Depuy Synthes BI‑MENTUM Serie Gebrauchsanweisung Seite 12

EN
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1. REVISION
No. edition Condition
& date Nature of modifications
No 2.1, Localisation in Bulgarian, Croatian,
March Czech, Danish, Estonian, Finnish,
2020 Greek, Hungarian, Latvian,
Lithuanian, Norwegian, Polish,
Romanian, Slovenian and Swedish.
N° 2, > Addition of the meaning of
May 2019 the symbols used on the device
packaging labels (figures
> Modification of paragraph No 10.
N° 1, Creation
Feb. 2019
2. MANUFACTURER
Refer to figure .
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3. DISTRIBUTOR
Refer to figure .
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4. GENERAL INFORMATION ON THE INSTRUMENTS
• This document only applies to the 4 following instrument kits:
– BI-MENTUM™ Primary Full Kit (consists of two trays),
– BI-MENTUM™ Expansion Full Tray,
– BI-MENTUM™ Plate Full Tray,
– BI-MENTUM™ Drill Full Kit.
The instruments contained in each kit are listed below.
• BI-MENTUM™ Primary Full Kit / Tray n° 1 (fig.
– ADA22-28: trial liner adaptor Ø 22/28 mm,
– CA701: angled hex wrench Ø 6 mm,
– ECM 8: liner remover,
– EI015: liner inserter tip,
– EI016: cup impactor,
– GE007-45 to GE007-61: trial cups Ø 45 - 61 mm,
– ICJB E: head impactor,
– IE006 45/22,2: trial liner Ø 45 mm / head 22.2 mm,
– IE006 47/28 to IE006 61/28: trial liners Ø 47 - 61 mm / head 28 mm,
– MP010: minimally invasive gripper shaft,
– MI 603: impaction shaft,
– PC-45 to PC-61: cup holder adaptors Ø 55 - 61 mm,
– PPN E: peg forceps.
• BI-MENTUM™ Primary Full Kit / Tray n° 2 (fig.
– ET: reamer adaptor,
– FT 43 to FT 61: countersinks Ø 43 - 61 mm,
– TFT-AO: reamer holder.
• BI-MENTUM™ Expansion Full Tray (fig.
– FT 41: countersink Ø 41 mm,
– FT 63 to FT 69: countersinks Ø 63 - 69 mm,
– GE007-41 to GE007-43: trial cups Ø 41 - 43 mm,
– GE007-63 to GE007-49: trial cups Ø 63 - 69 mm,
– IE006 41/22,2 to IE006 43/22,2: trial liners Ø 41 - 43 mm / head 22.2 mm,
– IE006 63/28 to IE006 69/28: trial liners Ø 63 - 69 mm / head 28 mm,
– PC-41 to PC-43: cup holder adaptors Ø 41 - 43 mm,
– PC-63 to PC-69: cup holder adaptors Ø 63 - 69 mm.
• BI-MENTUM™ Plate Full Tray (fig.
– ET: reamer adaptor,
– ESK E 50/43 to ESK E 60/53: trial plates,
– F 3,2-150 E: screw drill Ø 3.2 mm, length 150 mm,
– GE007-43: trial cup Ø 43 mm,
– GM 3,2-5 E: drill guide,
– IE006 43/22.2: trial liner Ø 43 mm / head 22.2 mm,
– MCFC 2: plate positioner,
– MV 700: depth gauge,
– PC-43: cup holder adaptor Ø 43 mm,
– TMA 3,5 E: manual hex screwdriver,
– TMO 3,5: motorised hex screwdriver.
URL
Internet
http://doc.serf.fr/0503.pdf
http://doc.serf.fr/0503-ed2.pdf
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http://doc.serf.fr/0503-ed1.pdf
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• BI-MENTUM™ Drill Full Kit (fig.
– EPMP6: peg extractor,
– F 3,2-150 E: screw drill Ø 3.2 mm, length 150 mm,
– GM 3,2-5 E: drill guide,
– IPCN: straight peg impactor,
– IPCNC: curved peg impactor,
– MF 5 E: flexible peg drill Ø 5 mm,
– MV700: depth gauge,
– TMA 3,5 E: manual hex screwdriver,
– TMO 3,5: motorised hex screwdriver.
5. TREATMENT AND RECYCLING OF INSTRUMENTS
BY THE MANUFACTURER PRIOR TO EXPEDITION:
• The manufacturer uses the requirements of directive DGS/R13/2011/449 from
the 1 of December 2011 and published by the French Department of Health – di-
st
rective on the updated recommendations for NCTA (Non-Conventional Transmis-
sible Agents) transmission risks reduction during invasive acts – to guarantee
clients delivery of instrument kits that are rigorously cleaned and disinfected:
– New instrument kits have been cleaned in an exceptionally efficient cleaning
chain that removes all manufacturing marks and residue.
– Recycled instrument kits undergo a cleaning cycle and thermal disinfection
at 93° C for 6 minutes in a "HAMO T21" type washer, then they are inspected
and cleaned again if necessary.
• However, since the parameters inherent to handling and transport cannot all be
controlled, the surgeon must carry out a disinfection and cleaning treatment
and, if necessary, an NCTA inactivation procedure.
6. WARNINGS:
• Operations the client must carry out on reception of the equipment, relative
to its storage:
– put it through a disinfection cycle,
– then store it in a dry, clean room.
These two operations ensure the removal of all traces of handling that could lead
to oxidation. Separate the equipment so that there is no contact with other devices.
• Composition of detergent and / or disinfecting products: the use of solutions
containing hydrogen peroxide (H
acid is not recommended for cleaning instruments made of titanium alloy or
aluminium boxes (risk of turning black). Similarly, we do not authorise the
immersion of any of our instruments in solutions containing aldehyde, or a
strong concentration of chlorine (sodium hypochlorite, etc.).
• IMPORTANT: clean and decontaminate immediately after use at the end of
the surgical operation; it is imperative that dirt be prevented from drying on
the equipment and any recyclable equipment must be soaked straight after
each use or treated immediately if using an automatic washer-disinfector. Pro-
longed contact with blood, bone and other residue may damage the equipment
and compromise the efficiency of the whole process.
7. LIMITS FOR REPROCESSING INSTRUMENT KITS:
Repeated cleaning and sterilisation cycles have little effect on ancillary equip-
ment. A piece of ancillary equipment's end of life is generally determined by
wear and damage due to use or how it is recleaned.
8. INSTRUCTIONS:
• The instructions below allow a medical device to be prepared for re-use (see
standard EN ISO 17664:2017 on the information that must be supplied by the
manufacturer regarding the re-sterilisation process for medical devices).
• The description of the products, materials and equipment, as well as their
conditions of use specified for each step, will favour safe reprocessing of the
instruments.
• It is always the surgeon's responsibility to ensure that the staff, the equipment
and the process implemented in reprocessing devices achieve the desired result.
This generally requires regular validation and checking of the procedures. Any
deviation from competent use relative to the given instructions should be cor-
rectly assessed in order to determine efficiency and any adverse consequences.
• The products, dosages, equipment and conditions of use given in brackets come
under the manufacturer's protocol for preparing equipment for sterilisation.
• The product references quoted have been tested by the manufacturer and are
given as examples.
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