Bow Frame A-70800 Instructions for Use June 2011 PDF download

INSTRUCTIONS FOR USE

Allen® Bow™ Frame A-70800 Warnings Prior to using this or any other type of medical apparatus with a patient, it is recommended that you read the Instructions for Use and familiarize yourself with the product.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

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.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE TABLE OF CONTENTS 1.0

Safety Precautions and General Information 1.1 General Safety Warnings 1.2 Table Compatibility 1.3 Product Specifications

2.0

Component Identification 2.1 Bow Frame 2.2 Bow Frame Labels

3.0

Equipment Setup and Use 3.1 Prior To Use 3.2 Setup 3.3 Device Controls & Indicators 3.4 Loading the Patient 3.5 Removal & Storage

4.0

Cleaning and Maintenance

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 1.0 SAFETY PRECAUTIONS AND GENERAL INFORMATION 1.1 GENERAL SAFETY WARNINGS Do not use if product shows visible damage. • All modifications, upgrades, or repairs must be performed by an authorized specialist. •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 serious injury to patient, additional restraints must be used to securely restrain the patient to the OR prior to tilting the system. •Do not tilt or flex the OR table while Bow Frame is on it. 1.2 TABLE COMPATIBILITY The Allen Bow Frame is compatible with the following surgical table styles: US, UK, EU, DEN, JP Spine Rail Compatibility •Jackson Table •Flex Frame •Most other tables with1 ¼” (32 mm)x 1 ½” (38 mm)Rails with 17” (432 mm) spacing Note: Refer to the surgical table manufacturer's user guide for instructions on use. Always refer to the surgical table manufacturer’s weight limits. Jackson is a trademark of Mizuho Orthopaedic Systems, Inc. ©2011 Allen Medical Systems, Inc. All Rights Reserved. D-720628-A5 JUN 28, 2011 Form D-FACT-722-05

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 1.3 PRODUCT SPECIFICATIONS • 500 lbs (227kg) patient weight limit •Pads Width Adjustable from 0” to 10 (255 mm)” •Height Adjustable from 11” (280 mm) to 13 ½ (345 mm)” •Compatible with Allen Flex Frame and most competitor tables with 1 ¼”W x 1 ½”H x 17” (32 mm x 38mm x 432 mm) spaced rails

29 ½” (750 mm)

11” (280 mm)

19” (485 mm)

NEVER EXCEED THE WEIGHT CAPACITY OF THE O.R. TABLE

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 2.0 COMPONENT IDENTIFICATION 2.1 Bow Frame

Front Catch Pads

Rail Rod Connectors

Buttons

Velcro Straps Crank Handle

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INSTRUCTIONS FOR USE 2.0 COMPONENT IDENTIFICATION 2.2 Bow Frame LABELS

Warning Label

Height Adjustment

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INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 3.1 PRIOR TO USE 1.

Verify table under Bow Frame is rated for patient weight. (If this information is not available confirm rating with table manufacturer prior to loading a patient).

2.

Verify Velcro Straps are in good condition.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.2 SET-UP (Flex Frame or Jackson Table) 1.

Hold Bow Frame above rails and verify there is enough room to lower the frame.

2.

Lower head end of Bow Frame onto rails and slide to desired location.

3.

Ensure velcro straps are in between rails.

4.

Lower frame completely onto rails.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.2 SET-UP (Flex Frame or Jackson Table) 5.

Bring velcro straps around rails and secure to Bow Frame.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.2 SET-UP (OR Table / Flat Surface) 1.

Hold Bow Frame above table and verify there is enough room to lower the frame.

2.

Place Frame on OR table with Buttons facing head end of OR table.

3.

Ensure enough room for head positioner.

4.

Ensure frame is centered between OR table rails.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.2 SET-UP (OR Table) 5.

Place Velcro straps through OR Table Rails.

6.

Bring Velcro straps around rails and secure back to Bow Frame.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.3 DEVICE CONTROLS AND INDICATORS To Adjust Pad height 1.

Insert Crank Handle into Bow Frame as shown.

2.

Press Crank Handle in until fully engaged.

3.

Support Crank Handle Rod with one hand and grab handle with other.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.3 DEVICE CONTROLS AND INDICATORS To Adjust Pad height •

To raise Bow Frame pads turn the handle counter-clockwise.

•

To lower Bow Frame pads turn the handle clockwise.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.3 DEVICE CONTROLS AND INDICATORS To adjust pad width 1.

Ensure pads are at lowest height.

2.

To release rail: press inward at free end of rail while pulling upward at center of rail.

3.

Pull rail out from front catch.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.3 DEVICE CONTROLS AND INDICATORS To adjust pad width 4.

Locate button at opposite end of frame.

5.

Press button firmly.

6.

Shift rail laterally to desired location and release button.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.3 DEVICE CONTROLS AND INDICATORS To adjust pad width 7.

Lower rail to front catch.

8.

Press firmly inwards and tuck into front catch.

NEVER EXCEED THE WEIGHT CAPACITY OF THE O.R. TABLE

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.4 Loading the Patient Note: 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. •

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

•

Prior to transferring the patient, crank frame to highest setting. After transferring the patient, lower to desired level.

•

Position the patient to reduce nerve contact and subsequent injury.

•

Additional support must be provided to the head, arms and legs.

NEVER EXCEED THE WEIGHT CAPACITY OF THE O.R. TABLE

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.4 Loading the Patient •

Check all surfaces exposed to patient to ensure there is no contact with any hard or sharp surfaces. Key areas to check are highlighted below.

•Cover Front Catch

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•Cover Cross Rod using Cross Rod Cover Disposable or use other padding Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12

INSTRUCTIONS FOR USE 3.5 REMOVAL AND STORAGE To remove from table 1.

Remove Velcro strap from Bow frame and unwrap from rail.

OR

2.

Remove from table and store.

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Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvinger, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 12