A
B
C
Use the Surgeon’s Control Sterile Handle to provide sterile protection of
lighthead controls on Harmony® LA, LC and LED lightheads with bezel
controls as follows:
1. Remove plastic light handle prior to installing Surgeon’s Control Handle
by unscrewing it from threaded handle adapter.
2. Refer to STERILIZATION RECOMMENDATIONS (following page), and ensure
handle is sterilized according to facility sterile protocols between each
surgical procedure.
NOTE: Before using silicone ring, note the following:
1) Reuse limit is 1000 cycles.
2)Replace ring if yellowing, deformation, cracking or other signs of
deterioration are present.
3. While wearing sterile gloves, place silicone ring in metal handle cup as
illustrated in Figure 1 "A". Do not tilt handle after silicone ring is in place.
Ensure ring does not block threaded opening on handle.
4. Screw handle (with silicone ring in place) onto threaded handle adapter.
Ensure handle is firmly tightened prior to use (see Figure 1 "B").
5. Operate and feel bezel control buttons through flexible silicone windows
(see Figure 1 "C").
6. Remove Surgeon’s Control Handle by unscrewing it from handle adapter.
WARNING – STERILITY
ASSURANCE HAZARD:
• Always sterilize both the
metal handle and
silicone ring (separately)
between procedures.
Refer to STERILIZATION
RECOMMENDATIONS for
further information.
• DO NOT use metal
handle or operate bezel
control buttons without
silicon ring in place.
!
INSTRUCTIONS FOR USE
Surgeon’s Control Sterile Handle
(03/03/20) P129389-095 Rev. 3
© 2020, STERIS Corporation. All rights reserved. Printed in U.S.A.
Figure 1. Install Surgeon’s Control Sterile Handle
For further information, please contact:
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060-1834 USA
440-354-2600 800-548-4873
www.steris.com
P129389-095 (03/03/20)
Cleaning
Recommendations
1. Remove visible debris by means of manual or automated cleaning
using an enzymatic or neutral PH cleaner/detergent and water. Any
cleaner used must be compatible with aluminum and silicone.
• If using the handle with the Surgeon Control silicone insert,
disassemble completely before cleaning.
• Follow instructions supplied with the cleaning agent regarding
temperature and dilution rates.
• Use a brush or cloth if needed.
2. Rinse thoroughly
Sterilization
Recommendation
1. Metal handle and silicone ring must be sterilized before use in any
surgical procedure.
2. When placing handle and ring in the sterilizer for processing, the best
practice is to orient all objects with openings downward, as if to allow
water (or air) to flow out.
3. Sterilize handle and silicone ring separately (disassembled, but in the
same chamber) using a cycle with either of the following parameters:
Prevacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Gravity
Temperature: 270°F (132°C)
Exposure Time: 10 minutes
Serious incidents that have occurred in relation to this medical device
should be reported to the manufacturer and competent authority in the
country where the incident occurred.
Table 1: Definition of Symbols
Symbol Definition
Medical Device
Unique Device Identifier
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