RUDOLF Medical GmbH
Bone Rongeur Forceps Instuctions for Use
4 Pages

Preview
Page 1
INSTRUCTIONS FOR USE (EN) D0820 / Rev.B / DCR00787
Bone Rongeur Forceps
Bone Rongeur Forceps
Item numbers See page 4. Indication Bone Rongeur Forceps are used if the bone must be kept, temporarily fixed, or bone parts have to be removed. Description The device consists of a handle with rings or branches and a jaw part. By pressing the handle or the branches together, the jaw part closes. The jaw part is strong enough for bones. It has a closing mechanism without locking and they have partly a double translation There are different sizes and models available. Lifetime The useful life of the instrument is limited to handling of the device. Bending or overloading causes damages. Careful reprocessing and easy handling ensures more than 1000 operations. If the jaw part is blunt or there are pores or cavities visible, then you must stop using the instruments.
Function check Following delivery and before each use new instruments must undergo a thorough visual examination and must be tested for functionality. If the instrument exhibits any external faults (scratches, breakages, cracks, notches, damaged insulation, bent parts or stiffness) or if they do not function in the way described, please inform us as manufacturer or our sales partners immediately. Warnings and precautions - Do not use damaged instruments. - The instrument has only a limited stability. Force applied too strongly can lead to damage and negatively affects it’s functioning. First use of new instruments - The instrument is delivered non-sterile. It must be cleaned and sterilized before the first use. Warnings and precautions - During preparation, the temperature affecting the instrument must not exceed 137°C, - Automatic cleaning and disinfection is to be preferred to manual cleaning and disinfection. The automatic cleaning and disinfection procedure is much safer.
- Never use metal brushes/sponges or abrasive cleaning agents for manual cleaning. - Only clean instruments and instruments of low microbiological contamination enable a successful sterilization. - In case of damage the devices should undergo the complete reprocessing process before being sent back to the manufacturer for repair. - Never use cleaning agents with bleaching agents, such as sodium hypochlorite, as it causes severe corrosion.
Robert-Koch Insitute (RKI) of the DGHM Deutsche Gesellschaft für Hygiene und Mikrobiologie (German society for hygiene and microbiology) and consider the instrument’s material and characteristics. See additional information of the preparation instructions at hand.
Application area - After use, the instruments must be prepared as fast as possible. - Remove residues and stains on the instrument immediately after use with a single use cloth or tissue. - Do not use a fixating agents or hot water (>40°C) as this can cause the fixation of residues which may influence the result of the reprocessing process. - Deposit them preferably in a dry place. - If necessary; soak the instruments in a solution with a suitable combination of cleaning and disinfecting agents. Please, observe the manufactures’ instructions of the cleaning and disinfecting agents. - Put the instruments in suitable wire baskets.
*the suitability of the cleaning agent as well as subsequently described method has been demonstrated based on preclinical testing / validation by RUDOLF Medical.
Transportation - Safe storage and transportation in a closed container to the reprocessing area to avoid any damage of the instruments and contamination of the environment. Cleaning Automated cleaning - Clean and disinfect the instrument only in suitable washers and disinfectors (WD) and with for the WD and the instrument validated procedure / program according to EN ISO 15883. - Suitable WDs are provided with special cleaning baskets / slide-in carts for sensitive instruments. - Avoid any rinsing shadows when loading the WD slide-in cart with instruments in order to obtain an ideal rinsing pressure for the entire instrument. Pay special attention to the jaws. - Do not overload the WD slide-in carts, do not pile them up. - Please observe the instructions for use and loading indications of the WD manufacturer. - When choosing the appropriate cleaning agents see the respective lists and recommendations of the
Cleaning agents for automatic cleaning in WD Manufacturer Trade name Dr. Weigert GmbH & Co. KG Neodisher FA Borer Switzerland Deconex 23 Neutrazym
A - Cleaning program (Miele G 7735) - 1 min. pre-cleaning with cold water - Draining - 3 min. pre-cleaning with cold water - Draining - 5 min cleaning at 55°C with 0,5 % alcaline detergent - or 5 min cleaning at 45°C with 0,5 % enzymatic detergent - Draining - 3 min. neutralization with warm water (>40°C) and neutralizer - Draining - 2 min. rinse with warm tap water (>40°C) - Draining Maintenance, Control and Inspection - After the cleaning and disinfection, the instruments must be inspected visually for cleanness. They must be macroscopically clean (no visible residues/soiling). Pay special attention to grooves, ratchets, closures and other difficult accessible areas. - Should there still be any visible residues or liquids repeat the cleaning and disinfecting procedure. - Prior to any sterilization the instruments must be assembled and inspected for function, wear and tear and for damages, and if necessary it has to be exchanged. After the inspection, dismantle the instrument if necessary for sterilization. - The lock must be oiled with medical grade white oil (RUDOLF RU 8880-03)
Page 1 of 4
INSTRUCTIONS FOR USE (EN) D0820 / Rev.B / DCR00787
Packaging - Appropriate packaging for sterilization according ISO 11607 and EN 868. - Generally, adjust the sterilizing accessories and the sterile packing to the content of the packing instrument and the sterilization procedure. - Please, observe the manufactures’ instructions of the sterilizer. Lubrication - The use of a water-soluble instrument lubricant that is compatible with pre-vacuum steam sterilization is recommended before instruments are sterilized. - After cleaning proper application of lubricants to movable parts will keep them moving freely and aid in protecting surface from mineral deposits regardless of the surface coating. - Use appropriate lubricants only (paraffin oil according DAB 8 and. Ph. Eur. or USP), e.g. RUDOLF RU 888003 Sterilization - Sterilization is to be carried out using a steam sterilization procedure validated by DIN EN ISO 13060 / ISO 17665 (fractionated vacuum procedure) in a sterilizer in accordance with EN 285, DIN 58946. - 3 pre-vacuum phases with at least 60 mbar pressure - 134°C - 5 min or 132°C - 4min. - Drying time: minimum 10 min. - Please, observe the manufactures’ instructions of the sterilizer. Storage - The reprocessed instruments must be stored in suitable and reusable sterilization containers in accordance with DIN EN 868-1 and DIN EN 868-8 and should be stored until use in accordance with DIN 58953-9. - The sterilizing container should be designed in such a way that the instrument is safely fixed and protected from damage. - Storage of sterilized instruments in a dry, dark, low microbiologically contaminated clean and dust free environment at moderate temperatures of 5°C to 40°C. - The storage area should be free of temperature fluctuations.
Bone Rongeur Forceps Additional Instructions - If the described chemistry and machines are not available, it is the duty of the user to validate his process. - It is the duty of the user to ensure that the reprocessing processes including resources, materials and personnel are capable to reach the required results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly. Likewise, any modification by the reprocessor from the instructions provided must be properly evaluated for effectiveness and potential adverse consequences. Repairs - Even when used as intended surgical instruments are subject to more or less severe wear, depending on how intensely they are used. This wear cannot be avoided due to technical reasons. - Please do not carry out any repairs yourself. Servicing and repairs may only be carried out by ourselves - the manufacturer - or by other persons we authorized. - Surgical instruments that are to be sent back for repair must be cleaned, disinfected and sterilized.
Caution! Failure to observe the warnings and precautions can lead to death or serious injuries.
Symbols and explanations Please read these instructions carefully before using the product for the first time. Always follow the instructions in this manual. Keep these instructions for use in a safe place.
Joint/Lock Types Detachable Sliding sheath with „Peacock-Eye“ lock, detachable:
Batch code
Article number
Non-sterile Indicates a possible danger to persons or property
1
CE marking
Symbol for manufacturer lubricate with white medical oil at the marked area
2
3 (1)
Push the sheath behind
(2)
Pull the sheath up
(3)
Pull the handle down
Page 2 of 4
INSTRUCTIONS FOR USE (EN) D0820 / Rev.B / DCR00787
-
PROCLEAN sliding sheath with “swing out” lock detachable:
Bone Rongeur Forceps Not detachable Sliding sheath with screw lock:
-
Box Lock
-
Screw Lock
-
Screw lock with lap joint
1
2
3
(1)
Lift up the opening lever
(2)
Push opening lever to right side
(3)
Remove upper part RUDOLF Medical GmbH + Co. KG Zollerstr. 1, 78567 Fridingen, Germany Tel. +49 7463 9956-0 Fax +49 7463 9956-56 [email protected] www.rudolf-med.com
Page 3 of 4
INSTRUCTIONS FOR USE (EN) D0820 / Rev.B / DCR00787
Bone Rongeur Forceps
Item numbers
RU 6481-02
RU 6481-03
RU 6481-21
RU 6494-04
RU 6495-00
RU 6495-08
RU 5555-12
RU 5557-14
RU 5558-01
RU 6481-22
RU 6481-23
RU 6482-01
RU 6495-10
RU 6495-65
RU 6495-79
RU 5558-02
RU 5559-17
RU 5560-12
RU 6482-01P
RU 6482-02
RU 6482-02P
RU 6496-22
RU 6496-35
RU 6496-65
RU 5560-14
RU 5560-15
RU 5561-15
RU 6482-03
RU 6482-03P
RU 6483-01
RU 6497-11
RU 6497-12
RU 6497-81
RU 5561-20
RU 5561-90
RU 5562-14
RU 6483-02
RU 6483-03
RU 6484-01
RU 6497-82
RU 6497-83
RU 6498-00
RU 5562-17
RU 5563-18
RU 5564-01
RU 6484-02
RU 6484-03
RU 6484-31
RU 6498-06
RU 6498-07
RU 6498-08
RU 5564-02
RU 5564-03
RU 5565-20
RU 6484-32
RU 6484-33
RU 6485-01
RU 6498-18
RU 8080-00
RU 8080-00P
RU 5566-16
RU 5568-16
RU 5569-03
RU 6485-01C
RU 6485-01P
RU 6485-02
RU 8080-02
RU 8080-03
RU 8081-00
RU 5569-04
RU 5570-16
RU 5570-19
RU 6485-02P
RU 6485-03
RU 6485-03P
RU 8081-00P
RU 8090-00
RU 8090-00P
RU 5571-16
RU 5571-19
RU 5572-18
RU 6485-101
RU 6485-102
RU 6486-01
RU 8090-01
RU 8090-01P
RU 8090-02
RU 5573-17
RU 5574-17
RU 5575-01
RU 6486-02
RU 6486-03
RU 6486-51
RU 8090-02P
RU 8090-03
RU 8090-03P
RU 5575-02
RU 5575-03
RU 5576-15
RU 6486-52
RU 6486-61
RU 6486-62
RU 8090-04
RU 8090-04P
RU 8090-05
RU 5576-19
RU 5577-18
RU 5578-19
RU 6487-01
RU 6487-02
RU 6487-03
RU 8090-05P
RU 8090-24
RU 8090-31
RU 5579-01
RU 5580-17
RU 5580-67
RU 6487-41
RU 6487-42
RU 6487-43
RU 8090-32
RU 8090-33
RU 8090-34
RU 5581-17
RU 5581-67
RU 5582-01
RU 6487-51
RU 6488-01
RU 6488-01P
RU 8091-00
RU 8091-00P
RU 8091-01
RU 5582-15
RU 5583-15
RU 5584-15
RU 6488-02
RU 6488-02P
RU 6488-03
RU 8091-01P
RU 8091-02
RU 8091-02P
RU 5585-01
RU 5585-02
RU 5585-21
RU 6488-03P
RU 6488-101
RU 6488-102
RU 8091-03
RU 8091-03P
RU 8091-04
RU 5587-02
RU 5587-11
RU 5587-12
RU 6489-01
RU 6489-02
RU 6490-01
RU 8091-05
RU 8091-24
RU 8091-31
RU 5587-13
RU 5588-03
RU 5588-15
RU 6490-02
RU 6490-03
RU 6490-21
RU 8091-32
RU 8091-33
RU 5589-13
RU 5589-15
RU 5590-18
RU 6490-31
RU 6490-32
RU 6490-33
RU 5592-18
RU 5593-17
RU 5594-02
RU 6491-01
RU 6491-02
RU 6491-03
RU 5594-18
RU 5594-23
RU 5594-24
RU 6492-01
RU 6492-02
RU 6492-03
RU 5594-34
RU 5594-51
RU 5594-53
RU 6493-01
RU 6493-02
RU 6493-02/23
RU 5595-20
RU 5596-24
RU 5597-03
RU 6493-03
RU 6493-04
RU 6493-05
RU 5597-13
RU 5597-14
RU 5597-15
RU 6493-06
RU 6493-07
RU 6493-08
RU 5597-23
RU 5597-24
RU 5597-25
RU 6493-103
RU 6493-21
RU 6493-22
RU 5598-01
RU 5598-02
RU 5598-11
RU 6493-23
RU 6493-24
RU 6493-25
RU 5598-12
RU 5600-22
RU 5600-22C
RU 6493-26
RU 6493-27
RU 6493-28
RU 5600-27
RU 5601-22
RU 5601-27
RU 6493-29
RU 6493-30
RU 6493-41
RU 5602-23
RU 5603-08
RU 5603-12
RU 6493-42
RU 6493-43
RU 6493-44
RU 5604-23
RU 5605-02
RU 5605-03
RU 6493-45
RU 6493-46
RU 6493-47
RU 5605-04
RU 5606-03
RU 5606-04
RU 6493-48
RU 6493-49
RU 6493-50
RU 5606-05
RU 5606-06
RU 5606-07
RU 6493-52
RU 6493-61
RU 6493-62
RU 5606-08
RU 5606-13
RU 5606-14
RU 6493-63
RU 6493-64
RU 6493-65
RU 5606-15
RU 5606-16
RU 5606-17
RU 6493-66
RU 6493-67
RU 6493-68
RU 5606-18
RU 5607-23
RU 5608-08
RU 6493-70
RU 6493-71
RU 6493-81
RU 5608-23
RU 5608-23S
RU 5610-29
RU 6493-82
RU 6493-83
RU 6493-84
RU 5611-29
RU 5616-34
RU 6480-01
RU 6493-85
RU 6493-86
RU 6493-87
RU 6480-02
RU 6480-03
RU 6481-01
RU 6493-90
RU 6494-02
RU 6494-03
Page 4 of 4