Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Brand: Steris

Model: Harmony La Surgical Lighting And Visualization System

Type: Operating instructions

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

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

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Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Steris Harmony La Surgical Lighting And Visualization System Operating instructions

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