CU Medical Systems i-PAD CU-SP2 User manual

1
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.

2
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]

3

4
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

5
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