B.Braun Aesculap Ennovate Cervical Mode D'emploi page 3

2.4.3 Sterility
Non-sterile products
The SecureSpan screws needed for the laminoplasty are supplied in an unsterile condition.
The screws are packaged individually.
►
Store the screws in their original packaging and only remove them from their original and protective packaging
immediately prior to processing.
►
Use the implant system storage devices for sterilization and sterile setup.
►
Ensure that the screws in their implant system storage devices do not come into contact with each other or with
instruments.
►
Ensure that the screws are not damaged in any way.
Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the fol-
lowing validated reprocessing procedure described below.
Sterile single-use products
All implants of the Ennovate Cervical System are provided as sterile single use implants. The products have been radi-
ation-sterilized and are supplied in sterile packaging.
►
Do not use products from open or damaged sterile packaging.
►
Do not use the product after its use-by date.
►
Do not reuse the product.
The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired
functionality of the product.
►
Do not reprocess the product.
2.5 Patient education
Within the framework of the patient education, the relevant circumstances needed for consent must be explained
to the patient in accordance with their level of understanding, pre-existing knowledge and need for information.
This includes:
■
Diagnosis, procedure and risk clarification
■
Operative procedure
■
Advantages and disadvantages of the procedure
■
All alternative procedures that can be considered
The patient must be properly informed about the procedure and in particular about the following information:
■
Delayed healing or incomplete fusion can cause the implant to fracture or loosen as a result of the extreme load
to which it is subjected.
■
The life-span of the implant depends on the patient's body weight.
■
The implant components must not be overloaded by extreme strains, hard physical labor or sports.
■
Corrective surgery may be necessitated by implant loosening, fracture or loss of correction.
■
Smokers present an increased risk of bone fusion failure.
■
The patient must undergo medical check-ups of the implant components at regular intervals.
3. Application
3.1 Documentation
The user shall devise an operation plan that specifies and accurately documents the following:
■
Selection of the implant components and their dimensions
■
Positioning of the implant components in the bone
■
Location of intraoperative landmarks
Important information concerning the implanted product and the operation can be noted down on the patient ID.
The patient ID can be ordered separately from the manufacturer.
Each package contains additional labels showing the designation, article and lot number and – if applicable– the
individual serial number of the product.
►
Use these labels for documentation in the patient's file (for the hospital) and the patient ID (for the patient).
3.2 Implantation
WARNING
All the risks related to the implantation are described in detail in the corresponding instruments' instruction
for use!
►
Thoroughly read the instruments' instructions for use before using any implant.
►
Implant all implants of the Ennovate Cervical system only with Ennovate Cervical instruments.
►
Implant SecureSpan screws only with Securespan instruments.
The surgical technique is described in detail in following documents:
Art. no. Designation
TA015763 IFU ENNOVATE CERVICAL BASIC INSTRUMENTS
TA015762 IFU ENNOVATE CERVICAL NAVIGATED INSTRUMENTS
TA015760 IFU ENNOVATE CERVICAL OCCIPUT INSTRUMENTS
TA015761 IFU ENNOVATE CERVICAL C1/C2 INSTRUMENTS
TA015766 IFU ENNOVATE CERVICAL MIS INSTRUMENTS
TA015755 IFU ENNOVATE CERVICAL TRAYS
TA013082 IFU SECURESPAN
TA013131 IFU SECURESPAN INSTRUMENTS
O03102 ENNOVATE CERVICAL - SURGICAL TECHNIQUE
O03202 ENNOVATE CERVICAL NAVIGATION - SURGICAL TECHNIQUE
O03302 ENNOVATE CERVICAL MIS - SURGICAL TECHNIQUE
O47602 SECURESPAN - SURGICAL TECHNIQUE
►
Note the following in particular:
– All requisite implant components must be ready to hand.
– All the implantation instruments, including the special Aesculap implant system instruments, must be com-
plete and in working order.
4. Validated reprocessing procedure
The validated reprocessing procedure applies to the SecureSpan screws, which are single use implants provided in
an unsterile condition.
►
Do not reuse the product.
All other implants are provided as sterile single use implants.
►
Do not reprocess the product.
4.1 General safety instructions
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
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
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician is responsible for this.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
4.2 Limitations on reprocessability
Influences of the reprocessing which lead to damage to the product are not known.
A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is
no longer functional, see Inspection.
4.3 Product-specific safety information on the reprocessing method
►
Use the implant system storage devices only for sterilization and sterile setup.
►
Use a suitable tray for cleaning/disinfection.
►
Ensure that the implant components do not come into contact with each other.
►
Ensure that the implant components are not damaged in any way.
Intraoperative contamination with blood, secretions, and other fluids may render the affected component unsuitable
for resterilization!
►
Handle the implants with new gloves only.
►
Keep the implant system storage devices/trays covered or closed.
►
Process implant system storage devices/trays separately from instrument trays.
►
Clean implants must not be cleaned together with contaminated implants.
►
Reprocess the implant components individually and separately if no implant system storage devices are available,
When doing this, make certain that the implant components are not damaged.
►
Mechanically clean and disinfect the implant components.
►
Do not reuse surgically contaminated implants.
Direct or indirect contamination may render implants unsuitable for resterilization!
►
Do not reprocess implants that have been directly or indirectly contaminated with blood.
4.4 Manual cleaning/disinfection
4.4.1 Manual cleaning with ultrasound and immersion disinfection
Phase Step T
[°C/°F]
I Ultrasonic cleaning RT
(cold)
II Intermediate rinse RT
(cold)
III Disinfection RT
(cold)
IV Final rinse RT
(cold)
V Drying RT
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, microbiological, at least drinking water quality)
RT: Room temperature
*Recommended: BBraun Stabimed fresh
Phase I
►
Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for 5 min. Ensure that all accessible surfaces
are immersed and acoustic shadows are avoided.
►
Do not clean with brushes or other abrasives that would damage the product surface.
Phase II
►
Rinse all accessible product surfaces under running water.
►
Drain any remaining water fully.
Phase III
►
Fully immerse the product in the disinfectant solution.
Phase IV
►
Rinse all accessible product surfaces under running water.
►
Drain any remaining water fully.
Phase V
►
Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air).
4.5 Mechanical cleaning/disinfecting with manual pre-cleaning
Note
The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark
according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
4.5.1 Manual pre-cleaning with ultrasound
Phase Step D
[°C/°F]
I Ultrasonic cleaning RT
(cold)
II Rinsing RT
(cold)
D–W: Drinking water
RT: Room temperature
*Recommended: BBraun Stabimed fresh
t Conc. Water Chemistry
[%] quality
[min]
5 2 D–W Concentrate, aldehyde-free,
phenol-free, pH ~ 9*
1 - D–W -
15 2 D–W Concentrate, aldehyde-free,
phenol-free, pH ~ 9*
1 - FD-W -
- - - -
t Conc. Water Chemical
[%] quality
[min]
5 2 D–W Concentrate, aldehyde-free,
phenol-free, pH ~ 9*
1 - D–W -