Small reciprocating saw GB130R

4.

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Prior to use, inspect the product and its accessories for any visible damage. ► Use the products and their accessories only if they are in perfect condition.

Aesculap® Small reciprocating saw GB130R Legend 1 Chuck 2 waistband 3 Centering lug 4 Release 5 Cover plate 6 Special shaft 7 Double-ended ring wrench SW 8 8 Groove 9 Surface 10 Nozzle 11 Tube olive 12 Spray nozzle

5.

Working with the small reciprocating saw

5.1

System set-up

Note Products marked as unsterile must be sterilized, prior to use, according to respective instructions, see Steam sterilization. Risk of injury due to accidental activation of the motor unit! ► Only replace the tool when the motor unit has been disconnected. WARNING Risk of contamination and infection due to unsterile components in the sterile area! ► Only use sterile or sterilized parts in the sterile area.

Symbols on product and packages WARNING Caution, general warning symbol Caution, see documentation supplied with the product

Risk of contamination and infection due to sharp-edged tool that damages the surgical glove! ► Never touch tool edges, neither when replacing the tool nor when using it. WARNING

1.

Applicable to

► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

WARNING

Risk of burns to the patient, caused by blunt saw blades or lack/inadequacy of maintenance of handpieces! ► Prior to each use and before clamping in a saw blade, check the saw blades for any wear or damage.

CAUTION

Damage to the product due to incorrect handling or operation! ► The product must only be coupled while the motor is inactive. ► Ensure that the maximum speed of 18,000 1/min is correctly set on the motor unit device.

at www.extranet.bbraun.com

2.

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician! ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user.

3.

Product description

3.1

Scope of supply

Attach the tool ► Open the chuck 1 with the double-ended ring wrench 7. ► Insert the tool as far as the stop. ► Using pressure, slowly turn the tool with the special shaft 6 in the chuck 1 until you feel it click into place. ► Close the chuck 1 with the double-ended ring wrench 7

Install spray nozzle ► Push the spray nozzle 12 onto the band 2. ► Plug the silicon hose into the tube clip 11. ► Bend spray nozzle 12 towards the intended direction.

Attaching the motor drive

Designation

Art. no.

Small reciprocating saw

GB130R

Double-ended ring wrench

TA004634

Instructions for use

TA005326

The motor unit is deactivated. ► Push the centering lug 3 of the motor unit from the rear into the small reciprocating saw. The motor unit clicks perceptibly into place when the cover plate 5 of the motor unit touches the circular connection face of the reciprocating saw.

5.2

Function checks

Note The following function checks must be carried out prior to every surgical application of the product!

3.2

Components required for operation Check that the tool is firmly fixed

Component

Art. no.

Small reciprocating saw

GB130R

Tool(s) with a special shaft

e.g., GC614R

Double-ended ring spanner

TA004634

SW 8

Motor from the Aesculap range

GA173 - or -

Flexible shaft (Elan-E, Elan-EC)

GD622

Micro-motor (microtron EC, integral EC)

3.3

Other data

between the saw blade and the chuck.

Intended use

The small reciprocating saw GB130R is used in osteosynthesis and small bone surgery (surgery on the hands and feet, and cranio- and maxillo-facial surgery as well as plastic surgery). Bones are separated using the small reciprocating saw GB130R in combination with saw blades. In combination with Rasps bone material is removed. Soft tissues are spared. The small reciprocating saw GB130R must only be operated with the motors, saws and files named in these instructions for use, see Components required for operation. Cooling/rinsing The spray nozzle 12 serves to cool with a sterile rinse solution, and flush out the surgical field. The danger of the occurrence of necrosis is reduced and enables precise and quick work that also preserves tissues.

3.4

► Grip the small reciprocating saw with one hand. ► Grip the rear of the tool with the thumb and index finger of the other hand. ► Check that it is firmly fixed by pulling on the tool. When doing so, ensure that there is no relative movement

Operating principle

The saw blade or the file moves back and forth on the bone with a stroke of 3mm. Thus, the bone is removed or disconnected. Soft tissues that touch the saw blade and are elastic to the stroke, remain undamaged. Cooling/rinsing The sterile rinsing solution sprays into the operating area through the spray nozzle 12. The bone, the tissue and the tool are cooled and the shavings are rinsed in order to avoid excessive temperatures on the tool that has direct contact with the bone.

Test run

WARNING

Burning of soft parts due to heated handpiece when the bearing is defective! ► Ensure that no wear of any kind can be seen at the site where the saw leaves the housing. ► Do not utilize the handpiece any more and perform maintenance on the handpiece.

► Switch on the small reciprocating saw briefly with a maximum speed of between 15 000 and 18 000 1/min. ► Press and hold the pedal for approximately 5 seconds.

The tool moves back and forth. ► Switch on the pump on the motor unit device and actuate the pedal until the rinsing solution sprays out of the

spray nozzle 12. ► Check for proper and reliable functioning. ► If unusual sounds occur or if the handpiece heats up significantly, do not utilize the handpiece any more.

5.3

Safe operation Risk of burns from a hot tool! Rapid heat formation from a blunt tool! ► Only use sharp tools that are in like new condition. WARNING Risk of burns to patient and user due to hot motor/hot tool! ► Put down the motor/hot tool beyond reach of the patient. ► Use a cloth to protect against burns when changing the motor or tool. 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. Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

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.

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING

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.

Injury to the tissue due to accidental loosening and sliding of the tool! ► Ensure that the tool is correctly clicked into place in the chuck and that the tool is firmly fixed. WARNING

WARNING

Connect the small reciprocating saw with the drive unit ► Push the spigot 3 of the motor unit from the rear into the small reciprocating saw. The motor unit clicks perceptibly into place when the cover plate 5 of the motor unit touches the circular connection face of the reciprocating saw.

Restriction of the healing process! ► Use the saw blade with the smallest possible cutting width in order to – perform the saw cut as quickly as possible. – To aid the healing process through low loss of bone and low thermal loading of bones and tissue.

Risk of infection and contamination due to unsterile parts! ► Only use sterile or 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 and protective goggles, suction extraction. WARNING

Risk of injury due to broken saw blade! ► Do not distort, twist or bend the saw blade. WARNING Risk of injury due to cracks and cuts on the fast-running and sharp-edged saw! ► Hold the saw firmly in your hand.

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

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.

WARNING

6.3

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.

Damage to the motor unit from incorrect coupling of the saw! ► Only couple the reciprocating saw with the motor unit when the motor is inactive CAUTION

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. ► Before the first mechanical cleaning/disinfection, fit the Eccos holder GB682R in a suitable perforated basket

(e.g. JF214R). ► Hold the saw firmly in your hand. ► Actuate the pedal for the motor unit and, if necessary, the pedal for the pump. ► Start with a low speed. ► As soon as the saw blade is introduced into the bone gap, continue working with a higher speed.

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

Note The saw achieves the best level of cutting performance when run at a high speed.

Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

► Move the saw forward in the bone with slight pressure and slow, wave-like movements. In so doing, ensure that

no jerky movements are performed. ► Keep the pressure exerted by the tool on the bone low. ► In order to ensure that the saw blade does not break, do not twist the tool. ► Ensure that there are no resonances on the saw blade when it is running idle. ► If resonances do occur, however, continue working with a different speed set.

Replacing the tool during surgery Risk of injury due to accidental activation of the motor unit! ► Only replace the tool when the motor unit has been disconnected. WARNING Disconnect the small reciprocating saw from the motor unit ► Switch off the motor unit. ► Press the release 4 and remove the small reciprocating saw from the motor unit. Tool change ► Open the chuck 1 with the double-ended ring spanner 7. ► Remove the tool that was just being used. ► Insert the mint-condition tool as far as the stop. ► Using pressure, slowly turn the tool with the special shaft 6 in the chuck 1 until you feel it click into place. ► Close the chuck 1 with the double-ended ring spanner 7. Check that the tool is firmly fixed ► Grip the small reciprocating saw with one hand. ► Grip the rear of the tool with the thumb and index finger of the other hand. ► Check that it is firmly fixed by pulling on the tool. When doing so, ensure that there is no relative movement between the saw blade and the chuck.

CAUTION

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 adjusted if applicable. ► 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.

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

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable hinges,

Chapter Manual cleaning/disinfecting and subsection:

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

■ Chapter Manual cleaning

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

and wipe disinfecting

► 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-

■ 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.)

■ Insert the product in its proper position in the

tions. Chapter Mechanical cleaning/ disinfecting and subsection:

Eccos holder.

■ Chapter Mechanical neutral

■ Follow the instructions for use of the Eccos

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

for approx. 1 s.

air for medical purposes

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

6.9

or mild alkaline cleaning and thermal disinfecting

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). ► 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.

6.7

► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

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.

6.11 Steam sterilization

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

Note The product may only be sterilized when dismantled.

Manual cleaning and wipe disinfecting

► 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). 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

-

-

-

-

► 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:

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.

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

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

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

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

To ensure reliable operation, the product must be maintained at least once a year. In so doing, the gearing and bearing grease should be replaced. Blunt or damaged tools must be replaced. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

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.

7.

8.

Maintenance

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Excessive noise

Hot small reciprocating saw

Worn gearing

Have product repaired by the manufacturer

Large clearance between the chuck 1 and the band 2

Mechanical neutral or mild alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical

Overheating small reciprocating saw

Hot small reciprocating saw

Worn gearing

Have product repaired by the manufacturer

3

D–W

-

Tool not moving

FD-W

Neutral:

Gap between the small reciprocating saw and the motor unit

Motor unit not coupled

10

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

Motor running, but not driving the attachment or tool

Defective gearings

Have product repaired by the manufacturer

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

■ 0.5 %* working solution Mildly alkaline:

■ Concentrate:

Worn cutting edges

Blunt tool

Install a new tool

■ 0.5 % solution

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

Debris on the tool or in the chuck 1

Debris

Cleaning the chuck 1

Chuck deformed 1

Deformation

Have product repaired by the manufacturer

– pH = 9.5 – <5 % anionic surfactant

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 neutral

Insufficient power

Coupling of reciprocating saw and motor unit defective

Tool cannot be coupled

Deformed tool

Install a new tool

Deformed tool

Install a new tool

► For further fault detection, see the respective instructions for use of the units.

9.

13.

Technical Service

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

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

TA-Nr. 005326

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.

10.

Accessories/Spare parts

Art. no.

Designation

TA004634

Double-ended ring spanner, SW 8

GA223R

Spray nozzle

JG693R

Perforated basket bracket

GB682R

Eccos holder

GB459R

Eccos mounting set for holders

TA005326

Instructions for use GB130R

GB600

Aesculap STERILIT oil spray

GB600810

STERILIT adapter

11.

Technical data

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

Designation

Class

GB130R

Small reciprocating saw

IIa

Dimensions (W x H x L)

22 mm x 40 mm x 160 mm

Weight

310 g

Max. motor speed

20 000 1/min

Ratio

Rotation in translation 1:1

Hub

3 mm

11.1 Ambient conditions Operation

Storage and transport

Temperature

Relative humidity

Atmospheric pressure

12.

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

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.

01/14

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Änd.-Nr. 48673