Instructions for Use US www.lucas-cpr.
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 SE-223 70 LUND Sweden Tel. +46 46 286 50 00 Fax. +46 46 286 50 10 www.jolife.
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 6 6 6 6 6 7 8 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 . . . . . . . . . . . . . . . . . . . . . . . . .
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 .
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.
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.
2.6 LUCAS ™ components 15 13 9 1 8 10 2 14 3 16 19 4 5 22 21 18 6 7 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19.
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. 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.
3 Safety precautions 3.3 Contraindications Do NOT use the LUCAS Chest Compression System in these cases: To ensure maximum safety, always read this section carefully before operating, carrying out any work on the equipment or making any adjustments. • If it is not possible to position LUCAS safely or correctly on the patient's chest. • Too small patient: If you cannot enter the PAUSE mode or ACTIVE mode when the pressure pad touches the patient's chest and LUCAS alarms with 3 fast signals. 3.
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 Caution – do not lift by the Patient Straps Do not use the Patient Straps to lift the patient. The straps are only to attach the patient’s arms to LUCAS.
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. 3.
Consult your distributor or JOLIFE AB for current information on where to send LUCAS for maintenance. 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. 4 First use preparations 4.
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.
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.
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.
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.
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.
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.
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.
5.6.2 Prepare to lift the patient 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. 1.
5.6.4 Move the patient 5.7.1 Change the Battery LUCAS can be active while you move the patient if: • LUCAS and the patient are safely positioned on the transportation device • LUCAS stays in the correct position and angle on the patient's chest Keep interruptions to a minimum while changing the Battery. Note: To minimize interruptions, we recommend to always have a charged spare LUCAS Battery in the Carrying Bag. 1. Push PAUSE to temporarily stop the compressions. 2.
5.7.2 Connect to the external Power Supply 5.8.1 Defibrillation Defibrillation can be performed while LUCAS operates. You can connect the LUCAS Power Supply or Car Power Cable in all LUCAS operating modes. 1. You can apply the defibrillation electrodes before or after LUCAS has been put in position. 2. Perform the defibrillation according to the instructions from the manufacturer of the defibrillator.
5.8.2 Ventilation Always follow local and/or international guidelines for ventilation. LUCAS can operate in two different modes: 6 Care after use and preparation for next use • ACTIVE (continuous) When you push this key LUCAS performs continuous compressions. The green LED signal will blink 8 times per minute to alert for ventilation during ongoing compressions. • ACTIVE (30:2) When you push this key, LUCAS performs 30 chest compressions and then temporarily stops for 3 seconds.
6.1 Cleaning routines Clean all surfaces and straps with a soft cloth and warm water with a mild cleaning agent or disinfectant agent, e.g. • 70% isopropyl alcohol solution • 45% isopropyl alcohol with added detergent 6.3 Remove and attach the Patient Straps Remove: 1. Open the Patient Straps and pull them out from the metal rings on the LUCAS support legs. Clean according to 6.1. • Quaternary ammonium compound • 10% bleach Follow the handling instructions from the manufacturer of the disinfectant.
6.4 Remove and attach the LUCAS ™ Stabilization Strap 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.
8 Troubleshooting 8.1 Indications and alerts during normal operation Refer to the table below to find the reason for sound and/or LED alarms during normal operation. Situation Visual LED indication Audible signals User action LUCAS is in the ON mode and there is more than 90% Battery capacity remaining. Fully charged Battery: None All 3 green Battery indication LEDs show a constant light. None LUCAS is in the ON mode and there is more than 60% and less than 90% Battery capacity remaining.
Situation Visual LED indication Audible signals In the ACTIVE (continuous) mode The ACTIVE (continuous) None key, LUCAS performs continuous chest compressions. The green LED signal will blink 8 times per minute In the ACTIVE (30:2) mode The ACTIVE (30:2) LED shows a green light with an intermittent LED during compressions number 26, 27, 28, 29 and 30. User action This is to alert for ventilation during ongoing compressions.
8.3 Malfunction alarms Below is a list of all alarms that can occur on LUCAS. You mute all alarms for 60 seconds if you push MUTE. Start with manual compressions immediately if LUCAS does not operate properly.
9 Technical specifications All specifications in this chapter apply to the LUCAS™2 Chest Compression System. 9.1 Patient parameters Category Specifications Patients eligible for treatment: Adult patients who fit into the device; • sternum height of 6.7 to 11.9 inches / 170 to 303 mm • a maximum chest width of 17.7 inches / 449 mm The use of LUCAS is not restricted by patient weight. 9.
9.5 Battery physical specifications Category Specifications Size (H × W × D) 5.1 x 3.5 x 2.2 inches / 13.0 × 8.8 × 5.7 cm Weight 1.3 lbs / 0.6 kg Type Rechargeable Lithium Ion Polymer (LiPo) Capacity 3300 mAh (typical), 86 Wh Battery voltage (nominal) 25.
9.7 Electromagnetic environmental declaration Guidance and manufacturer's declaration - electromagnetic emissions LUCAS 2 is intended for use in the electromagnetic environment specified below. The customer or the operator of LUCAS 2 must make sure that it is used in the correct environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 LUCAS 2 uses RF energy only for its internal operation.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment must not be used nearer to LUCAS 2 (cables included) than the recommended separation distance calculated with the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 10 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000-4-3 10 V/m 80MHz to 2.5GHz 10 Vrms 10 V/m d = 1.2 P d = 1.2 P d = 1.
Rated maximum output Separation distance according to frequency of transmitter power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz W 0.01 d = 1.2 P d = 1.2 P d = 1.3 P 0.12 0.12 0.24 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.
9.8 Limited warranty Subject to the limitations and exclusions set forth below, JOLIFE AB ("JOLIFE") warrants that JOLIFE products which are purchased from authorized JOLIFE representatives or dealers and are used in accordance with their instructions will be free from defects in material and workmanship appearing under normal service and use for the time period listed below. The time limit and the warranty schedule begin on the date of delivery to the first purchaser.
Appendix A; LUCAS™2 parts and accessories Description JOLIFE AB Part number LUCAS Back Plate 150208-00 3 x LUCAS 2 Suction Cup 150205-03 LUCAS 2 Carrying Bag 150200-00 LUCAS 2 Instructions for Use (regional versions) 100666-XX LUCAS 2 Battery 150201-00 LUCAS Stabilization Strap 150203-00 LUCAS Patient Straps 150204-00 LUCAS 2 Power Supply (regional versions) 150202-XX LUCAS 2 Car Power Cable 150206-00 LUCAS 2 Battery Charger 150207-00 LUCAS 2 Back Plate Grip Tape 150209-00 LUCAS
LUCASTM2 Chest Compression System – Instructions for Use 100666-00 F Valid from CO J2547, © 2011 JOLIFE AB
LUCASTM2 Chest Compression System – Instructions for Use 100666-00 F Valid from CO J2547, © 2011 JOLIFE AB
LUCASTM2 Chest Compression System – Instructions for Use 100666-00 F Valid from CO J2547, © 2011 JOLIFE AB
For more information, please contact your local Physio-Control representative or the manufacturer JOLIFE AB JOLIFE AB, Scheelevägen 17, SE-223 70 Lund, Sweden, Tel: +46 (0) 46 286 50 00, Fax: +46 (0) 46 286 50 10, E-mail: info@jolife.com jolife.com LUCAS is a trademark of JOLIFE AB.
Quick Reference Guide NOTE: This guide is not a complete Instructions for Use. Refer to the “Instructions for Use” for complete directions for use, indications, contraindications, warnings, precautions, and potential adverse events. ON/OFF ADJUST PAUSE ACTIVE ACTIVE (continuous) (30:2) Confirm cardiac arrest and start manual CPR with a minimum of interruptions until LUCAS is applied and ready.
