B. Braun Aesculap Spine ProSpace SN002R Gebrauchsanweisung Seite 2

ProSpace PEEK insertion instrument SN002R
Legend
1 Connector
2 Clamp
3 Tube
4 Adjustment knob
Symbols on product and packages
Symbol Explanation
Caution, general warning symbol
Caution, see documentation supplied with the product
Date of manufacture
Intended use
ProSpace PEEK insertion instrument SN002R is an instrument used for inserting ProSpace PEEK implants in the inter-
vertebral space of the lumbar spine.
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by or on order of a physician!
Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
Read, follow, and keep the instructions for use.
Use the product only for its intended purpose, see Intended use.
Remove the transport packaging and thoroughly clean the new product, either manually or mechanically, prior
to its initial sterilization.
Store any new or unused products in a dry, clean, and safe place.
Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.
Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
Replace any damaged components immediately with original spare parts.
Safe operation
Risk of injury and/or malfunction!
Always carry out a function check prior to using the product.
WARNING
Attach the clamp 2 and open ProSpace PEEK insertion instrument SN002R to its widest point, see Assembly.
Place the chosen implant onto the connector 1 of the clamp 2.
Turn the adjustment knob 4 clockwise until the implant is held securely, making sure that the pins on the con-
nector 1 of the clamp 2 have engaged with the rear sections of the implant.
Insert the implant into the prepared intervertebral disk cavity.
Keep turning the adjustment knob 4 counterclockwise until the two arrow markings meet see Fig. 4.
Release the implant from ProSpace PEEK insertion instrument SN002R.
Carefully remove ProSpace PEEK insertion instrument SN002R along the longitudinal axis of the implant.
Disassembly
Keep turning the adjustment knob 4 counterclockwise until the clamp 2 is released.
Pull clamp 2 out of tube 3 in the direction of the arrow, see Fig. 1.
Assembly
Insert the clamp 2 into the tube 3 in the direction of the arrow until it engages, see Fig. 2.
Note that the groove of the clamp 2 must align correctly with the expanding pins in the tube 3, see Fig. 3.
Once it has engaged, continue pushing the clamp 2 in the direction of the arrow and keep turning the adjustment
knob 4 clockwise until the two arrow markings meet, see Fig. 4.
The ProSpace PEEK insertion instrument SN002R has been opened to its widest point.
Validated reprocessing procedure
Note
National laws, national and international standards and directives, and product-specific hygiene regulations for
reprocessing must be observed.
Note
For patients with Creutzfeldt-Jakob Disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
It should be noted that successful reprocessing of this medical device can only be guaranteed following prior valida-
tion of the reprocessing method. The operator/sterile processing technician is responsible for this.
Note
Up-to-date information on reprocessing can be found on the Aesculap Extranet at www.aesculap-extra.net
General information
To prevent increased contamination of loaded instrument trays during use, please ensure that contaminated instru-
ments are collected separately and not returned to the instrument tray.
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion of stainless
steel. Consequently, the time interval between application and processing should not exceed 6 hours, pre-cleaning
fixating temperatures >45 °C should not be used, and no fixating disinfectants (containing aldehydes/alcohols)
should be used.
Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the
laser marking becoming unreadable visually or by machine for stainless steel.
Residues containing chlorine or chloride - e.g. in surgical residues, drugs, saline solutions, and water for cleaning,
disinfection, and sterilization - may cause corrosion damage to stainless steel (pinholing, stress corrosion), thus ren-
dering the products unusable. These must be removed by rinsing thoroughly with demineralized water and then dry-
ing.
Only use process chemicals that have been tested and approved (with VAH, DGHM, or FDA approval, for instance, or
a CE mark) and are recommended by the chemical manufacturer as being compatible with the materials. All the
chemical manufacturer's application specifications regarding temperature, concentration and contact time should
be strictly observed. Failure to do so can result in the following problems:
• Optical deterioration, e.g. fading or discoloration of titanium or aluminum surfaces. As regards aluminum, visible
changes to the surface may occur at a pH level of >8 in the application/working solution.
• Material damage such as corrosion, cracks, fractures, premature deterioration, or swelling.
Do not use oxidizing chemicals (e.g. H O ) for mechanical cleaning, as these can cause bleaching or layer loss.
2 2
Do not use process chemicals that cause stress cracks or brittleness in plastics.
Clean the product immediately after use.
Please see www.a-k-i.org for more detailed information on hygienically safe reprocessing which is protective of
materials and retains their value.
Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.
Preparations at the place of use
Disassemble the product immediately after use, as described in the respective instructions for use.
Rinse non-visible surfaces such as those in products with concealed crevices, lumens, or complex geometries,
preferably with distilled water, e.g. with a disposable syringe.
Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Preparation before cleaning
Disassemble the product prior to cleaning, see Disassembly.
Cleaning/disinfection
Damage to the product due to inappropriate cleaning/disinfecting agents and/or exces-
sive temperatures!
Use cleaning and disinfecting agents according to the manufacturer's instructions,
which
CAUTION
– are approved for use e.g. on aluminum, plastic materials, and stainless steel,
– do not attack softeners (e.g. silicone)
Observe specifications regarding concentration, temperature, and exposure time.
Do not exceed the maximum allowable cleaning temperature of 60 °C.
Carry out ultrasound cleaning:
– for additional cleaning of products with residues left after mechanical cleaning/disinfection.
Mechanical cleaning/disinfection with manual pre-cleaning
Note
The disinfector must be of tested and approved effectiveness (e.g. DGHM or FDA approval or CE mark according to DIN
EN ISO 15883).
Note
For thermal disinfection, always use fully desalinated water (demineralized, low microbial contamination: drinking
water quality at least) and ensure that Ao is >3 000 for the process.
Note
The disinfector used for processing must be serviced and checked at regular intervals.
Manual pre-cleaning with a brush
Phase Step T
[°C/°F] [min]
I Disinfectant RT
cleaning (cold)
II
Rinsing RT
(cold)
D–W: Drinking water
RT: Room temperature
Phase I
Fully immerse the product in the cleaning/disinfecting solution for at least 15 min. Ensure that all accessible sur-
faces are moistened.
Clean the product with a suitable cleaning brush until all discernible residues have been removed.
Use a suitable cleaning brush (e.g. TA007747) to clean all surfaces that are not visible, e.g. in instruments with
concealed crevices, lumens or complex geometries, for at least 1 min or until no further residues can be removed.
Maneuver non-rigid components, such as adjustable screws, hinges etc. during cleaning.
After cleaning, thoroughly rinse through these components (at least five times) with the cleaning solution using
a disposable syringe (20 ml).
Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
Phase II
Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.
Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
t Conc. Water Chemical
[%] quality
>15 2 D–W BBraun Stabimed; aldehyde-free,
phenol-free and QUAT-free
1 - D–W -