Hi-Line XXS Handpiece with shafts and reamers

► If necessary, align the tip of spray nozzle towards the tool. ► Set the irrigation flow at the control unit, as described in the instructions for use of HiLAN irrigation pump GA530

6.

Validated reprocessing procedure

6.1

General safety instructions

or microspeed uni control unit GD670. Disconnecting the spray nozzle ► Pull off irrigation tube 13 from tube connection 14. ► Remove spray nozzle 12 from shaft 7.

5.8

Function checks

► Always perform a trial run prior to using the system. ► Make certain the handpieces and handpiece shaft are in proper condition. ► Make certain the handpiece is coupled correctly. ► Verify that the handpiece shaft is coupled correctly. ► Make certain the tool is coupled correctly. ► Check for damage to, and irregular running noises, excessive vibrations and excessive heat-up of the handpiece

and the handpiece shaft. ► Check that the handpiece/handpiece shaft is only warm to touch after a short period of use, no hotter. ► Check all cutting edges for any mechanical damage.

5.9

Safe operation Risk of burns to patient and user due to hot motor/hot tool! ► Do not put the motor/hot tool down on the patient. ► Use a cloth to protect against burns when changing the motor or tool. WARNING

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

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

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING Risk of injury from bent or snapped tools! ► Only use perfectly straight tools. ► Only apply mild pressure when using a tool.

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!

Art. no.

Designation

GE802SU–GE818SU GE832SU–GE848SU

Tools

GB796SU, GB797SU

Spray nozzles

6.3

Reusable products

WARNING Eye injury caused by particles coming loose from the tool! ► Always wear protective goggles when using the motor system.

Art. no.

Designation

GB791R, GB793R

Handpiece shaft, straight

GB792R, GB794R

Handpiece shaft, curved

GB790R

Handpiece

WARNING Risk of burns and necroses from hot cutting edges of the tool! ► Tools must be continuously cooled during operation. ► Only use sharp tools. WARNING Coagulation of patient tissue if the handpiece or handpiece shaft is hot! ► Let the handpiece and handpiece shaft cool down. ► Do not use a handpiece or handpiece shaft whose bearings are damaged. WARNING Risk of injury due to small parts that could enter the operation site! ► Do not perform any change of reamer over the operating field. WARNING

WARNING

Risk of injury if the tool is uncoupled by activating the tool unlocking lever during operation! ► Never actuate the tool unlocking lever on the handpiece while the system is operating.

WARNING

Risk of injury or loss of function if handpiece shaft is disconnected during operation! ► Never actuate the shaft locking lever on the handpiece while the system is operating.

Risk of infection and contamination due to aerosol formation! ► Take appropriate protective measures, e.g. watertight protective clothing, face mask, protective goggles and a suction extraction system.

► Carry out sterile processing of the product prior to first use.

6.4

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.

6.5

Dismantling prior to carrying out the reprocessing procedure

► Disassemble the product immediately after use, as described in the respective instructions for use.

6.6

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.

WARNING

6.7 Risk of injury and damage to the tool/system! The rotating tool may catch cover drapes (textile or other). ► Never allow the tool to touch cover drapes (textile or other) during operation. WARNING

Preparation before cleaning

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

6.8

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure Damage to micro instruments caused by incorrect handling! ► Protect products against overstraining. ► Do not bend the handpiece shaft. CAUTION CAUTION Note The handpiece shaft has a limited service life. When used as intended, a minimum of 30 uses are guaranteed. The end of the service life will manifest itself through a relatively quick increase in the temperature of the shaft. ► Do not run the handpiece without a tool coupled for any length of time. ► For fully exploiting the advantages of this power system, operate it at maximum motor speed whenever possible. ► Remove any surface contamination with a moistened, disposable wipe/paper tissue immediately after use.

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 high-grade steel. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 60 °C.

► Do not clean handpieces/handpiece shafts 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.

► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

Validated cleaning and disinfection procedure

infection procedure. Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ Drying phase: Use a lint-free cloth or compressed air for medical

Chapter Manual cleaning/disinfecting and subsection:

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.)

■ Handpiece Manual cleaning with immersion disinfection

for phase I

■ Shafts

■ The inner lumen must not be brushed

■ Rinse the shaft with cleaning disinfectant solution a minimum of 5 times; to do so, attach the appropriate silicone tube (e.g. ID=4 mm) onto the shaft coupling and syringe

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

■ Chapter Manual cleaning with immersion disinfection

for phase II

■ Rinse the shaft with water (with syringe and silicone tube) ■ Blow dry the inside of the shaft with an empty syringe or compressed air for phase III for phase IV

■ Rinse the shaft with water for phase V

■ Blow dry the inside of the shaft with an empty syringe or compressed air

■ Insert the handpiece in its proper position in the Eccos holder ■ Mechanical cleaning of the handpiece is only permitted with the Eccos holder GB605R

■ Mechanical cleaning of the handpiece shaft is only permitted

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

with the wash tray GB696R. For this, observe instructions for use TA013855.

6.9

Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

■ Fill the shaft with disinfectant solution using a syringe

Mechanical alkaline cleaning and thermal disinfecting

Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.

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

6.10 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.

Manual cleaning/disinfecting

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

Mechanical alkaline cleaning and thermal disinfecting

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

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

Step

T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical/Note

3

D–W

-

10

FD-W

■ Concentrate, alkaline:

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

-

-

-

-

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11*

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature

RT:

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.

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

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

6.11 Inspection, maintenance and checks Risk of malfunction of the handpiece or handpiece shaft during surgical use due to inadequate maintenance! ► Lubricate the handpieces and handpiece shafts after every cleaning process.

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.

Manual cleaning with immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

CAUTION ► 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 Hi-Line XXS handpiece and handpiece shafts with Aesculap STERILIT oil spray GB600 with

adapter GB600820 until clear oil emerges from the product. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Set aside the product if it is damaged.

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

for Aesculap Eccos storage system).

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

► 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. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

6.13 Steam sterilization Note The product may only be sterilized when dismantled. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

opening any valves and faucets). ► Validated sterilization process

V D–W: FD–W:

Drying

RT

-

-

-

-

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed

– Disassemble the instrument – Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization through fractionated vacuum process at 134 °C/2 bar; holding time 5 min ► When sterilizing several instruments 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.

6.14 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.

Prevacuum

Time

270 °F/275 °F

4 min

Designation

GB791R

Hi-Line XXS Handpiece shaft, straight II

GB793R

Hi-Line XXS Handpiece shaft, straight III

GB792R

Hi-Line XXS Handpiece shaft, curved II

20 min

GB794R

Hi-Line XXS Handpiece shaft, curved III

GE802SU–GE818SU GE832SU–GE848SU

Hi-Line XXS Tools (single-use)

GB600

Aesculap maintenance oil

GB600820

STERILIT Power Systems adapter

GB459R

Eccos storage mounting set

6.15 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. ► Store sterile packed single-use products dust-protected in a dry, dark and temperature-controlled room.

Maintenance

To ensure reliable operation of the handpieces, Aesculap recommends having the product serviced at least once a year. The shafts are not serviceable. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

8.

Art. no.

Minimum drying time

*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.

7.

Accessories/Spare parts

GB605R

Eccos storage for handpiece

GB606R

Eccos storage for handpiece shafts

GB696R

Shaft rinsing device

GB796SU

Spray nozzle II

GB797SU

Spray nozzle III

Troubleshooting list 11.

Malfunction

Detection

Cause

Remedy

Handpiece cannot be coupled to the motor

–

Threaded ring not in ”unlocked” position

Turn the threaded ring in the direction of the arrow in symbol

Handpiece shaft cannot be coupled to handpiece

Symbol

not visible

-

Designation

Class

GB790R

Hi-Line XXS Handpiece

II a

Put shaft locking lever in open position

GB791R

Hi-Line XXS Handpiece shaft, straight II

II a

Shaft coupling damaged or deformed

Use a new handpiece shaft

GB792R

Hi-Line XXS Handpiece shaft, curved II

II a

GB793R

Hi-Line XXS Handpiece shaft, straight III

II a

GB794R

Hi-Line XXS Handpiece shaft, curved III

II a

Automatic locking mechanism defective

Couple the tool with the tool unlocking lever actuated

Tool cannot be uncoupled

Tool cannot be uncoupled even with the tool unlocking lever fully actuated

Tool coupling is worn

Have product repaired by the manufacturer

Handpiece shaft cannot be coupled even with shaft unlocking lever fully open

Tool coupling is worn

A tool is coupled to it

Handpiece shaft cannot be dismantled when a tool is coupled to it

Uncouple the tool

Handpiece blocked

Motor runs with handpiece decoupled

Have product repaired by the manufacturer

Motor locked

Motor safety setting is in ”0” position

Turn the safety setting on the motor to the ”I” position

During normal operation loud running noise

Gear or bearing worn

Have handpiece repaired by manufacturer

Bearings are worn

Use a new handpiece shaft

Gear or bearing worn

Have handpiece repaired by manufacturer

Bearings are worn

Use a new handpiece shaft

Loud running noise

Art. no.

Shaft locking lever not in open position

Pressure point cannot be passed

Handpiece not running

Classification acc. to Directive 93/42/EEC

until it stops

Tool cannot be coupled to handpiece

Handpiece shaft cannot be coupled

Technical data

Have product repaired by the manufacturer

Performance Data Art. no.

Weight

Dimensions (mm)

GB790R

72 g

65 mm x 17 mm x 22 mm

GB791R

10 g

6 mm x 109 mm

GB792R

10 g

6 mm x 109 mm

GB793R

12 g

6 mm x 139 mm

GB794R

12 g

6 mm x 139 mm

Ambient conditions Operation

Storage and transport

Temperature

Relative humidity Handpiece/shaft heats up too much

9.

Significant heat-up after short period of operation

Technical Service

Atmospheric pressure

Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculapp agency.

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: Aesculap Inc. 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.

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. 013837

10/13

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