Physio Control LUCAS 3 Bedienungsanleitung

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE

Thank you for choosing the

LUCAS® 3 Chest Compression System.

With the help of the LUCAS® 3device,

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® 3Chest 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

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

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

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

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

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

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

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

2.6 Device components ...................................................7

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

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

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

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

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

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

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

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

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

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

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

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

Table of Contents

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE

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 Cleaning routines ....................................................25

6.2 Remove and install the Suction Cup ......................................26

6.3 Remove and attach the Patient Straps ....................................26

6.4 Remove and attach the Stabilization Strap .................................27

6.5 Remove and recharge the Battery........................................27

7 Maintenance ............................................... 28

7.1 Routine checks ......................................................28

8 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 specications....................................... 32

9.1 Patient parameters ...................................................32

9.2 Compression parameters ..............................................32

9.3 Device physical speciﬁcation............................................32

9.4 Device environmental speciﬁcations ......................................32

9.5 Battery physical speciﬁcations ..........................................33

9.6 Battery environmental speciﬁcations......................................33

9.7 Power speciﬁcation (optional accessories) .................................33

9.8 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

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:

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE

2 Introduction

2.1 LUCAS Chest

Compression System

The LUCAS Chest Compression System

is a portable tool designed to overcome

problems identiﬁed with manual chest

compressions. The LUCAS device assists

rescuers by delivering effective, consistent

and continuous chest compressions as

recommended in the American Heart

Association guidelines1and 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

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

• 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.

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE

1. Hood

2. User Control Panel

3. Battery

4. DC input

5. Bellows

6. Suction Cup*

7. Patient wrist strap*

8. Release ring

9. Support leg

10. Support leg strap

(part of the Stabilization Strap)

11. Neck strap*

(part of the Stabilization Strap)

12. Back Plate*

13. Claw locks

14. Car Power Cable

15. Power Supply cord

16. Power Supply

17. External Battery Charger

18. Carrying Case

19. Charger port access

20. Transparent top window

21. Upper Part

22. Pressure pad*

23. Vent holes

* Applied part

(according to IEC 60601-1)

(3)

15 1614

2.6 Device components

LUCAS® 3 Chest Compression System – INSTRUCTIONS FOR USE

30:2

2.7 User Control Panel

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.

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.

Battery indicator:

The three green LEDs show the Battery

charge status:

• Three green LEDs: Fully charged

• Two green LEDs: 2/3 charged

• One green LED: 1/3 charged

• One intermittent 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

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

3.5 Symbols on the device

IP03

IP43

Symbols on

type labels IP40

IP44

Symbol Meaning

Caution – keep your ngers 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.

Do not reuse - Single use only.

DC input.

Symbol 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.

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.

Serial number

TYPE Variant

Batch code/lot number

Non-ionizing electromagnetic

radiation

Class II equipment

Complies with (USA) Federal

Communications Commission

regulations

Symbols on type labels

* 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

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