Arthrex AR-1627-03, Instructions For Use Manual

Page: 14 / 377

INSTRUCTIONS FOR USE
Document Number: 80028275
Page 14
Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
e. To prevent patient and/or user injury and/or equipment damage, verify the
device attaching clamps completely touch the table-side rails and are firmly in
place. Apply device only to U.S. standard side rails. Test the locking mechanism
to ensure no movement when elevated or pushed.
CAUTION:
a. Do not exceed safe working load shown in the product specification table
b. To prevent patient and/or user injury and /or equipment damage: all
modifications, upgrades, or repairs must be performed by an Allen authorized
specialist. Failure to comply may void warranty.
c. Do not raise or lower the shoulder chair when the safety strap is attached.
Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Mechanical Specifications Description
Product Dimensions 78" X 5" X 21
3
/
16
" (198 cm x 12.7 cm x 53.8 cm)
Material
 Stainless Steel
 Alloy steel
 Fusion 3
 Nylon
Safe Working Load on the device
500 lbs. (226 kg) patient
Overall Weight of Complete Device 3.5 lbs. (1.6 kg)
Storage Specifications Description
Storage temperature
-29
ᵒ
C to +60
ᵒ
C
Storage Relative humidity range 15% to 85%
Operating temperature
This device is intended to be used in a controlled
Operating Room environment.
Operating Relative humidity range
Electrical Specifications Description
Not Applicable. Not Applicable.
Software Specifications Description
Not Applicable. Not Applicable.
Compatibility Specifications Description
The Counter Traction Strap is
compatible with:
Clip-On
TM
Socket
F-ELS (US), F-40023 (EU), F-40024 (UK)
F-40030 (Japan)