 11,67 23,33
For transmitters rated at a maximum output power not listed above, the recom-
mended 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 pow-
er 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 propa-
gation is affected by absorption and reection from structures, objects and people.
Problem Cause Solution
Start-up failure after long
press the on/off key.
The batteries are worn
out.
Please recharge
the batteries.
Automatically shut down
in using process.
The batteries are worn
out.
Please recharge
the batteries.
The noise is too big or
the heart rate is random
in ECG sample process.
Your skin is dry.
Wipe them with disinfectant
alcohol or electric salve.
There is unwanted
movement in sample
process.
Please comfortably sit,
draw yourself up to carry on
sample.
The sample
environment has strong
electromagnetic noise.
Please close interference
source or resample in no
strong electromagnetic
noise environment.
Wireless communication
failure.
Unable to send or
receive data.
1.Restart the device.
2.Check whether the
bluetooth adapter, or mobile
phone bluetooth normally.
The sample
environment has strong
electromagnetic noise.
Please close interference
source or resample in no
strong electromagnetic
noise environment.
Signal Description Signal Description
Follow instructions for use Type BF applied part
Pulse rate (bpm) Bluetooth
Power button/function
button
IP22
Covering protection rate
USB WEEE disposal
%
Humidity limitation
Atmospheric pressure
limitation
Medical Device complies
with Directive 93/42/EEC
Store between
-40 and 55°C
Serial number Manufacturer
Date of manufacture
Caution: read instructions
(warnings) carefully
Keep away from sunlight Keep in a cool, dry place
Do not use this equipment
in the MRI scan room
Product code
Authorized representative
in the European
community
This side up
Fragile, handle with care
Guidance and manufacturer’s declaration – electromagnetic immunity – for
EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
No. Description Quantity
1 Host 1
2 USB cable 1
3 User Manual 1
Recommended separation distances between portable and mobile RF com-
munications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT or
SYSTEM that are not LIFE-SUPPORTING
Windows 8 32 bit system hardware requirements
Minimum
conguration
Suggested
conguration
Optimum
conguration
Central
processor
2 GHz (support
PAE, NX and SSE2)
2 GHz (support
PAE, NX and SSE2)
2 GHz multi-core
processor
Memory 2 GB 4 GB 4 GB DDR3
Graphics card Microsoft
Direct X 9 graphics
device with WDDM
driver program
Direct X 10
graphics device
with WDDM driver
program, with 128
MB memory
Direct X 11
graphics device
with WDDM driver
program, with 256
MB memory
Residual space
of hard disk
20 GB 45 GB above 128 GB SSD hard
disk
Windows 8 32 bit system hardware requirements
Minimum
conguration
Suggested
conguration
Optimum
conguration
Central
processor
1 GHz (support
PAE, NX and SSE2)
2 GHz (support
PAE, NX and SSE2)
2 GHz multi-core
processor
Memory 1 GB 2 GB 2 GB DDR3
Graphics card Microsoft
Direct X 9 graphics
device with WDDM
driver program
Direct X 10
graphics device
with WDDM driver
program, with 128
MB memory
Direct X 11
graphics device
with WDDM driver
program, with 256
MB memory
Residual space
of hard disk
16 GB 30 GB above 64 GB SSD hard
disk
3.5
E
1
√ P
d=
7
E
1
√ P
d=
3.5
E
1
√ P
d=
7
E
1
√ P
d=
33246 / PM10
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street,
Economic & Technical Development Zone,
Qinhuangdao, Hebei Province,
PEOPLE’S REPUBLIC OF CHINA
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiestrasse 80, 20537 Hamburg, Germany
Disposal: The product must not be disposed of along with other do-
mestic waste. The users must dispose of this equipment by bringing
it to a specic recycling point for electric and electronic equipment.
0123
IP22
55°C
-40°C
106kPa
50kPa
%
95%
0%
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