Physio-Control LUCAS 2 User Manual

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Instructions for Use

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LUCAS

Chest Compression System – Instructions for Use

Thank you for choosing the

LUCAS

With LUCAS will receive effective, consistent and continuous chest compressions as reommended in the American Heart Association guidelines.

If you have any questions about this product or its operation, please contac t your local Physio-Control representative or the manufacturer JOLIFE AB.

MANUFACTURER

JOLIFE AB Scheelevägen 17 SE-223 70 LUND Sweden

Tel. +46 46 286 50 00 Fax. +46 46 286 50 10

2 Chest Compression System!

2 your cardiac arrest patients

www.jolife.com info@jolife.com

The LUCAS is manufactured by JOLIFE AB in Sweden and distributed worldwide by Physio-Control, Inc. For information on local distribution, please visit www.physio-control.com.

2 Chest Compression System

LUCAS

2 Chest Compression System – Instructions for Use

Table of Contents

1 Important user information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

2.1 LUCAS™ Chest Compression System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.4 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.5 Main parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.6 LUCAS™ components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.7 User Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3 Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

3.1 Signal words . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.2 Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.4 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.5 Symbols on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3.6 General safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.7 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.8 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.9 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

4 First use preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

4.1 Delivered items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

4.2 The Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

4.2.1 Charge the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

4.3 Prepare the LUCAS™ Stabilization Strap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4.4 Prepare the Carrying Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

5 Use LUCAS™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

5.1 Arrival at the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

5.2 Unpack LUCAS™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

5.3 Apply to patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

5.4 Adjustment and operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

5.5 Apply the LUCAS™ Stabilization Strap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

5.6 Move the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.6.1 Secure the patient's arms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

5.6.2 Prepare to lift the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.6.3 Lift the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.6.4 Move the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

LUCASTM2 Chest Compression System – Instructions for Use

5.7 Replace the Power Supply during operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

5.7.1 Change the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

5.7.2 Connect to the external Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

5.8 Adjunctive therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

5.8.1 Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

5.8.2 Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5.8.3 Use in the catheterization laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5.9 Remove LUCAS™ from the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6 Care after use and preparation for next use . . . . . . . . . . . . . . . . . . . . 23

6.1 Cleaning routines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

6.2 Remove and install the Suction Cup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

6.3 Remove and attach the Patient Straps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

6.4 Remove and attach the LUCAS™ Stabilization Strap . . . . . . . . . . . . . . . . . . . . . . . . 25

6.5 Remove and recharge the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

7 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

7.1 Routine checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

8 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

8.1 Indications and alerts during normal operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

8.2 Battery replacement and Smart Restart feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

8.3 Malfunction alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

9 Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

9.1 Patient parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

9.2 Compression parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

9.3 Device physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

9.4 Device environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

9.5 Battery physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

9.6 Battery environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

9.7 Electromagnetic environmental declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

9.8 Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

LUCASTM2 Chest Compression System – Instructions for Use

1 Important user

information

The information in these Instructions for Use applies to the LUCAS™2 Chest Compression System, also referred to as LUCAS.

All operators must read the comp lete Instructions for Use before operating the LUCAS Chest Compression System.

The Instructions for Use must always be easily accessible to the operators of LUCAS.

Always follow local and/or international guidelines for cardiopulmonary resuscitation (CPR) when you use LUCAS.

The use of other medical equipment or drugs in conjunction with LUCAS can affect the treatment. Always consult the Instructions for Use for the other equipment and/or drugs to make sure that they are appropriate for use in conjunction with CPR.

LUCAS can only be bought by or on the order of a licensed medical practitioner.

INSTRUCTION OF USE REVISION HISTORY

Revision E = first released version Revision F = changes due to software version 2.1, including a finetu ning of compression depth to 2010 CPR guidelines and an assisted adjustment of the pressure pad's Start Position to the chest.

TRADEMARKS

LUCAS™ is a trademark of JOLIFE AB.

DECLARATION OF CONFORMITY

LUCAS Chest Compression System complies with the requirements of the European Medical Device 93/4 2/EEC. It is marked with the CE-symbol:

LUCASTM2 Chest Compression System – Instructions for Use

2 Introduction

2.1 LUCAS™ Chest Compression System

The LUCAS™ Chest Compression System is a portable tool designed to overcome problems identified with manual chest compressions. LUCAS assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association guidelines

2.2 Intended use

LUCAS Chest Compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

LUCAS must only be used in cases where chest compressions are likely to help the patient.

2.3 Contraindications

Do NOT use the LUCAS Chest Compression System in these cases:

• If it is not possible to position LUCAS safely or correctly on the patient's chest.

• Too small patient: If you cannot enter the PAUSE mode or ACTIVE mode when the pressure pad touches the patient's chest and LUCAS alarms with 3 fast signals.

• Too large patient: If you cannot lock the Upper Part of LUCAS to the Back Plate without compressing the patient's chest.

Always follow local and/or international guidelines for CPR when using LUCAS.

2.4 Side effects

The International Liaison Committee on Resuscitation (ILCOR) states these side effects of CPR "Rib fractures and other injuries are co mmon

but acceptable consequences of CPR given the alternative of death from cardia c arrest. After resuscitation, all patients should be reassessed and re-evaluated for resuscitation-related injuries."

Apart from the above, bruising and soreness of the chest are common during the use of the LUCAS Chest Compression System.

2.5 Main parts

The main parts of the LUCAS Chest Compression System include;

• A Back Plate which is positioned underneath the patient as a support for the external chest compressions.

• An Upper Part which contains the proprietary and rechargeable LUCAS Battery and the compression mechanism with th e disposable Suction Cup.

• A Stabilization Strap which helps to secure the position of the device in relation to the patient.

• A padded Carrying Bag.

1. 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Circulation 2010; 122: S639-946

2. 2005 International Concensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation 2005;67:195

LUCASTM2 Chest Compression System – Instructions for Use

2.6 LUCAS™ components

1. User Control Pan el

2. Hood

3. Patient Strap

4. Release ring

5. Support leg

6. Claw locks

7. Back Plate

8. DC input

9. Bellows

10. Su ctio n Cup

11. Power Supply

12. Power Supply cord

13. Battery

14. Pressure pad

15. Upper Part

16. V e nt ho les

17. Car Power Cable

18. Carrying Bag

19. External Battery Charger

LUCAS Stabilization Strap

20. C ush io n str ap

21. Buckle

22. S u p p o rt le g str a p

LUCASTM2 Chest Compression System – Instructions for Use

2.7 User Control Panel

ON/OFF:

LUCAS will power up/power down whe n you push this key for 1 second. When LUCAS powers up, it automatically does a self-test of the functions and the protective system. When the self-test is complete the green LED ( Light Emitti ng Diode) beside the ADJUST key illuminates. This procedure takes approximately 3 seconds.

ADJUST:

This mode is used when you want to adjust the position of the Suction Cup. When you push this key, you can move the Suction Cup up or down. To adjust the Start Position of the Suction Cup, manually push down the Suction Cup with two fingers onto the chest of the patient.

PAUSE:

When you push this key, the compression mechanism temporarily stops and is locked in the Start Position. Use this function when you want to stop LUCAS temporarily but still want to keep the Start Position of the Suction Cup.

ACTIVE (continuous):

When you push this key, LUCAS performs continuous chest compressions. The green LED signal will blink 8 times per minute to alert for ventilation during ongoing compressions.

MUTE:

If you push this key when LUCAS operates, you mute the alarm for 60 seconds. If you push this key when LUCAS is powered OFF, the Battery indicator shows the Battery charge status of the Battery.

Battery indicator:

The three green LEDs show the Battery charge status:

• Three green LEDs: Fully charged

• Two green LEDs: 2/3 charged

• One green LED: 1/3 charged

• One intermittent orange LED and alarm during operation: low battery, approximately 10 minutes of operating capacity remaining.

• One intermittent red LED and an alarm signal: the Battery is empty and must be recharged.

• One constant red LED and an alarm signal: the Battery is defective.

Note: When the LED to the far right is orange and not green, the Ba ttery has reached the end of its service life. JOLIFE AB recommends that you replace this Battery with a new one.

Alarm indicator:

A red LED and an alarm signal indi cate malfunction.

Refer to Troubleshooting 8;

8.1 for indications and alerts during normal operation.

8.3 for malfunction alarms.

ACTIVE (30:2):

When you push this key, LUCAS performs 30 chest compressions and then temporarily stops for 3 seconds. During the stop, the operator can perform 2 ventilations. After the stop the cycle starts again. An intermittent LED in combination with an alarm signa l sequence will alert the operator before each ventilation pause.

LUCASTM2 Chest Compression System – Instructions for Use

3 Safety precautions

To ensure maximum safety, always read this section carefully before operating, carrying out any work on the equipment or making any adjustments.

3.1 Signal words

Throughout the manual, signal words are indicated with, "WARNING" or "CAUTION".

• CAUTION - signal word used to indicate a potentially hazardous situation which, if not avoided, could result in minor or moderate injury.

• WARNING - signal word used to indicate a potentially hazardous situation which, if not avoided, could result in death or serious injury.

3.2 Personnel

JOLIFE AB recommends that LUCAS Chest Compression System is only used by persons with medical skills such as: First responders, ambulance personnel, nurses, physicians or medical staff, who have:

• undertaken a CPR course according to the resuscitation guidelines, e.g. American Heart Association, European Council of Resuscitation or equivalent,

• AND received training in how to use LUCAS.

3.3 Contraindications

Do NOT use the LUCAS Chest Compression System in these cases:

• If it is not possible to position LUCAS safely or correctly on the patient's chest.

• Too small patient: If you cannot enter the PAUSE mode or ACTIVE mode when the pressure pad touches the patient's chest and LUCAS alarms with 3 fast signals.

• Too large patient: If you cannot lock the Upper Part of LUCAS to the Back Plate without compressing the patient's chest.

Always follow local and/or international guidelines for CPR when using LUCAS.

3.4 Side effects

The International Liaison Committee on Resuscitation (ILCOR) states the following side effects of CPR

"Rib fractures and other injuries are common but acceptable consequences of CPR given the alternative of death from cardiac arrest. After resuscitation, all patients should be reassessed and re-evaluated for resuscitation-related injuries."

The above side effects, as well as bruising and soreness of the chest, are common during use of LUCAS Chest Compression System.

LUCASTM2 Chest Compression System – Instructions for Use

3. 2005 International Concensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommenda tions. Resuscitation 2005;67:195

Symbols on type label

Art no.

300000-00

12-24VDC

IP 43

3.5 Symbols on the device

Symbol Meaning

Caution – keep your fingers away

Do not put your hands on or below the Suction Cup when LUCAS operates. Keep your fingers away from the claw locks when attaching the Upper Part or lifting the patient.

Caution – do not lift by the Patient Straps

Do not use the Patient Straps to lift the patient. The straps are only to attach the patient’s arms to LUCAS.

Place the lower edge of the Suction Cup immediately above the end of the sternum, as indicated in the figure. The Suction Cup should be centered over the chest.

Pull the release rings to remove the Upper Part from the Back Plate.

Do not reuse - Single use only.

DC input.

Art no.

300000-00

12-24VDC

Symbols on type label

Symbol Meaning

Caution – see instructions for use

All operators must read the complete Instructions for Use before operating the LUCAS Chest Compression System.

Year of manufacture.

Battery and/or electronics may not be disposed in the normal waste stream.

Degree of protection provided by enclosure per IEC 60 529.

DC voltage.

Defibrillation protected type BF patient connection.

LUCASTM2 Chest Compression System – Instructions for Use

3.6 General safety precautions

Caution - use only approved accessories

Use only JOLIFE AB-approved accessori es with LUCAS. LUCAS may not operate correctly if you use accessories that are not approved. Use only LUCAS Batteries and the LUCAS Power Supply that are designed for LUCAS. If you use other batteries or power supply you can cause perm anent damage to LUCAS. This also voids the warranty.

Caution - liquid

Do not immerse LUCAS in liquid. The device can be damaged if liquid enters the hood.

3.7 Battery

WARNING - LOW BATTERY

When the orange Battery LED shows an intermittent light, do one of these:

• Replace the Battery with one that is charged.

• Connect the external LUCAS Power Supply.

WARNING - INCORRECT START POSITION

The patient's blood circulation is compromised if the pressure pad presses down too heavily or too lightly on the chest. Push the ADJUST key and adjust the height of the Suction Cup immediately.

WARNING - CHANGED POSITION DURING OPERATION

If the position of the Suction Cup changes during operation or during defibrillation, immediately push ADJUST and adjust the position. Always use the LUCAS Stabilization Strap to help secure the correct position.

Caution - defibrillation electrodes

Position the defibrillator electrodes and wires so that they are not under the Su ction Cup. If there are already electrodes on the patient, make sure that they are not under the Suction Cup. If they are, you must apply new electrodes.

Caution - gel on chest

If there is gel on the patient's chest (e.g. from ultrasound examination), the position of the Suction Cup can change during use.Remove all gel before you apply the Suction Cup.

Caution - keep Battery installed

The Battery must always be installed for LUCAS to be able to operat e, also wh en powered by the external Power Supply.

To minimize interruptions, we re commend to always have a charged spare LUCAS Battery in the Carrying Bag.

3.8 Operation

WARNING - UNSATISFACTORY POSITION

Start manual CPR again if it is not possible to position LUCAS safely and correctly on the patient's chest.

WARNING - INCORRECT POSITION OVER CHEST

If the pressure pad is not in the correct position in relation to the sternum, there is an increased risk of damage to the rib cage and the internal organs. Also, the patient's blood circulation is compromised.

Caution - Stabilization Strap application

Delay the application of the LUCAS Stabilization Strap if this prevents or delays any medical treatment of th e patient .

Caution - adjunctive therapies

WARNING - ECG interference

Chest compressions interfere with ECG analysis. Push PAUSE before you start the ECG analysis. Make the interruption as short as possible. Push ACTIVE (continuous) or ACTIVE (30:2) to start the compressions again.

LUCASTM2 Chest Compression System – Instructions for Use

WARNING - PATIENT INJURY

Do not let the patient or the device stay unattended when LUCAS operates.

Caution - keep your fingers away

Do not put your hands on or below the Suction Cup when LUCAS operates. Keep your fingers away from the claw locks when attaching the Upper Part or lifting the pati ent.

Caution - IV access

Make sure that IV access is not obstructed.

Caution - do not block the vent holes

Do not cause a blockage of the vent holes under the hood since this can cause the device to become too hot.

Caution - device alarms

If there is any malfunction during operation the red Alarm LED will illuminate and a buzzer signal will be heard. For troubleshooting, see section 8.3.

WARNING - MALFUNCTION

If there are interruptions, or the compressions are not sufficient, or something unusual occurs during operation: Push ON/OFF for 1 second to stop LUCAS and remove the device. Start manual chest compressions.

Caution - do not lift by the Patient Strap s

Do not use the Patient Straps to lift the patient. The straps are only to attach the patient's arms to LUCAS.

Consult your distributor or JOLIFE AB for current information on wher e to send LUCAS for maintenance.

4 First use preparations

4.1 Delivered items

LUCAS™2 Chest Compression System is supplied in one box with:

• A LUCAS device (Upper Part and Back Plate)

• 3 disposable LUCAS Suction Cups

• A LUCAS Carrying Bag

• Instructions for Use in the relevant language version

• A rechargeable LUCAS Battery

• A LUCAS Stabilization Strap

• LUCAS Patient Straps

Accessories (optional):

• Disposable LUCAS Suction Cups

• External LUCAS Battery Charger

• Extra LUCAS Batteries

• LUCAS Power Supply with Mains cord

• LUCAS 12-24V DC Car Power Cord

3.9 Service

We recommend a yearly servicing of LUCAS to make sure that it operates correctly. Use the original shipping box when you send LUCAS for servicing. Keep the original shipping box with padding for this purpose.

WARNING - DO NOT OPEN

Never open the casing of LUCAS. Do not change or modify external or internal parts of LUCAS.

Unless specified differently, all servicing and repairs must be done by service personnel that are approved by JOLIFE AB.

If the above conditions are not followed, this can lead to patient/operator injury or de ath, and will void the warranty.

For more accessories, please see appendix A: LUCAS™2 parts and accessories.

LUCASTM2 Chest Compression System – Instructions for Use

4.2 The Battery

The proprietary Lithium Polymer (LiPo) Battery is the exclusive power source for LUCAS. You can remove the Battery from LUCAS and recharge it. The Battery is mechanically keyed in LUCAS and in the Battery Charger to make sure you get t he correct installation. The top of the Battery has connections for power and communications to the Battery Charger and to LUCAS.

4.2.1 Charge the Battery

You can charge the LUCAS Battery in two ways:

• In the external LUCAS Battery Charger (optional)

- put the Battery in the slot of the Battery Charger,

- connect the Battery Charger power cord to the mains wall outlet.

• Installed in LUCAS:

- put the Battery in the slot of the hood of LUCAS,

- connect the Power Supply to the DC input on the side of LUCAS,

- connect the Power Supply to the mains wall outlet.

Green LEDs indicate a fully charged Battery.

Caution - keep Battery installed

The Battery must always be installed for LUCAS to be able to oper ate, also when powered by the external Power Supply.

Caution - use only approved accessories

Use only JOLIFE AB-approved accessories with LUCAS. LUCAS does not operate correctly if you use accessories that are not approved. Use only LUCAS Batteries and the LUCAS Power Supply that are designed for LUCAS. If you use other batteries or Power Supply you can cause permanent damage to LUCAS. This also voids the warranty.

LUCASTM2 Chest Compression System – Instructions for Use

4.3 Prepare the LUCAS™ Stabilization Strap

Before the first use of LUCAS, attach the support leg straps, which is a part of t he Stabilization Strap, to the LUCAS support legs.

1. Fold one support leg strap around each LUCAS support leg.

2. Fasten the buckles on the inner side of the support leg.

4.4 Prepare the Carrying Bag

1. Insert a fully charged LUCAS Battery in the Battery slot in the hood of LUCAS.

2. Make sure that a Suction Cup is mounted correctly.

3. Put the Upper Part in the Carrying Bag with the hood towards the open end.

4. Put the external Power Supply (optional) in one of the pockets between the LUCAS support legs.

5. Put an extra (optional) charged LUCAS Battery in the other pocket.

6. Put the cushion strap of the Stabilization Strap between the support legs.

7. Extra Suction Cups can be put in the side pockets close to the hood.

8. Position the Back Plate on top of the bag.

9. Close the green inner lock.

10. Put the Instructions for Use (IFU) in the transparent IFU pocket in the bag

11. Close the bag.

LUCASTM2 Chest Compression System – Instructions for Use

5Use LUCAS™

5.1 Arrival at the patient

When you have confirmed a cardiac arrest, immediately start manual cardiopulmonar y resuscitation (CPR). Continue with a minimum of interruptions.

5.2 Unpack LUCAS™

1. Position the bag with its top nearest to you.

2. Put your left hand on the black strap on the left side and pull the red handle so

that the bag unfolds.

3. Push ON/OFF on the User Control Panel for 1 second to power up LUCAS in the bag and start the self test. The green LED adjacent to the ADJUST key illuminates when LUCAS is ready for use.

Note: LUCAS powers down automatically after 5 minutes if you let it stay in the

ADJUST mode. Caution - device alarm

If there is a malfunction, the red Alarm LED illuminates and a buzzer signal is heard. For trouble shooting, refer to section 8.3.

Caution - keep Battery installed

The Battery must always be installed for LUCAS to be able to oper ate, also when powered by the external Power Supply.

LUCASTM2 Chest Compression System – Instructions for Use

5.3 Apply to patient

1. Remove the LUCAS Back Plate from the Carrying Bag.

2. Stop manual CPR.

3. Make sure that you support the patient's head.

4. Carefully put the LUCAS Back Plate under the patient, immediately below the arm pits. Use one of these procedures:

a. Hold the patient's shoulder and lift the

patient's upper body a small distance,

b. Roll the patient from side to side.

5. Start manual CPR again.

6. Hold the handles on the support legs to remove the LUCAS Upper Part from the bag. Pull the release rings once to make sure that the claw locks are open.

7. Let go of the release rings.

Note: An accurate position of the Back Plate makes it easier and faster to position the Suction Cup correctly.

LUCASTM2 Chest Compression System – Instructions for Use

Suction Cup outer edge

Pressure pad

8. Attach the support leg that is nearest to you to the Back Plate.

9. Stop manual CPR.

10. Attach the other support leg to the Back Plate, so that the two support legs lock against the Back Plate. Listen for click.

11. Pull up once to make sure that the parts are correctly attached.

5.4 Adjustment and operation

The compression point should be at the same spot as for manual CPR and ac cording to guidelines.

When the pressure pad in the Suction Cup is in the correct position, the lower edge of

the Suction Cup is immediately above the end of the sternum.

WARNING - INCORRECT POSITION OVER CHEST

Note: If the LUCAS Upper Part does not attach to the Back Plate, make sure that the claw locks are open and that you have released the release rings.

WARNING - TOO LARGE PATIENT

If the patient is too large, the Upper Part of LUCAS cannot lock to the Back Plate without compressing the patient's chest. Continue the manual compressions.

LUCASTM2 Chest Compression System – Instructions for Use

1. Use your finger to make sure that the lower edge of the Suction Cup is immediately above the end of the sternum

If necessary, move the device by pulling the support legs to adjust the position.

c. Push PAUSE to lock the Start

Position - then remove your fi ngers from the Suction Cup.

d. Check for proper position. If not, push

ADJUST, pull up the Suction Cup to readjust the central and/or height position for a new Start Position. Push PAUSE.

e. Push ACTIVE (continuous) OR

ACTIVE (30:2) to start the compressions.

2. Adjust the height of the Suction Cup to set the Start Position.

a. Make sure that LUCAS is in the

ADJUST mode.

b. Push the Suction Cup down with two

fingers until the pressure pad touches the patient's chest without compressing the chest.

Note: If the pressure pad is pushe d down too hard, or too loose to the chest, LUCAS will adjust the pressure pad to t he correct Start Position (within a range of 30 mm / 1.2 inches).

WARNING - UNSATISFACTORY POSITION

Start manual CPR again if it is not possible to position LUCAS safely and correctly on the patient's chest.

WARNING - TOO SMALL PATIENT

If you cannot enter the PAUSE mode or ACTIVE mode when the pressure pad touches the patient's chest and LUCAS alarms with 3 fast signals. Start manual compressions again.

LUCASTM2 Chest Compression System – Instructions for Use

WARNING - INCORRECT START POSITION

The patient's blood circulation is compromised if the pressure pad presses down too heavily or too lightly on the chest. Push the ADJUST key and adjust the height of the Suction Cup immediately.

Caution - gel on chest

If there is gel on the patient's chest (e.g. from ultrasound examination), the position of the Suction Cup can change during operation. Remove all gel before you apply the Suction Cup.

Caution - keep your fingers away

Do not put your hands or other body p arts on or below the Suction Cup when LUCAS operates. Do not touch the claw locks, especially when you lift the patient.

WARNING - PATIENT INJURY

Do not let the patient or the device stay unattended when LUCAS operates.

WARNING - CHANGED POSITION DURING OPERATION

Caution - do not block the vent holes

Do not cause a blockage of th e vent holes under the hood since this can cause the device to become too hot.

5.5 Apply the LUCAS™ Stabilization Strap

The LUCAS Stabilization Strap helps secure the correct position during operation. Apply it while LUCAS is active to keep interruptions to a minimum.

Caution - Stabilization Strap application

Delay the application of the LUCAS Stabilization Strap if this prevents or delays any medical treatment of th e patient .

1. Remove the cushion strap, which is a part of the Stabilization Strap, from the Carrying Bag (the support legs strap of the Stabilization Strap should already be attached to the support legs).

2. Extend the cushion strap fully at the buckles.

3. Carefully lift the pa tien t's head and put the cushion behind the patient's neck. Position the cushion as near the patient's shoulders as possible.

4. Connect the buckles on the support leg straps with the buckles on the cushion strap. Make sure that the straps are not twisted.

5. Hold the LUCAS support legs stable and tighten the cushion strap tightly.

WARNING - MALFUNCTION

WARNING - LOW BATTERY

When the orange Battery LED shows an intermittent light, do one of these:

• Replace the Battery with one that is charged.

• Connect the external LUCAS Power Supply.

LUCASTM2 Chest Compression System – Instructions for Use

6. Make sure that the position of the Suction Cup is correct on the patient's chest.

If it is not, adjust the position: a. Push ADJUST. b. Release the cushion straps from the

support leg straps.

c. Adjust the Suction Cup position (as

described in the section 5.4.2).

d. When the Suction Cup is in the corr ect

position, push ACTIVE (continuous) or ACTIVE (30:2) to start the compressions again.

e. Attach the cushion strap agai n. Refer

to the steps 2 to 5 above.

5.6 Move the patient

5.6.1 Secure the patient's arms

When you move the patient, you can secure the patient's arms with the Patient Straps on the LUCAS. This makes it easier to move the patient.

5.6.2 Prepare to lift the patient

1. Make a decision about what equipment you will move and where to put the transportation device.

2. Those at the patient's side: a. put one hand below the claw locks

under the support leg

b. with the other hand, hold the patient's

belt, trousers or under the thigh

3. Make sure that the patient's head is stable.

Caution - do not lift by the Patient Strap s

Do not use the Patient Straps to lift the patient. The straps are only to attach the patient's arms to LUCAS.

Caution - IV access

Make sure that IV access is not obstructed.

5.6.3 Lift the patient

1. Push PAUSE to temporarily stop the compressions.

2. Lift and move the patient to a stretcher or other transportation device (backboard, vacuum mattress or similar).

3. Make sure that the Suction Cup is in the correct position on the patient's chest.

4. Push ACTIVE (continuous) or ACTIVE (30:2) to start the compres- sions again.

LUCASTM2 Chest Compression System – Instructions for Use

5.6.4 Move the patient

LUCAS can be active while you move the patient if:

• LUCAS and the patient are safely positioned on the transportation device

• LUCAS stays in the correct position and angle on the patient's chest

5.7.1 Change the Battery

Keep interruptions to a minimum while changing the Battery.

Note: To minimize interruptions, we recommend to always have a charged spare LUCAS Battery in the Carrying Bag.

1. Push PAUSE to temporarily stop the compressions.

2. Pull the Battery out and then upwards to remove it.

If necessary, adjust the position of the Suction Cup.

WARNING - CHANGED POSITION DURING OPERATION

5.7 Replace the Power Supply during operation

When the Battery charge is low, LUCAS alarms with an intermittent orange LE D and an alarm signal.

3. Install a fully-charged LUCAS Battery. Put it in from above.

4. Wait until the green PAUSE mode LED illuminates.

5. Push ACTIVE (continuous) or ACTIVE (30:2) to start the chest com- pressions again. The LUCAS Smart Restart feature remembers the settings and Start Position for 60 seconds.

Note: If the Battery change takes more th an 60 seconds, LUCAS does a self test and you must adjust the Start Position again.

LUCASTM2 Chest Compression System – Instructions for Use

5.7.2 Connect to the external Power Supply

You can connect the LUCAS Power Supply or Car Power Cable in all LUCAS operating modes.

Caution - keep Battery installed

The Battery must always be installed for LUCAS to be able to operate, also when powered by the external Power Supply.

To use the Power Supply cable:

• Connect the Power Supply cable to LUCAS.

5.8.1 Defibrillation

Defibrillation can be performed while LUCAS operates.

1. You can apply the defibrillation electrodes before or after LUCAS has been put in position.

2. Perform the defibrillation according to the instructions from the manufacturer of the defibrillator.

Caution - defibrillation electrodes

Position the defibrillation electrodes and wires so that they are not under the Suction Cup. If there are already electrodes on the patient, make sure that they are not under the Suction Cup. If they are, you must apply new electrodes.

3. After defibrillation, make sure that the position of the Suction Cup is correct. If necessary, adjust the position.

• Connect the mains cable to the wall mains outlet (100-240V, 50/60Hz)

To use the Car Power Cable:

• Connect the Car Power Cable to LUCAS

• Connect the Car Power Cable to the car outlet (12-24V DC)

5.8 Adjunctive therapies

Caution - adjunctive therapies

The use of other medical equipment or drugs in conjunction with LUCAS can affect the treatment. Always consult the instructions for use for the other equipment and/or drugs to make sure that they are applicable in conjunction with CPR.

WARNING - CHANGED POSITION DURING OPERATION

WARNING - ECG INTERFERENCE

LUCASTM2 Chest Compression System – Instructions for Use

5.8.2 Ventilation

Always follow local and/or international guidelines for ventilation.

LUCAS can operate in two different modes:

• ACTIVE (continuous) When you push this key LUCAS performs continuous compressions. The green LED signal will blink 8 times per minute to alert for ventilation during ongoing compressions.

• ACTIVE (30:2) When you push this key, LUCAS performs 30 chest compressions and then temporarily stops for 3 seconds. During the stop, the operator can perform 2 ventilations. After the stop the cycle starts again. An intermittent LED in combination with an alarm signal sequence will alert the operator before each ventilation pause.

5.8.3 Use in the catheterization laboratory

LUCAS can be used in the catheterization laboratory. Except for the compressi on mechanism it is mainly radiotranslucent and allows for most X-ray projections.

5.9 Remove LUCAS™ from the

patient

1. Push ON/OFF for 1 second to power off the device.

2. If a LUCAS Stabilization Strap is attached to LUCAS, remove the cushion strap, which is part of the Stabilization Strap, from the support leg straps.

3. Pull the release rings to remo ve the Upper Part from the Back Plate.

4. If the patient's condition allows it, remove the Back Plate.

6 Care after use and

preparation for next use

Do the following after each use of the LUCAS Chest Compression System:

1. Remove the Suction Cup (refer to section

6.2).

2. If necessary, remove and clean the Patient Straps and the Stabilization Strap separately (refer to section 6.1 and 6.3).

3. Clean the device and let it dry (refer to section 6.1).

Preparation for next use:

4. Replace the used Battery with a fully charged Battery in the batte ry slot in the hood.

5. Mount a new Suction Cup.

6. Attach the Patient Straps again, if they are removed.

7. Attach the support leg straps of the LUCAS Stabilization Strap again, if they are removed.

8. Pack the device into the Carrying Bag:

• Put the Upper Part in the Ca rrying Bag

with the hood towards the open end.

• Put the external Power Supply

(optional) in one of the pockets between the LUCAS support legs.

• Put an extra (optional) charged

LUCAS Battery in the other pocket.

• Put the cushion strap of the Stabiliza-

tion Strap between the support legs.

• Extra Suction Cups can be put in the

side pockets near the hood.

• Position the Back Plate on top of the

bag.

• Close the green inner lock.

LUCASTM2 Chest Compression System – Instructions for Use

• Put the Instructions for Use (IFU) in the

transparent IFU pocket in the bag.

9. Close the bag.

Do routine checks weekly and after each use (refer to the maintenance section).

6.1 Cleaning routines

Clean all surfaces and straps with a soft cloth and warm water with a mild cleaning agent or disinfectant agent, e.g.

• 70% isopropyl alcohol solution

• 45% isopropyl alcohol with added detergent

• Quaternary ammonium compound

• 10% bleach

Follow the handling instructions from the manufacturer of the disinfectant.

Caution - liquid

Do not immerse LUCAS in liquid. The device can be damaged if liquid enters the hood.

Allow LUCAS to dry before you pack it into the bag.

6.2 Remove and install the Suction Cup

6.3 Remove and attach the Patient Straps

Remove:

1. Open the Patient Straps and pu ll th em out from the metal rings on the LUCAS support legs.

Clean according to 6.1. Install:

1. Thread the Patient Straps thro ug h the metal holder on the LUCAS support legs.

2. Fold the Patient Strap so that the symbol is visible.

3. Press the strap parts firmly together.

• Pull the Suction Cup off the black mounting tube.

• Discard the Suction Cup as contaminated medical waste.

• Bend a new Suction Cup onto the black mounting tube.

• Make sure the Suction Cup is safely attached on the mounting tube.

LUCASTM2 Chest Compression System – Instructions for Use

6.4 Remove and attach the

LUCAS™ Stabilization Strap

Remove the Support leg straps, whic h is a part of the Stabilization Strap, by opening the buckles.

Clean the Stabilization Strap according to 6.1. Install according to 4.3.

6.5 Remove and recharge the

Battery

1. Replace the Battery with a fully charged one.

2. Recharge the used Batt er y for fut ur e use.

You can charge the LUCAS Battery in two ways:

• In the external LUCAS Battery Charger

(optional)

- put the Battery in the slot of the

Battery Charger,

- connect the Battery Charger power

cord to the mains wall outlet.

• Installed in LUCAS:

- put the Battery in the slot of the hood

of LUCAS,

- connect the Power Supply/Car Power

Cable to the DC input on the side of LUCAS,

- connect the Power Supply to the

mains wall outlet.

Caution - use only approved accessories

7 Maintenance

7.1 Routine checks

Weekly, and after each use of the LUCAS Chest Compression System, do the following:

1. Make sure that the device is clean.

2. Make sure that a new Suction Cup is installed.

3. Make sure that the Patient Stra p s are attached.

4. Make sure that the two support leg straps of the Stabilization Strap are attached around the support legs.

5. Pull the release rings upwards to make sure that the claw locks are open.

6. Make sure that the Battery is fully charged. When LUCAS is in the OFF mode, push MUTE. The Battery indicator illuminates and shows the Battery charge status (see section 8.1).

7. Push ON/OFF to make LUCAS do a self test. Make sure the ADJUST LED illuminates with no alarm or warning LED.

8. Push ON/OFF to power down LUCAS again.

Green LEDs indicate a fully charged Battery.

Caution - keep Battery installed

The Battery must always be installed for LUCAS to be able to operat e, also wh en powered by the external Power Supply.

LUCASTM2 Chest Compression System – Instructions for Use

8 Troubleshooting

8.1 Indications and alerts during normal operation

Refer to the table below to find the reason for sound and/or LED alarms during normal operation.

Situation Visual LED indication Audible signals User action

LUCAS is in the ON mode and there is more than 90% Battery capacity remaining.

LUCAS is in the ON mode and there is more than 60% and less than 90% Battery capacity remaining.

LUCAS is in the ON mode and there is more than 30% and less than 60% Battery capacity remaining.

LUCAS is in the ON mode and there is less than 30% Battery capacity remaining (approximately 10 minutes of operating capacity).

An external LUCAS Power Supply is connected and charging the Battery.

An external LUCAS Power Supply is connected and the Battery is fully charged.

The Battery has been used more than 200 times with compressions of more than 10 minutes each or is older than 3 years.

In the ADJUST mode. The ADJUST LED

Fully charged Battery: All 3 green Battery indication LEDs show a constant light.

2/3 charged Battery: The 2 green Battery indication LEDs to the right show a constant light.

1/3 charged Battery: The green Battery indication LED farthest to the right shows a constant light.

Low Battery: The orange Battery indication LED farthest to the right illuminates intermittently.

Charging Battery: The 3 green Battery indication LEDs show a "running" light.

Fully charged Battery: All 3 green Battery indication LEDs show a constant light.

End of Battery service life: The Battery indication LED farthest to the right shows orange light instead of green, in all the above situations.

shows a green light.

None None

Intermittent alarm Replace the Battery

or connect to the external power supply.

None None

None Dispose of

Battery.

None None

In the PAUSE mode. The PAUSE LED shows

a green light.

LUCASTM2 Chest Compression System – Instructions for Use

None None

Situation Visual LED indication Audible signals User action

In the ACTIVE (continuous) mode The ACTIVE (continuous)

key, LUCAS performs continuous chest compressions. The green LED signal will blink 8 times per minute

In the ACTIVE (30:2) mode The ACTIVE (30:2) LED

shows a green light with an intermittent LED during compressions number 26, 27, 28, 29 and

30.

None This is to alert for

Alarm signal alert during compressions number 28 (“ding”), 29 (“ding”) and 30 (“dong”).

ventilation during ongoing compressions.

This is to alert the operator to ventilate the patient when LUCAS temporarily stops the compressions at number 30.

When the Suction Cup is in a lower position than for the minimum patient (sternum height below 6.7 inches / 17 cm) and you cannot enter the PAUSE mode or ACTIVE mode, the patient is too small.

Too large gap between the pressure pad and the patient's chest during operation. The patient will get too shallow compressions.

None 3 fast signals Continue with

manual compressions.

None 3 fast signals during

operation

Push ADJUST and readjust the Start Position to eliminate the gap. Restart the compressions.

8.2 Battery replacement and Smart Restart feature

If you change the Battery quickly in 60 seconds or less, with LUCAS in the ON mode, the LUCAS Smart Restart feature remembe rs the settings a nd Start Positi on according t o the table belo w. If the Battery change takes more than 60 seconds, LUCAS does a self test and you must adjust the Start Position again.

Mode when you remove the Battery Mode when the new Battery is in place again

PAUSE PAUSE (with the same Start Position)

ACTIVE (continuous) PAUSE (with the same Start Position)

ACTIVE (30:2) PAUSE (with the same Start Position)

ADJUST ADJUST

OFF OFF

LUCASTM2 Chest Compression System – Instructions for Use

8.3 Malfunction alarms

Below is a list of all alarms that can occur on LUCAS. You mute all alar ms for 60 se conds if you push MUTE.

Start with manual compressions immediately if LUCAS does not operate properly.

Reason Visual LED indication Audible alarms Result

Compression pattern outside limit (too deep, too shallow and timing failure)

Rising temperature in LUCAS Warning alarm None Too high temperature in LUCAS Red alarm LED Alarm Compressions stop

Hardware error Red alarm LED Alarm Compressions stop

Red alarm LED Alarm Compressions stop

Too high Battery temperature Intermittent red Battery

warning: The red Battery indication LED farthest to the right illuminates intermittently.

Battery charge too low Intermittent red Battery

warning: The red Battery indication LED farthest to the right illuminates intermittently.

Battery error Constant red Battery

warning: The red Battery indication LED farthest to the right shows a constant light.

Intermittent alarm Compressions stop

Intermittent alarm Compressions stop.

The Battery must be recharged in the external Battery Charger.

Alarm Compressions stop.

The Battery cannot be used anymore.

If the malfunction described above seems permanent, LUCAS must be examined by approved service personnel. Please consult your local Physio-Control representative or JOLIFE AB. Contact information is available at www.JOLIFE.com

LUCASTM2 Chest Compression System – Instructions for Use

9 Technical specifications

All specifications in this chapter apply to the LUCAS™2 Chest Compression System.

9.1 Patient parameters

Category Specifications

Patients eligible for treatment: Adult patients who fit into the device;

• sternum height of 6.7 to 11.9 inches / 170 to 303 mm

• a maximum chest width of 17.7 inches / 449 mm

The use of LUCAS is not restricted by patient weight.

9.2 Compression parameters

Category Specifications

Compression depth (nominal patient) Patients with sternum height over 7.3 inches / 185 mm:

• 2.1 ±0.1 inches / 53 ±2 mm

Smaller patients with sternum height less than 7.3 inches / 185 mm:

• 1.5 to 2.1 inches / 40 to 53 mm

Compression frequency 102 ±2 compressions per minute Compression duty cycle 50 ± 5% Compression modes (operator selectable) • 30:2 (30 compressions followed

by a 3 seconds ventilation pause)

• Continuous compressions

9.3 Device physical specifications

Category Specifications

Dimensions when assembled (H × W × D) 22.4 x 20.5 x 9.4 inches / 57 × 52 × 24 cm Dimensions Carrying Bag with device inside (H × W × D) 25.6 x 13 x 9.8 inches / 65 × 33 × 25 cm Weight of the device with the Battery 17.2 lbs / 7.8 kg

9.4 Device environmental specifications

Category Specifications

Operating temperature +32°F to +104°F / +0°C to +40°C

- 4°F / -20°C for 1 hour after storage at room temperature Storage temperature -4°F to +158°F / -20°C to +70°C Relative humidity 5% to 98%, non-condensing IP classification (IEC60529) IP 43 Operating input voltage 12-24 V DC

LUCASTM2 Chest Compression System – Instructions for Use

9.5 Battery physical specifications

Category Specifications

Size (H × W × D) 5.1 x 3.5 x 2.2 inches / 13.0 × 8.8 × 5.7 cm Weight 1.3 lbs / 0.6 kg Type Rechargeable Lithium Ion Polymer (LiPo) Capacity 3300 mAh (typical), 86 Wh Battery voltage (nominal) 25.9 V Initial Battery runtime (nominal patient) 45 minutes (typical) Maximum Battery charge time Less than 4 hours at room temperature

(72ºF / 22ºC)

Required interval for replacement of the Battery Recommendation to replace the Battery every 3 years or

after 200 uses (of more than 10 minutes use each time)

9.6 Battery environmental specifications

Category Specifications

Operating temperature 32ºF to 104ºF / 0ºC to +40ºC, ambient when installed in the

device

Charge temperature 41ºF to 95ºF / 5ºC to +35ºC ambient (68ºF to 77ºF / 20ºC to

25ºC preferred)

Storage temperature 32ºF to 104ºF / 0ºC to +40ºC ambient for less than six

months

IP classification (IEC60529) IP 44

LUCASTM2 Chest Compression System – Instructions for Use

9.7 Electromagnetic environmental declaration

Guidance and manufacturer's declaration - electromagnetic emissions

LUCAS 2 is intended for use in the electromagnetic environment specified below. The customer or the operator of LUCAS 2 must make sure that it is used in the correct environment.

Emissions test Compliance Electromagnetic

environment - guidance

RF emissions CISPR 11 Group 1 LUCAS 2 uses RF energy only for its

internal operation. This makes its RF emissions very low and not likely to cause interference with other electronic

equipment near LUCAS 2. RF emissions CISPR 11 Class B LUCAS 2 is suitable for use in all Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Complies

Guidance and manufacturer's declaration - electromagnetic immunity

LUCAS 2 is intended for use in the electromagnetic environment specified below. The customer or the operator of LUCAS 2 must make sure that it is used in the correct environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient / Burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on Power Supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

NOTE UT is the a.c. mains voltage prior to application of the test level. Guidance and manufacturer's declaration - electromagnetic immunity LUCAS 2 is intended for use in the electromagnetic environment speci fie d belo w. The customer or the operator of LUCAS

2 must make sure that it is used in the correct environment.

+/- 6 kV contact +/- 8 kV air

+/- 2 kV for Power Supply lines +/- 1 kV for input/output lines

+/- 1 kV differential mode +/- 2 kV common mode

<5 % UT (>95 % dip in UT) for 0.5 cycle

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT)) for 5 sec

30 A/m 30 A/m The power frequency magnetic

+/- 6 kV contact +/- 8 kV air

+/- 2 kV for Power Supply lines n/a. for input/output lines

+/- 1 kV differential mode n/a. for common mode

<5 % UT (>95 % dip in UT) for 0.5 cycle

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT)) for 5 sec

buildings including domestic homes

and places directly connected to the

public low-voltage Power Supply

network that supplies buildings used

for domestic purposes.

environment - guidance

Floors must be wood, concrete or ceramic tile. If there is synthetic material on the floor, the relative humidity must be 30% or more.

The mains power quality must be that of a typical commercial or hospital environment.

The mains power quality must be that of a typical commercial or hospital environment. If the user of the [Equipment or System] requires continued operation during power mains interruptions, JOLIFE recommends that the [Equipment or System] is energized from a Powe r Supply or Battery that cannot be interrupted.

fields must be at levels that are characteristic of a typical location in a typical commercial or hospital environment

LUCASTM2 Chest Compression System – Instructions for Use

d 1.2 P=

d 1.3 P=

Immunity test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601 test level

10 Vrms 150 kHz to 80 MHz

10 V/m 80MHz to 2.5GHz

Compliance level

10 Vrms

10 V/m

Electromagnetic environment - guidance

Portable and mobile RF communications equipment must not be used nearer to LUCAS 2 (cables included) than the recommended separation distance calculated with the equation applicable to the frequency of the transmitter.

Recommended separation distance

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, must be less than the compliance level in each frequency

range.

Interference can occur near equipment marked with the following symbol.

NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in some situations. Electromagnetic propagation is affected by absorption and reflected from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which LUCAS 2 is used exceeds the applicable RF compliance level above, LUCAS 2 should be observed to make sure it operates normally. If unusual or incorrect performance is observed, additional measures can be necessary, such as reorienting or relocating LUCAS 2.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. Recommended separation distances between portable and mobile RF communications equipment and the LUCAS 2 LUCAS 2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

The customer or the operator of LUCAS 2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and LUCAS 2 as recommended below, according to the maximum output power of the communications equipment.

LUCASTM2 Chest Compression System – Instructions for Use

d 1.2 P=

d 1.3 P=

Rated maximum output power of transmitter W

0.01 0.12 0.12 0.24

0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)

can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Separation distance according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

LUCASTM2 Chest Compression System – Instructions for Use

9.8 Limited warranty

Subject to the limitations and exclusions set forth below, JOLIFE AB ("JOLIFE") warrants that JOLIFE products which are purchased from authorized JOLIFE representatives or dealers and are used in accordance with their instructions will be free from defects in material and workmanship appearing under normal serv ice and use for the time period listed below. The time limit and the warranty schedule begin on the date of delivery to the first purchaser.

12 Months: LUCAS™2 Chest Compression System (including the LUCAS device (Upper Part and Back Plate), Carrying Bag, Battery, Stabilization Strap, Patient Straps).

JOLIFE does not warrant that JOLIFE products will perform error-free or without interruptions. The sole and exclusive remedy under this limited warranty is to repair or replace defective material or workmanship at the option of JOLIFE. To qualify for the repair or replacement, the pr oduct must not have been repaired or altere d in any way which, in the judgment of JOLIFE, affects its stability and reliability. The product must have been used and maintained in accordance with applicable operating instructions and in the intended environment or setting.

The Limited Warranty does not cover problems with products that have been caused by misuse, abuse, improper maintenance, modifications to the product or accident. JOLIFE or its authorized service provider shall, in its sole discretion, determine whether a reported problem is covered under this Limited Warranty and whether the product is field serviceable. If field serviceable and located within 100 miles of a JOLIFE designated service location, warranty service will be provided by JOLIFE or its authorized serv ice provider at the purchaser' s facility during normal business hours. If not field serviceable or if the product is located outside of such areas, all products requiring warranty service should be returned to a locatio n designated by JOLIFE or its authoriz ed service provider, freight prepaid, and must be accomp anied by a written, detailed explanation of the claimed failure.

Except for the Limited Warranty provided above, NEITHER JOLIFE NOR ITS AUTHORIZED SERVICE PROVIDER MAKES ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOMER OR OTHERWISE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON OR ENTITY. NEITHER JOLIFE NOR ITS AUTHORIZED SERVICE PROVIDER IS LIABLE FOR DIRECT OR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF BUSINESS OR PROFITS) WHETHER BASED ON CONTRACT, TORT, OR ANY OTHER SUPPORT LEGAL THEORY.

Any support legal action arising from the purchase or use of JOLIFE products shall be commenced within one year from the accrual of the cause of action, or be barred forever. In no event shall JOLIFE liability under this warranty or otherwise exceed the greater of $50,000 or the purchase price of the product giving ri se to the cause of action.

Products are warranted in conformance with applic able laws. If any part or term of this Limited Warranty is held to be illegal, unenforceable or in conflict with applicable law by any court of competent jurisdiction, the validity of the remaining portions of the Limited War ranty shall not b e affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. Some countries, and states within United States of America, do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. This Limited Warranty gives the user specific support legal rights. The user may al so have other rights which vary from state to state or country to country.

LUCASTM2 Chest Compression System – Instructions for Use

Appendix A; LUCAS™2 parts and accessories

Description JOLIFE AB Part number

LUCAS Back Plate 150208-00 3 x LUCAS 2 Suction Cup 150205-03 LUCAS 2 Carrying Bag 150200-00 LUCAS 2 Instructions for Use (regional versions) 100666-XX LUCAS 2 Battery 150201-00 LUCAS Stabilization Strap 150203-00 LUCAS Patient Straps 150204-00 LUCAS 2 Power Supply (regional versions) 150202-XX LUCAS 2 Car Power Cable 150206-00 LUCAS 2 Battery Charger 150207-00 LUCAS 2 Back Plate Grip Tape 150209-00 LUCAS PCI Back Plate 150211-00

LUCASTM2 Chest Compression System – Instructions for Use

For more information, please contact your local Physio-Control representative or the manufacturer JOLIFE AB

JOLIFE AB, Scheelevägen 17, SE-223 70 Lund, Sweden, Tel: +46 (0) 46 286 50 00, Fax: +46 (0) 46 286 50 10, E-mail: info@jolife.com

jolife.com

LUCAS is a trademark of JOLIFE AB.

1 Activate (A)

• Push ON/OFF for 1 second to

start self-test and power up LUCAS

2 Back Plate (B)

• Pause manual CPR

• Carefully put Back Plate under

the patient, below armpits

• Resume manual CPR

3 Compressor (C)

• Pull release rings once; claw

locks open. Then let go of the release rings

• Attach to Back Plate; listen

for “click”

• Pull up once to ensure

attachment

4 Position the Suction

Cup

• Center the Suction Cup over

the chest

• The lower edge of Suction Cup

should be immediately above the end of the sternum

5 Push down the

Suction Cup

• Push the Suction Cup down

with two ngers (make sure it is in the ADJUST mode)

• Pressure pad inside Suction

Cup should touch patient’s chest. If the pad does not touch or t properly, continue manual compressions

• Push PAUSE to lock Start

Position – then remove your ngers from the Suction Cup

6 Start compressions

• Check for proper position.

Adjust if necessary

• Push ACTIVE (continuous)

or ACTIVE (30:2)

• LUCAS provides chest

compressions according to guidelines.

7 LUCAS Stabilization

Strap

• Attach the LUCAS Stabilization

Strap

Quick Reference Guide

NOTE: This guide is not a complete Instructions for Use. Refer to the “Instructions for Use” for complete

directions for use, indications, contraindications, warnings, precautions, and potential adverse events.

Conﬁrm cardiac arrest and start manual CPR with a minimum of interruptions until LUCAS is applied and ready.

Always follow local and/or international guidelines for CPR when you use LUCAS.

ON/OFF

ADJUST PAUSE

ACTIVE

(continuous)

ACTIVE

(30:2)

JOLIFE AB, Scheelevägen 17, SE-223 70 Lund, Sweden, Tel: +46 (0) 46 286 50 00, Fax: +46 (0) 46 286 50 10, E-mail: info@jolife.com, jolife.com

Physio-Control LUCAS 2 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual