LUCAS
TM
2 Chest Compression System –
Instructions for Use
100901-00 Rev A, Valid from CO J2716 © 2014 Jolife AB
39
100901-00 Rev B, Valid from CO J3166 © 2017 Jolife AB
Страница 1: ...INSTRUCTIONS FOR USE US 100901 00 Rev B Valid from CO J3166 2017 Jolife AB ...
Страница 2: ...n guidelines If you have any questions about this product or its operation please contact your local Physio Control representative or the manufacturer JOLIFE AB MANUFACTURER JOLIFE AB Scheelevägen 17 Ideon Science Park SE 223 70 LUND Sweden Tel 46 46 286 50 00 Fax 46 46 286 50 10 The LUCASTM 2 Chest Compression System is manufactured by JOLIFE AB in Sweden and distributed worldwide by Physio Contr...
Страница 3: ...vice 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 LUCAS Stabilization Strap 14 4 4 Prepare the Carrying Bag 14 5 Use LUCAS 15 5 1 Arrival at the patient 15 5 2 Unpack LUCAS 15 5 3 Apply to patient 16 5 4 Adjustment and operation 17 5 5 Apply the L...
Страница 4: ...n Strap 25 6 5 Remove and recharge the Battery 25 7 Maintenance 25 7 1 Routine checks 25 8 Troubleshooting 26 8 1 Indications and alerts during normal operation 26 8 2 Battery replacement and Smart Restart feature 27 8 3 Malfunction alarms 28 9 Technical specifications 29 9 1 Patient parameters 29 9 2 Compression parameters 29 9 3 Device physical specifications 29 9 4 Device environmental specific...
Страница 5: ...uidelines for cardiopulmonary resuscitation CPR when you use LUCAS The use of other medical equipment or drugs in conjunction with LUCAS can affect the treatment Always consult the Instructions for Use for the other equipment and or drugs to make sure that they are appropriate for use in conjunction with CPR LUCAS can only be bought by or on the order of a licensed medical practitioner TRADEMARKS ...
Страница 6: ... the patient s chest Always follow local and or international guidelines for CPR when using LUCAS 2 4 Side effects The International Liaison Committee on Resuscitation ILCOR states these side effects of CPR2 Rib fractures and other injuries are common but acceptable consequences of CPR given the alternative of death from cardiac arrest After resuscitation all patients should be reassessed and re e...
Страница 7: ...late 8 DC input 9 Bellows 10 Suction Cup 11 Power Supply 12 Power Supply cord 13 Battery 14 Pressure pad 15 Upper Part 16 Vent holes 17 Car Power Cable 18 Carrying Bag 19 External Battery Charger LUCAS Stabilization Strap 20 Cushion strap 21 Buckle 22 Support leg strap Applied part according to IEC 60601 1 1 9 8 9 8 10 2 3 4 5 22 7 21 20 6 11 13 12 17 13 18 14 14 16 15 19 100901 00 Rev B Valid fro...
Страница 8: ... this key LUCAS performs 30 chest compressions and then temporarily stops for 3 seconds During the stop the operator can perform 2 ventilations After the stop the cycle starts again An intermittent LED in combination with an audible signal sequence will alert the operator before each ventilation pause MUTE If you push this key when LUCAS operates you mute the alarm for 60 seconds If you push this ...
Страница 9: ...w to use LUCAS 3 3 Contraindications Do NOT use the LUCAS Chest Compression System in these cases If it is not possible to position LUCAS safe ly or correctly on the patient s chest Too small patient If LUCAS alerts with 3 fast signals when lowering the Suction Cup and you cannot enter the PAUSE mode or ACTIVE mode Too large patient If you cannot lock the Upper Part of LUCAS to the Back Plate with...
Страница 10: ...wer 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 2 Symbol Meaning Follow instructions for use All operators must read the complete Instructions for Use before operating the LUCAS Chest Compression ...
Страница 11: ... CPR again if it is not possible to position LUCAS safely and correctly on the patient s chest WARNING INCORRECT POSITION OVER CHEST If the pressure pad is not in the correct position in relation to the sternum there is an increased risk of damage to the rib cage and the internal organs Also the patient s blood circulation is compromised WARNING INCORRECT START POSITION The patient s blood circula...
Страница 12: ... high priority alarm will be heard For troubleshooting see section 8 3 WARNING MALFUNCTION If there are interruptions or the compressions are not sufficient or something unusual occurs during operation Push ON OFF for 1 second to stop LUCAS and remove the device Start manual chest compressions Caution do not lift by the straps Do not use the straps for lifting The straps are only to fixate the pat...
Страница 13: ...rect installation The top of the Battery has connections for power and communications to the Battery Charger and to LUCAS 4 2 1 Charge the Battery You can charge the LUCAS Battery in two ways In the external LUCAS Battery Charger optional put the Battery in the slot of the Battery Charger connect the Battery Charger power cord to the mains wall outlet Installed in LUCAS put the Battery in the slot...
Страница 14: ... slot in the hood of LUCAS 2 Make sure that a Suction Cup is mounted correctly 3 Put the Upper Part in the Carrying Bag with the hood towards the open end 4 Put the external Power Supply optional in one of the pockets between the LUCAS support legs 5 Put an extra optional charged LUCAS Battery in the other pocket 6 Put the cushion strap of the Stabilization Strap between the support legs 7 Extra S...
Страница 15: ...FF 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 illumi nates when LUCAS is ready for use Note LUCAS powers down automatically after 5 minutes if you let it stay in the ADJUST mode Caution device alarms If there is any malfunction during operation the red Alarm LED will illuminate and a high priority alarm will ...
Страница 16: ...e arm pits Use one of these procedures a Hold the patient s shoulder and lift the patient s upper body a small distance b Roll the patient from side to side Note An accurate position of the Back Plate makes it easier and faster to position the Suction Cup correctly 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 onc...
Страница 17: ... If the patient is too large the Upper Part of LUCAS cannot lock to the Back Plate without compressing the patient s chest Continue the manual compressions 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 abo...
Страница 18: ...your fingers from the Suction Cup 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 pressure pad is pushed down too hard or too loose to the chest LUCAS will adjust the pressure pad to the correct Start Position within...
Страница 19: ...on Push ON OFF for 1 second to stop LUCAS and remove the device Start manual chest compressions WARNING LOW BATTERY When the orange Battery LED shows an intermittent light do one of these Replace the Battery with one that is charged Connect the external LUCAS Power Supply 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...
Страница 20: ...traps are only to fixate the patient to LUCAS Caution IV access Make sure that IV access is not obstructed Caution skin burns The temperatures of the hood and battery may rise above 118 F 48 C If hot avoid prolonged contact to prevent skin burns Remove patient hands from patient straps 5 6 2 Prepare to lift the patient 1 Make a decision about what equipment you will move and where to put the trans...
Страница 21: ...uring operation When the Battery charge is low LUCAS alarms with an intermittent orange LED and an alarm signal 5 7 1 Change the Battery 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 Pull the Battery out and then upwards to re...
Страница 22: ...brillation can be performed while LUCAS operates 1 You can apply the defibrillation elec trodes before or after LUCAS has been put in position 2 Perform the defibrillation according to the instructions from the manufacturer of the defibrillator Caution defibrillation electrodes Position the defibrillation electrodes and wires so that they are not under the Suction Cup If there are already electrod...
Страница 23: ...ove the Up per Part from the Back Plate 4 If the patient s condition allows it re move the Back Plate 6 Care after use and preparation for next use Do the following after each use of the LUCAS Chest Compression System 1 Remove the Suction Cup refer to section 6 2 2 If necessary remove and clean the Patient Straps and the Stabilization Strap separately refer to section 6 1 and 6 3 3 Clean the devic...
Страница 24: ...ers the hood Allow LUCAS to dry before you pack it into the bag 6 2 Remove and install the Suction Cup Pull the Suction Cup off the black mount ing tube Discard the Suction Cup as contaminated medical waste Bend a new Suction Cup onto the black mounting tube Make sure the Suction Cup is safely attached on the mounting tube 6 3 Remove and attach the Patient Straps Remove 1 Open the Patient Straps a...
Страница 25: ...h 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 7 Maintenance 7 1 Routine checks Weekly and after each use of the LUCAS Chest Compression System do the following 1 Make s...
Страница 26: ...ne LUCAS is in the ON mode and there is less than 30 Battery ca pacity remaining approximately 10 minutes of operating capa city Low Battery The orange Battery indication LED far thest to the right illu minates intermittently Medium priority alarm Replace the Bat tery or connect to the external pow er supply An external LUCAS Power Sup ply is connected and charging the Battery Charging Battery The...
Страница 27: ...d 30 Audible signal during compres sions This is to alert the operator to venti late the patient when LUCAS temporarily stops the compressions at number 30 When the Suction Cup is in a low er position than for the minimum patient sternum height below 6 7 inches 17 cm and you cannot enter the PAUSE mode or AC TIVE mode the patient is too small None 3 fast signals Continue with manual compres sions ...
Страница 28: ...w or timing failure Intermittent red alarm LED High Priority Alarm LATCHING ALARM SIGNAL Compressions stop High Priority Too high temperature in LUCAS Intermittent red alarm LED High Priority Alarm LATCHING ALARM SIGNAL Compressions stop High Priority Hardware error Intermittent red alarm LED High Priority Alarm LATCHING ALARM SIGNAL Compressions stop High Priority Too high Battery temperature Int...
Страница 29: ...ent Patients with sternum height over 7 3 inches 185 mm 2 1 0 1 inches 53 2 mm Smaller patients with sternum height less than 7 3 inches 185 mm 1 5 to 2 1 inches 40 to 53 mm Compression frequency 102 2 compressions per minute Compression duty cycle 50 5 Compression modes operator selectable 30 2 30 compressions followed by a 3 seconds ventilation pause Continuous compressions Category Specificatio...
Страница 30: ...aximum Battery charge time Less than 4 hours at room temperature 72ºF 22ºC Required interval for replacement of the Battery Recommendation to replace the Battery every 3 years or after 200 uses of more than 10 minutes use each time Category Specifications Operating temperature 32ºF to 104ºF 0ºC to 40ºC ambient when installed in the device Charge temperature 41ºF to 95ºF 5ºC to 35ºC ambient 68ºF to...
Страница 31: ... event to the generation of its alarm signal Audible signal name Sequence of tones Durations 5ms Tone frequency 10 Hz Sound level dB 1m 5dB Situations System delays 0 5s Result High priority alarm LATCHING ALARM SIGNAL td 200ms ts 100ms ts3 4 400ms ts5 6 500ms ts8 9 400ms tb 2 5s f0 530 Hz f1 1060 Hz f2 1590 Hz f3 2120 Hz f4 2650 Hz 85 Self test error during start up 1 to 10s Inoperable device Com...
Страница 32: ...peated The Suction Cup is placed below the lowest Start Position too small patient td 125ms ts 0ms tb 625ms f0 2 kHz 75 3 fast signals intermittently repeated Gap between pressure pad and patient s chest detected td 125ms ts 0ms tb 0ms f0 2 kHz 75 Recurrent fast signals intermittently repeated until Suction Cup is released Suction Cup is pressed down when device is locked in PAUSE mode Ventilate s...
Страница 33: ...he relative humidity must be 30 or more Electrical fast transient Burst IEC 61000 4 4 2 kV for Power Supply lines 1 kV for input output lines 2 kV for Power Supply lines n a for input output lines The mains power quality must be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode n a for common mode The mains power...
Страница 34: ...tructures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured f...
Страница 35: ...er not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in...
Страница 36: ...the product is located outside of such areas all products requiring warranty service should be returned to a location designated by JOLIFE or its authorized service provider freight prepaid and must be accompanied by a written detailed explanation of the claimed failure Except for the Limited Warranty provided above NEITHER JOLIFE NOR ITS AUTHORIZED SERVICE PROVIDER MAKES ANY WARRANTY EXPRESS OR I...
Страница 37: ...uctions for Use regional versions 100901 XX LUCAS 2 Battery 150201 00 LUCAS Stabilization Strap 150203 00 LUCAS Patient Straps 150204 00 LUCAS 2 Power Supply MWB100024A Art Nr 300 000 00 regional versions 150210 XX LUCAS 2 Power Supply MWA150028B Art Nr 300 000 00 regional versions 150214 XX LUCAS 2 Car Power Cable 12 28VDC 150206 00 LUCAS 2 Battery Charger 150207 00 LUCAS 2 Back Plate Grip Tape 1...
Страница 38: ...LUCASTM2 Chest Compression System Instructions for Use 100901 00 Rev A Valid from CO J2716 2014 Jolife AB 38 100901 00 Rev B Valid from CO J3166 2017 Jolife AB ...
Страница 39: ...LUCASTM2 Chest Compression System Instructions for Use 100901 00 Rev A Valid from CO J2716 2014 Jolife AB 39 100901 00 Rev B Valid from CO J3166 2017 Jolife AB ...
Страница 40: ...k Plate B s Pause manual CPR s Carefully put Back Plate under the patient below armpits s Resume manual CPR Compressor C s Pull release rings once claw locks open Then let go of the release rings s Attach to Back Plate listen for click s Pull up once to ensure attachment Position the Suction Cup s Center the Suction Cup over the chest s The lower edge of Suction Cup should be immediately above the...
