Stryker 70-76271 Anwendung

MANUFACTURED AND DISTRIBUTED BY:
Stryker Leibinger GmbH & Co. KG
®
Bötzinger Straße 41
D-79111 Freiburg (Germany)
Phone: +49 (0) 761 4512-0
Fax: +49 (0) 761 4512-120
ALL OF THESE INSTRUCTIONS FOR USE MUST BE READ
GB
CAREFULLY PRIOR TO CLINICAL USE
INIDCATION FOR USE:
The Stryker ® Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected
by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible
and/or full load bearing procedures.
CONTRAINDICATIONS
• Active Infection
• Patient conditions including blood supply limitations, insufficient quality or quantity of bone or latent infection
• Mandible or temporal mandibular joint
• Full load bearing procedures
POSSIBLE ADVERSE EFFECTS
In many instances, adverse results may be clinically related rather than implant related.
• Bone resorption and poor bone formation
• Infection
• Tissue damage as a result of surgical trauma
• Metal sensitivity reactions
HANDLING INFORMATION
The Torque-Limiting Drivers are components of the Delta System. The 1.7 mm Driver accepts the 1.7 mm Blade (Ref. 70-71770), the
2.2 mm Driver accepts the 2.2 mm Blade (Ref. 70-72270) and the 2.6 mm Driver accepts the 2.6 mm Blade (Ref. 70-72670). Each is
used to drive screws into the resorbable plates used in fixation of the craniofacial skeleton subsequent to trauma or reconstruction.
Before screw insertion make sure that the pilot hole has been tapped.
1. Pull back front collar of driver handle and insert blade fully. Release collar. Pull and twist blade to ensure it is securely installed.
2. To load a screw, align tips on blade with screw-head opening, and press firmly downward.
3. To activate torque limiting feature, slide switch to ON position.
4. Thread screw into tapped hole until fully seated against plate. Tighten until torque limiting feature engages.
CAUTION: If screw needs additional tightening, turn off the torque limiting feature by placing the switch in the OFF position. Proceed
carefully as excessive force may damage the torque-limiting feature.
NOTE: Screw may be able to take only a small amount of extra torque after torque limiting feature engages.
5. Rock driver slightly back and forth to remove blade from screw head.
SCREW REMOVAL
Turn torque limiting feature off to remove the screw. CAUTION: DO NOT reuse screw after it has been removed.
WARNINGS AND PRECAUTIONS
• Only trained and experienced health care professionals should use this equipment. Before using any system component or any
component compatible with this system, read and understand the instructions for use. Pay special attention to warning information,
intended uses, indications/contraindications, compatibility and correct handling of the implant, instruments and accessories. Failure to
comply may result in patient and/or operating room staff injury. As well as failure to use the proper component to maintain adequate
blood supply and provide rigid fixation may result in loosening, bending, or fracturing of the product and/or bone. Before the operation
ensure that all components needed for the operation are available in the operation theatre.
• Responsibility for proper selection and information of patients, adequate training, experience in the choice and placement of implants
and the decision to leave or remove implants postoperatively, rests with the surgeon. Misuse may cause injury to the patient.
• Implants, instruments and accessories are produced and designed to be used together. The use of products from other manufacturers´
along with Stryker ® products can involve incalculable risks and/or contamination of the material and misalignments of implants and
instruments, thereby endangering the patient, user or third parties. Only the products of one system should be used together.
• Contamination by non-conventional transmissible agents, e.g. vCJD, in accordance with the system indications for use, particularly
through contact with lymphatic tissue, is possible. Stryker
contaminated by non-conventional transmissible agents.
CLEANING & DISINFECTION PROCEDURE
New products must be carefully cleaned before initial sterilization. Trained personnel must perform cleaning along with maintenance and
mechanical inspection prior to initial sterilization. Instruments should be cleaned in accordance with the following decontamination and
cleaning specifications:
Two methods of cleaning Stryker medical devices are provided in these instructions, a manual method and a method using an automated
®
washer disinfector. Whenever possible the automated method should be used. The automated cleaning process is more reproducible and
therefore more reliable, and staff are exposed less to the contaminated devices and the cleaning agents used. Whichever method is used,
staff should use suitable protective clothing and equipment at all times. In particular take note of the instructions provided by the cleaning
agent manufacturer for correct handling and use of the product.
Please note that guidance concentrations and times for device immersion in the cleaning solutions and/or disinfectants given by the
detergent manufacturers are to be observed. If these concentrations and times are exceeded significantly then discoloration or corrosion
could occur with some materials. This could also happen if rinsing after cleaning and/or disinfecting is insufficient.
For cleaning or disinfecting medical devices, only specifically formulated cleaning agents and/or disinfectants (detergents) should be used.
In general, mild alkaline agents (up to pH 10.5) may be preferred for cleaning, however use only agents recommended for use in the used
washer/disinfector. In all cases respect the indications, instructions and warnings provided by the supplier of the cleaning agent.
For cleaning and/or disinfection of medical devices manufactured from aluminum alloys (for example modules and inlays), a pH neutral
agent should be used. Contact with strong alkaline detergents or solutions containing iodine or chlorine should be avoided, since the
aluminum can be chemically attacked and the instrument may be damaged.
The quality of the water used for diluting cleaning agents and/or disinfectants and for rinsing medical devices should be carefully considered
(application of freshly prepared Purified Water/Highly Purified Water or sterile water for rinsing aims (according to the pharmacopeias) with
less than 10 cfu/ml and 0.25 EU/ml is highly recommended). Mineral residues from hard water as well as higher contamination with
microorganisms and endotoxins can result in staining of the device or prevent effective cleaning and decontamination.
Cleaning and disinfection of equipped sterilization trays must not be performed (trays not designed for cleaning and disinfection in its
equipped state).
Point of use:
Directly after application (within a maximum of 2 h), remove gross soil using absorbent paper wipes. Additionally, rinsing of the medical
devices intensively with running water or transfer of the medical devices into a bath with an aldehyde-free (otherwise fixation of blood
impurities) disinfectant solution is highly recommended.
CAUTION: Stryker modules are intended for sterilization, transport and storage of medical devices. The module is not designed for cleaning
and disinfection of contaminated instrumentation and storage components. If contamination does occur, clean the storage components/
instrumentation separately before reassembling the components for sterilization.
Transport to processing area:
Avoid mechanical damage, e.g. do not mix heavy devices with delicate ones. Pay particular attention to cutting edges, both to avoid injury
and damage to the medical device. Get the medical devices to the point where cleaning is to be performed as soon as practical. (If transfer
to the processing area is likely to be delayed, consider covering the medical devices with a damp cloth or handle the medical devices in
closed boxes to avoid drying out of the soil.)
INSTRUCTIONS FOR USE:
DELTA Screwdriver Handles
REF. 70-76271, 70-76273, 70-76274
DISTRIBUTED IN THE USA BY:
Stryker Craniomaxillofacial
®
Kalamazoo, MI 49002
(USA)
Phone: +1-800-962-6558
Fax: +1-877-648-7114
® recommends incinerating any product that is suspected to have been
Preparation for cleaning:
Disassemble the device where possible. See instructions provided in the operative technique or separate information available from your
Stryker representative.
®
Pre-Cleaning:
Remark: The Pre-Cleaning step can be omitted in case of direct subsequent manual cleaning and disinfection.
Equipment required:
• Cleaning bath or vessel large enough to allow complete immersion of the instruments
• Freshly prepared cleaning solution comprising a cleaning agent with concentration, temperature, and soaking time not less than
according to the detergent manufacturers´ instructions (but temperature not more than 122 °F (50 °C))
• Personal protective equipment as recommended by the cleaning agent supplier (minimum overalls, gloves, face/eye shield)
• Absorbent paper
• Syringes (volumes 1 to 50 ml dependent on the size of the channels to be rinsed)
Procedure:
• Remove gross soil using paper wipes and solution of cleaning agent.
• Immerse medical device in solution of cleaning agent.
• Ensure that all surfaces are thoroughly wetted, using a syringe to ensure that solution reaches all parts of the device. Ensure that air is
not trapped within features of the device when immersing in the solution.
USA
• Soak at minimum for the time recommended by the detergent manufacturers´ instructions.
• Using suitable brushes (only soft brushes, in no event metal brushes or steel wool) to clean the medical device thoroughly paying
particular attention to rough surfaces and features where soil may be shielded from the brushing.
• Operate articulating devices and those with moving parts.
• Rinse in running water until all traces of cleaning solution are removed (for at least 1 min).
• Pay particular attention to blind holes (at least three times complete rinsing by application of a syringe (volume 1-50 ml) required) as
well as joints between mating parts.
• Visually inspect for any remaining soil and repeat the steps above if necessary.
• Allow to drain on absorbent paper or transfer immediately to cleaning step.
MANUAL CLEANING
Warning: Combined cleaning and disinfection procedures are only recommended in case of extremely low contaminated medical devices.
Equipment required:
• Ultrasonic bath large enough to allow complete immersion of the instrument. Frequency 25-50 kHz, temperature according to
detergent manufacturer`s instructions.
• Cleaning, concentration according to the detergent manufacturer's instructions.
• Suitable brushes (only soft brushes, in no event metal brushes or steel wool) or cleaning wires (for small channels) to reach all parts
of the device.
• Syringes (volumes 1-50 ml dependent on the size of the channels to be rinsed)
• Freshly prepared Purified Water/Highly Purified Water or sterile water for rinsing purposes.
Procedure:
• Prepare an ultrasonic bath with cleaning solution at concentration and temperature according to the detergent manufacturers´
instructions.
• Immerse the device completely and activate the bath at least for the time according to the detergent manufacturers´ instructions.
• Using suitable brushes (only soft brushes, no metal brushes or steel wool) or cleaning wires (for small channels) clean the device paying
particular attention to rough surfaces and features that may be shielded from the brushing action. Additionally, pay particular attention to
blind holes (at least three complete rinsing by application of a syringe required) as well as joints between mating parts.
• If, after completion of the cleaning step in the ultrasonic bath, encrusted soil remained on the device which had to be removed with the
brush, the cleaning step must be repeated as described above.
• Rinse in running water of the specified quality until all traces of cleaning solution are removed (for at least 1 min). Pay particular
attention to blind holes (at least three complete rinsings by application of a syringe (volume 1-50 ml) required) as well as joints
between mating parts.
MANUAL DISINFECTION
Equipment required:
• Bath large enough to allow complete immersion of the instrument, temperature according to detergent manufacturer`s instructions.
• Disinfectant, concentration according to the detergent manufacturer's instructions.
• Suitable brushes (only soft brushes, no metal brushes or steel wool) or cleaning wires (for small channels) to reach all parts of the
device.
• Syringes (volumes 1-50 ml dependent on the size of the channels to be rinsed)
• Freshly prepared Purified Water/Highly Purified Water or sterile water for rinsing purposes.
• Filtered medical compressed air (if available) or clean and lint-free single-use wipes.
Procedure:
• Prepare a bath with disinfectant solution at concentration and temperature according to the detergent manufacturers´ instructions.
• Immerse the device completely at least for the time according to the detergent manufacturers´ instructions.
• Using suitable brushes clean the device paying particular attention to rough surfaces and features that may be shielded from the
brushing action. Additionally, pay particular attention to blind holes (at least three complete rinsing by application of a syringe required)
as well as joints between mating parts.
• Rinse in running water of the specified quality until all traces of disinfectant solution are removed (for at least 1 min). Pay particular
attention to blind holes (at least five complete rinsings by application of a syringe (volume 1-50 ml) required) as well as joints between
mating parts.
• Dry the medical device using medical compressed air and clean and lint-free single-use wipes (if required supplemented by post-
drying at a clean place for not more than 2 hours) or by heating in an oven below 230 °F (110 °C).
• Visually inspect and repeat complete manual cleaning and disinfection if necessary.
AUTOMATED CLEANING AND DISINFECTION USING WASHER-DISINFECTOR (recommended)
Equipment required:
• Washer disinfector with fundamentally approved efficiency (for example CE marking or FDA approval according to ISO 15883),
properly installed, qualified and regularly maintenanced and tested
• Approved thermal disinfection program (A
(90 °C); chemical disinfection program not recommended (danger of remnants of the disinfectant on the instruments)) with sufficient
rinsing steps and filtered air for an active drying program (application of rinsing aids not recommended, danger of remnants)
• Final rinsing/disinfection only with freshly prepared Purified Water/Highly Purified Water
• Cleaning agent, concentration according to the detergent manufacturer's instructions.
Procedure:
• Load the medical devices into the washer disinfector.
• Avoid contact between devices (movement during washing could cause damage, and washing action could be obstructed).
• Arrange medical devices so that blind holes incline downwards (to assist drainage).
• Articulating devices should be in the open position.
• Operate the washer disinfector cycle.
• On completion unload the washer disinfector. Visually inspect each device for remaining soil and dryness. If soil remains repeat the
cleaning process, including the pre-cleaning stage. Remaining moisture may be removed with medical grade compressed air, clean
and lint-free single-use wipes (if required supplemented by post-drying at a clean place for not more than 2 hours) or by heating in
an oven below 230 °F (110 °C).
INSPECTION
Before preparing for sterilization, all medical devices should be inspected. Generally un-magnified visual inspection under good light
conditions is sufficient. All parts of the devices should be checked for visible soil and/or corrosion.
Particular attention should be paid to:
• Soil "traps" such as mating surfaces.
• Recessed features.
Functional checks should be performed where possible:
• Medical devices with moving parts should be operated to check correct operation (medical grade lubricating oil suitable for steam
sterilization can be applied as required).
NOTE:
Stryker ® does not define the maximum number of uses appropriate for re-usable medical devices. The useful life of these devices is
dependent on many factors including the method and duration of each use, and the handling between uses. Careful inspection and
functional test of the device before use is the best method of determining the end of serviceable life for the medical device.
CAUTION: DO NOT soak the handle in saline. Saline will cause internal corrosion.
STERILIZATION
CAUTION: Handle and blade must be separated for sterilization.
WARNING: DO NOT Flash autoclave components in the Delta System sterilization containers.
• Exact compliance is required with the manufacturers´ user instructions for sterilizers.
• If not expressly specified as sterile, the product is supplied non-sterile.
value greater than 3000 or – in case of older devices – application of at least 5 min at 194 °F
0