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

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 03/13 V6 Änd.-Nr. 47057

- DIR 93/42/EEC

Technical alterations reserved

 3.3 Operating principle
The micro-Line straight handpieces/angled handpieces are powered by a drive unit (coupling acc. to DIN 13940/ISO
3964).
Aesculap® micro-Line The drive speed is conveyed in different ways in the micro-Line straight handpieces/angled handpieces.
micro-Line Straight handpiece/angled handpiece Additionally, the micro-Line straight handpieces/angled handpieces can be operated with the spray nozzles listed
below.

micro-Line Straight handpiece/angled Marking Ratio Spray nozzle

Legend handpiece
1 Tool
2 Centering lug GD450M Blue ring 1:1 GD460R
3 Release mechanism (with button)
GD451M Blue ring 1:1 GD461R
4 Spray nozzle (attachment)
5 Direction of arrow (for attaching the spray nozzle) GD455M Red ring 1:2 GD460R
6 Cover sleeve
7 Rotary direction (to open the tool collet) GD456M Red ring 1:2 GD461R
8 Tension ring (rotary, for tightening the tools)
9 Mark (on tension ring) GD457M Red ring 1:2 GD462R
10 Mark (on handle part)
GD465M Blue ring 1:1 GD460R
11 Mark (= Tool tightened)
12 Handpiece coupling GD466M Blue ring 1:1 GD461R
13 Aesculap STERILIT oil spray and micro-Line adapter
14 Adapter ring (spray nozzle) GD467M Blue ring 1:1 GD462R

Symbols on product and packages 4. Preparation

Caution, general warning symbol Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the
part of Aesculap.
Caution, see documentation supplied with the product
► 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.
1. Applicable to
► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
4.1 Drive unit/Motor
at www.extranet.bbraun.com 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)
2. Safe handling ■ Microtron-EC GD631 with motor GD622
CAUTION ■ Microlan GA502R/GA553R
Federal law restricts this device to purchase by, or on instruction by a physician!
► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial
sterilization.
4.2 Allowable motor drive speed ranges
► Prior to use, check that the product is in good working order.
micro-Line Straight hand- Gear ratio Motor drive Tool speed (rpm) Application
► Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
piece/angled handpiece rpm (rpm)
► 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 man- GD450M 1:1 0–40 000 0–40 000 Drilling,
ufacturer liability: reaming,
– Only use the product according to these instructions for use. grinding
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other. GD451M 1:1 0–40 000 0–40 000 Drilling,
reaming,
► Ensure that the product and its accessories are operated and used only by persons with the requisite training,
grinding
knowledge, or experience.
► Keep the instructions for use accessible for the user.
GD455M 1:2 0–40 000 0-80 000 Reaming,
grinding
3. Product description GD456M 1:2 0–40 000 0-80 000 Reaming,
grinding
3.1 Components required for operation GD457M 1:2 0–40 000 0-80 000 Reaming,
■ Drive unit (with DIN 13940/ISO 3964 coupling)/Motor grinding
■ micro-Line Straight handpiece/angled handpiece
■ Tool GD465M 1:1 0–40 000 0–40 000 Drilling,
■ Spray nozzle (optional) reaming,
■ Irrigation set (optional) grinding

GD466M 1:1 0–40 000 0–40 000 Drilling,

3.2 Intended use reaming,
grinding
The micro-Line straight handpieces/angled handpieces are used for drilling and reaming in microsurgery and dental
surgery.
GD467M 1:1 0–40 000 0–40 000 Drilling,
The following drilling and reaming tools can be coupled to the handpieces: reaming,
grinding
Tool

micro-LinStraight hand- Shaft diameter (mm) Shaft length (mm, Tool length (mm, max.)
piece/ Angled handpiece min.) 5. Working with the micro-Line straight handpiece/angled handpiece
GD450M ∅ 2.35 46 70
5.1 System set-up
GD451M ∅ 2.35 76 95 Note
Products marked as unsterile must be sterilized, prior to use, according to respective instructions, see Steam steriliza-
GD455M ∅ 2.35 46 70 tion.
GD456M ∅ 2.35 76 95
Risk of contamination and infection caused by unsterile components in the sterile
GD457M ∅ 2.35 106 125 area!
► Use only sterile or sterilized parts in the sterile area.
GD465M ∅ 2.35 46 70
WARNING
GD466M ∅ 2.35 76 95
Risk of injury due to inadvertent activation of the drive unit/motor!
GD467M ∅ 2.35 106 125
► 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

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
WARNING correctly.
 Risk of burns to the patient caused by blunt tools or lack/inadequacy of mainte- 5.9 Safe operation
nance of handpieces!
► Prior to each use and before clamping in place, check the tools for any wear Risk of burns to patient and user, caused by hot tool!
WARNING or damage. ► Only use sharp tools.
► Use irrigation for cooling the tool and to remove any chipping.
WARNING ► Observe the correct reaming direction.
Damage to the product due to incorrect handling or operation! ► Put down the hot tool beyond reach of the patient.
► Couple the product only while the motor is inactive. ► Use a cloth to protect against burns when changing the tool.

CAUTION
Risk of injury and material damage due to incorrect operation of the micro-Line
straight handpiece/angled handpiece or drive units!
5.1.1 Connecting the accessories ► Always follow the safety advice and information given in the instructions for
Note WARNING use of the handpieces and motors.
Follow the instructions for use of individual accessories! ► Do not exceed the specified maximum motor speed.
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 Risk of injury and/or malfunction!
characteristics of the products.
► Always carry out a function check prior to using the product.
► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect;
for a contact address, see Technical Service.
WARNING

5.2 Connecting the spray nozzle (optional)

Risk of injury when using the product beyond the field of view!
Spray nozzle damage due to jammed adapter rings! ► Apply the product only under visual control.
► 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!
► Pull off cover sleeve 6 towards the front end of the micro-Line straight handpiece/angled handpiece. ► micro-Line Only apply minimal force when working laterally with the straight
► Slightly twist and push on spray nozzle 4 in the direction of arrow 5. handpiece.
► Check that adapter rings 14 at the tip are moving smoothly. WARNING
► Secure the irrigation tube to the tube connector.
This completes the installation of spray nozzle 4.
Risk of contamination and infection if surgical gloves are damaged by a sharp
tool!
5.3 Removing the spray nozzle (optional) ► Do not touch the cutting edges of the tool, neither when changing tools nor
► Remove the irrigation tube from the tube olive. WARNING during use.
► 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. 6. Validated reprocessing procedure
This completes the removal of spray nozzle 4.

6.1 General safety instructions

5.4 Coupling a tool Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
Note
hygiene instructions for sterile processing.
When coupling the tools 1, please note that the tools are tightened without using a wrench.
Note
► Rotate the tension ring 8 in the direction of the arrow 7 until it engages.
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
► Insert tool 1 down to the positive stop. national regulations concerning the reprocessing of products.
► 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. Note
The tension ring is closed. Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
► To check that tool 1 is mounted correctly: Pull at tool 1 (with the drive inactive). Note
Tool 1 is coupled firmly, without slack in the tool adapter. Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician is responsible for this.
5.5 Uncoupling the tool The recommended chemistry was used for validation.
Note
Damage to the micro-Line straight handpiece/angled handpiece caused by jammed If there is no final sterilization, then a virucidal disinfectant must be used.
drive unit/motor!
Note
► Make certain the tool was inserted correctly.
For the latest information on reprocessing and material compatibility see also the Aesculap extranet at
CAUTION ► Ensure that the tension ring of the micro-Line straight handpiece/angled
www.extranet.bbraun.com
handpiece is closed.
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

► Rotate the tension ring 8 in the direction of the arrow 7 until it engages.
► Remove tool 1. 6.2 General information
► Turn tension ring 8 against the direction of arrow 7 until mark 9 on the tension ring and mark 10 on the handle Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the
part are aligned with each other. time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temper-
This completes the uncoupling of tool 1. atures >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.
5.6 Coupling the drive unit/motor Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water
► Push centering lug 2 into the coupling of the micro-Line straight handpiece/angled handpiece so that the drive used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in
unit/motor engages audibly. the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water
► Pull at the drive unit/motor to check that it is coupled correctly. and then drying.
This completes the coupling of the drive unit/motor. 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
5.7 Uncoupling the drive unit/motor for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-
► Unlock release mechanism 3 by pressing at the drive unit/motor. ure to do so can result in the following problems:
► Remove the drive unit/motor. ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the applica-
This completes the uncoupling of the drive unit/motor. tion/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
5.8 Function checks
corrosion.
► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-
Damage to the product due to incorrect handling or operation! k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
► Couple the product only while the motor is inactive.

CAUTION
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 Preparations at the place of use
5.8.1 micro-Line Straight handpiece/angled handpiece ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
► Always carry out a trial run prior to using the product. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
► Check that tool 1 is coupled correctly.
► Briefly run tool 1 at maximum speed.
6.5 Preparation before cleaning
► Make certain the product does not produce atypical running noise or vibration during the trial run.
► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.
5.8.2 Irrigation set (optional) ► Prior to the first mechanical cleaning/disinfection process, mount Eccos holder GB681R or GB682R in a suitable
tray (e.g. JF214R).
► 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.
6.6 Cleaning/disinfection Phase IV
► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water.
6.6.1 Product-specific safety instructions for the reprocessing procedure ► Drain any remaining water fully.

Phase V
Damage to the product due to inappropriate cleaning/disinfecting agents! ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
► Only use cleaning/disinfecting agents approved for surface cleaning. Follow and disinfection procedure.
the manufacturer’s instructions for the respective cleaning/disinfecting agent.
CAUTION 6.7.2 Manual cleaning with ultrasound and immersion disinfection

Phase Step T t Conc. Water Chemical

Damage to the product due to inappropriate cleaning/disinfecting agents and/or [%] quality
[°C/°F] [min]
excessive temperatures!
► Use cleaning and disinfecting agents according to the manufacturer’s instruc- I Ultrasonic RT (cold) >15 2 D–W Aldehyde-free, phenol-free,
CAUTION tions which cleaning and QUAT-free concentrate,
– are approved for high-grade steel. pH ~ 9*
– do not attack softeners (e.g. in silicone).
► Observe specifications regarding concentration, temperature and exposure II Intermediate RT (cold) 1 - D–W -
time. rinse
► Do not exceed the maximum allowable temperature of 60 °C.
III Disinfection RT (cold) 15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
► Do not clean motors/handpieces by ultrasonic treatment and do not immerse them in any liquids. To avoid the pH ~ 9*
risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately.
► Tools: Carry out ultrasound cleaning: IV Final rinse RT (cold) 1 - FD-W -
– as an effective mechanical supplement to manual cleaning/disinfection.
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/ V Drying RT - - - -
disinfection.
– as an integrated mechanical support measure for mechanical cleaning/disinfection. D–W: Drinking water
– for additional cleaning of products with residues left after mechanical cleaning/disinfecting. FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
6.6.2 Validated cleaning and disinfection procedure RT: Room temperature
*Recommended: BBraun Stabimed
Validated procedure Special features Reference
► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
Manual cleaning and ■ Open and close the tool coupling. Chapter Manual cleaning/disin-
infection procedure.
wipe disinfection fecting and subsection:
■ Drying phase: Use a lint-free cloth
■ micro-Line Straight ■ Chapter Manual cleaning Phase I
handpiece/angled ■ Ensure that the product is positioned in such a and wipe disinfecting ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible
handpiece way that water will not enter the product e.g. surfaces are immersed and acoustic shadows are avoided.
through coupling interfaces. (Immediately
► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
remove any fluid that entered the product
from the surface.
inadvertently.)
► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.
Manual cleaning and ■ 20 ml disposable syringe Chapter Manual cleaning/disin- ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
wipe disinfection fecting and subsection: ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
■ After use, rinse with demineralized water.
■ Spray nozzle ■ Chapter Manual cleaning disposable syringe.
■ Drying phase: Use a lint-free cloth or com- and wipe disinfecting
pressed air for medical purposes Phase II
► Rinse/flush the product thoroughly (all accessible surfaces) under running water.
Manual cleaning with ■ 20 ml disposable syringe Chapter Manual cleaning/disin- ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
ultrasound and immer- fecting and subsection: ► Drain any remaining water fully.
■ Drying phase: Use a lint-free cloth or com-
sion disinfection
pressed air for medical purposes ■ Chapter Manual cleaning
■ Tool with ultrasound and immer-
Phase III
sion disinfection ► Fully immerse the product in the disinfectant solution.
► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
Mechanical alkaline ■ Close the tool coupling. Chapter Mechanical cleaning/ ► Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe.
cleaning and thermal disinfecting and subsection: Ensure that all accessible surfaces are moistened.
■ micro-Line Straight handpiece/angled hand-
disinfecting
piece: Insert the product in its proper position ■ Chapter Mechanical alka-
Phase IV
■ micro-Line Straight in the Eccos holder. line cleaning and thermal
► Rinse/flush the product thoroughly (all accessible surfaces) under running water.
handpiece/angled disinfecting
handpiece ■ Tool/Spray nozzle: Place the instrument in a ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse.
tray that is suitable for cleaning (avoiding ► Rinse lumens with an appropriate disposable syringe at least five times.
■ Tool/Spray nozzle rinsing blind spots). ► Drain any remaining water fully.

Phase V
6.7 Manual cleaning/disinfecting ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfection procedure.
► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
► After manual cleaning/disinfection, check visible surfaces visually for residues. 6.8 Mechanical cleaning/disinfecting
► Repeat the cleaning/disinfection process if necessary. Note
The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark
6.7.1 Manual cleaning and wipe disinfecting according to DIN EN ISO 15883).

Phase Step T t Conc. Water Chemical Note

[°C/°F] [min] [%] quality The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

I Cleaning RT (cold) - - D–W - 6.8.1 Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
II Drying RT - - - -
Phase Step T t Water Chemical/Note
III Wipe disinfec- - >1 - - Meliseptol HBV wipes [°C/°F] [min] quality
tion 50 % Propan-1-ol
I Prerinse <25/77 3 D–W -
IV Final rinse RT (cold) 0.5 - FD-W -

V Drying RT - - - -
II Cleaning 55/131 10 FD-W ■ Concentrate, alkaline:
– pH = 13
D–W: Drinking water – <5 % anionic surfactant
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality ■ 0.5 % working solution
at least) – pH = 11*
RT: Room temperature
III Intermediate >10/50 1 FD-W -
rinse
Phase I
► Clean the product under running faucet water, using a suitable cleaning brush until all visible residues have been IV Thermal disin- 90/194 5 FD-W -
removed from the surfaces. fecting
► Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
V Drying - - - According to the program for cleaning
Phase II and disinfection device
► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfection procedure. D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
Phase III
at least)
► Wipe all surfaces of the product with a single-use disinfectant wipe.
*Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

6.9 Inspection, maintenance and checks 9. 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. Risk of injury and/or malfunction!
► micro-Line Prior to sterilization, spray through the handpiece with Aesculap-STERILIT oil spray GB600 with ► Do not modify the product.
adapter GB600810 for approx. 1 s.
► Check the product for any damage, abnormal running noise, overheating or excessive vibration. WARNING
► Inspect tools for broken, damaged or blunt edges.
► Set aside the product if it is damaged. ► For service and repairs, please contact your national B. Braun/Aesculapagency.
► Prior to an extended period of non-use, store attachments cleaned, maintained and dried according to the Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
instructions. feiture of applicable licenses.

6.10 Packaging Service addresses

Aesculap Technischer Service
► Follow the instructions for use for the applied packaging and storage systems (e.g. instructions for use TA009721
Am Aesculap-Platz
for Aesculap Eccos storage system).
78532 Tuttlingen / Germany
► 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. Phone: +49 (7461) 95 -1601
► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). Fax: +49 (7461) 14 -939
► Ensure that the packaging will prevent a recontamination of the product. E-Mail: ats@aesculap.de
Or in the US:
Attn. Aesculap Technical Services
6.11 Steam sterilization 615 Lambert Pointe Drive
► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by Hazelwood
opening any valves and faucets). MO, 63042 USA
► Validated sterilization process Aesculap Repair Hotline
– Steam sterilization using fractionated vacuum process Phone: +1 (800) 214 -3392
– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 Fax: +1 (314) 895 -4420
– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min Other service addresses can be obtained from the address indicated above.
► 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.
10. Accessories/Spare parts
6.12 Sterilization for the US market
Art. no. Designation
■ 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. GD460R Spray nozzle for GD450M, GD455M, GD465M
To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters:
GD461R Spray nozzle for GD451M, GD456M, GD466M
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters* GD462R Spray nozzle for GD457M, GD467M

Sterilization method Temp. Time Minimum drying time GB600 Aesculap STERILIT oil spray

Prevacuum 270 °F/275 °F 4 min 20 min GB600810 STERILIT micro-Line adapter

GB681R Eccos holder (for 3 handpieces)

*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 GD682R Eccos holder (for 1 handpiece)
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 GB459R Eccos mounting set for holders
after processing, such as a wrap, pouch, etc.
TA012581 Instructions for use for GD450M, GD451M, GD455M, GD456M,
GD457M, GD465M, GD466M, GD467M
6.13 Storage
► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. see Aesculap catalog Power Systems - Tools (e.g. GD025R)
Burrs & Blades

7. Maintenance
To ensure reliable operation, the product must be maintained at least once a year. 11. Technical data
For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.
Classification acc. to Directive 93/42/EEC

8. Troubleshooting list Art. no. Designation Class

Malfunction Detection Cause Remedy GD450M, GD451M, micro-Line Straight handpiece/angled handpiece IIa
GD455M, GD456M,
micro-Line Straight Collet not locked Tension ring fixed/closed Turn the tension ring GD457M, GD465M,
handpiece/angled hand- or not tightened against the direction of GD466M, GD467M
piece not running the arrow until the marks
on the tension ring and
on the handle part are
aligned with each other micro-Line Straight hand- Gear Motor Tool speed Weight Tool Class
piece/angled handpiece ratio drive rpm (rpm) (g) length
Marks on the tension ring Tension ring fixed/closed Turn the tension ring (rpm) (mm,
and on the handle part no or not tightened against the direction of max.)
aligned with each other the arrow until the marks
on the tension ring and GD450M 1:1 0–40 000 0–40 000 69 70 II a
on the handle part are
aligned with each other GD451M 1:1 0–40 000 0–40 000 76 95 II a

Drive unit/motor not Drive unit/motor defec- Check drive unit/motor GD455M 1:2 0–40 000 0-80 000 90 70 II a
reacting tive according to appropriate
instructions for use GD456M 1:2 0–40 000 0-80 000 97 95 II a

Insufficient power Tool not cutting correctly Cutting edges worn Replace the tool GD457M 1:2 0–40 000 0-80 000 104 125 II a

Drive unit/motor not run- Drive unit/motor defec- Check drive unit/motor GD465M 1:1 0–40 000 0–40 000 90 70 II a
ning correctly tive according to appropriate
instructions for use GD466M 1:1 0–40 000 0–40 000 97 95 II a

Tool change impossible Tension ring does not Collet jammed Have repaired by manu- GD467M 1:1 0–40 000 0–40 000 104 125 II a
rotate freely or does not facturer
rotate at all
11.1 Ambient conditions
Tool blocked Tool is jammed Have repaired by manu-
facturer Operation Storage and transport

micro-Line Straight Irregular running noise Bearing defective Have repaired by manu- Temperature
handpiece/angled hand- facturer
piece vibrating
Tool shaft bent Tool damaged Replace the tool

micro-Line Straight Rapid temperature rise Bearing defective Have repaired by manu-
handpiece/angled hand- facturer
piece heating up during Relative humidity
operation
 Operation Storage and transport

Atmospheric pressure

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
3773 Corporate Parkway
Center Valley, PA, 18034,
USA

TA-Nr. 012581 03/13 V6 Änd.-Nr. 47057