Introduction; Intended Use; Contraindications; Warnings - Stryker SPY-PHI Manual Del Usuario

2. Introduction

The SPY-PHI Articulating Arm consists of three components:
Main Arm (HH1001), Table Clamp (HH1002) and Imaging Head
Holder (HH1003).

3. Intended Use

The SPY-PHI Articulating arm is intended as an accessory to
the SPY Portable Handheld Imaging System, HH9000, for use
during surgical procedures or other applications where the user
wishes to position the imaging head in a fixed location while
imaging, instead of holding it by hand.
Main Arm (HH1001): This component is used to position and
hold the Imaging Head Holder (HH1003).
Table Clamp (HH1002): This component is used to mount the
Main Arm (HH1001) to the table and hold position.
Imaging Head Holder (HH1003): This component is used to
hold the HH9000 Imaging Head.

4. Contraindications

This product is not intended for use except as indicated above.

5. Warnings

1. CAUTION: US Federal law restricts this device to sale by
or on the order of a physician.
2. The product must only be used by trained medical
personnel capable of judging and controlling danger to
patients.
3. The products will be delivered non sterile. Prior to the
initial use, and each following use, the products must be
cleaned, disinfected, and sterilized as well as checked for
visible irregularities and malfunctions according to the
instructions given in this Instructions for Use.
4. Components of the SPY-PHI Articulating Arm (including
table clamp, main arm and imaging head holder) are only
to be used with each other to make up the SPY-PHI
Articulating Arm. Components of the SPY-PHI Articulating
Arm may not be used with other manufacturer's products.
5. End of life is normally determined by wear and damage
due to use.
6. Use of this component for any purpose, or in any manner
other than those described here may cause component
damage or failure which could result in serious patient
injury or death. If needed, all SPY- PHI Articulating Arm
metal components or fragments thereof can be located by
means of an X-Ray.
©2020 IFU-0100 / rev3 6