Medical Econet ME PAD User manual

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Instructions for Use
ME PAD
The information in these Instructions for Use applies to the ME PAD. This information is subject
to change. Please contact Medical Econet GmbH. or its authorized representatives for
information on revisions.
Revision History
Edition 1
Publication Date: August 2011
Document No.: OPM-SP1- E-01
Published by: CU Medical Systems, Inc.
Printed in the Republic of Korea
Copyright
©2011 Medical Econet GmbH
No part of these Instructions for Use may be reproduced without the permission of CU
Medical Systems, Inc.
Medical Device Directive
The ME PAD complies with the requirements of the Medical Device Directive 93/42/EEC and its
revisions.
Important:
Quick defibrillation is needed if sudden cardiac arrest occurs. Since the chance of success is
reduced by 7% to 10% for every minute that defibrillation is delayed, defibrillation must be
performed promptly.

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The ME PAD is manufactured by:
CU Medical Systems, Inc.
Dongwha Medical Instrument Complex
1647-1 Dongwha-ri, Munmak-eup, Wonju-si, Gangwon-do,
220-801 Republic of Korea
Authorized EU Representative
Medical Device Safety Service
Schiffgraben 41, 30175 Hannover, Germany
Contact Us For Orders & Inquiries
Medical Econet GmbH
Im Erlengrund 20
D-46149 Oberhausen
Germany
Phone: [phone]
Fax: [phone] -55
E-Mail: [e-mail]

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ME PAD
Public Access Defibrillator

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Table of contents
INTRODUCTION........................................................................................................................... 7
OVERVIEW ...................................................................................................................................8
1. INTRODUCTION .................................................................................................................. 9
1.1 DEVICE DESCRIPTION 9
1.2 INDICATED USE 9
1.3 INTENDED USERS 10
1.4 LOCAL PROTOCOL 10
1.5 ADDITIONAL INFORMATION 10
2. DEVICE FEATURES .......................................................................................................... 11
3. PREPARATION FOR USE.................................................................................................14
3.1 STANDARD PACKAGE CONTENTS 14
3.2 SETTING UP THE ME PAD 15
4. HOW TO USE THE ME PAD.............................................................................................. 17
4.1 CHAIN OF SURVIVAL 17
4.2 PREPARATION FOR DEFIBRILLATION 18
4.3 DEFIBRILLATION IN ADULT MODE 22
Step 1: Place pads on the patient..........................................................................................22
Step 2: Press the Shock Button if instructed.........................................................................23
Step 3: Perform CPR.............................................................................................................25

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4.4 DEFIBRILLATION PROCEDURES IN PEDIATRIC
MODE 27
5. AFTER USING THE ME PAD ............................................................................................28
5.1 MAINTENANCE AFTER EACH USE 28
5.2 SAVING AND TRANSFERRING TREATMENT
DATA 29
5.2.1 Device Usage..........................................................................................................29
5.2.2 Transferring Treatment Data...................................................................................29
5.3 DEVICE SETTING 32
5.3.1 CPR Guide Setting..................................................................................................32
5.3.2 Setting the CPR Guide............................................................................................32
6. MAINTENANCE .................................................................................................................35
6.1 DEVICE STORAGE 35
6.2 MAINTENANCE 36
6.2.1 Device Inspection....................................................................................................36
6.2.2 Replacing Supplies .................................................................................................36
Disposable Battery Pack.....................................................................................................36
Replacing the Pads.............................................................................................................38
6.2.3 Cleaning the ME PAD .............................................................................................39
7. DISPOSAL .........................................................................................................................39
8. TROUBLESHOOTING.......................................................................................................40
8.1 SELF-TESTS 40
8.2 DEVICE STATUS 42

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8.3 TROUBLESHOOTING 43
8.3.1 Troubleshooting While the Device is Operating......................................................43
8.3.2 Troubleshooting While the Device is not Operating................................................44
9. DEVICE SERVICE..............................................................................................................45
APPENDIX .................................................................................................................................. 47
A . RESCUE PROTOCOL........................................................................................................... 47
B . PARTS AND ACCESSORIES...............................................................................................50
B.1 STANDARD ACCESSORIES 50
B.2 OPTIONAL ACCESSORIES 50
C . DESCRIPTION OF SYMBOLS .............................................................................................51
C.1 ME PAD DEFIBRILLATOR 51
C.2 ME PAD PACKAGING 52
C.3ACCESSORIES 53
C.3.1 Disposable Battery Pack (CUSA1103BB, CUSA1103BS)...........................................53
C.3.2 Pads (CUA1007S, CUA1102S)....................................................................................54
D . GLOSSARY...........................................................................................................................55
E . DEVICE SPECIFICATIONS................................................................................................... 60
F . ELECTROMAGNETIC COMPATIBILITY .............................................................................. 68

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INTRODUCTION
These Instructions for Use contain information necessary for the correct use of this device.
Please contact us regarding any questions or issues on the use of the device arising from
information found in these Instructions for Use [Chapter 9: Device Service].
The company or its authorized distributor is not responsible for any injury incurred by the user or
patient due to any apparent negligence or improper use by the user.
Hereinafter,
"device" refers to [CU-SP1]
"We" or “Us" refers to CU Medical Systems, Inc.
"Pads" refers to defibrillation electrode pads,
"Battery Pack" refers to a disposable battery pack.
These Instructions for Use emphasizes the safety procedures and precautions for the device
use by using the terms below. Please acquaint yourself with the warnings, cautions and
references stated in these Instructions for Use in order to safely use the device.
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 treatment 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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Overview
Thank you for purchasing the ME PAD. This device can be effectively and safely used for a long
period if you familiarize yourself with the instructions, warnings, precautions, and notices
contained in these Instructions for Use prior to its use.
A defibrillator discharges electric shock with high voltage and current. You must be well-
acquainted with the instructions, warnings, and precautions contained in these Instructions for
Use.
You must follow the instructions, warnings, cautions, and notices in these Instructions for Use
when using this device.
The manufacturer will not be responsible for any problems involving the device that are
caused by the user's negligence.
This device shall be serviced only by the manufacturer or its authorized service centers.
If the Device is intended to be connected to equipment other than those stated in these
Instructions for Use, contact the manufacturer.
If this Device does not operate properly, contact the manufacturer or its authorized service
center.

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1. Introduction
1.1 Device Description
CU-SP1 is an easy-to-use Semi-Automated External Defibrillator (AED) that is small, light, and
portable, and uses a battery.
The AED automatically reads the patient's electrocardiogram (ECG) and determines if a cardiac
arrest that requires defibrillation has occurred, so that both medical professionals and the
general public can easily operate it. Cardiac arrest can occur anytime to anyone at any place
and may threaten the patient's life if the appropriate CPR and/or electric shock with a
defibrillator are not applied within a few minutes.
The ME PAD is a semi-automated external defibrillator (AED). If connected to a patient, the ME
PAD automatically acquires and analyzes the electrocardiogram (ECG) of the patient for the
presence of Ventricular Fibrillation or Ventricular Tachycardia (also known as shockable
rhythms). If a shockable rhythm is detected, the device automatically charges itself. Defibrillating
shock is delivered when the you press the SHOCK button.
The ME PAD is easy to use. It guides the you throughout a rescue operation using voice
prompts and indicators (LED and graphical indicators).
The ME PAD is small, light, highly portable, and battery powered. It is highly suitable for use in
public, out-of-hospital settings.
1.2 Indicated Use
The ME PAD is indicated for use on patients that are exhibiting the symptoms of sudden cardiac
arrest (SCA) with all of the following signs:
a) No movement and no response when shaken
b) No normal breathing
Do not use the ME PAD on patients who show either of the following signs:
a) Movement or response when shaken
b) Presence of normal breathing

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1.3 Intended Users
The ME PAD is intended for use in or out of the hospital by emergency care personnel or
healthcare professionals or laypersons. The manufacturer recommends that users train on the
use of the device.
1.4 Local Protocol
Please contact your local health authority for information on the requirements of ownership and
usage of defibrillators.
1.5 Additional Information
Please contact Medical Econet GmbH or its local distributors for any additional information on
the ME PAD.

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2. Device Features
Adult/Pediatric Selection
Switch Cover
SD Card Port
IrDA Port
Battery Pack
CPR Detection Indicator
Do-Not-Touch-Patient Indicator
Pad Position Indicators
Defibrillator Pads Connector
Adult/Pediatric Selection Switch
Status LCD
Power Button
i-Button
Shock Button
Pad Connector Status Indicator
Pads Storage Compartment

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Power Button
Turns the device on or off. (When the device is on, a green
LED is lit)
i-Button
Reports device usage (the total hours of the last usage
and number of shocks)
checks the S/W version
downloads events and ECG data via an IrDA and SD
Card
sets the CPR mode (the number of compressions,
breaths and cycles; compression rate per minute; pausing
time; detailed guide on/off)
and checks for errors
Status LCD
Displays the current status of the device, battery and pads.
Shock Button
Delivers defibrillating shock when pressed while flashing in
orange.
Adult/Pediatric
Selection Switch
Selects Adult/Pediatric modes.
Adult/Pediatric
Selection Switch
Cover
Covers the Adult/Pediatric Selection Switch to prevent
accidental switching.
Defibrillator Pads
Connector
Connects with the connectors of the pads.
Pads Connector
Status Indicator
Indicates the connection status of the defibrillator pads
connector.
Pads Position
Indicators
Indicates the pads position on the patient.
Do-Not-Touch-Patient
Indicator
Warns when not to touch the patient.

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CPR Detection
Indicator
Indicates performance of CPR on the patient.
(The indicator is lit if CPR is performed, and flashes if CPR
is not performed)
Battery Pack
The disposable power source of the device.
IrDA Port
Transmits and receives treatment data between the device
and a personal computer.
SD Card (External
Memory) Port
Port for copying device records to a SD card.
Pads Storage
Stores pads.

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3. Preparation for Use
3.1 Standard Package Contents
The following are the standard package contents of this device
CU-SP1 Semi-automated External Defibrillator Instructions for Use
1 Pack of Adult Pads (Disposable)
Please contact the manufacturer for replacement supplies (refer to Appendix B: Parts and
Accessories of these Instructions for Use).
1 Battery Pack (Disposable)

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Only parts and accessories recommended and approved by CU Medical Systems, Inc. must
be used with the ME PAD. Using unapproved parts and accessories may compromise the safety
and effectiveness of the ME PAD.
Extra battery packs and pads are recommended.
3.2 Setting up the ME PAD
Do the following to set up the ME PAD
①Open the package and verify that it contains all the items listed in the packing list.
②Familiarize yourself with the device features by referring to [Chapter 2: Device Features] of
these Instructions for Use.
③Insert the battery pack into the battery compartment on the device as shown in the figure
below.
As the battery pack is inserted, the device starts a self-test. If the device status is normal,
is shown on the Status LCD. If , or is displayed on the Status LCD after the self-
test, please refer to [Chapter 8: Troubleshooting] of these Instructions for Use.
④If you have a carrying case, please safely store the Device in the carrying case. If you want to
purchase the carrying case, please contact us by referring to [Appendix A: Accessories] of
these Instructions for Use.

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⑤Storage and maintenance considerations:
•Refer to Section 6.1: Device Storage for proper device storage instructions.
•When the device is in storage, check the Status LCD periodically to ensure that the device
is in good condition.
•Store the CU-SP1 in accordance with your local emergency first aid protocol.
•Store the device in an easy-to-access location where its Status LCD can be checked
periodically and its technical alarms can be easily heard (e.g. alarm on low battery or other
device problems).
•It is also recommended to place an emergency use telephone near the device’s storage
area so that emergency medical services can be easily called during emergencies.
•Store the accessories along with the device in the device’s carrying case for easy and quick
access.
Electromagnetic interference may affect the performance of the device. While the device
is in use, it should be kept away from devices that cause electromagnetic interference.
Devices that may cause such interference include motors, X-ray equipment, radio transmitters,
and cell phones. Refer to [Appendix E: Electromagnetic Compatibility] of these Instructions for
Use for more information.
The use of accessories or cables other than those referred to in these Instructions for Use
may increase electromagnetic radiation from the device or reduce the device’s electromagnetic
immunity. Only accessories and cables that are authorized by the manufacturer should be
used with the ME PAD.

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4. How to Use the ME PAD
4.1 Chain of Survival
If you think that you are witnessing someone go down in sudden cardiac arrest, perform the
chain of actions recommended by the American Heart Association (AHA) in its Chain of Survival
emergency response to sudden cardiac arrest.
1
2
3
4
5
1. Immediate recognition and activation of the emergency response system.
•Check for a response by tapping the victim on the shoulder and shouting at the victim.
•Activate the community emergency response system (e.g. call 911 or the equivalent service
in your locality)
2. Early CPR
•Perform CPR.
3. Early defibrillation
•Use this device (ME PAD).
Using this device can be summarized in 3 steps:
After pressing the Power Button,
Step 1: Place pads on the patient.
Step 2: Press the Shock Button if instructed by the device.
Step 3: Perform CPR.
4. Effective advanced life support –Perform advanced care in order to restore spontaneous
circulation.
5. Integrated post-cardiac arrest care –Transfer the patient to a medical institution or a
specialized facility
If finding and/or operating the defibrillator takes time, monitor the patient's status until the
defibrillator is available, perform CPR if necessary.

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4.2 Preparation for Defibrillation
①Set the Adult/Pediatric Selection Switch to match the victim.
Adult victim
•Open the switch cover
•Set the switch to adult defibrillation mode as shown in the following picture
Child victim (victim is under 25kb or 8 years old)
If the pediatric pads are attached, the ME PAD automatically adjusts its defibrillation energy
output for pediatric defibrillation regardless of the position of the Adult/Pediatric Selection Switch
(i.e. the output will be pediatric even if the selection switch is set to adult)
If there are no pediatric pads for the pediatric patient, adult pads may be used. Ensure that the
Adult/Pediatric Selection Switch is set to Pediatric Mode. If the switch has not been set yet,
move it to Pediatric Mode as shown in the figures below
•Open the switch cover

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•Set the switch to pediatric defibrillation mode as shown in the following picture
If a young victim is over 25kg or 8 years old, or if you are not sure of the exact weight or
age:
•DO NOT DELAY TREATMENT
•Set the Adult/Pediatric Selection Switch to Adult mode.
•Use the adult pads.
Never perform defibrillation in pediatric mode to a patient who is either heavier than 25 kg or
older than 8 years old. Ensure the slide key for Adult/Pediatric Mode is as shown on the
bottom.
You can switch the adult/pediatric selection switch before or after turning on the ME PAD.
However, the defibrillation mode should be changed before placing the pads on the patient.
Once the pads are in place, you cannot change the defibrillation mode anymore. When the
mode is correctly selected, the defibrillation energy is set to an adult value (150 J) or pediatric
value (50 J).
②Turn the device on by pressing the Power Button.
When the power turns ON the following occurs in sequence:
the beeper will beep for 1 seconds
Voice instruction: “Call emergency Medical services, now”

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③Remove clothes from patient's chest.
Time is essential for the cardiac arrest patient. Tear or cut clothes if removing them will take
time.
Dry the patient's skin such that pads can adhere well on the chest. Shave hair on the chest if
necessary.
④Remove the pads package from the Pads Storage Compartment at the bottom of the
device.
⑤Open the pads package.