CU Medical Systems Paramedic AED Series User manual

1
CU'SEmergency Responder 2
Operator’s Manual
CU Medical Systems, Inc.
Paramedi
c
Series AED
CU – ER2

CU-ER2 Operator’s Manual _ver 2.00
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Paramedic CU-ER2
Quick Reference Card

CU-ER2 Operator’s Manual _ver 2.00
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Notice
Paramedic CU-ER2 Operator’s Manual
CU Medical Systems, Inc. reserves the right to make 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-ER2 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 ....................................................................................... 7
Warranty ..................................................................................... 8
Warranty Disclaimer .............................................................. 8
Service........................................................................................ 8
Contact Us ................................................................................. 10
1 How to Use This Manual .......................................................... 11
1.1 Contents of This Manual ................................................. 11
1.2 Manual Conventions ....................................................... 11
2 Device Operation Guidelines..................................................... 12
2.1 General Guidelines......................................................... 12
2.2 Electrical Safety Guidelines ............................................. 13
3 Introduction .......................................................................... 14
3.1 Product Description........................................................ 14
3.2 Indicated Use................................................................ 15
3.2.1 AED Mode .......................................................... 15
3.2.2 Manual Mode ...................................................... 15
3.2.3 ECG Monitoring ................................................... 16
3.3 Intended Users.............................................................. 17
3.3.1 AED Mode .......................................................... 17
3.3.2 Manual Mode ...................................................... 17
4 Operating Controls, Indicators and Accessories ........................... 18
4.1 Device Parts Illustration.................................................. 18
4.2 Accessories................................................................... 22
4.3 Screen Display Views ..................................................... 27
4.3.1 Initial Screen Display ........................................... 27
4.3.2 Screen Display; Rescue Operation Ongoing ............. 30
4.4 Voice and Text Prompts .................................................. 31
4.5 Menu Operation............................................................. 33
4.5.1 Device History .................................................... 34
4.5.2 Battery History ................................................... 36
4.5.3 Usage Review ..................................................... 38
4.5.4 ECG Review........................................................ 41
4.5.5 Voice Review ...................................................... 43
4.5.6 General Device Setup .......................................... 45

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4.5.7 Administration Device Setup ................................. 48
4.5.7.1 AED Settings............................................ 50
4.5.7.2 General Settings....................................... 52
4.5.7.3 Password................................................. 54
4.5.8 Printing and Transferring Data............................... 57
4.5.9 Return ............................................................... 59
4.5.10 Speaker Volume Adjustment ............................... 59
5 Device Setup and Storage........................................................ 60
5.1 Unpacking .................................................................... 60
5.2 Setup........................................................................... 60
5.2.1 Manual Self-Test.................................................. 60
5.2.2 Battery Charge Check .......................................... 61
5.2.3 Battery Charging................................................. 61
5.2.4 Configuration Settings.........................................661
5.3 Storage........................................................................ 62
6 Defibrillating in AED Mode ......................................................... 63
6.1 Overview...................................................................... 63
6.2 AED Automatic Reanalysis Mode ...................................... 64
6.2.1 Preparation ........................................................ 65
6.2.2 Step 3: ECG Acquisition and Analysis ..................... 67
6.2.3 Step 3 Shock Delivery.......................................... 69
6.2.4 Cardiopulmonary Resuscitation (CPR)..................... 71
6.3 AED NO Automatic Reanalysis Mode ................................. 72
7 Asynchronous Defibrillation in Manual Mode ............................... 74
7.1 Overview...................................................................... 74
7.2. Patient Preparation ....................................................... 76
7.3 Analysis ....................................................................... 77
7.4 Charging ...................................................................... 77
7.5 SHOCK......................................................................... 78
8 Synchronized Cardioversion ..................................................... 79
8.1 Overview...................................................................... 79
8.2 Patient Preparation ........................................................ 79
8.3 Synchronization............................................................. 79
8.4 Analysis ....................................................................... 79
8.5 Charging ...................................................................... 80
8.6 Shock .......................................................................... 80
9 ECG Monitoring In Manual Mode ............................................... 81
9.1 ECG Monitoring Mode ..................................................... 81
9.2 Patient Preparation ........................................................ 81
9.3 ECG Monitoring ............................................................. 81

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10 Power Supply ....................................................................... 83
10.1 Power Sources............................................................. 83
10.2 Internal Battery Pack.................................................... 83
10.3 External Battery Pack ................................................... 86
10.4 AC/DC Adapter ............................................................ 88
10.5 Car Cigar Lighter Jack................................................... 89
11 Testing, Maintenance, And Troubleshooting ............................... 90
11.1 Testing ....................................................................... 90
11.1.1 Automatic Self-Tests .......................................... 90
11.1.2 Power On Self Test............................................. 90
11.1.3 Periodic Self-Tests.............................................. 91
11.1.4 Run Time Self-Test............................................. 91
11.1.5 Manual Self-Test ................................................ 92
11.2 Maintenance................................................................ 92
11.3 Cleaning the Paramedic CU-ER2 ..................................... 95
12 Troubleshooting.................................................................... 96
12.1 Self-Tests ................................................................... 96
12.2 Prompts During Rescue Operation .................................. 98
13 Data Management and Review................................................ 99
13.1 Overview .................................................................... 99
13.2 Data Review Using The Paramedic CU-ER2 .....................100
13.2.1 Internal Flash Memory ......................................100
13.2.2 SmartMedia Card (Optional Accessory) ................100
13.3 Data Transfer To Personal Computer..............................102
13.3.1 IrDA ...............................................................102
13.3.2 UART Port........................................................104
13.4 Printing Using a Stand-alone Serial Printer......................105
APPENDIX A ..............................................................................111
e~cube Biphasic Technology ..............................................111
APPENDIX B ..............................................................................118
Rescue Protocol in AED Mode (Automatic Reanalysis) ..............118
APPENDIX C..............................................................................119
Parts and Accessories Number .............................................119
APPENDIX D..............................................................................120
Technical Specifications.......................................................120
Electromagnetic Compatibility ..............................................129

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◐General
Thank you for choosing the Paramedic CU-ER2.
Please read this Operator’s Manual carefully and thoroughly before using the Paramedic
CU-ER2 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:
zOnly persons authorized by CU Medical Systems, Inc. may service this device. There
are no user serviceable parts in this device.
zYou 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 workmanship 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 broken without proper authorization from CU Medical Systems,
Inc., this warranty becomes null and void.

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◐Service
yThe Paramedic CU-ER2 must be serviced only by authorized personnel. Unauthorized
servicing during the warranty period renders the warranty null and void.
yThe Paramedic CU-ER2 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.
yWhen the Paramedic CU-ER2 is not operating properly, immediately bring it for servicing
to an authorized service center.
yPlease fill up the following table with the necessary information when requesting for
service.
Product : Paramedic Model: CU-ER2
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 Marketing 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: [email protected]
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: servi[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
zThis Operator’s Manual contains all the information a user needs to operate the
Paramedic CU-ER2 properly.
zIn 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 taken.
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
zUse the correct power supply during recharging. See the Chapter on Power Supply for
more details.
zDuring 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 Paramedic CU-ER2 is used in
the presence of flammable a
g
ents or in an OXYGEN enriched atmosphere.
Do not use the Paramedic CU-ER2 if it has been submerged in water. Call
immediately for service assistance.
The Paramedic CU-ER2 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 Product Description
The Paramedic CU-ER2 is a portable external defibrillator with the following modes:
•Automated External Defibrillation (AED) Mode
•Manual Mode
In AED Mode, the Paramedic CU-ER2 analyzes the ECG of the patient to determine
whether the patient has a shockable or nonshockable ECG rhythm. In this mode, the
Paramedic CU-ER2 provides you with voice and text prompts throughout a rescue
operation.
In Manual Mode, the Paramedic CU-ER2 lets you control the defibrillation process. You
assess the ECG of the patient and set the energy of the shock to be delivered. You may
also perform synchronous cardioversion for the treatment of atrial fibrillation in this mode.
In synchronous cardioversion, the defibrillating shock is delivered within 60 milliseconds of
the occurrence of a QRS peak in the patient’s ECG.
The Paramedic CU-ER2 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 shocks may be delivered when the ECG
monitoring cable assembly is connected to the Paramedic CU-ER2.
The Paramedic CU-ER2 uses two kinds of electrodes. These are:
•Multifunction defibrillator electrode pads – used for ECG acquisition and shock
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-ER2 automatically records ECG and events such as shock 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-ER2 is powered by an internal rechargeable Nickel Metal Hydride
battery pack. It may also be powered by an optional external disposable LiMnO2battery
pack 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-ER2 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 Paramedic CU-ER2 is indicated for use on patients that are exhibiting
the symptoms of sudden cardiac arrest (SCA).
The Paramedic CU-ER2 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 Paramedic CU-ER2 on patients who show either of the
following signs:
a) Responsiveness
b) Presence of normal breathing
c) Presence of detectable pulse
3.2.2 Manual Mode
Indications
Asynchronous defibrillation – the shock delivery is not synchronized with the QRS peak
In asynchronous manual defibrillation, the Paramedic CU-ER2 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 shock delivery is synchronized with the QRS peak of the
patient’s ECG.
In synchronous manual defibrillation, the Paramedic CU-ER2 is indicated for use
on patients with ECGs that show the presence of Atrial Fibrillation:
Contraindications
The Paramedic CU-ER2 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 ECG Monitoring
Indications:
•ECG Monitoring is indicated when it is desired to monitor the heart rate of a
patient.
Contraindications:
•There are no known contraindications to ECG Monitoring.
In AED Mode:
The Paramedic CU-ER2 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
(Part 3: Overview of CPR, 2005 American Heart Association Guidelines for
Cardiopulmonary Resuscitation (CPR) 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-ER2 is intended for use by emergency rescue organizations.
3.3.1 AED Mode
In AED Mode, the Paramedic CU-ER2 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-ER2 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 know how to interpret ECGs.

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4. Operating Controls, Indicators and Accessories
4.1 Device Parts Illustration
Figure 4-1. Top view of the Paramedic CU-ER2

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Figure 4-2 Side view of the Paramedic CU-ER2

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Device Parts Explanation
LCD Screen Displays the ECG of the patient and the various prompts and
indicators.
Microphone Captures audio signals during a rescue operation.
Speaker Plays voice prompts during rescue operation and recorded
audio signal during recording playback.
Quick Reference Guide Outlines the steps to be taken during a rescue operation
Operating Controls
ON/OFF Switch
Turns the power of the Paramedic CU-ER2 ON or OFF.
SHOCK button
Flashes its red backlight when the Paramedic CU-ER2 is
ready to deliver a shock. Delivers the shock when pressed
while the backlight is flashing.
Controls special functions such as device setup and data
management and review.
In AED Mode
UP Button May be used to increase the volume of the
speaker for louder voice prompts
DOWN
Button
May be used to decrease the volume of the
speaker for softer voice prompts
MENU keys
The Menu Keypad buttons are also used to input the
password in Manual Mode