Sagittal saw GB390R

Risk of injury from cracks and cuts from high-speed saws and sharp tool! ► Hold the sagittal saw firmly in your hand.

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure WARNING Injury can result from use of inappropriate motor drives and/or coupling systems! ► Operate the devices in accordance with the rpm, torque and coupling parameters set forth in the instructions for 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, – 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.

CAUTION

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

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

WARNING

risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

WARNING

WARNING

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable hinges, ensure

Chapter Manual cleaning/disinfecting and subsection:

The sagittal saw can cause injury and/or be damaged if the saw blade snaps or becomes warped! ► Do not bend the saw blade. ► Replace any damaged saw blades immediately.

► Fix bones that are to be severed securely so as to prevent the bone from oscillating with the saw. ► Start the sagittal saw motor drive with a moderate rotational speed only. ► Place the saw blade on the bone that is to be severed. ► Once the saw blade has begun cutting into the bone, increase the rotational speed. ► Cut carefully, applying moderate pressure only.

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

■ Chapter Manual

■ Drying phase: Use a lint-free cloth ■ Ensure that the product is positioned in such a way

cleaning and wipe disinfecting

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

■ Insert the product in its proper position in the Eccos

Chapter Mechanical cleaning/disinfecting and subsection:

holder GB673R.

■ Follow the instructions for use of the Eccos holder.

■ Chapter Mechanical

Note Optimal cutting performance and chip removal can be achieved by using higher rotational speeds and a slight back and forth motion of the sagittal saw in the direction of the sawing.

6.

Validated reprocessing procedure

neutral or mild alkaline cleaning and thermal disinfecting

6.7

Manual cleaning/disinfecting

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

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.

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

Manual cleaning and wipe disinfecting

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.

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

I

Cleaning

RT (cold)

-

-

D–W

-

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.

II

Drying

RT

-

-

-

-

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

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

IV

Final rinse

RT (cold)

0.5

-

FD-W

-

V

Drying

RT

-

-

-

-

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.

D–W: FD–W: 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

► Remove the saw blade and motor drive from the sagittal saw.

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

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

Preparation before cleaning

► Prior to first mechanical cleaning/disinfection process: Eccos holder GB673R must be assembled in a suitable tray

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

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.

8.

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Troubleshooting list

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

Malfunction

Detection

Cause

Remedy

Saw blade cannot be inserted

Safety lever 5 is closed

Saw blade coupling is closed

Open safety lever 5 Rotate the sagittal saw 3 and coupler 4 against each other in the direction of the arrow

Saw blade doesn’t cut properly

Saw blade teeth worn Saw blade hot

Saw blade blunt

Insert a new saw blade

Safety lever 5 is open Saw blade 3 and coupler 4 are on

Saw blade coupling open

Rotate the sagittal saw 3 and coupler 4 against each other in the opposite direction of the arrow Close the safety lever 5

Bone vibrates excessively

Bone oscillates

Fix the bone well

■ 0.5 %* working solution Mildly alkaline:

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

■ 0.5 % solution III

Intermediate rinse

>10/50

1

FD-W

-

Sagittal saw oscillates with the saw blade

Excessive pressure applied to saw

Apply less pressure to the saw blade when cutting

IV

Thermal disinfecting

90/194

5

FD-W

-

Cutting speed too low

Rotational speed too low

Increase rotational speed

V

Drying

-

-

-

According to the program for cleaning and disinfection device

Sagittal saw cannot be attached securely to the motor drive

Tension ring can be rotated in the “open” direction of the arrow

Close tension ring

Rotate the tension ring in the direction of the arrow until it engages

Tension ring cannot be opened by hand

Tension ring cannot be rotated by hand in either direction

Tension ring tightened down too hard

Open the tension ring with the wrench

D–W: FD–W:

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.

6.9

9.

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

Inspection, maintenance and checks

Note Failure to lubricate the sagittal saw after each cleaning and prior to each sterilization will diminish performance and lead to increased wear. This in turn will considerably reduce the service life of the sagittal saw. ► 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 attachment with Aesculap-STERILIT oil spray GB600 with adapter GB600830 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. ► Prior to an extended period of non-use, always store attachments cleaned and dried according to the instructions

for use.

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.

6.11 Steam sterilization ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

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.

opening any valves and faucets). ► 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.

10.

Accessories/Spare parts

Art. no.

Designation

e.g., GA552

Motor drive

e.g., GC128R

Saw blade

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.

GB600

Aesculap STERILIT oil spray

GB600810

Aesculap STERILIT adapter

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

GB673R

Storage aid (for GB390R)

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

TA010409

Instructions for use GB390R

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.

11.

Technical data

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

Designation

Class

GB390R

Sagittal saw

IIa

Weight

approx. 100 g

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

Dimensions (L x W x H)

60 mm x 20 mm x 20 mm

7.

Motor drive rpm

max. 16 000 1/min

Conversion of rotation into oscillations

1:1

6.13 Storage

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.

11.1 Ambient conditions Operation

Storage and transport

Temperature

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.

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. 010409

07/13

V6

Änd.-Nr. 47650