Gima 49880 User manual

MISURATORE DI PRESSIONE DIGITALE
DIGITAL BLOOD PRESSURE MONITOR
TENSIOMÈTRE NUMÉRIQUE
MONITOR DE PRESIÓN ARTERIAL DIGITAL
MONITOR DIGITAL DA TENSÃO ARTERIAL
DIGITALES BLUTDRUCKMESSGERÄT
DIGITAL BLODTRYCKSMÄTARE
CIŚNIENIOMIERZ CYFROWY
MONITOR DIGITAL PENTRU MĂSURAREA TENSIUNII
ARTERIALE
Digitalni monitor za krvni tlak
ψηφιακο πιεσομετρο
جهاز مراقبة ضغط الدم الرقمي
M49880-M-Rev.0-10.22
PROFESSIONAL MEDICAL PRODUCTS
Contect Medical System Co., Ltd
Adress: No 112 Qinhuang West Street,
Economic&Technical Development
Zone, Qinhuangdao, Hebei Province,
People’s Republic of China
Made in China
CONTEC08E (GIMA 49880)
Shanghai International Holding Corp.
Gmbh (Europe)
Address: Eiffestrasse 80,
20537, Hamburg, Germany
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
700kPa
1060kPa
-20˚C
+55˚C
0%
95%
%

14
ENGLISH
This manual detailed introduce the steps must be noted when using the product, operaon which may result in abnormal, the risk may cause
personal injury and product damage and other contents, refer to the chapters for details. Any anomalies or personal injury and device damage arising
from use, maintain, store do not follow requirements of the User Manual, Our company is not responsible for the safety, reliability and performance
guarantees! The manufacturer’s warranty service does not cover such faults!
Our company has a factory record and user prole for each device, users enjoy free maintenance services for one year from the date of purchase. In
order to facilitate us to provide you with a comprehensive and ecient maintenance service, please be sure to return the warranty card when you need
repair service.
Described in this User Manual is in accordance with practical situaon of the product. In case of modicaons and soware upgrades, the informaon
contained in this document is subject to change without noce.
Described each measurement results combined with clinical symptoms by qualied doctors.
The reliability and operaon of using this product whether meets the operaon of this manual relate to the maintenance instrucons.
The intended operator of this product may be the paent.
Do not perform maintenance and service while the device is in use.
The operator must carefully read the User Manual before use this product, and strictly follow the operang procedure of the User Manual.
Fully consider the security requirements during product design, but the operator should not ignore the observation for the patient and the state
of machine.
The operator has the responsibility to provide the use condion of the product to our company.
Our company have the responsibility to provide qualified product which conform to company standard of this product
Our company will provide the circuit diagram, calibraon method and other informaon at the request of the user to help the appropriate and
qualied technicians to repair those parts designated by our company.
Our company have the responsibility to complete product maintenance according to the contract.
Our company have the responsibility to respond the requirements of user in me.
In the following case, our company is responsible for the impact on the safety, reliability and performance of the device:
Assembly, addion, debugging, modicaon or repair are carried out by personnel approved by our company.
The electrical facilies in the room are in compliance with the relevant requirements and the device is used in accordance with the User Manual.
Measure blood pressure and store the measurement results.
Data storage funcon, up to 199 records can be stored.
With data review interface which is convenient for reviewing blood pressure parameter.
The screen will prompt message when the power is low.
When the measurement result can not be obtained due to some factors during the measurement, the device will display the corresponding error
informaon.
Measurement units: mmHg and kPa, which can be switched by the buon.
With automac shutdown funcon, if there is no operaon, the device will automacally turn o.
Voice broadcast(optional for devices with vioce function)
The device apply to measure the non-invasive blood pressure of human. Record parameter value of blood pressure to provide the reference for the
health care professional.
In order to use it correctly, please read the “Safety Precauons” carefully before using it.
Operators do not need professional training, but should use this product aer fully understanding the requirements in this manual.
To prevent users from suering damage or loss due to improper use, please refer to “Safety Precauons” and use this product properly.
Good damage means the damage of house, property, domesc animal and pet.
No.
You must not perform NIBP measurements on paents with sickle-cell disease or under any condion which the skin is damaged or expected to
be damaged.
14

15 ENGLISH
For paents with severe disturbances of blood coagulaon, whether automacally measure the blood pressure should be based on the clinical
evaluaon, because limb fricon with the cu may cause the risk of hematoma.
For severe blood circulaon disorder or arrhythmia paents, please use the device under the guidance of a doctor. If the arm is squeezed during
measurement, it may cause acute internal hemorrhage or inaccurate measurement results.
To dierent paent condions, the oscillometric measurement has certain limitaons. The measurement is in search of regular arterial pressure pulse. In
those circumstances when the paent’s condion makes it dicult to detect, the measurement becomes unreliable and measuring me increases. The user
should be aware that the following condions could interfere with the measurement, making the measurement unreliable or longer to derive. In some cases,
the paent’s condion will make a measurement impossible.
Measurements will be unreliable or can not perform if the paent is moving, shivering or having convulsions. These moons may interfere with the detecon
of the arterial pressure pulses. In addion, the measurement me will be prolonged.
Measurements will be unreliable and may not be possible if the paent’s cardiac arrhythmia has caused an irregular heartbeat. The measuring me
thus will be prolonged.
Measurements will not be possible if the paent is connected to a heart-lung machine.
Measurements will be unreliable and may not be possible if the paent’s blood pressure is changing rapidly over the period of me during which the
arterial pressure pulses are being analyzed to obtain the measurement.
If the paent is in severe shock or hypothermia, measurements will be unreliable since reduced blood ow to the peripheries will cause reduced
pulsaon of the arteries.
Measurements can not be made at a heart rate of less than 40 bpm and greater than 240 bpm.
The thick fat layer of body will reduce the measurement accuracy, because the fat that come from the shock of arteries can not access the cus due
to the damping
Please hand measurement results to the doctor who knows your health and accept diagnosis.
Otherwise it may cause accident or dissension.
Otherwise it may cause accident or holdback
Otherwise it is possible that measurement result is incorrect.
Otherwise it may cause risk.
Otherwise it may cause risk.
Otherwise it may cause risk.
Otherwise it may cause harm to the environment or children.
Otherwise the measurement result may be inaccurate or an accident may occur.
Otherwise the device may be damaged due to moisture.
Otherwise it may cause measurement error.
Otherwise it cannot be accurately measured.
Otherwise it may cause measurement error.
Otherwise there is a risk of falling.
Replace accessories which not provided by our company may lead to the occurrence of errors.
This device can only be used for one test object at a me.
The device and accessories are processed with allergenic materials. If you are allergic to it , stop using this product.

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The device shall comply with the standard IEC 80601-2-30:Particular requirements for basic safety and essential performance of automated non-
invasive sphygmomanometers.
Otherwise it may cause trouble
Otherwise it may cause re or electric shock.
Otherwise it may cause re or electric shock.
Otherwise it may cause electric shock or injury.
Otherwise it may cause re.
Otherwise it may cause baery leakage, heat, rupture, and damage to Electronic Sphygmomanometer.
Otherwise it may cause baery leakage, heat, rupture, and damage to Electronic Sphygmomanometer.
It will cause blindness or other hazards, should immediately go to the nearest hospital for treatment.
Otherwise it may hurt the skin.
Do not strike or drop the device;
Do not inate before the cu wraps around the arm;
Do not inect the cu and the air tube forcibly.
The device applies measurement Blood Pressure (BP) and Pulse of adult .
All products are in the box. Open the box and conrm whether the product is whole.
Cu Plug
Cu Air Plug
Adult Cu
MEMORY Buon
START/STOP Buon
Dry Baery
Display

17 ENGLISH
(Specicaon: limb circumference 22-32 cm
(middle part of upper arm ),
please choice suited
cu when measuring other.)
Input: voltage: AC 100 V~240 V
frequency: 50 Hz/60 Hz
Rated current: AC 150 mA
Output:DC5.0 V±0.2 V 1.0 A
Extra large adult Cu: the range of limb circumference is 32-43 cm (middle part of upper arm)
Note:
◎ The cu is a consumable. Calculate by measuring 6 mes a day(3 mes each morning and evening), the service life of the cu is about 1 year.(using
our experimental condions);
◎ In order to correctly measure blood pressure, please replace the cu in me;
◎ If the cu leaks, please contact our company to buy a new one. The cu purchased separately does not include the airway tube plug. When replacing,
please do not throw the airway tube plug away, install it on the new cu.
Note
When the product and accessories described in this manual are about to exceed the period of use, they must be disposed according to relevant product
handling specicaon. If you want to know more informaon, please contact our company or representave organizaon.
① Cu socket( is cu idener) Le side
②Power adapter socket( is power socket idener) Back side
-
INSTALLATION
The producon can use baery and AC adapter.
① ② ③
① Demount the baery cover in the direcon of the arrow.
② Install “AA” baeries according to polaries.
③ Slide to close the baery cover.
Icon “ ”: the baeries power will exhaust. Replace with four new baeries (the same sort) at the same me. Test while low power may
cause data deviaon and other problems.
Turn the unit o before replacing the baeries.
1.Connect the sphygmomanometer and the power adapter. Plug the power adapter plug into the power adapter socket on the back of the device
2.Please insert the power plug of the adapter into the AC 100 V~240 V socket.
Note

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s
Note
All the operaons to the Electronic Sphygmomanometer are through buons. The names of the buons are above them. They are:
Le buon is “M” buon, under “OFF” state, press this buon to enter the review interface (refer to Chapter 8 for details.).
Right buon is “START/STOP” buon, under “OFF” state, press this buon to enter measurement mode, inate the cu to measure blood
pressure, press this buon again to turn o the device.
Under “OFF” state, press “M” buon and “START/STOP” buon simultaneously for 5 s to enter the seng interface, the default unit in this interface is
“mmHg”; short press “M” buon to switch the unit between “mmHg” and “kPa”.
Press “START/STOP” buon again in the unit seng interface to enter the volume seng interface. Press “M” buon to change the volume, the
maximum volume is 4, and the minimum is 0 (silence).
Aer compleng the seng, repeatedly press the “START/STOP” buon to turn the device o.
Note
The default unit of the device when leaving factory is mmHg.
In the volume seng interface, press “START/STOP” buon to enter the factory seng interface, in which the “CAL” is the stac pressure interface,
and the “FAC” is the aging interface, which does not require user to operate. If you want to end the interface, press the “START/STOP” buon
twice to turn the device o.
1. Adopt a comfortable sing posion, use back and arms to support the body.
2. Place your elbow on a table, the palm faces up and the body is relaxed.
3. The cu is level with your heart.
4. Feet at on the oor, and do not cross your legs.
The high and low locaon of cu will cause changes in measure results.
Do not touch the sphygmomanometer, cu and windpipe during measure.
Remain sll 4~5 minutes before measurement.
Do not talk and movement during the measurement. Relax the body, do not let the muscle acvity.
Wait 4~5 minutes between measurements.
Do not use precision instrument near the Sphygmomanometer.
When repeatedly measuring, the accurate blood pressure value may not be measured due to congeson in the arm. Please measure aer the blood
ow is smooth.
Repeated measurement for a long period of me, limbs rubbing with the cu may be accompanied by purpura, ischemia and nerve damage. When
measurement a paent, it is necessary to frequently check the color, warmth and sensivity of the distal of the limb. Once any abnormalies are
observed, place the cu in another posion or stop the blood pressure measurement immediately.
Please use the device at an environment of suitable temperature and humidity otherwise it will cause measurement error.
Do not twist or wrap the airway tube. It can cause constant pressure in the cu which can block blood ow and cause serious damage to the paent.
Do not use the cu on the injured area, which will cause more serious damage to the area.
Do not use the cu in the area where the treatment is being performed inside blood vessel or the arteriovenous connecon. This may cause
temporary blockage of blood ow and cause injury to the paent.
Do not use the cu on the side of the mastectomy.
When using the cu to pressurize, some of the body’s funcons may temporarily weaken. Do not use the measurement medical electrical equipment
at the appropriate arm posion.
Do not move during measurement, it will have a delayed eect on the paent’s blood ow.
The device need to be placed for 2 hours from the minimum storage temperature to being ready for its intended use.
The device need to be placed for 4 hours from the highest storage temperature to being ready for its intended use.
Note
Take the measurement in one hour aer meal or aer drinking alcohol, coee or aer smoking, exercise, bathing;
Using incorrect posture such as standing or lying down, etc;
The paent speak or move his body during measurement;
When measuring, the paent is nervous, excited, emoonal instability;

19 ENGLISH
The room temperature rise or fall sharply, or the environment of measurement oen changes;
Measuring in a moving vehicle;
The high and low locaon of cu will cause changes in measurement results;
Connuous measurement for a long me.
Both le and right arm can be measured.
Bare your arm or cloth close-ng clothing during measurement.
Carry out the operaon in a room with comfortable temperature.
① Insert the arm cu air plug in the cu socket of sphygmomanometer.
② Stretch cu into a barrel for the arm can conformable enter into the barrel
③ Le arm penetrate through the cu, the air tube of the cu will pass the top of your palm.
④ Wrap the cu to your upper arm. Make the air tube inside the forearm and aligned with your middle nger.
⑤ The boom of the cu should be approximately 2cm~3cm above your elbow.
⑥ Be xed with cloths, and wrapped ght cu, the arm and the cu should not have gaps.
① ② ③
④ ⑤ ⑥
①Under “OFF” state, press “START/STOP” buon to start measuring.
During measurement, please keep correct pose and quiet state, the body could not move.The “Movement” icon appears if paent moves, and connue
measuring may lead to inaccurate measurement.
Press【START/STOP】buon, the device will stop inang, and release the air from the cu.
②Display the measurement results aer nishing measuring.The pressure bar on the right side visually demonstrates the pressure level.
③Conrm the Measurement Value
The World Health Organizaon has established globally accepted standards for the assessment of high blood pressure readings.The SYS higher than
135mmHg or the DIA lower than 85mmHg are used as the criteria of hypertension, and the pressure bar at the right side lights up in red.
*Self-diagnosis and treatment using measured results may be dangerous. Follow the instrucons of your physician.
When repeatedly measuring, the accurate blood pressure value may not be measured due to congeson in the arm. Please measure aer the
blood ow is smooth.
When the screen displays Err, the measure can’t be carried out correctly.
Irregular pulse icon is displayed in the measurement results if the pulse internal is irregular during measuring, which may cause it is unable to take
measurement correctly. Please keep quiet and remeasure. If the irregular pulse icon appears frequently, please consult a doctor.
The minimum value of the paent’s physiological signal is the minimum limit that the device can measure. The device may obtain inaccurate
measurement results when it is operated below the minimum amplitude or minimum value of the paent’s physiological signal.
*The device will automacally turn o aer ve minutes in which there is no operaon to the device, even if you forget to turn the power o.
The device can store NIBP values automacally, display up to 199 set of measurement results.
If 199 set of measurement data have been stored in current device, when saving the 200th set of data, the earliest set of data will be overwrien. If no
measurement values, the memory values can be not numerated.
Memory funcon can not be used during measuring.
When there is no measurement values, “---” will display on the review interface.
1.Under “OFF” state, press “M” buon to display the average value of the latest three set of data, when the number of measurement data is less than
three groups, it will supplement automacally. Connue to press “M” buon in current interface to view all measurement records.
1.Users can delete all memory values of the current user instead of separately delete one memory value
2.Under the memory interface, press “M” buon and “START/STOP” buon simultaneously for more than 5 s, aer “DEL” appears on the screen, all
memory values will be deleted.
When querying the measurement records, please press “M” buon connuously to query one by one.
A

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Your device may not contain all the following symbols.
Signal Descripon Signal Descripon
Cauon: read instrucons (warnings) carefully Follow instrucons for use
SYS Systolic pressure DIA Diastolic pressure
MAP Mean blood pressure PUL (Pressione
del polso) Pulse rate (bpm)
IPXX Enclosure protecon grade EMC Electromagnec compability
Recyclable P/N Material code of manufacturer
Lot number Use by date
This way up Fragile, handle with care
Keep in a cool, dry place Atmospheric pressure limit
Temperature limit
%
Humidity limit
Manufacturer Date of manufacture
Baeries Power Serial number
Flang Deang
WEEE disposal Type BF applied part
Serial number Medical Device complies with Direcve 93/42/EEC
Authorized representave in the European community Class II applied
Socket for power adapter Interface for connecng cu
Voice deacvaon Voice acvaon
Great movement when measuring Cu ed correctly
Artery indicator label
When the high pressure posion appears “Err” and the low pressure posion appears the error number, the measurement is not normal.(Error
number are 02,04,06-16,19)
Error Mark Causes Soluons
Err02
Err15 Funcon abnormal Please contact us
Err04 Low baery Please replace the baery or link adapter
Err06 The cu is not wrapped correctly. Wrap the cu correctly (refer to Chapter 10)
Err07 Cu plug fall o Make sure the cu plug is securely inserted in the windpipe (refer to
Chapter 10)
Err08 Air pressure error Keep arm, body sll, measure again
Imported by

21 ENGLISH
Err09 The pulse signal is too weak or the cu is loose. Wrap the cu correctly (refer to Chapter 10)
Err10 Cu is blocked or squeezed Wrap the cu correctly (refer to Chapter 10)
Err14 Cu leakage Replace with a new cu
Err11
Err12
Err13
The signal amplitude is too big owing to the arm or
body moving or other reasons when measuring Keep arm, body sll, measure again
Err16
Err19 It takes too much me
Abnormal
Phenomenons Causes Soluons
BP measurement
values too high or
too low.
Cu is not connected correctly. Correctly connect cu.
Talk or move arm in measurement Keep quiet and restart a measurement.
The turnup close oppress the arm Take o the clothes, and restart a measurement
No pressure
Cu leakage Buy a new cu.
The cu windpipe is not correctly connected
with cu Correctly connect.
Cu not inate Contact us.
Cu deate in short
me Loose cu Correctly tangle cu.
It can not carry on measurement ,even if press the measurement buon Return on the power and restart a measurement.
Abruptly turn the
power o in adding
pressure
No use for a long me, the baeries can be
exhausted owing to the changed temperature Replace all four baeries with new ones.
Hold the on/o
buon but can not
start the device
Baeries are worn Replace all four baeries with new ones.
The baery polaries is reversed Check the baery installaon for proper placement of the baery
polaries.
Cu inaon start before press the measurement buon Stop using the device and contact us.
Cu never deaon Stop using the device and contact us.
Air pressure error Deaon error Pull out the cu to deate. Stop using the device and contact us.
Others Keep arm, body sll, measure again.
No press value displayed or the value unaltered when cu inang Pull out the cu to deate. Stop using the device and contact us.
Other phenomenon
Switch on the power once again and restart an operaon.
Replace the baeries.
If no, please contact us.
*Please do obey the precauons and correct operang methods in this user manual. Otherwise, we will not responsible for any fault.
High pressure disinfecon to the device and accessories is not allowed.
Do not let water or cleaning agent ow into the socket to avoid device damage.
Do not soak the device and accessories in liquid.
If any damage or deterioraon of the device and accessories is found, please do not use it.
Clean the device and accessories regularly. It is recommended to clean them every one month. When the device or accessory gets dirty, use a dry
and so cloth to wipe. If they are very dirty, it is available to dip the so cloth into water or mild detergent, and wring out, then use the cloth for
cleaning.
The device shall be inspected and calibrated regularly (or according to inspecon standard of hospital). The inspecon can be carried out in

22
ENGLISH
appointed instuons, or by professional personnel or contact us for inspecon. Under the seng interface, Press the “START/STOP” buon once,
aer “CAL” appears on the screen, press “M” buon for more than 15 s to enter the stac pressure interface.
Do not use gasoline, volale oil, diluent, etc. to wipe the device.
Do not clean or wet the cu.
Do not expose the device in direct sunlight for long me, otherwise the display screen maybe damaged.
The basic performance and safety of the device are not aected by the dust or coon wool in home
environment,while the device shall not be placed where with high temperature, humidity or dusty.
Aged cu may result in inaccurate measurement, please replace the cu periodically according to the user manual.
To avoid device damage, keep the device out the reach of children and pets.
Avoid the device close to extreme high temperature such as replace, otherwise the device performance may be aected.
Do not store the device with chemical medicine or corrosive gas.
Do not place the device where there is water.
Do not place the device where with slope, vibraon or impact
Take the baeries out if the device is not to be used for three months or longer.
Name Electronic Sphygmomanometer
The degree of protecon against ingress of water IPX1
Display LED
Measurement Method Oscillometric method
Working mode Automac
Operaon mode Continuous operation
Pressure Range 0~297 mmHg(0~39.6 kPa)
Measurement range Pressure SYS:30~270 mmHg(4~36 kPa)
DIA:10~220 mmHg(1.3~29.3 kPa)
Pulse: 40~240/min
Inaon 160±5 mmHg(21.33±0.67 kPa)
Overpressure protect 297±3 mmHg(39.6±0.4 kPa)
Resoluon Pressure: 1 mmHg(0.133 kPa)
Accuracy Static pressure: ±3 mmHg(±0.4 kPa)
Error
The BP value measured by the device is equivalent with the measurement value of
Stethoscopy, perform clinical verification in accordance with the requirements in ISO
81060-2: 2013, whose error meets the followings:
Maximum mean error: ±5 mmHg
Maximum Standard deviaon: 8 mmHg
Operang Temperature/ Humidity +5ºC~40 ºC . 15%RH~85%RH(no condensation)
Transport Transport by general vehicle or according to the order contract, avoid pounded, shake and
splash by rain and snow in transportaon.
Storage Temperature: -20 ºC~+55 ºC; Relative humidity: ≤95 %; No corrosive gas and drafty.
Atmospheric pressure 700 hPa~1060 hPa
Power supply 4 “AA” alkaline batteries, AC Adapter(AC, 100 V-240 V, oponal)
Rated current ≤ 600 mA
Baery life When the temperature is 23 ºC, limb circumference is 270 mm, the measured blood
pressure is normal, 4 “AA” alkaline batteries cab be used about 300 mes.
Main Unit Dimensions 129*101*72 mm
Main Unit Weight 281 gram(without baeries)
Safety classicaon
Class Ⅱ equipment (power supplied by power adapter)/Internally powered equipment
(power supplied by baeries)
Type BF applied part
Service life The service life of the device is ve years or 10000 mes of BP measurement.
Date of manufacturer See the label

23 ENGLISH
Standard Congure:
Adult Cu: limb circumference 22-32 cm (upper arm center)
User Manual, four “AA” alkaline baeries
AC Adapter:
Input: voltage: AC 100 V~240 V frequency: 50 Hz/60 H Rated current: AC 150 mA
Output: DC 5.0 V±0.2 V1.0 A
The device is intended for use in the electromagnec environment specied below. The customer of the user of the device should
assure that it is used in such and environment.
RF emissions
CISPR 11 Group 1
The device uses RF energy only for its internal funcon. 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 device is suitable for use in all establishments, including
domesc establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domesc purposes.
Harmonic emissions
IEC61000-3-2 Class A
Voltage uctuaons/ icker emissions
IEC61000-3-3 Complies
The device is intended for use in the electromagnec environment specied below. The customer or the user of the device should
assure that it is used in such an environment.
Electrostac discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete
or ceramic le. If oor are covered
with synthec material, the
relave humidity should be at
least 30%.
Electrical fast transient/
burst
IEC 61000-4-4
±2 kV for power supply lines ±2kV for power supply lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV dierenal mode
±2 kV common mode
±1 kV dierenal mode
±2 kV common mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interrupons and voltage
variaons on power supply
input lines
IEC 61000-4-11
<5% UT (>95% dip in UT)for
0.5 cycle
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 sec
<5% UT (>95% dip in UT)for
0.5 cycle
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 sec
Mains power quality should be
that of a typical commercial or
hospital environment. The device
can connue the operaon during
power mains interrupons due to
the usage of baery.
Power frequency (50/60Hz)
magnec eld
IEC61000-4-8
3A/m 3A/m
Mains power quality should be
that of a typical commercial or
hospital environment.
NOTE: UT is the a.c. mains voltage prior to applicaon of the test level.

24
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The device is intended for use in the electromagnec environment specied below. The customer or the user of the device should
assure that it is used in such an environment.
Portable and mobile RF communicaons equipment should be
used no closer to any part of the device, including cables, than the
recommended separaon distance calculated from the equaon
applicable to the frequency of the transmier.
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 V/m
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V/m
3 V/m
P
E
d
=
1
5.3
P
V
d
=
1
5.3
P
E
d
=
1
7
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power rang of the transmier in
was (W) according to the transmier manufacturer and d is the
recommended separaon distance in metres (m).
Field strengths from xed RF transmiers, as determined by an
electromagnec 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 situaons. Electromagnec propagaon is aected by absorpon and
reecon from structures, objects and people.
A Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theorecally with accuracy. To assess the
electromagnec environment due to xed RF transmiers, an electromagnec site survey should be considered. If the measured
eld strength in the locaon in which the device is used exceeds the applicable RF compliance level above, the device should
be observed to verify normal operaon. If abnormal performance is observed, addional measures may be necessary, such as
reorienng or relocang the device.
B Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
device
The device is intended for use in an electromagnec environment in which radiated RF disturbances are controlled.
The customer or the user of the device can help prevent electromagnec interference by maintaining a minimum
distance between portable and mobile RF communicaons equipment (transmiers) and the device as recommended
below, according to the maximum output power of the communicaons equipment.
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33

25 ENGLISH
For transmiers rated at a maximum output power not listed above, the recommended separaon distance d in metres
(m) can be esmated using the equaon applicable to the frequency of the transmier, where P is the maximum output
power rang of the transmier in was (W) according to the transmier manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separaon distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon
and reecon from structures, objects and people.
Acve medical devices are subject to special EMC precauons and they must be installed and used in accordance with these guidelines.
Electromagnec elds can aect the performance of the device, so other equipment used near the equipment must meet the appropriate EMC
requirements. Mobile phones, X-rays, or MRI devices are possible interference sources, as they emit high-intensity electromagnec radiaon.
The use of ACCESSORIES, transducers and cables other than those specied, with the excepon of transducers and cables sold by the
MANUFACTURER of the the device as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of
the ME EQUIPMENT or ME SYSTEM.
The device should not be used when they are close to or stacked with other equipment, if necessary, please observe and verify that they can
operate normally in the conguraons.
Devices or systems may sll be interfered by other equipment, even if other equipment meets the requirements of the corresponding naonal
standard.
The device requires special precauons for electromagnec compability (EMC) and requires qualied personnel to install and use in accordance
with the EMC informaon provided below.
The device should not contact the pins of connectors marked with an ESD warning symbol, unless electrostac discharge precauons are used, the
device should not connect to these connectors.
In order to avoid the accumulaon of electrostac charge, it is recommended to store, maintain and use the equipment at a relave humidity of
30 % or more. The oor should be covered with ESD dissipated carpets or similar materials. In the use of the components, non-synthec clothing
should be wore.
In order to prevent electrostac discharging to the ESD-sensive parts of the device, the personnel should contact the metal frame of the
components or the large metal objects near the device. When using the device, especially when it is possible to contact the ESD-sensive parts of
the device, the operator should wear a grounded bracelet designed for ESD-sensive devices. For more informaon on proper use, please refer to
the instrucons provided with the bracelet.
All potenal users are advised to understand the ESD warning symbols and receive training on ESD precauons.
The most basic content of the ESD precauonary procedure training should include an introducon to electrostac charge physics, voltage level
in the convenonal case, and damage to the electronic components when the operator with electrostac charge contacts them. In addion,
the methods for prevenng electrostac buildup, and the manner and reasons for the release of human body stac electricity to the ground or
equipment frame or the use of a bracelet to connect the human body to the equipment or the ground before establishing the connecon should
be described.
The following cable types must be used to ensure that they comply with interference radiaon and immunity standards:
Name Length (m)
Power adapter cable 1.5
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty
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 specific
recycling point for electric and electronic equipment
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