BBraun
micro-Line straight handpiece angled handpiece
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Aesculap® micro-Line
Aesculap Power Systems
Instructions for use/Technical description micro-Line straight handpiece/angled handpiece Gebrauchsanweisung/Technische Beschreibung micro-Line Geradeaus-Handstück/Winkel-Handstück Mode d’emploi/Description technique Pièce à main micro-Line droite/coudée Instrucciones de manejo/Descripción técnica micro-Line pieza de mano recta/pieza de mano acodada Istruzioni per l’uso/Descrizione tecnica Manipolo retto/manipolo angolato micro-Line Instruções de utilização/Descrição técnica Cabo recto/cabo angulado micro-Line Gebruiksaanwijzing/Technische beschrijving micro-Line recht handstuk/hoekhandstuk Bruksanvisning/Teknisk beskrivning micro-Line rakt handstycke/vinklat handstycke Инструкция по примению/Техническое описание Прямая насадка/угловая насадка micro-Line Návod k použití/Technický popis Rovný násadec/úhlový násadec micro-Line Instrukcja użytkowania/Opis techniczny Prostnica/kątnica micro-Line Návod na použivanie/Technický opis Rovná/zalomená rukoväť micro-Line Kullanım Kılavuzu/Teknik açiklama micro-Line düz el aleti/açılı el aleti
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 company TA-Nr. 012581
2017-03
- DIR 93/42/EEC Technical alterations reserved
V6
Änd.-Nr. 55992
3.3
Aesculap® micro-Line micro-Line straight handpiece/angled handpiece Legend 1 Tool 2 Centering lug 3 Release mechanism (with button) 4 Spray nozzle (attachment) 5 Direction of arrow (for attaching the spray nozzle) 6 Cover sleeve 7 Rotary direction (to open the tool collet) 8 Tension ring (rotary, for tightening the tools) 9 Mark (on tension ring) 10 Mark (on handle part) 11 Mark (= Tool tightened) 12 Handpiece coupling 13 Aesculap STERILIT oil spray and micro-Line adapter 14 Adapter ring (spray nozzle)
Symbols on product and packages
Applicable to at https://extranet.bbraun.com
Safe handling
CAUTION Federal law restricts this device to sale by, or on order of a physician! ► 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. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Only use drive unit with DIN 13940/ISO 3964 coupling. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Only use the product 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. ► Keep the instructions for use accessible for the user.
3.
Product description
3.1 Components required for operation ■ Drive unit (with DIN 13940/ISO 3964 coupling)/Motor ■ micro-Line straight handpiece/angled handpiece ■ Tool ■ Spray nozzle (optional) ■ Irrigation set (optional) 3.2
Marking
Ratio
Spray nozzle
GD450M
Blue ring
1:1
GD460R
GD451M
Blue ring
1:1
GD461R
GD455M
Red ring
1:2
GD460R
GD456M
Red ring
1:2
GD461R
GD457M
Red ring
1:2
GD462R
GD465M
Blue ring
1:1
GD460R
GD466M
Blue ring
1:1
GD461R
GD467M
Blue ring
1:1
GD462R
Preparation
Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Prior to using the micro-Line straight handpiece/angled handpiece and its accessories, check for visible damage. ► Use the micro-Line straight handpiece/angled handpiece and its accessories only if they are in perfect condition. ► Ensure that the maximum drive speeds for the individual micro-Line straight handpieces/angled handpieces is not exceeded.
► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
2.
micro-Line straight handpiece/angled handpiece
4.
Caution, general warning symbol Caution, see documentation supplied with the product
1.
Operating principle
The micro-Line straight handpieces/angled handpieces are powered by a drive unit (coupling acc. to DIN 13940/ ISO 3964). The drive speed is conveyed in different ways in the micro-Line straight handpieces/angled handpieces. Additionally, the micro-Line straight handpieces/angled handpieces can be operated with the spray nozzles listed below.
4.1
Drive unit/Motor
The following drive units/motors can be used with the micro-Line straight handpieces/angled handpieces: ■ microspeed uni motor GD678/GD679 ■ ELAN-EC GA830, GA835 with micro flexible cable GA176 (180 cm) or GA173 (230 cm) ■ Microtron-EC GD631 with motor GD622 ■ Microlan GA502R/GA553R
4.2
Allowable motor drive speed ranges
micro-Line straight handpiece/angled handpiece
Gear ratio
Motor drive rpm (rpm)
Tool speed (rpm)
Application
GD450M
1:1
0–40 000
0–40 000
Drilling, reaming, grinding
GD451M
1:1
0–40 000
0–40 000
Drilling, reaming, grinding
GD455M
1:2
0–40 000
0-80 000
Reaming, grinding
GD456M
1:2
0–40 000
0-80 000
Reaming, grinding
GD457M
1:2
0–40 000
0-80 000
Reaming, grinding
GD465M
1:1
0–40 000
0–40 000
Drilling, reaming, grinding
GD466M
1:1
0–40 000
0–40 000
Drilling, reaming, grinding
GD467M
1:1
0–40 000
0–40 000
Drilling, reaming, grinding
Intended use
The micro-Line straight handpieces/angled handpieces are used for drilling and reaming in microsurgery and dental surgery. The following drilling and reaming tools can be coupled to the handpieces: Tool micro-Line straight handpiece/angled handpiece
Shaft diameter (mm)
Shaft length (mm, min.)
Tool length (mm, max.)
GD450M
∅ 2.35
46
5.
Working with the micro-Line straight handpiece/angled handpiece
70
5.1
System set-up
Note Products marked as unsterile must be sterilized, prior to use, according to respective instructions, see Steam sterilization.
GD451M
∅ 2.35
76
95
GD455M
∅ 2.35
46
70
GD456M
∅ 2.35
76
95
GD457M
∅ 2.35
106
125
GD465M
∅ 2.35
46
70
GD466M
∅ 2.35
76
95
GD467M
∅ 2.35
106
125
Risk of contamination and infection caused by unsterile components in the sterile area! ► Use only sterile or sterilized parts in the sterile area. WARNING Risk of injury due to inadvertent activation of the drive unit/motor! ► Secure drive units/motors that are not in active operation against inadvertent activation by foot or hand controls. WARNING Risk of injury due to accidental activation of drive unit! ► Change the tool only when the drive unit is disconnected. WARNING
WARNING
Risk of injury and material damage caused by incorrectly coupled micro-Line straight handpiece/angled handpiece! ► Make certain the micro-Line straight handpiece/angled handpiece is coupled correctly.
WARNING
Risk of burns to the patient caused by blunt tools or lack/inadequacy of maintenance of handpieces! ► Prior to each use and before clamping in place, check the tools for any wear or damage.
5.9
Safe operation
WARNING Damage to the product due to incorrect handling or operation! ► Couple the product only while the motor is inactive. CAUTION
5.1.1
Connecting the accessories
Note Follow the instructions for use of individual accessories!
WARNING
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.
5.2
Risk of burns to patient and user, caused by hot tool! ► Only use sharp tools. ► Use irrigation for cooling the tool and to remove any chipping. ► Observe the correct reaming direction. ► Put down the hot tool beyond reach of the patient. ► Use a cloth to protect against burns when changing the tool. Risk of injury and material damage due to incorrect operation of the micro-Line straight handpiece/angled handpiece or drive units! ► Always follow the safety advice and information given in the instructions for use of the handpieces and motors. ► Do not exceed the specified maximum motor speed. Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.
WARNING
Connecting the spray nozzle (optional) Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.
Spray nozzle damage due to jammed adapter rings! ► Check that the adapter rings at the tip are moving smoothly. WARNING CAUTION
Risk of injury to the patient due to inadvertent slipping/rattling of the tool! ► Only apply minimal force when working laterally with the micro-Line straight handpiece.
► Pull off cover sleeve 6 towards the front end of the micro-Line straight handpiece/angled handpiece. ► Slightly twist and push on spray nozzle 4 in the direction of arrow 5. ► Check that adapter rings 14 at the tip are moving smoothly. ► Secure the irrigation tube to the tube connector.
WARNING
This completes the installation of spray nozzle 4.
5.3
Removing the spray nozzle (optional)
► Remove the irrigation tube from the tube olive. ► Remove tool 1. ► Slightly twist and remove spray nozzle 4 against the direction of arrow 5. ► Slide on cover sleeve 6 in the direction of the arrow.
This completes the removal of spray nozzle 4.
5.4
Coupling a tool
Note When coupling the tools 1, please note that the tools are tightened without using a wrench. ► Rotate the tension ring 8 in the direction of the arrow 7 until it engages. ► Insert tool 1 down to the positive stop. ► Turn tension ring 8 against the direction of arrow 7 until mark 9 on the tension ring and mark 10 on the handle
part are aligned with each other. The tension ring is closed. ► To check that tool 1 is mounted correctly: Pull at tool 1 (with the drive inactive). Tool 1 is coupled firmly, without slack in the tool adapter.
5.5
Uncoupling the tool
CAUTION
Damage to the micro-Line straight handpiece/angled handpiece caused by jammed drive unit/motor! ► Make certain the tool was inserted correctly. ► Ensure that the tension ring of the micro-Line straight handpiece/angled handpiece is closed.
► Rotate the tension ring 8 in the direction of the arrow 7 until it engages. ► Remove tool 1. ► Turn tension ring 8 against the direction of arrow 7 until mark 9 on the tension ring and mark 10 on the handle
part are aligned with each other. This completes the uncoupling of tool 1.
5.6
Coupling the drive unit/motor
► Push centering lug 2 into the coupling of the micro-Line straight handpiece/angled handpiece so that the drive
unit/motor engages audibly. ► Pull at the drive unit/motor to check that it is coupled correctly.
This completes the coupling of the drive unit/motor.
5.7
Uncoupling the drive unit/motor
► Unlock release mechanism 3 by pressing at the drive unit/motor. ► Remove the drive unit/motor.
This completes the uncoupling of the drive unit/motor.
5.8
Function checks Damage to the product due to incorrect handling or operation! ► Couple the product only while the motor is inactive. CAUTION
WARNING
Risk of contamination and infection if surgical gloves are damaged by a sharp tool! ► Do not touch the cutting edges of the tool, neither when changing tools nor during use.
6.
Validated reprocessing procedure
6.1
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 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. The recommended chemistry was used for validation. 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 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 information
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 Publications, Red Brochure – Proper maintenance of instruments.
6.3
Dismantling prior to carrying out the reprocessing procedure
► Disassemble the product immediately after use, as described in the respective instructions for use.
► Check all cutting edges for any mechanical damage.
6.4 5.8.1
micro-Line straight handpiece/angled handpiece
► Always carry out a trial run prior to using the product. ► Check that tool 1 is coupled correctly. ► Briefly run tool 1 at maximum speed. ► Make certain the product does not produce atypical running noise or vibration during the trial run.
5.8.2
Irrigation set (optional)
► Switch on the irrigation pump and check the irrigation set for any blockage or leaks.
5.8.3
Tool
► Check all cutting edges for any mechanical damage.
Preparations at the place of use
► 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.
6.5
Preparation before cleaning
► Carry out non-fixating/NaCl-free pre-cleaning immediately after use. ► Prior to the first mechanical cleaning/disinfection process, mount Eccos holder GB681R or GB682R in a suitable
tray (e.g. JF214R).
6.6
Cleaning/disinfection
6.6.1
Product-specific safety instructions for the reprocessing procedure Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent. CAUTION
Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
6.7.2 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 – are approved for high-grade steel. – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 60 °C.
CAUTION
Manual cleaning with ultrasound and immersion disinfection
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*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
► Dry the product for at least 10 minutes at a maximum of 120 °C.
Note The indicated drying temperature is a guide temperature only. It must be checked taking into account the specific conditions (e.g. load) and adjusted if applicable. ► Do not clean motors/handpieces by ultrasonic treatment and do not immerse them in any liquids. To avoid the
risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. ► Tools: Carry out ultrasound cleaning: – as an effective mechanical supplement to manual cleaning/disinfection. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/ disinfection. – as an integrated mechanical support measure for mechanical cleaning/disinfection. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.
6.6.2
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Validated cleaning and disinfection procedure
Validated procedure
Special features
Reference
Manual cleaning and wipe disinfection
■ Open and close the tool coupling. ■ Drying phase: Use a lint-free cloth ■ Ensure that the product is positioned in such a
Chapter Manual cleaning/disinfecting and subsection:
■ micro-Line straight handpiece/angled handpiece
Manual cleaning and wipe disinfection
■ Spray nozzle
■ Chapter Manual cleaning and wipe disinfecting
way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.)
■ 20 ml disposable syringe ■ After use, rinse with demineralized water. ■ Drying phase: Use a lint-free cloth or com-
Chapter Manual cleaning/disinfecting and subsection:
■ Chapter Manual cleaning and wipe disinfecting
pressed air for medical purposes Manual cleaning with ultrasound and immersion disinfection
■ 20 ml disposable syringe ■ Drying phase: Use a lint-free cloth or compressed air for medical purposes
■ Tool Mechanical alkaline cleaning and thermal disinfecting handpiece/angled handpiece
■ Chapter Manual cleaning with ultrasound and immersion disinfection
■ Close the tool coupling. ■ micro-Line straight handpiece/angled handpiece: Insert the product in its proper position in the Eccos holder.
■ micro-Line straight
Chapter Manual cleaning/disinfecting and subsection:
Chapter Mechanical cleaning/ disinfecting and subsection:
■ Chapter Mechanical alka-
■ Tool/spray nozzle: Place the instrument in a
■ Tool/spray nozzle
line cleaning and thermal disinfecting
tray that is suitable for cleaning (avoiding rinsing blind spots).
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. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
6.8 6.7
Manual cleaning/disinfecting
► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
Mechanical cleaning/disinfecting
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).
► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.
Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
6.7.1
6.8.1
Manual cleaning and wipe disinfecting
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical Phase
I
Cleaning
RT (cold)
-
-
D–W
-
II
Drying
RT
-
-
-
-
III
Wipe disinfection
-
>1
-
-
Meliseptol HBV wipes 50 % Propan-1-ol
IV
Final rinse
RT (cold)
0.5
-
FD-W
-
V
Drying
RT
-
-
-
-
Step
T [°C/°F]
I
Prerinse
<25/77
II
Cleaning
55/131
t [min]
Water quality
Chemical/Note
3
D–W
-
10
FD-W
■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant
■ 0.5 % working solution – pH = 11*
D–W: FD–W: RT:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature
Phase I ► Clean the product under running faucet water, using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Phase II ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure. Phase III ► Wipe all surfaces of the product with a single-use disinfectant wipe.
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 alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.
6.9
9.
Inspection, maintenance and checks
Technical Service
► Allow the product to cool down to room temperature. ► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged. ► Prior to sterilization, spray through the micro-Line handpiece with Aesculap-STERILIT oil spray GB600 with
adapter GB600810 for approx. 1 s. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Inspect tools for broken, damaged or blunt edges. ► Set aside the product if it is damaged. ► Prior to an extended period of non-use, store attachments cleaned, maintained and dried according to the instructions.
6.10 Packaging ► Follow the instructions for use for the applied packaging and storage systems (e.g. instructions for use TA009721
for Aesculap Eccos storage system). ► Insert the product in its proper position in the Eccos holder, or put it on a tray in such a way that the product is
protected against damage. Ensure that all cutting edges are protected. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.
6.11 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 fractionated 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 ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.
Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculapagency.
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] Or in the US: Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420 Other service addresses can be obtained from the address indicated above.
10. 6.12 Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method
Temp.
Time
Minimum drying time
Prevacuum
270 °F/275 °F
4 min
20 min
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.
► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
7.
Maintenance
To ensure reliable operation, the product must be maintained at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.
8.
Art. no.
Designation
GD460R
Spray nozzle for GD450M, GD455M, GD465M
GB600
Aesculap STERILIT oil spray
GB600810
STERILIT micro-Line adapter
GB681R
Eccos holder (for 3 handpieces)
GB682R
Eccos holder (for 1 handpiece)
GB459R
Eccos mounting set for holders
TA012581
Instructions for use for GD450M, GD451M, GD455M, GD456M, GD457M, GD465M, GD466M, GD467M
see Aesculap catalog Power Systems Burrs & Blades
Tools (e.g. GD025R)
11.
6.13 Storage
Accessories/Spare parts
Technical data
Classification acc. to Directive 93/42/EEC Art. no.
Designation
Class
GD450M, GD451M, GD455M, GD456M, GD457M, GD465M, GD466M, GD467M
micro-Line straight handpiece/angled handpiece
IIa
Troubleshooting list
Malfunction
Detection
Cause
Remedy
micro-Line straight handpiece/angled handpiece not running
Collet not locked
Tension ring fixed/closed or not tightened
Turn the tension ring against the direction of the arrow until the marks on the tension ring and on the handle part are aligned with each other
Marks on the tension ring and on the handle part no aligned with each other
Drive unit/motor not reacting
Insufficient power
Tool change impossible
micro-Line straight handpiece/angled handpiece vibrating
micro-Line straight handpiece/angled handpiece heating up during operation
Tension ring fixed/closed or not tightened
Drive unit/motor defective
Turn the tension ring against the direction of the arrow until the marks on the tension ring and on the handle part are aligned with each other Check drive unit/motor according to appropriate instructions for use
Tool not cutting correctly
Cutting edges worn
Replace the tool
Drive unit/motor not running correctly
Drive unit/motor defective
Check drive unit/motor according to appropriate instructions for use
Tension ring does not rotate freely or does not rotate at all
Collet jammed
Have repaired by manufacturer
Tool blocked
Tool is jammed
Have repaired by manufacturer
Irregular running noise
Bearing defective
Have repaired by manufacturer
Tool shaft bent
Tool damaged
Replace the tool
Rapid temperature rise
Bearing defective
Have repaired by manufacturer
micro-Line straight handpiece/angled handpiece
Gear ratio
Motor drive (rpm)
Tool speed (rpm)
Weight (g)
Tool length (mm, max.)
Class
GD450M
1:1
0–40 000
0–40 000
69
70
IIa
GD451M
1:1
0–40 000
0–40 000
76
95
IIa
GD455M
1:2
0–40 000
0-80 000
90
70
IIa
GD456M
1:2
0–40 000
0-80 000
97
95
IIa
GD457M
1:2
0–40 000
0-80 000
104
125
IIa
GD465M
1:1
0–40 000
0–40 000
90
70
IIa
GD466M
1:1
0–40 000
0–40 000
97
95
IIa
GD467M
1:1
0–40 000
0–40 000
104
125
IIa
11.1 Ambient conditions Operation Temperature
Relative humidity
Atmospheric pressure
Storage and transport
12.
Disposal
Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. ► Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap
agency, see Technical Service.
13.
Distributor in the US/Contact in Canada for product information and complaints
Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 012581
2017-03
V6
Änd.-Nr. 55992