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INSTRUCTION MANUAL
DIGITAL BLOOD PRESSURE MONITOR
Model: Prolife PA5 Comfort (BP136A)*,
Prolife PA5 Comfort AF (BP136A)*
en
IM-PA5COMFORT-AF-EN-V01
Issue date: 2024-07-16
Need for the user to follow this instruction manual thoroughly for your safety.
Please keep for future reference. For specific information about your own blood
pressure, CONSULT YOUR PHYSICIAN.
* In the text of the instruction manual, abbreviated names of devices are used: Digital Blood
Pressure Monitor Prolife PA5 Comfort, Digital Blood Pressure Monitor Prolife PA5 Comfort AF

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Summary of Contents for Prolife PA5 Comfort

  • Page 1 Please keep for future reference. For specific information about your own blood pressure, CONSULT YOUR PHYSICIAN. * In the text of the instruction manual, abbreviated names of devices are used: Digital Blood Pressure Monitor Prolife PA5 Comfort, Digital Blood Pressure Monitor Prolife PA5 Comfort AF...
  • Page 2: Table Of Contents

    CATALOGUE Introduction ......................4 1.1 Safety instructions ................... 4 1.2 Intended use ..................... 4 1.3 Intended users ....................4 1.4 Intended patient population ................ 5 1.5 Intended use environment ................5 1.6 Indications ......................5 1.7 Contraindications .................... 5 1.8 Intended clinical benefits to patients ............5 1.9 Introduction to the working principle ............
  • Page 3 Useful information ....................22 Error messages and troubleshooting .............24 Maintenance ......................25 8.1 Maintenance ....................25 8.2 Storage ......................26 8.3 Cleaning ......................26 8.4 Battery replacement and maintenance ...........26 8.5 Calibration and service ................27 8.6 Optional medical accessories ..............27 Limited warranty ....................27 10. Correct disposal of this product...............28 11. Manufacturer information .................28 12. Technical specifications ..................29 13. Symbols description .....................31...
  • Page 4: Introduction

    The Prolife PA5 Comfort AF model is designed to detect atrial fibrillation, a dangerous heart rhythm disorder that can often be asymptomatic, yet signif- icantly increases the risk of stroke and heart failure.
  • Page 5: Intended Patient Population

    1.4 Intended patient population The Blood Pressure Monitor is designed for use by both healthcare profes- sionals and home users. This device is suitable for adult. Consult with your physician before using this Blood Pressure Monitor if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation;...
  • Page 6: Introduction To The Working Principle

    1.9 Introduction to the working principle The device uses oscillometer method to measure blood pressure with the method of measuring during inflation. Working principle: the device uses an air pump to inflate the cuff and press the artery blood vessel with the inflatable cuff. With the pressure increase in cuff, the arterial vessels showed a change process of completely opening –...
  • Page 7 Do not use this device with a defibrillator. • Do not use this device during MRI (magnetic resonance imaging) exam- • ination. Do not use the device in a combustible environment (i.e., oxygen- • enriched environment). Never submerge the device in water or other liquids. Do not clean •...
  • Page 8: Caution

    Clean the device and cuff with a dry, soft cloth or a cloth dampened • with water and a neutral detergent. Never use alcohol, benzene, thin- ner or other harsh chemicals to clean the device or cuff. To measure blood pressure, the arm must be squeezed by the cuff hard •...
  • Page 9 During measurement, make sure that no mobile device or any other • electrical device that emit electromagnetic fields is within 30 cm of this Blood Pressure Monitor. This may result in incorrect operation of the Blood Pressure Monitor and / or cause an inaccurate reading. DO NOT use this Blood Pressure Monitor in a moving vehicle such •...
  • Page 10: General Precautions

    DO NOT use other types of batteries. DO NOT use new and used • batteries together. DO NOT use different brands of batteries together. Remove batteries if this Blood Pressure Monitor will not be used for • a long period of time. If battery fluid should get in your eyes, immediately rinse with plenty •...
  • Page 11 Model: PA5 Comfort mmHg Cuff connection TIME MEMORY Power opening button button Connector ON / OFF button Model: PA5 Comfort AF Power Cuff connection TIME MEMORY ON / OFF button Connector opening button button...
  • Page 12: Digital Lcd Display Description

    Memory Set No Pressure Unit mmHg Irregular Heartbeat Diastolic Value Indicator (IHB) Heart Symbol Pulse Battery Warning Symbol Model: PA5 Comfort AF Time and Date Systolic Value Scale Indicator Memory Symbol Memory Set No Pressure Unit Diastolic Value Irregular Heartbeat Indicator (IHB)
  • Page 13: Common Functions

    3.3 Common Functions: Blood pressure and heart rate are measured. • Memory storage and clearing functions. • Date and time Settings. • Note: The above basic normal functions can be safely used by the user. 3.4 Functional Description low battery warning: If the battery warning icon appears in the display, the batteries remain 20% power to warn user the batteries will be run out.
  • Page 14: Preparation Before Use

    PREPARATION BEFORE USE Please check the complete accessories before using this product. Final assembly includes this battery installed (see section 4.1) and cuff wear- ing (see section 5.1). 4.1 Installing Batteries 1. Insert the batteries (4 x size AAA 1.5V), thereby observing the indicated polarity.
  • Page 15 You must then re–enter the date and current time. For this, please proceed as follows. 1. Press the TIME button for at least 3 seconds firstly, indicator «Year» will blink. The correct year can be entered by pressing the MEMORY button. 2. Press the TIME button again.
  • Page 16 6. Press the TIME button again to complete the setup device. The TIME setting is confirmed and the clock starts running. On the screen the current time is displayed. 7. To view the date, press the TIME button. DATE TIME Additional information With each press of the button (TIME, MEMORY) one input is made (e.g.
  • Page 17: Use Equipment

    USE EQUIPMENT 5.1 Applying the Arm Cuff Attempt to carry out the measurements regularly at the same time of day, since the blood-pressure changes during the course of the day. 1. Remove tight-fitting clothing or tight rolled up sleeve from your left upper arm.
  • Page 18: Sitting Correctly

    2. Stay at rest. The device measures blood pressure during inflation of the cuff, using the technology ComfortPro. 3. Only for Prolife PA5 Comfort AF. If the cuff is not firmly fixed and TIME TIME does not fit snugly to the arm,...
  • Page 19 4. Only for Prolife PA5 Comfort AF. In case of insignificant movement TIME of the arm during the measure- ment, the symbol , will appear on the display and the measure- ment will continue, otherwise the display will show the error Err2.
  • Page 20 measurement the If the symbol appears on the display after a pause of 1 hour, symbol is no longer displayed, there is no cause for concern. In this case, it is recommended to measure again the next day. Keep the arm still during measuring to avoid false readings. This device is not intended for use in people with pacemakers or defibrillators..
  • Page 21: Discontinuing A Measurement

    By pressing the MEMORY button, an average value of the last 3 measurements as well as the last measurement and the further last 198 measurements (MR199,MR198,…,MR1) can be displayed one after the other. For Prolife PA5 Comfort AF: TIME DATE TIME...
  • Page 22: Useful Information

    Deleting All Readings Before you delete all readings stored in the memory, make sure you will not need refer to the readings at a later date. Keeping a written record is prudent and may provide additional information for your doctor’s visit. In order to delete all stored readings, depress the MEMORY button for at least 5 seconds, the display will show the symbol «CL»...
  • Page 23 beat. Atrial fibrillation may be asymptomatic, but significantly increases the risk of stroke. This case requires medical supervision. How does AFIB impact my family or me? People with AFIB have a five-fold higher risk of getting stroke. Since the chance of having a stroke increases with age, AFIB screening is recom- mended for people over 65 years and older.
  • Page 24: Error Messages And Troubleshooting

    Grade 2 hypertension 160–179 100–109 Grade 3 hypertension ≥180 ≥110 Isolated systolic ≥140 ≤90 hypertension Isolated diastolic ≤140 ≥90 hypertension ERROR MESSAGES AND TROUBLESHOOTING If any of the below problems occur during measurement, check to make sure that no other electrical device is within 30 cm. If the problem persists, please refer to the table below.
  • Page 25: Maintenance

    Other possible malfunctions and their elimination If problems occur when using the device, the following points should be checked and if necessary, the corresponding measures are to be taken: Malfunction Remedy Check batteries for correct polarity and The display remains empty when the if necessary insert correctly.
  • Page 26: Storage

    8.2 Storage Keep your device in the storage case when not in use. 1. Remove the arm cuff from the device. Caution To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself. 2. Gently fold the air tube into the arm cuff.
  • Page 27: Calibration And Service

    Prolife conic cuff 22–45 cm. LIMITED WARRANTY The Digital Blood Pressure Monitor Prolife PA5 Comfort / PA5 Comfort AF has a 10 years warranty from the date of purchase. The warranty does not apply to damage caused by improper handling, accidents, not following the operating instructions or alterations made to the device by third parties.
  • Page 28: Correct Disposal Of This Product

    disassembly, traces of attempts to repair outside the authorized maintenance center, traces of moisture ingress or aggressive agents, or any other foreign interference in the construction of the device, as well as in other cases of violation by the consumer of the rules for storage, cleaning, transportation and technical operation of the device, provided in the instruction manual;...
  • Page 29: Technical Specifications

    5~40 ° C 15%~85%RH (non-condensing) Operation conditions 700 hPa~1060 hPa -10~55 ° C 10%~95%RH(non-condensing) Storage / transport conditions 500 hPa ~ 1060 hPa Protection against electric CLASS II and INTERNALLY POWERED shock Prolife PA5 Comfort: 175х90х44 ±1.0 mm Dimensions Prolife PA5 Comfort AF: 175х90х44 ±1.0 mm...
  • Page 30 4 size AAA batteries (optional); Instruction manual; Warranty card; AC Adapter. Contents Digital Blood Pressure Monitor Prolife PA5 Comfort AF (BP136A): Blood Pressure Monitor; Prolife conic cuff 22–45 cm; 4 size AAA batteries (optional); AC Adapter; Prolife case; Instruction manual;...
  • Page 31: Symbols Description

    SYMBOLS DESCRIPTION Symbols Description Symbols Description Indicates the authorized repre- Applied part – Type BF. sentative in the Degree of protection European Community / against electric shock European Union (leakage current) Batch code Electrical and electronic equipment marks. Indicates the manufacturer’s batch code so that the batch Reduce electronic and or lot can be identified...
  • Page 32: Guidance And Manufacturer's Declaration

    Warning! Not suitable for chil- Direct current dren under 3 years old Indicates the entity importing Indicates the entity dis- the medical device into the tributing the medical locale device into the locale GUIDANCE AND MANUFACTURER’S DECLARATION Important Information Regarding (EMC). Important information regarding Electro Magnetic Compatibility (EMC).
  • Page 33 Electromagnetic immunity: (IEC 60601-1-2) Guidance & Declaration — electromagnetic immunity This product is suitable for the following electromagnetic environment. Users should ensure that they are used in such an environment IEC 60601-1-2 Compliance Electromagnetic environ- Immunity test test level level ment –...
  • Page 34 NOTE: UT – is the a. c. mains voltage prior to application of the test level. Guidance & Declaration - Electromagnetic immunity This product is suitable for use in the electromagnetic environment specified below. Users should ensure that they are used in such an environment Immunity IEC 60601-1-2 Compliance...
  • Page 35 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 models are used exceeds the applicable RF compliance level above, the model Air Mi 1 should be observed to verify normal operation.

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