Dechoker 1DCH01, 1DCH02 Instructions For Use Manual

Models-1DCH01 and 1DCH02
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TABLE OF CONTENT
INSTRUCTIONS FOR USE 7 Table of Contents 2 Introduction & Overview 5
Introduction 5 Requirements 6 Indications for Use (Purposes of the Dechoker) 6 Contraindications (When this device should not be used) 7 About This User’s Guide 7 Important Symbols 7 Technical Support 8 General Warnings 9 Dechoker Description & Features Dechoker Features 11
Dechoker Components 11 Dechoker Setup 13 Dechoker Labels 17
Package Label 17 Dechoker Use 19
Dechoker Use 19 Troubleshooting 26 Troubleshooting the Dechoker Device 26
Cleaning Specications 26
Cleaning the Dechoker 26 Device Specications 27 Dechoker Dimensions 27 Operating Conditions 27 Transportation and Storage Conditions 28 Maintenance 28 Maintenance 28 Whom to Call for Help 28 Replaceable Parts 29 Device Disposability 29 Dechoker Limited Warranty 30
©2016 by Dechoker LLC All Rights Reserved.
Dechoker LLC 1191 Speedway Blvd Salisbury, NC 28146 1-704-638-5445
EC Rep Ltd/M Devices Group Health Education Centre The Church, Portland Street, Southport. PR8 1HU United Kingdom
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TABLE OF FIGURES
Figure 1: Dechoker storage box ........................................... 13
Figure 2: Dechoker open storage box.................................. 14
Figure 3: Dechoker removed from storage box ................. 15
Figure 4: Dechoker removed from storage bag ................. 16
Figure 5: Dechoker Package Labels .................................... 17
Figure 6: Dechoker Shipping Labels ................................... 18
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INTRODUCTION
No part of this text shall be reproduced or transmitted in any form or by any means, electronic or mechanical, including, but not limited to: recording, photocopying, or by any information or retrieval system without written permission from Dechoker LLC.
The information in this manual is condential and may not be disclosed to third parties
without the prior written consent of Dechoker LLC.
The only warranty Dechoker LLC makes is the express written warranty extended on the sale or of its products.
TABLE OF TABLES
Table 1: Import Symbols and Descriptions .......................... 8
Table 2: Warning / Caution Decriptions ............................. 10
To order additional copies of this manual (DECH-LAB012), refer to the contact information on the front cover.
Caution: All users must read and understand the Dechoker Instructions for Use, including indications, contraindications, operating instructions, warnings and precautions before using the device. Failure to do so may result in injury to the patient or caregiver or cause damage to the Dechoker Device.
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Requirements The Dechoker is used within the home healthcare environment, restaurants, hospitals, and within commercial facilities. Operators of the Dechoker shall be familiar with this manual. The Dechoker provides peace of mind that the Dechoker is available to assist in the removal of acute obstruction of a choking victim.
Contraindications (When this device should not be used)
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The Dechoker is contraindicated for use by patients / users with the following:
The Dechoker should not be used without contacting 911 or emergency assistance.
Indications for Use (Purposes of the Dechoker)
The Dechoker is a medical device that creates suction to clear the acute upper airway from obstruction in the relief of choking. The Dechoker device can be applied to a choking victim to generate a suction to remove the acute obstruction, and is intended for use as an aid to family members, healthcare professionals, caregivers, EMTs, restaurant workers or any average user.
Warning: Safety and eectiveness of the Dechoker has not been
established for uses outside of those specied herein.
The Dechoker model-1DCH01, 1DCH02 and 1DCH03 should not be used on infants.
About This User’s Guide
This manual provides general instructions for the Dechoker operations, usability, and safety criteria. Observing the warnings and cautions
listed within this manual will provide e󰀨ect use of the device.
Important Symbols
The table below shows all symbols and the corresponding meaning of the symbols used within this manual and on the Dechoker labeling. Operators must pay careful attention to these symbols as they provide important safety precautions and warnings.
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Technical Support
For questions regarding the Dechoker, please contact Dechoker LLC
Technical Support Team at 1-844-638-5445 in North America or
the EU Authorized
Label Symbol
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Meaning
Attention, Caution, Warning, Danger, Important, Note, or Refer to Accompanying Documentation
Refer to Instruction manual / Booklet
Device has not been sterilized.
Batch code
Temperature limitation
Use by date
Manufacturer
Authorized Representative in the European Community
Keep Dry
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