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Models-1DCH01 and 1DCH02

Summary of Contents for 1DCH01

Page 1: ...1 Models 1DCH01 and 1DCH02 ...

Page 2: ...3 2 ...

Page 3: ...Dechoker Use 19 Dechoker Use 19 Troubleshooting 26 Troubleshooting the Dechoker Device 26 Cleaning Specifications 26 Cleaning the Dechoker 26 Device Specifications 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 TABLE OF CONTENT...

Page 4: ...mation or retrieval system without written permission from Dechoker LLC The information in this manual is confidential 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 To order additional copies of this manual DECH LAB012 refer to the contact infor...

Page 5: ...workers or any average user Warning Safety and effectiveness of the Dechoker has not been established for uses outside of those specified herein Contraindications When this device should not be used The Dechoker is contraindicated for use by patients users with the following The Dechoker should not be used without contacting 911 or emergency assistance The Dechoker model 1DCH01 1DCH02 and 1DCH03 s...

Page 6: ...in North America or the EU Authorized Label Symbol 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 ...

Page 7: ...eness of the Dechoker has not been established for uses outside of those specified herein The Dechoker is a non sterile device Never use organic solvents e g acetone ammonia compounds or strong acids to clean any portion of the Dechoker The device can be reused on a single patient or disposed of after use The Dechoker is not certified waterproof Never immerse the Dechoker in water or any other flu...

Page 8: ...iduals who may have sensitivity or allergic reaction to ABS materials Do not open or modify the Dechoker If a problem occurs with the Dechoker identify the symptom then attempt to resolve the problem as indicated in the Instructions for Use If the problem cannot be resolved under NO condition should the device be used Warning Cautions Statement Precautions should be taken regarding the exposure of...

Page 9: ...tion barrel encapsulates the piston to create the appropriate set suction level to remove the acute obstruction 3 Pull Handle The pull handle provides a simple grip to drawing back the piston 4 Exhaust valve The exhaust valve permits the pull handle to move the piston back to its original position to allow another suction attempt in removing the acute obstruction 5 Enclosure The enclosure is used ...

Page 10: ...ward Figure 2 Dechoker open storage box Remove the Dechoker Package from the box Figure 3 Dechoker removed from storage box DECHOKER SETUP Follow the simplified steps below to prepare the Dechoker for use Open the Dechoker Bag and remove the Dechoker Device Reference Dechoker use section for usability steps on choking individual ...

Page 11: ... returned please have the device lot number available for reference when contacting Dechoker LLC or the EU authorized representative Shipping Package Label The following label is affixed to the Dechoker shipping box This label provides the de vice Lot number manufacturer EC Authorized representative and applicable symbols In the event that the Dechoker needs to be returned please have the device l...

Page 12: ...be into the mouth respirator face mask covering the mouth and nose for no longer than 3 second intervals 4 Apply thumb at the bottom of the chin index finger on one side of respirator and middle finger on the other side of the respirator 5 Apply light pressure on the respirator while pulling the plunger upward Repeat steps 4 and 5 if necessary 7 Roll individual over on side to allow debris out of ...

Page 13: ...ndividual to remove the acute obstruction the device can be cleaned to be used by the same patient If required dispose of the device with the regulations of the country in which it was sold The Dechoker is not a biohazard device DEVICE SPECIFICATIONS Dechoker Dimensions Dimensions 317 5mm x 63 5mm 12 5 x 2 5 Weight 16oz 1 lbs Suction capability typical 34kPA Operating Conditions Temperature 5 C to...

Page 14: ...ing a clean cloth moistened with an Enzol cleaning solution made per manufacturer s recommendations Clean the device with the prepared cleaning solution and soft bristle brush Difficult to reach areas can be flushed with a clean syringe Rinse the device under running water until no visible signs of the cleaning solution remains A clean syringe can be used to flush parts of the device Boil the devi...

Page 15: ... any replaceable parts This device can be reused by single patient DEVICE DISPOSABILITY Dechoker device can be reused by a single patient use device and may also be disposed into a trash can The Dechoker does not contain any biohazardous or hazardous materials MAINTENANCE CAUTION Do not attempt to disassemble the device The manufacturer or an authorized representative must perform device failure e...

Page 16: ...Date Originator Reviser Reason for Release Impact of Changes on Reporting A 5 25 16 John Popow Initial Re lease Released into doc control and DMR DECHOKER LIMITED WARRANTY PRIVACY Dechoker LLC will maintain and use customer information in accordance with the Dechoker LLC Customer Privacy Policy GENERAL No Dechoker LLC reseller agent or employee is authorized to make any modification extension or a...

Page 17: ...32 Contact Dechoker LLC North America 1 704 638 5445 EU Authorized Representative 441704544944 ...

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