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RF emissions CISPR 11

Group 1

Emissions 

Test

Electromagnetic Environment - 

Guidance 

Guidelines and manufacturer's declaration - electromagnetic emissions 

The e-sphyg 3 Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The 

customer or the user of e-sphyg 3 Blood Pressure Monitor should assure that it is used in such an environment.

Compliance

The e-sphyg 3 Digital Blood Pressure Monitor 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 emissions CISPR 11

Class B

Harmonic emissions 

IEC 61000-3-2 

Class A

The e-sphyg 3 Digital Blood Pressure Monitor 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.

 

 

 

 

7

Voltage fluctuations/ 

flicker emissions 

IEC 61000-3-3 

Complies

Electrostatic discharge  

 

(ESD) 

 

IEC 61000-4-2 

± 6 kV contact  
 
± 8 kV air 

± 6 kV contact  
 
± 8 kV air 

± 2 kV for power 
supply lines 

± 1 kV for input/ 
output lines

± 1 kV 
differential mode 

± 2 kV common 
mode 

Immunity 

Test

IEC 60601 
Test Level

Electromagnetic 

Environment - Guidance 

Guidance and manufacturer’s declaration – electromagnetic immunity

 

 

The e-sphyg 3 Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. 

The customer or the user of the e-sphyg 3 Digital Blood Pressure Monitor should  assure that it is used in such an environment.

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

Compliance 

Level

Floors should be wood, concrete or ceramic tile. If 
floors are covered with synthetic material, the relative 
humidity should be at least 30%.

Electrostatic 

transient / burst 

 

IEC 61000-4-4 

± 2 kV for power 
supply lines 

± 1 kV for input/ 
output lines

3 A/m

3 A/m

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 

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 

Power frequency 

(50/60 Hz) 

magnetic field 

 

IEC 61000-4-8 

< 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. If the user of the 
e-sphyg 3 Digital Blood Pressure Monitor requires 
continued operation during power mains 
interruptions, it is recommended that the e-sphyg 3 
Digital Blood Pressure Monitor be powered from an 
uninterruptible power supply or a battery. 

Power frequency magnetic fields should be at levels 
characteristic of a typical location in a typical 
commercial or hospital environment. 

Annex of Report

Manufacturer’s Declaration of the EUT 

Report No.: TRE14120020

A 2

Issued: 2014-12-15 

 

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

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

Summary of Contents for e-shpyg 3

Page 1: ...Digital Blood Pressure Monitor Instructions for Use CAUTION Federal law restricts this device to sale by or on the order of a physician or licensed healthcare provider...

Page 2: ...e Correct Cuff 16 17 Measurement Procedure 17 Patient position 17 Apply the cuff 17 Taking Measurements 18 Turn on the power 18 Connect the cuff 18 Select maximum in ation pressure 18 Select an operat...

Page 3: ...ower Adapter 27 Using the Power Adapter 27 Rechargeable Battery 27 Troubleshooting 28 Error Messages 28 29 Safety and Protection 30 Cleaning the Unit 31 Cleaning the Cuff 31 Calibration 32 33 Technica...

Page 4: ...l blood pressure monitor using oscillometric technique and an upper arm blood pressure cuff to measure systolic and diastolic blood pressures pulse rate and mean arterial pressure MAP It can be used i...

Page 5: ...surement in humans and experimental animals Part 1 Blood pressure measurement in humans a statement for professionals from the subcommittee of professional and public education of the American Heart A...

Page 6: ...essary WARNING Inaccurate measurement risk Do not use the device on patients who are connected to heart lung machines WARNING Electric shock hazard Do not open the device or attempt repairs There are...

Page 7: ...ting or re WARNING Do not disassemble modify or alter the battery WARNING For proper patient electrical isolation and battery charging use only the provided external power supply to charge the device...

Page 8: ...ensure safe and accurate blood pressure measurements WARNING Patient injury risk When several blood pressure measure ments are taken on the same patient regularly check the cuff site and extremity fo...

Page 9: ...perly positioned to ensure blood pressure accuracy and patient safety Be sure to position the artery mark directly over the brachial artery Wrapping the cuff too loosely preventing proper in ation may...

Page 10: ...loss of data CAUTION Consult operating instructions for use IFU before using Fragile handle with care On Off Switch Start Stop Button Memory Button Adjust measurement interval times Adjust maximum in...

Page 11: ...ge Adult Cuff 34cm 50cm 1X Power Adapter 4X Power Plugs US Europe UK Australia Input 100 240V 50 60Hz 0 5A Output 7 5V 1 5A 13 T TM 34 50 cm Reusable BP Cuff 12 Large Adult 13 T TM 23 40 cm Reusable B...

Page 12: ...Parts and Assembly Cuff Socket Extension Tubing Handle Recharge Indicator Display Memory Button Mode Switch Start Stop Button On Off Switch Power Adapter Socket Battery Compartment 12...

Page 13: ...Pa 3x SYS DIA PAM MAP MIN Display Power Mode Selection Single Reading Manual Three Reading Average Unit of Measure Rest Count Down Maximum In ation Pressure Auto In ation Memory Systolic Value Diasto...

Page 14: ...nect the Extension Tubing The e sphyg 3 comes with a 140 cm 4 5 foot extension tube that allows you to customize the distance between the unit and the patient depending on your platform type or mounti...

Page 15: ...is switched off 2 Press and hold the Memory Button and then turn on the power with the On Off Switch 3 Release the Memory Button when backlight illuminates 4 Press the Start Stop Button to select the...

Page 16: ...n of the correct cuff size An artery mark indicates bladder midpoint for correct cuff positioning Hook and loop adhesive surface provides a snug in nitely variable t and is designed to withstand a min...

Page 17: ...ted the patient should have their back and arm supported and their legs should not be crossed Prior to measurement the patient should relax comfortably for ve minutes and should refrain from talking o...

Page 18: ...et maximum in ation pressure Select desired maximum in ation pressure or choose AUTO Refer to page 23 for the section on Set maximum in ation pressure Select an operation mode There are three measurem...

Page 19: ...nual Mode Select Manual Mode if auscultatory blood pressure measurement is preferred above using the oscillometric method In Manual Mode the device serves only as a pressure gauge No oscillometric mea...

Page 20: ...HI error message When the cuff pressure reaches 20 mmHg during the de ation cycle the remaining pressure is vented and the e sphyg 3 goes into standby mode Push the Start Stop Button at any time to s...

Page 21: ...to 15 30 45 or 60 seconds The average measurement reading is displayed and saved after all three measurements are complete The user can manually select measurement interval times of 15 30 45 or 60 se...

Page 22: ...r heartbeat detector in 1x Mode The device detects irregular heartbeat in 1x Mode The irregular heartbeat symbol shows up if during the blood pressure measurement the heart rate has varied by more tha...

Page 23: ...ate to a pressure 30 mmHg higher than the previous in ation pressure and attempt another cycle This can be repeated increasing the maximum in ation by 30 mmHg each time If a maximum in ation pressure...

Page 24: ...before and between measurements in Mode can be skipped by pressing the Start Stop Button When the Start Stop Button is pressed during countdown the device will immediately begin the next measurement T...

Page 25: ...e set as 15 30 45 or 60 seconds 1 Press and hold the Start Stop Button for three seconds 2 Press the Memory Button to adjust the measurement interval time then press the Start Stop Button to con rm Th...

Page 26: ...the device is in standby mode In 1x Mode In Mode Press the Memory Button to reveal the average of the triple measurements Continue pressing the Memory Button to review individual measurements The dev...

Page 27: ...o the power socket on the back of the device 2 Plug the adapter plug into an AC wall socket After the battery is fully recharged the charging will stop No battery power will be used while the adapter...

Page 28: ...connected to the device Check for cracks on the tube or the bladder Replace the blood pressure cuff if necessary Switch to 1x or Mode and repeat the measurements 28 Error Messages If an error occurs d...

Page 29: ...erefore no result can be displayed Switch to Manual Mode and determine blood pressure with a stethoscope using traditional Korotkoff method HI Pulse rate or cuff pressure The pressure in the cuff is t...

Page 30: ...eci cations on page 33 Only activate the pump when the cuff is connected to the device Do not use the device if you think it is damaged or if anything appears unusual Read further safety instructions...

Page 31: ...over with warm water 43 C 110 F and a mild detergent in the washing machine Pasteurization Wash the cuff cover in 75 C 167 F hot water for 30 minutes Air dry the cuff DO NOT iron the cuff cover Adcuff...

Page 32: ...fter mechanical impact e g been dropped 1 Set up for accuracy test 2 Push and hold Start Stop Button turn the power on then release the Start Stop Button A series of codes will ash on screen then 0 0...

Page 33: ...and the reference manometer For example the 201 0 displayed on the device stands for 201 0 mmHg 5 Pump the pressure to nearly 300 mmHg Compare the pressure displayed on the screens of the device and t...

Page 34: ...s per minute pulse Cuff pressure display Range 0 299 mmHg Resolution 1 mmHg Static accuracy pressure within 3 mmHg Pulse accuracy 5 of the readout value Power source Rechargeable battery pack 4 8V 350...

Page 35: ...an environment Note UT is the a c mains voltage prior to application of the test level Compliance Level Floors should be wood concrete or ceramic tile If floors are covered with synthetic material th...

Page 36: ...itters and the e sphyg 3 Digital Blood Pressure Monitor as recommended below according to the maximum output power of the communications equipment 80 MHz to 800 MHz 800 MHz to 2 5GHz For transmitters...

Page 37: ...tation may not apply to you To Obtain Warranty Service Send item s postage paid to ADC Attn Repair Dept 55 Commerce Dr Haup pauge NY 11788 Please include your name and address phone no proof of purcha...

Page 38: ...Langkou Community Dalang Street Longhua District Shenzhen Microlife AG Espenstrasse 139 9443 Widnau Switzerland Dist By ADC 55 Commerce Drive Hauppauge NY 11788 www adctoday com email info adctoday c...

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