Supine Top Sections and Access Tops A-704xx Instructions for Use Rev A6 Nov 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-720527

A6

17 NOV 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

2 of 30

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 500lb (227 kg) patient weight limit. To avoid injury to patient, ensure Supine Tops are properly latched and locked prior to loading a patient. Ensure patient’s flesh does not protrude between sections. To avoid serious injury to patient, additional restrains 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.

PRODUCT DESCRIPTION This product is an attachable top section that is used as an accessory to a spine frame. It is used to support the patient in the supine position. Typically, four top sections are needed on an Allen Flex Frame to create a full operating surface. The Allen Supine Access Top has a space to attach an Armboard Rail.

SPECIFICATIONS

Allen Supine Access Top



500 lb patient weight capacity



Radiolucent (less than 2mm Al equiv)



Compatible with Allen Flex Frame and most competitor spinal tables with 1¼”W x 1½”H x 17” spaced rails



Pads required

Document Number

Revision

Effective Date

D-720527

A6

17 NOV 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

3 of 30

INSTRUCTIONS FOR USE SET-UP AND USE

Operative Sight

Installation 1. Place the Supine Access Top on the Allen Flex Frame. Orient latch away from the operative sight.

2. (For System Set-up Only) Place four Allen Supine Access Tops on the Allen Flex Frame as illustrated. •

Orient latches away from operative sight.

•

Allen Armboard Rails and Allen Armboards are recommended to support the arms.

Latches

3. Attach Supine Top Pads. 4. Push down firmly on both clamp latches to lock the Supine Top into place. Pull outward on the clamp latches to ensure the clamps are locked. Removal 5. Push the white clamp locks down to unlock. Pull up firmly on the clamp latches to release. Ensure both latches are released during removal.

Document Number

Revision

Effective Date

D-720527

A6

17 NOV 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 30

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 low-level disinfection.

•

Read the cleaning product’s directions and follow the instructions on the label. Use caution in areas where fluid migration may occur.

•

Wipe device with a clean, dry cloth.

•

Make certain the product is dry prior to reinstalling to avoid damage.

•

Do not Autoclave.

•

Do not use tape on this product.

•

Flex-Frame should be clean and dry prior to attaching Supine Tops WARNING: Damage may result if product is cleaned with bleach.

Suggested Accessories 

Supine Top Pad, 2” or 3” Astrus

A-70430 (2”) or A-70431 (3”)



Allen Flex Frame

A-70100



Allen Armboard Rail

A-70500, A-70500-UK, A-70500-EU, A-70500-DEN, A-70500-JP



Dura-Board Armboard

A-30003 (US only)

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-720527

A6

17 NOV 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

5 of 30