CU Medical Systems i-PAD CU-SP2 User manual

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Instructions for Use
i-PAD CU-SP2
The information in these Instructions for Use applies to the i-PAD CU-SP2. This information is
subject to change. Please contact CU Medical Systems, Inc. or its authorized representatives
for information on revisions.
Revision History
Edition 3.1
Publication Date: April 2, 2018
Document No.: SP2-OPM-E-03
Published by: CU Medical Systems, Inc.
Printed in the Republic of Korea
Copyright
© 2018 CU Medical Systems, Inc.
No part of these Instructions for Use may be reproduced without the permission of CU Medical
Systems, Inc.
Medical Device Directive
The i-PAD CU-SP2 complies with the requirements of the Medical Device Directive 93/42/EEC
and its revisions.
Important:
Quick defibrillation is needed if sudden cardiac arrest (SCA) occurs. Since the chance of
success is reduced by 7% to 10% for every minute that defibrillation is delayed, defibrillation
must be performed promptly.
However, defibrillation may not work on some patients even when administered promptly due to
the fundamental causes of SCA.

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The i-PAD CU-SP2 is manufactured by:
CU Medical Systems, Inc.
130-1, Donghwagongdan-ro, 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
Product and Order Inquiries
Overseas Sales Team
CU Medical Systems, Inc.
5F, Cheonggye Building, 221, Anyangpangyo-ro,
Uiwang-si, Gyenggi-do, Korea
Tel : [phone] / Fax: [phone]
E-mail addresses : [e-mail]
German Branch Office
CU Medical Germany GmbH, Cicero Str.26,
10709 Berlin, Germany
Tel: [phone]
Fax: [phone]
Service and Technical Support
Customer Service Team
CU Medical Systems, Inc.
4F, Cheonggye Building, 221, Anyangpangyo-ro,
Uiwang-si, Gyenggi-do, Korea
Tel : [phone] / Fax: [phone]
E-mail addresses : [e-mail]

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Table of Contents
INTRODUCTION ................................................................................................................................ 7
OVERVIEW......................................................................................................................................... 8
1. PRODUCT INFORMATION...................................................................................................... 9
1.1 DEVICE DESCRIPTION......................................................................................................................................... 9
1.2 INDICATED USE.....................................................................................................................................................9
1.3 INTENDED USERS.............................................................................................................................................. 10
1.4 ADDITIONAL INFORMATION.............................................................................................................................. 10
2. DEVICE FEATURES............................................................................................................... 11
3. PREPARATION FOR USE ..................................................................................................... 13
3.1 STANDARD PACKAGE CONTENTS................................................................................................................. 13
3.2 KEY ACCESSORIES........................................................................................................................................... 14
3.3 PREPARATION FOR USE................................................................................................................................... 15
4. HOW TO USE THE I-PAD CU-SP2 ....................................................................................... 17
4.1 LCD SCREEN..................................................................................................................................................... 17
4.2 SOFT KEYS ......................................................................................................................................................... 20
4.3 MODE CHANGE.................................................................................................................................................. 22
4.4 PROCEDURE FOR USING THE DEVICE......................................................................................................... 23
4.5 PREPARATION FOR DEFIBRILLATION............................................................................................................ 24
4.6 DEFIBRILLATION IN ADULT MODE.................................................................................................................. 27
Step 1: Place pads on the patient. ................................................................................................................. 27
Step 2: Press the Shock Button when instructed. ................................................................................... 28
Step 3: Perform CPR. .......................................................................................................................................... 30
4.7 DEFIBRILLATION IN PEDIATRIC MODE.......................................................................................................... 32
4.8 PRINTER .............................................................................................................................................................. 33
4.9 MONITOR MODE................................................................................................................................................ 34
4.10 CU-EM1 (ECG TRANSMISSION DEVICE).................................................................................................. 36
4.10.1 Device Features .................................................................................................................................. 36
4.10.2 Button and Indicators ........................................................................................................................ 37
4.10.3 Beeper ..................................................................................................................................................... 37
4.10.4 How to Use the CU-EM1 .................................................................................................................. 38
4.10.5 Where to Attach ECG Pads ............................................................................................................ 38

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4.11 MANUAL MODE (OPTIONAL)........................................................................................................................... 40
4.11.1 Changing the Energy Value ............................................................................................................ 40
4.11.2 Charging the Device and Administering Electric Shock Treatment ............................... 41
4.11.3 Using R-Sync ........................................................................................................................................ 42
5. AFTER USING THE I-PAD CU-SP2...................................................................................... 44
5.1 MAINTENANCE AFTER EACH USE................................................................................................................. 44
5.2 SAVING AND TRANSFERRING TREATMENT DATA....................................................................................... 45
5.2.1 Device Usage ....................................................................................................................................... 45
5.2.2 Transferring Treatment Data .......................................................................................................... 45
5.3 DATA REVIEW..................................................................................................................................................... 49
5.3.1 Event Review ........................................................................................................................................ 50
5.3.2 ECG .......................................................................................................................................................... 51
5.3.3 Partial Print ............................................................................................................................................ 51
5.3.4 Print All .................................................................................................................................................... 52
5.4 DEVICE SETUP................................................................................................................................................... 53
5.4.1 Configuring the Menu Mode ........................................................................................................... 53
5.4.2 Setting the Operation of the Device ............................................................................................ 54
5.4.3 Setting the CPR Guide ..................................................................................................................... 62
6. MAINTENANCE...................................................................................................................... 64
6.1 DEVICE STORAGE............................................................................................................................................. 64
6.2 MAINTENANCE.................................................................................................................................................... 65
6.2.1 Device Inspection ................................................................................................................................ 65
6.2.2 Recharging and Replacing the Battery ...................................................................................... 65
6.2.3 Replacing the Pads ............................................................................................................................ 70
6.2.4 Cleaning the i-PAD CU-SP2 ........................................................................................................... 71
6.2.5 Disposal .................................................................................................................................................. 71
7. TROUBLESHOOTING............................................................................................................ 72
7.1 SELF-TESTS ....................................................................................................................................................... 72
7.2 DEVICE STATUS................................................................................................................................................. 74
7.3 TROUBLESHOOTING ......................................................................................................................................... 75
8. DEVICE SERVICE .................................................................................................................. 76
APPENDIX........................................................................................................................................ 78
A. PARTS AND ACCESSORIES................................................................................................ 78

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A.1 STANDARD ACCESSORIES.................................................................................................................................. 78
A.2 OPTIONALACCESSORIES................................................................................................................................... 78
B. DESCRIPTION OF SYMBOLS .............................................................................................. 79
B.1 CU-SP2 DEFIBRILLATOR................................................................................................................................... 79
B.2 CU-SP2 PACKAGING.......................................................................................................................................... 80
B.3ACCESSORIES....................................................................................................................................................... 81
B.3.1 Rechargeable Battery Pack .................................................................................................................. 81
B.3.2 Disposable Battery Pack(CUSA1103BB) ........................................................................................ 82
B.3.3 Pads ................................................................................................................................................................ 83
C. GLOSSARY............................................................................................................................. 84
D. DEVICE SPECIFICATIONS.................................................................................................... 89
E. ELECTROMAGNETIC COMPATIBILITY............................................................................ 101

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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 8: 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-SP2], "We" or “Us" refers to CU Medical Systems, Inc.,
"Pads" refers to disposable defibrillation electrode pads for adult or pediatric modes, and
"Battery Pack" refers to the rechargeable or disposable battery pack.
These Instructions for Use emphasize 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 i-PAD CU-SP2. 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.
This device is a semi-automated external defibrillator that can be administered on sudden
cardiac arrest (SCA) patients.
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.
Users of this device must follow these instructions.
You must follow the instructions, warnings, cautions, and notices in these Instructions for Use
when using this device.
The manufacturer or its authorized distributor 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.
The manufacturer or its authorized service centers will not be liable for devices serviced at the
user’s own discretion.
If the device is intended to be connected to equipment other than that 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. Product Information
1.1 Device Description
The i-PAD CU-SP2 is an easy-to-use dual mode (Semi-Automated and Manual) Defibrillator.
It is small, light, portable, and internally powered by a battery pack.
①Semi-Automated Mode
The AED automatically reads the sudden cardiac arrest (SCA) patient's electrocardiogram (ECG)
and determines if a cardiac arrest that requires defibrillation has occurred, so that licensed
emergency medical technicians, medical professionals and the general public can easily
operate it. SCA 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.
②Manual Mode
In manual mode, the user determines whether the patient needs a defibrillation shock or not.
1.2 Indicated Use
①Semi-Automated Mode
The i-PAD CU-SP2 is indicated for use on patients that are exhibiting the symptoms of sudden
cardiac arrest (SCA) with all of the following signs:
No movement and no response when shaken
No normal breathing
If the patient is suspected of displaying the symptoms above, attach the pads and use the
defibrillator according to each step of the voice instructions.
②Manual Mode
Asynchronous defibrillation: The same indicated use as in Semi-Automated Mode.
Synchronous cardioversion: The i-PAD CU-SP2 is indicated for the treatment of atrial
fibrillation. During synchronous cardioversion, the shock is delivered within 60 milliseconds of
the occurrence of a QRS peak in the patient’s ECG.

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1.3 Intended Users
①Semi-Automated Mode
In this mode, the i-PAD CU-SP2 is intended for use by licensed emergency medical
technicians or medical professionals. Also, the general public untrained in CPR or the use of
the defibrillator may use this device according to its settings. However, the manufacturer
recommends that inexperienced users complete training in CPR or the use of the defibrillator for
quick and systematic emergency treatment.
②Manual Mode
In this mode, the i-PAD CU-SP2 is intended for use by health care professionals and
emergency rescue personnel who have been trained in advanced cardiac life support.
1.4 Additional Information
Please contact CU Medical Systems, Inc. or its local distributors for any additional information
on the i-PAD CU-SP2.

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2. Device Features
SD Card Port
IrDA Port
Battery Pack
Defibrillator Pads Connector
Graphic LCD
Power Button
i-Button
Shock Button
Pads Storage Compartment
Soft Keys

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Power Button
Turns the device on or off. (When the device is on, a green
LED backlight is lit.)
i-Button
Provides the following information by voice and LCD screen
•Reports device usage
(the total hours of the last usage and number of shocks)
•Checks the S/W version
•Checks for errors
Transmits event and ECG data through IrDA and SD Card
Mode Change(Adult / Pediatric Mode, AED / Manual Mode)
Graphic LCD
Displays the current status of the device, user's guide, ECG,
heart rate, etc.
Shock Button
Delivers defibrillating shock when pressed.
Defibrillator Pads Connector
Connects with the connectors of the pads.
Battery Pack
The rechargeable (disposable is optional) 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 an SD card.
Soft Keys
Three buttons that control device settings and operation
Pads Storage
Compartment
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.
1 Battery Pack (Disposable)
CU-SP2 Semi-automated / Manual
External Defibrillator
Instructions for Use
1 Pack of Adult Pads (Disposable)

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3.2 Key Accessories
1 Pack of Pediatric Pads
IrDA Adapter
1 Battery Pack (Rechargeable)
SD Card
Printer
CU-EM1 (ECG Transmission Device)
Battery Charge Dock
Battery Charger

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The accessories above are not included in the standard package contents.
Please contact us after referring to [Appendix A: Parts and Accessories] for additional supplies.
Please keep spare pads and battery packs handy to quickly respond to emergency situations.
3.3 Preparation for Use
Do the following to set up the i-PAD CU-SP2.
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 figures
below.
As the battery pack is inserted, the device starts a self-test and displays the following on the
Monitor LCD.
After the self-test is complete, the device will automatically shut down.
If the self-test fails, please refer to [Chapter 7: 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: Parts and
Accessories] of these Instructions for Use.

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⑤Store the device referring to the following considerations.
•You must store the defibrillator according to the storage conditions specified in [Section 6.1:
Device Storage].
•Store the defibrillator in an easy-to-access location where its technical alarms can be easily
heard (e.g. alarm on low battery or other device problems).
•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. Please refer to [Appendix D: 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 i-PAD CU-SP2.
When the product is used for asynchronous defibrillation treatment in Manual mode, do not
use it on patients who show any of the following symptoms:
- responsiveness, normal movement, normal breathing and detectable pulse.
There is a possibility of explosion or fire if the product is used in the presence of flammable
agents or in an OXYGEN enriched atmosphere due to the arc discharged caused by electric
shock.
Do not deliver an electric shock when the patient's ECG signal is in the asystole state. It may
lead to a failure to restore cardiac pacemaker functions in the heart, meaning the cardiac
function will not be restored.
This product must not be applied on patients implanted with the implantable pacemaker. If
patients show all of the symptoms including no response, and abnormal breathing, use the
product in the following ways:
- Attach the pad at least 3cm away from the implantable pacemaker attached to the patient.
- Do not attach the pad right on the area implanted with the implantable pacemaker.

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4. How to Use the i-PAD CU-SP2
4.1 LCD Screen
The configuration of the Graphic LCD Screen is as shown below. The screen configuration can
be changed according to the 'Graphic Instruction'. For detailed instructions on setting the
'Graphic Instruction', please refer to [Section 5.4: Device Setup] of these Instructions for Use.
[Screen configuration: Image guide ON]
[Screen configuration: Image guide OFF]
Operation Time
Printer / CU-EM1
Connection Status
Adult /
Pediatric Mode
Compression : Breath Ratio
No. of Shocks
Shock Energy
Battery Status
Heart Rate
ECG
Button Description
Image Guide
Text Guide
Text Guide
ECG

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Image Guide
Guides the user in operating the device.
Operation Time
Displays the actual operation time of the device.
Printer / CU-EM1
Connection Status
Displayed when using the Printer / CU-EM1.
Printer:
CU-EM1:
Adult / Pediatric Mode
Changes based on the Adult / Pediatric Mode of the device.
Adult:
Pediatric:
Compression : Breath
Ratio
Displays the CPR setting of the device.
Can be changed by pressing the Soft Keys during operation
when in Pediatric Mode.
The chest compression number is fixed to 30 when in Adult
Mode.
No. of Shocks
Displays the number of administered shocks.
Shock Energy
Displays the amount of shock energy administered to the patient.
Battery Status
Displays the status of the battery in 4 steps.
Step 1: - The battery is full.
Step 2: - Less than half of the battery is remaining.
Step 3: - Less than ¼ of the battery is remaining.
Step 4: - The battery is almost depleted.
Heart Rate
Displays the heart rate of the patient after the pads are attached.
ECG
Displays the ECG of the patient after the pads are attached.
Text Guide
Uses the text to guide the user in operating the device.
Button Description
Describes the functions of the three Soft Keys.

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The Graphic LCD Screen illustrated in these Instructions for Use may not match the actual
screen during operation depending on the device settings.
The Printer and CU-EM1 are not a part of the standard package contents. If you want to
purchase them, please contact us by referring to [Appendix A: Parts and Accessories] of
these Instructions for Use.

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4.2 Soft Keys
There are three Soft Keys in the center of the i-PAD CU-SP2, which operate the device and the
menu mode. The Soft Keys operate in two modes: Operation Mode and Menu Mode.
When in Operation Mode, the functions of the Soft Keys are changed according to the 'Manual
Override'. For further details on 'Manual Override', please refer to [Section 5.4: Device Setup] of
these Instructions for Use.
※Soft Keys are labeled 1~3 from left to right.
Soft Key Functions in Menu Mode
Button 1
Moves left/up on the menu.
Button 2
Selects or sets the current item.
Plays ECG (used when loading previous ECG).
Pauses ECG (used when loading previous ECG).
Button 3
Moves right/down on the menu.
For further details on the Menu Mode and the use of Soft Keys in Menu Mode, please refer to
[Section 5.4: Device Setup] of these Instructions for Use.
※Soft Keys are labeled 1~3 from left to right.
Soft Key Functions in Operation Mode (Before attaching pads on the patient)
Button
Indication
Function
Button 1
MONITOR
MODE
When pressed, the i-PAD CU-SP2 will attempt to establish
Bluetooth connection to the CU-EM1 (ECG transmission device). If
successful, the device will operate in Monitor Mode.
In Monitor Mode, ECG analysis and shock treatment will not be
available.
SEMI-AUTO
The i-PAD CU-SP2 operates in Monitor Mode. When pressed, the i-
PAD CU-SP2 will disconnect from the CU-EM1 and switch to Semi-
automated mode
Button 2
30:x
This function is activated when the 'No. of Chest Compressions'
under the CPR setting of the device is set to '15 times'. When
pressed, the setting will change to '30 times'.
(The 'x' refers to the 'No. of Artificial Respirations' under the CPR
setting.)
15:x
This function is activated when the 'No. of Chest Compressions'
under the CPR setting of the device is set to '30 times'. When
pressed, the setting will change to '15 times'.