LUCAS 2 Instructor Guidebook Rev A

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LUCAS 2 Chest Compression System ®

Instructor Guidebook

PHYSIO-CONTROL TRAINING

LUCAS® 2 Chest Compression System

Instructor Guidebook Classroom and Hands-On Training

Physio-Control, Inc. Redmond, Washington

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Chapter 1: Instructor Training Preparation Things to know before each training session...9 Facility Planning and Logistics...9 What You Need ...10 Device Preparation and Readiness...11

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Chapter 2: Classroom Training Introduction and Overview Introductions...15 Agenda Review...15 Videos...15 Device Overview...16 Comprehensive in-depth device and operation overview...18 Application Demonstration...26

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Chapter 3: Small Group Hands-on Training and Application Practice Learning Objectives...37 Roles, Responsibilities and Expectations...37 Detailed Step-By-Step Overview...38 Real-time Application Demonstration...42 Student Device Application...42 Completing the User Performance Evaluation ...43

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Chapter 4: Training Evaluation

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Appendix A: Important Contacts

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Appendix B: Frequently Asked Questions

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Appendix C: LUCAS in the Cath Lab The 2010 AHA Guidelines on Resuscitation in the Cath Lab...65 2010 AHA Class IIa Recommendation for Mechanical CPR during PCI...65 LUCAS in the Cath Lab...66

References

Contents

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7 PREFACE

Instructor Notes: This Instructor 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 Physio-Control. It is not a substitute for high-quality training. Refer to the Instructions For Use (IFU) for complete directions for use, indications, contraindications, warnings and cautions, and technical specifications. The IFU is included with each device and can also be found in the Documents section of the LUCAS product page on the Physio-Control website, www.physio-control.com/LUCAS/, under LUCAS 2 Instructions for Use (PDF).

Preface

All operators must read the complete IFU before operating the LUCAS chest compression system.

Chapter 1: Instructor Training Preparation

1 / INSTRUCTOR TRAINING PREPARATION

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11 1 / INSTRUCTOR TRAINING PREPARATION

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. Who is your regional or state contact for the training session? Each training session should have a designated point of contact in either the district/region or with the state in which the LUCAS devices are being deployed. Be sure to know who the contact is, and if they are attending the training session or helping coordinate the session. “Super trainers” can act as a resource to answer questions and may assist with leading the training session. 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 for hands-on instruction). §§ 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 to LUCAS and Device Overview” that is 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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LUCAS 2 Chest Compression System ®

Instructor Guidebook

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 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, computer capable of playing a CD/ DVD, and audio for the videos. §§ If no computer available on-site, ensure that laptop can be connected to projection system. 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 6 students (e.g. class of 40 will require seven devices/manikins) §§ Each LUCAS device must have present all the accessories that were included in the grant: ŸŸ Suction Cup mounted to the piston ŸŸ Patient Straps (wrist straps), attached to Support legs ŸŸ Stabilization Strap, present in bag with two Support leg straps that buckle to Support legs ŸŸ Two charged batteries, one installed in device with spare in bag pocket ŸŸ External Power Supply Cord, present in bag pocket ŸŸ LUCAS Back Plate ŸŸ Two additional Suction Cups §§ One manikin for each LUCAS device Training materials and handouts §§ LUCAS Device Size Comparison Chart (Physio-Control GDR 3303600) §§ User Performance Evaluation Form (Physio-Control GDR 3302907) §§ Annotated User Performance Evaluation Form (Physio-Control GDR 3323653) §§ LUCAS Chest Compression System Training Quiz (Physio-Control GDR 3318854) §§ Training Answer Key and Annotated Test (Physio-Control GDR 3318947)

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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

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 that 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 LUCAS batteries as needed

§§ Installed in LUCAS device (power supply cord) – less than two hours ŸŸ Put battery in the slot in the Hood of the LUCAS device ŸŸ Connect the Power Supply to the DC input on the side of the LUCAS device ŸŸ Connect the Power Supply to the mains wall outlet §§ In the external LUCAS Battery Charger (if available) – less than four hours ŸŸ Put the battery in the slot of the battery charger ŸŸ Connect the battery charger power cord to the mains wall outlet

Chapter 2: Classroom Training Introduction and Overview

2 / CLASSROOM TRAINING INTRODUCTION AND OVERVIEW

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2 / CLASSROOM TRAINING INTRODUCTION AND OVERVIEW

Classroom Training-Introduction and Overview INTRODUCTIONS Introduce lead trainer and support staff present (i.e., Physio-Control Team Members, Super Users, etc.) 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 – two brief videos will be shown §§ Introduction to LUCAS and device overview, 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 two videos that are played at the beginning of each training session. Have the videos prepared prior to starting the class. Tim Phalen, Physiology of CPR (found on LUCAS In-Service DVD, menu) §§ This video provides an overview of the physiology of CPR, including the importance of maintaining coronary perfusion pressure (CPP). Both human1,2 and experimental 3,4 studies have shown that the LUCAS device can produce coronary perfusion pressures of over 15mmHg during prolonged CPR, better than manual CPR. Cypress Creek application video (Found on Resource Flash Drive in “Videos” folder) §§ This video shows a coordinated application of the LUCAS device, focused on minimizing total interruption time. Focus should be on the process of starting manual CPR, inserting the Back Plate, resuming manual CPR, and then applying the Upper Part. The video on the physiology of CPR is intended to highlight the importance of consistent, high-quality chest compressions for generating adequate CPP, which the LUCAS device helps accomplish.

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The Cypress Creek application video is meant to show a coordinated application process, specifically how performance of manual CPR between each step, such as placing the Back Plate, helps to minimize interruptions in CPR. DEVICE OVERVIEW The LUCAS Chest Compression System The LUCAS chest compression system is a portable tool designed to overcome the problems identified with manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the current American Heart Association Guidelines.5 Intended Use The 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. The LUCAS device must only be used in cases where chest compressions are likely to help the patient. 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 §§ Patient too small: If the LUCAS device alerts with three fast signals when lowering the Suction Cup, and you cannot enter the PAUSE or ACTIVE mode; this will be demonstrated later when discussing patient size in the Comprehensive In-depth Device and Operation Overview section. §§ Patient too large: If you cannot lock the Upper Part of the LUCAS device to the Back Plate without compressing the patient’s chest Always follow current local and/or international guidelines for CPR when using the LUCAS device in addition to your local protocols and/or medical direction. Personnel It is recommended that 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 how to use the LUCAS device

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Side Effects The International Liaison Committee on Resuscitation (ILCOR) states these side effects of CPR:6 “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 these, bruising and soreness of the chest are common during the use of the LUCAS chest compression system. Autopsy studies have shown that LUCAS compressions are safe for the patient7–10 with the same type of side-effects as for manual CPR. Main Components The main components 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 §§ Patient Straps which help secure the patient’s arms to the LUCAS device §§ A padded Carrying Bag 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 Bag 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 bag and demonstrate to the audience. Carrying Bag The LUCAS Carrying Bag was designed to be quick and easy to deploy. Instructor Notes:

Begin by demonstrating how to properly and quickly open the Carrying Bag and turn on the device while it is still in the bag. While the LUCAS chest compression system is still in the bag, 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. When the device is packaged in the bag, there is a large strap that is used to secure all the components. The strap has a graphic that reminds users to turn on the device before taking it out of the bag. This will be reviewed in more detail later during the Application Demonstration.

2 / CLASSROOM TRAINING INTRODUCTION AND OVERVIEW

Back Plate Instructor Notes:

Remove the Back Plate from the bag, explain what the picture on the Back Plate means and where the claw locks attach. The Back Plate can be oriented in either direction. 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 the Suction Cup*.

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. An accurate position of the Back Plate makes it easier and faster to position the 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. *Positioning of the piston and Suction Cup will be explained when reviewing the Upper Part of the LUCAS chest compression system. Bag Contents Instructor Notes:

Set the Back Plate aside. Remove the Upper Part from the Carrying Bag and set aside to review contents of the bag. Show the audience where each component is located in the Carrying Bag. In addition to the Back Plate and the Upper Part (including battery), the LUCAS device is delivered with: §§ Three disposable Suction Cups – one will be attached to the LUCAS device, and two will be packaged and in side pockets within the bag close to the Hood.

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There are two pockets in the middle of the Carrying Bag 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 Bag, 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 IP 43 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.

2 / CLASSROOM TRAINING INTRODUCTION AND OVERVIEW

Underneath the Hood is the piston, which contains the Pressure Pad and the Suction Cup. The Pressure Pad is at the end of the piston. The Pressure Pad acts as the heel of your hand when performing manual CPR, in that 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 AHA 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 that the claw locks are open, then release the rings.

It is important that you release the rings when attaching the Upper Part to the Back Plate so that 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 device is active: ŸŸ Remove the Stabilization Strap from the Carrying Bag and extend the strap fully at the buckles. ŸŸ Carefully position the Cushion strap behind the patient’s neck, as close to the patient’s shoulders as possible. ŸŸ Connect the Buckles on the Support leg straps to the Buckles on the Stabilization Strap. Make sure straps are not twisted. ŸŸ 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 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.

2 / CLASSROOM TRAINING INTRODUCTION AND OVERVIEW

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 bag, is to press this button and turn the device on. Remember, the graphic on the strap inside the bag is a reminder to turn the device on. button. It is also labeled with a “1”. When you turn the The orange button is the ADJUST 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 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 is pressed firmly to 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) other is ACTIVE (30:2) .

and the

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. 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 eight times per minute to alert for ventilation during ongoing compressions. On the top of the Control Panel, in the middle of the gray bar, are the MUTE the Alarm indicator .

button and

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.

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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. Battery The Battery is in the Hood, opposite the Control Panel. It is a Lithium Polymer battery with a runtime of 45 minutes when fully charged. If the battery is fully depleted, it takes less than four hours to charge in the standalone battery charger, and less than two hours when the power supply cord is used. On the top right of the Control Panel is the Battery indicator the charge status.

. Three green LEDs show

§§ 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 orange LED and hear an intermittent alarm during operation, it means the Battery has less than 30% capacity, or approximately 10 minutes of operating capacity left. (For a complete list of Battery indicators, refer to the Instructions for Use.) To minimize interruptions, having a charged spare LUCAS battery in the carrying bag 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 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.