LUCAS 2 Instructions for Use Rev B

2

Thank you for choosing the LUCASTM 2 Chest Compression System! With LUCASTM 2 your cardiac arrest patients 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 contact your local Physio-Control representative or the manufacturer JOLIFE AB.

MANUFACTURER JOLIFE AB Scheelevägen 17 Ideon Science Park SE-223 70 LUND Sweden Tel. +46 46 286 50 00 Fax. +46 46 286 50 10

The LUCASTM 2 Chest Compression System 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.

LUCASTM 2 Chest Compression System – Instructions for Use

100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00

3

Table of Contents 1

Important user information... 5

2

Introduction... 6 2.1 2.2 2.3 2.4 2.5 2.6 2.7

3

Safety precautions... 9 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9

4

LUCAS™ Chest Compression System... 6 Intended use... 6 Contraindications... 6 Side effects... 6 Main parts... 6 LUCAS™ components... 7 User Control Panel... 8

Signal words... 9 Personnel... 9 Contraindications... 9 Side effects... 9 Symbols on the device... 10 General safety precautions... 11 Battery... 11 Operation... 11 Service... 12

First use preparations... 13 4.1 4.2

Delivered items... 13 The Battery... 13 4.2.1 Charge the Battery... 13

4.3 4.4

5

Prepare the LUCAS™ Stabilization Strap... 14 Prepare the Carrying Bag... 14

Use LUCAS™... 15 5.1 5.2 5.3 5.4 5.5 5.6

Arrival at the patient... 15 Unpack LUCAS™... 15 Apply to patient... 16 Adjustment and operation... 17 Apply the LUCAS™ Stabilization Strap... 19 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 100901-00 Rev B, A, Valid from CO J3166 J2716 © 2017 2014 Jolife AB AB

4

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

6

Care after use and preparation for next use... 23 6.1 6.2 6.3 6.4 6.5

7

Routine checks... 25

Troubleshooting... 26 8.1 8.2 8.3

9

Cleaning routines... 24 Remove and install the Suction Cup... 24 Remove and attach the Patient Straps... 24 Remove and attach the LUCAS™ Stabilization Strap... 25 Remove and recharge the Battery... 25

Maintenance... 25 7.1

8

Remove LUCAS™ from the patient... 23

Indications and alerts during normal operation... 26 Battery replacement and Smart Restart feature... 27 Malfunction alarms... 28

Technical specifications... 29 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8

Patient parameters... 29 Compression parameters... 29 Device physical specifications... 29 Device environmental specifications... 29 Battery physical specifications... 30 Battery environmental specifications... 30 Power supply specification (optional accessory)... 30 Audible SIGNALS... 31 9.8.1 Audible ALARM SIGNALS, characteristics... 31 9.8.2 Audible INFORMATION SIGNALS, characteristics... 32

9.9 Electromagnetic environmental declaration... 33 9.10 Limited warranty... 36

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00

5

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 complete 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. TRADEMARKS LUCAS™ is a trademark of JOLIFE AB. DECLARATION OF CONFORMITY LUCAS Chest Compression System complies with the requirements of the European Medical Device 93/42/EEC. It is marked with the CE-symbol:

2460 © Copyright JOLIFE AB 201. Allrightsreserved.

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev B, A, Valid from CO J3166 J2716 © 2017 2014 Jolife AB AB

6

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 guidelines1.

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 LUCAS alerts with 3 fast signals when lowering the Suction Cup, and you cannot enter the PAUSE mode or ACTIVE mode.

2.4 Side effects The International Liaison Committee on Resuscitation (ILCOR) states these side effects of CPR2: "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." 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 the disposable Suction Cup. • A Stabilization Strap which helps to secure the position of the device in relation to the patient. • A padded Carrying Bag.

• 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.

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 100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00

7

2.6 LUCAS ™ components 15

13

9

1

8 10

2 14

3

16 19

4 5 22 21

18 6

7

20

13

1. User Control Panel 2. Hood 3. Patient Strap* 4. Release ring 5. Support leg 6. Claw locks 7. Back Plate* 8. DC input 9. Bellows 10. Suction Cup* 11. Power Supply 12. Power Supply cord 13. Battery 14. Pressure pad 15. Upper Part 16. Vent holes 17. Car Power Cable 18. Carrying Bag 19. External Battery Charger

12

11

LUCAS Stabilization Strap* 20. Cushion strap 21. Buckle 22. Support leg strap

* Applied part (according to IEC 60601-1).

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev B, A, Valid from CO J3166 J2716 © 2017 2014 Jolife AB AB

17

8

2.7 User Control Panel

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:

ON/OFF: LUCAS will power up/power down when 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 Emitting 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.

• 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 too hot or empty. Note: When the LED to the far right is orange and not green, the Battery has reached the end of its service life. JOLIFE AB recommends that you replace this Battery with a new one. Alarm indicator: One intermittent red LED and an alarm signal sequence indicate 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 audible signal sequence will alert the operator before each ventilation pause.

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00

9

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 LUCAS alerts with 3 fast signals when lowering the Suction Cup, and you cannot enter the PAUSE mode or ACTIVE mode. • 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 CPR3: "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.

3. 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 100901-00 Rev B, A, Valid from CO J3166 J2716 © 2017 2014 Jolife AB AB

10

3.5 Symbols on the device

Symbols on type label

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.

Symbols on type label Symbol Meaning Follow instructions for use All operators must read the complete Instructions for Use before operating the LUCAS Chest Compression System.

Caution - do not lift by the straps Do not use the straps for lifting. The straps are only to fixate the patient to LUCAS.

Year of manufacture and manufacturer.

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.

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

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

IP 43

2

Degree of protection provided by enclosure per IEC 60 529.

Do not reuse - Single use only. DC voltage. Defibrillation protected type BF patient connection.

DC input.

SN

Serial number

TYPE

Variant

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00

11

3.6 General safety precautions Caution - use only approved accessories Use only JOLIFE AB-approved accessories 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 permanent 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. WARNING - FIRE Do not use LUCAS in oxygen rich environments or in conjunction with flammable agents or with flammable anaesthetics. Caution - electrical device To isolate mains from LUCAS disconnect the mains plug from mains outlet. Caution - other medical equipment LUCAS can affect other medical electrical equipment with regards to EMC (Electromagnetic Compatibility). Take into account the technical information in section 9.9 Electromagnetic environmental declaration.

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

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev B, A, Valid from CO J3166 J2716 © 2017 2014 Jolife AB AB

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. 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 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. 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 - Stabilization Strap application Delay the application of the LUCAS Stabilization Strap if this prevents or delays any medical treatment of the patient. 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 appropriate for use in conjunction with CPR.

12

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. WARNING - ELECTRICAL SHOCK If the external Power Supply cord (optional accessory) is damaged, remove and replace it immediately to avoid the risk of electrical shock or fire. 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 patient.

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 death, and will void the warranty. Consult your distributor or JOLIFE AB for current information on where to send LUCAS for maintenance.

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 high priority alarm 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 straps Do not use the straps for lifting. The straps are only to fixate the patient to LUCAS. Caution - skin burns The temperatures of the hood and battery may rise above 118 °F / 48 °C. If hot, avoid prolonged contact to prevent skin burns. Remove patient hands from patient straps.

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00

13

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

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.

Accessories (optional): • Disposable LUCAS Suction Cups • External LUCAS Battery Charger • Extra LUCAS Batteries • LUCAS Power Supply with Mains cord • LUCAS 12-28V DC Car Power Cable For more accessories, please see appendix A: LUCAS™2 parts and accessories.

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 the correct installation. The top of the Battery has connections for power and communications to the Battery Charger and to LUCAS.

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev B, A, Valid from CO J3166 J2716 © 2017 2014 Jolife AB AB

Three green LEDs indicate a fully charged Battery. 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. 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.

14

4.3 Prepare the LUCAS™ Stabilization Strap

4.4 Prepare the Carrying Bag

TM

Before the first use of LUCAS, attach the support leg straps, which is a part of the 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.

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 100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00

15

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

30:2

5.1 Arrival at the patient

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.

3

5 Use LUCAS™

5.2 Unpack LUCAS™

TM

LU CA S2

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.

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev B, A, Valid from CO J3166 J2716 © 2017 2014 Jolife AB AB

Note: LUCAS powers down automatically after 5 minutes if you let it stay in the ADJUST mode. Caution - device alarms If there is any malfunction during operation the red Alarm LED will illuminate and a high priority alarm will be heard. For troubleshooting, refer to section 8.3. 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.

16

5.3 Apply to patient 1. Remove the LUCAS Back Plate from the Carrying Bag.

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.

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.

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 100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00

17

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

5.4 Adjustment and operation The compression point should be at the same spot as for manual CPR and according 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.

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.

Suction Cup outer edge Pressure pad

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.

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 100901-00 Rev B, A, Valid from CO J3166 J2716 © 2017 2014 Jolife AB AB

18

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

c. Push PAUSE to lock the Start Position - then remove your fingers from the Suction Cup.

If necessary, move the device by pulling the support legs to adjust the position. 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 pushed down too hard, or too loose to the chest, LUCAS will adjust the pressure pad to the 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 LUCAS alerts with 3 fast signals when lowering the Suction Cup, and you cannot enter the PAUSE mode or ACTIVE mode. Start manual compressions again.

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00

19

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 - 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.

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 - 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 parts 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 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. 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. 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 100901-00 Rev B, A, Valid from CO J3166 J2716 © 2017 2014 Jolife AB AB

Caution - Stabilization Strap application Delay the application of the LUCAS Stabilization Strap if this prevents or delays any medical treatment of the 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 patient'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.

20

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 correct position, push ACTIVE (continuous) or ACTIVE (30:2) to start the compressions again. e. Attach the cushion strap again. Refer to the steps 2 to 5 above.

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

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.

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.

5.6.3 Lift the patient Caution - do not lift by the straps Do not use the straps for lifting. The straps are only to fixate the patient to LUCAS. Caution - IV access Make sure that IV access is not obstructed. Caution - skin burns The temperatures of the hood and battery may rise above 118 °F / 48 °C. If hot, avoid prolonged contact to prevent skin burns. Remove patient hands from patient straps.

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 compressions again.

LUCASTM2 Chest Compression System – Instructions for Use 100901-00 Rev Rev A, B, Valid Valid from from CO CO J2716 J3166 © © 2014 2017 Jolife Jolife AB AB 100901-00