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INSTRUCTIONS FOR USE
Cart, HDS
Stabilizer Leg, HDS
Operative Spar, HDS
HDS, WELL LEG SPAR
HDS, Table Clamp Set, UK
HDS, Table Clamp Set, DEN
HDS, Table Clamp Set, JP
Perineal Post Pad, Dense
Name of Consumable
HDS, Disposable Pad Kit
Note: Consult the corresponding IFU for the products mentioned in the above table.
CAUTION: Reuse of disposables will lead to patient cross contamination and/or
device failure.
2.4 Indication for use:
The Hip Distractor System is used for hip surgery. These devices are capable of being
used with a broad patient population as determined appropriate by the caregiver
or institution.
2.5 Intended use:
The Hip Distractor System is designed to position, support and/or distract the
patient's hip, posterior Lower torso and foot for hip surgery. These devices are
intended to be used by healthcare professionals within the Operating Room
setting.
2.6 Residual risk:
This product complies with relevant performance, safety standards. However,
patient, user or device harm from misuse, device damage or malfunction, device,
function or mechanical hazards cannot be completely excluded.
Document Number: 80028286
Version: C
Product Number
Page 14
AR-6529-13
AR-6529-16
AR-6529-05
AR-6529-14
AR-6529-18
AR-6529-19
AR-6529-20
AR-6529-21
AR-6529-11
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E
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