Drill attachment GB377R, GB389R

3.4

Operating principle

The drill attachment A/B is driven either by the motor unit ACCULAN mini 9 or microspeed uni mini pistol handpiece 8. It rotates at the speed of the motor and transfers the rotation to the coupled tool. For speed specifications, see Technical data. The drill attachment can be attached to the motor in four different positions (4 x 90°).

Aesculap® mini-Line Drill attachment GB377R, GB389R Legend

4.

A B 1 2 3 4 5 6 7 8 9

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Before using the drill attachments and their accessories, check to be sure that neither are damaged. ► Use the attachments and their accessories only if they are in perfect condition. ► Only use motor units with a maximum motor speed of 16 000 1/min. If necessary adjust the motor unit.

mini-Line HD drill attachment large Jacobs chuck GB377R mini-Line drill attachment hexagonal quick-action chuck GB389R Jacobs chuck Key for Jacobs chuck attachments GA031201 Motor coupling Tool coupling Unlocking sleeve Wrench GA186209 Tension ring Motor unit microspeed uni mini pistol handpiece GD684 Motor unit ACCULAN mini GA647

Preparation

5.

Working with the drill attachments GB377R and GB389R

5.1

System set-up

Connecting the accessories

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product WARNING

Aesculap hexagon coupling

WARNING

Damage to the attachments due to excessive motor speed (>20 000 rpm)! ► When using adjustable electric motor drives, set the rotational speed to 16 000 rpm. ► Follow the instructions for use of the motor.

WARNING

Risk of infection and contamination! The drill attachment and its accessories and motors are supplied in unsterile condition. ► Prior to putting into operation the drill attachment, process its accessories and motor units.

Heavy-duty gearing

HD

1.

Risk of injury damage caused by inadvertent activation of the motor! ► Ensure that the motor is not unintentionally put into operation by the foot control, hand control, etc. ► Couple the drill attachment and change tools only with the motor unit securely locked.

Applicable to

► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at www.extranet.bbraun.com

2.

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.

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician! ► Prior to use, check that the product is in good working order. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► 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. ► Keep the instructions for use accessible for the user. ► Use the drill attachment only with tools of maximum diameter of ∅ = 11 mm, see Accessories/Spare parts

3.

Product description

3.1

Scope of supply

Note When using Kirschner wires as guide wires: Use drill attachment only in combination with cannulated motor unit ACCULAN mini GA647/cannulated microspeed uni mini pistol handpiece GD684 with accompanying protective sleeve! ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect;

for a contact address, see Technical Service.

Connecting the drill attachment to the motor unit Coupling ► Open tension ring 7 of motor unit 8/9. ► Insert coupling 3 on the drill attachment A/B in one of the four possible locations on the motor unit 8/9. ► Tighten tension ring 7 by hand, until the drill attachment A/B is firmly seated. Uncoupling ► Open tension ring 7 of motor unit 8/9. ► If tension ring 7 of motor unit 8/9 cannot be loosened by hand, use wrench 6 supplied with the product. ► Remove drill attachment A/B.

Tool change Damage to the drill attachment caused by using inappropriate tool! ► Only use appropriate tools for the drill attachment.

GB377R Designation

Art. no.

mini-Line HD drill attachment large Jacobs chuck

GB377R

Cleaning brush

TA011327

Designation

Art. no.

mini-Line drill attachment hexagonal quick-action chuck

GB389R

Cleaning brush

TA011327

Components required for operation

Note Motor units and drill attachments can be used in any combination. Designation

Art. no.

Motor unit ACCULAN mini

GA647

Motor unit microspeed uni mini Pistol handpiece

GD684

mini-Line HD drill attachment large Jacobs chuck

GB377R

mini-Line drill attachment hexagonal quick-action chuck

GB389R

3.3

GB377R Coupling a tool ► Slide the tool at least 20 mm deep into Jacobs chuck 1. ► Firmly close Jacobs chuck 1 with key 2.

GB389R

3.2

CAUTION

Uncoupling the tool ► Open Jacobs chuck 1 with key 2. ► Remove the tool. GB389R Coupling a tool ► Slide the tool into mini-Line drill attachment hexagonal quick-action chuck B. ► Turn the tool to find the correct position in the Aesculap hexagon shaft and push the tool in as far as it will go. Uncoupling the tool ► Slide back unlocking sleeve 5. ► Remove the tool.

5.2

Function checks

► Perform a test run of the motor unit ACCULAN mini 9/microspeed uni mini pistol handpiece 8 with drill

attachment A/B and tool prior to each use.

Intended use

The drill attachment A/B is used for applying femoral and tibial drill channels in cruciate-ligament reconstruction operations.

► Ensure that drill attachment A/B is coupled correctly. ► Verify that the tools are clamped in/coupled correctly. ► Ensure that drill attachment A/B and the tool are in proper condition. ► Check for any damage, irregular running noises, excessive vibration and overheating of drill attachment A/B.

5.3

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

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure 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.

WARNING

WARNING

CAUTION

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

► 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.

WARNING

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

► 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.

Validated cleaning and disinfection procedure

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

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.

WARNING

a way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.)

WARNING

moderate speed. ► To avoid slipping, apply only moderate pressure. ► To avoid tool breakage, do not bend the tool.

6.

Validated reprocessing procedure

6.1

General safety instructions

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

6.7 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.

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

■ Follow instructions for use of Eccos holder.

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

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.

Dismantling prior to carrying out the reprocessing procedure

► Remove tool and motor from drill attachment.

6.4

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

► Prior to first mechanical cleaning/disinfection process: Assemble Eccos holder GB674R in a suitable tray (e.g.,

JF214R). ► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Manual cleaning/disinfecting

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

Manual cleaning and wipe disinfecting Phase

Step

T [°C/°F]

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:

t [min]

Conc. [%]

Water quality

Chemical

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. 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 6.3

Chapter Mechanical cleaning/ disinfecting and subsection:

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

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.

and wipe disinfecting

■ Drying phase: Use a lint-free cloth ■ Ensure that the product is positioned in such

Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

► Start the motor unit ACCULAN mini 9/microspeed uni mini pistol handpiece 8 of the drill attachment A/B at a

■ Chapter Manual cleaning

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

8.

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Troubleshooting list

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

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

Neutral:

Malfunction

Detection

Cause

Remedy

Excessive noise

Drill attachment A/B heats up

Worn gearing

Have product repaired by the manufacturer

Tool not moving

Drill attachment A/B cannot be removed from the motor unit ACCULAN mini 9/the microspeed uni mini pistol handpiece 8

Drill attachment A/B not coupled correctly

Couple drill attachment A/B correctly, see Connecting the drill attachment to the motor unit

Chuck 1/tool coupling 4 not turning with the motor

Defective gearings

Have product repaired by the manufacturer

Worn tool blades; tool heating up

Blunt tool

Use a new tool

-

Performance or speed of the motor unit ACCULAN mini 9/microspeed uni mini pistol handpiece 8 too slow

See instructions for use of the motor unit ACCULAN mini 9/microspeed uni mini pistol handpiece 8

Drill attachment GB389R: Tool cannot be coupled

Tool is not part of current product range

Wrong tool

Insert fitting tool with hexagon shaft

Tension ring 7 cannot be opened by hand

Tension ring 7 cannot be turned by hand

Tension ring 7 tightened down too hard

Open the tension ring with the wrench 6

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

■ 0.5 %* working solution Mildly alkaline:

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

■ 0.5 % solution 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 neutral

Deficient cutting performance

9.

Technical Service

► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

6.9

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

Inspection, maintenance and checks

WARNING

► 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 the MiniLine motor/handpiece with Aesculap-STERILIT oil spray with Adapter GB600830 for

approx. 1 s. ► 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 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 Note The product may only be sterilized when dismantled.

► 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.

► 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).

10.

► 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.

6.12 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

Accessories/Spare parts

Designation

Art. no.

Aesculap-STERILIT-Power-Systems oil spray

GB600 (+adapter GB600830)

Eccos holder

GB674R

Cleaning brush

TA011327

10.1 GB377R Designation

Art. no.

Drill: Shaft ∅ max. 6.5 mm Working ∅ max. 11.0 mm

e.g.: FR549R

10.2 GB389R *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.

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

7.

Maintenance

In order to ensure reliable operation, the product must be maintained after 300 reprocessing cycles or at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

Designation

Art. no.

Headed drill ∅ 4.5 mm, cannulated

FO079R

Headed drill ∅ 5.0 mm, cannulated

FO081R

Headed drill ∅ 5.5 mm, cannulated

FO082R

Headed drill ∅ 6.0 mm, cannulated

FO083R

Headed drill ∅ 6.5 mm, cannulated

FO084R

Headed drill ∅ 7.0 mm, cannulated

FO085R

Headed drill ∅ 7.5 mm, cannulated

FO086R

Headed drill ∅ 8.0 mm, cannulated

FO087R

Headed drill ∅ 8.5 mm, cannulated

FO088R

Headed drill ∅ 9.0 mm, cannulated

FO089R

Headed drill ∅ 9.5 mm, cannulated

FO090R

Designation

Art. no.

Headed drill ∅ 10.0 mm, cannulated

FO091R

Headed drill ∅ 10.5 mm, cannulated

FO092R

Headed drill ∅ 11.0 mm, cannulated

FO093R

Twist drill ∅ 5.0 mm, cannulated

FR541R

Twist drill ∅ 5.5 mm, cannulated

FR542R

Twist drill ∅ 6.0 mm, cannulated

FR543R

Twist drill ∅ 6.5 mm, cannulated

FR544R

Twist drill ∅ 7.0 mm, cannulated

FR545R

Twist drill ∅ 7.5 mm, cannulated

FR546R

Twist drill ∅ 8.0 mm, cannulated

FR547R

Twist drill ∅ 8.5 mm, cannulated

FR548R

Twist drill ∅ 9.0 mm, cannulated

FR549R

Twist drill ∅ 9.5 mm, cannulated

FR550R

Twist drill ∅ 10.0 mm, cannulated

FR551R

Twist drill ∅ 10.5 mm, cannulated

FR552R

Twist drill ∅ 11.0 mm, cannulated

FR553R

11.

Technical data

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

Designation

Class

GB377R, GB389R

Drill attachment

IIa

Drill attachment

GB377R

GB389R

Dimension Length x ∅ (mm)

approx. 90 x 28

approx. 71 x 25

Weight (g)

230

145

Max. motor speed (1/min)

16 000

16 000

Gear ratio

36:1

36:1

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. 011679

01/14

V6

Änd.-Nr. 48673