Kinetik WBP1 Скачать руководство пользователя страница 14

COMPLIED STANDARDS LIST AND EMC GUIDANCE

COMPLIED STANDARDS LIST AND EMC GUIDANCE

24

25

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
Warning: Don’t near active HF surgical equipment and the RF shielded room of an ME

system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be 

avoided because it could result in improper operation. If such use is necessary, this 

equipment and the other equipment should be observed to verify that they are operating 

normally.
Warning: Use of accessories, transducers and cables other than those specified or provided

by the manufacturer of this equipment could result in increased electromagnetic emissions

or decreased electromagnetic immunity of this equipment and result in improper operation.”
Warning: Portable RF communications equipment (including peripherals such as antenna 

cables and external antennas) should be used no closer than 30 cm (12 inches) to any part 

of the equipment WBP1, including   cables   specified   by   the   manufacturer.   Otherwise, 

degradation of the performance of this equipment could result.

Technical description:

Table 1 

Group I 

Class B

Not application

Not application

1. all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFOR-

MANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity

RF emissions
CISPR I I 

RF emissions
CISPR I I

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Harmonic emissions
IEC 61000-3-2

 

Immunity Test

 

±

8 kV contact

±

2 kV, 

±

4kV, 

±

8 kV,  

±

15 kV air 

 

30 A/m
50Hz/60Hz

Table 2 

Compliance level

Electrostatic 
discharge 

(ESD)

 

IEC 61000-4-2 

30 A/m
50Hz/60Hz

Power frequency 
magnetic field
IEC 61000-4-8

Voltage dips, short 
interruptions and 
voltage variations 
on power supply
input lines 
IEC 61000-4-11

Electrical fast 
transient/burst 
IEC 61000-4-4 

Surge
IEC61000-4-5

IEC 60601-1-2  Test level

±

8 kV contact

±

2 kV, 

±

4kV, 

±

8 kV,  

±

15 kV air 

Conduced RF
IEC61000-4-6

10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz

10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz

Radiated RF
IEC61000-4-3

Not application

Not application

Not application

Not application

Not application

Not application

Not application

Not application

EMC Guidance

Guidance and manufacturer’s declaration - electromagnetic emissions

Emissions test 

Compliance

Guidance and manufacturer’s declaration – electromagnetic Immunity 

NOTE

     

U

T  

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

Содержание WBP1

Страница 1: ...Blood Pressure Monitor Instruction Manual WBP1...

Страница 2: ...MENT 15 16 Check the memory Delete the Readings INFORMATION FOR USER 17 Tips for measurement Maintenance ABOUT BLOOD PRESSURE 18 19 What are systolic pressure and diastolic pressure What is the standa...

Страница 3: ...in measuring blood pressure and heartbeat rate with arm circumference 22cm to 42cm about 8 16 It is intended for adult indoor use only 1 The device is not suitable for use on may be pregnant women or...

Страница 4: ...st be treated with caution Observe the storage and operating conditions described in this booklet The equipment is not AP APG equipment and not suitable for use in the presence of a flammable anesthet...

Страница 5: ...d sales service centers Please report to Harvard Medical Devices if any unexpected operation or events occur Keep the unit out of reach of infants young children or pets to avoid inhalation or swallow...

Страница 6: ...is dim The display does not light up 1 Battery powered mode 6VDC 4 AAA batteries Do not use new and used batteries together Do not use different types of batteries together Do not dispose the batterie...

Страница 7: ...is stored in the memory The setting range of the year 2017 2057 Time format 24H the YEAR Each press will increase the numeral by one in a cycling manner mmHg mmHg min for 3 seconds to enter the mode...

Страница 8: ...same level as your heart Turn your palm upwards Sit upright in a chair and take 5 6 deep breaths Rest for 5 minutes before first measuring Wait at least 3 minutes between measurements This allows you...

Страница 9: ...off otherwise it will turn off within 1 minute 1 When the monitor is off please press button to show the average value of the latest three records If the records are less than 3 groups it will displa...

Страница 10: ...ken in the following circumstances 1 Within 1 hour after drinking or eating 2 Immediate measurement after tea coffee or smoking 3 Within 20 minutes after taking a bath 4 When talking or moving your ng...

Страница 11: ...records all the pulse intervals and calculate the average if there are two or more pulse intervals the difference between each interval and the average is more than the average value of 25 or there a...

Страница 12: ...nd frequently asked questions for problems you may encounter with your blood pressure monitor If the product is not operating as you think it should check here before arranging for servicing Type BF a...

Страница 13: ...cation of usability engineering to medical devices EN 62304 2006 AC 2008 IEC 62304 2006 A1 2015 Medical device software Software life cycle processes Risk management Labeling User manual General Requi...

Страница 14: ...lt Technical description Table 1 Group I Class B Not application Not application 1 all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFOR MANCE with regard to electromagnetic dis...

Страница 15: ...2 0 3 9 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation b 18Hz 2 0 3 28 1720 1845 1970 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse m...

Отзывы: