BBraun
Acculan 3Ti oscillating saw GA673
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Aesculap® Acculan 3Ti
Aesculap Power Systems en
Instructions for use/Technical description Acculan 3Ti oscillating saw GA673 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.aesculapusa.com and clicking the "Products" menu. 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 1-800-282-9000. A paper copy will be provided to you upon request at no additional cost.
pt
Instruções de utilização/Descrição técnica Serra oscilatória Acculan 3Ti GA673
nl
Gebruiksaanwijzing/Technische beschrijving Acculan 3Ti oscillerende zaag GA673
sv
Bruksanvisning/Teknisk beskrivning Acculan 3Ti oscillerande såg GA673
ru
Инструкция по примению/Техническое описание Осциллирующая пила Acculan 3Ti GA673
cs
Návod k použití/Technický popis Oscilační pila Acculan 3Ti GA673
de
Gebrauchsanweisung/Technische Beschreibung Acculan 3Ti Oszillierende Säge GA673
pl
Instrukcja użytkowania/Opis techniczny Piła oscylacyjna Acculan 3Ti GA673
fr
Mode d’emploi/Description technique Scie oscillante Acculan 3Ti GA673
sk
Návod na použitie/Technický opis Acculan 3Ti oscilačná píla GA673
es
Instrucciones de manejo/Descripción técnica Sierra oscilante Acculan 3Ti GA673
tr
Kullanım Kılavuzu/Teknik açiklama Acculan 3Ti titreşimli testere GA673
it
Istruzioni per l’uso/Descrizione tecnica Sega oscillante Acculan 3Ti GA673
ko
사용 설명서 / 기술 설명 전동식의료용핸드피스 (ACCULAN 3Ti saw, 형명 개별기재 )
USA
en
Aesculap® Acculan 3Ti Acculan 3Ti oscillating saw GA673 Note Store the instructions for use for Acculan 3Ti in a folder!
Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use.
Legend 1 Saw blade 2 Saw head 3 Safety catch 4 Oscillating saw 5 Control trigger for oscillation frequency 6 Button for saw blade release/fixation 7 Locking pin 8 Battery 9 Battery removal device 10 Cover release button 11 Cover 12 Sterile funnel 13 Coding
YYYY-MM
Maintenance label Indication of the next maintenance appointment (Date: YearMonth) Machine-readable, two-dimensional code The code contains a unique serial number which can be used for electronic tracking of the individual instrument. The serial number is based on the global standard sGTIN (GS1). Date of manufacture
Follow the instructions for use
Labeling of electrical and electronic devices pursuant to directive 2002/96/EG (WEEE)
Classification Type BF
2
en Motor speed control
LOT
Manufacturer’s batch designation
SN
Manufacturer’s serial number
REF
Manufacturer’s article number Non-sterile medical product Temperature limits during transport and storage
Air humidity limits during transport and storage
Atmospheric pressure limits during transport and storage
S9
Operating mode
Contents 1. 1.1 1.2 1.3 1.4 1.5 2. 3. 3.1 3.2 3.3 4. 5. 5.1 5.2 5.3 6. 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 7. 8. 9. 10. 11. 11.1 11.2 12.
General information... 4 Intended use... 4 Main functions and design characteristics . . 4 Indications... 4 Absolute contraindications... 4 Relative contraindications... 4 Safe handling... 4 Product description... 5 Scope of supply... 5 Components required for operation... 5 Operating principle... 5 Preparation... 5 Working with the Acculan 3Ti oscillating saw 6 System set-up... 6 Function checks... 11 Safe operation... 12 Validated reprocessing procedure... 13 General safety information... 13 General notes... 13 Preparation at the place of use... 14 Preparation before cleaning... 14 Cleaning/disinfection... 14 Manual cleaning with wipe disinfection... 15 Automatic cleaning/disinfection with manual pre-cleaning... 16 Inspection, maintenance and checks... 17 Packaging... 17 Steam sterilization... 18 Storage... 18 Maintenance... 18 Troubleshooting list... 19 Technical Service... 20 Accessories/Spare parts... 20 Technical data... 20 Operating mode... 21 Ambient conditions... 21 Disposal... 21
3
en 1. 1.1
General information
1.3
Intended use
The type and area of application depend on the tool selected.
Task/Function The oscillating saw GA673, combined with the relevant tool, is used for processing hard tissue, cartilage and the like, as well as for bone replacement materials.
1.4
Application Environment The product fulfills the requirements for type BF pursuant to IEC/DIN EN 60601-1 and is used in operating rooms in sterile environments of explosion risk areas (such as areas with pure oxygen or anesthesia gases).
1.5
1.2
Main functions and design characteristics
Oscillation frequency
min. 0 min-1 to max. 15 000 min-1
Operating mode
Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1)
■ 30 second application, 30 second pause
Indications
Absolute contraindications
The product is not licensed for use on the central nervous system or central circulatory system.
Relative contraindications
The safe and effective use of the product greatly depends on influences which can only be controlled by the user. Therefore the specifications provided represent framework conditions only. Clinically successful use of the product is dependent on the knowledge and experience of the surgeon. The surgeon must decide which structures it is sensible to treat and take into account the safety and warning information contained in these instructions for use.
2.
Safe handling
WARNING
Risk of injury and material damage if this product is not used as intended! ► Use the product only for its intended purpose.
WARNING
Risk of injury and damage to property due to improper handling of the product! ► Follow the instructions for use of all products used.
■ 5 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Electrical systems generally heat up during continual operation. It is advised to give the system a break after use to cool down, as listed in the table on operating mode. Heating depends on the tool used and the load. After a certain number of repetitions, the system should cool down. This procedure prevents the system overheating as well as possible injury to the patient or user. The user is responsible for the use and adherence to the pause sequence described.
4
► Remove the transport packaging and clean the new
product, either manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► See “Information on electromagnetic compatibility (EMC) for Acculan components" TA022450; see Aesculap Extranet at https://extranet.bbraun.com
en ► To prevent damage caused by improper setup or
operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Use product and accessories in surgery and/or in the framework of emergency medical treatment. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Follow the Acculan 3Ti charger TA022160 instructions for use.
3.
Product description
3.1
Scope of supply
Designation
Art. no.
Oscillating saw
GA673
Cover
GA675
Battery
GA676
Sterile funnel
GA678
Instructions for use GA676
TA011867
Instructions for use GA673
TA011868
3.2
Components required for operation
Designation
Art. no.
Oscillating saw
GA673
Battery (rechargeable, charged)
GA676
Charger
GA677
Cover
GA675
Sterile funnel
GA678
Saw blade according to indication
–
3.3
Operating principle
The oscillating saw 4 incorporates an electric motor powered by a rechargeable battery, and electronic circuitry for controlling the rotational speed of the motor. The oscillation of the saw can be adjusted continuously by pressing oscillation frequency control trigger 5. The oscillating saw 4 converts the motor rotation into oscillation of the saw blade. The bone is dissected by the oscillating movement of the saw blade. No key or wrench is required for inserting the saw blades. The saw head 2 of oscillating saw 4 can be pivoted to eight different angular positions, in steps of 45°.
4.
Preparation
Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Do not use products from open or damaged sterile packaging. ► Prior to use, inspect the product and its accessories for any visible damage. ► Use the products and their accessories only if they are in perfect technical condition.
5
en 5.
Working with the Acculan 3Ti oscillating saw
WARNING
WARNING
WARNING
WARNING
WARNING
6
Risk of infection and contamination! Product is delivered unsterilized! ► Sterilize the product before use pursuant to the operating instructions. Risk of injury and material damage due to accidental activation of the product! ► Products which are not being actively used must be secured against accidental activation (position OFF). Risk of injury and material damage due to inappropriate use of tools! ► Always follow the safety advice and information given in the instructions for use. ► When coupling/uncoupling, handle tools with cutting edges with care. Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check. Risk of burns to skin and tissue through blunt tools or if product has not been maintained properly! ► Use tools only if they are in perfect condition. ► Replace blunt tools. ► Maintain the product properly, see maintenance guide.
5.1
System set-up
Connecting the accessories
DANGER
Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device.
Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service.
en Inserting the battery
CAUTION
Damage to, or destruction of the batteries due to processing! ► Do not sterilize batteries.
► Hold oscillating saw 4 with the battery compart-
► Have a second person guide battery 8 (unsterile)
into the battery compartment, see Fig. 2. Observe coding 13 when doing this.
8
ment upwards and attach funnel 12 (sterile), see Fig. 1.
12 12
13
4
Fig. 2 Note The coding on the floor of the battery compartment of the unit must match the coding at the bottom of the battery.
Fig. 1
Note After insertion of the battery, a series of acoustic blips will indicate that the Acculan 3Ti oscillating saw is ready for operation.
7
en ► Once the battery has been inserted, have a helper
remove sterile funnel 12 (unsterile), see Fig. 3.
► Mount cover 11 (sterile) in such a way that it
engages at both cover release buttons 10, see Fig. 4.
12
Fig. 4 Note Sterility of the unit is ensured only if the cover is mounted correctly. Fig. 3
8
en Removing the battery
► Hold oscillating saw 4 with the battery compart-
ment facing upward.
WARNING
CAUTION
CAUTION
Risk of injury from hot battery! Battery may be hot after use in the machine. ► Let the battery cool in the machine and then remove. – or – ► Remove the battery with the battery removal device and let it cool.
► Press both cover release buttons 10 on the
cover 11 simultaneously and remove cover 11. ► Hold the battery compartment at its lower end,
with the first two fingers protruding, see Fig. 5.
Damage to the battery caused by knocking it against hard objects! ► Only remove battery by tapping the product on the palm of the hand. Damage to, or destruction of the batteries due to processing! ► Do not sterilize batteries.
The battery must be removed after the operation and prior to processing of the unit. Note If necessary, the battery removal device can be used to facilitate removal of the battery, see Fig. 7!
Fig. 5
9
en ► In this position, remove battery 8 from the battery
Intraoperative battery change
compartment by knocking the unit against the palm of the hand, see Fig. 6. WARNING
Risk of injury from hot battery! Battery may be hot after use in the machine. ► Remove the battery with the battery removal device and let it cool.
The battery removal device is used for intraoperative battery changes ensuring that sterile conditions are safely maintained. ► Turn oscillating saw 4 so that the battery compartment faces upward, and remove cover 11. ► Mount sterile battery removal device 9, see Fig. 7.
8 9
4 Fig. 6
Fig. 7 ► Gently shake oscillating saw 4 with battery
removal device 9 attached and the battery compartment facing down. The battery slides smoothly into battery removal device 9. ► Hand over battery removal device 9 containing the discharged battery to an unsterile person. ► Insert a charged battery, see Inserting the battery.
10
en Coupling the saw blade
Protection against inadvertent activation
► Secure oscillating saw 4 against inadvertent acti-
To prevent inadvertent activation of oscillating saw 4 during tool change/alignment of saw head 2, oscillation frequency control trigger 5 can be locked. ► To lock oscillation frequency control trigger 5: Turn safety catch 3 to its OFF position, see Fig. 10. Oscillation frequency control trigger 5 is locked and oscillating saw 4 cannot be activated. ► To unlock oscillation frequency control trigger 5: Turn safety catch 3 to its ON position, see Fig. 10. Oscillation frequency control trigger 5 is unlocked and oscillating saw 4 can be activated.
vation by engaging safety catch 3. ► Insert saw blade 1 with its coupling end in the slot of the saw blade coupling as far as it will go. Ensure that the locking pin engages in the saw blade fenestration, and that the lateral stops of the saw blade rest on the coupling, see Fig. 8.
1
2
3
5
Fig. 8
6
► If necessary press button for saw blade release/fix-
ation 6.
4
Uncoupling the saw blade ► Secure oscillating saw 4 against inadvertent acti-
vation by engaging safety catch 3. ► Fully press down button for saw blade release/fixa-
tion 6. ► Pull out saw blade 1 from the saw blade coupling,
see Fig. 9.
1
Fig. 10
5.2
Function checks
Note The function checks must be carried out prior to each surgical application of the unit and after each intraoperative battery change! ► Make certain that a battery has been installed. ► Check that the tool is seated properly: Pull at the
saw blade. Fig. 9
Aligning the saw head Saw head 2 can be turned to eight different positions, in steps of 45°. ► Secure oscillating saw 4 against inadvertent activation by engaging safety catch 3. ► Slightly pull out saw head 2 towards the saw blade and turn it to the required position (in steps of 45°). Saw head 2 clearly engages at each step.
► Check that the saw head is seated properly: Turn
the saw head without pulling it out. ► Briefly run the oscillating saw at maximum speed. ► Only use the device if it is in perfect condition.
11
en 5.3
Safe operation
WARNING
WARNING
Risk of infection or injury through aerosol formation or particles ejected from the tool! ► Use suitable protection (such as waterproof protective clothing, face mask, safety gases, suction).
WARNING
Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.
WARNING
Risk of injury when attaching/removing sawblades in the ON position through inadvertent activation of the product! ► Only attach/remove saw blades in the OFF position.
WARNING
12
Coagulation of patient tissue or risk of burns for patients and user through hot product! ► Cool the tool during operation. ► Keep product/tool out of the reach of patients. ► Let the product/tool cool down. ► Use a cloth to protect against burns when changing the tool.
Risk of injury due to application of the product outside the field of view! ► Only use the product under vision.
WARNING
WARNING
WARNING
Risk of injury and damage to the tool/system! The tool may get caught in drapes (such as textiles). ► Do not let the tool come into contact with drapes (such as textiles) during operation. Risk of injury when twisting the saw head in the ON position through inadvertent activation of the product! ► Only twist saw head in the OFF position. Risk of injury caused by inadvertent loosening of the saw blade during operation! ► Do not press the button for saw blade release/fixation during operation. ► Check for secure fixation of the tool after any tool change.
Note The motor found within this Acculan 3Ti hand piece is powered by a magnetic system. To ensure that the motor of this powered instrument does not inadvertently activate, do not allow the hand piece to come in contact with any magnetic sources (i.e. magnetic instrument pads). Please note that having the safety switch in the locked position does not assure that the motor will not run inadvertently. Note The low whistling noise at startup of oscillating saw 4 is normal for this type and design of saw! ► To run oscillating saw 4: Press oscillation frequency
control trigger 5. The saw runs at the continuously controlled oscillation frequency.
en 6. 6.1
Validated reprocessing procedure General safety information
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. 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 It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessor is responsible for this. The recommended chemical was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
6.2
General notes
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, no more than 6 hours should be left between use and preparation, pre-clean temperatures >45 °C liable to fusing should not be employed and disinfectants liable to fusing (aldehyde or alcohol-based) should not be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine in case of non stainless steel. On stainless steel, residues containing chlorine or chloride (such as surgical residues, drugs, saline solutions in water for cleaning, disinfection and sterilization) may lead to corrosion (pitting corrosion, tensile corrosion) and thus to the destruction of the product. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform 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 reprocessing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Visual material changes (such as fading or color changes in titanium or aluminum). For aluminum, the application/process solution only needs to be pH >8 to cause visible surface changes. ■ Material damage (such as corrosion, cracks, breaks, premature aging or swelling). ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, section Publications, Red Brochure – Proper maintenance of instruments.
13
en 6.3
Preparation at the place of use
► Remove all attached components from the product
(tool an accessories). ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.
6.4
6.5
Cleaning/disinfection
Product-specific safety instructions for the reprocessing procedure
CAUTION
Preparation before cleaning
► Prior to the first mechanical cleaning/disinfection
process, mount the ECCOS fixations in a suitable tray (e.g. GB243800). ► Insert the product in its proper position in the ECCOS fixation.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – be approved for plastic material and highgrade steel, – do not attack softeners (e.g. in silicone). ► Do not use cleaning agents that contain acetone. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum temperature of 60 °C during chemical cleaning and/or disinfection. ► Do not exceed the maximum temperature of 96 °C during thermal disinfection with FD water. ► Dry the product for at least 10 minutes at a maximum of 120 °C. Damage or destruction of the batteries due to processing! ► Protect battery from moisture.
Note The indicated drying time is a guide time only. It must be checked taking into account the specific conditions (e.g. load) and if applicable adjusted.
14
en 6.6
Manual cleaning with wipe disinfection
Phase
Step
D [°C/°F]
t [min]
Conc. [%]
Water quality
Chemistry
I
Pre-cleaning
RT (cold)
≥2
-
DW
until visually clean
II
Cleaning with enzyme solution
RT (cold)
≥2
0.8
D–W
pH-neutral*
III
Intermediate rinse
RT
≥5
-
DW
–
IV
Drying
RT
-
-
-
-
V
Wipe disinfection
-
>1
-
-
Meliseptol HBV wipes 50 % Propan-1-ol
VI
Final rinse
RT (cold)
0.5
-
FD–W
-
VII
Drying
RT
-
-
-
-
D–W: FD–W: RT: *
Drinking water Fully desalinated water (demineralized, microbiological, at least of drinking water quality) Room temperature validated with enzyme cleaner “Cidezyme Johnson & Johnson”
► Do not clean the product in a ultrasonic bath and
do not immerse the product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function. Phase I ► Mobilize non-rigid components during cleaning. ► Clean the product under running water, using a
suitable cleaning brush until all visible residues have been removed from the surfaces. ► Brush difficult to access surfaces with a suitable plastic cleaning brush for at least 1 min. Note For details on difficult to access surfaces, see Acculan pre-cleaning and care information TA016000 (available in Aesculap Extranet at https://extranet.bbraun.com). Phase II ► Follow the operating instructions of the enzyme
cleaner with regard to correct concentration, dilution, temperature and water quality. ► Spray products with a pH neutral enzyme solution, let soak in for at least 2 minutes and then wipe off.
Phase III ► Mobilize non-rigid components during cleaning. ► Rinse product under running tap water for at least 5 minutes. ► Follow the operating instructions of the enzyme cleaner with regard to correct concentration, dilution, temperature and water quality. ► Contamination should be removed with a lint-free cloth or soft brush moistened with enzyme cleaner. ► Flexible components should be rinsed for 20 seconds with the water pistol (cold water, at least 2.5 bar). ► After manual cleaning, check visible surfaces and areas of flexible components for residues. ► If necessary, repeat the cleaning process (phase 1 to 3). Phase IV ► Dry the product in the drying phase with suitable equipment (such as lint-free cloths, pressurized air). Phase V ► Wipe all surfaces of the product with a single-use disinfecting wipe.
15
en Stage VI ► Rinse disinfected surfaces after the prescribed reaction time for at least 1 minute under running demineralized water. ► Drain any remaining water fully. Stage VII ► Dry the product in the drying phase with suitable
equipment (such as lint-free cloths, pressurized air).
6.7
Automatic cleaning/disinfection with manual pre-cleaning
Note The cleaning and disinfection device must fundamentally have a tested efficacy (such as FDA approval or CE label pursuant to DIN EN ISO 15883).
Note The washer-disinfector machine used for processing must be serviced and checked at regular intervals.
Manual pre-cleaning with brush Phase
Step
D [°C/°F]
t [min]
Conc. [%]
Water quality
Chemistry/Note
I
Rinsing
RT (cold)
-
-
D–W
until visually clean
II
Brushes
RT (cold)
-
-
D–W
until visually clean
D–W: RT:
Drinking water Room temperature
► Do not clean the product in a ultrasonic bath and
do not immerse the product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function. Phase I ► Mobilize non-rigid components during cleaning. ► Thoroughly clean the product under running water.
Phase II ► Mobilize non-rigid components during cleaning. ► Brush difficult to access surfaces with a suitable
plastic cleaning brush for at least 1 min. ► After manual preparation, check visible surfaces for
residue and repeat the pre-cleaning process as needed. Note For details on difficult to access surfaces, see Acculan pre-cleaning and care information TA016000 (available in Aesculap Extranet at https://extranet.bbraun.com).
16
en Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase
Step
D [°C/°F]
t [min]
Water quality
Chemistry/Note
I
Pre-rinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD–W
■ Concentrate, alkaline: – pH ~ 13 – <5 % anionic surfactant
■ working solution 0.5 % – pH ~ 11* III
Intermediate rinse
> 10/50
1
FD–W
-
IV
Thermal disinfection
90/194
5
FD–W
-
V
Drying
-
-
-
mind. 10 min at max. 120 °C
D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) *Recommended: BBraun Helimatic Cleaner alcaline ► Insert the product in its proper position in the
6.9
ECCOS fixation. ► Set the saw head 2 between two locking positions for cleaning. ► After automatic cleaning/disinfection, check visible surfaces for residues and repeat the cleaning/disinfection process as needed.
► Always follow the instructions for use of the
6.8
Inspection, maintenance and checks
Note Aesculap recommends occasional spraying of moving parts (such as knobs, couplings, cover caps) with the Aesculap STERILIT-Power-Systems oil spray.
Packaging
respective packaging and storage devices (e.g. instructions for use TA009721 for the AesculapECCOS fixation system). ► Insert the product in its proper position in the ECCOS fixation. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.
► Allow the product to cool down to room tempera-
ture. ► Inspect the product after each cleaning and disin-
fecting cycle to be sure it is: clean, functional, and undamaged. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Inspect the saw blades for broken, damaged or blunt cutting edges. ► Set aside the product if it is damaged.
17
en 6.10 Steam sterilization
CAUTION
Damage or destruction of the batteries due to processing! ► Do not sterilize the rechargeable battery.
7.
Maintenance
To ensure reliable operation, the product must be maintained once per year as indicated on the maintenance label, see Fig. 11, e.g. February 2012.
Note Remove all attached components from the product (tools, accessories) before 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). ► Use a validated sterilization method: – Steam sterilization using fractional vacuum process – Steam sterilizer DIN EN 285 and validated pursuant to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min When sterilizing several products at the same time in one steam sterilizer: ► Ensure that the maximum permitted load specified by the manufacturer for the steam sterilizer is not exceeded.
6.11 Storage ► Store sterile products in germ-proof packaging,
protected from dust, in a dry, dark, temperaturecontrolled area.
18
Fig. 11 For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.
en 8.
Troubleshooting list
Malfunction
Detection
Cause
Remedy
Saw blade not moving
Loud running noise from motor
Defective gearings
Have repaired by manufacturer
Insufficient cutting performance of the saw blade
Saw blade worn
Blunt saw blade
Replace saw blade
Battery too weak
Insufficient motor power/speed
Charge battery
Saw blade overheated
Inadequate chip removal
Move the saw back and forth during sawing and ensure sufficient irrigation of the saw blade
-
Battery not fully charged
Charge the battery in the charger
Symbol "Battery replacement recommended" illuminated on the charger
End of service life of battery
Have battery repaired by the manufacturer
-
Motor defective
Have motor repaired by the manufacturer
No acoustic signal on insertion of the battery
Battery defective
Have battery repaired by the manufacturer
Coupling components or saw blades deformed
Deformation
Have repaired by manufacturer
-
Incompatible saw blade
Insert a fitting Aesculap saw blade, see Accessories/Spare parts
Locking pin not fully releasing the saw blade
Button for saw blade release not pressed completely
Fully press the saw blade release button, see Uncoupling the saw blade
Battery worn/defective
Insufficient power output
Motor not running
The saw blade cannot be coupled
Saw blade cannot be uncoupled
Replace battery
19
en 9.
Technical Service
WARNING
Danger to life of patients and users if the product malfunctions and/or protective measures fail or are not used! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. ► Do not modify the product.
Note For further information about the Aesculap ECCOS fixation system, see TA009721.
11.
Technical data
Classification acc. to Directive 93/42/EEC Art. no.
Designation
Class
GA676
Battery
I
GA673
Acculan 3Ti oscillating saw
IIa
► For service and repairs, please contact your
national B. Braun/Aesculapp agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.
10. Accessories/Spare parts Art. no.
Designation
GA675
Cover
GA676
Battery
GA677
Charger
GA678
Sterile funnel
GA679
Battery removal device
GB243R
ECCOS tray with fixations for Acculan 3Ti
GB600
Aesculap STERILIT Power Systems oil spray
20
GA673
Acculan 3Ti oscillating saw
DC voltage
9.6 V
Rated current
approx. 10 A
Max. power
250 W
Oscillation frequency
0 1/min to approx. 15 000 1/min
Weight (operational)
approx. 1.6 kg
Dimensions L x W x H
approx. 162 mm x 47 mm x 200 mm
Applied part
Type BF
EMC
IEC/DIN EN 60601-1-2
Conforming to standard
IEC/DIN EN 60601-1