macro-Line Transversal saw GB124R Instructions for Use v3 Oct 2009

9

1 AUF

8

GC500

ZU

10

11

8 GC523 GC502 2 3 4 6 5

7

8

8

GC510

12

17

18

19

13

14

20

15

GA550-GC554

16

Aesculap Power Systems

macro-Line transversal saw GB124R

Legend

Contents

Double wrench Nut 3 Lock washer 4 Disk (with two slits) 5 Saw blade slot 6 Saw blade 7 Pin 8 Triangular shaft 9 Denticulation 10 Lubrication point (for clamping lever) 11 Fixing screw 12 Clamping lever 13 Chuck 14 Tool coupling 15 Fixing screw 16 Hexagon wrench 17 Face plate (motor unit) 18 Nose 19 Centering lug 20 Triangular shaft

1. 2. 2.1 2.2 2.3 2.4 3. 4. 4.1

1 2

Symbols on product and packages Symbol

Explanation Caution: See documentation supplied with the product

2

4.2 4.3

5. 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6. 7. 8. 9. 10.

Safe handling ... 3 Product description ... 3 System components ... 3 Components necessary for use ... 3 Intended use ... 3 Operating principle ... 3 Preparation and setup ... 3 Working with the macro-Line transversal saw GB124R ... 3 System set-up ... 3 Connecting the accessories... 3 Function checks ... 3 Test run ... 3 Safe operation ... 4 Coupling a motor unit ... 4 Uncoupling the motor unit ... 4 Mounting a saw blade on the shaft ... 4 Clamping a saw blade... 4 Sawing ... 4 Validated processing procedure ... 5 General notes ... 5 Preparations at the place of use ... 6 Preparation prior to cleaning ... 6 Cleaning/Disinfecting ... 6 Manual cleaning/disinfecting ... 7 Manual cleaning and wipe disinfection ... 7 Inspection, maintenance and checks ... 7 Packaging ... 7 Sterilization method and parameters ... 8 Storage ... 8 Maintenance ... 8 Troubleshooting list ... 8 Technical Service ... 9 Accessories/Spare parts ... 9 Technical specifications ... 9

1. Safe handling

2.3 Intended use

¾ Thoroughly clean the new product after removing its transport packaging and prior to its initial sterilization. ¾ Prior to use, check for proper condition and functioning of the product. ¾ 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. – Observe all safety information and maintenance advisories. – Only combine Aesculap products with each other. ¾ Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge or experience. ¾ Keep the instructions for use accessible for the user.

2. Product description

2.1 System components Designation

Art. no.

Handpiece

GB124R

Hexagon wrench

GB020R

Double wrench (SW 14)

GC523

2.2 Components necessary for use • macro-Line transversal saw GB124R • Flexible shaft GA156 (1.6 m) with Elan® EC and foot switch - or • Flexible shaft GA172 (2.1 m) with Elan® EC and foot switch - or • AIRLAN® pneumatic motor GA200

The macro-Line transversal saw GB124R is used for the dissection of bones in osteosynthesis surgery.

2.4 Operating principle The saw handpiece provides 1:1 conversion of the rotational movement of the motor unit to oscillating movement. The bones are dissected by the oscillating movement of the saw blade. Any soft tissue parts touched by the saw blade remain unharmed.

3. Preparation and setup Non-compliance with these rules will result in complete exclusion of any responsibility and liability on the part of Aesculap.

4. Working with the macro-Line transversal saw GB124R

4.1 System set-up Connecting the accessories Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products.

4.2 Function checks ¾ Check all cutting edges for any mechanical damage. Test run ¾ Briefly run the transversal saw at maximum speed. Check for proper and reliable functioning.

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Aesculap Power Systems

macro-Line transversal saw GB124R

4.3 Safe operation

WARNING

WARNING

WARNING

WARNING

Risk of burns to patient and user, due to hot motor/hot tool! ¾ Put down the motor/hot tool beyond reach of the patient. ¾ Use a cloth to protect against burns when changing the motor or tool. Risk of injury and material damage due to inappropriate use of handpieces or motors! ¾ Always follow the safety advice and information given in the instructions for use of the handpieces and motors. ¾ Do not exceed the specified maximum motor speed. Risk of injury and/or malfunction! ¾ Always carry out a function check before using the product. Risk of injury when applying the product outside the field of view! ¾ Apply the product only under visual control.

Coupling a motor unit The saw can be powered via a flexible shaft GA156/GA172 or by the AIRLAN® pneumatic motor GA200. ¾ Turn clamping lever 12 towards the AUF (OPEN) position and release the clamping of the transversal saw. ¾ Install the handpiece on centering lug 19 in such a way that it touches the face plate 17 of the motor unit and nose 18 engages in the recess at the handpiece. ¾ Turn clamping lever 12 towards the ZU (CLOSED) position. Moving the clamping lever to be parallel with the motor unit ¾ Tighten clamping lever 12 hand-tight. ¾ Undo fixing screw 11 with hexagon wrench 16 until the denticulation 9 disengages. ¾ Move clamping lever 12 to the intended position and engage denticulation 9. ¾ Tighten fixing screw 11 with hexagon wrench 16.

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Uncoupling the motor unit ¾ Turn clamping lever 12 towards the AUF (OPEN) position and release the clamping of the transversal saw. ¾ Remove the motor unit. Mounting a saw blade on the shaft ¾ Install saw blade 6 in the intended position on shaft 8. Be careful to position pin 7 in saw blade slot 5. ¾ Install disk 4 in such a way that a slit engages over pin 7. ¾ Position lock washer 3 and nut 2 and tighten the nut with double wrench 1. Clamping a saw blade Note Any saw blade or trepan with triangular shaft 20 can be clamped in. ¾ Insert triangular shaft 8 in tool coupling 14 and secure it with fixing screw 15. Sawing The optimum cutting performance is achieved by sawing with high motor speed and moving the handpiece back and forth. Note To avoid resonant oscillations of the saw blade, do not run the handpiece at maximum speed without load. ¾ Start the sawing procedure at moderate motor speed, which is then slowly increased.

5. Validated processing procedure 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 the products. Note Up-to-date information on processing can be found on the Aesculap Extranet at www.aesculap-extra.net Note Successful processing of this medical product can only be ensured if processing is performed through a validated processing procedure. The user/processor is responsible for the validation. Due to process tolerances, the manufacturer’s specifications can only serve as an approximate guide for assessing the processing procedures applied by the individual operator/processors.

5.1 General notes Encrusted or fixated residues from surgery can make the cleaning process more difficult or ineffective, and can cause corrosion of stainless steels. To avoid this, the time interval between application and processing should not exceed 6 h, and neither fixating pre-cleaning temperatures >45 °C nor any fixating disinfecting agents (active ingredients: aldehyde, alcohol) be used. Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading and obliteration of laser inscriptions on stainless steel surfaces, regarding visual reading and machine-readability of the inscriptions. 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. To remove such residues, the products must be rinsed sufficiently with fully desalinated water and dried thoroughly. Only process chemicals that have been tested and approved (e.g. VAH/ DGHM 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 process parameters specified by the chemical’s manufacturer, such as temperatures, concentrations and exposure times, must be strictly observed. Failure to do so can result in the following problems: • Optical changes to the material, e.g. fading or discoloration of titanium or aluminum. For aluminum, pH >8 in the application/process solution is sufficient to cause visible surface changes. • Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ¾ Do not use process chemicals that cause stress cracking or brittleness of plastic materials. ¾ For further detailed advice on hygienically safe and material-/valuepreserving reprocessing, see www.a-k-i.org

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Aesculap Power Systems

macro-Line transversal saw GB124R

5.2 Preparations at the place of use ¾ Disassemble the product immediately after use, as described in the respective instructions for use. ¾ Remove visible surgical residues as completely as possible, using a lintfree wet wipe.

5.3 Preparation prior to cleaning ¾ Have the product dry in a disposal container and ready for immediate cleaning and disinfecting within 30 min after use.

5.4 Cleaning/Disinfecting

CAUTION

CAUTION

CAUTION

Damage to, or destruction of the product caused by mechanical cleaning/disinfecting! ¾ Only clean and disinfect the product manually. Damage to the product due to inappropriate cleaning/disinfecting agents! ¾ Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/ disinfecting agent. Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ¾ Use cleaning and disinfecting agents according to manufacturers’ instructions. The cleaning/ disinfecting agents must - be approved for plastic materials and highgrade steel, - not attack softeners (e.g. silicone). ¾ Observe specifications regarding concentration, temperature and exposure time.

¾ Do not clean motors/handpieces by ultrasonic treatment and do not immerse them in any fluid. Let any fluid that penetrates into the product drain out to avoid the risk of corrosion/malfunctioning of the product.

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5.5 Manual cleaning/disinfecting Manual cleaning and wipe disinfection Stage

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

-

-

-

-

D–W: FD–W: RT:

Drinking water Fully desalinated water (demineralized) Room Temperature

Stage I

5.6 Inspection, maintenance and checks

¾ Clean the product under running tap water, using a suitable cleaning brush if necessary, until all visible residues have been removed from the surfaces. ¾ Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ¾ Make certain 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.) ¾ Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion.

¾ Allow the product to cool down to room temperature. ¾ Inspect the product after each cleaning and disinfecting cycle to be sure it is clean, functional and undamaged. ¾ After every cleaning and disinfecting cycle, lubricate the product at lubrications point 10 and centering lug 19 with one drop from STERILIT® Power Systems drip lubricator GA059. ¾ Check the product for any damage, atypical running noise, overheating or excessive vibration. ¾ Inspect tools for broken, damaged or blunt edges. ¾ Set aside the product if it is damaged.

Stage II ¾ Dry the product with lint-free tissue or medical-quality filtered compressed air. Stage III ¾ Wipe all surfaces of the product with a single-use disinfecting wipe. Stage IV ¾ After the specified exposure time (of at least 1 minute), rinse the disinfected surfaces under running FD water. ¾ Hold the product in such a way that water cannot enter it e.g. through couplings or adapters. ¾ Allow water to drip off for a sufficient length of time.

5.7 Packaging ¾ Always observe the instructions for use of packaging and storage devices. ¾ Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ¾ Ensure that the packaging provides sufficient protection against recontamination of the product (DIN EN ISO 11607).

Stage V ¾ Dry the product with lint-free tissue or medical-quality filtered compressed air.

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Aesculap Power Systems

macro-Line transversal saw GB124R

5.8 Sterilization method and parameters

5.9 Storage

¾ Prior to sterilization, remove any tools and adapters and uncouple the handpiece from the motor unit. ¾ Check to make certain that the sterilizing agent will be in contact with all external and internal surfaces (e.g. by opening any valves and faucets). ¾ Validated sterilization process – Disassemble the product – Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285, validated according to DIN EN ISO 17665 – Sterilization through fractionated vacuum process at 134 °C/2 bar; holding time 5 min. ¾ When sterilizing several products at the same time in one steam sterilizer: Make certain that the maximum allowable load capacity of the steam sterilizer, as specified by the manufacturer, is not exceeded.

¾ Store sterile products in germ-proof packaging under dust protection in a dry, dark and temperature-controlled room.

6. Maintenance To ensure reliable operation, Aesculap recommends having the product serviced at least once a year. For services to that end, please contact your national B. Braun/Aesculap agency, see Technical Service.

7. Troubleshooting list Malfunction

Cause

Finding

Remedy

Excessive noise

Motor unit not coupled correctly

Motor unit can be pulled out from handpiece Couple the motor unit, see Coupling a motor unit

Worn gearing

Handpiece hot

Have product repaired by the manufacturer

Lack of power at handpiece

Worn gearing

Excessive noise

Have product repaired by the manufacturer

Insufficient cutting power of saw blades

Saw blade blunt

Saw blade worn

Replace saw blade

-

Motor unit not running correctly

Observe the instructions for use of the motor unit

Saw blade not moving

Coupling defective

Coupling parts broken

Have product repaired by the manufacturer

Defective gearing

Motor unit running, but not powering the handpiece

Have product repaired by the manufacturer

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8. Technical Service

Risk of injury and/or malfunction! ¾ Do not modify the product.

9. Accessories/Spare parts Art. no.

Designation

GA059

STERILIT® Power Systems drip lubricator

GA156

Motor unit: Flexible shaft

WARNING GA172 ¾ For service and repairs, please contact your national B. Braun/Aesculap agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses.

GA200

AIRLAN® pneumatic motor

GB020R

Hexagon wrench

GC500R

Saw blade only GC501 and shaft GC520

Service addresses

GC502R

Saw blade only GC503 and shaft GC520

Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 14-939 E-mail: [email protected] Other service addresses can be obtained from the address indicated above.

GC504R

Saw blade only GC505 and shaft GC520

GC510R

Saw blade only GC511, GC512 and shaft GC521

GC513R

Saw blade only GC514, limiting disk GC515 and shaft GC521

GC520/204

Nut

GC523R

Double wrench (SW 14)

GC550R

Hollow reamer, ∅: 8 mm

GC554R

Hollow reamer, ∅: 16 mm

GC562R

Trepan, ∅: 8 mm

GP024/210

Disk (with two slits)

GP024/211

Lock washer

TA004103

Fixing screw

10. Technical specifications Classification acc. to Directive 93/42/EEC Weight

300 g

Maximum motor speed

20 000 1/min

Transmission Rotation to oscillation

1:1

Saw blade coupling

Triangular shaft

suitable for sterilization

up to 143 °C (3 bar)

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