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11

 

BPAro 

ENG Revision A

 

 

Application, Safety Information 

 

 

 

 

 

 

 

 

 

 

Warning 

 Risk to Persons — 

 

The equipment has no protection against the 

ingress of liquids. Liquids must not enter the 

equipment. Equipment into which liquids 

have entered must be inspected by a service 

technician before use. 

 

Before cleaning, the device must be dis-

connected from other equipment (e.g. a PC). 

 

Dispose of the packaging material, observing 

the applicable waste-control regulations. Keep 

the packaging material out of children's 

reach. 

  

 Incorrect measurements — 

 

Magnetic and electrical fields are capable of 

interfering with the proper performance of the 

equipment. For this reason, make sure that 

external equipment operated in the vicinity of 

the device complies with the relevant 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 persons— 

 

Before connecting the battery charger to the 

power line, check that the voltage ratings on 

the nameplate match those of your local 

power line. 

 

The battery charger is not a medical device. 

Its use in the patient environment is not 

permitted. 

 

Before using the equipment, the operator 

must ascertain that it is in correct working 

order and operating condition. 

 

The operator must be trained in the use of 

the equipment. 

 

Only persons who are trained in the use of 

medical technical equipment and are 

capable of applying it properly are 

authorized to apply such equipment. 

 

There are no user-replaceable components 

inside the equipment. Do not open the 

housing. For service or repair, please 

contact the manufacturer or your local, 

authorized dealer. 

Содержание BPAro

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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