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36

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 
 
3 V/m 

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.

Compliance 

Level

Portable and mobile RF communications equipment 
should be used no closer to any part of the e-sphyg 3 
Digital Blood Pressure Monitor, including cables, than 
the recommended separation distance calculated from 
the equation applicable to the frequency of the 
transmitter. 

Recommended separation distance

 

d  [3.5] P V 1 

d  [3.5] P 80 MHz to 800 MHz E1 

d  [ 7 ] P 800 MHz to 2.5 GHz E1 

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 metres (m).b 

Field strengths from fixed RF transmitters, as 
determined by an electromagnetic 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:

0.01

0.12

0.23

d  [ 7 ] P 

d  [3.5] P E1

d  [3.5] P V 1

Rated maximum  

output of transmitter 

 

W

150 kHz to  

80 MHz

Separation distance according to frequency of transmitter m

Recommended separation distances between portable and mobile RF communications 

equipment and the e-sphyg 3 Digital Blood Pressure Monitor

 

The e-sphyg 3 Digital Blood Pressure Monitor is intended for use in an electromagnetic environment in which radiated RF 

disturbances are controlled. The customer or the user of the e-sphyg 3 Digital Blood Pressure Monitor can help prevent 

electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment 

(transmitters) 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 rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be 
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the 
transmitter in watts (W) according to the transmitter manufacturer. 

NOTE 1:

 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. 

NOTE 2:

 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from 

structures, objects and people. 

NOTE 1:

 At 80 MHz and 800 MHz, the higher frequency range applies. 

NOTE 2:

 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, 

objects and people. 

a. Field strengths from fixed 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 e-sphyg 3 Digital Blood Pressure Monitor is used exceeds the applicable RF compliance level above, the e-sphyg 3 Digital Blood 
Pressure Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the e-
sphyg 3 Digital Blood Pressure Monitor .b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

0.1

0.38

0.73

1

1.2

2.3

10

3.8

7.3

100

0.12

0.38

1.2
3.8

12

12

23

Guidance and manufacturer’s declaration – electromagnetic immunity –  

for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the 

EQUIPMENT or SYSTEM -  or EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

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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