Stryker Lucas 3 Instructions For Use Manual
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Stryker Lucas 3 Instructions For Use Manual

Stryker Lucas 3 Instructions For Use Manual

Chest compression system
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Version 3.1
INSTRUCTIONS FOR USE
EN
LUCAS
3 Chest Compression System – INSTRUCTIONS FOR USE
®
101086-01 Rev A valid from CO J3292 © February 2023 Jolife AB

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  • Page 1 Version 3.1 INSTRUCTIONS FOR USE LUCAS 3 Chest Compression System – INSTRUCTIONS FOR USE ® 101086-01 Rev A valid from CO J3292 © February 2023 Jolife AB...
  • Page 2 European Resuscitation Council (ERC) guidelines for cardiopulmonary resuscitation. If you have any questions about this product or its operation, please contact your local Stryker representative or the manufacturer Jolife. This is the original master which constitutes the basic information for all translations of the Instructions for Use.

  • Page 3: Table Of Contents

    Table of Contents Important user information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Introduction .
  • Page 4 Appendix A: LUCAS 3, Version 3 . 1 parts and accessories . . . . . . . . . . . . . . .

  • Page 5: Important User Information

    The LUCAS Chest Compression System can only be bought by or on the order of a licensed medical practitioner. If a serious incident occurs when using the LUCAS device, report the incident to your local Stryker representative or Jolife AB, and the relevant national competent authority. TRADEMARKS LUCAS is a registered trademark of Jolife AB.

  • Page 6: Introduction

    2 Introduction 2.4 Side effects 2.1 LUCAS Chest Compression System The International Liaison Committee on Resuscitation (ILCOR) states these side The LUCAS Chest Compression System effects of CPR is a portable tool designed to overcome problems identified with manual chest “Rib fractures and other injuries are common compressions.

  • Page 7: Device Components

    2.6 Device components Hood 14. Car Power Cable 21. Upper Part User Control Panel 15. Power Supply cord 22. Pressure pad* Battery 16. Power Supply 23. Vent holes DC input 17. External Battery Charger Applied part 18. Carrying Case (according to IEC 60601-1) Bellows Suction Cup* 19.

  • Page 8: User Control Panel

    2.7 User Control Panel PAUSE: When you push the PAUSE key after adjusting the Suction Cup to This chapter describes the User Control the patient’s chest, the height position Panel of the LUCAS device with factory of the Suction Cup is fine-tuned and default settings.
  • Page 9 Push this key to send device data and receive new setup options. The device has to be in Power OFF mode to send and receive data. For more information, please refer to Stryker data management programs, or contact your local Stryker representative. Caution – radio frequency...

  • Page 10: Safety Precautions

    3 Safety precautions 3.3 Contraindications To ensure maximum safety, always read this section carefully before operating, carrying out any work on the equipment or Do NOT use the LUCAS Chest making any adjustments. Compression System in these cases: • If it is not possible to position the LUCAS device safely or correctly on the patient’s chest.

  • Page 11: Symbols On The Device

    3.5 Symbols on the device IP03 Symbols on IP40 type labels IP43 IP44 Symbol Meaning 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.
  • Page 12 Symbols on type labels Symbol Symbol Name and meaning Manufacturer Name and address Date of Manufacture Catalogue Number Lot (Batch) Code Serial Number European Medical Device Class II equipment Refer to Instruction Manual/Booklet/Follow IFU All operators must read the complete Instructions for Use before operating the LUCAS Chest Compression System.
  • Page 13 WEEE Symbol Battery and/or electronics may not be disposed in the normal waste stream. LUCAS Logo Device / trade name Australia Wireless Conformity Mark Indicates the device complies with the applicable ACMA requirements for radiocommunication Japan Wireless Conformity Mark Indicates the device is certified to the applicable Japanese R XXX-XXXXXX wireless requirements US (FCC) Wireless Conformity Mark...

  • Page 14: General Safety Precautions

    3.6 General safety • Replace the Battery with one that is charged. precautions • Connect the external LUCAS Power Supply. WARNING – USE ONLY APPROVED ACCESSORIES Caution – keep Battery installed Use only Jolife-approved accessories The Battery must always be installed for with the LUCAS Chest Compression the LUCAS device to be able to operate, System.

  • Page 15: Service

    Part or lifting the patient. and will void the warranty. Caution – IV access Consult your local distributor, Stryker or Jolife for Make sure that IV access is not obstructed. current information on where to send the LUCAS device for maintenance.

  • Page 16: First Use Preparations

    4 First use preparations 4.1 Delivered items 4.2.1 Charge the Battery You can charge the LUCAS Battery in LUCAS Chest Compression System two ways: is supplied in one box with: • In the LUCAS Battery Charger: • A LUCAS device (Upper Part and Back Plate) - put the Battery in the slot of the Battery Charger,...

  • Page 17: Prepare The Stabilisation Strap

    If you want to change the factory default settings, please refer to Stryker data management programs, or contact your local Stryker representative. 5. In the Carrying Case compartment between the LUCAS support legs, you Factory default settings and setup options are identified in chapter 9 in this document.

  • Page 18: Use The Lucas Device

    5 Use the LUCAS device 5.1 Arrival at the patient 2. Push ON/OFF on the User Control Panel for 1 second to power up the LUCAS device and start the self When you have confirmed a cardiac arrest, test. The green LED adjacent to the immediately start manual cardiopulmonary ADJUST key illuminates when the resuscitation (CPR).

  • Page 19: Apply To Patient

    5.3 Apply to patient 2. Minimise interruption to manual CPR by planning for and coordinating the placement of the back plate. Keep interruptions to CPR to a minimum when applying the LUCAS device to the • Make sure to support the patient’s patient.

  • Page 20: Attach The Upper Part

    5.3.2 Attach the Upper Part 4. Minimise interruptions to manual CPR by planning and coordinating 1. Hold the handles on the support legs to the attachment and correct positioning remove the LUCAS Upper Part from the of the Upper Part: Carrying Case. a.

  • Page 21: Adjustment And Operation

    5.4 Adjustment and operation 1. Use your finger to make sure that the lower edge of the Suction Cup is immediately above the end of the The compression point should be at sternum. the same spot as for manual CPR and according to guidelines.
  • Page 22 c. Push PAUSE to lock the Start WARNING – TOO SMALL PATIENT Position. 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 –...

  • Page 23: Apply The Stabilisation Strap

    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: •...

  • Page 24: Move The Patient

    5.6 Move the patient 2. Those at the patient’s side: a. put one hand below the claw locks under the support leg 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.

  • Page 25: Lift And Move The Patient

    5.7 Replace the Power Supply 5.6.3 Lift and move the patient during operation The LUCAS Chest Compression System can deliver compressions while you lift or When the Battery charge is move the patient if: low, the LUCAS device sounds • The LUCAS device and patient are safely an alarm with an intermittent positioned on the transportation device.

  • Page 26: Connect To The External Power Supply

    5.7.2 Connect to the external applicable in conjunction with CPR. Power Supply 5.8.1 Defibrillation You can connect the LUCAS Power Supply or Car Power Cable in all operation modes Defibrillation can be performed while the of the LUCAS device. LUCAS device operates. Caution –...

  • Page 27: Ventilation

    the compressions again. mechanism it is mainly radiotranslucent and allows for most X-ray projections. 5.8.2 Ventilation 5.9 Remove the device Always follow local and/or international guidelines for ventilation. from the patient The LUCAS Chest Compression System 1. Push ON/OFF for 1 second to power can operate in two different modes: off the device.

  • Page 28: Care After Use And Preparation For Next Use

    Radio frequency communications can affect other medical electrical equipment. • Put a spare (optional) charged LUCAS Battery in the compartment For more information, please refer to Stryker data between the LUCAS support legs. management programs, or contact your local Stryker representative.

  • Page 29: Cleaning Routines

    6.3 Cleaning routines 6.5 Remove and attach the Patient Straps Clean all surfaces and straps with a soft cloth and warm water with a mild cleaning Remove: agent or disinfectant agent, e.g. 1. Open the Patient Straps and pull them •...

  • Page 30: Remove And Attach The Stabilisation Strap

    6.6 Remove and attach Caution – keep Battery installed The Battery must always be installed for the Stabilisation Strap the LUCAS device to be able to operate, also when powered by the external Power Remove the Support leg straps, which are Supply. a part of the Stabilisation Strap, by opening the buckles.

  • Page 31: Maintenance

    7 Maintenance 7.1 Routine checks Weekly, and after each use of the LUCAS Chest Compression System, perform the following: Optional: Push TRANSMIT data key to send and receive device data. The device has to be in Power OFF mode. Caution – radio frequency Radio frequency communications can affect other medical electrical equipment.

  • Page 32: Troubleshooting

    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 The LUCAS device is in the Fully charged Battery: None None...

  • Page 33: Battery Replacement

    Situation Visual LED indication Audible signals User action In the ACTIVE (continuous) The ACTIVE None This is to alert mode (continuous) key, for ventilation Optional setup: Audible the LUCAS device during ongoing signal to prompt before performs continuous compressions. each ventilation alert. chest compressions.

  • Page 34: Malfunction Alarms

    LATCHING ALARM SIGNAL If the malfunction described above seems permanent, the LUCAS device must be examined by approved service personnel. Please consult your local Stryker representative. Contact information is available at www.lucas-cpr.com. LUCAS 3 Chest Compression System – INSTRUCTIONS FOR USE ®...

  • Page 35: Technical Specifications

    All specifications, factory default settings and setup options in this chapter apply to the LUCAS 3 Chest Compression System, version 3.1. For more information, please refer to Stryker data management programs, or contact your local Stryker representative. 9.1 Patient parameters...
  • Page 36 Category Specifications Compression mode ACTIVE 30:2 Factory default setting 30:2 (30 compressions followed by a 3-second ventilation pause) Setup options The device can be setup to provide a compression/ ventilation ratio of any of the following ratios: 30:2 and 50:2. The device can be setup to provide a ventilation pause duration of a value between 3 to 5 seconds.

  • Page 37: Device Physical Specification

    Category Specifications Pressure pad in ACTIVE modes Factory default setting The pressure pad returns to Start Position between each compression Setup options To allow for chest rise during asynchronous ventilation, the device can be setup so that the pressure pad moves up 0.4 inch/10 mm above the Start Position at every compression.

  • Page 38: Device Environmental Specifications

    Factory default setting TRANSMIT mode: Bluetooth Optional setup - Bluetooth availability: On/Off - Wi-Fi connection to Stryker data management programs: On/Off - AutoTransmit Wi-Fi to Stryker data management programs when connected to external power supply and in Power OFF mode: On/Off Vibration, air ambulances Rotary wing (helicopter) –...

  • Page 39: Battery Physical Specifications

    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 V Initial Battery runtime (nominal patient) 45 minutes (typical)

  • Page 40: Audible Signals

    9.8 Audible SIGNALS 9.8.1 Audible ALARM SIGNALS, characteristics Audible Sequence of tones Durations Tone Sound Situations System Result signal +/- 5ms frequency level delays name +/- 10 Hz (dBA@1m) +/-0.5s +/- 5dB High ■ ■ ■ (...) ■ ■ (...) = 200ms = 530 Hz Self-test error...

  • Page 41: Audible Information Signals, Characteristics

    9.8.2 Audible INFORMATION SIGNALS, characteristics Audible Sequence of tones Durations Tone Sound Description Situation signal +/- 5ms frequency level name +/- 10 Hz (dBA@1m) +/- 5dB Power ON = 375ms = 1 kHz Continues Self-test during signal = 0ms until self-test Power ON of ■...

  • Page 42: Electromagnetic Environmental Declaration

    9.9 Electromagnetic environmental declaration Guidance and manufacturer’s declaration – electromagnetic emissions The LUCAS device is intended for use in the electromagnetic environment specified below. The customer or the operator of the device must make sure that it is used in the correct environment. Emissions test Compliance Electromagnetic environment –...
  • Page 43 Electro Magnetic Interference (EMI) The expected electromagnetic environments throughout the whole lifecycle of the LUCAS 3 device according to the specifications stated in IEC 60601-1-2:2014 +A1:2020 are Home Healthcare and Professional Healthcare Facility environments. Immunity IEC 60601 Compliance Electromagnetic environment – test test level level...
  • Page 44 Rated maximum output Separation distance according to frequency of transmitter power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2 √P d = 1.2 √P d = 2.3 √P 0.01 0.12 0.12...

  • Page 45: Limited Warranty

    The time limit and the warranty schedule begin on the date of delivery to the first purchaser. 12 Months: LUCAS 3 Chest Compression System (including the LUCAS device (Upper Part and Back Plate), Carrying Case, Battery, Stabilisation Strap, Patient Straps).

  • Page 46: Appendix A: Lucas 3, Version 3 . 1 Parts And Accessories

    Appendix A: LUCAS 3, Version 3 . 1 parts and accessories Description LUCAS Back Plate, slim LUCAS Suction Cup LUCAS Carrying Case, Hard Shell LUCAS 3, Version 3.1 Instructions for Use (regional versions) LUCAS Battery, Dark grey LUCAS Stabilisation Strap LUCAS Patient Straps LUCAS Power Supply, Art.

  • Page 47: Appendix B: Maintenance - Routine Checks

    Appendix B: Maintenance – Routine checks Make copies of this check list to track the routine maintenance of your LUCAS device. Weekly, and after each use of the LUCAS Chest Compression System, do the following: 1. Make sure that the device is clean. 2.
  • Page 48 This page is intentionally left blank. LUCAS 3 Chest Compression System – INSTRUCTIONS FOR USE ® 101086-01 Rev A, valid from CO J3292 © February 2023 Jolife AB...
  • Page 49 This page is intentionally left blank. LUCAS 3 Chest Compression System – INSTRUCTIONS FOR USE ® 101086-01 Rev A, valid from CO J3292 © February 2023 Jolife AB...
  • Page 50 QUICK REFERENCE GUIDE LUCAS 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).

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