CardiAI BPAro Operator'S Manual Download Page 30

30

 

BPAro 

ENG Revision A

 

Electromagnetic Compatibility (EMC) 

 

 

 

 

 

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity 

The ABPM devices are intended for use in the electromagnetic environment specified below. It is the responsibility of the 

customer or user to ensure that the ABPM devices are used in such an environment. 

Immunity Test 

EN/IEC 60601 Test Level 

Compliance 

Level 

Electromagnetic environment— 

Guidance 

 

Conducted RF to EN 

61000-4-6 / 

IEC 61000-4-6 

 

 

 

Radiated RF to EN 

61000-4-3 / 

IEC 61000-4-3 

3.0 V

rms

 

150 kHz bis 80 MHz 

6.0 V

rms

 

150 kHz bis 80 MHz 

 

 

10.0 V/m 

80 MHz bis 2.7 GHz 

3.0 V

rms

 

 

6.0 V

rms

 

 

 

 

10.0 V/m 

Portable and mobile RF communications 

equipment should be used no closer to any 

part of the ABPM devices, including 

cables, than the recommended separation 

distance calculated from the equation 

applicable to the frequency of the 

transmitter. 

Recommended separation distance: 

d = 1.17 

√P

 

d = 1.17 

√P

 at 80 MHz to 800 MHz 

d = 2.33 

√P

 at 800 MHz to 2.7 GHz  

where 

is the maximum output power rat-

ing of the transmitter in watts (W) accord-

ing to the transmitter manufacturer and 

is the recommended separation distance in 

meters (m). 

Field strengths from fixed RF transmitters, 

as determined by an electro-magnetic site 

survey

a

, should be less than the compli- 

ance level in each frequency range

b

Interference may occur in the vicinity of 

equipment marked with the following 

symbol 

 

NOTE 1: At 80 MHz and 800 MHz, 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. 

a)

 

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile 

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 ABPM devices are used exceeds the applicable RF compliance 

level above, the ABPM devices should be observed to verify normal operation. If abnormal performance is observed, 

additional measures may be necessary, such as reorienting or relocating the equipment. 

 

b)

 

Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3.0 V/m. 

Summary of Contents for BPAro

Page 1: ...BPAro Ambulatory Blood Pressure System Firmware Version 3 0 Operator s Manual A8135 ENG Revision A...

Page 2: ...please inform us so that we can resolve the discrepancies as soon as possible Due to continuing product innovation specifications in this manual are subject to change without notice To find out about...

Page 3: ...NiMH batteries 16 3 5 Charging Batteries with the VARTA Charging Unit 17 3 6 Switching ABPM Devices ON and OFF 18 3 7 Performance Check 18 3 8 Clock Display 18 4 Application 19 4 1 Applying the cuff...

Page 4: ...Aro ENG Revision A General Information 6 5 Disposal of the Product 25 7 Technical Specifications 26 7 1 Blood Pressure Measurement 26 8 Order Information 27 9 Appendix Electromagnetic Compatibility EM...

Page 5: ...vision History This manual is subject to change order service The revision index a letter that follows the order number changes with every update of the manual Order Number Revision Date Comment A8135...

Page 6: ...ance of the information given in the manual is a prerequisite for proper equipment performance and correct operation and ensures patient and operator safety Please note that information pertinent to s...

Page 7: ...7 BPAro ENG Revision A General Information CardiAI Inc 201 3151 27th St NE Calgary Alberta T1Y 0B4 Canada www cardiai com The country of manufacture is indicated on the device label...

Page 8: ...ence The cuffs are wrapped around the uninjured upper arm so that they come in contact only with intact skin The devices are not intended to be used in intensive care medicine or for raising alarm in...

Page 9: ...ic value Once the systolic value is determined the cuff can immediately and quickly be deflated The measurement typically takes only approx 20 seconds See Fig 1 2 If disturbances occur during measurem...

Page 10: ...result of the proposed combination of equipment The standards IEC 60601 1 or IEC 60950 1 must be observed in any case Connection of this device to an IT network that includes other equipment could res...

Page 11: ...EMC requirements X ray equipment MRI devices radio systems etc are possible sources of interference as they may emit higher levels of electromagnetic radiation Caution Equipment damage risk to person...

Page 12: ...During a long term measurement the buttons on the device have the following functions To start and stop a measurement and to confirm entries To display the most recent measurement values or error mess...

Page 13: ...hases is only possible if two measure intervals were programmed when the ABPM device was started with the PC software and the day night button has not been deactivated If more or less than two measure...

Page 14: ...hase selected Night phase selected Further relevant symbols used on the battery charger Eurasian Conformity Conformity with the current technical regulations of the Customs Union Protection class II e...

Page 15: ...of operation or 400 blood pressure measurements The capacity of rechargeable batteries decreases with age If the capacity of fully charged batteries is consider ably less than 24 hours the batteries...

Page 16: ...arity when inserting the batteries Note The energy source needs to be selected only when the BP monitor is put into service for the first time or when you change from NiMH to alkaline batteries and vi...

Page 17: ...r in the charging unit display where each symbol corresponds to one of the charger compartments Fig 3 4 During the charge cycle the corresponding bar in the battery sym bols blinks Note If the battery...

Page 18: ...have a capacity of 100 i e they are fully charged b 50 means that the alkaline batteries have a capacity of only 50 i e they are half depleted The minimum battery capacity for a 24 hour measure ment...

Page 19: ...to the patient due to blood flow interference The application of the cuff over a wound can cause further injury The application of the cuff and its pressurization on the arm on the side of a mastecto...

Page 20: ...onnect it to the blood pressure cuff port of the ABPM device see Fig 2 3 Do not wrap the pressure tubing completely around the neck to avoid strangulation of the patient You must hear the connector cl...

Page 21: ...remove the pressure hose only in emergency situations see warning below that the cleaning may only be carried out by qualified medical personnel and not by the patient Absolute contraindications The...

Page 22: ...e inflates the cuff to a pressure which is 25 mmHg above the systolic value of the previous measurement minimum inflation pressure 120 mmHg The determination of the blood pressure values takes place w...

Page 23: ...on measurement method Tighten the cuff so that one finger but not two can be inserted between the patient s arm and the cuff At the same time the device switches to a deflation rate of 4 mmHg s When i...

Page 24: ...idin Foam or equivalent disinfectants that are used in practices or hospitals are suitable Please respect the information of the manufacturer especially regarding the exposure time After cleaning rins...

Page 25: ...uest CardiAI provides a Service Manual The device does not require any other maintenance Technical Inspections of the Measuring System The non invasive pressure measurement system of the ABPM devices...

Page 26: ...tion atmospheric pressure 500 1060 hPa altitude relative to sea level 400 4500 m Protection Class IP20 ABPM device IP02 wearable pouch of the ABPM device IP22 ABPM device in wearable pouch Expected Se...

Page 27: ...ith D ring A 2535 xl BPAro BP Cuff for Adults Extra Large 38 46 cm with D ring Operator Manuals USB flash drive Optional Accessories and Combinable Medical Products A 2535 s BPAro BP Cuff cuff for adu...

Page 28: ...issions to EN 55011 CISPR 11 Group 1 The ABPM devices use RF energy only for their internal function Therefore their RF emissions are very low and are not likely to cause any interference in nearby el...

Page 29: ...ommercial or hospital environment Surge to EN 61000 4 5 IEC 61000 4 5 0 5 kV differential mode 1 0 kV differential mode 0 5 kV common mode 1 0 kV common mode 2 0 kV common mode not applicable not appl...

Page 30: ...nd d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electro magnetic site surveya should be less than the compli ance level in each f...

Page 31: ...Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 7 GHz d 2 33 P 0 0 1 0 1 2 0 1 2 0 2 4 0 1 0 3 7...

Page 32: ...om the wearable pouch Please wear the pouch over your clothes You do not have to clean the device after the long term measurement Sometimes the device internally stops the long term measurement In thi...

Page 33: ...33 BPAro ENG Revision A CardiAI Inc 201 3151 27th St NE Calgary Alberta T1Y 0B4 Canada www cardiai com...

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