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CU Medical Systems i-PAD CU-SP1 AUTO User Manual

CU Medical Systems i-PAD CU-SP1 AUTO
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Instructions for Use
i-PAD CU-SP1 AUTO
The information in these Instructions for Use applies to the i-PAD CU-SP1 AUTO. This
information is subject to change. Please contact CU Medical Systems, Inc. or its authorized
representatives for information on revisions.
Revision History
Edition1
Publication Date: March 2014
Document No.: SPA-OPM-E-01
Published by: CU Medical Systems, Inc.
Printed in the Korea
Copyright
© 2014 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-SP1 AUTO complies with the requirements of the Medical Device Directive
2007/47/EC 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.

Table of Contents

Questions and Answers:

CU Medical Systems i-PAD CU-SP1 AUTO Specifications

General IconGeneral
Device TypeAutomated External Defibrillator (AED)
Voice PromptsYes
CPR GuidanceYes
CPR FeedbackYes
Data RecordingYes
Storage Temperature-20°C to 60°C (-4°F to 140°F)
Relative Humidity5% to 95% (non-condensing)
IP RatingIP55
ECG AnalysisYes
Warranty5 years
WaveformBiphasic
Energy SelectionAutomatic
Energy (Fixed)150 Joules
Self-TestDaily, weekly, monthly
Battery TypeLithium Manganese Dioxide (LiMnO2)
Battery Capacity200 shocks or 4 hours of operating time
Operating Temperature0°C to 43°C (32°F to 109°F)
Weight2.4 kg (including battery)
Battery Life5 years (standby life)

Summary

1. Introduction

1.1 Device Description

Describes the i-PAD CU-SP1 AUTO as an easy-to-use, portable AED device.

1.2 Indicated Use

Specifies the intended patient population and symptoms for using the i-PAD CU-SP1 AUTO.

2. Device Features

3. Preparation for Use

3.2 Setting up the i-PAD CU-SP1 AUTO

Provides instructions on how to set up the i-PAD CU-SP1 AUTO, including battery insertion.

4. How to Use the i-PAD CU-SP1 AUTO

4.2 Preparation for Defibrillation

Details how to prepare the device for defibrillation, including adult/pediatric selection.

4.3 Defibrillation Procedures in Pediatric Mode

Guides on using the device for pediatric patients, including pad placement and energy settings.

5. After Using the i-PAD CU-SP1 AUTO

5.2 Saving and Transferring Treatment Data

Explains how to save and transfer patient treatment data using SD card or IrDA.

6. Maintenance

6.1 Device Storage

Provides precautions for storing the device to prevent damage.

6.2 Maintenance Procedures

Covers device inspection, replacing supplies, and cleaning procedures.

7. Disposal

8. Troubleshooting

8.2 Device Status

Describes the symbols used to indicate the status of the i-PAD CU-SP1 AUTO.

8.3 Troubleshooting Scenarios

Addresses issues and provides solutions for device operation and non-operation.

9. Device Service

E. Device Specifications

F. Electromagnetic Compatibility

Electromagnetic Immunity Guidance

Declares the device's compliance with electromagnetic immunity standards.

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