Wing Set Systems A-702xx Instructions for Use Rev A8 July 2015

INSTRUCTIONS FOR USE IMPORTANT NOTICES READ THESE INSTRUCTIONS COMPLETELY BEFORE USING THIS PRODUCT.

•

Read and understand all warnings in this manual and on the device itself prior to use with a patient.

•

The symbol is intended to alert the user to important procedures or safety instructions regarding the use of this device.

•

The symbol on the labels is intended to show when the IFU should be referenced for use.

•

The techniques detailed in this manual are only manufacturer’s suggestions. The final responsibility for patient care with respect to this device remains with the attending physician.

•

Device function should be checked prior to each usage.

•

This device should only be operated by trained personnel.

•

All modifications, upgrades, or repairs must be performed by an authorized specialist.

•

Keep this manual available for future reference.

Document Number

Revision

Effective Date

D-720529

A8

01 JUL 2015 Hill Rom S.A.S BP. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax +33 (0) 2 97 50 92 00

©2015 Allen Medical Systems, Inc. D-FACT-722-11 All Rights Reserved Allen Medical Systems 100 Discovery Way Acton, MA, 01720 USA Tel. +1 (978) 263-5401 Fax +1 (978) 263-8846

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INSTRUCTIONS FOR USE PRODUCT DESCRIPTION This product is a patient support system that is used as an attachment to a spine frame to support the patient in the prone position.

This system contains: A) B) C) D) E) F) G) H)

Hip Support Chest Support Hip Pad, Left Hip Pad, Right Hip Pad, Centre Chest Pad, Left Chest Pad, Right Chest Pad, Centre

G

D

H

E

F

B

A

C

SPECIFICATIONS     

500 lb (227 kg) Patient Weight Capacity Width Adjustable from: -10" to 18" (A-70200, A-70202, A-70203, A-70204, A-70205) -16” to 18” (A-70201, A-70206) 25° Angular adjustability Radiolucent (less than 2mm Al equiv) Compatible with Allen Flex Frame and most competitor tables with 1 ¼"W x 1 ½"H x 17" spaced rails

Document Number

Revision

Effective Date

D-720529

A8

01 JUL 2015 Hill Rom S.A.S BP. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax +33 (0) 2 97 50 92 00

©2015 Allen Medical Systems, Inc. D-FACT-722-11 All Rights Reserved Allen Medical Systems 100 Discovery Way Acton, MA, 01720 USA Tel. +1 (978) 263-5401 Fax +1 (978) 263-8846

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3 of 42

INSTRUCTIONS FOR USE SAFETY INFORMATION Prior to using this or any other type of medical apparatus, it is recommended that you read the Instructions for Use and familiarize yourself with the product prior to application on a patient. Do not use if product shows visible damage. Do not exceed 500 lb (227 kg) patient weight limit. To reduce the chances of patient tissue damage, care should be taken to ensure proper orientation and location of supports.

To reduce the chances of skin maceration and shear, it is recommended that a disposable cover be used between the patient and the pads. To avoid injury to patient, ensure Wing Sets are properly latched and locked prior to loading a patient. To avoid serious injury to patient, additional restraints must be used to securely restrain the patient to the OR table prior to tilting the system. All modifications, upgrades, or repairs must be performed by an authorized specialist.

SYMBOLS

Left Chest

Left Hip

Right Hip

Right Chest

SET-UP AND USE 1.

Place the Allen Wing Sets on the Allen Flex Frame. The indicated labels denote the proper orientation of the pads.

Document Number

Revision

Effective Date

D-720529

A8

01 JUL 2015 Hill Rom S.A.S BP. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax +33 (0) 2 97 50 92 00

©2015 Allen Medical Systems, Inc. D-FACT-722-11 All Rights Reserved Allen Medical Systems 100 Discovery Way Acton, MA, 01720 USA Tel. +1 (978) 263-5401 Fax +1 (978) 263-8846

Page

4 of 42

INSTRUCTIONS FOR USE 2.

To match up the pads, hold the pad upside down and match the images as shown.

3.

Attach the pads with the inside edge first and then pull the skirt around the bottom.

Inside Edge Skirt

Installation 4.

Adjust the location to the desired spacing for each patient.

5.

Push down firmly on the clamp latch to lock the Wing Sets into place.

6.

Pull outward on the clamp latch to ensure the clamp is locked.

Adjust the width 7.

Push down the locking level to unlock the Wing Set supports.

8.

Adjust the Wing Set supports to the desired width. Remove the centre pads if further inward adjustment is needed. Slightly nudge the supports to free the internal brake pads if needed.

9.

Push up the locking levels to lock the Wing Set supports.

Document Number

Revision

Effective Date

D-720529

A8

01 JUL 2015 Hill Rom S.A.S BP. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax +33 (0) 2 97 50 92 00

©2015 Allen Medical Systems, Inc. D-FACT-722-11 All Rights Reserved Allen Medical Systems 100 Discovery Way Acton, MA, 01720 USA Tel. +1 (978) 263-5401 Fax +1 (978) 263-8846

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5 of 42

INSTRUCTIONS FOR USE Loading the patient Wing Set Hydrophilic Disposable

10. (Optional/Recommended) Place moisture absorbing/friction reducing covers over the supports.

Allen Spinal Leg Supports

11. Transfer the patient onto the Wing Sets. Position the patient to reduce nerve contact and subsequent injury. Additional support must be provided to the head, arms, and legs. It is recommended that Leg Support pads be used to elevate the legs.

Prone Arm Supports

Allen Flex Frame

Allen C-Prone Head Positioner

Removal 12. Push the white clamp locks down to unlock. 13. Pull up firmly on the clamp latch to release. 14. Remove.

Document Number

Revision

Effective Date

D-720529

A8

01 JUL 2015 Hill Rom S.A.S BP. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax +33 (0) 2 97 50 92 00

©2015 Allen Medical Systems, Inc. D-FACT-722-11 All Rights Reserved Allen Medical Systems 100 Discovery Way Acton, MA, 01720 USA Tel. +1 (978) 263-5401 Fax +1 (978) 263-8846

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INSTRUCTIONS FOR USE CLEANING AND MAINTENANCE • • • • • • • • • • •

After each use, clean the device. Clean and disinfect using a quaternary ammonium disinfecting/cleaning solution following the manufacturers recommendation for achieving lowlevel disinfection. Read the cleaning product’s directions and follow the instructions on the label. Use caution in areas where fluid migration may occur. After each use or disinfection, clean the device with alcohol-based wipes. Wipe device with a clean, dry cloth. Make certain the product is dry prior to reinstalling to avoid damage. If Wing Set becomes saturated with biohazard fluids, remove pads and gently wash Wing Set under running water. After rinse, repeat cleaning steps (2) and (4). Do not submerge. Do not Autoclave. Damage may result if product is cleaned with bleach. Do not use tape on this product. Flex-Frame should be clean and dry prior to attaching Wing Sets.

WARNING: Damage may result if product is cleaned with bleach.

Suggested Accessories Allen Comfort Covers Allen Spinal Leg Supports Allen Flex Frame Allen C-Prone Head Positioner Prone Arm Support

A-70260 A-70440 A-70100 A-70300 A-70610

For ordering information please see catalog. All modifications, upgrades, or repairs must be performed by an authorized specialist. NORTH AMERICA

INTERNATIONAL

(800) 433-5774

001 978 266 4200 ext. 4286

(978) 263-8846 FAX

001 978 263 5230 FAX

Document Number

Revision

Effective Date

D-720529

A8

01 JUL 2015 Hill Rom S.A.S BP. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax +33 (0) 2 97 50 92 00

©2015 Allen Medical Systems, Inc. D-FACT-722-11 All Rights Reserved Allen Medical Systems 100 Discovery Way Acton, MA, 01720 USA Tel. +1 (978) 263-5401 Fax +1 (978) 263-8846

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使用説明書 Allen® Standard Wing Set System, Cut-out Wing Set, Pediatric Wing Set, Standard Wing Set, Chest Wing Set with Radiotranslucent Screws, Hip Wing Set with Radiotranslucent Screws, Hip Cut-out Wingset with Radiotranslucent screws A-70200, A-70201, A-70202, A-70203, A-70204, A-70205, A-70206 警告 この製品あるいはその他のタイプの医療用装置を患者に対して使用する前に、ま ず使用方法をよく読んで理解するようにしてください。

Document Number

Revision

Effective Date

D-720529

A8

01 JUL 2015 Hill Rom S.A.S BP. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax +33 (0) 2 97 50 92 00

©2015 Allen Medical Systems, Inc. D-FACT-722-11 All Rights Reserved Allen Medical Systems 100 Discovery Way Acton, MA, 01720 USA Tel. +1 (978) 263-5401 Fax +1 (978) 263-8846

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