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23

ENGLISH

Accessories

Standard Configure:

Adult Cuff: limb circumference 22-32

 

cm (upper arm center) 

User Manual, four “AA” alkaline batteries

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

 

V

   

1.0

 

A

APPENDIX

Guidance and manufacturer’s declaration – electromagnetic emissions-for all EQUIPMENT and SYSTEMS 

Guidance and manufacturer’s declaration – electromagnetic emission

The device is intended for use in the electromagnetic environment specified below. The customer of the user of the device should 

assure that it is used in such and environment.

Emission test

Compliance

Electromagnetic environment – guidance

RF emissions

CISPR 11

Group 1

The device 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  device  is  suitable  for  use  in  all  establishments,  including 

domestic  establishments  and  those  directly  connected  to  the 

public low-voltage power supply network that supplies buildings 

used for domestic purposes.

Harmonic emissions

IEC61000-3-2

Class A

Voltage fluctuations/ flicker emissions

IEC61000-3-3

Complies

Guidance and manufacturer’s declaration – electromagnetic immunity –for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s 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

IEC 60601 test level

Compliance level

Electromagnetic environment - 

guidance

Electrostatic 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 tile. If floor are covered 

with synthetic material, the 

relative 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 differential mode

±

2 kV common mode

±

1 kV differential mode

±

2 kV common mode

Mains power quality should be 

that of a typical commercial or 

hospital environment.

Voltage dips, short 

interruptions and voltage 

variations on power supply 

input lines

IEC 61000-4-11

<5% U

T

 (>95% dip in U

T

)for 

0.5 cycle

40% U

T

(60% dip in U

T

)for 5 

cycles

70% U

T

(30% dip in U

T

)for 25 

cycles

<5% U

T

 (>95% dip in U

T

)for 

5 sec

<5% U

T

 (>95% dip in U

T

)for 

0.5 cycle

40% U

T

(60% dip in U

T

)for 

5 cycles

70% U

T

(30% dip in U

T

)for 

25 cycles

<5% U

T

 (>95% dip in U

T

)

for 5 sec

Mains  power  quality  should  be 

that  of  a  typical  commercial  or 

hospital  environment.  The  device 

can continue the operation during 

power mains interruptions due to 

the usage of battery.

Power frequency (50/60Hz) 

magnetic field

IEC61000-4-8

3A/m

3A/m

Mains power quality should be 

that of a typical commercial or 

hospital environment.

NOTE: U

T

 is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity –for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Summary of Contents for 49880

Page 1: ... ψηφιακο πιεσομετρο زاهج ةبقارم طغض مدلا يمقرلا 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 Ma...

Page 2: ...oduct to our company Responsibility for 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 calibration method and other information at the request of the user to help the appropriate and qualified technicians to repair those parts designated by our company Our company have the r...

Page 3: ...nd the person who can t express oneself please use the device under the guidance of a doctor Otherwise it may cause accident or dissension Please do not use for any other purpose except BP measurement Otherwise it may cause accident or holdback Please use special cuff Otherwise it is possible that measurement result is incorrect Please do not keep the cuff in the over inflated state for a long tim...

Page 4: ...e manganese or alkaline batteries do not use batteries of other types Otherwise it may cause fire Do not mix old and new batteries and batteries of different types Otherwise it may cause battery leakage heat rupture and damage to Electronic Sphygmomanometer Please don t put wrong the positive and negative of battery When the batteries power exhausts replace with four new batteries at the same time...

Page 5: ...nd digital equipment connected to this device must be certified to IEC standards such as IEC60950 Information technology equipment Safety and IEC60601 1 Medical electrical equipment Safety and all equipment should be connected to in accordance with the requirement of the valid version of the IEC60601 1 1 system standard The person connecting the additional equipment to the signal input and output ...

Page 6: ...ur legs Advice Try to measure your blood pressure at the same time each day with the same arm and the same pose for consistency The high and low location of cuff will cause changes in measure results Do not touch the sphygmomanometer cuff and windpipe during measure Measurements should be taken in a quiet place and the body relax Remain still 4 5 minutes before measurement Do not talk and movement...

Page 7: ...ay be dangerous Follow the instructions of your physician Note Wait at least 4 5 minutes between measurements When repeatedly measuring the accurate blood pressure value may not be measured due to congestion in the arm Please measure after the blood flow 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...

Page 8: ...er Medical Device complies with Directive 93 42 EEC Authorized representative in the European community Class II applied Socket for power adapter Interface for connecting cuff Voice deactivation Voice activation Great movement when measuring Cuff tied correctly Artery indicator label CHAPTER 10 ERROR MESSAGE When the high pressure position appears Err and the low pressure position appears the erro...

Page 9: ...ion start before press the measurement button Stop using the device and contact us Cuff never deflation Stop using the device and contact us Air pressure error Deflation error Pull out the cuff to deflate Stop using the device and contact us Others Keep arm body still measure again No press value displayed or the value unaltered when cuff inflating Pull out the cuff to deflate Stop using the devic...

Page 10: ...hod Oscillometric method Working mode Automatic Operation 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 Inflation 160 5 mmHg 21 33 0 67 kPa Overpressure protect 297 3 mmHg 39 6 0 4 kPa Resolution Pressure 1 mmHg 0 133 kPa Accuracy Static pressure 3 mmHg 0 4 kPa Error The BP value meas...

Page 11: ...elow The customer or the user of the device 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 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at l...

Page 12: ...ixed 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 device is ...

Page 13: ... the pins of connectors marked with an ESD warning symbol unless electrostatic discharge precautions are used the device should not connect to these connectors In order to avoid the accumulation of electrostatic charge it is recommended to store maintain and use the equipment at a relative humidity of 30 or more The floor should be covered with ESD dissipated carpets or similar materials In the us...

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