Gima PM10 User Manual
PROFESSIONAL MEDICAL PRODUCTS
PM10 PALM ECG MONITOR
Foreword
Thank you very much for purchasing the PM10 Portable ECG Monitor.
This user manual introduces detail product information about its character, requirement, structure, performance, specication, appropriate methods of transportation,
installation, usage, operation, repair, maintenance and storage, and safety measures of
how to protect the operator and product. Please read details in the following chapters.
Please read the user manual carefully before using the product and strictly follow its
regulations to operate. The user manual indicates the operations that users need to
pay much attention to, that may lead to abnormality, or may danger to the device or
human body during using. Our company will not response the security, reliability and
performance for any abnormality or device and human body damage caused by not
following this user manual to use, maintain and store, nor provide free service for any
situations above.
We apologize for the content in the manual is subject to change according to product
upgrades without notice.
The product is reusable as a medical instrument.
Warning:
• The reliability depends on whether users are following the operation and maintenance in the user manual or not.
• Our company’s website: http://www.contecmed.com is the unique route for downloading APP software and PC software, also the updates of rmware, if user download software and rmware updates from other unauthorized channels , it will cause
the risks associated with cyber security, our company will not take responsibility for
the consequence it may cause.
• All servicing and future upgrade to the device must be carried out by personnel
trained and authorized by our company, and using the original ttings for maintenance. The schematic diagram and component list can only be provided to the service station or maintenance personnel designated by our company.No modication
of this equipment is allowed.
• User should be aware of life-circle of battery, discard the battery in accordance with
local laws when the life-circle of battery expire.
• MR-unsafe!
Do not expose the device to a magnetic resonance (MR) environment.
- The device may present a risk of projectile injury due to the presence of ferromag-
netic materials that can be attracted by the MR magnet core.
- Thermal injury and burns may occur due to the metal components of the device
that can heat during MR scanning.
- The device may generate artifacts in the MR image. The device may not function
properly due to the strong magnetic and radiofrequency elds generated by the
MR scanner.
This user manual contains proprietary information, which is protected by copyright.
All rights reserved. Reproduction, adaption or translation, for any part of the manual
without prior written permission, is prohibited.
Our company takes the responsibilities as follows:
1. To provide qualied products according to enterprise standard for users.
2.
To provide services of installation, debugging and training according to the contract.
3. To provide one year warranty and product maintenance after warranty period ac-
cording to the contract.
4. To respond user’s requests in time.
Chapter 1 Notice
1.1 Indication for Use
The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any
time to manually record transient cardiac events, suitable for home health care use,
which can detect, display and store ECG signal, and if possible, provide average heart
rate message after ECG measurement. The users can use it themselves to check their
heart condition.
It is suitable for the adult users, who suffers from cardio-vascular diseases, or the
adult people who are caring about their heart working conditions during their daily
life. This device is not intended for use as a conventional diagnostic tool, but use as a
healthcare tool which can provide doctor the recorded data as references.
The product is not a conventional diagnostic tool.
1.2 Generic Notice
1) Do not use the device in locations subject to high temperatures or humidity. Use in
the temperature within 5~40˚C and humidity within 25%~80% RH.
2) Do not wash the device with water.
3) Pre-set up time is within 30mins, at condition of:
• Warm from the minimum storage temperature until it is ready to use at ambient
temperature of 20°C.
• Cool from the maximum storage temperature until it is ready to use at temperature of 20°C.
4) Do not use or store the device in the following ambient conditions:
• Near res or open ames.
• Locations exposed to strong vibration.
• Locations exposed to strong electromagnetic elds.
5) Do not disinfect the device in autoclave or gas sterilizer.
6) Such as skin allergies or skin damage, do not use this device.
7) The device service lift is 3 years. Do not throw away the device and accessories
when they can’t work. If the device needs to dispose, it should meet the local laws
and regulations requirement.
8) lay responsible organization must contact its local authorities to Determine the
proper method of disposal of potentially bio hazardous parts and accessories.
9) Please don’t use multiple wireless devices connected to the product at the same
time.
10) This device is no contraindication.
11) The parameters displayed by ECG should be interpreted by professional physician.
12) Please don’t use the device for infants weighing less than 10 kg.
1.3 Measurement Notice
1) If your skin is dry, wipe them with disinfectant alcohol or electric salve to strengthen the electric capability.
2) You are better to comfortably sit, draw yourself up, begin to measure when the
heart rate level off.
3) When measuring, the nger and chest electrodes should touch your skin exactly,
roundly and well.
1.4 Safety Notice
1) No sampling in the battery-charging. (sampling means acquiring ECG data of patient in the designated anatomical areas.) When the battery is charging, the device
will not record ECG. The following symbol will present on the use interface to
remind the charging state, device cannot be operated in battery charging state.
2) Lay the device in shady and cool environment when you are not going to use it for
a long period of time, and electrify per three months.
3) Do not use the device in the environment placed inammables objects, such as
anesthetic.
4) Other equipment connected with it must meet national safety standards.
5) That conductive parts of ELECTRODES and associated connectors for TYPE BF
APPLIED PARTS including the NEUTRAL ELECTRODE, should not contact other
conductive parts including earth;
1.5 EMC Notice
1) Please note the effect from EMC when using the device, because it can be inuenced by portable or movable high electromagnetic compatibility RF devices.
2) This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS.
3) Wireless communications equipment can affect ME EQUIPMENT and should be
kept at least a distance d away from the equipment. The distance d is calculated
by the MANUFACTURER from the 800 MHz to 2,5 GHz column of Table 5 or Table
6 of IEC 60601-1-2:2014.
1.6 RF Instruction
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
A. This device may not cause harmful interference;
B. This device must accept any interference received, including interference that may
cause undesired operation.
Any changes or modications not expressly approved by the party responsible
for compliance could void the user’s authority to operate the equipment.
Some electronic devices are susceptible to electromagnetic interference sent by this
equipment if inadequately shielded. Please use this equipment at least 20 cm or as
far as you can from TV set, radio and other automated ofce equipment so as to
avoid interference.
This device is a radio transmitter and receiver. It is designed and manufactured not to
exceed limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission (FCC) of the U.S. Government. These limits are part of comprehensive guidelines and establish permitted levels of RF energy for the general population. The guidelines are based on standards that were developed by independent
scientic organizations through periodic and thorough evaluation of scientic studies.
The standards include a substantial safety margin designed to assure the safety of all
persons, regardless of age or health.
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
A. Reorient or relocate the receiving antenna.
B. Increase the separation between the equipment and receiver.
C. Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
D. Consult the dealer or an experienced radio/ TV technician for help.
A minimum separation distance of at least 0.2 m between this equipment and
all persons shall be guaranteed to satisfy the RF exposure compliance.
1.7 Quality of Service and Security
The device assures timely, reliable, accurate, and secure data and wireless information transfer by the following design.
When you want to establish wireless connection with the portable ECG monitor, you
must input correct communication instruction. Therefore, unauthorized access to the
ECG data is prevent.
1.8 Intended Operator
Lay Person, with the following requirements:
1. Be able to read and understand the content in the user manual;
2. Be able to distinguish the following anatomic sites: chest, left /right palm, upper
extremity and low extremity.
Chapter 2 Introduction
The portable ECG monitor is designed for family and individual users. It is a good
helper for family members to prevent from cardiovascular disease. The device can
record and display user’s ECG waveform and heart rate anytime at anyplace with
easy operation.
2.1 Characteristic
1) Handsome shape, handy operation, convenient tote.
2) Record real-time heart rate anytime and anywhere.
3) Built-in large capability rechargeable lithium battery, continuously sample 200 ECG
waveform after charged once.
4) QRS intervals and VEB measurement
2.2 Application
1) Occasion: family, medical clinic and hospital. The device can’t be used as a general
electrocardiogram for clinical examination.
2) Object: people under high pressure and workload for long time, heart disease pa-
tients, middle aged and aged people, sub-health people
3) Purpose: The device is only used for heart rate record. Operation method is simple
and less requirement for the operating personnel.
Chapter 3 Primary Technical Orders
3.1 Normal Work Environment
1) Operation environment
• Temperature: +5°C~+40°C
• Relative humidity: 25%~80%
• Atmospheric pressure: 70 kPa~106 kPa
• Power supply: built-in rechargeable lithium battery, voltage: 3.7 V
2) Transportation and storage environment
• Temperature: -40°C~+55°C
• Relative humidity: ≤95%
• Atmospheric pressure: 50 kPa~106 kPa
3.2 Basic Parameters
1) Lead: Standard 3 leads, I II III
2) Calibration voltage: 1 mV±5%
3) Standard sensitivity: 10 mm/mV±5%
4) Amplitude frequency characteristic: standard: 10 Hz; 1 Hz~20 Hz; (+0.4 dB, -3 dB)
5) Noise level: ≤30 μV
6) Input impedance: ≥50 MΩ
7) CMRR: ≥60 dB
8) Scanning speed: 25 mm/s±5%
9) Sampling rate: 250 dots/s
10) HR measurement range: 30 bpm~300 bpm, error: ±1 bpm or 1%
11) Battery Voltage: DC 3.7 V
12) Type of protection against electric shock: Internal power device
13) Degree of protection against electric shock: Type BF applied part
14) Degree of waterproof: IP22
15) Display: 1.77” color TFT-LCD
16) Size: 100 mm (L)*45 mm (W)*15 mm (H)
17) Weight: about 60 g
18) Bluetooth specications:
• Bluetooth protocol: Bluetooth V4.0,Classic and Low Energy
• Operating frequency: 2.4 GHz ISM band
• Modulation: GFSK (Gaussian Frequency Shift Keying)
• Transmitting power: <10 dBm, Class 1
• Sensitivity: -92 dBm at BER <.001 with DH5
• Transfer rate: 1.5 Mbps data throughput
• Safety features: Authentication and encryption
• Support Services: Bluetooth SPP/IAP/HID/OBEX
• Effective RF Radiated Power Output: <10 dB
• Operating Range: 2400 MHz – 2485 MHz
• Bandwidth of Receiving Section: 85 M
19) FCC ID: 2AB0GPM10
Chapter 4 Operation Directions
4.1 The Sketch Map and Components Name
4.2 2 How to Use
There are several measurement methods as shown in the following pictures
Caution: You shall ensure that the electrode fully contact the skin.
4.3 Menu Operations
1) Start-up
Long press the on/off key for 3 seconds, you will hear a beep sound and see the
screen lighting. The device will keep level off when not measuring.
2) Start measurement
After start-up, the device will enter into pre-sample interface. Please use the cor-
rect measurement method as guided, the ECG waveform and heart rate will displayed on the screen, as shown in Figure 4.1.The calculation method of heart rate:
number of heart beats without interference in ECG fragment is set as N, then the
calculation formula of heart rate is as follows:
HR=60000/(Sum of R-R intervals during numbers(N) of heart beats/N )
heart rate
ECG
waveform
sample time
Figure 4.1 Pre-sample Interface
When the waveform becomes stable, the device will start formal sampling automat-
ically, sample time countdown on the bottom right corner begins until nished one
time sample and the color of sample time turns to red. See Figure 4.2:
The device will enter into case review interface after completed sampling. Case
review interface displays the sampling start time and heart rate. See Figure 4.3.
When the device enters into case review interface, it will display the latest sampled
case. Click the button to review other cases information. The device can store
100 pieces of cases at most. If reaches to the limit, new stored case will cover the
original case, the one that stored at the earliest, piece by piece.
The device will automatically turn to sampling interface to continue if the user hold-
ing the electrode at both ends again when the device is under the case review
interface.
3) Battery Operation Notes
The device can continuously work for more than 2 hours when battery is complete-
ly charged. The cycle life of the battery up to 200 times.
Two method for charging:
(a) Connect the device with a computer by using Micro USB cable, charging com-
pleted after about 2 hours.
(b) Use a Micro USB to connect the device with a power adapter (output current
>500 mA, 5 V), charging completed after about 2 hours.
(c) when the battery is charging, the device will not record ECG. The following
symbol will present on the use interface to remind the charging state, device can
not be operated in battery charging state.
Figure 4.4
Battery display
No. Indicator Description
a full power
b capacity: 3/4
c capacity: 1/2
d capacity: 1/4
e
4) Auto power off
The device will automatically shut down after no operations within 1 minutes.
4.4 PC Sync Software Operation and Communication
1) The intended use of PC software:
PC Management software is intended to be used as supportive software for porta-
ble ECG device, Functions include setting of device parameters (language setting
and acquisition types setting, etc), downloading ECG data from portable ECG
device, data management.
2) PC software Download:
Website: http://www.contecmed.com DOWNLOAD Software
Users can operate in the PC synchronous software according to necessary, which
including sample mode and time setting, upload case, case review, measurement,
etc.
3) Software Installation
Run the setup software, and you can see a window as follows, Click the button
“OK”.
Click the button “Next”, and the dialog box in Fig.4.6 shows up, then if you click
“Browse...”, you can set the installation path, otherwise the default installation path
is “C:\ PM10”. Click the button “Next” again, and the dialog box showed in Fig.4.7
shows up. Click “Browse...”, you can reset the apellation in Startup Menu folder,
the default folder will be “PM10”.
Using battery, low power, it is recommended to recharge
the battery. The device will automatically shut down.
Figure 4.2 Formal Sample Interface
Figure 4.3 Case Review Interface
Figure 4.5
Figure 4.6 Figure 4.7
Click the button “install”, and the software will be installed at the appointed posi-
tion. When the installation nished, the dialog box showed in Fig.4.9 shows up.
Figure 4.8 Figure 4.9
Click “Finish” to end installation.
Figure 4.10 Figure 4.11
4) Data Communication
Start the software under the circumstance of no device connected, it will enter to
the following interface shown as Figure 4.12.Turn on the device, insert to USB port,
click “New search”, then the software starts to search the device, shown as Figure
4.13.
Figure 4.12 Figure 4.13
After searching, device information will be displayed in “List” form, including: cases
ID, time length, check time, heart rate, shown as Figure 4.14. Click the button “?”,
you can get help from the operation.
Figure 4.14
5) Operation
• Download case: double-click a case selected to download, or select multi-case,
then click “Download selected” to download these cases, or click “Download
all” to download all cases.
Figure 4.15
• Delete case: select a case or multi-case, then click “Delete selected” to delete
the case selected, or click “Delete all” to delete all cases. To prevent mistake,
before deleting, the system will prompt user, the system will delete the records
after selecting “Yes”..
Figure 4.16
• Firmware upgrade: click “Upgrade”, select a rmware (naming rules: le name_
version.bin, for example: xxx_USB_Vxxx.bin). If the rmware needs to upgrade
from low to high version, then click “OK”. Otherwise “Force Upgrade” should be
selected rstly, then click “OK”. During upgrading, please keep connection state
between the computer and the device.
Figure 4.17
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
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)
Figure 4.20
Windows 8 32 bit system hardware requirements
Central
processor
Minimum
conguration
1 GHz (support
PAE, NX and SSE2)
Suggested
conguration
2 GHz (support
PAE, NX and SSE2)
Optimum
conguration
2 GHz multi-core
processor
Memory 1 GB 2 GB 2 GB DDR3
Graphics card Microsoft
Residual space
of hard disk
Direct X 9 graphics
device with WDDM
driver program
16 GB 30 GB above 64 GB SSD hard
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
disk
64 bit (×64)
Windows 8 32 bit system hardware requirements
Central
processor
Minimum
conguration
2 GHz (support
PAE, NX and SSE2)
Suggested
conguration
2 GHz (support
PAE, NX and SSE2)
Optimum
conguration
2 GHz multi-core
processor
Memory 2 GB 4 GB 4 GB DDR3
Graphics card Microsoft
Residual space
of hard disk
Direct X 9 graphics
device with WDDM
driver program
20 GB 45 GB above 128 GB SSD hard
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
disk
Windows 8 tablet computer
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
Hard disk/NAND
Flash
Push button "n/off", "rotation lock ", "Windows key",
Touch screen at least 5 points touch controlled capacitor screen, the
with higher version driver program
10 GB Memory capacity or above after installation
of system
"increase volume", "decrease volume"
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
System starting
rmware
Wi-Fiand bluetooth 4.0
UEFI
Others Speaker, microphone ,gyroscope, gravity sensor
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, currently , 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.
Problem Cause Solution
Start-up failure after long
press the on/off key.
Automatically shut down
in using process.
The noise is too big or
the heart rate is random
in ECG sample process.
Wireless communication
failure.
The batteries are worn
out.
The batteries are worn
out.
Your skin is dry.
There is unwanted
movement in sample
process.
The sample
environment has strong
electromagnetic noise.
Unable to send or
receive data.
The sample
environment has strong
electromagnetic noise.
Please recharge
the batteries.
Please recharge
the batteries.
Wipe them with disinfectant
alcohol or electric salve.
Please comfortably sit,
draw yourself up to carry on
sample.
Please close interference
source or resample in no
strong electromagnetic
noise environment.
1.Restart the device.
2.Check whether the
bluetooth adapter, or mobile
phone bluetooth normally.
Please close interference
source or resample in no
strong electromagnetic
noise environment.
Chapter 6 Maintenance & Transportation & Storage
6.1 Cleaning and Disinfecting
Turn off the device before cleaning. Medical alcohol is available for the device disinfection, 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 instrument 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 performance of the device.
4) The device should avoid the use of violent shaking or impact.
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 contract 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, relative humidity no more than 95%, atmospheric pressure 500 hPa~1060 hPa, no
corrosion gas and well-ventilated room.
Chapter 7 The Explanation of Symbols
Signal Description Signal Description
Follow instructions for use Type BF applied part
Pulse rate (bpm) Bluetooth
Power button/function
button
Covering protection rate
IP22
USB WEEE disposal
%
Humidity limitation
Medical Device complies
with Directive 93/42/EEC
Atmospheric pressure
limitation
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
Authorized representative
in the European
community
Product code
This side up
Fragile, handle with care
Chapter 8 Packing List
No. Description Quantity
1 Host 1
2 USB cable 1
3 User Manual 1
Chapter 9 Electromagnetic Compatibility and Interference
Guidance and manufacturer’s declaration – electromagnetic emissionsfor all EQUIPMENT and SYSTEMS
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
RF emission
CISPR 11
Guidance and manufacturer’s declaration – electromagnetic immunity
The PM10 is intended for use in the electromagnetic environment specied below. The customer or the user of PM10 should assure that it is used in such an
environment.
Immunity test IEC 60601
Electrostatic
discharge
(ESD)
IEC 61000-4-2
Power
frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
Group 1 The PM10 uses RF energy only for its internal
Class B The PM10 is suitable for use in all establish-
test level
±8 kV contact
±15 kV air
30 A/m 30 A/m Mains power quality should be
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
ments, including domestic and those directly
connected to a low voltage power supply network which supplies buildings used for domestic purposes.
Compliance
level
±8 kV contact
±15 kV air
Electromagnetic
environment - guidance
Floors should be wood, concrete or ceramic tile. If oor are
covered with synthetic material, the relative humidity should
be at least 30%.
that of a typical commercial or
hospital environment.
Guidance and manufacturer’s declaration – electromagnetic immunity – for
EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The PM10 is intended for use in the electromagnetic environment specied below. The customer or the user of PM10 should assure that it is used in such an
environment.
Immunity test IEC 60601
Radiated RF
IEC 61000-4-3
NOTE 1
NOTE 2
gation is affected by absorption and reection from structures, objects and people.
a
Field strengths from xed 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 xed RF transmitters, an electromagnetic 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 performance is observed, additional measures may be necessary, such as reorienting
or relocating the PM10.
Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT or
SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF communications 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 communications equipment.
Rated
maximum
output power
of transmitter
(W)
test level
10 V/m
80 MHz to
2.7 GHz
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propa-
Separation distance according to frequency of transmitter (m)
Compliance
level
10 V/m Portable and mobile RF communi-
80 MHz to 800 MHz 800 MHz to 2,7 GHz
3.5
√ P
d=
1
E
Electromagnetic environment guidance
cations equipment should be used
no closer to any part of the PM10,
including cables, than the recommended separation distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
3.5
√ P
d=
80 MHz to 800 MHz
1
E
7
800 MHz to 2,7 GHz
√ P
d=
1
E
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 metres (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic site survey,a should be
less than the compliance level in
each frequency range.
Interference may occur
in the vicinity of
equipment marked
with the following symbol:
b
7
√ P
d=
1
E
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 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 reection from structures, objects and people.
Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing
it to a specic recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
95%
%
50kPa
0%
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
Imported by:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
106kPa
0123
55°C
IP22
-40°C
M33246-GB-Rev.2.03.20
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