Pneumatic motor GA553

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SYSTEM AESCULAP-DRÄGER

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SYSTEM DIN

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SYSTEM SCHRADER

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Aesculap® Pneumatic motor GA553

Pneumatic motor Aesculap GA553®

Legend 1 Foot control socket 2 Foot control plug 3 Pneumatic motor 4 Fast-lock coupling (motor-side) 5 Sleeve (motor-side) 6 Plug (motor side) 7 Motor hose 8 Pull out plug 9 Sleeve 10 Hose for foot control 11 Plug (for foot control) 12 Sleeve (for foot control) 13 Fast-lock coupling (for foot control) 14 Schrader plug/diffuser 15 Pull out DIN connector 16 Aesculap-Dräger socket 17 DIN socket 18 Pressure reducer 19 Schrader socket 20 Intra-coupling 21 Release button 22 Ring for selecting the rotational direction

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product Speed setting “right”/“left”

Contents 1. 2. 3. 3.1 3.2 3.3 4. 5. 5.1 5.2 5.3 6. 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 6.13 7. 8. 9. 10. 11. 11.1 12. 13.

1.

Applicable to Safe handling Product description Components required for operation Intended use Operating principle Preparation and setup Working with the pneumatic motor GA553 System set-up Function checks Safe operation Validated reprocessing procedure General safety instructions General information Dismantling prior to carrying out the reprocessing procedure Preparations at the place of use Preparation before cleaning Cleaning/disinfection Manual cleaning/disinfecting Mechanical cleaning/disinfecting Inspection, maintenance and checks Packaging Steam sterilization Sterilization for the US market Storage Maintenance Troubleshooting list Technical Service Accessories/Spare parts Technical data Ambient conditions Disposal Distributor in the US/Contact in Canada for product information and complaints

2 3 3 3 3 3 3 4 4 5 5 5 5 6 6 6 6 6 7 8 9 9 9 9 9 9 10 10 11 11 11 11 11

Applicable to

► For item-specific instructions for use and information on material

compatibility, see also www.extranet.bbraun.com

2

the

Aesculap

Extranet

at

2.

Safe handling

3.2

Intended use

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.

The pneumatic motor GA553 is used as a drive for the Aesculap handpieces in hand and foot surgical, in neurosurgery, in jaw and spine surgery and in ear, nose and throat surgery.

3.

Product description

Exit-air recycling via the compressed-air hose

3.1

Components required for operation

Operating principle

In the pneumatic motor, the energy provided by the compressed air supply is converted into rotary movement. The pneumatic motor is provided with a zero position. The zero position prevents accidental starting of the motor. The pneumatic motor can be switched from clockwise to counterclockwise rotation. Compressed-air hoses All compressed-air hoses have a fast-lock coupling. Consequently, the compressed air hose need not be disconnected from the compressed air supply when changing the motor.

■ Complete exit-air recycling (Aesculap Dräger system): The exit air is

Compressed-air hoses: System

Compressed-air hose

AesculapDräger

GA464R (3 m), GA466R (5 m) GA194R (3 m), GA195R (5 m)

DIN

With diffuser: GA461R (3 m) Without diffuser: GA463R (3 m), GA465R (5 m)

GA087 (5 m)

Motor hose

GA513R (3 m)

GA194R (3 m), GA195R (5 m)

Optional extension hose

Other components:

■ Foot control GA521 ■ Pneumatic motor ■ Handpiece with Intra-coupling (Aesculap micro-Line) ■ Compressed air supply with compressed air cylinder: – Pressure reducer, e.g. GA099

3.3

passed outside the operating room. Absence of air turbulence in the operating room: no effect on either ambient air temperature or hygiene in the operating room. ■ Partial exhaust-air recycling (DIN system and others): The exit air emerges from the hose end, either directly or through a diffuser inside the operating room. Foot control The foot control GA521 is equipped with a forced ventilation system. The motor side is vented whenever the pedal is in rest position. This causes the motor to stop quickly.

4.

Preparation and setup

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► When setting up and operating the product, adhere to – national regulations for installation and operation, – national legal regulations pertaining to compressed air supply, – national regulations on fire and explosion protection.

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Aesculap® Pneumatic motor GA553

5.

Working with the pneumatic motor GA553

5.1

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. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service. Coupling handpieces Handpiece with Intra-coupling 20 and pneumatic motor 3: ► Push the pneumatic motor 3 intra-coupling 20 into the micro-Line

handpiece until it rests against the end face of the motor and snaps in. Detaching the handpiece Handpiece with Intra-coupling 20 and pneumatic motor 3:

The gas supply must provide clean, dry air and must be set as follows: Nominal operating pressure (gauge pressure)

8 bar

Maximum allowable operating pressure

10 bar

Minimum operating pressure

6 bar

Maximum allowable backup pressure in exit air con- 0.4 bar duit while motor is operating (with exit air recycling) Minimum gas-supply delivery

300 l/min

Operation with compressed-gas cylinders according to DIN EN ISO 11117 The following conditions must be met: ■ Compressed air or nitrogen is used ■ An adequate stock of full gas cylinders is in place ■ Cylinder pressure of appr. 150 to 200 bar must be reduced with a pressure reducer (e.g. GA099) to a nominal operating pressure of 8 bar ► Operating pressure must be read from the scale on the device and set with the T-screw. When operating the motor with compressed gas cylinders, the exhaust air is not removed from the operative field, but instead emerges from the end of the hose, away from the operative site.

► Press the release button 21 and pull the handpiece off.

Connecting the motor to the compressed air supply Connecting the compressed-air supply

DANGER

Danger of fire and explosion when operating devices that run on oxygen! ► Never operate the pneumatic motor with oxygen! ► Operate the pneumatic motor with compressed air or nitrogen.

Note Long hoses may cause a backup of exhaust air and thus a loss of performance of the pneumatic motor. ► Use hose lines that are as short as possible. ► Make certain that the hose lines are not kinked or crushed. ► Use a compatible extension hose if necessary.

Connecting the motor to the foot control

CAUTION

Operating pressures in excess of 10bar will damage the pneumatic motor! ► Set a flow pressure of between 6 and 10 bar.

► Make certain the ring for selecting the direction of rotation 22 on the

pneumatic motor is in ”0” position. ► Pull back the sleeve 5 on the motor hose 7 and connect the motor hose

with the fast-lock coupling 4 on the motor 3. Note For operation, a compressed air supply of 6 bar to 10 bar (0.6 MPa to 1.0 MPa) is needed. Operation with central gas supply as per DIN 13260 and EN 737 and with low-pressure hose line systems for use with medical gases as per DIN EN ISO 5359

► Insert the plug 8 of the motor hose 7 into the foot control.

Connecting the foot control to the compressed air supply ► Depending on the compressed air system, choose the appropriate hose

for the Aesculap Dräger system, DIN system or Schrader system. ► Pull back the sleeve 12 on the hose 10 and connect the hose with the

fast-lock coupling 13 on the foot control. ► Insert the plug 8/14/15 of the hose 10 into the compressed air supply

can 16/17/19.

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5.2

Function checks

► Always do a test run of the pneumatic motor system (pneumatic motor,

foot control, hose) prior to use. ► Make certain that the pneumatic motor and foot control are in good

working order. ► Make certain that all hoses are properly connected and free of leaks.

Note For particularly delicate (sawing ) work, maximum speed can be reduced by approximately 65 percent with intermediate ratcheting. ► Carefully press down the foot control pedal.

The pneumatic motor runs in the preselected rotational direction. ► In order to regulate the motor speed, press the pedal with less or more

pressure.

5.3

Safe operation

WARNING

WARNING

WARNING

WARNING

Danger of damage to patients’ hearing from sound of motor! ► When using the pneumatic motor for ear, nose and throat procedures, keep the motor as far away as possible from the patient’s ears. 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. Injury to the operator and damage to the device components can result from accidentally putting the pneumatic motor into operation. ► Secure the compressed air motor against unintentional operation. ► Only attach handpieces, tools and the compressed air supply when the pneumatic motor is shut off.

► In order to secure the compressed air motor against unintentional

operation, put the ring for selecting the direction of rotation 22 in the "0" position. Note Owing to the cutting geometry of the tool, the optimal rotational direction of the pneumatic motor is clockwise. Operation with the foot control ► In order to select left or right as the direction, turn the direction selec-

► In order to select the maximum motor speed, push the pedal down

fully. ► In order to switch off the compressed air motor, e.g. when changing

the tool or handpiece, turn the ring for direction selection 22 to the "0" position.

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.

tion ring 22 to the right arrow (for right-running) or the left arrow (left-running), until it clicks.

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Aesculap® Pneumatic motor GA553

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 precleaning 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.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure Note The compressed air motor, accessory parts and handpieces are delivered as non-sterile items.

WARNING

CAUTION

CAUTION

Risk of infection and contamination! ► Sterilize the compressed air motor, accessory parts and handpieces before putting them into operation. 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. 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 highgrade 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 50 °C.

► Dry the product for at least 10 minutes at a maximum of 120 °C.

6.3

Dismantling prior to carrying out the reprocessing procedure

► Remove the pneumatic motor from the handpiece and hose.

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.

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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.

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable hinges, ensure that these are in

Chapter Manual cleaning/disinfecting and subsection:

an open position and, if applicable, move the joint while cleaning.

■ Drying phase: Use a lint-free cloth ■ Ensure that the product is positioned in such a way that water will not

■ Chapter Manual cleaning and wipe disinfecting

enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.) Mechanical alkaline cleaning and thermal disinfecting

■ Mount the holder GB685R in a suitable wire basket. ■ Insert the product in its proper position in the GB685R holder.

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

6.7

Manual cleaning/disinfecting Danger to the patient! ► Only mechanically clean the product.

DANGER ► Prior to manual disinfecting, allow water to drip off for a sufficient

length of time to prevent dilution of the disinfecting 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

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, low microbiological contamination: drinking water quality at least) Room temperature

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Aesculap® Pneumatic motor GA553

Phase I

Phase III

► Clean the product under running faucet water, using a suitable clean-

► Wipe all surfaces of the product with a single-use disinfectant wipe.

ing brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning.

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 II ► Dry the product in the drying phase with suitable equipment (e.g. cloth,

compressed air), see Validated cleaning and disinfection procedure.

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.

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

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* 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: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

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6.9

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. ► Spray through the motor/handpiece with Aesculap STERILIT oil spray GB600 with the appropriate adapter for approx. 1 s. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Set aside the product if it is damaged.

6.10 Packaging

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

► Always observe the instructions for use of packaging and storage

devices. ► Insert the product in its proper position in the holder, or put it on a tray in such a way that the product is 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

*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.

► 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 – 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.

6.13 Storage ► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area.

7.

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.

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Aesculap® Pneumatic motor GA553

8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Motor is not running

Gas cylinder empty Pressure Gauge set to "0"

No compressed air

Fill or change cylinder

Insufficient power

No compressed air at the wall outlet

Open valve

The ring for rotation direction selection 22 is on "0"

Turn the ring for rotation direction selection 22 to the right or the left

Hoses are not correctly connected

Fully connect the hose connector

Pedal can be easily pressed or cannot be pressed at all

Foot control defective

Have product repaired by the manufacturer

The ring for rotation direction selection 22 is not on the end stop

Compressed air supply pressure too low

Turn the ring for rotation direction selection 22 until it clicks on the stop (preferred direction of rotation: clockwise)

Operating pressure of the central compressed air supply too low (min. 6 bar)

Have compressed-air supply checked

Pressure reducer on gas cylinder defective

Have pressure reducer checked

Pressure on pressure reducer set too low

Set higher pressure

Hose is too long

Do not kink or squeeze hoses

Exit air does not flow freely

Diffuser 14 or exhaust air channel Pneumatic motor faulty

Have product repaired by the manufacturer

Pneumatic motor heats up

Have product repaired by the manufacturer

Pneumatic motor runs jerkily

Have product repaired by the manufacturer

Technical Service 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.

10

Use shorter hoses

Hoses excessively kinked or crushed

Motor does not run in spite of correct compressed-air supply

9.

High air resistance in the hose

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

Dimensions

Value

Noise level at a distance of 1 meter

< 70 dB(A)

Weight

approx. 150 g

Size

∅ 22 mm x 95 mm

Motor types

Pneumatic motor

Coupling

Control unit

GA553

microLAN

Intra-coupling

Foot control

11.1 Ambient conditions Operation

Art. no.

Designation

e.g. GD305

micro-Line handpiece

GB600

Aesculap STERILIT oil spray

GB600820

Oil spray adapter hi

GA513R (3 m)

Motor hose

GA521

Foot control

GA464R (3 m) GA466R (5 m)

Connection hoses for Aesculap Dräger system

GA461R (3 m) GA463R (3 m) GA465R (5 m)

Connection hose system DIN

GA468R (5 m)

Connection hose for Aesculap Schrader system

GA194R (3 m) GA195R (5 m)

Extension hose for Aesculap Dräger system

GA087 (5 m)

Extension hose system DIN

GB685R

Holder for GA553

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 avail-

able through your national B. Braun/Aesculap agency, see Technical Service.

11. Technical data Dimensions

Value

Operating pressure

8 ± 2 bar

Max. operating pressure

10 bar

Air consumption

approx. 200 l/min

Max. permissible backup in the exit air

0.4 bar

Max. motor speed

20 000 1/min

Max. power

100 W

13. Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA 11

- DIR 93/42/EEC

Technical alterations reserved

Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com Aesculap – a B. Braun company

TA-Nr. 010075 Änd.-Nr. 48673

01/14

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