Lifepad RH 112 - Defibrillator BEURER - Free user manual and instructions

Product type	Resuscitation aid (medical device)
Brand	Beurer
Model	LifePad RH 112
Dimensions (pad)	210 x 160 x 3 mm
Dimensions (housing)	15 mm (thickness)
Weight	Approx. 130 g
Power supply	1 CR2032 battery (3V)
Battery life	Approx. 1 hour of continuous operation
Compression rate	100 compressions per minute (guided by audible signal)
Feedback system	LED (orange, yellow, green) and audible signal
Indications	Sudden cardiac arrest in persons over 12 years
Contraindications	Obvious fatal injury, normal breathing, under 12 years
Target group	Adults and adolescents (12+); use by non-professionals
Usage	Single use, non-reusable
Operating conditions (temperature)	5 °C to 40 °C
Operating conditions (relative humidity)	15 to 93 %
Operating conditions (ambient pressure)	700 to 1060 hPa
Storage conditions (temperature)	5 °C to 35 °C
Storage conditions (relative humidity)	45 to 85 %
Storage conditions (ambient pressure)	700 to 1060 hPa
Protection class	IP44 (protected against splashing water)
Expiration date	5 years after production (see rating plate)
Warranty	See the included warranty card
Package contents	1 LifePad, 1 instruction manual, 1 quick guide

Frequently Asked Questions - Lifepad RH 112 BEURER

How to use the LifePad in an emergency?

Check the person's consciousness and breathing. If they do not respond and are not breathing normally, call emergency services (112 in Europe). Expose the upper body, place the LifePad on the bare chest aligning the red lines, remove the battery strip to activate the device, then perform chest compressions at the pace of the audible signal (100/min) following the LED feedback system.

Is the LifePad reusable?

No, the LifePad is single-use. It cannot be reused after activation because the battery drains and for hygiene reasons. After use, dispose of it according to local regulations.

What is the recommended compression rate?

The LifePad guides compressions at a rate of 100 compressions per minute using an audible signal. You must press on each beep.

How to check that compressions are effective?

Use the LED feedback system: the LEDs light from orange to green when the pressure is sufficient (depth of 5 to 6 cm). Full release is indicated by the green and yellow LEDs turning off, only the orange LED remains on.

Can I use the LifePad on a child?

No, the LifePad is designed for persons over 12 years. It should not be used on children under 12 years.

What to do if the LifePad appears damaged?

If the LifePad shows visible damage, do not use it. Perform chest compressions without the device (100 compressions/min) until help arrives. Contact your dealer or customer service for a replacement.

How to store the LifePad?

Store the LifePad in a dry, easily accessible place, protected from shocks, dust, moisture, and extreme temperatures (5-35°C). Regularly check the expiry date.

What is the battery life?

The CR2032 battery provides approximately 1 hour of continuous operation. Only remove the battery strip at the time of use.

How to turn off the audible signal?

You can deactivate the audible signal by briefly pressing the ON/OFF button. This is useful if you are using a defibrillator that also emits signals. Note that you will lose the audio guidance of the rate.

What should I do after using the LifePad?

After use, remove the battery and dispose of the LifePad in accordance with the WEEE directive. Do not throw it in household waste. Consult local collection points for electronic waste.

USER MANUAL Lifepad RH 112 BEURER

EN Unfold page 3 before reading the instructions for use.

Read these instructions for use carefully. Observe the warnings and safety notes. Keep these instructions for use for future reference. Make the instructions for use accessible to other users. If the device is passed on, provide the instructions for use to the next user as well.

Table of contents

1. Included in delivery 14
2. Signs and symbols 14

3. Intended use 15
   4.Warnings and safety notes.. 16
   5.Storage 18

4. Device description.. 18
   7.What to do in an emergency? 18
   8.Disposal. 19

5. Technical specifications 20
6. Warranty/Service 20

1. INCLUDED IN DELIVERY

Check that the exterior of the cardboard delivery packaging is intact and make sure that all contents are present. Before use, ensure that the device and accessories have no visible damage and all packaging material is removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address.

1xLifePad®

1x these instructions for use

1x brief instructions

2. SIGNS AND SYMBOLS

The following symbols are used on the device, in these instructions for use, on the packaging and on the device's type plate:

Warning Warning notice indicating a risk of injury or damage to health	i	Consult instructions for use
Important Safety note indicating possible damage to the device/accessory	i	Product information Note on important information
Single-use Not suitable for reuse	2	Use by
Manufacturer	MD	Medical device
Swiss authorised representative
Unique device identifier (UDI) Identifier for unique product identification	REF	Item number

SN	Serial number Batch designation	LOT
IP44	Protection classProtected against solid foreign objects ≥ 1 mm in diameter and against splashing water.	❤●●	Defibrillation-proof type CF applied part
	Temperature limitThe temperature limit values to which the medical device can safely be exposed are indicated	CE	CE labellingThis product satisfies the requirements of the applicable European and national directives
	Humidity, limitIndicates the humidity range to which the medical device can safely be exposed		Atmospheric pressure, limitIndicates the range of atmospheric pressures to which the medical device can be safely exposed
	DisposalDisposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE	Pb Cd Hg	Battery disposalDo not dispose of batteries containing harmful substances with household waste
	Direct currentThe device is suitable for use with direct current only	A	Marking to identify the packaging material.A = Material code, B = Material number:1-7 = Plastics, 20-22 = Paper and cardboard
	Disposition of packaging in an environmentally friendly manner
	Separate the product and packaging elements and dispose of them in accordance with local regulations.

3. INTENDEDUSE

Use the LifePad for the purpose it was developed for only and in the manner specified in these instructions for use.

Intended use

TheLifePad® motivates and supports first-aiders in cardiopulmonary resuscitation (CPR) of individuals over 12 years of age after a sudden cardiac arrest (SCA) through an acoustic and visual feedback system to evaluate the compressions performed. The LifePad is intended for single use only and must not be used multiple times under any circumstances.

Intended users

TheLifePad® is intended for use by adults and adolescents over the age of 12 and has been specially designed for use by lay persons. Therefore, no specific knowledge or professional ability is required to use the LifePad®.

Clinical benefit

TheLifePad® is not only intended to motivate more people to provide first aid, but also to support inexperienced first-aiders in performing cardiopulmonary resuscitation.

Indications

TheLifePad® should be used once the first-aider has identified that the patient is experiencing a cardiac arrest.

Contraindications

• Do not use the LifePad if the patient has suffered an obviously fatal injury.
• Do not use the LifePad if you are sure that the patient is breathing normally - even if they are not responding.
• Do not use the LifePad on people under the age of 12.

4. WARNINGS AND SAFETY NOTES

General warnings

• Even if resuscitation is initiated immediately, this does not guarantee that the patient will survive, even if it is performed optimally. In some cases, the underlying problem causing the cardiac arrest means that the patient will not survive, despite the best care.
• Patients with serious injuries should not be moved. Without using the LifePad, the layperson (user) should also not move the patient on another ground.
• Cardiac massage with and without LifePad® is less effective for people lying on soft ground.
• Rib fractures and other injuries are common, but acceptable consequences of resuscitation given that the alternative is death due to cardiac arrest. After resuscitation, all patients should be assessed for injuries caused during resuscitation.
• In addition to the above-mentioned consequences, skin abrasions, bruises and wounds on the chest can often occur during resuscitation. Despite this, do not stop performing the compressions, but continue CPR until professional help arrives.

Other undesirable side effects of CPR can be:

• Rib fractures
• Sternum fractures
• Atelectasis
• Collapse of the lung
• Hemothorax
• Pleural effusion

• Infection of the lung

• Never delay treatment to find out the exact age of the patient.

• Check the LifePad surface for integrity before starting resuscitation to prevent sharp edges or dangerous areas.
• In the event of a defect, perform the cardiac massage without the assistance of the LifePad. Do not delay or interrupt the start of first aid measures to rectify the defect. Continue to follow the instructions for carrying out CPR illustrated by the pictograms.
• Even if the device fails, continue cardiac massage at a pressure frequency of at least 100 per minute until clear signs of life are once again perceptible or the emergency doctor takes over. The pressure must be high enough to achieve a pressure depth on the chest of 50mm to 60mm .
• TheLifePad® is only intended to support the emergency services (which have been alerted) and cannot completely replace them.
• TheLifePad® is not intended to replace possible training measures in the field of first aid. Prior knowledge is a benefit, but not absolutely necessary for use.
• Keep packaging material away from children. There is a risk of suffocation.
• TheLifePad® is not a toy. Store the LifePad® out of the reach of children.

• To reduce the risks associated with strong electromagnetic fields, such as device failure, do not use the LifePad near strong high-frequency signals or portable and/or mobile HF devices.

• The use of accessories, converters and cables other than those intended for the LifePad may result in increased HF emissions or decreased immunity of the LifePad.

• To avoid unnecessarily shortening the service life of the LifePad, only switch it on when treating a patient.
• If you pull out the battery strip prematurely, the battery life can no longer be guaranteed.
• If the LifePad is used in combination with a defibrillator follow the safety instructions of the defibrillator.
• Please report any unexpected operation or events to the manufacturer.
• Device not suitable for use in presence of anaesthetic mixtures inflammable with air, oxygen or nitrogen protoxide.
• The device does not have an ECG function.

General precautions

• TheLifePad® is intended for single use only and is therefore not suitable for reuse:

• After a single use and the associated closing of the circuit through pulling the battery strip, the supplied battery is discharged, meaning that it can no longer be ensured that the product can be used again at a later time.

• Furthermore, the product cannot be used on different people for hygienic reasons, as it cannot be disinfected or cleaned.

• Protect the LifePad against impacts, moisture, dust, chemicals, strong temperature fluctuations, direct sunlight, water, sand and sources of heat that are too close to it (ovens or heaters), as faultless functionality of the LifePad® can no longer be guaranteed thereafter.

• Under no circumstances should you open or repair the LifePad, as faultless functionality can no longer be guaranteed thereafter and you may receive an electric shock. The LifePad cannot be maintained and/or calibrated.
• Do not use additional parts that are not recommended by the manufacturer or offered as accessories.
• If you see or suspect damage to the LifePad, you must replace it with a new LifePad.
• TheLifePad® is protected against splashes. Never submerge the LifePad® in water.

Notes on handling batteries

• If your skin or eyes come into contact with battery fluid, wash the affected area with water and seek medical assistance.
• Choking hazard! Small children may swallow and choke on batteries. Therefore, batteries should be stored out of the reach of small children.
• Observe the plus (+) and minus (-) polarity signs.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
• Protect batteries from excessive heat.
• Risk of explosion! Do not throw batteries into a fire.
• Do not charge or short-circuit the batteries.
• Do not use rechargeable batteries.
• Do not disassemble, open or crush the batteries.
• Battery must comply with IEC 60086-4.

5. STORAGE

Possible damage due to incorrect storage

• Store the LifePad in a dry environment with no external stresses.
• Make sure to store the product in a place that is quick and easy to access in case of an emergency.
• TheLifePad® must not be bent or subjected to other external stresses during storage, as this could damage the pressure sensor.
• Regularly check that the printed use-by date has not been exceeded when the LifePad is in storage. In this case, replace the product immediately with a new one.

6. DEVICE DESCRIPTION

The device is shown on the fold-out page.

1 ON/OFF button (with battery strip removed: short press -> ON / long press -> OFF) / mute button (short press again after switching on -> muted)
2 LED feedback system
3 Battery strip
4 Pressure sensor

7. WHAT TO DO IN AN EMERGENCY?

The associated drawings are shown on the fold-out page.

Check for consciousness and breathing

Check if the person that has collapsed is responsive. To do this, shake them lightly by their shoulders and ask loudly: "Is everything OK?" If they respond, try to find out what the problem is with them and get help if necessary. Regularly check their condition.

If they do not respond, check their breathing using sight, hearing and touch. To do this, turn the patient onto their back. Inspect the oral cavity for objects or foreign bodies and remove them if necessary. Place your hand on their forehead and gently tilt their head backwards using your other hand's fingertips in order to clear the airways. If you are unsure whether breathing is normal, work on the basis that it is not normal and start resuscitation. Gasping, wheezing or shallow breathing should not be regarded as normal breathing.

Make an emergency call

If the patient is not responsive and is not breathing normally, immediately alert the emergency services (the number for Europe, for example, is 112).

Expose the upper body

As far as possible, ensure that the patient is lying on a firm and level surface. Expose the patient's upper body. The LifePad must be able to rest directly on bare skin.

Place the LifePad

Place the LifePad on the patient's bare upper body as shown. Align the product using the red reference lines. The LifePad should be positioned on the patient's upper body so that the vertical red line is in the middle of the body and the lower edge of the product is in line with the sternum/ breastbone so that the pressure sensor 4 is in the lower half of the sternum.

E Pull out the battery strip

Then pull the battery strip 3 completely out of the housing to activate the LifePad. An acoustic signal begins to sound on the LifePad.

F Place your hands on the patient

Kneel next to the patient. Place the ball of one hand on the raised part of the LifePad pressure sensor 4. Place the ball of your other hand on the first hand and interlace your fingers. Make sure that they do not press on the patient's ribs and do not put any pressure on the upper abdomen.

G Perform the compressions

Place your shoulders vertically over the patient's chest and extend your arms. Now start the cardiac massage in the rhythm of the acoustic signal. Each time the beep sounds, press the sternum down by at least 5cm , but not more than 6cm .

The coloured LED feedback system 2 will tell you whether you are applying enough pressure. You are applying sufficient pressure to the chest if you make all of the LEDs light up one after the other in ascending order from orange to green.

If you only light up the orange or the two yellow LEDs, you are not applying enough pressure. Increase the pressure for the subsequent compressions until all LEDs light up.

H Release the chest again

Completely release the chest after each compression you perform without losing contact between your hands and the LifePad.

Here, too, the LED feedback system 2 helps you to assess this.

After each compression, release the chest until the LEDs go out one after the other in descending order from green to orange until only the orange LED lights up.

If the green and yellow LEDs do not go out completely, the chest has not been released sufficiently. During subsequent compression, release the chest even more until all LEDs except the orange LEDs go out.

Repeat steps G and H in the rhythm of the acoustic signal to ensure a frequency of 100 compressions per minute. Perform cardiac massage until there are clear signs of life again or until the emergency doctor takes over.

(Clear signs of life: opening eyes, waking up, moving and starting to breathe normally)

If you are trained to do so, you can give 2 rescue breaths after 30 compressions.

1 Deactivate acoustic signal (optional)

You can deactivate the acoustic signal at any time when the product is activated by pressing the ON/OFF button again. This can be useful, for example, if a defibrillator is being used at the same time, as it also emits acoustic signals. Please note, however, that in this case you can no longer receive feedback on the frequency required for the compressions to be carried out.

8. DISPOSAL

Disposal of the device

For environmental reasons, do not dispose of the LifePad with your household waste after a single use. Dispos of the device at a suitable collection point in your country. Dispos of the LifePad in accordance with EC Directive - WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal. When disposing of the LifePad, ensure that the battery has been removed and dispose of it separately.

Disposal of the batteries

• Batteries must not be disposed of in the household waste. They may contain poisonous heavy metals and are subject to special refuse treatment.
• The codes below are printed on batteries containing harmful substances:

Pb = Battery contains lead,

Cd = Battery contains cadmium,

Hg = Battery contains mercury.

9. TECHNICAL SPECIFICATIONS

Model LifePad	®
Type RH 112
Dimensions 210 x 160 x 3 mm (pad) / 15 mm (housing)
Weight Approx. 130 g
Volume ≥37 (max. 66) dB
Permissible operating conditions 5°C to 40°C,15 to 93% relative humidity700 -1060 hPa ambient pressure
Permissible storage and transport conditions	5°C to 35°C,45-85% relative humidity700 -1060 hPa ambient pressure
Protection class IP44
Power supply 1x CR2032 (3 V)	————
Battery life Approx. 1 hour in continuous operation
Frequency of the acoustic signal 100 bpm
Use-by date See type plate	(5 years after production)
Expected useful life	Single-use product
Classification	Internal supply, continuous operation, application part defibrillation-proof type CF (back side of device is considered as defibrillation-proof type CF applied part)

The technical data is subject to change without notice, as updates are possible.

The serial number is located on the device or in the battery compartment.

• The device complies with the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, as well as the respective national provisions.
• This device complies with European standards EN 60601-1 and EN 60601-1-2 (in compliance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8) and is subject to special precautionary measures with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this device. Further information can be obtained from the Customer Services address provided.

10. WARRANTY/SERVICE

Further information on the warranty and warranty conditions can be found in the warranty leaflet supplied.

For users/patients in the European Union and identical regulation systems (EU Medical Device Regulation (MDR) 2017/745), the following applies: If during or through use of the product a major incident occurs, notify the manufacturer and/or their representative of this as well as the respective national authority of the member state in which the user/patient is located.

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