Flexible shafts GA156, GA172, GA173, GA176, GA186

1.

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician! ► Clean the new product after removing its transport packaging and prior to its initial sterilization: – GA156 and GA172 (manually) – GA173, GA176, GA186 (manually or mechanically) ► Prior to use, check that the product is in good working order. ► 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.

2.

Product description

2.1

Scope of supply

Designation

Art. no.

Enclosed

Instructions for use

TA008517

with all flexible shafts

Wrench

GA186209

with Mini flexible shaft GA186

Mini-STERILIT Power Systems adapter

GB600830

with Mini flexible shaft GA186

Micro-STERILIT Power Systems adapter

GB600810

with Micro flexible shafts GA173 and GA176

3

Aesculap® Flexible shafts GA156, GA172, GA173, GA176, GA186 2.2

Components required for operation

■ ELAN-E or -EC ■ Aesculap handpiece with appropriate coupling ■ Flexible shaft 2.3

Operating principle

The output power generated by the ELAN-E or -EC is transferred to the Aesculap handpiece via the flexible shaft. The flexible shaft used for this purpose is enclosed in a protective tube. The flexible shafts provide 1:1 transmission of the rotation of the ELAN-E or -EC to the handpiece. The speed range is preset by the ELAN-E or -EC. The flexible shafts GA156, GA172 are only suitable for operation in right (clockwise) rotation mode. The flexible shafts GA173, GA176 and GA186 are suitable for both right (clockwise) and left (counterclockwise) rotation mode.

3.

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 flexible shafts and their accessories, check for visible damage. ► Use the flexible shafts and their accessories only if they are in perfect condition.

4

Working with the flexible shafts

4.1

System set-up

Intended use

The flexible shafts connect the ELAN-E or -EC with the Aesculap handpieces. The flexible shafts are used for large bone surgery, small bone surgery and microsurgery.

2.4

4.

CAUTION

Damage to the flexible shaft due to incorrect handling or operation! ► Flexible shaft must only be coupled while the motor is inactive.

Note Products marked as unsterile must be sterilized, prior to use, according to respective instructions, see Steam sterilization.

4.1.1

Connecting the accessories

DANGER

Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device.

Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service.

4.1.2

Coupling/uncoupling the flexible shaft to/from ELAN-E

► To uncouple handpiece 8: Release clamping lever 9

and remove handpiece 8, see Fig. 2.

Note The flexible shafts GA156, GA172 can only be coupled with the right rotation version of ELAN-E!

9

► To couple the flexible shaft: Fully engage the flex-

ible shaft on adapter stud 11. ► To uncouple the flexible shaft: Pull back sleeve 1

and remove the flexible shaft.

4.1.3

Coupling/uncoupling the flexible shaft to/from ELAN-EC

The ELAN-EC features flexible-shaft recognition. When a macro flexible shaft is coupled, the ELAN-EC automatically switches to right (clockwise) rotation and reduces the maximum speed to 15 000 rpm When the sensor detects a micro flexible shaft, the ELAN-EC can be operated in right-left mode at speeds up to 20 000 rpm.

4.1.4

Fig. 2

Flexible shafts

GA176 and GA173 (micro flexible shafts) The micro flexible shafts GA176 and GA173 can be used to drive Aesculap handpieces with ISO 3964 adapter. ► To couple handpiece 8: Slide handpiece 8 onto centering lug 5 until it engages, see Fig. 3.

Coupling/uncoupling of handpieces on flexible shafts

8

GA156 and GA172 (macro flexible shafts)

5

► To couple handpiece 8: Push the handpiece all the

way down on centering lug 5, making certain that lug 6 is seated in the groove of handpiece 8. ► Tighten clamping lever 9 at handpiece 8, see Fig. 1.

8

6 Fig. 3

9

Fig. 1

Coupling the flexible shaft

5

Coupling the flexible shaft

5

Aesculap® Flexible shafts GA156, GA172, GA173, GA176, GA186 ► To uncouple handpiece 8: Press button 10 and

detach handpiece 8, see Fig. 4.

► To uncouple handpiece 8: Twist tension ring 16

towards OFFEN (open) until handpiece 8 can be detached, see Fig. 6.

8

8

4

10 Fig. 4

Uncoupling the flexible shaft

GA186 (mini flexible shaft) Note Do not use the wrench for tightening the coupling under any circumstances! ► To couple handpiece 8: Fully insert handpiece 8 in

close coupling 15, see Fig. 5.

8

Fig. 6

Uncoupling the flexible shaft

► If the tension ring 16 of the coupling cannot be

loosened by hand, use the wrench 17 supplied with the product.

4.2

Function checks

Note The function checks must be carried out prior to every surgical application of the product!

4.2.1

Test run

► Check that the flexible shaft is securely coupled. ► Briefly run the flexible shaft at maximum speed,

4 Fig. 5

Coupling the flexible shaft

► Tighten the tension ring 16 only by hand and with

the device inactive. ► Twist tension ring 16 towards the ZU (closed) posi-

tion until handpiece 8 is firmly clamped to the flexible shaft.

6

both on its own and with a handpiece coupled. Check for proper and reliable functioning. The flexible shaft should develop neither excessive heat, nor untypical running noise. In case of any malfunction of the flexible shaft, see Troubleshooting list.

4.3

Safe operation

WARNING

WARNING

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. 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.

WARNING

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

WARNING

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

CAUTION

Uneven, noisy running and excessive heat-up of the flexible shafts due to kinking! ► Make certain the flexible shafts are always extended during operation.

Overloading can cause warping of macro flexible shafts. ► Remove the tool from the operating site. The macro flexible shaft returns to its original, extended condition, see Fig. 7.

Fig. 7 The micro flexible shafts feature a slip clutch for overload protection. Slipping, accompanied by significant noise, is triggered as soon as the maximum load is exceeded. ► Reduce the load on the micro flexible shaft.

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Aesculap® Flexible shafts GA156, GA172, GA173, GA176, GA186 5. 5.1

Validated reprocessing procedure 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.

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5.2

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.

5.3

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 con-

CAUTION

tainer for cleaning and disinfection within 6 hours.

5.4

Preparation before cleaning

► Carry out non-fixating/NaCl-free pre-cleaning

immediately after use.

5.5

Cleaning/disinfection

5.5.1

Product-specific safety instructions for the reprocessing procedure

CAUTION

CAUTION

Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► For flexible shafts GA156 and GA172, only apply manual cleaning/disinfecting. 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

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 plastic material and highgrade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. Damage to the flexible shafts due to incorrect mechanical cleaning! ► Clean the flexible shafts only in appropriate storage devices. ► Always use a suitable cleaning and disinfecting program for mechanical cleaning. ► Do not use alkaline cleaning agents.

► 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.

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Aesculap® Flexible shafts GA156, GA172, GA173, GA176, GA186 5.5.2

Validated cleaning and disinfection procedure

When cleaning mechanically: Note Use appropriate (neutral, enzymatic and mild-alkaline) detergents on this product with its aluminum components. Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with

Chapter Manual cleaning/disinfecting and subsection: ■ Chapter Manual cleaning and wipe disinfecting

movable 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 compressed air for medical purposes

■ Ensure that the product is positioned in 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

■ Mount holder GB675R (for GA186) and GB680R (for GA173 and GA176) in a suitable tray (e.g. JF214R)

■ Insert the product in its proper position in holder GB675R or GB680R.

■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

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Chapter Mechanical cleaning/disinfecting and subsection: ■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

5.6

Manual cleaning/disinfecting

► Prior to manual disinfecting, allow water to drip off

► Repeat the cleaning/disinfection process if neces-

for a sufficient length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues.

5.6.1

sary.

Manual cleaning and wipe disinfecting

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

Phase III

► Clean the product under running faucet water,

► Wipe all surfaces of the product with a single-use

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.

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.

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Aesculap® Flexible shafts GA156, GA172, GA173, GA176, GA186 5.7

Mechanical cleaning/disinfecting

CAUTION

5.7.1

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).

Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► For flexible shafts GA156 and GA172, only apply manual cleaning/disinfecting.

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

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

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: ■ 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

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► Check visible surfaces for residues after mechani-

► Mobilize the movable parts several times after

cal cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

lubrication. In this way it is ensured that the oil is evenly spread over the friction surfaces. ► Dab off excess oil with a lint-free wipe. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Set aside the product if it is damaged.

5.8

Inspection, maintenance and checks

► Allow the product to cool down to room tempera-

ture. ► Inspect the product after each cleaning and disin-

5.9

fecting cycle to be sure it is: clean, functional, and undamaged. ► After each cleaning cycle, lubricate the product by spraying Aesculap-STERILIT oil spray GB600 on lubricating points A for 1 second, or by applying 1 or 2 drops of oil from STERILIT Power Systems drip lubricator GA059 at the same lubricating points, see Fig. 8/see Fig. 9/see Fig. 10.

► Always follow the instructions for use of the

A

Packaging

respective packaging and storage devices (e.g. instructions for use TA009721 for the Aesculap storage system). ► Insert the product in its proper position in the holder, or put it on a tray in such a way that the product is protected against damage. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

5.10 Steam sterilization ► Check to ensure that the sterilizing agent will come

Fig. 8

A

Fig. 9

A

into contact with all external and internal surfaces (e.g. by opening any valves and faucets). ► Validated sterilization process – Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractional 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.

Fig. 10

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Aesculap® Flexible shafts GA156, GA172, GA173, GA176, GA186 5.11 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/27 5 °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.

5.12 Storage ► Store sterile products in germ-proof packaging,

protected from dust, in a dry, dark, temperaturecontrolled area.

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6.

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.

7.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Motor not running

–

ELAN-E or -EC not working

Refer to instructions for use of ELAN-E or -EC

Flexible shaft juddering and/or lashing

Loud running noises Connections heating-up

Kinks in the flexible shaft; worn bearings

Have product repaired by the manufacturer

Handpiece cannot be coupled

–

Incorrect handpiece

Check system compatibility

Sleeves/lugs showing signs of impact or other deformations (e.g. caused by dropping the product)

Sleeve, button or lugs damaged

Have product repaired by the manufacturer

Clamping lever tightened

Handpiece clamping lever closed

Release the clamping lever

Incorrect ELAN-E model

Flexible shafts GA156, GA172 can only be coupled to right (clockwise) rotation motors

Check system compatibility

Sleeves/lugs showing signs of impact or other deformations (e.g. caused by dropping the product)

Connection elements for coupling the flexible shaft to ELAN-E or -EC are damaged

Have product repaired by the manufacturer

micro flexible shaft twisted or warped

Excessive load Slip clutch triggered

Reduce (torsional) load

Handpiece blocked

–

Refer to instructions for use of handpiece

Slip clutch triggered by minor load

Slip clutch out of adjustment

Have product repaired by the manufacturer

ELAN-E or -EC is running Flexible shaft not coupled correctly

Flexible shaft broken

Have product repaired by the manufacturer

Flexible shaft cannot be coupled to ELAN-E or -EC

micro flexible shaft is rattling

Drive shaft not turning

15

Aesculap® Flexible shafts GA156, GA172, GA173, GA176, GA186

Malfunction

Detection

Cause

Remedy

Handpiece not working

Protruding part of the drive shaft broken off

Drive shaft driver broken

Have product repaired by the manufacturer

Handpiece not moving

–

Refer to instructions for use of handpiece

8.

Technical Service

WARNING

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

► 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.

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9.

Accessories/Spare parts

Art. no.

Designation

GA059

STERILIT Power Systems drip lubricator

GA186209

Wrench

GB600

Aesculap STERILIT oil spray

GB675R

Holder (for GA186)

GB680R

Holder (for GA173 and GA176)

10.

Technical data

Flexible shaft Art. no.

Type

Lengt h (cm)

Coupling (handpiece-end)

Weight (g)

Max. motor speed (rpm)

Rotational direction

Max. torque (Ncm)

Ratio

GA156

macro

160

macro-line coupling

1 100

15 000

Right

70

1:1

GA172

macro

210

macro-line coupling

1 300

15 000

Right

70

1:1

GA186

mini

230

mini-linecoupling

700

16 000

Right/Left

28

1:1

GA176

micro

180

micro-line coupling according to ISO 3964

600

20 000

Right/Left

28

1:1

GA173

micro

230

micro-line coupling according to ISO 3964

700

20 000

Right/Left

28

1:1

11.

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.

12.

Distributor in the US/Contact in Canada for product information and complaints

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA

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