Small oscillating saw GB128R

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING Injuries to tissue if the tool is unintentionally released or moved! ► Make certain that the tool is correctly tightened in the chuck adapter with the straining screw and that the tool is seated tightly. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING

WARNING

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. Impaired healing process! ► Use the saw blade with the smallest possible cutting width to – complete the saw incision in the shortest possible time. – This facilitates the healing process due to low bone loss and low thermal stress of the bone and tissue. Risk of injury from a broken saw blade! ► Do not twist, cant or bend the saw blade.

WARNING Risk of injury from cracks and cuts in high-speed saws with sharp edges! ► Hold the saw tightly in the hand. WARNING Risk of burns from a hot tool! A blunt tool can cause heat to develop quickly. ► Use only sharp tools in new condition. WARNING Risk of infection and contamination from unsterile parts! ► Use only sterile/sterilized parts in the sterile area. WARNING 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. WARNING

WARNING

Risk of injury from metal chippings! Damage to the tool! ► Dissect and ablate bone only! Ensure that no instruments are sawed into in the operating field.

Check the tool is firmly seated ► Hold the saw with one hand. ► Hold the back of the tool with the thumb and index finger of the other hand. ► Check that the tool is firmly seated by pulling on the tool. When doing so, ensure that no relative motion occurs between the saw blade and chuck adapter. Connecting the saw to the motor unit The motor unit must be switched off. ► Insert the centering lug 4 of the motor unit into the saw. You will feel the motor unit click into place when the cover plate 6 of the motor unit touches the ring-shaped connection surface of the small oscillating saw.

6.

Validated reprocessing procedure

6.1

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 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

6.3

CAUTION

Note The saw achieves the best cutting performance at a high speed.

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

► Hold the saw tightly in the hand. ► Activate the foot control switch for the motor unit and if applicable the foot control switch for the pump. ► Begin at a low speed. ► Once the saw blade is inserted in the bone gap, continue at a higher speed.

Dismantling prior to carrying out the reprocessing procedure

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

6.4 Damage to the motor unit due to incorrect coupling of the saw! ► Couple the saw with the motor unit only while the motor is inactive.

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.

Preparation before cleaning

► Remove the tool, see Changing the tool during an operation. ► This product should be disassembled for cleaning ► Prior to the first mechanical cleaning/disinfection process, mount the Eccos holder GB682R in a suitable tray (e.g.

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

6.6

Cleaning/disinfection

► Move the saw forwards in the bone using mild pressure and slow, wave-like movements. When doing so, make

certain that no jerky movements are made. ► Ensure the tool only applies mild pressure on the bone. ► Do not cant the tool so that the saw blade does not break. (This does not make sense, but cannot decifer what

Product-specific safety instructions for the reprocessing procedure

is trying to be said) ► Make sure there are no resonances in the saw blade when idle. ► If resonances do occur, continue working at a different speed.

Changing the tool during an operation Risk of injury from the tool due to accidental activation of the motor! ► Change tools only with the motor unit uncoupled. WARNING Disconnect the saw from the motor unit ► Switch off the motor unit. ► Press release 5. ► Remove the saw. Tool change ► Undo straining screw 3 on the chuck adapter 8 using the hexagon socket screw key 1. ► Remove the tool. ► Insert the new tool into the adapter as far as it will go. ► Turn the tool with triangular shaft 9 in the chuck adapter 8 slowly, applying pressure. You will feel the tool click into position. ► Tighten straining screw 3 on the chuck adapter 8 using the hexagon socket screw key 1.

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.

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

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with mov-

Chapter Manual cleaning/disinfecting and subsection:

able 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

6.9

compressed air for medical purposes

■ Ensure that the product is positioned

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

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

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

for approx. 1 second.

■ Insert the product in its proper posi-

Chapter Mechanical cleaning/disinfecting and subsection:

tion in the Eccos holder.

► 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.

■ Chapter Mechanical neutral or mild

■ Follow the instructions for use of the

alkaline cleaning and thermal disinfecting

Eccos holder.

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).

6.7

Manual cleaning/disinfecting

► 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

► 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.

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.

6.11 Steam sterilization

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

-

-

-

-

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).

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.

► 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

*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.

Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully.

6.13 Storage

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

7.

6.8

Mechanical cleaning/disinfecting

Note The cleaning and disinfecting machine must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).

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

Maintenance

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 tools must be replaced. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

8.

Troubleshooting list

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

Malfunction

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Excessive noise

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:

Detection

Cause

Remedy

Hot, small oscillating saw

Gearing worn

Have repaired by Aesculap Service

Large clearance between the chuck 8 and the attachment 7 Overheating small oscillating saw

Hot, small oscillating saw

Gearing worn

Have repaired by Aesculap Service

Tool not moving

Gap between small oscillating saw and drive unit

Motor unit not coupled

Couple the motor unit as described, see Attaching the motor unit

Motor running, but not driving the attachment or tool

Defective gearings

Have repaired by Aesculap Service

– 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

Insufficient power

Small oscillating saw motor unit coupling defective

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

Saw blade hot

Inadequate chip removal

Back and forth movement during sawing

11.1 Ambient conditions

Malfunction

Detection

Cause

Remedy

Tool cannot be coupled

Debris on the tool or in the chuck 8

Debris

Cleaning the chuck 8

Chuck deformed 8

Deformation

Have repaired by Aesculap Service

Operation

Storage and transport

Temperature

Deformed tool

Install a new tool

Tool is not part of current product range

9.

Wrong tool

Insert appropriate tool Relative humidity

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

Atmospheric pressure

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.

12.

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

GB020

Hexagon socket screw key

GA221R

Spray nozzle

JG693R

Tray clamp

TA005325

Instructions for use GB128R

TE470

Straining screw

GB682R

Eccos holder

GB459R

Eccos mounting set for holders

GB600

Aesculap STERILIT oil spray

GB600810

STERILIT adapter

11.

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

agency, see Technical Service.

13.

TA-Nr. 005325

Technical data

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

Designation

Class

GB128R

Small oscillating saw

IIa

Size (W x H x L)

37 mm x 37 mm x 116 mm

Weight

385 g

Saw blade adapter

Triangular shaft

Max. motor speed

18 000 1/min

Ratio

Rotation to oscillation 1:1

Oscillation angle

10.4°

Sterilization

Steam sterilization

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

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

Accessories/Spare parts

Art. no.

Disposal

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

01/14

V6

Änd.-Nr. 48673