Reciprocating saw GB391R

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

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

Preparation before cleaning

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

► Prior to first cleaning/disinfection process: Assemble Eccos holder GB673R in a suitable tray (e.g. JF214R). ► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

Cleaning/disinfection Product-specific safety instructions for the reprocessing procedure Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► For cleaning the reciprocating saw, always place it in an appropriate storage device. ► 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). ► Do not use alkaline cleaning agents. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 60 °C.

WARNING CAUTION Injury can result from use of inappropriate motor drives and/or coupling systems! ► Always observe the motor specifications (speed) and coupling options that are described in the instructions for use. WARNING

WARNING

Risk of injury/damage to the reciprocating saw caused by a broken or bent saw blade! ► Do not bend the saw blade. ► Replace any damaged saw blades immediately.

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.

► 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 adjusted if applicable. ► 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. Damage to the tool, and risk of the tool dropping out of the coupling, when actuating the pushbutton during operation! ► Do not unlock the saw blade coupling during operation.

CAUTION

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

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

Chapter Manual cleaning/disinfecting and subsection:

► Fix bones that are to be severed securely so as to prevent the bone from oscillating with the saw. ► Only start the motor of the reciprocating saw at a moderate speed. ► 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.

Note The cutting and chip removal performance are best when the motor is run at high speed and the reciprocating saw is slightly moved back and forth in the direction of the cut.

pressed air for medical 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.) Mechanical neutral or mild alkaline cleaning and thermal disinfecting

■ Insert the product in its proper position in the Eccos holder GB673R.

■ Follow the instructions for use of the Eccos holder.

Validated reprocessing procedure

■ Chapter Manual cleaning and wipe disinfecting

Chapter Mechanical cleaning/ disinfecting and subsection:

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

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.

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.

Manual cleaning and wipe disinfecting Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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.

I

Cleaning

RT (cold)

-

-

D–W

-

II

Drying

RT

-

-

-

-

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

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

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.

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.

Dismantling prior to carrying out the reprocessing procedure ► Separate the saw blade and the motor drive from the reciprocating saw.

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.

Mechanical cleaning/disinfecting

Troubleshooting list

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).

Malfunction

Detection

Cause

Remedy

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

Reciprocating saw cannot be coupled to the motor

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

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

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

Saw blade cannot be inserted

-

Saw blade coupling dirty

Clean saw blade coupling

-

Saw blade coupling defective

Have the product repaired by the Technical Service

Worn, deformed reciprocating saw blade

Saw blade shaft defective

Insert a new saw blade

Saw blade teeth worn, saw blade hot

Saw blade blunt

Insert a new saw blade

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

■ 0.5 %* working solution Mildly alkaline:

Saw blade doesn’t cut properly

■ 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

Bone vibrates excessively

Bone oscillates

Fix the bone well

Reciprocating saw oscillates with the saw blade

Excessive pressure applied to saw

Apply less pressure to the saw blade when cutting

Cutting speed too low

Rotational speed too low

Increase rotational speed

No saw blade stroke, or only a reduced stroke, with the motor running

Reciprocating saw defective

Have the product repaired by the Technical Service

-

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

Technical Service

D–W: FD–W:

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

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

Inspection, maintenance and checks Note Failure to lubricate the reciprocating saw after each cleaning cycle and prior to each sterilization cycle will lead to a loss of performance and increased wear and tear. 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 tool 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 instruc-

tions.

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

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.

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.

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 – 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.

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*

Accessories/Spare parts Art. no.

Designation

e.g. GA552

Motor drive

e.g. GC615R

Saw blade

GB600

Aesculap-STERILIT oil spray

GB600830

Aesculap-STERILIT adapter

GB378

Spray nozzle

GB673R

Eccos holder (for GB391R)

GB613R

Storage aid for tools

TA011363

Instructions for use GB391R

Technical data Classification acc. to Directive 93/42/EEC

Sterilization method

Temp.

Time

Minimum drying time

Art. no.

Designation

Class

Prevacuum

270 °F/275 °F

4 min

20 min

GB391R

Reciprocating saw

IIa

*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.

Storage ► 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. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

Dimensions

74 mm x 20 mm x 25 mm

Weight

approx. 110 g

Motor drive rpm

max. 16 000 1/min

Transmission ratio, rotation in reciprocating movement

1:1.15

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.

Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 011363

01/14

V6

Änd.-Nr. 48673