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

Guidance and manufacturer’s declaration – electromagnetic immunity 
The  [EQUIPMENT  or  SYSTEM]  is  intended  for  use  in  the  electromagnetic  environment 
specified below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure that 
it is used in such an environment. 

Immunity test 

IEC 60601 test 

level 

Compliance 

level 

Electromagnetic environment - 

guidance 

Conducted RF   
IEC 61000-4-6 
 
Radiated RF   
IEC 61000-4-3 

3 Vrms 
150 kHz to 80 MHz 
 
3 V/m 
80 MHz to 2.5 GHz 

3V 
 
 
3V/m 
 

Portable 

and 

mobile 

RF 

communications  equipment  should  be 
used  no  closer  to  any  part  of  the 
[EQUIPMENT  or  SYSTEM],  including 
cables, 

than 

the 

recommended 

separation  distance  calculated  from  the 
equation  applicable  to  the  frequency  or 
the transmitter. 
Recommended separation distance 

d = 1.2 

p

 

d = 1.2 

p

  80 MHz to 800 MHz 

d = 2.3 

p

  800 MHz to 2.5 GHz 

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). 
Field 

strengths 

from 

fixed 

RF 

transmitters,  as  determined  by  an 
electromagnetic  site  survey,  should  be 
less  than  the  compliance  level  in  each 
frequency range. 
Interference may occur in the vicinity of 
equipment  marked  with  the  following 
symbol: 

 

 

    Recommended separation distances between portable and mobile
  RF communications equipment and the EQUIPMENT or SYSTEM –
For EQUIPMENT and SYSTEMS that are not LIFE – SUPPORTING

21

 Rev

:A1

Содержание BA2318

Страница 1: ...Model BA2318 Arm Automatic Blood Pressure Monitor Instruction Manual...

Страница 2: ...Noted 10 10 f f u c e h t g n i t t i F 2 4 4 3 Body posture during measurement 11 4 4 Take Measurement 12 4 5 Memory 15 5 Error Indication 15 6 Trouble Shooting 16 7 Specification 17 8 About Blood Pr...

Страница 3: ...therapy device or in an environment where combustible gas may be generated Do not install the unit in the following locations Locations subject to vibration such as ambulances and emergency helicopte...

Страница 4: ...evice are equivalent to those obtained by a trained observer using the cuff stethoscope auscultatory method within the limit prescribed by the American National Standard Manual electronic or automated...

Страница 5: ...or apoplexy problem please use under the physician s instruction Clinical testing has not been conducted on newborn infants and pregnant women Do not use in infants and pregnant women Do not use the b...

Страница 6: ...not disassemble or modify the structure of the unit and damage the safety performance If you need service please contact the manufacturer the maintenance should be done by authorized persons of manuf...

Страница 7: ...Body Fig 1 Rev A1 5 Cuff Type BF Applied Part Model BC1000 Applicable Arm Circumference 220 mm to 360 mm Cuff Air Tube Air Tube Connector LCD Display Air socket SET Memory ON OFF...

Страница 8: ...YPE BF APPLIED PART Rev A1 6 Display Fig 3 Systolic Diastolic Pulse Rate Blood Pressure Level Indicator Date and Time Battery Symbol Memory1 Memory2 Unit of Pressure Heart Mark Irregular Heat Rate Sym...

Страница 9: ...ry if low battery icon is displayed If the low battery symbol is display replace with new batteries otherwise the unit will not function properly Use 4 same brand 1 5 Volt A alkaline batteries AA Do n...

Страница 10: ...on for 3 seconds Year digits blinking a Change number i Press the M M button to advance one number ii Hold down the button the number will change rapidly b Enter the two digit of the year number c Pre...

Страница 11: ...ata conversion With monitor power off hold the ON OFF button until the selected Memory displayed The machine is complete setting ready to use Press the ON OFF button will automatically change the memo...

Страница 12: ...nd calmly The blood pressure cuff should fit over about 3 4 of your upper arm It should easily go around the arm and the Velcro should close tightly If you can use the same arm for every reading Measu...

Страница 13: ...r the air tube To detach the cuff unplug the air tube connector from the main unit Do not inflate prior fitting the cuff Rev A1 Change the cuff if it there is a leakage or if the cuff is not working p...

Страница 14: ...1 Rev A1 3 Then the display on switch to Fig 12 a beep sound indicates the monitor has begun taking the measurement 4 When the device detects a pulse the heart symbol will flash as shown on Fig 13 The...

Страница 15: ...the screen Fig10 Fig11 Fig13 Fig12 6 You may turn off the unit or compare with the previous results 7 Automatic shut off in 3 minutes 8 If a problem occur during the test Err will display on the scree...

Страница 16: ...re provider The pillar in the left of the display and the segment color in the unit will indicate the level of the blood pressure the blood pressure level classification and definition as show in Fig...

Страница 17: ...st date When holding the button the user can view vice versa 2 Delete memory data a b Press and hold the memory button until the displayed to 15mmHg 2kPa does not exceed 10s If cuff inflated up to 300...

Страница 18: ...e use refer to table below Rev A1 Abnormal How to correct After batteries installation power on no display 1 Check batteries polarity 2 If still cannot power on reinstall the batteries or change new b...

Страница 19: ...BF IP classification IP21 Operating Environment Temperature 5 40 Humidity 15 93 Pressure 70 0kPa 106 0kPa Altitude 3 000 m Storage and transport Environment Temperature 25 70 Humidity 10 95 Pressure 5...

Страница 20: ...y can be disposed of in an environmentally acceptable manner Please remove the battery before disposing of the equipment Do not dispose of old batteries with your household waste but dispose of them a...

Страница 21: ...mobile cellular telephones and other devices which generate strong electrical or electromagnetic fields near the medical device This may result in incorrect operation of the unit and create a potenti...

Страница 22: ...Not applicable 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 Not applicable Mains power quality should...

Страница 23: ...any part of the EQUIPMENT or SYSTEM including cables than the recommended separation distance calculated from the equation applicable to the frequency or the transmitter Recommended separation distan...

Страница 24: ...utput power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power ra...

Страница 25: ...your risk of your vascular walls becoming overstretched and injured Reducing your risk of your heart having to pump harder to compensate for blockages Protecting your entire body so that your tissue r...

Страница 26: ...y on a Monday amongst all the other days of the week Organ damage and diabetic complications have also been shown to be linked with morning blood pressure surges just in the same way as small artery d...

Страница 27: ...e Collateral standard Electromagnetic compatibility Requirements and tests ANSI AAMI ISO 81060 2 2009 Non invasive sphygmomanometers Part 2 Clinical validation of automated measurement type Blood Pres...

Страница 28: ...h is not in accordance with the product requirements Defects resulting from repair by unauthorized persons Damages caused by user whom disassemble or modify the structure of the unit and damage the sa...

Страница 29: ...s of solid foreign objects 12 5mm diameter Against ingress of water with harmful effects vertical dripping Symbol for AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Symbol for manufacturer Symbol...

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