Defibtech RMU-1000 User manual

User Manual
Defibtech RMU-1000
Automated Chest
Compression System
ELECTRONIC
DISTRIBUTION
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Notices
Defibtech, L.L.C. shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use of
this material.
Information in this document is subject to change without notice. Names and data
used in the examples are fictitious unless otherwise noted.
Limited Warranty
The “Limited Warranty” shipped with Defibtech ACC products serves as the sole
and exclusive warranty provided by Defibtech, L.L.C., with respect to the products
contained herein.
Copyright
Copyright © 2019 Defibtech, L.L.C.
All rights reserved. Copyright questions should be directed to Defibtech. For contact
information, refer to Chapter 10 of this manual.
Patents
For patent information, see www.defibtech.com/patents.
CAUTION
Federal Law (USA) restricts this device
to sale by or on the order of a physician.
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Issued: 2019- 06-19

Contents
1 Introduction to the RMU-1000 ACC ................................. 7
1.1 Overview .......................................................7
1.2 The Defibtech RMU-1000 ACC ......................................8
1.3 Indications for Use ...............................................10
1.4 Contraindications ................................................10
1.5 Side Effects ....................................................10
1.6 Intended Use ...................................................10
1.7 Operator Training Requirements ....................................11
2 Warnings and Cautions............................................ 13
2.1 Warnings..................................................13
2.2 Cautions ..................................................15
3 Setting Up the RMU-1000 ACC .................................... 17
3.1 Overview ......................................................17
3.2 Complete Initial Assembly of the ACC ................................18
3.3 The Backboard ..................................................18
3.4 The Frame .....................................................18
3.5 Attaching the Patient Wrist Straps to the Frame . . . . . . . . . . . . . . . . . . . . . . . .19
3.6 The Compression Module .........................................21
3.7 Installing and Removing the Patient Interface Pad.......................23
3.8 Installing and Removing the Battery Pack .............................23
3.9 Charging the Battery Pack .........................................24
3.10 Completing and Testing the RMU-1000 ACC...........................26
3.11 Disassembling and Storing the RMU-1000 ACC ........................27
4 Using the RMU-1000 ACC .........................................29
4.1 Overview ......................................................29
4.2 Arrival and Setup ................................................31
4.3 Operation and Adjustment .........................................34
4.4 Stabilization ....................................................36
4.5 Securing the Patient Wrist Straps to the Patient ........................37
4.6 Transport ......................................................39
4.7 Power .........................................................40
4.8 Other Therapies .................................................41
4.9 Removal from Patient.............................................42
4.10 Post-Use Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
4.11 Operational Environment ..........................................42
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5 Maintenance and Troubleshooting .................................43
5.1 Routine Unit Maintenance ........................................ 43
5.2 Cleaning ...................................................... 43
5.3 Storage ....................................................... 44
5.4 Troubleshooting ................................................ 44
5.5 USB Port ......................................................46
5.6 Event Data .....................................................46
5.7 Service ........................................................46
5.8 Recycling Information.............................................46
6 RMU-1000 ACC Accessories ....................................... 47
6.1 Patient Interface Pad .............................................47
6.2 Battery Pack ....................................................47
6.3 External AC Adapter..............................................47
6.4 Stabilization Strap ............................................... 48
6.5 Patient Wrist Straps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
6.6 USB Cable .................................................... 48
6.7 Battery Pack Charging Station ..................................... 48
6.8 Tactical Case....................................................49
7 Technical Specifications .......................................... 51
7.1 Defibtech RMU-1000 ACC.........................................51
7.2 Battery Pack ....................................................52
7.3 AC Power Adapter ...............................................52
7.4 Notice to European Union Customers ................................53
8 Electromagnetic Conformity ......................................55
8.1 Guidance and Manufacturer’s Declaration .............................55
9 Glossary of Symbols ..............................................59
10 Contacts .........................................................63
11 Warranty Information .............................................65
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1 Introduction to the RMU-1000 ACC
This User Manual provides information to guide trained operators in the use and maintenance of
the Defibtech RMU-1000 Automated Chest Compressor (ACC) and its accessories.
This chapter includes an overview of the ACC, intended use information, a discussion of when it
should and should not be used, and information on operator training.
1.1 Overview
The RMU-1000 ACC is an automated, portable, battery-powered device that provides chest
compressions on adult patients who have cardiac arrest.
The ACC, when applied to a patient who is unconscious and not breathing, is designed to:
• Provide consistent depth and rate chest compressions.
• Allow for automated chest compressions in both the in-hospital and out-of-hospital settings
including during patient transport.
• Be applied to the patient with minimal interruption of CPR.
The major components of the RMU-1000 ACC are the Backboard, the Frame and the Compression
Module. The Backboard is placed under the patient to provide a base for the ACC system.
The Frame is placed over the patient and snaps into the Backboard with self-locking latches.
The Compression Module mounts into the Frame and contains the user interface, a replaceable
Battery Pack and the piston drive used to generate the chest compressions.
Compressions are initiated using a simple three-step operational sequence once the RMU-1000
ACC has been applied to a patient: the unit is turned on, the piston height is adjusted for the patient’s
chest size, and the compressions button is pushed. Additional user interface features include a
pause function, a warning indicator to notify the operator for possible misuse or malfunction, an
audible warning mute, and a Battery Pack capacity gauge.
The RMU-1000 ACC can be operated using a replaceable, rechargeable Battery Pack or with an
external power adapter. A fully-charged, new Battery Pack can provide continuous operation for
over an hour and can be recharged in the Compression Module.
A USB port on the Compression Module allows the Module to be connected to a personal
computer and for ACC data retrieval and event reporting when used in conjunction with utility
software available at www.defibtech.com.
1. Introduction
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1.2 The Defibtech RMU-1000 ACC
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5
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1. User Control Panel. The User Control
Panel contains the user interface for the
ACC system.
2. Compression Module. The Compression
Module contains all the therapeutic
components of the ACC system, including
the piston drive mechanism, the control
electronics, the User Control Panel, and the
Battery Pack interface.
3. Serial Number. The serial number can be
found on the Compression Module.
4. External Power Input. The External
Power Input jack is used to connect an
external power adapter to operate the unit
or to charge the Battery Pack.
5. USB Port. The USB Port is located on
the bottom of the Compression Module.
It allows the Module to be connected to
a personal computer and for ACC data
retrieval and event reporting when used in
conjunction with utility software available at
www.defibtech.com. It is not intended to
be used during rescue operation.
6. Frame. The Frame attaches to the
Backboard and holds the Compression
Module. It is used to maintain the
Compression Module’s position over the
patient.
7. Backboard. The Backboard is the base
for the ACC system. It is placed under the
patient and provides an interface that the
Frame attaches to.
8. Backboard Latches. One on each side
of the Frame, the Backboard Latch is the
mechanism that secures the Frame to the
Backboard.
9. Stabilization Strap Connectors. One on
each side of the Frame, the Stabilization
Strap Connectors allow the Stabilization
Strap to be secured to the Frame to
maintain the ACC position over the patient's
chest.
10. Backboard Release Lever. One on each
side of the Frame, the Backboard Release
Levers are used to release the Frame from
the Backboard.
11. Handles. One on each side of the Frame,
the Handles provide a secure way to grasp
the Frame during ACC assembly and patient
transport.
12.Battery Pack. The Battery Pack provides
a replaceable primary power source for the
Compression Module.
13. Battery Pack Release. The Battery Pack
Release ejects the Battery Pack from the
Compression Module.
14. Patient Interface Pad. The Patient
Interface Pad is a user-replaceable, single
use component that provides the interface
between the piston and the patient’s chest.
15. Compression Piston. The Compression
Piston is driven by a motor housed inside
the Compression Module and, with the
Patient Interface Pad attached to the
distal end of the Piston, provides the
compressions to the patient's chest.
The Defibtech RMU-1000 ACC (continued)
1. Introduction
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1.3 Indications for Use
The RMU-1000 Automated Chest Compressor (ACC) is to be used for performing external cardiac
compressions, as an alternative to manual CPR, on adult patients who have acute circulatory
arrest, defined as the absence of spontaneous breathing and loss of consciousness.
The RMU-1000 should only be used in situations where chest compressions are likely to help the
patient.
Federal Law (USA) restricts this device to sale by or on the order of a physician.
1.4 Contraindications
Do not use the RMU-1000 ACC in the following cases:
• It is not possible to position the ACC safely or correctly on the patient’s chest
• The patient is too small for the starting piston height to reach the patient’s chest
• The patient is too large for the Frame to attach to the Backboard or if the Compression
Module/Piston cannot be mounted without compressing the patient’s chest
Always follow local and/or recognized resuscitation guidelines for CPR when using the RMU-
1000 ACC.
1.5 Side Effects
The International Liaison Committee on Resuscitation (ILCOR) states the following side effects
of CPR:
“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.” (From the 2005 International Consensus
Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science
With Treatment Recommendations, hosted by the American Heart Association in Dallas, Texas,
January 23–30, 2005. Published in Circulation. 2005; 112: III-5-III-16.)
The above side effects, as well as bruising and soreness of the chest, may commonly occur after
the use of the RMU-1000 ACC. (Black CJ, Busuttil A, Robertson C. Chest wall injuries following
cardiopulmonary resuscitation. Resuscitation. 2004 Dec;63(3):339-43.)
1.6 Intended Use
The RMU-1000 ACC, when applied to a patient who is unconscious and not breathing, is intended
to:
• Provide consistent depth and rate chest compressions.
• Allow for automated chest compressions in both the in-hospital and out-of-hospital settings
including patient transport.
• Be applied to the patient with minimal interruption of CPR.
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1.7 Operator Training Requirements
In order to safely and effectively operate the RMU-1000 ACC, it is the responsibility of the
operator to obtain the following training:
• RMU-1000 ACC training in accordance with the User Manual including handling of the
actual device
• CPR training in accordance with resuscitation guidelines as required by local, state,
provincial, and/or national regulations, e.g. American Heart Association, European Council of
Resuscitation
• Thorough knowledge and understanding of the material presented in this User Manual
The RMU-1000 ACC is intended for use by qualified medical personnel certified to administer
CPR (e.g. first responders, ambulatory personnel, nurses, physicians or medical staff).
1. Introduction
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2 Warnings and Cautions
This chapter includes a list of warnings and cautions that relate to the RMU-1000 ACC and its
accessories. Many of these messages are repeated elsewhere in this User Manual and on the
RMU-1000 ACC or accessories.
2.2 WARNINGS:
Immediate hazards that will result in serious personal injury or death.
None known.
Conditions, hazards, or unsafe practices that may result in serious personal injury or death.
• Improper use can cause injury to patient. Use the RMU-1000 ACC only as instructed in the
User Manual.
• Improper use can cause injury to operator or bystander. Keep fingers and hands away from
Piston during operation.
• Improper maintenance can cause the RMU-1000 ACC not to function. Maintain the RMU-
1000 ACC and rechargeable Battery Pack only as described in the User Manual. Failure to
maintain the Battery Pack per the instructions outlined in this User Manual will result in the
RMU-1000 ACC becoming inoperable.
• No modification of this equipment is allowed. The RMU-1000 ACC contains no user-
serviceable parts. Do not disassemble, repair or alter the RMU-1000 ACC or any of its
components.
• Do not immerse Compression Module or Battery Pack in water or other liquids. Immersion
in fluids may result in fire or explosion.
• Do not sterilize the RMU-1000 ACC or its accessories.
• Do not let fluids get into the RMU-1000 Compression Module. Avoid spilling fluids on the
ACC or its accessories. Spilling fluids into the RMU-1000 ACC may damage it or cause a
fire or shock hazard.
• If the patient is too large for the Frame, remove Frame and continue manual CPR
compressions. Do not use the ACC if the Frame cannot be latched to the backboard.
• If the Piston cannot be adjusted to reach the patient's chest, the patient is too small.
Remove Frame and continue with manual CPR compressions.
• Do not initiate ACC compressions if the Piston is not in the proper position. An incorrect
start position may compromise the patient’s blood circulation.
• Do not use the ACC if the Frame cannot be latched in place (for any reason).
• Incorrect position over chest can result in injury or lack of effectiveness.
• Incorrect Piston start height can result in injury or lack of effectiveness.
• Carefully monitor the position of the Piston on the patient's chest to ensure that it has not
moved from the appropriate target area.
• Changed position over the chest during operation can result in injury or lack of effectiveness.
• Do not leave the ACC running while unattended. Patient injury may result if the unit is left
unattended.
2. Warnings and Cautions
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• The ACC can become hot during extended use. The applied part of the piston may rise 5°C
above ambient.
• If the position of the Piston changes as a result of defibrillation or other therapies,
immediately stop compressions and re-adjust the position of the ACC.
• Mechanical chest compressions may cause artifact and interfere with ECG analysis.
Always pause compressions before performing ECG analysis with other equipment.
• When the Battery Pack indicator shows one red segment, replace the Battery Pack as
soon as possible with a sufficiently charged Battery Pack or apply external power.
• To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
• If a spare Battery Pack or external power source are not available and the ACC stops
compressions, remove the unit from the patient and begin manual compressions
immediately.
• If there is a malfunction, the compressions are not sufficient, or something unusual
occurs during operation, then push the ON/OFF Button for one second to stop the ACC
from delivering compressions and remove the unit from the patient. Start manual chest
compressions as soon as possible.
• If there is a malfunction and the unit will not turn OFF, remove Battery Pack to stop
compressions. Remove the unit from the patient. Start manual chest compressions as
soon as possible.
• The Patient Wrist Straps are designed only for use with Defibtech RMU-1000 Automated
Chest Compression Systems. Do not apply to other items such as a stretcher or bedside
rails.
• Do not use the Patient Wrist Straps if damaged, soiled, or if Velcro does not bond
sufficiently to securely fasten the patient’s wrists to the RMU-1000 ACC.
• Do not over-tighten the Patient Wrist Straps to prevent potential injury. If the Patient
Wrist Straps are too loose, they may not securely fasten the patient’s arms to the ACC
appropriately.
• Do not use the Patient Wrist Straps to lift the patient. The straps are only intended to
attach the patient’s arms to the RMU-1000 ACC during transport.
• Observe the patient’s arms during use of the Patient Wrist Straps. Do not leave a patient
unattended when using the ACC or its accessories (e.g. Patient Wrist Straps).
• Do not obstruct intravenous (IV) access when deploying the RMU-1000 or when attaching
the Patient Wrist Straps.
• Use of damaged equipment or accessories may cause the device to perform improperly
and/or result in injury to the patient or operator.
• The ACC system components must be cleaned and the Patient Interface Pad replaced
between patients to avoid cross contamination.
• The use of accessories other than those specified may result in increased emissions or
decreased immunity of the RMU-1000 ACC.
• Portable and mobile RF communications equipment should be used no closer to any part
of the RMU-1000 ACC, including cables, than necessary.
WARNINGS (continued)
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• The RMU-1000 ACC should not be used adjacent to other equipment and that if adjacent,
the RMU-1000 ACC should be observed to verify normal operation in the configuration in
which it will be used.
• Do not use in the presence of flammable gases or anesthetics. Use care when operating
this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing).
Turn off gas source or move away from patient, if necessary.
2.3 CAUTIONS:
Conditions, hazards, or unsafe practices that may result in minor personal injury, damage
to the RMU-1000 ACC, or loss of data.
• The Compression Module must be assembled and locked to the Frame for proper operation.
• The Frame must be latched to the Backboard for proper operation.
• A new battery is set to ship mode. Must be activated before use! Activate battery by
charging in unit or charger.
• Follow all Battery Pack labeling instructions. Do not use a Battery Pack after its expiration date.
• Use only Defibtech approved batteries and accessories.
• The ACC must be paused in order to replace a Battery Pack. Failure to do so will require the
user to power up the ACC and reset the start position in order to resume compressions.
• Only use Defibtech accessories to power the ACC from an external power source.
• The Battery Pack must always be installed to operate the ACC from external power.
Without the Battery Pack, the ACC will flash the warning indicator and will not perform
compressions.
• The mains power quality must be that of a typical commercial or hospital environment.
• Defibrillation electrodes and pads should not be in contact with and be clear of the Piston
and other ACC components.
• Make sure other equipment and/or drugs are applicable for use with the ACC. Consult the
equipment's operating instructions.
• Avoid gel on chest. Gel on the chest (e.g. from defibrillation pads or ultrasound) in the
Patient Interface Pad target area may result in movement of the piston. Be sure to remove
any gel before use.
• Defibrillation pads or electrodes must be removed or moved away from the Patient
Interface Pad target area.
• Do not use on open wounds or if visible signs of existing injuries.
• The ACC should be applied to the patient’s bare chest. Remove clothing, undergarments
and jewelry before use.
• If the RMU-1000 ACC becomes hot, prolonged contact with the patient’s skin could result
in skin burns. If necessary, remove the patient’s arms from the Patient Wrist Straps.
• Do not allow the use of Stabilization Strap to delay or prevent other treatment of the
patient. Apply strap as soon as possible after beginning compressions and always before
patient movement.
WARNINGS (continued)
2. Warnings and Cautions
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• Recycle or dispose of lithium-ion batteries in accordance with local, state, provincial, and/
or national regulations. To avoid fire and explosion hazard, do not burn or incinerate the
Battery Pack. Do not crush.
• Use and store the RMU-1000 ACC only within the range of environmental conditions
specified in the technical specifications.
• Always store the ACC so it is ready to go for use. Store the Compression Module with a
fully charged Battery Pack installed and a Patient Interface Pad attached to the Piston. It
is recommended to maintain a charged spare Battery Pack and have the external power
adapter available with the unit at all times.
• Although the RMU-1000 ACC is designed for a wide variety of field use conditions, rough
handling beyond specifications may result in damage to the unit.
• Federal Law (USA) restricts this device to sale by or on the order of a physician.
CAUTIONS (continued)
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3 Setting Up the RMU-1000 ACC
This chapter describes the steps required to make your Defibtech RMU-1000 ACC operational.
The RMU-1000 ACC is designed to be stored in a Carrying Case with a small number of easy to
assemble components or stored in a fully assembled “ready” state. This chapter explains how to
set up the RMU-1000 ACC device.
3.1 Overview
The following components and accessories are included with the RMU-1000 ACC. Replacement
and other accessories are detailed in the “RMU-1000 ACC Accessories”section. Before getting
started, identify each component and ensure that the package is complete.
Backboard Battery Pack
Frame Compression
Module
Carrying Case AC Adapter
Patient
Interface Pad
(package of 3)
Stabilization
Strap
Top Bottom
Patient Wrist
Straps
User Manual
and Quick
Reference Guide
RMU-1000 Quick Reference Guide
Before and during deployment of the RMU-1000:
• Confirm patient is not breathing and unresponsive.
• Start manual compressions.
• Minimize compression interruptions.
• Perform manual compressions whenever possible.
Run
Continuous
Runwith
Breaths
1
4
5
Place Backboard under patient
and expose chest.
Adjust Piston height until it touches
the patient’schest.
Start compressions.
Apply Stabilization Strap.
3
2AttachFrame to Backboard, with
patient’sarms outside the Frame.
Insert Compression Module with
Patient Interface Pad installed into
Frame (down and twist).
Turnon (press and hold
for at least 1 second).
XXXX
YYYY
Defibtech,L.L.C.
741Boston Post Road, Suite 201
Guilford,CT 06437 USA
EmergoEurope
Molenstraat15
2513BH The Hague, The Netherlands
EC REP
Minimize compression interruptions.
Performmanual compressions whenever possible.
Place Backboard under patient
and expose chest.
Adjust Piston height until it touches
the patient’schest.
Start compressions.
Apply Stabilization Strap.
AttachFrame to Backboard, with
patient’sarms outside the Frame.
Insert Compression Module with
Patient Interface Pad installed into
Frame (down and twist).
Turnon (press and hold
for at least 1 second).
2513BH The Hague, The Netherlands
Defibtech RMU-1000
Automated Chest
Compression System
User Manual
3. Setting Up the
RMU-1000 ACC
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3.2 Complete Initial Assembly of the ACC
Before being placed into service, the RMU-1000 ACC unit should be completely assembled and
operationally checked to ensure that all components are present and functional.
3.3 The Backboard
The Backboard is the base for the ACC system. It is placed under the patient and has attachment
points to which the Frame latches. There are no moving parts on the Backboard.
Attachment
Points
Attachment
Points
3.4 The Frame
The Frame holds the Compression Module. It attaches to the Backboard and is used to maintain
the Compression Module’s position over the patient.
To attach the Frame to the Backboard:
• Place the Backboard on a flat surface, such that the patient position diagram is visible.
• Attach the Frame to the Backboard by aligning the Frame latches over the Backboard pins
and pushing down until the latches snap into place. The latches may be clicked into place
one at a time or simultaneously.
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To remove the Frame, push in on the two backboard release levers and lift the Frame off of the
Backboard. The latches may be released together or one at a time.
3.5 Attaching the Patient Wrist Straps to the Frame
Frame Strap
Forearm
Strap
Frame
Strap
Loop
The Patient Wrist Straps are designed to attach a patient’s arms to the ACC for ease of transporting
the patient and the ACC. As shown in the above left illustration, each Patient Wrist Strap is
comprised of two main strap sections: a Frame Strap that attaches to the ACC’s Frame and an
Forearm Strap that wraps around the patient’s wrist.
Note: As shown in the above right illustration, when attaching the ACC’s Frame to the Backboard,
the Patient Wrist Straps can be oriented towards the patient’s head to maintain access to the ACC
Frame’s Backboard Release Levers or on the opposite side of the ACC Frame as appropriate.
The Frame (continued)
3. Setting Up the
RMU-1000 ACC
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To maximize the available time to perform a rescue, Defibtech recommends that the Patient Wrist
Straps be affixed to the ACC Frame using the instructions shown below prior to a rescue and that
the Frame be stored in the ACC’s Carrying Case with the Patient Wrist Straps already attached
to the Frame.
1. Attach the Frame Strap to the ACC Frame by inserting the rounded end of the Frame Strap
through the Frame Strap Loop, as shown in the above left illustration.
2. After the Frame Strap has been inserted through the Frame Strap Loop, pull the end of the
Frame Strap in the opposite direction so that the Frame Strap is tightly wrapped around the
ACC Frame, as shown in the above right illustration. Secure in place using the Velcro®on the
underside of the Frame Strap.
3. If necessary, rotate the attached Patient Wrist Strap so that the Forearm Strap component
faces up. This allows the procedure described in Section 4.5 to be performed.
4. Repeat the above three steps to attach the second Patient Frame Strap’s Frame Strap to the
ACC Frame.
Attaching the Patient Wrist Straps to the Frame (continued)
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