LUCAS Instructions for Use Rev E

Important user information All users must read and fully understand the entire Instructions for Use before operating LUCAS Chest Compression System. The Instructions for Use should always be easily accessible to the users of LUCAS. Always follow local and/or international guidelines for CPR when using LUCAS. The use of other medical equipment or drugs in conjunction with external chest compressions may reduce the effect of compressions. Always consult the instructions for use for other equipment or drugs to check that they are appropriate to use in conjunction with the treatment and compressions being performed with LUCAS. When LUCAS is used on a non intubated patient the device can safely be stopped to allow intermittent manual ventilation. Switch off the device by turning the ON/OFF knob to the Lock position, ventilate and turn the ON/OFF knob back to the Active position again. See Section 1.5 on page 7 for information about the ON/OFF knob positions. REQUIRED SKILLS

Jolife AB strongly recommends that LUCAS Chest Compression System is only used by persons with basic medical skills such as: First responders, ambulance personnel, nurses, physicians or medical staffs, who have: • completed a CPR course according to the American Heart Association or equivalent, AND • received training in how to use LUCAS LUCAS can only be bought by or on the order of a licensed medical practitioner. TRADEMARKS

LUCASTM 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:

MANUFACTURER, MAIN OFFICE

Jolife AB Scheelev. 17 SE-223 70 LUND Sweden Tel: +46 46 286 50 00 www.lucas-cpr.com DISTRIBUTOR, USA

Medtronic Emergency Response Systems 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073-9706 USA Tel: 425.867.4000 Fax: 425.867.4121 www.medtronic-ers.com

LUCAS Chest Compression System, Instructions for Use ENGLISH (US)

Art. No. 100057-00 E, Valid from CO J2243 © Copyright Jolife AB 2006. All rights reserved. 2

Table of Contents IMPORTANT USER INFORMATION ... 2 INTRODUCTION...5 1.1 INTENDED USE ...5 1.2 CONTRAINDICATIONS ...5 1.3 LUCAS CHEST COMPRESSION SYSTEM...5 1.4 LUCAS COMPONENTS ... 6 1.5 ON/OFF-KNOB, POSITIONS ...7 1.6 DESCRIPTION ... 8 1.7 SYMBOLS ON THE DEVICE... 9 1.8 DELIVERED ITEMS ...10 1.9 THE LUCAS TEAM ...10 1.10 BACKGROUND ...11 1.11 CHEST COMPRESSIONS USING LUCAS...11 1.12 SIDE EFFECTS ...11 2 WARNINGS AND PRECAUTIONS ... 12 2.1 ASSEMBLY ...12 2.2 USING LUCAS CHEST COMPRESSION SYSTEM ...12 2.3 CONNECTION TO AIR SUPPLY ... 13 2.4 ADJUSTING LUCAS TO THE PATIENT ... 13 2.5 HANDLING LUCAS CHEST COMPRESSION SYSTEM ... 13 3 USING LUCAS ... 14 3.1 ARRIVAL AT THE PATIENT ...14 3.2 UNPACKING AND CONNECTING THE AIR ...14 3.3 ASSEMBLY ...16 3.4 ADJUSTMENT ...17 3.5 OPERATING LUCAS CHEST COMPRESSION SYSTEM ...18 3.6 DEFIBRILLATION ...19 3.7 TRANSPORTING THE PATIENT...19 3.8 CHANGING AIR SOURCES ...21 3.9 REMOVING LUCAS FROM THE PATIENT...22 4 CARE AFTER USE ... 22 4.1 CLEANING ROUTINES...22 4.2 ROUTINE CHECKS ... 23 4.3 STORAGE ... 23 4.4 SERVICE ... 23 5 PACKING AWAY THE DEVICE ... 24 1

6

TECHNICAL SPECIFICATION ... 25

APPENDIX A ... 28 WEEKLY CHECK AND CHECK AFTER USE, LUCAS...28

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APPENDIX B - LUCAS STABILIZATION STRAP ... 29 INSTRUCTIONS FOR USE ... 29 1 INTRODUCTION ... 30 1.1 OVERVIEW ... 30 1.2 CONTRAINDICATIONS ... 30 1.3 ASSOCIATED DOCUMENTATION ... 30 1.4 LUCAS STABILIZATION STRAP ... 30 1.5 DESCRIPTION ... 30 1.6 THE LUCAS TEAM... 31 2 PREPARING LUCAS STABILIZATION STRAP FOR USE... 32

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WARNINGS AND PRECAUTIONS ... 32 USING LUCAS STABILIZATION STRAP ... 32 USING LUCAS STABILIZATION STRAP ... 33 INTRODUCTION ...33 ATTACHING LUCAS STABILIZATION STRAP ...33 CARE AFTER USE ... 35 CLEANING ROUTINES ... 35 ROUTINE CHECKS ... 35 STORAGE ... 35 PACKING AWAY THE STABILIZATION STRAP ... 36

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TECHNICAL SPECIFICATION ... 36

3

3.1

4

4.1 4.2

5

5.1 5.2 5.3

APPENDIX C... 37 WEEKLY CHECK AND CHECK AFTER USE, LUCAS STABILIZATION STRAP ... 37

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1 Introduction 1.1

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 manual chest compression would be used. LUCAS is only intended for temporary use.

1.2 CONTRAINDICATIONS Do NOT use LUCAS Chest Compression System in the following cases:

• Too small adult patient: The suction cup is not

being completely compressed when it is lowered as far as possible. • Too large patient: The support legs of LUCAS cannot be locked to the back plate without compressing the patient. • Patient is a child. • Patient with traumatic injury (wounds resulting from sudden physical injury or violence). • Pregnant patients. The woman has to lie 10–15° to one side to prevent vena cava syndrome (impaired venous return to the heart as the uterus compresses the inferior vena cava). • If there is no indication that chest compression is likely to help the patient.

1.3

LUCAS CHEST COMPRESSION SYSTEM LUCAS is a portable device for external cardiac compressions. It is stored and easily carried in a backpack, giving the user free hands until the device is needed. The components of LUCAS are shown in the illustration in Section 1.4.

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1.4 LUCAS COMPONENTS

q w

i

e h r

s o

a

t g f

y u

d

1. ON/OFF Knob 2. Hood 3. Patient strap 4. Release ring 5. Support leg 6. Claw lock 7. Back plate 8. Hose attachment 9. Bellows 10. Suction cup 11. Height adjustment handle 12. Air hose 13. LUCAS unique connector 14. Pressure pad 15. Upper part

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1.5

ON/OFF-KNOB,

1.

Adjust: The suction cup

POSITIONS

can be adjusted to fit the patient, using the height adjustment handles. 2. Lock: The compression mechanism is locked. This is used during defibrillation and when moving the patient. 3. Active: This is the operating position. When LUCAS Chest Compression System is connected to an air supply of specified capacity, it performs compressions at a rate of about 100 per minute.

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1.6

DESCRIPTION 1.6.1

h

MAIN PARTS

LUCAS consists of an upper part (h) and a back plate (u). The back plate is placed underneath the patient to form a support for the external chest compressions. The upper part contains a pneumatically driven piston rod, which acts on the patient’s chest via a pressure pad. The pressure pad is surrounded by a suction cup.

t

The support legs (t) of the upper part are fastened to the back plate prior to starting compressions.

1.6.2

u

CONNECTION TO AIR SUPPLY

LUCAS is powered by compressed air from a wall outlet or a cylinder. See Section 6 for specification of air sources. The air hose is permanently mounted on LUCAS, and has a unique male connector at the open end. A suitable pressure regulator is delivered with LUCAS.

j

LUCAS requires no electrical supply and has no conducting parts on the outside, except the hose attachment, the claw lock bar, and the upper attachment of the bellows.

LUCAS STABILIZATION STRAP LUCAS Stabilization Strap (j) is an accessory 1.6.3

which is attached to LUCAS to prevent downward movement of LUCAS during operation. Please see Appendix B for instructions for use of LUCAS Stabilization Strap.

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1.7

SYMBOLS ON THE DEVICE

Symbol/ Location

Meaning

Caution – see instructions for use. All users must read the entire Instructions for Use before operating LUCAS Chest Compression System.

Year of manufacture.

WARNING – Crushing hazard. The

pressure pad and suction cup are drawn into the bellows with high force when LUCAS is connected to an air supply. Keep all body parts away from the suction cup, the bellows and the height adjustment handles when connecting the air hose, and during operation. WARNING – Crushing hazard. Keep

your fingers away from the claw locks when attaching the upper part to the back plate. Caution – Do not lift by the straps.

The straps are only intended for securing the patient’s arms to LUCAS.

Place the suction cup immediately above the end of the sternum, as indicated in the figure. The suction cup should be centred over the sternum.

Pull up the release rings to release the support legs from the back plate.

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1.8

DELIVERED ITEMS Before using LUCAS Chest Compression System, make sure that the following items are delivered: 1. 2. 3.

1.9

q

LUCAS in carrying bag together with Instructions for Use. Pressure regulator. LUCAS Stabilization Strap (packed in carrying bag).

THE LUCAS TEAM It is strongly recommended that qualified personnel work in teams of two. This enables one person to perform cardiopulmonary resuscitation (CPR) while the other person unpacks LUCAS Chest Compression System. The Instructions for Use will refer to “The LUCAS team” (Figure q), consisting of two people who have the required skills stated on page 2 .

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1.10 BACKGROUND

1.11 CHEST COMPRESSIONS USING LUCAS

The single most common cause of death in western society is cardiovascular disease either on its own or as a contributory factor.

In situations where it is possible to use LUCAS Chest Compression System, many of the problems with manual chest compressions can be eliminated.

There is only a short space of time after the heart stops during which it is possible to reverse the situation and restore spontaneous circulation.

LUCAS works by pressing down very quickly on the rib cage and holding it down for 50% of the period/ cycle.

If the heart is not started quickly, the two most important organs, the heart and brain, will be damaged by the lack of oxygen.

When following normal routines for CPR, the use of LUCAS has the following advantages over manual chest compression:

Effective chest compressions can restore circulation to a level, which may be sufficient to prevent heart and brain damage during a short period of time.

• The device maintains consistent chest

compression over a long period of time.

• One person becomes free to provide other care. • It is possible and safer for the user to give

For optimal results the compressions should be performed in such a way that the rib cage is held down for approximately half of the time, and subsequently released for the remaining half of the time

effective chest compression even in a moving vehicle.

1

.

It is very difficult to perform manual chest compressions effectively, even for experienced CPR practitioners, and especially in a vehicle, moving ambulance, during transport or when there is no firm surface under the patient .

1.12 SIDE EFFECTS Bruising and soreness of the chest is common during use of LUCAS External Cardiac Compressor.

2 3

The International Liaison Committee on Resuscitation (ILCOR) states the following side effects of CPR : 4

• 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 resuscitationrelated injuries.

American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation 2005;112: 24, Supplement; December 13, 2005. Hightower D, Thomas SH, Stone CK et al. Decay in Quality of ClosedChest Compressions Over Time. Ann Emerg Med 1995;26:300-303. Sunde K, Wik L, Steen P A: Quality of Mechanical, manual Standard and active compression-decompression CPR on the arrest site and during transport in a manikin model. Resuscitation 1997;34:235-242. 1

2

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

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2 Warnings and precautions

2.2 USING LUCAS CHEST COMPRESSION SYSTEM WARNING – IMPROPER USE Improper use of the device can cause serious injury to the patient and ineffective chest compressions.

Important This section contains safety information. All users must read this section before using LUCAS Chest Compression System and observe the safety information at all times during use.

Jolife AB strongly recommends that the equipment only be used by personnel who have undertaken training in use and handling of LUCAS Chest Compression System.

Sections 2.1 to 2.5 summarize warnings and precautions during assembly and use of LUCAS Chest Compression System.

Other personnel may assist those with the necessary training in using LUCAS.

Additional hazards are described in relevant sections of the Instructions for Use. All users must observe the safety information in Warnings and Cautions during use of LUCAS Chest Compression System.

2.1 ASSEMBLY

WARNING – DEVICE STATUS If your LUCAS unit does not appear as in the illustration in Section 1.4, or if the device does not function in the same way as in training, or according to specification: Discontinue use and continue with manual chest compressions.

WARNING – LETHAL PINCH HAZARD If the air is connected during the assembly procedure, and the ON/OFF-knob is in the Active position, the compressions may seriously injure the patient or create conditions leading to death of the patient. Always follow the described sequence of air connection and assembly.

WARNING – MALFUNCTION If there is air leakage, interruption in compressions or insufficient compressions, if the frequency is wrong, or there is jarring, or there is something else that cannot be classified as normal running: Disconnect the air hose immediately, turn the ON/ OFF knob to Adjust and remove the device. Start manual chest compressions.

Caution - Keep hose and connectors clean The mechanical parts of LUCAS may be damaged if sand or soil enters the air hose, resulting in reduced performance. Always keep the hose and connectors clean, do not leave these parts on the ground.

WARNING – SUCTION CUP SLIDING ON GEL If there is gel on the patient’s chest (e.g. from ultrasound examination), the position of the suction cup may change during use. Remove any gel left before applying the suction cup.

WARNING – PATIENT INJURY OR DEATH Do not leave the patient or device unattended while LUCAS Chest Compression System is active.

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2.3 CONNECTION TO AIR SUPPLY WARNING – INTERRUPTING AIR SUPPLY TO LIFE SUPPORT DEVICES If other life support equipment is disconnected from the air supply, serious injury or death may result.

2.5 HANDLING LUCAS CHEST COMPRESSION SYSTEM WARNING – CRUSHING HAZARD Avoid placing your hands or other body parts on, or below the suction cup, when LUCAS is active.

Never remove attachments to air outlets without first checking that this will not put a patient at risk.

WARNING – CRUSHING HAZARD WARNING – EMPTY AIR SUPPLY When the air in the cylinder runs out, the pressure falls and compressions delivered by LUCAS lose force.

Keep your fingers away from the claw locks, particularly when lifting the patient from the floor to the stretcher with LUCAS in position.

Immediately start manual chest compressions and ensure that the air cylinder is exchanged. Always change air cylinder if the pressure gauge is on red.

2.4 ADJUSTING LUCAS TO THE PATIENT WARNING – INCORRECT HEIGHT ADJUSTMENT If the suction cup presses down too hard or too lightly on the rib cage, the patient’s circulation will be compromised. Turn the ON/OFF knob to Adjust and adjust the height of the suction cup immediately.

WARNING – INCORRECT POSITION If the suction cup is not positioned correctly in relation to the sternum, there is an increased risk of damage to the rib cage and internal organs. In addition, the patient’s circulation will be compromised. Make sure that the suction cup is positioned according to instructions in Section 3.4 before starting compressions. If the position changes during operation, immediately turn the ON/OFF knob to Adjust and adjust the position of the suction cup.

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3 Using LUCAS w

LUCAS Chest Compression System should be used to treat patients following the same routines as for manual CPR. This section describes the use of LUCAS. It is divided into nine steps: 1. 2. 3. 4. 5. 6. 7. 8. 9.

e

3.1

Arrival at the patient Unpacking and connecting the air Assembly Adjustment Operating Defibrillation Transporting the patient Changing air sources Removing LUCAS from the patient

ARRIVAL AT THE PATIENT Upon arrival at the patient, confirm cardiac arrest by determining level of consciousness, breathing and pulse (Figure w). If the patient has suffered a cardiac arrest, commence cardiopulmonary resuscitation (CPR) with the LUCAS team immediately. If CPR is already being carried out when you arrive, assist as required. Do not interrupt CPR.

3.2 UNPACKING AND CONNECTING THE AIR

r

On arrival, one of the LUCAS team members should immediately start to unpack and connect LUCAS Chest Compression System.

3.2.1 1.

2.

14

UNPACKING LUCAS

Place the bag on the floor/ground with the straps downwards and the top opposite you (Figure r). Take hold of the straps on the side of the cover and open up the cover so that the entire bag unfolds (Figure r).

100057-00 E, ©JOLIFE AB 2006 LUCASTM CHEST COMPRESSION SYSTEM, INSTRUCTIONS FOR USE

3.2.2 CONNECTING THE AIR WARNING – INTERRUPTING AIR SUPPLY TO LIFE SUPPORT DEVICES If other life support equipment is disconnected from the air supply, serious injury or death may result. Never remove attachments to air outlets without first checking that this will not put a patient at risk.

WARNING – CRUSHING HAZARD The suction cup is drawn into the bellows with high force when the air hose is connected. Keep all body parts away from the suction cup, the bellows and the height adjustment handles when connecting the air hose. 1. 2. 3. 4.

Confirm that the ON/OFF knob is in the Adjust position. If not already connected, attach the air hose to the connector. Attach the connector to a wall outlet or to a portable air cylinder. If using a pressure regulator, open the air valve.

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t

3.3 ASSEMBLY WARNING – LETHAL PINCH HAZARD If the air is connected during the assembly procedure, and the ON/OFF-knob is in the Active position, the compressions may seriously injure the patient or create conditions leading to death of the patient. Always follow the described sequence of air connection and assembly. 1.

y

u

Take the back plate out of the bag and approach the patient (Figure t). 2. Instruct those carrying out CPR to interrupt chest compression. 3. Work in a pair, one person on each side of the patient. 4. Take hold of the patient’s arms. One of the LUCAS team should support the patient’s head. 5. Lift up the patient’s upper body and lay the back plate below the armpits. Ensure that the patient’s arms are outside the back plate (Figure y). 6. Continue manual chest compressions. 7. Take the upper part of LUCAS out of the bag. Lift it out by holding on to the handles of the support legs. Ensure that the support legs have reached their outer position (Figure u). 8. Pull up once on the release rings to check that the claw locks are open. 9. Interrupt manual chest compression. 10. Place the upper part of LUCAS over the patient’s chest so that the claw locks of the support legs will engage with the back plate (Figure i). 11. Start by pressing on the support leg nearest to you and then the one on the other side so the support legs lock against the back plate. 12. Check by pulling upwards, that both support legs have locked against the back plate.

i

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3.4 ADJUSTMENT

o

3.4.1

INTRODUCTION

To achieve effective compressions, it is very important that the suction cup is positioned correctly on the patient (Figure o). The lower edge of the suction cup should be positioned immediately above the end of the sternum. The suction cup should be centred over the sternum (Figure a).

3.4.2 ADJUSTMENT PROCEDURE

a

WARNING – MINIMUM PATIENT SIZE If the suction cup cannot be completely compressed and lowered enough to make the pressure pad touch the patient's chest, the patient is too small for LUCAS to be used. Continue manual compressions. To adjust the position of LUCAS: 1. 2.

s

d

>0 mm

Set the ON/OFF knob to Adjust . Lower the suction cup with the heightadjustment handles until the pressure pad inside the suction cup touches the patient’s chest without compressing the chest (Figure s). If there is a distance between the pressure pad inside the suction cup and the sternum, LUCAS cannot be used on the patient(Figure d). Note: By simultaneously holding up the outer rim of the suction cup you will more easily see or feel when the pressure pad touches the chest.

3.

If the suction cup is not correctly positioned in relation to the patient, adjust the position of LUCAS by pulling on the support legs (Figure f). The person assembling the device determines whether the position is correct.

f

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3.5 OPERATING LUCAS CHEST COMPRESSION SYSTEM 3.5.1

STARTING COMPRESSIONS

When the position of the suction cup is correctly adjusted according to Section 3.4, LUCAS can be switched on: 1. ACTIVE

Turn the ON/OFF knob to Active will now give chest compressions.

. LUCAS

WARNING – PATIENT INJURY OR DEATH Do not leave the patient or device unattended while LUCAS is active. 2. 3. LOCK

Check that the device is working as it should regarding frequency and compression. When you want to stop chest compressions, turn the ON/OFF knob to the Lock position, without changing the respective positions of the patient and device.

3.5.2 APPLYING LUCAS STABILIZATION STRAP

g

18

When LUCAS is applied to the patient and performing compressions under the supervision of one person of the LUCAS team, attach the Stabilization Strap to LUCAS (Figure g). For detailed instructions, please refer to Appendix B.

100057-00 E, ©JOLIFE AB 2006 LUCASTM CHEST COMPRESSION SYSTEM, INSTRUCTIONS FOR USE

3.6 DEFIBRILLATION WARNING – INCORRECT ECG ANALYSIS Compressions interfere with ECG analysis. Switch off LUCAS before ECG analysis. Make the interruption as short as possible

WARNING – INADEQUATE COMPRESSION Patient’s movements may change adjustment of suction cup. Verify position of suction cup after defibrillation, re-adjust if necessary.

h

Note: Self-adhesive electrodes should be used during defibrillation as these make it easier to work with LUCAS. Position the defibrillator electrodes and wires so they are not under the suction cup; if electrodes are already on the patient, you may need to apply new electrodes. Defibrillation can be performed when LUCAS is applied to the patient (Figure h). 1.

2.

j

Apply electrodes and perform the defibrillation according to manufacturer’s instruction for the defibrillator. After defibrillation or analysis of the outcome verify the position of the suction cup and readjust if necessary.

3.7 TRANSPORTING THE PATIENT 3.7.1

SECURING THE PATIENT’S ARMS

The patient’s arms can be fixed to the device during transport, using the straps on the support legs (Figure j). This makes it easier to move the patient, especially if not in a hospital environment.

WARNING – BLOCKED INTRAVENOUS CATHETER Do not tighten the patient strap/straps if drugs are administered to the patient via an intravenous catheter.

Caution – Do not lift by the straps The straps are only intended for securing the patient’s arms to LUCAS. Apply the straps tightly enough to secure the arms, but do not overtighten as this may reduce blood circulation to the patient’s hands. 100057-00 E, ©JOLIFE AB 2006 LUCASTM CHEST COMPRESSION SYSTEM, INSTRUCTIONS FOR USE

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3.7.2 LIFTING THE PATIENT At least three people should lift the patient and LUCAS – one should support the patient’s head and there should be one person on each side. Plan carefully before lifting the patient. Consider which equipment needs to be moved and where to place the stretcher.

k

LOCK

Those at the side should lift with one hand beneath the claw locks of the back plate. The other hand should be used to lift the patient’s belt, trouser or under the thigh. Use appropriate lifting technique to avoid injuries when lifting the patient (Figure k).

WARNING – CRUSHING HAZARD Do not insert your fingers in the claw locks. To lift a patient: 1. 2.

3.

4.

l

Secure the patient’s arms with the straps on the support legs. Turn the ON/OFF knob to Lock , to pause compressions while lifting the patient, for example when: – lifting to a stretcher – moving from one stretcher to another When the patient has been placed on the stretcher (or other surface), verify correct position of the suction cup on the patient. Turn the ON/OFF knob to Active .

Once the patient is placed on the stretcher, LUCAS may be in active state during all horizontal lifts and movements.

3.7.3

MOVING HORIZONTALLY

When the situation absolutely demands that the patient be moved while undergoing chest compression, the patient’s chest should be horizontal throughout the entire movement (Figure l).

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