Reamer and drill attachments

5.2

Tool change

5.4 Damage to the attachment caused by inappropriate tool! ► Only use appropriate tools for the attachment.

Connecting the spray nozzle

Note For cooling the tools and in particular to avoid necrosis, spray nozzle GB378 can be attached to the reamer and drill attachments (except for GB373R). ► To attach the spray nozzle, push spray nozzle 10 into adapter 4 of the attachments and, using a tube set, e.g.

CAUTION

GA390, connect it to a suitable irrigation pump, e.g. GD631. ► To remove the spray nozzle, remove spray nozzle 10 from the adapter 4.

► Avoid handling the cutting edges of tools when changing them.

Inserting tools with 2.35 mm round shaft (GB376R, GB380R) Risk of damage to the attachment and motor due to operation with open tension sleeve! ► Operate the attachment with the tension sleeve closed. CAUTION

5.5

Function checks

► Prior to each use, always perform a trial run of the motor with attachment and tool attached. ► Make certain the reamer and drill attachments are coupled correctly. ► Make certain the tool is coupled correctly. ► Make certain the attachment and tool are in proper condition. ► Watch out for damage, irregular running noises, excessive vibrations and excessive heat developed by the attach-

ments. Risk of damage to the attachment and motor if the tension sleeve is turned during operation! ► Do not turn the tension sleeve during operation.

5.6

Safe operation Risk of injury due to excessive motor speed! ► Verify that the motor speed does not exceed 16 000 1/min.

CAUTION WARNING

For reaming, only attachment GB376R may be used. For drilling, only attachment GB380R and a drill with a diameter of 2.35 mm may be used. Coupling: ► Turn tension sleeve 7 in rotary direction 13 as far as it will go. ► Push the tool into the attachment as far as it will go. ► Turn back tension sleeve 7, until the markings 6 are congruent.

WARNING

Uncoupling: ► Turn tension sleeve 7 in rotary direction 13 as far as it will go. ► Remove the tool.

Risk of burns to patient and user due to hot motor and/or hot tool! ► Put down the hot motor/hot tool beyond reach of the patient. ► Use a cloth to protect against burns when changing the motor or tool.

Inserting tools with Aesculap square shaft (GB381R)

WARNING

Coupling: ► Push tool with the Aesculap square shaft into attachment GB381R. ► Turn the tool so that the correct position for the square shaft is found and insert it as far as it will go.

Risk of skin and tissue burns! Blunt tools can heat up very quickly. ► Do not use mechanically damaged tools.

Uncoupling: ► Retract unlocking sleeve 8 in the direction of the attachment. ► Remove the tool.

WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Inserting tools with AO shaft (GB382R) Coupling: ► Retract unlocking sleeve 8 in the direction of the attachment and hold. ► Insert tool with AO shaft into the correct position in the flat section as far as it will go. ► Release unlocking sleeve 8. Unlocking sleeve 8 clicks into position. Uncoupling: ► Retract unlocking sleeve 8 in the direction of the attachment. ► Remove the tool.

Inserting tools in the Jacobs chuck (GB383R and GB386R) Coupling: ► Push the tool into the Jacobs chuck as far as it will go. ► Securely close the Jacobs chuck with the appropriate key. Uncoupling: ► Open the Jacobs chuck with the appropriate key. ► Remove the tool.

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING For cooling, spray nozzle GB378 is required. This must be connected to a suitable irrigation pump, e.g. motor drive with irrigation pump GD631, via a tube set, e.g. GA390. Cooling improves the chip removal and reduces the risk of necrosis. ► Start the motor powering the reamer or drill attachment at moderate speed. ► To avoid slipping, apply only moderate pressure. ► To avoid tool breakage, do not bend the tool. ► Cool the tool during operation.

Operating FREEHAND tools (attachment GB384R) RIsk of damage to or shearing of the FREEHAND wire due to excessive motor speed when resuming work with the wire using the tissue protection sleeve! ► Start the motor powering the FREEHAND attachment at moderate speed.

Inserting FREEHAND tools (GB384R) Coupling: ► Push FREEHAND tools into the attachment GB384R. ► Turn the tool until the pin on the tool finds one of the recesses 12 and insert it as far as it will go. Uncoupling: ► Retract unlocking sleeve 8 in the direction of the attachment. ► Remove the tool.

Inserting tools for angular shaft according to DIN EN ISO 1797-1 Coupling: ► Move the lever flap 9 to the right. ► Push the tool into the attachment as far as it will go. ► Move the lever flap 9 back to the center. ► Check the tool is firmly seated: To do this, pull gently on the tool. Uncoupling: ► Move the lever flap 9 to the right. ► Remove the tool.

5.3

Connecting the attachment to the motor unit

► Adjust the motor speed to max. 16 000 1/min.

Coupling: ► Open tension ring 2 of motor 1. ► Insert coupling 3 on the reamer/drill attachment 5 in one of the four possible locations on the motor 1. ► Close tension ring 2 of motor 1. Uncoupling: ► Open tension ring 2 of motor 1. ► If tension ring 2 of motor 1 cannot be released by hand, use wrench GB186209 supplied with the product. ► Remove reamer/drill attachment 5.

Risk of injury and material damage due to inappropriate use of handpieces or motors! ► 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.

CAUTION Inserting the FREEHAND wire: ► Insert the FREEHAND wire into the bone with the motor in clockwise rotation mode. ► Remove the FREEHAND wire in counterclockwise rotation mode. The FREEHAND wire stays inserted in the bone. ► Remove the attachment with coupled tissue protection sleeve. Moving or removing the FREEHAND wire: ► Push FREEHAND attachment with coupled tissue protection sleeve over the FREEHAND wire. ► Resume work with the FREEHAND wire with the motor in slow clockwise rotation mode.

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 the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

6.2

Single-use products

WARNING

Manual cleaning and wipe disinfecting

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product!

Designation

Art. no.

FREEHAND tools

e.g., GD530

6.3

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.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

-

-

-

-

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. Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully.

► Separate tool and motor from attachment.

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

6.5

6.9

6.4

Dismantling prior to carrying out the reprocessing procedure

Preparations at the place of use

Mechanical cleaning/disinfecting

► 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.

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).

6.6

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

Preparation before cleaning

► Prior to first mechanical cleaning/disinfection process: Assemble Eccos holder GB673R in a suitable tray (e.g.,

JF214R).

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

6.7

Machine type: single-chamber cleaning/disinfection device without ultrasound

Cleaning/disinfection

Phase

Product-specific safety instructions for the reprocessing procedure

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfectant agents in line with the manufacturer's instructions that are approved for stainless steel. ► Observe specifications regarding concentration, temperature and exposure time. ► Avoid encrustation of residues/proteins (e.g. caused by aldehyde/alcohol). ► Only use bactericidal, fungicidal, and virucidal disinfectants. ► Preferably use thermal disinfecting processes. ► Do not exceed the maximum allowable temperature of 60 °C.

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

Neutral:

■ Concentrate: – pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution Mildly alkaline:

■ Concentrate: – pH = 9.5 – <5 % anionic surfactant

■ 0.5 % solution

► 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

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

risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately.

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable

Chapter Manual cleaning/disinfecting and subsection:

hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

■ Drying phase: Use a lint-free cloth or

■ Chapter Manual cleaning and wipe disinfecting

compressed air for medical purposes

■ Ensure that the product is positioned in

■ Insert the product in its proper position in the Eccos holder.

■ Follow instructions for use of Eccos holder.

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

6.10 Inspection, maintenance and checks

such a way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.) Mechanical neutral or mild alkaline cleaning and thermal disinfecting

D–W: FD–W:

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

► 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. ► Spray through attachment with Aesculap-STERILIT oil spray GB600 with adapter GB600830 for approx. 1 second. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Set aside the product if it is damaged. ► Prior to an extended period of non-use, always store attachments cleaned and dried according to the instruc-

tions.

6.11 Packaging ► Follow the instructions for use for the applied packaging and storage systems (e.g. instructions for use TA009721

6.8

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. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

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.

6.12 Steam sterilization

10.

Note The product may only be sterilized when dismantled.

Art. no.

► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

FR103800

Key for GB383R

GA031201

Key for GB386R

opening any valves and faucets). ► Validated sterilization process

– Disassemble the product – Steam sterilization through 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.

6.13 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.

Accessories/Spare parts Designation

GB378

Spray nozzle

GB373205

Injector needle

GB186209

Wrench

GB673R

Eccos holder for mini-attachments

GB600

STERILIT oil spray with adapter GB600830

To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters*

Attachment

Type of tool

Clamping length

Max. Tool ∅

Example tool

GB373R

Drill

13 mm

2.1 mm

GC895R

Sterilization method

Temp.

Time

Minimum drying time

GB376R*

Reamer

29 mm

8 mm

GD896R

Prevacuum

270 °F/275 °F

4 min

20 min

GB380R

Drill

29 mm

3.2 mm

GC884R

GB381R

Drill

Aesculap socket

4 mm

GC414R

GB382R

Drill

AO socket

4 mm

GC314R

GB383R

Drill

18 mm

4 mm

GC010R

GB384R

Drill, Kirschner wire

FREEHAND tools

3.2 mm

GD506

GB386R

Drill

26 mm

9 mm

FR515R

*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.

6.14 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

7.

* max. tool length 70 mm

Maintenance

Attachments must be lubricated after every cleaning process and before every sterilization process to avoid increased wear and reduced performance of the attachment. To ensure reliable operation, the attachment gearing must be maintained once every 2-3 years. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

8.

Troubleshooting list

11.

Technical data

Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

GB373R-GB386R

mini-attachments

IIa

Malfunction

Detection

Cause

Remedy

Excessive noise

Attachment is getting hot

Worn gearing

Have product repaired by the manufacturer

Attachment

Dimensions: Length x ∅ in mm

Tool not moving

Attachment can not be extracted from the motor unit

Attachment not coupled properly

Couple the attachment correctly, see Connecting the attachment to the motor unit

GB373R

86 x 20

90 g

16 000 1/min

8:1

GB376R

100 x 20

108 g

16 000 1/min

1:2

Motor running, but not driving the attachment or tool

Defective gearings

Have product repaired by the manufacturer

GB380R

100 x 20

130 g

16 000 1/min

4:1

GB381R

67 x 20

98 g

16 000 1/min

16:1

Worn tool blades; tool heating up

Blunt tool

GB382R

69 x 20

98 g

16 000 1/min

16:1

GB383R

75 x 22

160 g

16 000 1/min

16:1

Deficient cutting performance

Use a new tool

Weight

Max. motor speed

Gear ratio

See instructions for use of the motor unit

Insufficient motor power/speed

See instructions for use of the motor unit

GB384R

60 x 20

97 g

16 000 1/min

16:1

Tool cannot be coupled

Tool is not part of current product range

Wrong tool

Insert appropriate tool

GB386R

87 x 28

225 g

16 000 1/min

16:1

GB373R

86 x 20

90 g

16 000 1/min

8:1

Tension ring 2 cannot be opened by hand

Tension ring cannot be rotated by hand in either direction

Tension ring tightened down too hard

Open the tension ring with the wrench GA186209

GB376R

100 x 20

108 g

16 000 1/min

1:2

GB380R

100 x 20

130 g

16 000 1/min

4:1

GB381R

67 x 20

98 g

16 000 1/min

16:1

► For further information on detecting and rectifying defects, see instructions for use of the respective motor.

9.

Technical Service Risk of injury and/or malfunction! ► Do not modify the product.

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

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.

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. 010459

01/14

V6

Änd.-Nr. 48673