LUCAS 3 ver 3.1 Instructor Guide Book Rev AA

Contents Preface...1 Instructor notes... 3

Chapter 1...5 Instructor training preparation... 7 Things to know before each training session... 7 Facility planning and logistics... 7 What you need... 8 Device preparation and readiness... 9

Chapter 2...11 Classroom training: introduction and overview... 13 Introductions... 13 Agenda review... 13 Videos... 13 Device overview... 14 Comprehensive in-depth device and operation overview... 16 Application demonstration... 25

Chapter 3...33 Small group: hands-on training and application practice ... 35 Learning objectives... 35 Roles, responsibilities and expectations... 35 Detailed step-by-step overview... 36 Real-time application demonstration... 40 Student device application... 41 Completing the user performance evaluation... 41

Chapter 4...43 Training evaluation... 45

Appendix A...47 Important contacts... 49

Appendix B...51 Frequently asked questions... 53

Appendix C...61 The LUCAS device in the cath lab... 63 The 2020 AHA and 2021 ERC Guidelines on resuscitation in the cath lab... 63 The LUCAS device in the cath lab... 64

References...69

Preface

Preface | 1

Instructor notes This guidebook is an introduction to the basic operations of the LUCAS chest compression system* and acts as a guide for conducting classroom and hands-on training in a manner consistent with training provided by Stryker. Refer to the Instructions for Use (IFU) for complete directions for use, indications, contraindications, warnings, cautions and technical specifications. The IFU is included with each device. All operators must read the complete IFU before operating the LUCAS chest compression system.

*This training is relevant for LUCAS 2, LUCAS 3 (v3.0 and v3.1). It does not include training on optional setup features (v3.1).

Instructor notes | 3

Chapter 1 Instructor training preparation

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Instructor training preparation Things to know before each training session Who is your audience? There may be a combined audience of both prehospital and hospital providers. It is helpful to know whether the audience you will be instructing will be EMTs, paramedics, nurses, etc., to tailor your examples and discussion to be the most relevant for the audience present.

How large is your audience? § In order for the hands-on training to be the most effective, it is important to maintain an instructor to student ratio of 1:6 (one instructor to six students). § Determine the need for additional trainers and make arrangements for resources such as LUCAS devices, manikins and training materials accordingly, prior to the training session.

Facility planning and logistics Each training session will require a classroom setting for the “Introduction and device overview” large enough to accommodate the audience attending. In addition, there needs to be ample space for multiple small groups, with an instructor to student ratio of 1:6, to perform small group hands-on training and application practice. This may require reserving a second room for the hands-on training depending on space available in the classroom.

Training should follow the timing outlined below: 15 min.

Introduction

45 min.

Classroom training

10 min.

Break

120 min.

Small group hands-on training and application practice

5 min.

Break

30 min.

Training evaluation

15 min.

Q&A/additional hands-on (as needed)

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Room layout § Basic classroom layout should include tables and chairs for students to take notes and complete evaluations at the conclusion of the training. § For the small group hands-on training, ensure enough floor space for hands-on training with a manikin.

Audio/visual needs § There are several videos that will be played at the beginning of the classroom session. The room will need to be set up with a projector. A computer with internet access will allow streaming of the videos. If internet access is slow or limited the videos can be downloaded ahead of time.

Power Ensure there is an adequate power supply and power strips for A/V equipment or in the event that LUCAS devices need to be charged.

What you need Devices, accessories, manikins § At least one LUCAS device and one manikin for every six students (e.g., class of 40 will require seven devices/manikins) § Each LUCAS device in carrying case should have the following present: { Suction cup mounted to the piston { Patient straps (wrist straps), attached to support legs { Stabilization strap, present in carrying case with two support leg straps that buckle to support legs { Two charged batteries, one installed in device with spare in carrying case compartment { External power supply cord, present in case compartment { LUCAS device back plate { One additional suction cup § One manikin for each LUCAS device

Training materials and handouts (Contact your local Stryker representative for copies of these training materials:) § § § § § § §

LUCAS 3 device fits large patients LUCAS 3 device user performance evaluation form LUCAS 3 device training quiz LUCAS 3 device training answer key and annotated test LUCAS 3 device - First use preparation video LUCAS 3 device - Prehospital application video LUCAS 3 device - Hospital application video

§ § § §

LUCAS 3, v3.1 - Implementation guide LUCAS 3 device quick reference guide - trifold Information on defibrillation and ventilation with the LUCAS device LUCAS 3 device instructor guidebook

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Device preparation and readiness Prior to each training session, ensure all LUCAS devices are checked and ready for use. Always complete device preparation to allow at least four hours for charging batteries. 1. Make sure a suction cup is attached to the piston. 2. Make sure the patient straps are attached. 3. Make sure the two support leg straps of the stabilization strap are buckled around the support legs with the buckles on the inside. 4. Make sure batteries are fully charged. When the LUCAS device is in the OFF mode, push the MUTE button. The battery indicator illuminates and shows the battery charge status. 5. Push and hold the ON/OFF button to turn on the device so the LUCAS device does a self-test. Make sure the ADJUST LED illuminates with no alarm or warning LED. 6. Push and hold the ON/OFF button for one second to power down the LUCAS device again. 7. Charge batteries as needed. { Installed in LUCAS device (power supply cord) – less than two hours – Put battery in the slot in the hood of the LUCAS device – Connect the power supply to the DC input on the side of the LUCAS device – The LUCAS device can be charged using the charge port in the back of the carrying case – Connect the power supply to the wall outlet { In the external battery charger (if available) – less than four hours – Put the battery in the slot of the battery charger – Connect the battery charger power cord to the wall outlet

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Chapter 2 Classroom training: introduction and overview

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Classroom training: introduction and overview Introductions Introduce lead trainer and support staff. Confirm your audience (e.g., “By a show of hands, how many of you are EMTs? Paramedics? Nurses?” etc.)

Agenda review Provide brief overview of the agenda for the training session: § Introductions § Videos § Introduction and overview of LUCAS device, including intended use, indications and contraindications for use, main parts, etc. § Comprehensive device and operation overview § Break (15 minutes) § Small groups hands-on training and application practice § Training evaluations § Q&A

Videos There are three videos that can be played at the beginning of each training session. Have the videos prepared prior to starting the class. All videos available for streaming at https://www. strykeremergencycare.com/learn-and-train/videos/.

LUCAS 3 chest compression system - First use preparation § This video provides an overview of the LUCAS device first time assembly, standard and optional accessories and device storage.

LUCAS 3 chest compression system – Prehospital application § This video provides an overview of LUCAS device application in the EMS setting.

LUCAS 3 chest compression system – Hospital application § This video provides an overview of LUCAS device application in the hospital setting.

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Device overview 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 Guidelines for CPR1 and the European Resuscitation Council guidelines2. Both human3,4 and experimental5,6 studies have shown that the LUCAS device can produce coronary perfusion pressures (CPP) of over 15mmHg during prolonged CPR, better than manual CPR.

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 an absence of spontaneous breathing and pulse, and loss of consciousness. The LUCAS device must only be used in cases where chest compressions are likely to help the patient. The LUCAS device is for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., transport, extended CPR, fatigue, insufficient personnel). (U.S. Only)

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 three 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.

Personnel It is recommended the LUCAS device 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 Resuscitation or equivalent) § AND received training in using the LUCAS device

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Side effects The International Liaison Committee on Resuscitation (ILCOR) states these side effects of CPR:7 “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.” Apart from the above, skin abrasions, bruising and soreness of the chest are common during the use of the LUCAS chest compression system. Clinical as well as autopsy studies have shown that LUCAS device compressions are as safe and effective for the patient as manual CPR, and with the same type of side effects as for manual CPR.8–10

Main components 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 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. Each part of the LUCAS device and its operation will be covered in the next section, comprehensive in-depth device and operation overview.

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Comprehensive in-depth device and operation overview Instructor notes: Begin with a complete LUCAS chest compression system packed in the carrying case on a table at the front of the room and visible to the attendees. As you review each component and aspect of operation, physically remove the component from the case and demonstrate to the audience.

Carrying case The LUCAS device carrying case was designed to be compact, portable, durable and easy to deploy. Instructor notes: Begin by demonstrating the key components of the case; the hard shell, the top window and the rear charge port. Next demonstrate how to open the carrying case and turn on the device while still in the case. While the LUCAS chest compression system is still in the case, push the power ON button for one second to allow the device to perform a self-test to make sure it is ready to operate before applying it to the patient. The case and power on procedure will be reviewed in more detail later during the application demonstration.

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Back plate Instructor notes: Remove the back plate from the case, explain what the picture on the back plate means and where the claw locks attach. The graphic on the back plate is intended to provide a reminder of where to orient the back plate in relation to the patient, and where to position the piston and suction cup. (Positioning of the piston and suction cup will be explained when reviewing the upper part of the LUCAS chest compression system.) The carbon fiber LUCAS PCI back plate is intended specifically for use in the cath lab. It is fully radiotranslucent, with minimum shadows. The PCI back plate is compatible with LUCAS 2 and LUCAS 3 devices.

Standard LUCAS back plate

Optional LUCAS PCI back plate

The back plate should be placed under the patient, immediately below the arm pits, either by lifting the patient’s upper body a small distance or by rolling the patient from side to side. Accurate positioning of the back plate makes it easier and faster to position the upper part and suction cup correctly. The rods on each end of the back plate are where the claw locks on the support legs attach the upper part to the back plate. The LUCAS device is specifically designed to be used with the LUCAS back plate. It cannot be applied directly to any other backboard or transportation device.

Carrying case contents Instructor notes: Set the back plate aside. Remove the upper part from the carrying case and set aside to review contents of the bag. Show the audience where each component is located in the carrying case. In addition to the back plate and the upper part (including battery), the LUCAS device is delivered with: § Two disposable suction cups-one will be attached to the LUCAS device, and one will be packaged and in the mesh storage compartment.

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There is a storage compartment in the middle of the carrying case that can hold a spare battery and a battery charger. The stabilization strap is also placed in the bag where it can be easily accessed. When returning the stabilization strap to the carrying case, loosen the strap and roll it for the next use.

Upper part Instructor notes: Highlight all of the components of the upper part of the LUCAS device. Point out each component and demonstrate. Note: some parts, such as the control panel, may be difficult to see from a distance. Explain that attendees will have a chance to review all of these components up close during the hands-on portion of the training. The hood of the LUCAS device contains the battery and the user control panel. Internally, the hood houses the compression module and all of the electronics of the LUCAS device. Do not immerse the LUCAS device in liquid. The device can be damaged if liquid enters the hood. Underneath the hood of the LUCAS device are the vent holes. Do not block the vent holes as this can cause the device to become too hot. The LUCAS device has an IP43 rating, which is the level of ingress protection against particulate matter (first number) and liquid (second number). A rating of 3 for liquid indicates protection against spraying water, such that water falling as a spray at any angle up to 60 degrees from the vertical will not have a harmful effect. This is consistent with what you would expect from rainfall. Instructor notes: After showing the vent holes under the hood, point out the pressure pad at the end of the piston and suction cup.

Underneath the hood is the piston, which contains the pressure pad and the suction cup.

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The pressure pad is at the end of the piston. The pressure pad acts as the heel of your hand when performing manual CPR, it is what makes contact with the chest when performing compressions. The compression point should be in the middle of the chest, at the same spot as for manual CPR and according to current 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 bone. The lower edge of the suction cup should not be placed over the tip of the sternum (xiphoid process), but over the lower edge of the main body of the sternum. If the pressure pad is not in the correct position, there is an increased risk of damage to the rib cage and the internal organs. Also, the patient’s blood circulation is compromised. The suction cup is disposable and should be replaced after each use. To replace the suction cup, pull it off the black mounting tube and discard it. Bend a new suction cup back onto the tube and make sure it is safely attached. The support legs contain several components: § The patient straps – When you move the patient, you can secure the patient’s arms with the patient straps on the LUCAS device. This makes it easier to move the patient. Do not use the straps for lifting, and make sure that IV access is not obstructed.

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§ The release rings – The release rings operate the claw locks, which attach the upper part to the back plate. These are used for removing the LUCAS device from the back plate. However, before applying the upper part, you should pull the release rings once to make sure the claw locks are open, then release the rings.

It is important you release the rings when attaching the upper part to the back plate so the claw locks can click onto the back plate. Listen for the click and make sure the parts are correctly attached by pulling up on the device. Instructor notes: Point to the claw locks and demonstrate opening a closed claw lock by pressing one side closed, and pulling the release rings once to demonstrate opening the claw locks. § Support leg strap for the stabilization strap – The stabilization strap helps secure the correct position during operation. Apply it while the LUCAS device is active to keep interruptions to a minimum. Delay the application of the stabilization strap if it prevents or delays any medical treatment of the patient. § Once the device is active: { Remove the stabilization strap from the carrying case and extend the strap fully at the buckles. { Carefully position the cushion of the stabilization strap behind the patient’s neck, as close to the patient’s shoulders as possible. { Connect the buckles on the support leg straps to the buckles on the stabilization strap. Make sure straps are not twisted. { Hold the LUCAS device support legs stable and tighten the stabilization strap. Only tighten as much as needed to secure the device. Be careful not to pull the device out of position. Instructor notes: Attach the upper part of the LUCAS device to the back plate. In the next section you will demonstrate the too small patient alarm and explain the control panel.

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Control panel The control panel is intended to be simple and easy to use, and after you turn the device on, the steps are numbered 1 through 3.

The ON/OFF button is in the top left of the control panel in the gray bar. Push and hold this button for one second to power up or power down the LUCAS device. 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 beside the ADJUST key illuminates. This takes approximately three seconds. § When you are using the LUCAS device, the very first thing you do, even before taking it out of the carrying case, is to press the ON/OFF button and turn the device on. The orange button is the ADJUST button. It is also labeled with a “1”. When you turn the device on, it automatically enters the ADJUST mode, which is used to adjust the position of the suction cup. When you push this button, 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, extending the piston with two fingers onto the chest of the patient, ensuring the pressure pad touches the patient’s chest. Press the PAUSE button, labeled with a “2”, to lock the piston in the start position. Also, use this when you want to stop the device and temporarily pause compressions but still want to keep the start position of the suction cup. There are two ACTIVE modes on the device. One is ACTIVE (continuous) ACTIVE (30:2) .

and the other is

In continuous mode the device will perform continuous compressions at 102 ± 2 compressions per minute; use this setting if the patient is intubated. The green LED next to the button for continuous mode will blink ten times per minute to alert for ventilation during ongoing compressions. When you push the ACTIVE (30:2) button, the device will perform 30 compressions, then temporarily stop for three seconds to allow for giving two ventilations, and continues this cycle. An intermittent LED in combination with an alarm signal sequence on the 28th, 29th and 30th compression will alert the operator before each ventilation pause.

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On the top of the control panel, in the middle of the gray bar, are the MUTE alarm indicator .

button and the

Pushing the MUTE button will mute the alarm for 60 seconds. If you push this button when the device is powered OFF, the battery indicator will show the charge status of the battery. On the alarm indicator, a red LED and alarm signal indicate a malfunction. If there is a malfunction while the device is performing chest compressions, push ON/OFF for one second to stop the device, remove the device, and perform manual CPR immediately to minimize interruptions in compressions. If your protocols allow, you can attempt to reset the alarm once by pushing ON/OFF , removing and replacing the battery and following proper steps to deploy the device in the APPLICATION DEMONSTRATION section of this guide. TRANSMIT data: This key is used to transmit data after the use of the LUCAS device. The device must be in power OFF mode to transmit data. More information about data will be covered in the ‘LUCAS 3, v3.1 - Implementation guide’. Caution - Radio frequency communications can affect other medical electrical equipment.

Battery The battery is in the hood, opposite the control panel. The lithium polymer battery has a runtime of 45 minutes when fully charged. If the battery is fully depleted, it takes less than two hours to charge when the power supply cord is used, and less than four hours in the standalone battery charger. In the center of the top row of the control panel is the battery indicator LEDs show the charge status.

. Three green

§ Three green LEDs means the battery is fully charged § Two green LEDs means the battery is 2/3 charged § One green LED means the battery is 1/3 charged If you see one intermittent yellow LED and hear an intermittent alarm during operation, it means the battery has less than 30 percent capacity, or approximately 10 minutes of operating capacity left. (For a complete list of battery indicators, refer to the Instructions for Use.) The status of the battery charge can be evaluated without removing the device from the carrying case. Simply pressing MUTE through the top window, will illuminate the battery indicator.

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To minimize interruptions, having a charged spare battery in the carrying case is always recommended. When the battery gets low during operation, it can be replaced by a new one without turning the device off. To change the battery during operation: 1. Press PAUSE to temporarily stop compressions 2. Pull the battery out and then upwards to remove it 3. Install a fully charged spare and wait until the green PAUSE mode LED illuminates 4. Push either ACTIVE (continuous) or ACTIVE (30:2) to start chest compressions again If the battery change takes less than 60 seconds, the LUCAS device Smart Restart feature remembers the settings and start position for 60 seconds. If the battery change takes more than 60 seconds, the device does a self-test and you must adjust the start position again. If there is no spare battery present, the device can be connected to the power supply in all operating modes. The battery must always be installed for the device to be able to operate, including when it is powered by the external power supply. The power supply connects to the LUCAS device just below the hood. The device can run for as long as needed on a nominal patient chest when connected to the power supply. It is recommended to replace the battery every three to four years or after 200 uses of more than 10 minutes each time. Instructor notes: Turn the LUCAS device on. Point out the self-test. Demonstrate moving the piston up and down.

Patient size Remember, do not use the LUCAS device if the patient is too small (the LUCAS device alarms with three fast signals and you can’t enter the PAUSE or ACTIVE modes) or if the patient is too large (you can’t lock the upper part to the back plate without compressing the patient’s chest). When the LUCAS device was launched in the United States, a survey of four different EMS systems on the use of the device on over 300 patients showed that it fit 95 percent of patients. Of those who didn’t fit, 3 percent were too large and 2 percent were too small.11 This was also confirmed in the LINC Trial, a large, randomized controlled trial including 2,589 patients in Europe who received LUCAS device chest compressions.10 The LUCAS device will fit patients with: § Chest width up to 44.9 cm / 17.7 inches § Sternum height of 6.7 to 17 - 30.3 cm / 11.9 inches The use of the device is not restricted by patient weight. If the device does not fit on the patient, remove the device and immediately perform manual CPR.

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