FIS-001
Page 3 of 33
1.0
INTRODUCTION
The Healthmark Inspection Camera is intended for inspection of medical and surgical
instrumentation after cleaning, and prior to sterilization, or post sterilization. It may be used on
the outside or inside surfaces of instruments including devices such as arthroscopy routers,
shavers, reamers, and Yankauer etc….
2.0
PURPOSE
This Instructions For Use (IFU) manual describes how the camera device is to be used. Software
installation instructions are also included.
This IFU contains essential information on using this device safely and effectively. Before use,
thoroughly review and be familiar with this manual and the manuals of all equipment that will be
used during the inspection procedure. Use the devices as instructed. Keep this and all related
instruction manuals in a safe, accessible location. If you have any question or comment about
any information in this IFU, please contact Healthmark at (800) 521-6624 x6657 or e-mail at
[email protected].
3.0
GENERAL DESCRIPTION
The Healthmark Inspection Camera has an extrusion with a light source and camera lens at the
distal tip. The outer diameter of the extrusion and camera head is 3.1mm max. The device
should never be inserted into a lumen or working space smaller than 3.2mm in diameter. Any
smaller lumen may cause the device to become stuck, rendering the inspected equipment
unusable, and possibly damaging the camera device.
Use this device only in spaces 3.2mm or larger in diameter.
The camera extrusion is 50cm from the distal tip to the control handle. Using the camera device
in lumens longer than this may lead to inadequate inspection because the target areas to be
inspected may be beyond the effective focal length of the device.
Ensure that all areas of equipment to be inspected are accessible by the inspection
camera; failure to do so may lead to inadequate inspection.
