MATHYS European Orthopaedics
MATHYS Gripping Head Handle Processing Instructions
2 Pages
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Page 1
Processing Instruction for Handle with Gripping Head (55.02.0520 – 55.02.0522) The reprocessing of the Handle with Gripping Head (hereinafter: the «instrument») of the RM Classic Cup / RM Pressfit instrument set needs to be performed as followed.
No.
Step
Media
1
The rod with impact plate has to be disassembled from the instrument. The disassembled instrument must be brushed with a plastic brush* and a bottle brush under tap water surface for 2 minutes to remove all visible contamination. All gaps and crevices must be rinsed with a water jet gun (1.5 – 2 bar) for at least 1.5 minute (see pictures step 3).
• Nylon brushes • Tap water • Water jet gun
2
The instrument must be immersed for 5 minutes in a cleaning solution at 40 °C and sonicated at 35 – 47 kHz. Afterwards the instrument must be rinsed unter running tap water.
• Tap water •M ildly alkaline-enzymatic cleaner 0.5 % Neodisher MediClean forte (v / v) in DI water 3 (≤ 45° C (113° F))
3
Every gap and open space of the instrument but also the gap around the rotation plate must be rinsed with a water jet gun (1.5 – 2 bar) for 10 seconds each (see blue arrows).
• Water jet gun • DI water
4
Make sure that no visible residues are present any longer. If necessary, repeat procedure. If the outflowing water is still discoloured, repeat steps 1 – 3.
• Visually
* Decontaminate brushes after use and sterilise or dispose of them. Do not use steel brushes.
1. Manual pre-cleaning For efficient manual pre-cleaning, the rotating plate in the Gripping Head must be rotated by rotating the rod with impact plate up to the uppermost stop, a quarter turn back and the rotary plate is in the cleaning position. Pictures
• N/A
• N/A
2. Automated cleaning Step
Medium
1
Pre-rinse
Duration: 2 minutes
• Cold tap water
2
Cleaning process
Duration: 10 minutes Temperature: 55 (131) °C (°F)
• Mildly alkaline–enzymatic cleaner 0.5 % Neodisher MediClean forte (v / v) in DI water 3 (≤ 45° C (113° F))
3
Rinse
Duration: 2 minutes Temperature: < 40 (104) °C (°F)
• Deionised water
4
Thermal Disinfection 1
Duration: 5 minutes Temperature: 90 (194) °C (°F)
• Deionised water
5
Drying
Duration: 15 minutes Temperature: 115 (239) °C (°F)
• Hot air
6
Make sure that no visible residues are present any longer.
Figure 2
Thermal disinfection according to DIN EN ISO 15883-1+2
3. Control and maintenance To ensure that all contamination has been removed, it is important to inspect the instrument carefully and check it for cleanliness. If any contamination should be discovered adhering to instruments, the complete cleaning process must be repeated immediately. Once the instrument is clean, it must be serviced. Mathys Ltd Bettlach recommends use of a care agent product based on paraffin / white oil that is vapour-biocompatible, suitable for steam sterilization, and steam-permeable. Alternative products must be mineral oil-free and free of silicone oil containing care products, suitable for steam sterilisation and biocompatible (see the «Red Brochure» by the AKI). The care agent must be manually applied left and right of each pin. Apply the lubricant carefully and drop by drop (Fig. 1: yellow arrow).
Figure 3
Figure 4
5. Sterilisation process with saturated steam Minimum temperature in °C
Minimum sterilisation time in minutes
Minimum drying time in minutes
Minimum pressure in mbar
Pre-vacuum 1
134
18
50
≥ 3042
Pre-vacuum 2
134
3
50
≥ 3042
Type of cycle
Figure 1
Mathys Ltd Bettlach • Robert Mathys Strasse 5 • P. O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com
1
Recommended sterilisation process
2
Validated sterilisation process
Item no. 336.010.148 03-0321-DV 2021-03 © Mathys Ltd Bettlach
1
No.
4. Function testing Insert the rod with impact plate into the hollow of the instrument, push and turn slightly to lock until a click sounds (Fig. 2). Afterwards turn the rod clock- and anticlockwise (Fig. 3). The pins must be movable in- and outwards (Fig. 4).