Medtronic RC404022-E Instructions for Use

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Reprocessing Instructions

Issue Date

2009/08/03

Product Rod cutter; manual surgical instrument intended for medical purposes to cut metallic bone xation appliances non-insitu for orthopedic surgery.

Caution This side up. Do not extend past line when cutting. Slide collar to disengage . Add 10 mm to length for cut. Lubricate all moving parts prior
to use.

Warnings Instruments are provided non-sterile. Clean and sterilize prior to each use. Disassemble instruments prior to cleaning and sterilization. During cleaning of
tight lumina or drill holes special attention might be required. USA – RX ONLY – Caution: Federal (USA) law restricts this device to sale by or on the
order of a licensed healthcare practitioner.

Advice In case of damage, the device should be reprocessed before returning to the manufacturer for repair.

Reprocessing Limitations Repeated reprocessing has minimal effect upon manual instruments. End of life is determined by wear and damage due to use.

Preparation at the Point of Use Remove gross soiling by submerging the instrument into cold water (<40°C) immediately after use. Don’t use a xating detergent or hot water (>40°C) as
this can cause the xation of residua which may inuence the result of the reprocessing process. Remove surface contamination with paper tissue.

Containment / Transportation Follow hospital protocols when handling contaminated and bio-hazardous materials. Instrument should be cleaned within 30 minutes after use to minimize
the potential of staining, damage, and drying.

Preparation for Decontamination The devices must be reprocessed in a disassembled and opened state.

Figure 1. To disassemble, slide the retaining collar
forward.

SLIDE COLLAR FORWARD

SLIDE COLLAR FORWARD

Figure 2. While holding the retaining collar
forward, remove the handle.

REMOVE HANDLE

REMOVE HANDLE

Figure 3. To re-assemble, slide the retaining
collar forward.

INSERT HANDLE UNTIL

INSERT HANDLE UNTIL

A “CLICK” IS HEARD

A "CLICK" IS HEARD

Document Number

KLIFUHHRC-00

Figure 4. Slide the retaining collar forward
and insert the handle until it “clicks”.

SLIDE COLLAR BACK

SLIDE COLLAR BACK

Pre-Cleaning Not required. Not required.

Disinfection

Drying

Maintenance Lubricate hinges, threads and other moving parts with a commercial water-based surgical grade instrument lubricant (such as instrument milk) to reduce

friction and wear. Follow lubricant manufacturer’s instructions. Discard blunt or damaged instruments.

Inspection / Functional Testing 1. Carefully inspect each device to ensure that all visible blood and soil has been removed.

2. Visually inspect for damage and / or wear.

3. Check the action of moving parts (such as hinges and box-locks) to ensure smooth operation throughout the intended range of motion.

4. Check instruments with long slender features (particularly rotating instruments) for distortion.

5. Where instruments form part of a larger assembly, check that the devices assemble readily with mating components.

Note: If damage or wear is noted that may compromise the function of the instrument, do not use the instrument, and notify the appropriate
responsible person.

Packaging Appropriate packaging for sterilization.

Sterilization Sterilize instruments by applying a fractionated pre-vacuum process (according to DIN EN 554 / ISO 11134) under consideration of the respective country

requirements. We have validated and recommend using the following parameters for the fractionated pre-vacuum process or gravity-process: 132°C -
137°C / 270° - 278,6 °F, (pressure depends on the temperature), 4 and < 20 minutes temperature holding time. Flash sterilization is not allowed on

lumen instruments! Store sterilized instruments in a dry, clean, and dust-free environment at modest temperatures of 5°C to 40°C.

Information The instructions provided above have been validated by the manufacturer of the medical device as being CAPABLE of preparing a medical device for

re-use. It remains the responsibility of the processor to ensure that the reprocessing as actually performed using equipment, materials and personnel in
the reprocessing facility achieve the desired result. This normally requires validation and routine monitoring of the process.

Manual Disinfection:

• Submerge instruments in a disinfection detergent according to the
detergent manufacturer’s instructions.

• Rinse the instrument with sterile water to remove the detergent.

Manual Drying:

• Dry the instrument with a lint-free towel. The instrument may never be
heated up >140°C. To avoid water residues, insufate cavities of
instruments by using sterile compressed air.

Automated Disinfection:

• Automated Thermal Disinfection in washer/disinfector under
consideration of national requirements in regards to A0-Value.

Automated Drying:

• Dry the outside of instrument through drying cycle of washer/disinfector.
If needed, additional manual drying can be performed using a lint-free
towel. Insufate cavities of instruments by using sterile compressed air.

Patented
Not for use in-situ use. Fully seat rod before cutting. Do not bend or twist instrument while cutting.

Beere and KMedic are registered tradmarks of Teleex Medical, Inc. ©2009 All righst reserved.

5307 95th Avenue
Kenosha, WI 53144
800-295-8505
262-657-2819 (Fax)

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Medtronic, USA