promed HGP-40 Wrist Blood Pressure Monitor Instructions

promed HGP-40 Wrist Blood Pressure Monitor Instructions

About this device

• A. Start / Stop button
• B. Memory / Set button
• C. WHO scale
• D. Wrist cuff
• E. Battery compartment cover
• F. Battery compartment
• G. Batteries
• H. Storage box

**LCD display

**

1. Date / time display
2. Vibration sensor
3. Blood pressure analysis display
4. Battery status display
5. Systolic blood pressure
6. Selected measurement unit
7. Diastolic blood pressure
8. Display for pulse
9. Pulse rate display

Explanation of display symbols

SYMBOL

| DESCRIPTION|

EXPLANATION

---|---|---

SYS

| Systolic blood pressure| Highest measurement value

DIA

| Diastolic blood pressure| Lowest measurement value
| Pulse| Heart beats / minute
| Vibration sensor| Vibrations lead to inaccurate measurement results
| Battery status display| This symbol appears when the battery is empty. As soon as this symbol appears, we recommend you replace all batteries with new ones.
kPa| kPa| The selected measurement unit is kPa (1 kPa=7.5 mmHg)
mmHg| mmHg| The selected measurement unit is mmHg (1 mmHg = 0.133 kPa)
| Display for irregular heart beat| This symbol appears when an irregular heart beat was detected during measurement
| Date / time| Display for date and time
| Blood pressure analysis display| The arrowhead indicates the colour index of the WHO scale which matches your measured value.
| Display for pulse| When a pulse is measured, the symbol flashes with each heart beat.

SCOPE OF DELIVERY/ACCESSORIES

The following components are included in the scope of delivery of your Promed HGP-40 blood pressure monitor:

• 1x blood pressure monitor with wrist cuff (circumference 135 – 215 mm)
• 2x batteries 1.5 VDC AAA
• 1x storage box
• 1x instructions for use
• 1x blood pressure card

The following spare parts are available at Promed:

• batteries 4x 1.5 VDC AAA item no.: 359994
• storage box item no.: 964002
• blood pressure card item no.: 984006

DESCRIPTION OF THE DEVICE

Please keep the instructions carefully!

Please read the user manual thoroughly before using the device for the first time. Many thanks for purchasing the Promed HGP-40 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 HGP-40 unit has been designed and manufactured in accordance with the 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 HGP-40. In the following we would like to familiar rise you with the Promed HGP-40 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 information’s can be found on our homepage: www.promed.de

PROPER USE

Promed HGP-40 is a blood pressure monitor which automatically measures the systolic and diastolic blood pressure using the oscillometric measuring method. Furthermore, it measures the pulse and displays an irregular heartbeat, where appropriate. It is only intended for the application to human beings. Promed HGP-40 has been developed for the use at home and should only be used by adults over 18 years with a wrist circumference in the range of 135mm to 195mm.

MEDICAL LIABILITY NOTE

These instructions and the described products are not intended as a substitute for the advice provided by your own physician. The information contained herein or the values measured by the product shall not be used for self- diagnosis, self-treatment of a health problem or for self-prescription of medicaments. If you suspect, based on the measurement results, that you have a medical problem, please consult your physician.

SAFETY INFORMATION

Special warnings!

• This device is only intended for use by adults.
• This device is intended for the non-invasive measurement and monitoring of arterial blood pressure. It is not intended for use on extremities other than the wrist or for functions other than blood pressure measurement.
• If you are taking any medication, consult your physician to determine the time of day that is best suitable for measuring your blood pressure. Never change any prescribed medication without consulting your physician.
• If the cuff pressure reaches 300 mmHg (40 kPa), the device will be emptied automatically. If the cuff is not emptied when the pressure reaches 300 mmHg (40 kPa), release the cuff from the wrist and press the START / STOP button (A) to stop inflation.
• Read these instructions for use carefully before using the product in order to avoid measurement errors.
• The device is not an AP / APG device and is not suitable for use in presence of a flammable anaesthetic mixture with air, oxygen or laughing gas.
• The operator must not touch the poles of batteries and the patient at the same time.
• The user must ensure the safe function and the flawless state of the device before use.
• Only use accessories that are specified / approved by the manufacturer. Otherwise, this may result in damage to the device or danger for the user / patient.
• This device is not suitable for continuous monitoring during medical emergencies or surgeries. Otherwise, the patient’s wrist and fingers will become narcotic, swollen and even purple due to a lack of blood.
• The device does not need to be calibrated together with the service every two years.
• When the device is used for measurements on patients with frequent arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, this may result in deviations of the result. Please consult your physician on the result.
• Too frequent or continuous measurements may lead to disturbed circulation and injuries.
• Do not use the cuff on a wound, since this may lead to further injury.
• Do not inflate the cuff on a limb that is monitored by other medical devices at the same time since this may result in a temporary loss of function of the devices used at the same time as well as in an impairment of the patient’s blood circulation.
• Persons with arrhythmia, diabetes, circulatory disorders or apoplexia must only use this device under medical supervision.
• This product is not suitable for:
• pregnant women
• people with arrhythmia
• people with an intravenous injection
• during the dialysis treatment
• women with a preeclampsia (pregnancy poisoning)
• For people who underwent a mastectomy (especially after the removal of lymph nodes), it is recommended to carry out the measurement on the unaffected side.
• When handling this device, consider that the following situations may interrupt blood circulation and impair the patient’s circulation:
  • too frequent and continuous multiple measurements;
  • the use of the cuff and its pressurisation on a wrist where an intravascular access or therapy or an arteriovenous shunt is present; this may cause harmful injuries to the patient.
• Results of blood pressure measurements should be interpreted by a physician or a qualified medical professional who is familiar with your case history. Write down your measurement results regularly for your physician and keep your physician up to date regarding the lasting changes of your blood pressure.
• Remember that the blood pressure will certainly vary throughout the day and in influenced by many factors, like stress, eating, smoking, alcohol consumption, medicament and physical activity, etc. Usually, the blood pressure increases during work and is lowest during sleep.
• Consult your physician regarding specific information on your blood pressure – selfdiagnosis and self-treatment using the measurement results may be dangerous. Please follow the instructions of your physician.
• If you suffer from circulatory problems, such as arteriosclerosis, diabetes, liver diseases, kidney diseases, severe hypertension, peripheral circulatory disorders, etc., please consult your physician or a medical professional before using this device.
• Blood pressure measurements which were carried out using this device correspond to those which are obtained by a trained observer using a cuff/stethoscope auscultation method, and are within the accuracy limits which are stipulated in the standard EN 1060-4.
• Modifications to this device are prohibited.
• If this device was modified, a respective inspection and test must be carried out in order to ensure a safe use of the device.
• Only qualified technicians are allowed to repair, dismount and maintain this device. This also applies to possible software upgrades.
• Do not use a mobile phone near the device. This may result in an operational failure.
• Please avoid using the device close to radiating surfaces in order to not falsify the measurements.
• The device is not intended for use in an MR (magnetic resonance) environment.
• Only use approved cuffs, otherwise the correct functionality of the device cannot be guaranteed.

Consider before commissioning:

• Only for use in indoor spaces.
• When using a device in the presence of children, an attentive supervision is required.
• Never position or use the device in a wet or moist environment.
• Do not use the device under water, e.g. in a shower.
• Never bring the device into direct contact with fire, gas or oxygen as well as hot objects, such as hobs.
• Take every possible precaution to ensure that the device does not fall down or is damaged otherwise.
• If problems at the device occur, absolutely have it repaired immediately.
• Do not lubricate or wash the device.
• Never press the Start/Stop button (A) when no cuff is applied.

Danger!

• Do not bring the device into direct contact with water or other liquids.
• The device must not be used outdoors.
• Do not touch the device with wet hands.

Warning!

• Do not leave the device without supervision when there are children or persons not used to handling the device around.
• Make sure that children do not play with the device.
• Only use the device for applications as described in this manual.
• This device is not intended to be used by persons (including children) with limited physical, sensory or mental aptitude or lack of experience and/or  knowledge unlessthey are supervised by a person responsible for their safety or have received instruction from this person as to how the device is used.
• Do not use this device under blankets and pillows as this may lead to excessive heat, fire, injuries or an electrical shock.
• The device must not be used outdoors.
• Do not allow children to play with the packing material as there is a risk of suffocation.
• Never use old and new batteries together.
• Never put heavy objects onto the device.

INTRODUCTION

The Promed HGP-40 blood pressure monitor uses the oscillometric method of the blood pressure measurement and is thus particularly suitable for the personal blood pressure measuringand monitoring. With this measuring method, the device measures the flow of your blood through the arm artery and converts this into readable measured values. Furthermore, this measuring technologies does not require the use of a stethoscope. Promed HGP 40 is an automatic blood pressure monitor which is able to measure the systolic and the diastolic pressure as well as the pulse. This device is only intended for the use by an adult. An intelligent control of the inflation ensures that the uncomfortable feeling in the event of an incorrect inflation is reduced and that the measurement time is decreased. Thus, the lifetime of the wrist cuff is significantly increased. Each measurement result is shown on the display and stored automatically. 3X40 memory locations are available for this. Promed HGP-40 has a WHO (World Health Organization) blood pressure classification index which enables you to interpret the measured values more easily.

What is irregular heartbeat?

The Promed HGP-40 blood pressure monitor can measure blood pressure and pulse even in the event or an irregular heartbeat. An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring the systolic and diastolic blood pressure. This device records the heartbeat intervals during each measurement and determines the standard deviation. When the calculated value is or exceeds 15, the symbol for irregular heartbeat appears on the display when the measurement results are shown. It is important for you to sit still and relaxed and do not speak during measurement.

Note: An appearance of the symbol for irregular heartbeat indicates that an irregular pulse was detected in connection with an irregular heartbeat. This is normally not a cause of concern. However, if the symbol appears frequently, we recommend you see a doctor. Please note that the device does not replace a heart examination, but is for detecting pulse irregularities early.

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.

Why does blood pressure change over the day?

1. Your individual blood pressure varies several times per day. It also depends on how you attach the cuff and on your position during measurement. You should therefore always carry out the measurement under the same conditions.
2. If you are taking medication, there will be more variations of pressure.
3. Wait at least for 3 minutes before starting another measurement.
4. When you are anxious.

Take 2-3 deep breaths before starting the measurement.

Note:  Relax for 4-5 minutes to calm down.

The blood pressure classification index of the WHO

Standards for assessing high blood pressure without consideration of age have been defined by the World Health Organisation (WHO) and the International Society of Hypertension (ISH) in accordance with the following table.

Blood pressure level

| Systol (mmHg)| Diastol (mmHg)| Colour|

Recommendations

---|---|---|---|---
Grade 3| Sever hypertension| =!180| =!110| red| Immediately repeat the measurement. If the result is confirmed, you have a severe hypertension and have to check your blood pressure at least once a day.
Grade 2| Moderate blood pressure| 160 ~ 179| 100 ~ 109| red| Immediately repeat the measurement. If the result is confirmed, you have a moderate hypertension and have to check your blood pressure several times per week.
Grade 1| Slight blood pressure| 140 ~ 159| 90 ~ 99| red| Immediately repeat the measurement. If the result is confirmed, you have a slight hypertension and have to check your blood pressure several times per month.
High-normal| 130 ~ 139| 85 ~ 89| Orange| Your blood pressure is slightly increased. It is recommended to seek advice regarding changes in lifestyle and to check the blood pressure regularly.
Normal| 120 ~ 129| 80 ~ 84| Yellow|
Optimal| < 120| < 80| Green

OPERATING THE DEVICE

Caution:

Your normal blood pressure / pulse range can only be determined by a physician. Please consult a physician if your measurement result is outside the permissible range. Please note that only a physician can determine whether your blood pressure value has reached a dangerous level.

Inserting / replacing the battery

To insert and/or replace the batteries, remove the cover of the battery compartment (E) and insert 2 1.5 V AAA batteries (G). While doing so, make sure that the batteries are inserted in the correct polarity (+/-). After inserting, close the battery compartment again.

In order not to falsify the measurement result, the batteries must be replaced immediately if:

• The battery status display (4) on the display shows the symbol
• The display becomes darker
• The display does not light up

Caution:

• Remove the batteries when the device is not used for a longer time.
• Do not use old and new batteries or different battery types at the same time.
• Warning: If batteries leak and come in contact with skin or eyes, immediately clean these areas with plenty of water.
• Batteries shall only be used by adults. Keep the batteries out of the reach of children.
• It is recommended to use batteries of the same or similar type.
• Remove empty batteries from the device.
• Dispose of the batteries according to the instructions of the battery manufacturer.
• Do not use batteries when they have expired.

Note

If the power supply is interrupted or the battery status display (4) lights up during measurement, the measurement must absolutely be repeated.

Setting the date, time and measurement unit

Note:

It is important to set the clock before using your blood pressure monitor , so that a time stamp can be assigned to every dataset stored in the memory. (Year: 2014 – 2054, time format: 24 H / 12 H).

This basic setting can only be carried out when Promed HGP-40 is switched off.

1. Press and hold the Memory / Set button (B) for approx. 3 seconds to enter the setting mode. The figure that is flashing now is for the year to be set.
2. Now press the button again to change the setting. The year will increase by one every time you press the button.
3. When you have reached the correct year, press the Start / Stop button (A) to confirm your selection. The device automatically passes to the next step.
4. Repeat the steps 2 and 3 to set and save the month and the day.
5. The device now enters the time format setting. Repeat the steps 2 and 3 to set the time format to 24 or 12 hours.
6. Repeat the steps 2 and 3 to set and save the time (hour / minute).
7. Repeat the steps 2 and 3 to set and save the measurement unit (mmHg / hPa).
8. After you have saved the measurement unit, the display shows all settings that you have made again and then switches off.
   

Tips for the measurement

Before you carry out a blood pressure measurement, you should remain entirely calm for 5 minutes before the measurement.

For an informative comparison, try to measure under similar conditions if possible. For example, carry out daily measurements approximately at the same time of day, on the same wrist or as prescribed by your physician.

The following factors may influence the measurement result and should therefore be observed:

• After eating, wait for at least 1 hour before carrying out a measurement.
• After bathing, wait for at least 20 minutes before carrying out a measurement.
• Do not take measurements immediately after sporting activities.
• Do not take measurements in a very cold environment.
• Do not take measurement immediately after having consumed tea, coffee or alcohol.
• Do not take measurements immediately after smoking.
• Do not speak during the measurement.
• Do not move during the measurement.
• Do not carry out a measurement when you are feeling the need to urinate / to have a bowel movement.
• Remove all items of clothing that are tight-fitting on your arm before the measurement.

Other factors that can lead to inaccurate 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 used for the measurement. If the arm artery is lower or higher than the heart, this will lead to an inaccurate measurement result.

Note:

Use the Promed HGP-40 only if the cuff is intact. A loose cuff or a defective cuff with an exposed inflation bladder leads to inaccurate measurement results. In the event of repeated measurements, blood is accumulated in the arm arteries and may thus result in inaccurate measurement results. Continuous blood pressure measurements should be repeated after a break of at least 3 minutes so that the blood circulation can normalize. It is important in this case to hold the arm up in order to ensure that the accumulated blood can drain off.

Note:

Do not use the Promed HGP-40 on a wrist where wounds or other injuries are present.

Note: Only use the Promed HGP-40 on the wrist.

Putting the cuff on

1. Remove all items (wristwatch, bracelet, etc.) from your wrist. If your physician diagnosed poor circulation of one wrist, please use  the other one.

2. Remove any items of clothing from your wrist to make sure that the device is positioned directly on your skin.

3. Put the cuff on the wrist with the hook-and-loop side facing downwards so that the display is on the inner side of the arm. No clothes may be  between the cuff and the wrist. Any item of clothing that is tight-fitting on the arm must be removed.

4. Make sure that the lower edge of the cuff is positioned at a distance of about 1 -1.5 cm from the lower edge of your palm.

5. Secure the cuff using the hook-and-loop fastener in such a way that it fits comfortably and is not too tight.

6. Sit comfortably with your legs not crossed, your feet fl at on the ground, your back and wrist supported and place your arm on a table (palm facing upwards) so that the cuff is at the level of your heart. This is particularly important for hypertensive patients.

Will the result be the same if the measurement is carried out on the right wrist?

If it is not possible to put the cuff on the left arm, it can also be placed on the right side. However, all measurements should be carried out on the same arm.

Measurement

1. When the device is switched off, press the Start / Stop Taste (A) to switch it on and the measurement is carried out automatically.
   

2. After reading the measured values, press the Start / Stop button (A) again to switch the device off. Otherwise, it is switched off automatically within 1 minute.

Note: If the device does not stop inflating, press the Start / Stop button (A), this leads to an interruption of the measurement and the immediate reduction of the cuff pressure.

Note:

If it is necessary to abort the measurement for whatever reason (e. g. discomfort) this is possible by pressing the Start / Stop button (A) at any time. This interrupts the measurement and immediately reduces the cuff pressure.

Using the memory function

This device has a memory for storing 60 measurements. Every time a measurement is completed, the device automatically saves the blood pressure and the pulse frequency. If 60 datasets have already been saved, the oldest measured values will be replaced by the latest ones.

Reading the measured values

The stored measured values can only be accessed when the Promed HGP-40 is switched off.

1. Press the Memory / Set button (B) to display the average value of the last three measurements.

2. By pressing the Memory / Set button (B) again, you can see the individual measurement results including the date and time of measurement. The last measurement is displayed first. By pressing the Memory / Set button (B) again, you enter the next dataset. The data set number is displayed once and then the date and the time of day are displayed alternately.

3. After reading the desired measured value, press the Start / Stop button (A) to switch off the device. Otherwise, it is switched off automatically within 1 minute.
   

Note:

The latest dataset (1/XX) is always displayed fi rst. Every new measurement is assigned to the first (1) dataset. All other datasets are pushed back by one position (e. g. 2 becomes 3 and so on) and the last dataset (60) is deleted from the list.

Deleting measured values

1. In memory mode, press and hold the Memory / Set button (B) for 3 seconds and the display will show “dEL All”.

2. Press the Memory / Set button (B) again to confi rm the deletion. The display shows “dEL dONE” and the device switches off.
   Note: To leave the deletion mode without deleting datasets, press the Start / Stop button (A) instead of the Memory / Set button (B).

3. If no dataset is present, the display looks like this.

Note: The deletion of measured values cannot be reversed.

TROUBLESHOOTING

In this section, you will find a list of error messages and frequently asked questions regarding problems that may occur with your Promed HGP-40 blood pressure monitor. If the device does not function as it should in your opinion, check the following points before contacting the customer service.

Insert the batteries correctly.
Weak batteries| appears on the display| The batteries are empty.| Replace the batteries with new ones.
Error code| E1 appears on the display| The inflation pressure is too low| Attach the cuff correctly and repeat the measurement.
E2 appears on the display| The cuff is not attached correctly.
E3 appears on the display| The cuff cannot be inflated during the measuring process.
E4 appears on the display| The cuff is too tight.
E5 appears on the display| The pressure of the cuff is too high.| Relax for a moment and repeat the measurement.
E6 appears on the display| The battery voltage is too low during inflation.| Repeat the measurement. If E6 is displayed again, replace the batteries with new ones.
E10 or E11 appears on the display| The device detected a movement during measurement.| Movements can influence the measurement. Relax for a moment and repeat the measurement.
E20 appears on the display| The measuring process cannot detect a pulse.| Loosen the clothes on the wrist and repeat the measurement.
E21 appears on the display| Incorrect measurement.| Relax for a moment and repeat the measurement.
EExx appears on the display| A calibration error has occurred.| If the problem persists, please contact the retailer or our customer service department for further support.
Warning message| “OUT” shows| Out of measurement range| Relax for a moment. Refasten the cuff and thenmeasure again. If the problem persists, contact your physician.

If the fault persists, please contact the manufacturer before trying to Repair the device on your own.

CARE/MAINTENANCE/STORAGE

• Clean the device with a soft dry cloth.
• Do not use abrasives or volatile cleaning agents.
• Do not immerse the device or parts thereof in water.
• Thoroughly wipe off all surfaces of the blood pressure monitor and the cuff and ensure that you clean the inner and outer surface of the cuff. Ensure that no moisture can enter the main device.
• For cleaning, you can use a dilution of neutral cleaning agents or soap solution.
• Carefully wipe off with a dry cloth in order to remove excess moisture which may remain on the blood pressure cuff. Lay down the cuff unrolled in your apartment in order to allow it to air-dry.
• Ensure that the cuff is completely dry before using it again.

Note:

• For cleaning, use only tap water.
• Do not bring the device into direct contact with water or other liquids.
• Switch off the device when it is not in use.
• Before storing the Promed HGP-40 for a longer period, remove the batteries from the battery compartment. Leaking batteries may damage the device.
• Always store and transport the device after use in the storage bag.
• Store the device and its accessories in a cool, dry place.
• Do not expose the device to direct sunlight and protect it against dirt and moisture.
• For inspection and recalibration, the device does not have to be sent to the dealer or the manufacturer.
• If you detect other problems, please contact your dealer who sends in the device, if necessary. Never try to correct an error on your own.

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. Rechargeable batteries/batteries should be collected, recycled, or disposed of in an environmentally friendly manner.

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 modifi cations 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 modifi ed 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 profi ts, 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

EXPLANATION FOR THE SYMBOLS

• Symbol for WARNING! Indicates sections of the user manual that are safety-relevant!
• Symbol for type BF devices
•  Pay attention to the symbol for the user manual!
• Symbol for Manufacturer and manufacturing Factory
•  Symbol for date of manufacture
• Symbol for Notified Body

CE-DIRECTIVES

The requirements of the EU Directive 93/42/EEC in conjunction with the EU Directive 2007/47/EC for class IIa medical devices were met according to the standard EN 60601-1-2:2015. CE according to the EU Directives 2014/30/EU, 2011/65/EU, 1907/2006/EC, 93/68/EEC.
The CE marking for the device refers to the EU Directive93/42/EEC in conjunction with the EU Directive 2007/47/EC.
Device classification: Class IIa. Furthermore, the device fulfils the requirements of the standards:
EN 60601-1:2006 +A1:2013
EN 60601-1-2:2015
EN 60601-1-11:2015
EN 60601-1-6:2010+A1:2015
EN ISO 81060-1:2012
EN 1060-3:1997+A2:2009
EN 1060-4: 2004
IEC/EN 62304:2006+AC: 2008

TYPE LABEL

CERTIFICATION NO

TECHNICAL SPECIFICATIONS

• Device type
  Wrist blood pressure monitor

• Measuring method: Oscillometry

• Measuring range Rated cuff pressure:
  0 mmHg ~ 299 mmHg
  (0 kPa ~ 39.9 kPa)

• Measurement pressure:
  SYS: 60 mmHg ~ 230 mmHg
  (8.0 kPa ~ 30.7 kPa)
  DIA: 40 mmHg ~ 130 mmHg
  (5.3 kPa ~17.3 kPa)
  Pulse: 40 – 199 beats/min

• Measuring accuracy: Blood pressure: +/- 3 mmHg (0.4 kPa) at a room temperature from 5 °C – 40 °C Pulse: ± 5 %

• Measurement data memory: 60 datasets

• Power supply: 3 VDC (2×1.5 VDC AAA batteries)

• Automatic switch-off: After 1 minute

• Protection class: IP 22

Display

• Digital LCD display: 32 mm × 45 mm
• Dimensions (LxWxH): 88 mm x 67 mm x 28 mm
• Weight: 86 g without batteries
• Cuff circumference: 13.5 – 21.5 cm

TRANSPORT/STORAGE/OPERATING CONDITIONS

Transportation only in the original packaging

Transportation/storage conditions

• Transportation and storage temperature: -20 °C – +60 °C
• Relative humidity:  93 %, non-condensing, at a water vapour pressure up to 50 hPa

Operating conditions:

• Operating temperature: +5 °C – +40 °C
• Relative humidity: 15 % to 90 %, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa
• Air pressure: 700 to 1060hPa

A sudden change in temperature is to be avoided due to the possible condensation of the device. Use the device only after a temperature equalization.

MANUFACTURER

Promed GmbH · Lindenweg 11· D-82490 Farchant · Tel: +49 (0)8821/9621-0
Fax: +49 (0)8821/9621-21
info@promed.de
www.promed.de

References

• promed

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