BBraun
Pneumatic foot control GA521
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Page 1
Aesculap® Pneumatic foot control GA521 Legend 1 Transport brace 2 Pedal (for rotational speed control) 3 Coupling (for connecting the motor) 4 Connector (for connecting the compressed-air source) 5 Mounting holes for bracket 6 Connector (foot control-side) 7 Unlocking sleeve (foot control-side) 8 Fast-lock coupling (for gripping) 9 Aesculap Dräger socket 10 Unlocking sleeve (source-side) 11 Connector (source-side) 12 Pneumatic motor 13 Fast-lock coupling (motor-side) 14 Unlocking sleeve (motor-side) 15 Fast-lock coupling (for gripping) 16 Tube connector (on pneumatic motor) 17 Unlocking sleeve (foot control-side) 18 Connector (foot control-side)
Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product
Coupling: ► Pull back unlocking sleeve (foot control end) 7 on connecting tube and connect tube with fast-lock coupling 8 to plug 4 on the pneumatic foot control. ► Release unlocking sleeve (foot control end) 7. ► Insert connector (source-side) 11 of connecting tube in Aesculap Dräger socket 9 making sure it engages. Uncoupling: ► Pull back unlocking sleeve (foot control end) 7 at connecting tube. ► Remove fast-lock coupling 8 from plug 4 at the pneumatic foot control. ► Pull back unlocking sleeve (source-side) 10 at connector (source-side)11 of connecting tube. ► Unplug connector (source-side) 11 from the Aesculap Dräger socket.
Connecting the pneumatic motor to the pneumatic foot control The following connecting tubes can be used: Connecting tube GA513R or GA523R with and without extension tube GA194R or GA195R. Coupling: ► Pull back unlocking sleeve (motor-side) 14 on the motor tube and connect motor tube with fast-lock coupling (motor-side) 13 to the tube connection 16 on the pneumatic motor 12. ► Release unlocking sleeve (motor-side) 14. ► Insert connector (foot control end) 18 of motor tube into coupling 3 at the pneumatic foot control, making sure it engages. Uncoupling: ► Pull back unlocking sleeve (motor-side) 14 at motor tube. ► Remove fast-lock coupling (motor-side) 13 from pneumatic motor 12. ► Pull back unlocking sleeve (foot control end) 17 at connector (foot control end) 18 of motor tube. ► Unplug connector (foot control end) 18 from the coupling 3 at the pneumatic foot control.
5.2
prior to each use. ► Make certain that the pneumatic motor and pneumatic foot control are in good working order. ► Make certain that all connecting tubes are properly connected and free of leaks. ► Make sure that the pneumatic motor rotates at maximum speed when the foot pedal is fully pressed down.
5.3
1.
Applicable to
Safe operation
► Carefully press down the pedal 2 at the pneumatic foot control.
► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
2.
Function checks
► Always do a dry run of the pneumatic motor system (pneumatic motor, pneumatic foot control, connecting tubes)
Safe handling
CAUTION Federal law restricts this device to sale by, or on order of a physician! Danger of fire and explosion when operating devices that run on oxygen! ► Never operate the pneumatic motor with oxygen!
The motor starts running. ► Adjusting speed: Press down on the pedal 2 to a greater or lesser extent. ► To select maximum speed: Press down on the pedal 2 as far as it will go.
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.
DANGER ► Clean the new product after removing its transport packaging. ► 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 man-
ufacturer 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. ► Always adhere to applicable standards.
3.
Product description
3.1
Intended use
The pneumatic foot control GA521 is used to control the Aesculap pneumatic motors GA740R, GA741R, GA519, GA520R, GA551, GA553, GA502, GA522R and GA742R.
3.2
Operating principle
The supplied compressed-air is regulated via a valve that is actuated by means of the pedal (for rotational speed control) 2.
4.
Preparation
Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap.
4.1
First use
► Suspending the transport bracket: Widen the transport brackets 1 slightly and insert them into the mounting
holes for brackets 5 provided in the housing.
5.
Operating using the pneumatic foot control
5.1
System set-up
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.
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.
Connect pneumatic foot control to compressed-air source
6.3
The following connecting tubes can be used:
► 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.
System
Tubes
Aesculap Dräger
Connecting tubes GA464R, GA466R with and without extension tube GA194R, GA195R
Aesculap standard
Connecting tubes GA461R, GA463R, GA465R with and without extension tube GA087
Aesculap Schrader
Connecting tube GA468R
6.4
Preparations at the place of use
Preparation before cleaning
► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.
6.5
10.
Cleaning/disinfection
Product-specific safety instructions for the reprocessing procedure Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. ► Do not sterilize the product under any circumstances.
CAUTION
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. CAUTION
Validated cleaning and disinfection procedure
Accessories/Spare parts
Art. no.
System
Designation
GA521200
–
Bracket
GA464R (3 m) GA466R (5 m)
Aesculap Dräger
Connecting tube
GA461R (3 m) GA463R (5 m) GA465R (5 m)
Aesculap standard
GA468R (5 m)
Aesculap Schrader
GA194R (3 m) GA195R (5 m)
Aesculap Dräger
Validated procedure
Special features
Reference
GA087 (5 m)
Aesculap standard
Wipe disinfection for pneumatic devices without sterilization
No
Chapter Wipe disinfection for electrical devices without sterilization
GA513R (3 m) GA523R (2.3 m)
–
6.6
Wipe disinfection for electrical devices without sterilization
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Wipe disinfection
RT
≥1
-
-
Meliseptol HBV wipes 50 % Propan-1-ol
RT:
11.
Phase I ► Remove any visible residues with a disposable disinfectant wipe. ► Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe. ► Observe the specified application time (1 min minimum).
Inspection, maintenance and checks
Coupling system (motor-side)
Aesculap Dräger coupling
Coupling system (source-side)
Aesculap fast-lock connector
Dimensions with bracket (W x H x D)
160 mm x 240 mm x 170 mm
Dimensions without bracket (W x H x D)
100 mm x 240 mm x 55 mm
Disposal
agency, see Technical Service.
13. Maintenance
To ensure reliable operation, the product must be maintained at least once every 2-3 years. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.
8.
approx. 3 kg
► Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap
► Check the product after each cleaning cycle to be sure it is clean, functional, and undamaged. ► Set aside the product if it is damaged.
7.
Technical data
Pneumatic foot control GA521
12. 6.7
Troubleshooting list
Distributor in the US/Contact in Canada for product information and complaints
Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 009595
Malfunction
Detection
Cause
Remedy
Motor not running
Cylinder empty (pressure gauge reads 0)
No compressed air
Fill or replace cylinder
No compressed air at the wall outlet
Open valve
Tubes not correctly connected
9.
Motor tube
Weight
Room temperature
Extension tube
Fully connect the tube couplings
Pedal can be too easily pressed or cannot be pressed at all
Foot control faulty
Have product repaired by the manufacturer
Whistling sound audible
Foot control leaking
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. 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.
03/13
V6
Änd.-Nr. 46031