BBraun
Ennovate Storage System
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Aesculap® Ennovate
Aesculap Spine
en USA
de fr es it pt nl sv ru cs pl sk tr
Instructions for use/Technical description Storage System Note for U.S. users This Instructions for Use is NOT intended for United States users. Please discard. The Instructions for Use for United States users can be obtained by visiting our website at www.aesculapImplantsystems.com. If you wish to obtain a paper copy of the Instructions for Use, you may request one by contacting your local Aesculap representative or Aesculap's customer service at 1-866-229-3002. A paper copy will be provided to you upon request at no additional cost. Gebrauchsanweisung/Technische Beschreibung Lagerungssystem Mode d’emploi/Description technique Système de stockage Instrucciones de manejo/Descripción técnica Sistema de alojamiento Istruzioni per l’uso/Descrizione tecnica Sistema di alloggiamento Instruções de utilização/Descrição técnica Sistema de bandejas Gebruiksaanwijzing/Technische beschrijving Opslagsysteem Bruksanvisning/Teknisk beskrivning Lagringssystem Инструкция по примению/Техническое описание Система хранения Návod k použití/Technický popis Úložný systém Instrukcja użytkowania/Opis techniczny System uchwytów Návod na použitie/Technický opis Úložiskový systém Kullanım Kılavuzu/Teknik açiklama Depolama sistemi
Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com Aesculap® – a B. Braun brand TA015394
2020-03
V6
Ennovate Set Open Implantation SZ200 Art. no.
Designation
Cleaning in Tray?
Notes (see legend)
SZ201R
Ennovate Tray Open Implantation
–
–
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
TF311
Graphic Template for SZ201R (SZ200)
–
TA014010
TF291
Packing Stencil for SZ201R (SZ200)
–
–
FW692R
S4 Cleaning Device
SZ222R
Ennovate Quick Connect Ratchet Straight Handle, Medium
U+W+C
SZ224R
Ennovate Quick Connect Ratchet T-Handle
U+W+C
–
SZ225R
Optional: Ennovate Quick Connect Ratchet Drop Shaped Handle
U+W+C
SZ241R
Ennovate Pedicle Awl
–
SZ242R
Ennovate Lumbar Pedicle Probe, Straight
–
SZ243R
Ennovate Lumbar Pedicle Probe, Curved
–
SZ244R
Optional: Ennovate Thoracic Pedicle Probe, Straight
–
SZ245R
Optional: Ennovate Thoracic Pedicle Probe, Curved
–
SZ246R
Ennovate Pedicle Sounder, Straight
–
SZ247R
Ennovate Pedicle Sounder, Curved
–
SZ254R
Ennovate Screw Tap, ∅ 4.5 mm
B+C
SZ255R
Ennovate Screw Tap, ∅ 5.5 mm
B+C
SZ256R
Ennovate Screw Tap, ∅ 6.5 mm
B+C
SZ257R
Ennovate Screw Tap, ∅ 7.5 mm
B+C
SZ258R
Optional: Ennovate Screw Tap, ∅ 8.5 mm
B+C
SZ259R
Optional: Ennovate Screw Tap, ∅ 9.5 mm
B+C
SZ260R
Optional: Ennovate Screw Tap, ∅ 10.5 mm
B+C
SZ262R
Ennovate Screw Driver
U+W+C
SZ263R
Optional: Ennovate Lumbar Pedicle Probe Straight Large
–
SZ264R
Optional: Ennovate Thoracic Pedicle Probe Straight Large.
–
SZ265R
Ennovate Screw Body Manipulator
–
Change No. 61047
0482
SZ228R
Ennovate Torque Wrench Handle, 10Nm
U+W
SZ267SU
Ennovate Rod Template, 300 mm
R
SZ272R
Ennovate Rod Holding Forceps
U
SZ273R
Ennovate Rod Pusher
–
SZ280R
Ennovate Set Screw Driver
T
SZ282R
Ennovate Counter Torque L-Handle
B+C
SZ391R
Ennovate Set Screw Driver, Short
T
SZ204R
Ennovate K-Wire Tray
–
SZ369S
Ennovate MIS K-Wire, Short
R
SZ370
Ennovate MIS K-Wire, Short, Nitinol
R
Ennovate Set Open Manipulation / Optional SZ250
Ennovate Set Open Auxiliary Instruments SZ220
Art. no.
Designation
Cleaning in Tray?
Notes (see legend)
Art. no.
Designation
Cleaning in Tray?
Notes (see legend)
SZ251R
Ennovate Tray Open Manipulation/Optional
–
–
SZ221R
Ennovate Tray Open S4 Instruments
–
–
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
TF320
Graphic Template for SZ251R (SZ250)
–
TA014010
TF321
Graphic Template SZ221R (SZ220)
–
TA014010
TF300
Packing Stencil for SZ251R (SZ250)
–
–
TF301
Packing Stencil SZ221R (SZ220)
–
–
AA804R
Ennovate Screw Length Scale
–
FW023R
Ennovate/SSE/S4 Distraction Forceps Small
TA015368
SZ233R
Ennovate Open Parallel Distractor Handle
U
FW181R
Ennovate/S4 Distraction Forceps
TA014770
SZ234R
Ennovate Open Parallel Compressor Handle
U
FW210R
Ennovate/S4 Compression Forceps New Version
TA013756
SZ252R
Ennovate Open Parallel Working Tips
–
SZ253R
Ennovate Open Offset Working Tips
–
Ennovate Set MIS Implantation SZ360
SZ242R
Optional: Ennovate Lumbar Pedicle Probe Straight
–
Art. no.
Designation
Cleaning in Tray?
Notes (see legend)
SZ361R
Ennovate Tray MIS Implantation
–
–
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
TF312
Graphic Template for SZ361R (SZ360)
–
TA014010
TF292
Packing Stencil for SZ361R (SZ360)
–
SZ222R
Ennovate Quick Connect Ratchet Straight Handle, Medium
U+W+C
SZ224R
Ennovate Quick Connect Ratchet T-Handle
U+W+C
SZ225R
Optional: Ennovate Quick Connect Ratchet Drop Shaped Handle
U+W+C
SZ254R
Ennovate Screw Tap, ∅ 4.5 mm
B+C
SZ255R
Ennovate Screw Tap, ∅ 5.5 mm
B+C
SZ256R
Ennovate Screw Tap, ∅ 6.5 mm
B+C
SZ257R
Ennovate Screw Tap, ∅ 7.5 mm
B+C
SZ258R
Optional: Ennovate Screw Tap, ∅ 8.5 mm
B+C
SZ259R
Optional: Ennovate Screw Tap, ∅ 9.5 mm
B+C
SZ260R
Optional: Ennovate Screw Tap, ∅ 10.5 mm
B+C
SZ372T
Ennovate MIS Dilator, Small
B+C
SZ373T
Ennovate MIS Dilator, Medium
B+C
SZ374T
Ennovate MIS Dilator, Large
B+C
SZ243R
Optional: Ennovate Lumbar Pedicle Probe Curved
–
SZ244R
Ennovate Thoracic Pedicle Probe, Straight
–
SZ245R
Ennovate Thoracic Pedicle Probe, Curved
–
SZ248R
Ennovate Pedicle Marker, Dual Band
–
SZ249R
Ennovate Pedicle Marker, Single Band
–
SZ254R
Optional: Ennovate Screw Tap ∅ 4.5 mm
B+C
SZ255R
Optional: Ennovate Screw Tap, ∅ 5.5 mm
B+C
SZ256R
Optional: Ennovate Screw Tap, ∅ 6.5 mm
B+C
SZ257R
Optional: Ennovate Screw Tap, ∅ 7.5 mm
B+C
SZ258R
Ennovate Screw Tap, ∅ 8.5 mm
B+C
SZ259R
Ennovate Screw Tap, ∅ 9.5 mm
B+C
SZ260R
Ennovate Screw Tap, ∅ 10.5 mm
B+C
SZ263R
Optional: Ennovate Thoracic Pedicle Probe Straight Large
–
SZ264R
Optional Ennovate Lumbar Pedicle Probe Straight Large
–
SZ270R
Ennovate French Rod Bender
–
SZ276R
Ennovate Rod Persuader Counter Torque Handle
–
SZ277R
Ennovate Rod Persuader
D+U+W+C
SZ283R
Ennovate Torque Wrench Shaft, 10Nm
T
SZ393R
Ennovate PolyBlocker
B
FW281R
S4 Element Distraction Forceps
TA015598
FW282R
S4 Element Compressor Forceps
TA015598
SR137R
Ennovate Open Injection Cannula Sleeve
–
Ennovate Set Open Connector Application SZ205
–
SZ375T
Ennovate MIS Dilator Handle
–
SZ377R
Ennovate MIS Screw Length Measuring Device
B+C
SZ379R
Ennovate MIS Downtube Locking Wrench
S+C
SZ380R
Ennovate MIS Removal Key, Short
B
SZ381R
Ennovate MIS Screw Driver, Short
D+U+W+C
SZ382R
Ennovate MIS Rod Length Caliper
D
FW692R
S4 Cleaning Device
–
Art. no.
Designation
Cleaning in Tray?
Notes (see legend)
SZ228R
Ennovate Torque Wrench Handle, 10Nm
U+W
SZ206R
Ennovate Tray Open Connector Application
–
–
SZ367R
Ennovate MIS K-Wire Forceps
B
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
SZ384R
Ennovate MIS Rod Inserter, Short Construct
D+B+W+C
TF316
Graphic Template for SZ206R (SZ205)
–
TA014010
SZ387R
Ennovate MIS Rod Indicator
T
TF296
Packing Stencil for SZ206R (SZ205)
–
–
SZ390R
Ennovate MIS Rod Pusher Handle
S+C
SZ229R
Ennovate Torque Wrench Handle, 5Nm
U+W
SZ392R
Ennovate MIS Counter Torque Handle
–
SZ275R
Ennovate Rod Rocker, Curved
–
SZ393R
Ennovate PolyBlocker
B
SZ290R
Ennovate Cross Connector Holder
D
SZ204R
Ennovate K-Wire Tray
–
SZ291R
Ennovate Cross Connector Caliper
–
SZ369S
Ennovate MIS K-Wire, Short
R
SZ292R
Ennovate Counter Torque Handle, Cross Connectors
B+C
SZ370
Ennovate MIS K-Wire, Short, Nitinol
R
SZ295R
Ennovate Rod-to-Rod Holder
–
SZ297R
Ennovate Torque Wrench Shaft Connectors, 5Nm
–
Ennovate Set MIS Manipulation SZ238
Ennovate Set Open/MIS FRI SZ400
Art. no.
Designation
Cleaning in Tray?
Notes (see legend)
Art. no.
Designation
Cleaning in Tray?
Notes (see legend)
SZ239R
Ennovate Tray MIS Manipulation
–
–
SZ401R
Ennovate Tray Open/MIS FRI
–
–
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
TF318
Graphic Template for SZ239R (SZ238)
–
TA014010
TF324
Graphic Template for SZ401R (SZ400)
–
TA014010
TF298
Packing Stencil for SZ239R (SZ238)
–
–
TF304
Packing Stencil for SZ401R (SZ400)
–
SZ378R
Ennovate MIS Downtube, Short
TA014987+C
FW237R
Ennovate FRI Fixation Nut Wrench
–
–
SZ389R
Ennovate MIS Rod Pusher, Short
TA014987+C
FW238R
Ennovate FRI Parallel Distractor
D+B
SZ391R
Ennovate MIS Set Screw Driver, Short
T
FW241R
Ennovate FRI Distraction Spindle
D
SZ397R
Ennovate MIS Quick Rod Pusher, Short
B+C
SR139R
Ennovate MIS Cannula Sleeve
B
SZ231R
Ennovate MIS Parallel Distractor Forceps
TA014987
SZ411R
Ennovate FRI Distraction Arm, Short
B
SZ232R
Ennovate MIS Parallel Compressor Forceps
TA014987
SZ412R
Ennovate FRI Spindle C-Ring
–
Ennovate FRI Downtube, Short
TA014988+C
SZ388R
Ennovate MIS Parallel Sleeves
B+C
SZ405R
SZ395R
Ennovate MIS CoDi C-Rings
B
SZ406R
Ennovate FRI Insert Pusher, Short
TA014988+C
Ennovate FRI Rod Pusher, Short
TA014988+C
Ennovate FRI Set Screw Driver, Short
T
SZ396R
Ennovate MIS Cage Sleeves
B+C
SZ407R
SZ398P
Ennovate MIS Alignment Working Port, Short
D
SZ408R
SZ399R
Ennovate MIS Alignment Tool, Short
D+B+C Ennovate Set Open FRI SZ402
Ennovate Set MIS Extension SZ235 Art. no.
Designation
Art. no.
Designation
Cleaning in Tray?
Notes (see legend)
Cleaning in Tray?
Notes (see legend)
SZ403R
Ennovate Tray Open FRI
–
–
SZ236R
Ennovate Tray MIS Extension
–
–
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
TF322
Graphic Template for SZ403R (SZ402)
–
TA014010
–
TF317
Graphic Template for SZ236R (SZ235)
–
TA014010
TF302
Packing Stencil for SZ403R (SZ402)
TF297
Packing Stencil for SZ236R (SZ235)
–
–
SR139R
Ennovate MIS Cannula Sleeve
–
SZ378R
Ennovate MIS Downtube, Short
TA014987+C
SZ379R
Ennovate MIS Downtube Locking Wrench
S+C
SZ385R
Ennovate MIS Rod Inserter, Long Construct
D+B+W+C
SZ380R
Ennovate MIS Removal Key, Short
B
B
SZ389R
Ennovate MIS Rod Pusher, Short
TA014987+C
SZ381R
Ennovate MIS Screw Driver, Short
D+U+W+C
SZ391R
Ennovate MIS Set Screw Driver, Short
T
SZ382R
Ennovate MIS Rod Length Caliper
D
SR139R
Ennovate MIS Cannula Sleeve
B
SZ384R
Ennovate MIS Rod Inserter, Short Construct
D+B+W+C
SZ390R
Ennovate MIS Rod Pusher Handle
S+C
SZ392R
Ennovate MIS Counter Torque Handle
–
SZ393R
Ennovate PolyBlocker
B
Ennovate Set MIS Optional SZ362 Art. no.
Cleaning in Tray?
Notes (see legend)
Ennovate Tray MIS Optional
–
–
JA455R
Lid for Aesculap OrthoTray DIN w/o handle
–
TA012714
TF313
Graphic Template for SZ363R (SZ362)
–
TA014010
TF293
Packing Stencil for SZ363R (SZ362)
–
–
SZ254R
Optional: Ennovate Screw Tap ∅ 4.5 mm
B+C
SZ255R
Optional: Ennovate Screw Tap, ∅ 5.5 mm
B+C
SZ256R
Optional: Ennovate Screw Tap, ∅ 6.5 mm
B+C
SZ257R
Optional: Ennovate Screw Tap, ∅ 7.5 mm
B+C
SZ258R
Ennovate Screw Tap, ∅ 8.5 mm
B+C
SZ259R
Ennovate Screw Tap, ∅ 9.5 mm
B+C
SZ260R
Ennovate Screw Tap, ∅ 10.5 mm
B+C
SZ270R
Ennovate French Rod Bender
–
SZ365R
Ennovate MIS K-Wire Trocar, Short
D+B
SZ366R
Ennovate MIS K-Wire Sleeve, Short
B+C
SZ368R
Ennovate MIS Slotted Hammer
–
SZ371R
Ennovate MIS Skin Incision Guide
B+C
SZ376R
Ennovate MIS Lumbar Pedicle Probe
B+C
SZ394T
Ennovate MIS CoDi Device
–
SZ363R
Designation
en
3.2.2 ®
Aesculap Ennovate Storage System 1.
Key to illustration Process product in storage without manual pre-cleaning. Process product in storage after manual pre-cleaning. Do not process product in storage.
Product
Product-specific safety information ► In order to prevent areas from being missed, always remove the graphic template from the storage unit before cleaning. ► For instruments that are processed outside of the storage units: observe instructions for use of the instrument. ► In addition to the information in these usage instructions, see also the following documents: Art. no.
Designation
TA012714
Instructions for use, trays and storage units
TA013756
Instructions for use, multi-part instruments with fitted top
TA014010
Instructions for use, graphic templates
TA014770
Instructions for use of the spinal column instrument
TA015598
Instructions for use, distractor and compression forceps
TA014987
Instructions for use, Ennovate instruments for MIS access
TA014988
Instructions for use, Ennovate instruments for FRI
–
Not applicable
TAXXXXXX
See the specific instructions for use.
B
Manual pre-cleaning with brush
U
Manual pre-cleaning with ultrasound and brush
W
Manual pre-cleaning with water pistole
C
Connect components with lumens and channels directly to the rinsing port of the injector carriage.
The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.
D
Disassemble product prior to processing.
3.3
3.2.3
R
Never resterilize and reuse used, explanted, damaged or contaminated implants. This implant may not be reprocessed following contamination with blood (directly or indirectly).
S
Rinse the product under running water. Move the moving parts while doing so.
D
Manually pre-clean the instrument (using a brush) if there are residues of bone, tissue or ancillary materials (such as plaster or bone cement).
The depictions in this document are schematic representations only and may deviate from the actual product.
2.
About this document
Note General risk factors associated with surgical procedures are not described in these instructions for use.
2.1
Scope
These instructions for use apply for the Ennovate storage systems and their graphics templates listed in the set lists at the start of this document. Note The applicable CE mark for the product can be found on the label of the packaging of the product.
Sterility
Application
The instrument storage units consist of a tray, a graphic template and a packing template. Every tray has pictograms which indicate the position and orientation of the respective instruments. WARNING Intraoperative contamination with blood, secretions, and other fluids may render the affected component unsuitable for resterilization! ► Completely remove contaminations. WARNING Risk of infection from unwashed areas! ► Remove the graphic template and cover before cleaning the tray. ► Equip tray according to pictograms/templates. Ensure that only the instruments that can be cleaned in the tray
are in the tray. Note Instruments that cannot be cleaned in the tray are identified in the tray with " ". ► Manually pre-clean instruments according to set lists at the beginning of this document. ► Process equipped trays, see Validated reprocessing procedure. ► Clean instruments that cannot be cleaned in the tray according to the respective instructions for use.
Note All instruments can be laid in the tray for sterilization.
► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at
eifu.bbraun.com
2.2
Safety messages
Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.
3.
Clinical use
3.1
Areas of use and limitations of use
3.1.1
Intended use
4.
Validated reprocessing procedure
4.1
General safety information
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 Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this.
Ennovate storage units serve to receive and store Ennovate instruments during sterilization and transport, including during cleaning for selected instruments.
Note If there is no final sterilization, then a virucidal disinfectant must be used.
3.1.2
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.
Indications
Indications are described in the corresponding instructions for use of Ennovate implant TA014887.
3.1.3
Absolute contraindications
Absolute contraindications are described in the corresponding instructions for use Ennovate Implants TA014887.
4.2
3.1.4
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: 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 chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKI-Brochures", "Red brochure".
Relative contraindications
Relative contraindications are described in the corresponding instructions for use of Ennovate Implants TA014887.
3.2
Safety information
3.2.1
Clinical user
General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.
4.3
General information
Reusable products
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 option to determine if a product is no longer functional, see Inspection.
4.4
Preparations at the place of use
► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► 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.
4.5
Cleaning/Disinfection
4.7.1
Manual pre-cleaning with a brush
4.5.1
Product-specific safety information on the reprocessing method
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants according to the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.
I
Disinfectant cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
► With PVD coated products, do not use oxidizing process chemicals (e.g. H2O2), as these can cause bleaching or
II
Rinsing
RT (cold)
1
-
D–W
-
layer loss. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foaming and
degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water ► Manually pre-clean the product (with a cleansing brush) if there are residues of bone, tissue or ancillary materials (such as plaster or bone cement).
D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh
4.5.2
► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
Validated cleaning and disinfection procedure
Validated procedure Mechanical alkaline cleaning and thermal disinfection
Specific requirements
■ Place the product on a tray that
Chapter Mechanical cleaning/disinfection and subsection:
is suitable for cleaning (avoid rinsing blind spots).
■ Instruments in set lists with
■ Chapter Mechanical alkaline cleaning and thermal disinfection
Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection
■ Use a suitable cleaning brush. ■ SZ384R and SZ385R: Connect
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:
individual parts with lumens and channels directly to the rinsing port of the injector carriage.
■ Instruments in set lists with and B
■ Chapter Manual pre-cleaning with a brush
■ Chapter Mechanical alkaline
■ Place the product on a tray that
cleaning and thermal disinfecting
is suitable for cleaning (avoid rinsing blind spots). Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection
■ Instruments in set lists with and U/W
■ Use a suitable cleaning brush. ■ Place the product on a tray that
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:
is suitable for cleaning (avoid rinsing blind spots). Instruments in set lists with "Notes" W:
Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
4.7.2
Manual pre-cleaning with ultrasound and brush
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
with ultrasound and brush
II
Rinsing
RT (cold)
1
-
D–W
-
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
– Phase I: Clean lumen with a suitable bottle brush in the solution until all discernible residues have been removed from the surface. – Phase II: rinse lumen with spray nozzle (3.8 bar water pressure) at least 3 times for 20 seconds each.
D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Mechanical cleaning/disinfection
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.
4.6.1
Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.
■ Chapter Manual pre-cleaning
■ Manual Pre-Cleaning:
4.6
infection procedure.
Reference
Mechanical alkaline cleaning and thermal disinfection
Machine type: single-chamber cleaning/disinfection device without ultrasound
Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
4.7.3
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical/Note Phase
I
Pre-rinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant
Step
T [°C/°F]
t [min]
Water quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline: – pH ~ 13 – <5 % anionic surfactant
■ 0.5 % working solution
■ working solution 0.5%
– pH = 11*
– pH = 11* III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning and disinfection device
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline
III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
In accordance with the program for the cleaning and disinfecting machine
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline
► Check visible surfaces for residues after mechanical cleaning/disinfecting.
4.7
Mechanical cleaning/disinfection 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.
► Check visible surfaces for residues after mechanical cleaning/disinfecting.
4.8
Inspection
► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.
4.8.1
Visual inspection
5.2.3
Ennovate FRI
► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed
areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely
scratched and fractured components. ► Check the product for missing or faded labels (such as handle colors, gold layers). ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical service.
4.8.2
Functional test
CAUTION Damage (metal cold welding /friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) and identified locations with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Check that the product functions correctly. ► Check the product for the function of the opening and closing mechanism between the basket and the cover. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
4.9
Packaging
► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.
4.10 Steam sterilization ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by
opening any valves and faucets). ► Validated sterilization process
– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.
4.11 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
5.
Maintenance and Service
5.1
Technical service
CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.
5.2
Spare parts
5.2.1
Ennovate Open
Art. no.
Designation
TF291
Packing template for SZ201R (SZ200)
TF296
Packing template for SZ206R (SZ205)
TF300
Packing template for SZ251R (SZ250)
TF301
Packing template for SZ221R (SZ220)
TF311
Graphic template for SZ201R (SZ200)
TF316
Graphic template for SZ206R (SZ205)
TF320
Graphic template for SZ251R (SZ250)
TF321
Graphic template for SZ221R (SZ220)
5.2.2
Ennovate MIS
Art. no.
Designation
TF292
Packing template for SZ361R (SZ360)
TF293
Packing template for SZ363R (SZ362)
TF297
Packing template for SZ236R (SZ235)
TF298
Packing template for SZ239R (SZ238)
TF312
Graphic template for SZ361R (SZ360)
TF313
Graphic template for SZ363R (SZ362)
TF317
Graphic template for SZ236R (SZ235)
TF318
Graphic template for SZ239R (SZ238)
Art. no.
Designation
TF302
Packing template for SZ403R (SZ402)
TF304
Packing template for SZ401R (SZ400)
TF322
Graphic template for SZ403R (SZ402)
TF324
Graphic template for SZ401R (SZ400)
6.
Disposal
WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents the product from causing injury. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA015394
2020-03
V6
Change No. 61047