Summary of Contents for CardiAI BPAro
- Page 1 BPAro Ambulatory Blood Pressure System Firmware Version 3.0 Operator’s Manual A8135-ENG Revision A...
- Page 2 General Information Note The information in this manual only applies to BPAro with firmware version 3.0. It does not apply to earlier firmware versions. This manual was created with great care. In case you find details, which do not correspond to the system please inform us so that we can resolve the discrepancies as soon as possible.
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Page 3: Table Of Contents
Audio Signal ............................... 22 5 Error Codes 6 Cleaning, Maintenance, Disposal Cleaning and Disinfection of the Equipment Surface ..................24 Cleaning and Disinfection of the Cuffs ......................24 Cleaning and Disinfection of Cables ........................24 Maintenance ............................... 25 ENG Revision A BPAro... - Page 4 General Information Disposal of the Product ............................25 7 Technical Specifications Blood Pressure Measurement ..........................26 8 Order Information 9 Appendix–Electromagnetic Compatibility (EMC) ENG Revision A BPAro...
- Page 5 Revision 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-ENG Revision A 2022-03-22 Initial Release ENG Revision A BPAro...
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Page 6: General Information
B. recommend using only original accessories available • through CardiAI. The user is responsible for application This manual is an integral part of the equipment. It of accessories from other manufacturers. will be enclosed in electronic form. The data medium... - Page 7 General Information CardiAI Inc. 201, 3151 27 St. NE Calgary, Alberta, T1Y 0B4 Canada www.cardiai.com The country of manufacture is indicated on the device label. ENG Revision A BPAro...
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Page 8: Application, Safety Information
The intended patient populations for the blood pressure CardiAI or its representative. measurement are adults, children and infants but not neonates, with a circumference of the upper arm in the range of 17 to 46 cm. -
Page 9: Functional Description
If disturbances occur during measurements with the in- flation measurement method, which may be due to mo- tion artifacts, for example, the ABPM device will automatically switch to the deflation measurement method and complete the blood pressure measurement. ENG Revision A BPAro... -
Page 10: Safety Information
− Chemicals required, for example, for the maintenance of the equipment must under all circumstances be prepared, stored, and kept at hand in their specific containers. Failure to observe this instruction may have severe consequences. ENG Revision A BPAro... - Page 11 For service or repair, please requirements. X-ray equipment, MRI devices, contact the manufacturer or your local, radio systems etc. are possible sources of authorized dealer. interference as they may emit higher levels of electromagnetic radiation. ENG Revision A BPAro...
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Page 12: Controls And Indicators
To manually switch the measure interval between the day phase and the night phase (see section “Toggling Between Day and Night Phase”) Fig. 2.2 Nameplates of the ABPM devices ENG Revision A BPAro... - Page 13 PC software and the day/night button has not been deactivated. If more or less than two measure intervals have been set, the day/night button does not have an influence on the measure intervals. ENG Revision A BPAro...
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Page 14: Explanation Of Signs And Symbols
Eurasian Conformity - Conformity with the current technical regulations of the Customs Union CE marking, blood pressure cuff Protection class II equipment complies with the EU guidelines. For indoor use only Polarity of the DC input (charger only) ENG Revision A BPAro... -
Page 15: Connections
Energizer, Duracell, Varta, GP) with a capacity data, the device needs to be connected to a web > 1500 mAh or high-rate discharge, size AA application (BPAro software) via Bluetooth. For more alkaline batteries (such as Panasonic Evoia, information, visit www.bparo.com/support. -
Page 16: Inserting Batteries
PC software. 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 vice versa. ENG Revision A BPAro... -
Page 17: Charging Batteries With The Varta Charging Unit
If the batteries are correctly inserted and the displayed battery symbols show no bars, the charger has identified a battery problem. The charging current will be cut off. Remove the batteries and discard, observing the applicable waste disposal regulations. ENG Revision A BPAro... -
Page 18: Switching Abpm Devices On And Off
− the measuring phase (day / night ), and − whether data are stored in the BP monitor ( ) (see Fig. 3.7). The BP monitor will also emit an audio signal if enabled. ENG Revision A BPAro... -
Page 19: Application
− Select the appropriate cuff size as a cuff that is too small will lead to overrated BP values and when the cuff is too big, the measured values will be too low. Fig. 4.2 Applying the cuff ENG Revision A BPAro... -
Page 20: Performing A Trial Measurement
• switched on or off if necessary. An additional If the trial measurement has been completed evaluation program is required for these activities successfully, the device is ready for automatic when starting and programming. measurements. ENG Revision A BPAro... -
Page 21: Patient Information
− to remove the cuff if it is not deflated after activation of the button. This could be due to kinked tubing. The cuff must be reapplied as described earlier before additional measurements can be taken. ENG Revision A BPAro... -
Page 22: General Information On Ambulatory Bp Measurement
If the measured value is above the inflation pressure, the device will increase the cuff pressure another 50 mmHg. Inflation Measurement Method: For each measurement, the device inflates the cuff about 20 mmHg above the determined systole and then immediately vents the cuff completely. ENG Revision A BPAro... -
Page 23: Error Codes
E 03 Internal hardware error. Please contact your local authorized dealer E 10 Memory space is full. 400 pressure (http://www.bparo.com). measurements have been taken and thus the storage capacity is exhausted. E 04 Batteries depleted. Code appears when the battery capacity is insufficient for new BP E 11 Motion artifact during diastole detection. -
Page 24: Cleaning, Maintenance, Disposal
Warning Risk to Persons — Equipment and accessory have to be disinfected between the uses on different patients. Additionally national regulations for the cleaning and disinfection have to be considered ENG Revision A BPAro... -
Page 25: Maintenance
If you detect damage or impaired functions which may Caution result in a hazard to the patient, the operator or third These checks shall be carried out by CardiAI or persons, the device must be repaired before it can be authorized companies. - Page 26 20 °C. Transport and Storage − temperature -25 to +70 °C − relative humidity 10 - 93 %, no condensation − atmospheric pressure 500 - 1060 hPa − altitude (relative to sea level) -400 - 4500 m ENG Revision A BPAro...
- Page 27 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 adults, small (17…26 cm) with D-ring ENG Revision A BPAro...
- Page 28 Harmonic emissions to not applicable connected to the public low-voltage power supply network EN 61000-3-2/IEC 61000-3-2 that supplies buildings used for domestic purposes. Voltage fluctuations/flicker not applicable emissions to EN 61000-3- 3/IEC 61000-3-3 ENG Revision A BPAro...
- Page 29 5000 ms (250 cycles) Power frequency (50/ 30.0 A/m 30.0 A/m Power frequency magnetic fields 60 Hz) magnetic field to should EN 61000-4-8/IEC be at levels characteristic of a typical 61000-4-8 location in a typical commercial or hospital environment. ENG Revision A BPAro...
- Page 30 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. ENG Revision A BPAro...
- Page 31 NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all instances. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. ENG Revision A BPAro...
- Page 32 The device measures your systolic, diastolic and mean arterial blood pressure and your heartrate. The blood pressure is measured with an accuracy of ± 3 mmHg. The device can record up to 400 blood pressure measurements. Note down here the additional instructions of your doctor: ENG Revision A BPAro...
- Page 33 CardiAI Inc. 201, 3151 27th St. NE Calgary, Alberta, T1Y 0B4 Canada www.cardiai.com ENG Revision A BPAro...
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