Laerdal 20-10468 CPR card User Guide

Approved Record
Document Nr: 00072686
Rev: C DA-00083976
20-10468 CPR card
User Guide

C
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Approved Record Date:| 2021-05-12T1 3:27:37Z
Lifecycle:| Production (when released in PLM System)
Tool Information:|
Replaces Document:|
Site:| LMAS (Stavanger)

Attachments (Electronic Files)

Electronic Signatures

2021-05-12T12:18:19Z
Verify and approve the document| Nguyen, Phuong Helen| 2021-05-12T13:27:37Z
Verify and approve the document| Risinger, John Sigve| 2021-05-12T12:56:29Z
Verify and approve the document| Eilevstjønn, Joar| 2021-05-12T13:12:41Z

Part References Valid at Time of Print (for current status see Agile PLM system)

Additional Info

Specifics

See Att 4 to 00072686 for folding instructions and size guidelines.
See Att 5 to 00072686 for print specifications.

Important Information and User Instructions
(on the back of the card)

Intended Use
CPRcard is a single-use device intended to provide chest compression feedback to a CPR-trained rescuer performing CPR on a suspected cardiac arrest patient, 8 years or older, lying flat on the back on a firm surface.

Indication for Use
When performing CPR on a suspected sudden cardiac arrest patient.

Operating Principle

A battery-powered device is placed between the patient’s bare chest and the rescuer’s hands for giving feedback on compression depth and rate to a rescuer performing CPR. Using an accelerometer, the device measures its own relative movement perpendicular to the device surface and uses this to give input to an algorithm for the calculation of correct feedback on compression rate and depth. The device is equipped with wireless communication functionality for the transfer of performance data.

Warnings and Cautions

A Warning states a condition, hazard, or unsafe practice that can result in serious personal injury or death.
A Caution states a condition, hazard, or unsafe practice that can result in minor personal injury or damage to the product

Note
A Note states important information about the product or its operation.

Important Information
Before using CPRcard, read these instructions thoroughly. Observe all warnings, cautions, and instructions in this User Guide. Retain this guide for future reference.
CPR cannot ensure survival regardless of how well chest compressions are performed. For some patients, cardiac arrest is not reversible despite any available care.
Common side effects of properly performed CPR include skin abrasion, bruises, rib and sternum fractures, and occasionally injuries to internal organs.
The CPRcard does not guide the decision of whether or not to perform CPR on a suspected cardiac arrest victim. This decision must be made independent of the device.

Warnings

• Do not use CPRcard on a patient on a “soft surface” (e.g. bed/mattress, stretcher, or transportation cot) as it will provide inaccurate feedback that can result in too shallow compressions.
• Do not delay CPR to search for the CPRcard or if you experience any problem using it. Begin CPR without the card.
• Do not use the CPRcard in a moving environment (e.g. during patient transport in a car, boat, or aircraft) as it may provide inaccurate feedback.
• Do not use CPRcard on an open wound or recent incision site as this may lead to cross-contamination and cause further injury.

Caution

Using CPRcard under sunlight might affect the visibility of the feedback from the card. Continue CPR even if you don’t see the feedback from the card.

Turn On/Off

Chest Compression Feedback
Feedback on compression depth and the rate is provided by indicator lights. The green lights indicate the targets according to the 2020 international CPR guidelines.

Compression Depth

Compression Rate

Caution
Release pressure between compressions to allow the chest to recoil completely to maintain efficient compressions.
Note
The CPRcard does not provide feedback on incomplete release (leaning) between compressions.

Idle Indicator
When no compressions are detected for more than 1.5 seconds, the idle indicator will blink.

Note
If there are no compressions detected for one minute, the CPRcard shuts down automatically.

Warning Indicator
If a device error is detected, the red Warning Indicator will turn on and compression feedback will stop. Such an error may be caused by a depleted battery or a technical malfunction. The CPRcard should be replaced.

Warning
Do not interrupt CPR if compression feedback stops. Continue CPR without feedback.

Use with a Defibrillator
Follow defibrillator voice guidance when using the CPRcard together with a defibrillator. There is no need to remove the CPRcard before delivering a shock.

Caution
Do not place the defibrillation pads on top of the CPRcard as this may obstruct the CPR feedback and interfere with the defibrillation.

Bluetooth® Wireless Technology

CPRcard allows wireless connectivity using Bluetooth® Low Energy*.
Possible uses with compatible apps are:

• Firmware upgrade
• Transfer of stored data. Summary data is stored for events with more than 50 compressions
• Live streaming of CPR feedback during use CPRcard is only available for Bluetooth connection after the card is turned on and before chest compressions are initiated.

Refer to www.laerdal.com/CPRcard for more information.

Warning
Do not delay CPR if you are not able to establish a Bluetooth connection.
*Bluetooth is a trademark owned by Bluetooth SIG, Inc.

Single-Use

The CPRcard is intended for single-use only and should not be re-used.
After use on a patient, the CPRcard may be contaminated and must be disposed of in accordance with local protocol.
If data transfer is required after patient use, the CPRcard can be placed in a plastic bag. The compatible app or software can perform the transfer through the bag.

Maintenance and Inspection

Perform functional tests quarterly to ensure that the CPRcard is functioning as it should.

1. Inspect the CPRcard for physical damage (e.g. tears and cracks).
2. Turn on the device.
3. Observe and verify that all the lights function (see illustration), the lights should display for one second.
4. Turn off the device.

Replace the card if it doesn’t work properly or is severely damaged.

Caution
Do not attempt to modify the CPRcard in any way before use as it can affect its functionality.

Get Familiar with CPRcard

CPR is best performed by CPR-trained rescuers. It is also recommended to get familiar with the CPRcard by practicing on a training manikin using standard CPR technique.

Practice following the feedback from the CPRcard:

1. Turn on CPRcard.

2. Place the card correctly without removing the liner from the adhesive. (See Correct Placement on page 6).

3. Focus on depth feedback (See Compression Depth on page 8).
   Gradually increase the depth of compression so that the recommended depth target is reached.

4. Focus on rate feedback (see Compression Rate on page 8).
   Compress slowly and gradually increase the rate of compression until each of the rate indicators lights up.

5. Focus on performing compressions at an adequate depth and rate.

6. Remember to release between each compression.

To stay familiar with the CPRcard, repeat it as often as needed.

Caution
Do not practice on a person as this may cause injuries to the person.

Troubleshooting

sufficiently pressed
•Card temperature is
below 0 °C (32 °F)
•The device is broken| •Press and hold the ON Off button firmly to try to turn on the CPRcard.
•If the problem persists. do not use the CPRcard on a patient.
Warning LED turns on at start-up and stays on for 1 minute| •Internal error detected
•Depleted battery| •Turn the card off and on again.
•If the problem persists. do not use the CPRcard on a patient.
Not all LEDs light up at start-up| The device is broken.
CPRcard turns off during CPR| •Compression inactivity > 1 min
•Accidental act-Nation of On/Off button
•Internal error detected.
•Depleted battery| Do not interrupt CPR -continue CPR without feedback
Depth target (green LED) not achieved during CPR| •Too shallow
compressions
•Incomplete release (leaning)| Press harder and release completely between compressions.
The CPRcard moves around during CPR| The liner was not removed before the CPRcard was placed on the patient.| Remove the liner and place the CPRcard on
the patient’s bare chest as quickly as possible to avoid interrupting CPR
Inactivity indication while performing compressions| •Chest compressions not detected
•Too shallow compressions (<1 cm)
•Too slow compressions (<40/min)| Press harder anchor faster. Release completely between compressions.
Bluetooth connectivity issues| | Do not interrupt CPR -continue CPR

Specifi cations

Compression Depth| Depth feedback is based on the median depth of the last 5 compressions.

Compressions with a depth of less than 1 cm or more than 10 cm will not be detected

---|---
Compression depth accuracy| ±5 mm or ±10%. whichever is greater
Compression Rate| Rate feedback is based on the median rate of the last 5 compressions.

Compression rate accuracy| ±5%

Electromagnetic Conformity
The device is intended for use outdoors and indoors except for near HF surgical equipment, and the RF shielded room for magnetic resonance imaging.
No particular actions are required to maintain safety and performance with regard to electromagnetic disturbances for the expected service life.

Warnings

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the CPRcard. Otherwise, degradation of the performance of this equipment could result.

Electromagnetic Emissions Tests

Electromagnetic Immunity Tests

Immunity Test +A7:C15CA7:C18| Standard or test
method| Compliance Level and
Immunity Test Level
---|---|---
Electrostatic discharge| IEC 61000-4-2| ±8 kV contact
±2kV, ±4kV, ±8kV
±15 kV air
Radiated RF EM fields| IEC 61000-4-3| 10 V/m
80 MHz – 2.7 GHz
80% AM at 2 Hz
Proximity fields from RF
wireless communication
equipment| IEC 61000-4-3| 380-390 MHz: 27 V/m
430-470 MHz: 28 V/m
704-787 MHz: 9 V/m
800-960 MHz: 28 V/m
1700-1990 MHz: 28 V/m
2400-2470 MHz: 28 V/m
5100-5800 MHz: 29 V/m
Rated power frequency| IEC 61000-4-8| 30 A/m
50 Hz or 60 Hz
Electrical fat transients
/ bursts| IEC 61000-4-4| ±2 kV
100 kHz repetition frequency
Surges: Line-to-line| IEC 61000-4-5| ±0.5 kV. ±1 kV
Surges: Line-to-ground| IEC 61000-4-5| ±0.5 kV. ±1 kV. ±2 kV
Conducted disturbances
induced by RF fields| IEC 61000-4-6| 3 V; 0.15 MHz – 80 MHz
6 V in ISM and amateur radio
bands between 0.15 MHz
and 80 MHz
80% AM at 1 kHz
Voltage dips| IEC 61000-4-11| 0% UT
; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0% UT ; 1 cycle and 70% UT ;
25/30 cycles
Single-phase: at 0°
Voltage interruptions| IEC 61000-4-11| 0% UT
; 250/300 cycle
UΤ is the a.c. mains voltage prior to application of the test level.

Federal Communications Commission (FCC) and Industry Canada (IC) Statements
This device complies with part 15 of the FCC Rules and Industry Canada’s license-exempt RSS. Operation is subject to the following two conditions:
1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation.

Caution
Changes or modifications not expressly approved by Laerdal Medical could void the user’s authority to operate the equipment.

FCC ID: QHQ-20-10468
IC: 20263-2010468

This product is in compliance with the essential requirements of EU Council Directive 93/42/ EEC as amended by EU Council directive 2007/EC, Council
Directive 2014/53/EU on Radio Equipment (RED) and Council Directive 2011/65/ EU on the restriction of the use of certain hazardous substances (RoHS).

Symbol Glossary

part
| Warning/Caution
| Device catalog number reference
| Unique Device Identification
| Ingress protection rating
| Temperature limitations
| Humidity limitations
| Pressure limitations
| Machine-readable Unique Device Identification (UDI). Datamatrix with UDI numbers (XXX = last three UDI digits)
| Not to be used in a bed or on soft surfaces
| Not for patients under 8 years

Support
If you need assistance or to report any issues, contact a local Laerdal representative or visit www.laerdal.com/CPRcard for more information.

Waste Handling
WEEE
This appliance is marked according to the European directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE).
By ensuring this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health, which could otherwise, be caused by inappropriate waste handling of this product.
The symbol on the product indicates that this appliance may not be treated as household waste. Instead, it shall be handed over to the applicable collection point for the recycling of electrical and electronic equipment.
Disposal must be carried out in accordance with local environmental regulations for waste disposal.

Caution
Do not cut the device as this may damage the battery and expose harmful chemicals.

Service and Warranty
CPRcard does not have any replaceable or serviceable parts.
The CPRcard has a one-year limited warranty. Refer to the Laerdal Medical Warranty for terms and conditions.
For more information visit www.laerdal.com.

www.laerdal.com/CPRcard

http://www.laerdal.com/CPRcard

Laerdal® and CPRcard (logo)® and CPRcard™ are trademarks of
Laerdal Medical AS. Ownership and all rights reserved.

© 2021 Laerdal Medical AS. All rights reserved.
Manufactured in China for:
Laerdal Medical AS,
P.O. Box 377
Tanke Svilandsgate 30,
4002 Stavanger, Norway

CPRcard

www.laerdal.com

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