LUCAS 3 Instructions For Use Rev F

2 Thank you for choosing the LUCAS® 3 Chest Compression System. With the help of the LUCAS® 3 device, your cardiac arrest patients will receive effective, consistent and continuous chest compressions as recommended in the American Heart Association (AHA) and European Resuscitation Council (ERC) guidelines for cardiopulmonary resuscitation. 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 LUCAS® 3 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.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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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 Device 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 Delivered items ... 13 4.2 The Battery ... 13 4.2.1

Charge the Battery... 13

4.3 Prepare the Stabilization Strap... 14 4.4 Prepare the Carrying Case... 14

5

Use the LUCAS device... 15 5.1 Arrival at the patient... 15 5.2 Unpack the device ... 15 5.3 Apply to patient... 16 5.3.1

Place the Back Plate ... 16

5.3.2 Attach the Upper Part ... 16

5.4 Adjustment and operation... 18 5.5 Apply the Stabilization Strap ... 20 5.6 Move the patient ... 20 5.6.1

Secure the patient’s arms... 20

5.6.2 Prepare to lift the patient ... 21 5.6.3 Lift the patient ... 21 5.6.4 Move the patient... 21

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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5.7 Replace the Power Supply during operation ... 22 5.7.1

Change the Battery ... 22

5.7.2

Connect to the external Power Supply... 22

5.8 Adjunctive therapies... 23 5.8.1

Defibrillation... 23

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

5.9 Remove the device from the patient... 24 5.10 Transmit data after the event... 24

6

Care after use and preparation for next use... 25 6.1 6.2 6.3 6.4 6.5

7

Maintenance... 28 7.1

8

Cleaning routines... 25 Remove and install the Suction Cup... 26 Remove and attach the Patient Straps... 26 Remove and attach the Stabilization Strap... 27 Remove and recharge the Battery... 27

Routine checks ... 28

Troubleshooting... 29 8.1 Indications and alerts during normal operation... 29 8.2 Battery replacement and Smart Restart feature... 30 8.3 Malfunction alarms... 31

9

Technical specifications... 32 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8

Patient parameters... 32 Compression parameters... 32 Device physical specification... 32 Device environmental specifications... 32 Battery physical specifications... 33 Battery environmental specifications ... 33 Power specification (optional accessories)... 33 Audible SIGNALS... 34 9.8.1

Audible ALARM SIGNALS, characteristics... 34

9.8.2 Audible INFORMATION SIGNALS, characteristics... 35

9.9 Electromagnetic environmental declaration ... 36 9.10 Limited warranty ... 39

Appendix A; LUCAS 3 parts and accessories... 40 Appendix B; Maintenance - Routine checks... 41

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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1 Important user information The information in these Instructions for Use applies to the LUCAS® 3 Chest Compression System, also referred to as the LUCAS device. 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 the LUCAS device. Always follow local and/or international guidelines for cardiopulmonary resuscitation (CPR) when you use the LUCAS chest compression system. The use of other medical equipment or drugs in conjunction with the LUCAS device 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. The LUCAS chest compression system can only be bought by or on the order of a licensed medical practitioner. TRADEMARKS LUCAS® is a registered trademark of Jolife AB. DECLARATION OF CONFORMITY LUCAS Chest Compression System complies with the requirements of the European Medical Device Directive 93/42/ECC. It is marked with the CE-symbol:

© Copyright Jolife AB 2016. All rights reserved.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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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. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association guidelines1 and the European Resuscitation Council guidelines2. The LUCAS chest compression system can be used in a wide variety of situations and settings; on the scene, during patient movement, during transportation in road and air ambulances, in hospitals and catheterization laboratories.

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. The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/ consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

2.3 Contraindications

• Too large patient: If you cannot lock the Upper Part of the LUCAS device to the Back Plate without compressing the patient’s chest. Always follow local and/or international guidelines for CPR when you use the LUCAS chest compression system.

2.4 Side effects The International Liaison Committee on Resuscitation (ILCOR) states these 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 reevaluated for resuscitation-related injuries.” Apart from the above, skin abrasions, 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 Carrying Case.

Do NOT use the LUCAS Chest Compression System in these cases: • If it is not possible to position the LUCAS device safely or correctly on the patient’s chest. • Too small patient: if the LUCAS device alerts with 3 fast signals when lowering the Suction Cup, and you cannot enter the PAUSE mode or ACTIVE mode.

1. 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Circulation 2015; 132; S313-S573 2. European Resuscitation Council Guidelines for Resuscitation 2015, Resuscitation 2015;95:1-311 3. 2005 International Concensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations, Resuscitation 2005;67:195

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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2.6 Device components

20

1 2

3 19 18

7

4 5

8 6

9 10

17

12

13

11

14

(3)

15

16

1.

Hood

14. Car Power Cable

21. Upper Part

2.

User Control Panel

15. Power Supply cord

22. Pressure pad*

3.

Battery

16. Power Supply

23. Vent holes

4.

DC input

17. External Battery Charger

5.

Bellows

18. Carrying Case

6.

Suction Cup*

19. Charger port access

7.

Patient wrist strap*

20. Transparent top window

8.

Release ring

9.

Support leg

* Applied part (according to IEC 60601-1)

21

10. Support leg strap (part of the Stabilization Strap)

11. Neck strap* (part of the Stabilization Strap)

12. Back Plate* 13. Claw locks

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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23

8

2.7 User Control Panel

Battery indicator: The three green LEDs show the Battery charge status: • Three green LEDs: Fully charged • Two green LEDs: 2/3 charged

3 1

2

• One green LED: 1/3 charged 30:2

ON/OFF: The LUCAS device will power up/power down when you push this key for 1 second. When the device 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 manually 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 the device temporarily but still want to keep the Start Position of the Suction Cup. ACTIVE (continuous): When you push this key, the LUCAS device performs continuous chest compressions. The green LED signal will blink 10 times per minute to alert for ventilation during ongoing compressions. 30:2

ACTIVE (30:2): When you push this key, the LUCAS device 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.

• One intermittent yellow 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, or the Battery is too hot. Note: When the LED to the far right is yellow 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. MUTE: If you push this key when the LUCAS device operates, you mute the alarm for 60 seconds. If you push this key when the LUCAS device is powered off, the Battery indicator shows the Battery charge status of the Battery. High priority alarms: One intermittent red LED and an alarm signal sequence indicate malfunction. A high priority alarm will take precedence over lower priority or information alarms. Refer to Troubleshooting 8; 8.1 for indications and alerts during normal operation. 8.3 for malfunction alarms. TRANSMIT data: This key is used to transmit data after the use of the LUCAS device. The device has to be in power OFF mode to transmit data. For more information please refer to the instructions in your data transfer program, or contact your local Physio-Control representative. Caution - radio frequency Radio frequency communications can affect other medical electrical equipment.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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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 the 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 the LUCAS device.

3.3 Contraindications Do NOT use the LUCAS Chest Compression System in these cases: • If it is not possible to position the LUCAS device safely or correctly on the patient’s chest. • Too small patient: if the LUCAS device 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 the LUCAS device to the Back Plate without compressing the patient’s chest. Always follow local and/or international guidelines for CPR when you use the LUCAS chest compression system.

3.4 Side effects The International Liaison Committee on Resuscitation (ILCOR) states the following side effects of CPR4: ”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 skin abrasions, bruising and soreness of the chest, are common during the use of LUCAS Chest Compression System.

4. 2005 International Concensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation 2005;67:195

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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3.5 Symbols on the device

IP03 Symbols on type labels

IP40

IP43

IP44

Symbols on type labels Symbol

Meaning

Symbol

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

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

Enclosure ingress protection* DC voltage Defibrillation protected type BF patient connection.

SN

TYPE

2

Meaning Follow instructions for use All operators must read the complete Instructions for Use before operating the LUCAS Chest Compression System. Year of manufacture and manufacturer.

Serial number Variant Batch code/lot number

Do not reuse - Single use only.

Non-ionizing electromagnetic radiation

DC input.

Class II equipment Complies with (USA) Federal Communications Commission regulations

*

IPXX

Mechanical (1st number)

Water (2nd number)

IP03 (Carrying Case)

Non-protected

Water spraying from above up to ±60° from the vertical direction

IP40 (Power Supply)

1mm objects

Non-protected

IP43 (Device)

1mm objects

Water spraying from above up to ±60° from the vertical direction

IP44 (Battery)

1mm objects

Water spraying from all directions

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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3.6 General safety precautions Caution - use only approved accessories Use only Jolife AB-approved accessories with the LUCAS chest compression system. The LUCAS device 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 the LUCAS device. If you use other batteries or power supply you can cause permanent damage to the LUCAS device. This also voids the warranty. Caution - liquid Do not immerse the LUCAS chest compression system in liquid. The device can be damaged if liquid enters the hood. WARNING - FIRE Do not use the LUCAS chest compression system in oxygen rich environments or in conjunction with flammable agents or with flammable anaesthetics. Caution - electrical device To isolate mains from the LUCAS device, disconnect the mains plug from mains outlet. Caution - other medical equipment The LUCAS device 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 yellow 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 the LUCAS device 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 Case.

3.8 Operation WARNING - UNSATISFACTORY POSITION Start manual CPR again if it is not possible to position the LUCAS device safely or 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.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

12 Caution - adjunctive therapies The use of other medical equipment or drugs in conjunction with the LUCAS device 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. 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 the LUCAS device operates. Caution - keep your fingers away Do not put your hands on or below the Suction Cup when the LUCAS device operates. Keep your fingers away from the claw locks when attaching the Upper Part or lifting the patient. 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 - do not lift by the straps Do not use the straps for lifting. The straps are only to fixate the patient to the LUCAS device. 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.

3.9 Service We recommend a yearly servicing of the LUCAS device to make sure that it operates correctly. Use the original shipping box when you send the device for servicing. Keep the original shipping box with padding for this purpose. WARNING - DO NOT OPEN Never open the casing of the LUCAS device. Do not change or modify external or internal parts of the LUCAS chest compression system. Unless specified differently, all servicing and repairs must be done by service personnel that are approved by Physio-Control, Inc. or 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 local distributor, Physio-Control, Inc., or Jolife AB for current information on where to send the LUCAS device for maintenance.

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 mechanical chest compressions and remove the device. Immediately start manual chest compressions.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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4 First use preparations 4.1 Delivered items

4.2.1 Charge the Battery

LUCAS Chest Compression System is supplied in one box with:

You can charge the LUCAS Battery in two ways:

• A LUCAS device (Upper Part and Back Plate)

• In the LUCAS Battery Charger: -- put the Battery in the slot of the Battery Charger, -- connect the Battery Charger power cord to the mains wall outlet.

• 2 disposable LUCAS Suction Cups • A LUCAS Carrying Case • Instructions for Use in the relevant language version

• Installed in the LUCAS device: -- put the Battery in the slot of the hood of the LUCAS device, -- connect the Power Supply to the DC input on the side of the LUCAS device, -- connect the Power Supply to the mains wall outlet.

• 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 12-28V DC Car Power Cable For more accessories, please see appendix A: LUCAS parts and accessories.

4.2 The Battery The proprietary Lithium Polymer (LiPo) Battery is the exclusive power source for the LUCAS chest compression system. You can remove the Battery from the LUCAS device and recharge it. The Battery is mechanically keyed into the LUCAS device 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 the LUCAS device.

Three green LEDs indicate a fully charged Battery. Caution - keep Battery installed The Battery must always be installed for the LUCAS device 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 the LUCAS chest compression system. The LUCAS device 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 the LUCAS device. If you use other batteries or Power Supply you can cause permanent damage to the LUCAS device. This also voids the warranty.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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4.3 Prepare the Stabilization Strap Before the first use of the LUCAS chest compression system, attach the support leg straps, which are 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.

5. In the Carrying Case compartment between the LUCAS support legs, you may put optional accessories such as the external Power Supply, a charged spare LUCAS Battery and extra Suction Cups. 6. Make sure the neck strap of the Stabilization Strap is placed on top in the Carrying Case compartment and is easy to find. 7. Slide the Back Plate into the Carrying Case cover lid compartment. 8. Put the Instructions for Use in the transparent pocket.

XXXXXX-00

Rev A, valid

from CO J2860

© 2016 Jolife

AB

QUICK REFERENCE

GUIDE

QUICK REFER

Please note this is not a complete directions for Instructions For use, indications, Use contraindications, (IFU). Refer to the IFU for complete warnings, precautions and potential

ENCE GUIDE

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9. Close the Carrying Case.

4.4 Prepare the Carrying Case 1. Insert a fully charged LUCAS Battery in the Battery slot in the hood of the LUCAS device. 2. Make sure that a Suction Cup is mounted correctly. 3. Make sure that the patient straps and the support leg straps are attached to the Upper Part. 4. Put the Upper Part in the Carrying Case with the DC input placed downward.

Note: Putting the LUCAS device in this position makes it possible to charge the device through the Carrying Case charger port access and to check Battery charge status through the Carrying Case top window.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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5 Use the LUCAS device 5.1 Arrival at the patient When you have confirmed a cardiac arrest, immediately start manual cardiopulmonary resuscitation (CPR). Minimize interruptions to manual chest compressions during the preparation and application of the LUCAS chest compression system.

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

Note: The LUCAS device powers down automatically after 5 minutes if you let it stay in the ADJUST mode.

5.2 Unpack the device 1. Open the Carrying Case.

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 the LUCAS device to be able to operate, also when powered by the external Power Supply.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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5.3 Apply to patient Keep interruptions to CPR to a minimum when applying the LUCAS device to the patient.

2. Minimize interruption to manual CPR by planning for and coordinating the placement of the back plate. • Make sure to support the patient’s head. • Pause manual CPR briefly while putting the LUCAS Back Plate under the patient, immediately below the arm pits. Use one of these procedures:

It is possible to deploy the device with interruptions to CPR of less than 20 seconds.

5.3.1 Place the Back Plate 1. Remove the LUCAS Back Plate from the Carrying Case.

a. Hold the patient’s shoulder and lift the patient’s upper body a small distance, b. Roll the patient from side to side. 3. Resume manual CPR immediately.

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LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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5.3.2 Attach the Upper Part 1. Hold the handles on the support legs to remove the LUCAS Upper Part from the Carrying Case.

4. Minimize interruptions to manual CPR by planning and coordinating the attachment and correct positioning of the Upper Part: a. During ongoing manual chest compressions, attach the support leg that is nearest to you to the back plate.

2. Pull the release rings once to make sure that the claw locks are open. 3.

Let go of the release rings.

b. Stop manual CPR while attaching the other support leg to the Back Plate, so that the two support legs lock against the Back Plate. c. Listen for click. Pull up once to make sure that the parts are correctly attached.

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 the LUCAS device cannot lock to the Back Plate without compressing the patient’s chest. Immediately resume manual compressions.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

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

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

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.

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

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 may be compromised.

2. Adjust the height of the Suction Cup to set the Start Position. a. Make sure that the LUCAS device 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.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

19 c. Push PAUSE to lock the Start Position

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 the LUCAS device operates. Do not touch the claw locks, especially when you lift the patient.

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. Note: If the Suction Cup is pushed down too hard, or too loose to the chest, the LUCAS device will adjust the Suction Cup to the correct Start Position (within a range of 30 mm / 1.2 inches). WARNING - UNSATISFACTORY POSITION Immediately start manual CPR again if it is not possible to position the LUCAS device safely or correctly on the patient’s chest. WARNING - TOO SMALL PATIENT If the LUCAS device alerts with 3 fast signals when lowering the Suction Cup, and you cannot enter the PAUSE mode or ACTIVE mode. Immediately start manual compressions again. WARNING - INCORRECT START POSITION The patient’s blood circulation may be 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 - PATIENT INJURY Do not let the patient or the device stay unattended when the LUCAS device 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 mechanical chest compressions and remove the device. Immediately start manual chest compressions. WARNING - LOW BATTERY When the yellow 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 - 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.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB

20

5.5 Apply the Stabilization Strap

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

The LUCAS Stabilization Strap helps secure the correct position during operation. Apply it while the LUCAS device 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 the patient. 1. Remove the neck 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 neck 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 neck strap. Make sure that the straps are not twisted. 5. Hold the LUCAS support legs stable and tighten the neck strap tightly.

If it is not, adjust the position: a. Push ADJUST. b. Release the neck 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 neck strap again. 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 device. This makes it easier to move 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 the LUCAS device. 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.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE 100925-00 Rev F, valid from CO J3021 © 2016 Jolife AB