CU Medical Systems Paramedic AED Series User manual

1
CU' S Emergency Responder 3
Operator’s Manual
CU Medical Systems, Inc.
Paramedic
Series AED
C
U
–
ER
3

CU-ER3 Operator’s Manual _ver 2.00
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aramedic CU-ER3
Quick Reference Card

CU-ER3 Operator’s Manual _ver 2.00
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Notice
aramedic CU-ER3 Operator’s Manual
CU Medical Systems, Inc. reserves the right to ma e changes on the
device specifications contained in this manual at any time without prior
notice or obligation to customers.
Printed in the Republic of Korea
Publication Date: April 2006
Operator’s Manual Part No.: CU-ER3 version 2.00
© 2006 CU Medical Systems, Inc.
No part of this manual may be reproduced without the permission of CU
Medical Systems, Inc.

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TABLE OF CONTENTS
Table Of Contents .......................................................................... 4
General ........................................................................................ 8
Warranty ...................................................................................... 9
Warranty Disclaimer............................................................... 9
Service ........................................................................................10
Contact Us ...................................................................................11
1 How to Use This Manual ............................................................12
1.1 Contents of This Manual ...................................................12
1.2 Manual Conventions.........................................................12
2 Device Operation Guidelines ......................................................13
2.1 General Guidelines...........................................................13
2.2 Electrical Safety Guidelines ...............................................14
3 Introduction ............................................................................15
3.1 Product Description..........................................................15
3.2 Indicated Use..................................................................16
3.2.1 AED Mode ............................................................16
3.2.2 Manual Mode........................................................16
3.2.3 SPO2 Monitoring ...................................................17
3.2.4 ECG Monitoring.....................................................17
3.3 Intended Users ...............................................................18
3.3.1 AED Mode ............................................................18
3.3.2 Manual Mode........................................................18
4 Operating Controls, Indicators and Accessories ............................19
4.1 Device Parts Illustration ...................................................19
4.2 Accessories.....................................................................24
4.3 Screen Display Views .......................................................29
4.3.1 Initial Screen Display ............................................29
4.3.2 Screen Display; Rescue Operation Ongoing ..............32
4.4 Voice and Text Prompts....................................................33
4.5 Menu Operation...............................................................35
4.5.1 Device History ......................................................36
4.5.2 Battery History .....................................................38
4.5.3 Usage Review.......................................................40
4.5.4 ECG Review .........................................................43
4.5.5 Voice Review ........................................................45
4.5.6 General Device Setup ............................................47

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4.5.7 Administration Device Setup ..................................50
4.5.7.1 AED Settings .............................................52
4.5.7.2 General Settings ........................................54
4.5.7.3 Password ..................................................56
4.5.8 Device Setup, Monitor ...........................................59
4.5.9 Printing and Transferring Data ................................63
4.5.10 Return ...............................................................65
4.5.11 Spea er Volume Adjustment.................................65
5 Device Setup and Storage .........................................................66
5.1 Unpac ing ......................................................................66
5.2 Setup.............................................................................66
5.2.1 Manual Self-Test ...................................................66
5.2.2 Battery Charge Chec ............................................67
5.2.3 Battery Charging ..................................................67
5.2.4 Configuration Settings ...........................................67
5.3 Storage ..........................................................................68
6 Defibrillating in AED Mode ...........................................................69
6.1 Overview........................................................................69
6.2 AED Automatic Reanalysis Mode........................................70
6.2.1 Preparation ..........................................................71
6.2.2 Step 3: ECG Acquisition and Analysis ......................73
6.2.3 Step 3 Shoc Delivery ...........................................75
6.2.4 Cardiopulmonary Resuscitation (CPR) ......................77
6.3 AED NO Automatic Reanalysis Mode...................................78
7 Asynchronous Defibrillation in Manual Mode.................................80
7.1 Overview........................................................................80
7.2. Patient Preparation .........................................................82
7.3 Analysis .........................................................................83
7.4 Charging ........................................................................83
7.5 SHOCK...........................................................................84
8 Synchronized Cardioversion .......................................................85
8.1 Overview........................................................................85
8.2 Patient Preparation ..........................................................85
8.3 Synchronization ..............................................................85
8.4 Analysis .........................................................................85
8.5 Charging ........................................................................85
8.6 Shoc ............................................................................86
9 ECG Monitoring In Manual Mode.................................................87
9.1 ECG Monitoring Mode.......................................................87
9.2 Patient Preparation ..........................................................87
9.3 ECG Monitoring ...............................................................87

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10 SPO2 Monitoring...................................................................889
10.1 Overview ....................................................................889
10.2 Pulse Oximetry Sensors..................................................90
10.3 Application and Connection of the Sensor .........................91
10.4 SPO2 Monitoring............................................................91
10.5 Setting the Alarm ..........................................................93
10.6 Responding to an Alarm .................................................93
10.7 SPO2 Monitoring Notes and Warnings...............................94
11 Power Supply .........................................................................96
11.1 Power Sources ..............................................................96
11.2 Internal Battery Pac .....................................................96
11.3 External Battery Pac .....................................................99
11.4 AC/DC Adapter ............................................................101
11.5 Car Cigar Lighter Jac ..................................................102
12 Testing, Maintenance, And Troubleshooting ..............................103
12.1 Testing.......................................................................103
12.1.1 Automatic Self-Tests..........................................103
12.1.2 Power On Self Test ............................................103
12.1.3 Periodic Self-Tests .............................................104
12.1.4 Run Time Self-Test ............................................104
12.1.5 Manual Self-Test................................................105
12.2 Maintenance ...............................................................105
12.3 Cleaning the Paramedic CU-ER3 ....................................108
13 Troubleshooting....................................................................109
13.1 Self-Tests ...................................................................109
13.2 Prompts During Rescue Operation..................................111
14 Data Management and Review ...............................................112
14.1 Overview ....................................................................112
14.2 Data Review Using The Paramedic CU-ER3......................113
14.2.1 Internal Flash Memory .......................................113
14.2.2 SmartMedia Card (Optional Accessory) ................113
14.3 Data Transfer To Personal Computer ..............................115
14.3.1 IrDA ................................................................115
14.3.2 UART Port ........................................................117
14.4 Printing Using a Stand-alone Serial Printer.................. 11818
APPENDIX A ...............................................................................124
e~cube Biphasic Technology...............................................124
APPENDIX B ...............................................................................131
Rescue Protocol in AED Mode (Automatic Reanalysis) ..............131
APPENDIX C ...............................................................................132
Parts and Accessories Number ..............................................132

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APPENDIX D...............................................................................133
Technical Specifications .......................................................133
Electromagnetic Compatibility...............................................143

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◐
◐◐
◐ General
Than you for choosing the Paramedic CU-ER3.
Please read this Operator’s Manual carefully and thoroughly before using the Paramedic
CU-ER3 to be fully acquainted with its operating and maintenance instructions.
CU Medical Systems, Inc. designs and manufactures all of its products in accordance with
international standards (NS-EN ISO9001:2000/ ISO13485:2003-MDD 93/42/EEC). This
ensures that CU Medical Systems, Inc. provides products of high quality and reliability. In
this regard:
Only persons authorized by CU Medical Systems, Inc. may service this device. There
are no user serviceable parts in this device.
You must operate this device in accordance with the instructions specified in this
manual.
To ensure safety and reliability, use only parts and accessories recommended by CU
Medical Systems, Inc.
If you intend to use this device in conjunction with other devices not specified in this
manual, please notify the manufacturer.

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◐
◐◐
◐ WARRANTY
•This device is warranted by CU Medical Systems, Inc. against defects in materials
and wor manship for two full years from the date of original purchase. During the
warranty period, we will repair or, at our option, replace at no charge a product that
proves to be defective, provided you return the product, shipping prepaid, to us or to
our authorized representative.
•This warranty does not apply if the product has been damaged by accident or misuse
or as the result of service or modification by an entity other than CU Medical Systems,
Inc. or its authorized representatives. IN NO EVENT SHALL CU MEDICAL SYSTEMS,
INC. BE LIABLE FOR CONSEQUENTIAL DAMAGES.
•Only products with serial numbers and their accessories are covered under this
warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT
COVERED UNDER THE WARRANTY. Items such as cables and modules without serial
numbers are not covered under this warranty.
Warranty Disclaimer
•Servicing by unauthorized personnel renders this warranty null and void.
•If the factory seal is bro en without proper authorization from CU Medical Systems,
Inc., this warranty becomes null and void.

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◐ Service
 The Paramedic CU-ER3 must be serviced only by authorized personnel. Unauthorized
servicing during the warranty period renders the warranty null and void.
 The Paramedic CU-ER3 will be serviced free of charge during the warranty period. After
the warranty period, the cost of material and service shall be shouldered by the user.
 When the Paramedic CU-ER3 is not operating properly, immediately bring it for servicing
to an authorized service center.
 Please fill up the following table with the necessary information when requesting for
service.
Product : Paramedic Model: CU-ER3
Serial No.: Date of Purchase:
Sales
Representative /
Authorized Dealer
Address
Name
Customer
Information
Contact No.
Brief Description
of Problems

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◐
◐◐
◐ CONTACT US
You may contact us at the following address and telephone number for services and
supplies.
Product and Order Inquiries:
International Mar eting Team
CU Medical Systems, Inc.
Room No. 534, DooSan Venture Digm,
126-1, Pyeongchon-dong, Dongan-gu, Anyang-si,
Gyeonggi-do, Republic of Korea
Tel: [phone]
Fax: [phone]
email address: [e-mail]
Service Request and Technical Support
Customer Service Team
CU Medical Systems, Inc.
Medical Industry Complex, Bldg. No.2,
1720-26, Taejang-dong, Wonju-si,
Gangwon-do, 220-120 Republic of Korea
Tel: [phone]
Fax: [phone]
email address: se[email protected]
Our website:
http://www.cu911.com
EU Authorized Representative of CU Medical Systems, Inc.
A.M.I Italia s.r.l
Via Cupa Reginella N 17A
80010 Quarto (Napoli) Italy
Tel No 0039 (0) 81 806 34 75
0039 (0) 81 806 34 75
Fax No 0039 (0) 81 876 47 69
Email: [e-mail]
Website: www.amitaliasrl.it

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1 How to Use This Manual
1.1 Contents of This Manual
This Operator’s Manual contains all the information a user needs to operate the
Paramedic CU-ER3 properly.
In case you have any problems regarding the operation of the device, please don’t
hesitate to contact the manufacturer.
1.2 Manual Conventions
This Operator’s Manual uses the following conventions:
Conditions, hazards, or unsafe practices that can result in
serious personal injury or
loss of life
.
Conditions, hazards, or unsafe practices that can result in minor
or moderate personal injury, damage to the device, or loss of
data stored in the device, particularly if precautionary steps are
not
take
n.
Used to denote items that are important during installation,
operation, or maintenance of the device.

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2 Device Operation Guidelines
2.1 General Guidelines
Do not operate or store the device in conditions that are beyond
the following specified limits.
Operating Conditions
Temperature 32 °F to 104 °F (0 °C to 40 °C)
Humidity 5 % to 95 % (non-condensing)
Standby conditions (Stored with defibrillator electrode pads, ready
for rescue)
Temperature 32 °F to 109 °F (0 °C to 43 °C)
Humidity 5 % to 95 % (non-condensing)
Storage Conditions (Device only, no defibrillator electrode pads)
Temperature -4 °F to 140 °F (-20 °C to 60 °C)
Humidity 5 % to 95 % (non-condensing)
Do not store the device in areas that are directly exposed to
sunlight
Do not store the device in areas with highly fluctuating
temperatures
Do not store the device near heating equipment or appliances.
Do not store the device in areas where there is high vibration (in
excess of Category 10 of MIL-STD-810F Method 514.5)
Do not operate or store the device in environments with high
concentration of flammable gas, anesthetics, or other flammable
chemicals.
Do not operate or store the device in areas with high
concentration of dust
Only personnel authorized by the manufacturer may open the
device for servicing. There are no user serviceable components
inside the device.

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2.2 Electrical Safety Guidelines
Use the correct power supply during recharging. See the Chapter on Power Supply for
more details.
During recharging, do not place the device where the environmental conditions
exceed the operating conditions specified in the Device Operation Guidelines
To ensure safety and reliability, use only parts and accessories approved by
CU Medical Systems, Inc.
There is a possibility of explosion or fire if the aramedic CU-ER3 is used in
the presence of flammable agents or in an OXYGEN enriched atmosphere.
Do not use the aramedic CU-ER3 if it has been submerged in water. Call
immediately for service assistance.
The aramedic CU-ER3 is classified as follows:
- It is a Class I, BF equipment in terms of electrical shock prevention (EN
60601-1). Therefore this device is not rated for use around combustible
anesthetic or solvents.
- The Electromagnetic emission level is Class B according to EN 60601-1
(Safety of Electric Medical Equipment), and the noise redemption is B level
according to the EN 60601-1-2 (Electromagnetic Compatibility
Requirements).
Electromagnetic interference may alter device performance. During
operation, the device should be placed away from sources of electromagnetic
interference such as motors, generators, X-Ray equipment, radio
transmitters, cellular mobile telephones and others, as these might interfere
with the signals being acquired and analyzed.

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3 Introduction
3.1 roduct Description
The aramedic CU-ER3 is a portable external defibrillator with the following modes:
•Automated External Defibrillation (AED) Mode
•Manual Mode
In AED Mode, the Paramedic CU-ER3 analyzes the ECG of the patient to determine
whether the patient has a shoc able or nonshoc able ECG rhythm. In this mode, the
Paramedic CU-ER3 provides you with voice and text prompts throughout a rescue
operation.
In Manual Mode, the Paramedic CU-ER3 lets you control the defibrillation process. You
assess the ECG of the patient and set the energy of the shoc to be delivered. You may
also perform synchronous cardioversion for the treatment of atrial fibrillation in this mode.
In synchronous cardioversion, the defibrillating shoc is delivered within 60 milliseconds of
the occurrence of a QRS pea in the patient’s ECG.
The Paramedic CU-ER3 may also be used to do ECG monitoring only when it is in Manual
mode. ECG monitoring only is done by connecting the custom designed ECG monitoring
cable assembly from CU Medical Systems, Inc. No shoc s may be delivered when the ECG
monitoring cable assembly is connected to the Paramedic CU-ER3.
The Paramedic CU-ER3 uses two inds of electrodes. These are:
•Multifunction defibrillator electrode pads – used for ECG acquisition and shoc
delivery. These pads are used during rescue operations.
•ECG electrode pads – used for ECG acquisition only together with the ECG monitoring
cable and connector assembly.
The Paramedic CU-ER3 is capable of monitoring pulse oximetry (SPO2) in manual and AED
modes. Pulse oximetry measurement is automatically done when the pulse oximetry
sensor is connected to the appropriate port of the device.
The Paramedic CU-ER3 automatically records ECG and events such as shoc deliveries in
nonvolatile memory during rescue operations. These data may be printed directly using a
portable printer or downloaded to a personal computer for printing and archiving.
The Paramedic CU-ER3 is powered by an internal rechargeable Nic el Metal Hydride
battery pac . It may also be powered by an optional external disposable LiMnO
2
battery
pac or its AC/DC adapter. While the internal battery is being recharged by the AC/DC
adapter, the AC/DC adapter also supplies power to the whole device which enables it to be
fully functional.
The Paramedic CU-ER3 runs automatically initiated self-tests even during storage to test
its readiness for rescue operations. Faults during these tests are communicated to the user
through prompts and alarms.

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3.2 Indicated Use
3.2.1 AED Mode
In AED Mode, the aramedic CU-ER3 is indicated for use on patients that are exhibiting
the symptoms of sudden cardiac arrest (SCA).
The Paramedic CU-ER3 is to be used on patients that are suspected of suffering from
sudden cardiac arrest with all of the following signs:
a) Unresponsiveness
b) Absence of normal breathing
c) Lack of detectable pulse
Do not use the aramedic CU-ER3 on patients who show either of the
following signs:
a) Responsiveness
b) resence of normal breathing
c) resence of detectable pulse
3.2.2 Manual Mode
Indications
Asynchronous defibrillation – the shoc delivery is not synchronized with the QRS pea
In asynchronous manual defibrillation, the aramedic CU-ER3 is indicated for use
on patients with the following symptoms
a) Unresponsiveness
b) Absence of normal breathing and
c) Lack of detectable pulse.
These are the same symptoms indicated for AED defibrillation
Synchronous defibrillation – the shoc delivery is synchronized with the QRS pea of the
patient’s ECG.
In synchronous manual defibrillation, the aramedic CU-ER3 is indicated for use
on patients with ECGs that show the presence of Atrial Fibrillation:
Contraindications
The Paramedic CU-ER3 must not be used in Asynchronous Manual Mode on patients who
show any of the following symptoms:
a) Responsiveness
b) Normal breathing
c) Detectable pulse.

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3.2.3 S O2 Monitoring
Indications:
•SPO2 Monitoring is indicated when it is beneficial to assess a patient’s
oxygen saturation level.
Contraindications
•There are no nown contraindications for SPO2 Monitoring.
3.2.4 ECG Monitoring
Indications:
•ECG Monitoring is indicated when it is desired to monitor the heart rate of a
patient.
Contraindications:
•There are no nown contraindications to ECG Monitoring.
In AED Mode:
The aramedic CU-ER3 may be used on children from 1 to 8 years old or
under 25kg (55 lb) in weight.
If the patient appears to be from 1 to 8 years old or less than 25kg (55
lb), use the reduced-energy defibrillator pads.
For children older than 8 years old, the American Heart Association
recommends using the adult Chain of Survival and resuscitation sequence
( art 3: Overview of C R, 2005 American Heart Association Guidelines for
Cardiopulmonary Resuscitation (C R) and Emergency Cardiovascular Care
(ECC).
In Manual Mode:
Clinicians must select an appropriate level
for patients under 8 years old.

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3.3 Intended Users
The Paramedic CU-ER3 is intended for use by emergency rescue organizations.
3.3.1 AED Mode
In AED Mode, the Paramedic CU-ER3 is intended for use by emergency rescue personnel
who have been trained in basic life support that includes the use of AEDs
3.3.2 Manual Mode
In Manual Mode, the Paramedic CU-ER3 is intended for use by health care professionals
and emergency rescue personnel who have been trained in advanced cardiac life support.
In this mode, the user must now how to interpret ECGs.

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4 Operating Controls, Indicators and Accessories
4.1 Device arts Illustration
Figure 4-1. Top view of the aramedic CU-ER3

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Figure 4-2 Side view of the aramedic CU-ER3