promed PBM – 3.5 Upper Arm Blood Pressure Meter Instruction Manual

promed PBM - 3.5 Upper Arm Blood Pressure Meter Instruction Manual

GETTING STARTED

SCOPE OF DELIVERY/ACCESSORIES

The following are included in the scope of supply of your Promed PBM-3.5 blood pressure meter:
– 1x blood pressure meter
– 1x arm cuff size M (arm circumference 22-32 cm)
– 1x tube connecting piece
– 4x batteries 1.5V AA
You can buy the following accessories and following replacement parts: 1. Accessories: – arm cuff size L (arm circumference 30-42 cm) Item No.: 402091 – mains adapter Item No.: 402093 2. Replacement Parts – arm cuff size M (arm circumference 22-32 cm) Item No.: 402092 – tube connecting piece Item No.: 402094 – batteries 1.5V AA Item No.:359993

DESCRIPTION OF THE UNIT

Please keep this user manual in a safe place! DE

Please read the user manual thoroughly before using the device for the first time. Many thanks for purchasing the Promed PBM-3.5 blood pressure meter. You have acquired a high-quality medical product for the personal checking of health. Promed is a leading company with decades of experience in personal hygiene, wellness and health areas. The Promed PBM-3.5 unit has been designed and manufactured in accordance with the IT Medical Device Directives 93/42/EEC to guarantee quality during use. The device may be used once this user manual has been read. We, as the manufacturer, cannot be made liable in any way for injury or damages to people or objects that arise from failure to comply with this user manual. We wish you a lot of enjoyment with your new Promed PBM-3.5. In the following we would like to familiarise you with the Promed PBM-3.5 blood pressure meter. Please read the user manual thoroughly before using the device for the first time. You can receive professional advice wherever Promed products are sold or get in touch with us if you have any questions. We can provide you with the name of the representative responsible for you.

Promed GmbH Kosmetische Erzeugnisse
Lindenweg 11, D-82490 Farchant, Ph: +49 (0) 8821/9621-0,

Fax: +49 (0) 8821/9621-21, E-Mail: info@promed.de

Further informations can be found on our homepage: www.promed.de

INTRODUCTION

The Promed PBM-3.5 blood pressure meter uses the oscillometric method of blood pressure measurement and is thus particularly suitable for the personal measurement and monitoring of blood pressure. With the oscillometric measurement method the meter measures the flow of your blood through the upper arm artery and converts these into readable measured values. In addition to this, it is not necessary to use a stethoscope with this measurement technique. The Promed PBM-3.5 is an automatic blood pressure meter that can measure the systolic, diastolic pressure and pulse. This device is only intended for use by adults. An intelligent control system for the pumping process ensures that the unpleasant feeling caused by incorrect pumping is reduced and shortens the measuring time. In this way, the useful life of the arm cuff is substantially extended. Each measurement result is displayed on the screen and automatically saved. 2×90 memory spaces are available for this. The Promed PBM-3.5 possesses a WHO (World Health Organisation) blood pressure classification index with which you can interpret the measured values more easily. Before using the Promed PBM-3.5 blood pressure meter, please read through the operating instructions carefully and keep the operating instructions in a safe place.

What is irregular heartbeat?

The Promed PBM-3.5 blood pressure meter can measure blood pressure and pulse even in the event of an irregular heartbeat. An irregular heartbeat is defined as a heartbeat that differs by at least 25 % from the average of all the heartbeats during the blood pressure measurement. It is important that you sit still and relaxed during the measurement and do not speak. Please note: If, when measuring, you frequently see the symbol for irregular heartbeat we recommend that you make sure that you see a doctor.

What is blood pressure?

Blood pressure is the force exerted by the blood against the walls of the arteries. Systolic pressure occurs when the heart contracts. Diastolic pressure occurs when the heart expands. Blood pressure is measured in millimetres of mercury (mmHg). The natural blood pressure of a person is represented by blood pressure at rest. This is obtained by measuring blood pressure in the morning before getting up.

What is high blood pressure and how can this be controlled?
High blood pressure is abnormally high arterial blood pressure which, if it remains uncontrolled, can cause many health problems such as stroke and heart attack. High blood pressure can be regulated by means of lifestyle, the avoidance of stress and medication under medical supervision. In order to prevent high blood pressure or keep it under control, the following principles should be adhered to:

• do not smoke
• regularly do a sport
• eat less salt and fat
• go to the doctor regularly
• keep to the correct weight

Why should one measure one’s blood pressure at home?
Visiting a clinic or doctor’s practice can lead to nervousness and thus produce increased blood pressure The measured values can be 25 to 30 mmHg higher than in a measurement at home. Measuring at home reduces the effects of other influences on the blood pressure measurement and thus supplements the measurements taken at the doctors and show the course of blood pressure more accurately and completely.

The blood pressure classification index of the WHO
Standards for assessing high blood pressure, without taking age into account, have been specified by the World Health Organisation (WHO) in accordance with the following table.

OPERATING THE UNIT

Testing/replacement of the battery

Remove the cover of the battery compartment (H) and insert the batteries. Ensure that the batteries are inserted with right polarity (+/-). If the batteries are too weak, this will be shown by the device on the battery status display (6). As soon as this symbol lights up the batteries absolutely must be replaced, because otherwise the measurement result will be incorrect.

Caution:

1. Remove the batteries if the device is not in use for long periods of time.
2. Do not mix old and new batteries or different types of batteries.
3. Warning: If batteries leak and come into contact with the skin or eyes, wash immediately with copious amounts of water.
4. Batteries must be handled by an adult. Keep batteries out of the reach of children.
5. Only batteries of the same or equivalent type are recommended.
6. You can also use rechargeable batteries.
7. Remove exhausted batteries from the unit.
8. Dispose of batteries safety according to battery manufacturer’s instructions.
9. Do not use batteries that are past their expiry date.

Using a mains adapter
The device can also be operated with a mains adapter. Make sure that the adapter is permitted for use with medical products and meets the following technical requirements; output voltage: 6 VDC, output current: 600 mA, mains barrel connector: plus internal, external diameter 5.5 mm internal diameter 2.1mm. You can always purchase a tested mains adapter from Promed

⚠ Please note:
If a mains adapter and rechargeable batteries are used at the same time, the rechargeable batteries will not be recharged. Rechargeable batteries must always be recharged in a separate charging device.

⚠ Please note: If, during a measurement, the electricity supply is interrupted or the battery status display (6) lights up, then the measurement absolutely must be repeated.

Connection of the upper arm arm cuff
In order to connect the upper arm arm cuff (G) to the device, insert the tube connecting piece (F) into the tube connection (E). While doing this, do not use excessive force to insert the connecting IT piece in the device.

Setting mode

1. Setting the units of measurement to be used In order to set whether mmHg or kPa should be displayed, press the “SET” button (B) and the following display will appear. By pressing the save button “MEM” (C) you can switch between the units. You can save your setting by pressing the “SET” button (B) ­ Standard = mmHg.
2. User setting mode Next, “User 1” or “User 2” is displayed on the screen. PL By pressing the save button “MEM” (C), you can choose between “User 1” and “User 2”. By pressing the “SET” button (B) again, you can save your setting. It is possible to change the user before every measurement. To do this, press twice the “Set” button (B) and choose the user by pressing the save button “MEM” (C). In order to leave the setting mode and to start the measurement, now press the AR START/STOP button (A).

Before the measurement

Before you carry out a blood pressure measurement you should remain entirely calm for 5 – 10 minutes, not eat, not drink any alcohol, not smoke, not do any sport and not bathe. All of these factors influence the measurement result. Remove items of clothing that are tight on your upper arm. Always measure on the same arm (normally left). Carry out the measurement regularly at the same time of day, because blood pressure changes during the day.

Factors that can lead to incorrect measurements
Everything that supports the arm during measurement can increase the blood pressure. Make sure that you are in a comfortable position and do not move your arm during the measurement. If necessary, you can place a cushion under the arm to be measured If the arm artery is lower or higher than the heart this will lead to an incorrect measurement result.

⚠ Please note:
Only use arm cuffs that are permitted by the manufacturer and clinically approved! A loose arm cuff or a defective arm cuff in which the bladder is exposed causes incorrect measurement values. In the case of repeated measurements, blood accumulates in the arm arteries, which can lead to incorrect measurement values. Continuous blood pressure measurements should be repeated no sooner than after a 1 minute break. Here it is important that the arm is held upward to ensure that the accumulated blood can flow away.

Putting on the arm cuff

Measurement
After the arm cuff has been suitably positioned you can start the measurement.

Please note:

If kPa is displayed as a unit, you have chosen this unit of measurement during setting. In order to have mmHg displayed, you must switch the unit of measurement. The symbol is shown together with the measured values if an irregular heartbeat is ascertained during the measurement.

Interrupting a measurement

If for some reason (e.g. feeling unwell) it is necessary to interrupt the measurement of the blood pressure, this can be done at any time by pressing the START / STOP button (A). This causes the arm cuff pressure to be reduced immediately and the measurement to be interrupted.

Data storage of the measurement results
This blood pressure meter saves 90 measurement results per user. As soon as there are more PL than 90 measured values per user, the oldest entry is deleted.

Reading the memory
If the device has been switched off, press the save button “MEM” (C) and the last 3 average measured values will be shown on the display. The last measured values are shown by pressing the save button “MEM” (C) once more. At every press, the memory moves to the older measured value.

Deletion of the memory

If you are sure that you want to delete all the saved measured values of the chosen user, press the “SET button (B) 8 times until CL appears in the display. The device now switches itself off. Now press the START / STOP button (A) and CL will flash 3 times in order to delete all saved measurement results. Now press the save button “MEM” (C) and M and “no” will be shown on the display. This means that there are no measurement results in the memory

SAFETY INSTRUCTIONS

⚠ Special warnings!

• People with arrhythmia, diabetes, circulatory disorders or apoplexy problems must only use the device under medial supervision.
• Contact your doctor for specific information on your blood pressure. Self-diagnosis and self-treatment based on the measurement results can be dangerous. Always follow the instructions of your doctor. It is not permitted to make changes to this device. Do not change anything on this device without the manufacturer’s approval.
• If this device has been changed, an appropriate inspection and check must be carried out in order to ensure that the device can be safely used. Do not use a mobile phone close to the device. This can lead to failure of the device.
• Please avoid proximity to radiating surfaces, in order to avoid distortion of the measurements.
• Never place the arm cuff tube around the neck as this can lead to choking.
• Only use approved arm cuffs, because otherwise the correct functioning of the device cannot be guaranteed.

Pay attention to the following before first time operation:

• Only for home use.
• Scrupulous supervision is required when the device is being used in the vicinity of children. Never place or use the unit in a wet or moist environment.
• Do not use the unit under water, e.g., under the shower.
• Never place the unit in direct contact with fire, gas or oxygen, or hot objects such as hot plates.
• Take every precaution possible to ensure that the unit does not fall down or get damaged in any other way.
• If problems do arise with the unit, take it immediately to get it repaired. · Do not lubricate or wash the unit.

Danger!

• Do not place the unit in direct contact with water or other fluids.
• It is not permitted to use the unit outdoors.
• Never touch the unit with wet hands.
• Do not store the unit near a wash basin or bath tub as there is the danger that the unit may fall or be pulled into the wash basin or the bath tub.

Warning!

• Never leave the unit unattended when children or inexperienced persons are in the vicinity of the unit.
• Make sure that children do not play with the device.
• Only use the unit for the applications described in this manual.
• This unit is not designed for use by people (including children) who have limited physical, sensory, or intellectual abilities or who do not have sufficient experience and/or sufficient knowledge. This does not apply if these people are supervised by a person responsible for their safety or receive instructions from them on how to use the unit.
• Do not use the unit underneath blankets or cushions as excessive heat may cause fire, injury or an electrical shock.
• It is not permitted to use the unit outdoors.
• Never let children play with the packaging material; there is a risk of suffocation.
• Never mix old and new batteries.
• Never place heavy objects on the device.
• Do not make any sharp bends in the tube.

TROUBLESHOOTING

Error displays

The following symbols can appear on the display if a measurement is not correct.

If the fault cannot be rectified, contact the manufacturer before you try to repair the AR device yourself.

CARE, MAINTENANCE AND STORAGE

• Clean the device with a soft dry cloth.
• Do not use any abrasives or volatile cleaning agents.
• Do not dip the device or parts of it in water.
• Wipe all surfaces of the blood pressure meter and of the arm cuff thoroughly, and make sure that you clean the inner side and outer side of the arm cuff. Take care that no moisture gets into the main device.
• Wipe carefully with a dry cloth in order to remove excess moisture that may still be on the blood pressure arm cuff. Lay the arm cuff out in your home in a rolled-out position so that it can air-dry.
• Do not place the unit in direct contact with water or other fluids.
• Switch the unit off when it is not in use.
• Before putting the Promed PBM-3.5 into storage for a longer period of time, remove the batteries from the compartment. Leaking batteries can damage the unit.
• Keep the device and its accessories safe in a cool, dry place.
• Do not expose the device to direct sunlight and protect it against dirt and moisture.
• You can clean your Promed PBM-3.5 by wiping it over carefully with a cloth moistened with mild soapy water. You may also use isopropyl alcohol or a soap solution. Household detergents and cleaning products are not suitable.
• The unit must not be returned to your dealer or the manufacturer for inspection and recalibration.
• If you should experience other problems, consult your dealer, returning the unit if necessary. Never DE attempt to repair a fault yourself.

DISPOSAL

Power tools, accessories, and packaging should be recycled in an environmentally suitable manner.

Only for EU countries:

Do not throw power tools in with the domestic waste! In accordance with the European Directive 2012/19/EU on waste electrical and electronic equipment and its implementation into national law, non-functioning power tools must be collected separately and recycled in an environmentally suitable manner. This symbol indicates that disposal of this product in the domestic waste is not permitted within the EU. Waste devices contain valuable recyclable material that should be recycled. Recycling also prevents uncontrolled waste disposal from damaging the environment and human health. Therefore, please dispose of all waste devices using the appropriate collection systems or send the device to the place of purchase for disposal. The place of purchase will then recycle the device.

Rechargeable batteries/batteries: Do not throw your rechargeable batteries/batteries in the domestic waste, in fire, or in water. RU Rechargeable batteries/batteries should be collected, recycled, or disposed of in an environmentally friendly manner.

PL Only for EU countries:

According to the directive 91/157/EEC, defect or used rechargeable batteries/batteries must be recycled. Waste rechargeable batteries/batteries can be directly handed to: Promed GmbH, Lindenweg 11, D-82490 Farchant.

WARRANTY CONDITIONS

This product was produced with the utmost care and was thoroughly tested before it left the factory. Therefore, we provide a warranty period of 36 months from the date of purchase for this product. Promed products conform to their description and the relevant specifications; it is your responsibility to ensure that the product which you have purchased is designed for your intended use.

• In the event of material defects and/or manufacturing errors which appear during proper use and are detected during the warranty period, we will replace all defective parts of the product free of charge within the warranty period, including the labour costs for warranty repairs.
•  The warranty does not cover:
  • Normal wear on the product
  • Defects which were caused during transportation or storage of the product
  • Defects or damage which were caused through improper use or inadequate maintenance
  • Damage resulting from disregarding the notes in the operating manual
  • Damage resulting from modifications to the product which were not carried out by Promed.
  • Damage caused by sharp objects or as a result of torsion, compression, being dropped, an abnormal impact or other actions which are beyond Promed’s reasonable control.
  • Parts which are subject to wear (e.g. moving parts such as ball bearings, etc., fasteners, etc.) are generally excluded from the warranty.
• A claim under the warranty is not enforceable if:
  • the product is not sent back in its original packaging or in adequately secure packaging;
  • it has been modified or repaired by a person or company other than Promed or one of Promed’s authorised dealers;
  • the product has been repaired using parts which are not approved by Promed;
  • the serial number / LOT number of the product has been removed, deleted, changed or made illegible.
  • For reasons of hygiene, any products which have been exposed to direct contact with a body or with bodily fluids (e.g. blood) must be packaged in an additional plastic bag before they are sent back. In this case, a specific note of this situation must be made in the package or in the accompanying documents.
• For components or products which are replaced during the warranty period, a warranty is only provided for the remainder of the original warranty period; provided that the product or part replacement was carried out by Promed or one of Promed’s authorised dealers.
  • The warranty period begins on the day of purchase. Claims under the warranty must be established within the warranty period. Complaints arising after the expiry of the warranty period cannot be considered.
  • Under these warranty conditions, the warranty shall only apply if the date of purchase can be proven by means of a sales receipt or similar.
  • We reserve the right to make technical and visual changes as well as changes to the features.
• This warranty is only valid and enforceable in the country in which it was purchased by the original buyer, provided that it was Promed’s intention that the product should be offered for sale in this country. This warranty is also enforceable in any country within the European Economic Area in which Promed has an authorised importer or sales partner. Depending on each country, specific and differing warranties and guarantees may be applicable owing to the particular applicable legislation. These legal provisions are neither excluded nor limited by these warranty conditions. To the extent permissible under national law, the warranty period shall not be extended, renewed or otherwise affected by any subsequent resale, repair or replacement of the product.
• The provisions of the UN Convention on Contracts for the International Sale of Goods shall not apply.
• Our warranty conditions do not affect the seller’s legal warranty obligation.
• To the fullest extent possible under the applicable mandatory legislation, these warranty conditions constitute your sole and exclusive legal remedy and shall apply in place of any other express or implied warranty conditions. Promed is not liable for any unusual, incidental, punitive or consequential damages including, but not limited to loss of profits, loss of use, loss of revenue, costs of replacement equipment or facilities, third party insurance claims, and damage to property which are the result of the purchase or use of the product or occur owing to a breach of warranty, a breach of contract, negligence, product defects or any other legal or statutory circumstances, even though Promed was aware of the possibility of such damages. Promed is not liable for any delay in warranty claims.
• Promed cannot be held liable for any possible translation errors.

The following information is essential for smooth processing:

1. Original proof of purchase/receipt or dealer’s stamp with date of purchase
2. Defect discovered
3. Product designation / type / serial/batch number

References

• promed

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