Allen Medical Systems
Flex-Frame OR Table Clamp A-70510 Instructions for Use Rev A6 July 2015
Instructions for Use
24 Pages
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INSTRUCTIONS FOR USE
Allen® Flex Frame OR Table Clamp Set A-70510, A-70510-UK, A-70510-EU, A-70510-DEN, A-70510-JP
(For use with Allen Flex Frame A-70100) WARNING 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.
Document Number
Revision
Effective Date
D-720532
A6
13 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
1 of 24
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.
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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.
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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-720532
A6
13 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
2 of 24
INSTRUCTIONS FOR USE SAFETY INFORMATION
Ensure clamps are secure prior to attaching frame.
Ensure OR table leg section does not contact clamps.
For use with Allen Flex Frame ONLY.
See Allen Flex Frame IFU for operation of this device.
A-70510
(3/8” x 1 1/8”)
A-70510-UK
(6.35 x 31.75 mm)
A-70510-EU
(10 x 25 mm)
A-70510-DEN
(6.35 x 38.1 mm)
A-70510-JP
(9 x 32 mm) Left
Right
PRODUCT DESCRIPTION This product is a required accessory clamp that is used to attach an Allen Flex Frame to the end of a surgical table.
SPECIFICATIONS
500 lb (227 kg) Patient Weight Capacity. (Do not exceed Surgical Table weight rating.)
Fits standard OR rails.
Fits OR table width range of 20” to 24” (outside to outside of rail).
INSTALLATION Attach clamps to OR table.
Ensure knob is retracted.
Clip on near open area on table rail.
Slide to end of rail and tighten knob securely.
Document Number
Revision
Effective Date
D-720532
A6
13 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
3 of 24
INSTRUCTIONS FOR USE CLEANING AND MAINTENANCE •
After each use, clean the device.
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Clean and disinfect using a quaternary ammonium disinfecting/cleaning solution following the manufacturers recommendation for achieving low-level disinfection.
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Read the cleaning product’s directions and follow the instructions on the label. Use caution in areas where fluid migration may occur.
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After each use or disinfection, clean the device with alcohol-based wipes.
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Wipe device with a clean, dry cloth.
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Make certain the product is dry prior to reinstalling to avoid damage.
WARNING: Damage may result if product is cleaned with bleach.
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-720532
A6
13 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 24