Micro reciprocating saw GD305

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.

Manual cleaning and wipe disinfecting Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

I

Cleaning

RT (cold)

-

-

D–W

-

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.

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

-

-

-

-

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.

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.

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

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.

6.8

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). 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

Cleaning/disinfection

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:

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 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.

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

■ 0.5 %* working solution Mildly alkaline:

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

► 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

■ 0.5 % solution III

Intermediate rinse

>10/50

1

FD-W

-

Note Use appropriate (neutral, enzymatic and mild-alkaline) detergents on this product with its aluminum components.

IV

Thermal disinfecting

90/194

5

FD-W

-

Validated procedure

Special features

Reference

V

Drying

-

-

-

Manual cleaning and wipe disinfection

■ When cleaning products with

Chapter Manual cleaning/disinfecting and subsection:

According to the program for cleaning and disinfection device

When cleaning mechanically:

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

■ Chapter Manual cleaning and wipe disinfecting

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

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

■ Follow the instructions for use of the Eccos holder.

6.7

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.

■ Ensure that the product is posi-

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

D–W: FD–W:

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. ► Prior to sterilization, spray through the product with Aesculap-STERILIT oil spray GB600 with adapter GB600810

for approx. 1 second. Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

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.

► 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. ► Prior to an extended period of non-use, always store attachments cleaned and dried according to the instruc-

tions.

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.

10.

6.11 Steam sterilization

Accessories/Spare parts

► 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).

Art. no.

Designation

Effective length

► 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.

GB600

Aesculap STERILIT oil spray

-

GB600810

STERILIT adapter

-

GB681R or GB682R

Eccos holder

-

GB459R

Eccos mounting set for holders

-

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.

GD320R

Saw blade

13 mm

GD321R

Saw blade

20 mm

To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters:

GD322R

Saw blade

13 mm

Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters*

GD323R

Saw blade

13 mm

TA006508

Instructions for use GD305

-

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

Note Intra coupling 5 and nut 4 must always be firmly tightened. To ensure reliable operation, the product must be maintained at least once a year. The grease for the gears and ball bearing should always be changed during this maintenance procedure. Blunt or damaged blades must be replaced. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

8.

11.

Technical data

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

Designation

Class

GD305

Micro reciprocating saw

IIa

Motor drive rpm

0-20 000 1/min

Hub

1.3 mm

Stroke rate

8 000 1/min

Gear reduction

2.5:1

Weight without saw blade

48.5 g

11.1 Ambient conditions Operation

Troubleshooting list

Storage and transport

Temperature Malfunction

Detection

Cause

Remedy

Excessive noise

Hot micro compass saw

Worn gearing

Have product repaired by the manufacturer

Overheating micro reciprocating saw

Hot micro reciprocating saw

Worn gearing

Have product repaired by the manufacturer

Tool not moving

Gap between micro reciprocating saw and motor unit

Motor unit not coupled

Couple the motor unit as described, see Coupling a motor unit

Motor running, but not driving the attachment or tool

Defective gearings

Have product repaired by the manufacturer

Worn cutting edges

Blunt tool

Install a new tool

See instructions for use of the motor unit

Insufficient power or speed of the drive unit

See instructions for use of the motor unit

Deformed clamping elements

Deformation

Have product repaired by the manufacturer

Insufficient power

Tool cannot be coupled

Coupling between micro reciprocating saw and motor unit defective

Deformed tool

Install a new tool

Relative humidity

Atmospheric pressure

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. Tool is not part of current product range

Wrong tool

Insert appropriate tool

13. 9.

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

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

3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 006508

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.

04/13

V6

Änd.-Nr. 46955