User Guide
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Resuscitation System Model 100
User Guide
P/N 12555-001 Rev 10
User Guide
Notice About this Guide The information in this User Guide applies to the ZOLL AutoPulse Resuscitation System Model 100. ZOLL 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.
Copyright © Copyright ZOLL Circulation, Inc. 2022. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, mechanical, electronic, photocopying, recording, or otherwise, without prior written permission of ZOLL. AutoPulse and LifeBand® are trademarks of ZOLL. All other trademarks mentioned herein belong to their respective owners. Patent: www.zoll.com/patents
0344
USA ZOLL Circulation, Inc. 2000 Ringwood Avenue San Jose, CA 95131 U.S.A.
EU Authorized Representative ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands
+1 (408) 541-2140 (main) +1 (408) 541-1030 (fax)
t: +31 481 366 410 CH REP
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ZOLL Medical Switzerland A.G. Bahnhofstrasse 20 6300, Zug Switzerland
User Guide
Table of Contents Figures ...v Tables ... vii Preface ...ix Who Should Read this Guide ...ix General Warnings and Precautions ...ix Symbols ...xi 1 Introduction of the AutoPulse® System ... 1-1 1.1 Indication for Use ... 1-1 1.2 Description of the System ... 1-1 1.3 System Components ... 1-2 1.3.1 Platform ... 1-2 1.3.2 LifeBand Load-distributing Band ... 1-3 1.3.3 AutoPulse Power System ... 1-3 1.4 User Controls and Indicators ... 1-4 1.4.1 On/Off Button ... 1-4 1.4.1.1 On/Off Button ... 1-4 1.4.2 User Controls ... 1-4 1.4.2.1 Start/Continue Button ... 1-5 1.4.2.2 Stop/Cancel Button ... 1-5 1.4.2.3 Menu/Mode Switch Button ... 1-6 1.4.2.4 Move Up/Move Down Button ... 1-6 1.4.2.5 Select Choice Button ... 1-7 1.4.2.6 Tone Mute Button ... 1-7 1.4.2.7 Increase/Decrease Contrast Button ... 1-8 1.4.2.8 Power (Green LED) ... 1-8 1.4.2.9 Alert (Red LED) ... 1-8 1.4.3 Battery Charge Status ... 1-8 1.4.4 Performance Characteristics ... 1-10 2 Preparing the AutoPulse System for Use ... 2-1 2.1 LifeBand Load-distributing Band ... 2-1 2.1.1 Installing the LifeBand ... 2-1 2.1.2 Removing the LifeBand ... 2-4 2.1.2.1 Removing a LifeBand that is Cut or Not in the Home Position ... 2-7 2.2 Battery Installation and Removal ... 2-9 2.2.1 AutoPulse Li-Ion Battery Installation and Removal ... 2-9 2.3 Administrative Menu: User Pre-set Options ... 2-10 3 Using the AutoPulse System ... 3-1 3.1 Deploying the AutoPulse System ... 3-1
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3.2 Starting Chest Compressions ... 3-7 3.3 Ending Active Device Use ... 3-14 3.4 Preparing the Platform for Its Next Use ... 3-14 3.5 Periodic Electrocardiogram (ECG) Monitoring and/or Defibrillation ... 3-14 3.6 Patient Alignment and Securing for Transport ... 3-15 3.6.1 Recommended Method of Patient Extrication ... 3-16 3.7 Viewing Platform Information ... 3-18 3.8 Uploading Platform Information to your PC ... 3-19 3.8.1 Information Upload Procedure ... 3-20 4 Maintaining the AutoPulse System ... 4-1 4.1 Charging Batteries in the Battery Charger ... 4-1 4.2 Cleaning the Platform ... 4-2 4.3 Storing the Platform ... 4-3 4.4 Maintenance ... 4-3 4.5 Disposal and Recycling ... 4-5 4.5.1 Platform ... 4-5 4.5.2 Battery Charger ... 4-5 4.5.3 Batteries ... 4-5 4.5.4 LifeBand ... 4-5 5 Troubleshooting Procedures ... 5-1 5.1 Troubleshooting Batteries ... 5-1 5.2 Troubleshooting User Advisories and Faults ... 5-2 5.2.1 User Advisory (45) ... 5-4 5.3 Troubleshooting Errors ... 5-5 Appendix A AutoPulse Daily Checklist ... A-1 Appendix B Technical Specifications ...B-1 B.1 Patient Parameters ...B-1 B.2 LifeBand ...B-1 B.3 Operating Parameters ...B-1 B.4 Platform Physical ...B-1 B.5 Platform Environmental ...B-2 B.6 Li-Ion Battery Physical and Environmental ...B-2 B.7 Battery Charger Physical And Environmental ...B-4 B.8 FCC Statement ...B-6 B.9 Guidance and Manufacturer’s Declaration–Electromagnetic Emissions ...B-6 B.10 Limited Warranty for AutoPulse Resuscitation System ...B-11 Index ...I-1
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Figures
0
Figure 1-1 The AutoPulse System ... 1-2 Figure 1-2 Platform (Patient and Back Surfaces) ... 1-3 Figure 1-3 On/Off Button Location ... 1-4 Figure 1-4 User Control Panel ... 1-5 Figure 1-5 Low Battery Warning ... 1-9 Figure 2-1 Sliding the LifeBand Band Clip into the Driveshaft Slot ... 2-1 Figure 2-2 Seating the LifeBand Band Clip Properly into the Driveshaft Slot ... 2-2 Figure 2-3 Snapping the LifeBand Cover Plate into Place ... 2-3 Figure 2-4 Flip Down the Hinged Belt Guards of the LifeBand ... 2-3 Figure 2-5 Flip Up the Hinged Belt Guards of the LifeBand ... 2-4 Figure 2-6 Pinching the Locking Tabs of the LifeBand ... 2-5 Figure 2-7 Removing the LifeBand from the Platform ... 2-6 Figure 2-8 LifeBand NOT in the Home Position: Do Not Remove! ... 2-7 Figure 2-9 Positioning the LifeBand for Removal ... 2-8 Figure 2-10 LifeBand in the Home Position: Ready for Removal ... 2-8 Figure 2-11 AutoPulse Li-Ion Battery Installation and Removal ... 2-9 Figure 2-12 Administrative Menu ... 2-11 Figure 2-13 Administrative Menu (scrolled down) ... 2-11 Figure 2-14 Compression Mode Menu ... 2-12 Figure 2-15 Mute Duration Menu ... 2-13 Figure 2-16 Ventilation/Pause Tone Volume Menu ... 2-14 Figure 2-17 Continuous Mode Ventilation Tone Menu ... 2-15 Figure 3-1 On/Off Button Location ... 3-1 Figure 3-2 Self-Test Display Panel Screen ... 3-2 Figure 3-3 Patient-Readiness Display Panel Screen ... 3-2 Figure 3-4 Cutting Patient Clothing and Positioning of AutoPulse ... 3-3 Figure 3-5 Removal of all Clothing from the Torso ... 3-4 Figure 3-6 Correct Patient Alignment ... 3-5 Figure 3-7 Aligning the LifeBand ... 3-6 Figure 3-8 Fastening the LifeBand ... 3-7 Figure 3-9 Analyzing Patient Size Display Panel Screen ... 3-8 Figure 3-10 Verifying Patient Alignment Display Panel Screen ... 3-9 Figure 3-11 Chest Compression Display Panel Screen ... 3-10 Figure 3-12 Ventilation Pause Display Panel Screen ... 3-11 Figure 3-13 Mode Change Confirm Display Panel Screen ... 3-12 Figure 3-14 Stopping Compressions Display Panel Screen ... 3-13 Figure 3-15 Restart/Continue Compressions Display Panel Screen ... 3-13 Figure 3-16 Securing the Patient for Transport ... 3-16 Figure 3-17 Transporting the Patient ... 3-17 Figure 3-18 Main Menu ... 3-20 Figure 3-19 Infrared Communication Set-up ... 3-20 Figure 3-20 Waiting for Connection... Display Panel Screen ... 3-21
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Figure 3-21 Connected Display Panel Screen ... 3-21 Figure 3-22 Transmitting... Display Panel Screen ... 3-22 Figure 4-1 Battery Charger with Charging Bay ... 4-1 Figure 4-2 Battery Charger Control Panel ... 4-2 Figure 5-1 Low Battery Warning ... 5-1 Figure 5-2 Replace Battery Screen ... 5-2 Figure 5-3 A User Advisory Screen ... 5-3 Figure 5-4 A Fault Screen ... 5-3 Figure 5-5 User Advisory (45) ... 5-4 Figure 5-6 System Error Screen ... 5-5
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Tables
0
Table 1-1 Patient/AutoPulse System Operating Parameters ... 1-1 Table 1-2 Battery Charge Status Indicator Specifics ... 1-10 Table 1-3 Operating Characteristics ... 1-10 Table B-1 Operating Parameters ... B-1 Table B-2 Physical Specifications ... B-1 Table B-3 Environmental Specifications ... B-2 Table B-4 Li-Ion Battery Specifications ... B-2 Table B-5 Battery Charger Specifications ... B-4 Table B-6 Guidance and Manufacturer’s Declaration–Electromagnetic Emissions ... B-6 Table B-7 Guidance and Manufacturer’s declaration – Electromagnetic immunity for Platform ... B-7 Table B-8 Guidance and manufacturer’s declaration – electromagnetic immunity ... B-8 Table B-9 Recommended separation distances between portable and mobile RF communications equipment and the Platform ... B-9
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Preface
0
This document describes the operating steps and maintenance requirements for the AutoPulse® Resuscitation System Model 100. Proper use of the AutoPulse System requires a thorough understanding of the product, appropriate training and practice. Please read the entire User Guide before operating the AutoPulse System.
Who Should Read this Guide
0
This document should be read by personnel who will use this product and who are trained in Basic Life Support (BLS) and/or Advanced Life Support (ALS) techniques. This includes emergency medical technicians, paramedics, nurses, physicians, police, and fire rescue personnel, and people certified to administer cardiopulmonary resuscitation (CPR).
General Warnings and Precautions
0
Warning: •
The AutoPulse System is intended for use on adults, 18 years of age or older.
•
The AutoPulse System is not intended for patients with traumatic injury (wounds resulting from sudden physical injury or violence).
•
When CPR is indicated, it should start immediately and should not be postponed.
•
The AutoPulse System must be used only in cases that manual CPR would normally be initiated. Personnel certified in manual CPR must always be present during the AutoPulse System operation.
•
The AutoPulse Platform is not intended to be the sole means of carrying a patient. The AutoPulse Platform should be secured to the top of a backboard or other equipment used to carry or transport the patient such as the AutoPulse Quick Case or AutoPulse Soft Stretcher, if necessary. During transport, regular checks of the patient’s alignment should be performed.
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Warning: •
If a user advisory or fault cannot be cleared or a system error occurs during active operation, immediately revert to manual CPR.
•
Operating the Platform on a patient for extended periods of time may result in minor skin irritation to the patient.
•
Do not use the Platform in the presence of an oxygen-rich (greater than 25% oxygen) atmosphere, flammable anesthetics, or other flammable agents (such as gasoline). Using the Platform near the site of a gasoline spill may cause an explosion.
•
To avoid the risk of electric shock, connect the AutoPulse Multi-Chemistry Battery Charger (Battery Charger) only to a supply mains with protective earth.
•
Always charge a new Battery upon receipt. Failure to charge a Battery may cause reduced Battery performance.
•
Always charge a stored Battery before placing the Battery into active operation. The Battery slowly self-discharges when not in use. Failure to charge a Battery before use may cause device power failure. In no case should any Battery be used if it has not been charged within the previous 60 days.
•
No modification of the AutoPulse Platform, the LifeBand, or the AutoPulse Power System is allowed.
Caution: United States federal law restricts this device to sale by or on the order of a licensed physician. Caution: The AutoPulse System is designed to be used only with ZOLL-approved accessories. The AutoPulse System will perform improperly if non-approved accessories are used. Caution: Only use ZOLL Batteries specifically designed for use with the AutoPulse System. The use of other batteries may cause permanent damage to the AutoPulse System and will void the warranty. Caution: Do not store an AutoPulse Battery in an unpowered Battery Charger (unplugged or AC power is off). Irreversible damage to the Batteries occurs within 10 days, depending on the initial state of charge. Caution: Do not autoclave the Platform, the LifeBand, or the AutoPulse Power System. Caution: Retain the original product literature for future reference. Caution: Do not use or stack the unit with other equipment. If the unit is used or stacked with other electrical equipment, verify proper operation before using it. Caution: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
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User Guide
Symbols
0
The symbols below may be found in this User Guide, on the Platform, the LifeBand, the MultiChemistry Battery Charger (Battery Charger), or Li-Ion Battery. Follow instructions for use
Date of Manufacture
Manufacturer
Authorized Representative Serial Number
SN Defibrillation Protected, Type BF Patient Connection
Degree of Protection Provided by Enclosure Per IEC 60529
IP25 Do Not Reuse-Single Use Only
Recycle Li-Ion
Temperature Limitations
Dispose of in accordance with local governing ordinances and recycling plans for lithium ion batteries.
Rechargeable Battery
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Do Not Incinerate
Fuse DC Voltage Caution: Charging
Ready
Fail
Test Cycle
Power
Caution
REF Rx ONLY
Catalog number
Prescription use only Importer
Medical device
MD
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User Guide
Introduction of the AutoPulse® System
1
The AutoPulse System is an automatic cardiopulmonary resuscitation (CPR) product.
1.1
Indication for Use
The AutoPulse is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
1.2
Description of the System
The Platform is an automated, portable, battery-powered chest compressor, which provides chest compressions as an adjunct to performing manual CPR (see Figure 1-1). Use of the AutoPulse System is intended to reduce the impact of rescuer fatigue and will enable the rescuer to address additional patient needs. The AutoPulse System has the following operating parameters: •
Chest displacement: equal to 20% reduction in anterior-posterior chest depth.
•
Consistent compression rate and depth.
•
Physiological duty cycle: fixed at 50 ± 5%.
Standardized 30:2, or 15:2 compressions (30 or 15 compressions followed by two consecutive 1.5 second ventilation pauses) or continuous compressions (user selectable). Table 1-1
Patient/AutoPulse System Operating Parameters
Patient Parameter
AutoPulse Specification
Patient chest circumference permitted
29.9 to 51.2 in. (76 to 130 cm)
Patient chest width permitted
9.8 to 15 in. (25 to 38 cm)
Maximum patient weight permitted
300 lbs.(136 kg)
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User Control Panel
Battery Charger
AutoPulse Platform
LifeBand
Li-Ion Batteries (Primary and Spare)
Figure 1-1
1.3
The AutoPulse System
System Components
Figure 1-1 shows the main components of the AutoPulse System. The AutoPulse System consists of the following: •
Platform
•
LifeBand
•
Power System
1.3.1
Platform
The Platform contains the mechanical drive mechanism, control system, and electronics necessary to generate and control the force required to perform mechanical chest compressions. User controls and indicators are contained in the User Control Panel. Figure 1-2 shows the patient surface (front) and back surface details of the Platform. The Platform features carry handles to facilitate transporting it to the scene of the arrest.
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ON/OFF Button Battery
User Control Panel
Back Surface
Start/Continue Button
Cooling Vent
Stop/Cancel Button
Patient Alignment Reference
Carry Handle
Cooling Vent AutoPulse Slotted Drive Shaft
LifeBand® Roller Guide
Patient Surface Figure 1-2
1.3.2
Platform (Patient and Back Surfaces)
LifeBand Load-distributing Band
The LifeBand is a load-distributing band that consists of a cover plate and two bands integrated with a compression pad with a Velcro® fastener. Attached to the Platform, the LifeBand is automatically adjusted to the patient and provides compressions to the patient's chest in the region of the heart. The latex-free LifeBand is a single-use component that is attached to the Platform before each use. Note:
The LifeBand and the patient surface of the Platform (Figure 1-2) together comprise the “applied parts” (as defined by IEC 60601-1, 3rd ed.), i.e., the part of the system that in normal use necessarily comes into physical contact with the patient.
1.3.3
AutoPulse Power System
The AutoPulse Power System consists of a battery and battery charger: •
Battery: the AutoPulse Li-Ion Battery (a Lithium-Ion battery)
•
Battery charger: the Multi-Chemistry Battery Charger
Battery: The AutoPulse Li-Ion Battery is a proprietary, rechargeable, removable battery designed to supply power for AutoPulse operation. The Battery is mechanically keyed to the Platform and to the Battery Charger to facilitate correct installation. One end of the Battery contains connections for power and communication to the Battery Charger and to the Platform. A Battery Status Check button illuminates the Battery’s status light-emitting diodes (LED’s).
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Battery Charger: The Battery Charger is a stand alone unit designed to charge and automatically maintain the Li-Ion Battery. The Battery Charger has two charging bays, and each bay has its own indicators. The Battery should always be properly maintained and be fully charged and ready for use before deploying the AutoPulse. For more information, refer to the AutoPulse Power System User Guide.
1.4
User Controls and Indicators
1.4.1
On/Off Button
The On/Off button is located adjacent to the Battery on the Platform (see Figure 1-3).
User Control Panel
ON/OFF button
Figure 1-3 1.4.1.1
On/Off Button Location
On/Off Button When the AutoPulse Battery is inserted into the AutoPulse Platform, the Platform is in “stand-by”, and ready for activation by the On/Off button. Pressing the On/Off button once then powers up the Platform and initiates a selftest. The User Control Panel's green Power LED lights up. Pressing the On/Off button again powers down the Platform and returns it to “stand-by”.
1.4.2
User Controls
All user controls and indicators (except the On/Off button) are contained in User Control Panel (see Figure 1-4).
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Alert LED (red) Display Panel Power LED (green)
Increase Contrast
Move Up Select Choice
Decrease Contrast
Move Down
Tone Mute Stop/Cancel LED Start/Continue Stop/Cancel Menu/Mode Switch
Start/Continue LED
Figure 1-4 1.4.2.1
User Control Panel
Start/Continue Button The green Start/Continue button is active when “Start” or “Continue” appears on the display panel above the button and its green LED is illuminated. Use the Start/Continue button to start or continue:
1.4.2.2
•
Analyzing patient size
•
Chest compressions
Stop/Cancel Button The orange Stop/Cancel button is active when “Stop”, “Quit”, or “Cancel” appears on the display panel above the button and its orange LED is illuminated. Use the Stop/Cancel button to stop or cancel: •
Analyzing patient size (see Figure 3-9)
•
Chest compressions (the Platform releases the tension on the LifeBand) (see Figure 3-11)
•
Verify patient alignment pause (see Figure 3-10)
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1.4.2.3
Menu/Mode Switch Button On initial power-up the gray Menu/Mode Switch button functions as the Menu button. Pressing this button allows you to: 1.
Enter the communication mode
2.
View last patient session information
3.
View AutoPulse Platform information
4.
View AutoPulse Battery information
For a complete description of the available information and how to access it, refer to section Section 3.7, “Viewing Platform Information,” on page 3-18. For more information on the Communication Mode, see Section 3.8, “Uploading Platform Information to your PC,” on page 3-19. While the Platform is actively doing compressions this button may function as the Mode Switch button. The Mode Switching feature is only active when the “30:2 or Continuous” or “15:2 or Continuous” option has been set in Mode section of the Administration Set-up (refer to section Section 2.3, “Administrative Menu: User Pre-set Options,” on page 2-10). If the “30:2 or Continuous” or “15:2 or Continuous” option has been set, the Mode Switch button will allow you to switch on-the-fly between 30:2 and Continuous or 15:2 and Continuous compression modes respectively. The current mode (either “30:2”, “15:2” or “CONTINUOUS”) is displayed on the upper left portion of the User Control Panel. 1.4.2.4
Move Up/Move Down Button These buttons allow you to highlight for selection different menu or list items. Pressing the Move Up button (upward pointing triangle) moves up to the next menu item. Pressing the Move Down button (downward pointing triangle) moves down to the next menu item.
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1.4.2.5
Select Choice Button Pressing the Select Choice button selects the currently highlighted menu or list item.
1.4.2.6 c
Tone Mute Button The ventilation and pause tones are always generated at the appropriate times by the system and cannot be turned off, but they can be muted for a short period of time as set in the Administration Menu (refer to section Section 2.3, “Administrative Menu: User Pre-set Options,” on page 2-10). Selecting the Tone Mute button will mute or enable the audible tone feedback generated by the Platform. When the audio feedback is audible, pressing the Tone Mute button will mute it. When the audio feedback is muted, pressing the Tone Mute button will make it audible once again. Once audio feedback has been muted with the Tone Mute button, it will automatically be reactivated when one of the following occurs: 1.
The Mute Duration time set in the Administrative Menu has expired.
2.
You press the Tone Mute button again.
3.
You press the Start/Continue button to begin compressions.
4.
You press the Stop button during compressions.
5.
A low battery condition is reached (refer to Figure 1-5 on page 1-9).
6.
You switch between compression modes (refer to Figure 3-13 on page 3-12).
The icon displayed on the User Control Panel display when tones are audible.
The icon displayed on the User Control Panel display when tones are muted.
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User Guide
1.4.2.7
Increase/Decrease Contrast Button Pressing the Increase Contrast button (plus sign) increases the contrast of the display panel screen. Each key press increases the contrast of the display panel screen by one level. There are a total of eight contrast levels. Pressing the Decrease Contrast button (minus sign) decreases the contrast of the display panel screen. Each key press decreases the contrast of the display panel screen by one level. You can adjust the contrast of the display panel screen at any time the AutoPulse Platform is powered up.
1.4.2.8
Power (Green LED)
The green Power LED lights whenever the Platform is powered on and able to respond to user input. 1.4.2.9
Alert (Red LED)
The red Alert LED lights whenever a user advisory, fault or system error condition exists for the Platform. For a list of advisory, fault and error conditions, refer to Chapter 5, “Troubleshooting Procedures”.
1.4.3
Battery Charge Status
The User Control Panel displays the battery charge status. The Battery charge status icon only appears when the Platform is powered up. Indicates the level of charge of the Battery. A graphic battery icon indicating four proportional levels of battery charge is displayed.
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