AMATECH P150830530 Instrucciones De Uso página 11

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INSTRUCTIONS FOR USE
2.3 List of Accessories and Consumable Components Table:
The following list are accessories and components that may be used with this
device.
Name of Accessory
Reverse Trend. Restraint Strap
Fluid Collector
Name of Consumable
Fluid Collector Bag
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 Stirrup is used in a variety of surgical procedures including, but not limited to
gynecology, urology, laparoscopy, general and robotic 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 Stirrup is designed to position and support the patient's foot, lower leg and
upper leg in a variety of surgical procedures including, but not limited to
gynecology, urology, laparoscopy, general and robotic 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 harm from misuse, device, function or mechanical hazards cannot be
completely excluded.
Document Number: 80028296
Version: A
Product Number
Product Number
P056397909 &P056397910 (Sterile)
Page 11
P056397904
P056397906
Issue Date: 19 MAR 2020
Ref Blank Template: 80025118 Ver. E
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