Pediatric craniotome GB292

5.3

Safe operation

WARNING

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.

6.5

Preparation before cleaning

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use. ► Prior to the first mechanical cleaning/disinfection process, mount the Eccos holder GB681R or GB682R in a suit-

able tray (e.g. JF214R).

6.6

Cleaning/disinfection

6.6.1

Product-specific safety instructions for the reprocessing procedure

Risk of injury and overheating of bones and tissues (necrosis) from tools that are not cooled while being used! ► Use an appropriate coolant/irrigation fluid, e.g., physiologic saline.

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, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 60 °C.

WARNING CAUTION

WARNING

Risk of injury from metal cuttings! Restriction of the tool! ► Only separate and remove bones. Ensure that the operating field instruments are not sawed.

Risk of injury from flying metal filings or broken tools when rotating tools are in use! ► Always wear protective gear (goggles etc.). WARNING

► 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 if applicable adjusted. ► Do not clean motors/handpieces by ultrasonic treatment and do not immerse them in any liquids. To avoid the

Risk of injury due to broken bone cutter! ► Do not distort, twist or bend the bone cutter. WARNING Risk of injury and/or damage to the tool and/or motor drive if drape or other fabrics are cut through! ► Keep rotating tools away from drape and other fabrics.

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

6.6.2

Special features

Reference

Manual cleaning and wipe disinfection

■ Drying phase: Use a lint-free cloth or com-

Chapter Manual cleaning/disinfecting and subsection:

■ Pediatric craniotome

■ Ensure that the product is positioned in

micro-Line

WARNING Risk of contamination and infection due to sharp-edged tool that damages surgical gloves! ► Do not touch the tool edges, neither when replacing the tool nor when using it. WARNING ► Cool tools down with an external coolant supply. ► Use only physiologic, sterile coolant. ► Ensure that there is no air in the coolant flow pathway.

Note Optimal results with the pediatric craniotome GB292 can be achieved with a motor speed of approx. 15 000 rpm.

6. 6.1

Validated cleaning and disinfection procedure

Validated procedure

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.

Manual cleaning and wipe disinfection

■ Craniotome attachment Manual cleaning with ultrasound and immersion disinfection

Mechanical alkaline cleaning and thermal disinfecting

6.3

Dismantling prior to carrying out the reprocessing procedure

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

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.

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

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

and wipe disinfecting Chapter Manual cleaning/disinfecting and subsection:

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

ment

6.7

■ Chapter Manual cleaning

■ Chapter Manual cleaning

micro-Line

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.

6.7.1

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

-

-

-

-

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.

Chapter Manual cleaning/disinfecting and subsection:

■ Pediatric craniotome

■ Bone cutter ■ Craniotome attach-

6.2

■ 20 ml disposable syringe ■ After use, rinse with demineralized water. ■ Drying phase: Use a lint-free cloth or com-

with ultrasound and immersion disinfection

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

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.

and wipe disinfecting

■ Bone cutter

Mechanical alkaline cleaning and thermal disinfecting

Note If there is no final sterilization, then a virucidal disinfectant must be used.

■ Chapter Manual cleaning

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

pressed air for medical purposes

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 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.

pressed air for medical purposes

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

6.7.2

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

6.9

Inspection, maintenance and checks

► 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 motor/handpiece with Aesculap-STERILIT oil spray GB600 with adapter GB600810 for approx.

1 second. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Inspect tools for broken, damaged or blunt edges. ► Set aside the product if it is damaged.

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

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*

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 ► 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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

– Steam sterilization using 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:

infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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 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 five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► 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.

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

*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

To ensure reliable operation, the product must be maintained at least once a year. For relevant services contact your national B. Braun/Aesculap agency, see Technical Service.

8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

The bone cutter cannot be inserted or changed.

Tension ring does not rotate freely or does not rotate at all

Tension ring jammed

Have product repaired by the manufacturer

The craniotome attachment cannot be mounted properly

Craniotome attachment not reaching the frontal contact surface at the handpiece (gap)

The bone cutter is not properly inserted

Insert the bone cutter correctly (see Connecting the bone cutter to the handpiece)

The motor drive cannot be coupled to the handpiece

Defective Intra-coupling

Intra-coupling

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

Have product repaired by the manufacturer

6.8.1

Pediatric craniotome not running

Motor drive not switched on

Motor drive

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

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).

Mechanical alkaline cleaning and thermal disinfecting

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

Motor drive defective

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* 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.

Switch on motor drive Check motor drive as explained in the instructions for use

Bone cutter not rotating

Remove the bone cutter

Insufficient tension in tensioning device

Close the locking mechnism

Pediatric craniotome vibrating

Atypical sound while operating

Defective bearing

Have product repaired by the manufacturer

9.

Technical Service

12.

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

► Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap

agency, see Technical Service.

WARNING

13.

► 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.

10.

Designation

GB109

Craniotome handpiece

GB291R

Craniotome attachment

GB600

Aesculap STERILIT oil spray

GB600810

STERILIT micro-Line adapter

GB681R

Eccos holder (for 3 handpieces)

GD682R

Eccos holder (for 1 handpiece)

GB459R

Eccos mounting set for holders

TA012582

Instructions for use GB292

GC304R

Bone cutter

GD100

Instrument stands

Technical data

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

Designation

Class

GB292

Micro-Line Pediatric craniotome

IIa

Art. no.

Ratio

Weight in grams

Max. motor speed

GB109

1:1

80

20 000

GB291R

-

8.5

-

GC304R

-

10

-

11.1 Ambient conditions Operation Temperature

Relative humidity

Atmospheric pressure

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

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 010252

Accessories/Spare parts

Art. no.

11.

Disposal

Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure.

Storage and transport

07/15

V6

Änd.-Nr. 52905