BBraun
HiLAN pneumatic motor GA519 GA520R GA529
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Page 1
GA523 (2.3 m)
GA523 (2.3 m)
GA464 (3 m)
Aesculap® HiLAN HiLAN pneumatic motor GA519/GA520R/GA529
HiLAN pneumatic motor GA519/GA520R/GA529 Aesculap® HiLAN
Legend 1 HiLAN pneumatic motor 2 Fast-lock coupling (motor-side) 3 Unlocking sleeve (motor-side) 4 Fast-lock coupling (for gripping) 5 Motor tube 6 Connector (foot control-side) 7 Unlocking sleeve (foot control-side) 8 Socket (foot control-side) 9 Connector (foot control-side) 10 Tube coupling (source-side) 11 Unlocking sleeve (foot control-side) 12 Fast-lock coupling (for gripping) 13 Connecting tube for foot control switch/wall socket 14 Connector (source-side) 15 Unlocking sleeve (source-side) 16 Lever extension 17 Hand lever 18 Slide 19 Tube connection 20 Safety stop 21 Nibs 22 Notches (motor) 23 Notches (handpiece) 24 Threaded ring 25 Hi-Line handpiece 26 Hi-Line XS handpiece
Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product Rotate "right" (clockwise) to unlock the handpiece
Rotate "left" (counterclockwise) to lock the handpiece
I/ 0
2
HiLAN pneumatic motor "ready" HiLAN pneumatic motor "off"
Contents 1. 2. 3. 3.1 3.2 3.3
Applicable to Safe handling Product description Components required for operation Intended use Operating principle HiLAN pneumatic motor Compressed-air tubes Exit-air recycling via the compressed-air tube Foot control 4. Preparation 4.1 Compressed-air supply Operation with central gas supply according to DIN 13260 and EN 737 Operation with compressed-gas cylinders according to DIN 4664 5. Working with the HiLAN pneumatic motor 5.1 System set-up Connecting the accessories Connecting the compressed-air supply 5.2 Function checks 5.3 Safe operation Operation with the hand lever 6. Validated reprocessing procedure 6.1 General safety instructions 6.2 General information 6.3 Preparations at the place of use 6.4 Preparation before cleaning 6.5 Cleaning/disinfection Product-specific safety instructions for the reprocessing procedure Validated cleaning and disinfection procedure 6.6 Manual cleaning/disinfecting Manual cleaning and wipe disinfecting 6.7 Mechanical cleaning/disinfecting Mechanical alkaline cleaning and thermal disinfecting 6.8 Inspection, maintenance and checks 6.9 Packaging 6.10 Steam sterilization 6.11 Sterilization for the US market 6.12 Storage 7. Maintenance 8. Troubleshooting list 9. Technical Service 10. Accessories/Spare parts 11. Technical data
3 3 3 3 4 4 4 4 4 4 4 4 4 4 5 5 5 5 6 7 7 8 8 8 8 8 9 9 10 10 10 11 11 12 12 12 12 12 12 13 14 14 15
11.1 Ambient conditions 12. Disposal 13. Distributor in the US/Contact in Canada for product information and complaints
15 15
3.
Product description
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3.1
Components required for operation
When putting the HiLAN XS pneumatic motor into operation, the following components are required
1.
Applicable to
► For item-specific instructions for use and information on material
compatibility, see also www.extranet.bbraun.com
2.
the
Aesculap
Extranet
at
Designation
Special features
Compressed-air supply with a minimum of 6 bar (0.6 MPa)
If compressed air is sup- Pressure reducer: plied via a compressed- e.g., GA099 gas cylinder, use a pressure reducer
Compressed-air tubes
Aesculap Dräger system
GA464 (3 m), GA466 (5 m) If needed, extension tubes GA194 (3 m), GA195 (5 m)
DIN connection
GA461 (3 m, with diffuser) GA463 (3 m, without diffuser) GA465 (5 m, without diffuser) If needed, extension tube GA087 (5 m)
Motor tube
GA513 (3 m) GA523 (2.3 m) GA505 (5 m) If needed, extension tubes GA194 (3 m), GA195 (5 m)
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 information 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. ► Only use handpieces and tools expressly approved for the HiLAN power system. Foot control
Art. no.
GA521
HiLAN XS pneumatic motor Hi Line XS handpiece
3
Aesculap® HiLAN HiLAN pneumatic motor GA519/GA520R/GA529
3.2
Intended use
4.1
Compressed-air supply
The HiLAN pneumatic motors GA519, GA520R, and GA529 are used for powering the Aesculap Hi-Line handpieces in microsurgery, neurosurgery, spinal surgery, ENT, and maxillary surgery, as well as in orthopedics. DANGER
3.3
Operating principle
3.3.1
HiLAN pneumatic motor
In the HiLAN pneumatic motor, the energy provided by the compressedair supply is converted into rotary movement. The HiLAN pneumatic motor is equipped with a safety stop, which prevents any unintended startup of the HiLAN pneumatic motor. 3.3.2
Compressed-air tubes
All compressed-air tubes have a fast-lock coupling. Consequently, the compressed-air tube need not be disconnected from the compressed-air supply when changing the HiLAN pneumatic motor. 3.3.3
Exit-air recycling via the compressed-air tube
■ Complete exit-air recycling (Aesculap Dräger system): The exit air is 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 exit-air recycling (DIN connection and others): The exit air emerges from the tube end, either directly or through a diffuser inside the operating room. 3.3.4
Foot control
The foot control GA521 is equipped with a forced ventilation system. As soon as the foot control pedal is released, the supply air is vented on the motor side. This allows the HiLAN pneumatic motor to stop more rapidly.
4.
Preparation
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 – The national regulations for installation and operation – National regulations on fire and explosion protection ► Prior to using the HiLAN pneumatic motor and its accessories, check for any visible damage. ► Use the HiLAN pneumatic motor and its accessories only if they are in perfect condition.
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CAUTION
4.1.1
Danger of fire and explosion when operating devices that run on oxygen! ► Never operate the HiLAN pneumatic motor with oxygen. ► Operate the HiLAN pneumatic motor with compressed air or nitrogen. Operating pressures in excess of 10 bar will damage the HiLAN pneumatic motor! ► Set an operating pressure of between 6 bar and 10 bar.
Operation with central gas supply according to DIN 13260 and EN 737
The gas supply must provide clean, dry air and must be set as follows: Nominal operating pressure
8 bar
Maximum allowable operating pressure
10 bar
Minimum operating pressure
6 bar
Minimum gas-supply delivery
300 l/min
4.1.2
Operation with compressed-gas cylinders according to DIN 4664
The following conditions must be met: ■ Compressed air or nitrogen is used ■ An adequate stock of full gas cylinders is in place ■ Cylinder pressure reduced to operating pressure of 6 bar to 10 bar through a pressure reducer (e.g., GA099) ► Operating pressure must be read from the scale on the device and set with the T-screw.
5.
Working with the HiLAN pneumatic motor
Detaching the handpiece ► Turn or slide safety stop 20 or slide 18 on the HiLAN pneumatic
motor 1 to position "0". ► Turn threaded ring 24 in the direction of the arrow/rotation in
5.1
System set-up
WARNING
WARNING
5.1.1
Injury to the operator and damage to the device components can result from accidentally putting the HiLAN pneumatic motor into operation! ► Use the safety stop to prevent any accidental activation of the HiLAN pneumatic motor. ► Only attach handpieces, tools, and the compressed-air supply when the HiLAN pneumatic motor is shut off. Risk of infection and contamination! The HiLAN pneumatic motor, its accessories, and the handpieces are delivered in an unsterile condition. ► Sterilize the HiLAN pneumatic motor, its accessories, and the handpieces before putting them into operation.
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 contact your B. Braun/Aesculap partner or Aesculap Technical Service (address: see Technical Service) with any inquiries in this respect. Coupling the Hi-Line or Hi-Line-XS handpiece (e.g., GB519R, GB520R–GB535R, or GB740R-GB758R) ► Turn or slide safety stop 20 or slide 18 on the HiLAN pneumatic
motor 1 to position"0". ► Turn threaded ring 24 in the direction of the arrow/rotation in
symbol
symbol
as far as it will go.
► Remove handpiece 25 or 26 from the HiLAN pneumatic motor 1.
5.1.2
Connecting the compressed-air supply
Long tubes may cause a backup of exit air and thus a loss of performance of the HiLAN pneumatic motor. ► Keep tube lines as short as possible. ► Make certain that the tube lines are not buckled or crushed. ► Use a suitable extension tube if necessary, see Components required for operation. Note The HiLAN pneumatic motors GA519/GA520R and GA529 including the motor tube are sterile. Sterile separation takes place at the motor tube. Connecting the HiLAN pneumatic motor at the foot control switch Coupling: ► Pull back unlocking sleeve (motor-side) 3 on motor tube 5 and connect the motor tube with its fast-lock coupling (motor-side) 2 to the tube connection 19 on the HiLAN pneumatic motor 1. ► Release unlocking sleeve (motor-side) 3. ► Insert connector (foot control-side) 6 of motor tube 5 into socket (foot control-side) 8 on the foot control switch until it engages. Uncoupling: ► Pull back unlocking sleeve (motor-side) 3 on motor tube 5. ► Remove fast-lock coupling (motor-side) 2 from the HiLAN pneumatic motor 1. ► Pull back unlocking sleeve (foot control-side) 7 on connector (foot control-side) 6 of motor tube 5. ► Pull connector (foot control-side) 6 out of socket (foot control-side) 8 on the foot control switch.
as far as it will go.
► Attach the Hi-Line handpiece to the HiLAN pneumatic motor 1 so that
the nibs 21 on the HiLAN pneumatic motor 1 engage in the notches 23 on handpiece 25. The handpiece can be mounted in 4 different positions. ► Attach Hi-Line XS handpiece 26 to the HiLAN pneumatic motor 1 so that the pin on the handpiece engages in one of the notches 22 on the motor. The handpiece can be mounted in 15 different positions. ► Turn threaded ring 24 in the direction of the arrow/rotation in symbol as far as it will go. The handpiece is locked now. ► Make certain that the threaded ring is fastened to its limit stop, because otherwise it may come loose due to vibrations during operation.
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Aesculap® HiLAN HiLAN pneumatic motor GA519/GA520R/GA529
Note If coolant pump GA530 is employed for cooling/irrigating the tool blades, connect the coolant pump between the foot control switch and the HiLAN pneumatic motor, see TA022140. Connecting the HiLAN pneumatic motor with hand lever to the compressed-air supply The HiLAN pneumatic motor GA529 is controlled via hand lever 17 and is connected to the compressed-air source directly via a tube. Coupling: ► Make sure that slide 18 is in position "0". ► Select the compressed-air-tube system appropriate for the systems installed at your site. ► Pull back unlocking sleeve (motor-side) 3 at fast-lock coupling 4 and attach motor tube 5 to tube connection 19 on the HiLAN pneumatic motor 1. Pull at 4 to check that the coupling is correct. ► Join connector (source-side) 14 and connecting tube 13 to the compressed-air source in the operating room. Connecting the foot control switch to the compressed-air supply
DIN connection Coupling: ► Pull back unlocking sleeve (foot control-side) 11 at connecting tube 13 and connect the tube with fast-lock coupling 12 to connector (foot control-side) 9 on the foot control switch. ► Release unlocking sleeve (foot control-side) 11. ► Insert the DIN connector of connecting tube 13 into the DIN socket until it engages. Uncoupling: ► Pull back unlocking sleeve (foot control-side) 11 at connecting tube 13. ► Remove fast-lock coupling 12 from connector (foot control-side) 9 on the foot control switch. ► Pull back unlocking sleeve (source-side) 15 at connector (sourceside) 14 of connecting tube 13. ► Pull connector (source-side) 14 out of the DIN socket.
5.2
Function checks
► Always check the pneumatic motor system (HiLAN pneumatic motor,
Aesculap Dräger system Coupling: ► Pull back unlocking sleeve (foot control-side) 11 at connecting tube 13 and connect the tube with fast-lock coupling 12 to connector (foot control-side) 9 on the foot control switch. ► Release unlocking sleeve (foot control-side) 11. ► Insert connector (source-side) 14 of connecting tube 13 into the Aesculap Dräger socket until it engages. Uncoupling: ► Pull back unlocking sleeve (foot control-side) 11 at connecting tube 13. ► Schnellabsperrkupplung 12 am Stecker (fußschalterseitig) 9 an der Fußsteuerung abziehen. ► Pull back unlocking sleeve (source-side) 15 at connector (sourceside) 14 of connecting tube 13. ► Pull connector (source-side) 14 out of the Aesculap Dräger socket.
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foot control switch, tubes) by performing a trial run prior to use. ► Make certain that the HiLAN pneumatic motor and foot control switch
are in good working order. ► Make certain that all tubes are properly connected and free of leaks.
5.3
Safe operation
5.3.1
Operation with the hand lever
► Adjust the length of hand lever 17 to corresponding handpiece 25: To
WARNING
WARNING
WARNING
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. 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.
do this, pull out lever extension 16 to a greater or lesser extent. until it engages. ► Carefully press down hand lever 17. The HiLAN pneumatic motor 1 starts to run. ► Adjusting speed: Press down hand lever 17 to a greater or lesser extent. ► Maximum speed: Press down hand lever 17 as far as it will go. ► Switching off the HiLAN pneumatic motor, e.g., to change a tool or handpiece intraoperatively: Turn safety stop 20 until the mark on the unlocking sleeve is aligned with the “0” mark on the motor. ► Push slide 18 to position
Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. Danger of damage to patients’ hearing from sound of motor! ► When using the HiLAN pneumatic motor in otology, keep as much distance from the ear as possible.
► Turn safety stop 20 on HiLAN pneumatic motors GA519 and GA520R
until the mark on safety stop 20 is aligned with the "I" mark on the motor. ► Carefully press down the foot control pedal. The motor starts running. ► Adjusting speed: Press down on the pedal to a greater or lesser extent. ► To select maximum speed: Press down on the pedal as far as it will go. ► Switching off the HiLAN pneumatic motor, e.g., to change a tool or handpiece intraoperatively: Turn safety stop 20 until the mark on the unlocking sleeve is aligned with the “0” mark on the HiLAN pneumatic motor.
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Aesculap® HiLAN HiLAN pneumatic motor GA519/GA520R/GA529
6. 6.1
Validated reprocessing procedure 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.
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.
6.3
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.
6.4
Preparation before cleaning
► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.
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6.5
Cleaning/disinfection
6.5.1
Product-specific safety instructions for the reprocessing procedure
DANGER
CAUTION
CAUTION
Fire hazard! ► Do not use flammable or explosive cleaning or disinfecting solutions. ► Ensure that no fluids will penetrate the product. 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 – be approved for plastic material and highgrade steel, – do not attack softeners (e.g. in silicone). – do not cause stress cracks in plastics (e.g., PPSU). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 55 °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.
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Aesculap® HiLAN HiLAN pneumatic motor GA519/GA520R/GA529
6.5.2
Validated cleaning and disinfection procedure
Validated procedure
Special features
Reference
Manual cleaning and wipe disinfection
■ When cleaning instruments with movable hinges, ensure that these
Chapter Manual cleaning/disinfecting and subare in an open position and, if applicable, move the joint while clean- section: ing. ■ Chapter Manual cleaning and wipe disinfecting ■ Drying phase: Use a lint-free cloth
■ 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 alkaline cleaning and thermal disinfecting
6.6
■ Insert the product in its proper position in the Eccos holder. ■ The products may only be cleaned mechanically with an appropriate Eccos holder.
Chapter Mechanical cleaning/disinfecting and subsection:
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
Manual cleaning/disinfecting
► 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.
6.6.1
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
Phase I
Phase II
► Clean the product under running faucet water, using a suitable clean-
► Dry the product in the drying phase with suitable equipment (e.g. cloth,
ing brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
compressed air), see Validated cleaning and disinfection procedure.
10
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.
6.7
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. 6.7.1
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.
11
Aesculap® HiLAN HiLAN pneumatic motor GA519/GA520R/GA529
6.8
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 HiLine motor/handpiece with Aesculap STERILIT oil spray GB600 with adapter GB600820 until clear oil emerges from the product. ► 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. Note Lubricating the HiLAN pneumatic motors with the original Aesculap oil spray can lead to oil residues entering the compressed-air tubes. These oil residues do not harm the materials from which the compressed-air tubes are made.
6.9
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. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.
6.10 Steam sterilization Note Regarding materials and temperatures, the HiLAN pneumatic motors have been designed for steam sterilization. Consequently, do not sterilize HiLAN pneumatic motors with hot air or ethylene oxide (EO). HiLAN pneumatic motors can be sterilized in their storage device. ► 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 instrument – 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 instruments 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. 12
6.11 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
*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.
6.12 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.
8.
Troubleshooting list
Malfunction
Detection
Cause
Remedy
HiLAN pneumatic motor not running
Gas cylinder empty Manometer set to "0"
No compressed air
Have gas cylinder refilled or changed
Insufficient power
No compressed air at the wall outlet
Open valve
Safety stop 20 set to "0"
Turn safety stop 20 to "I"
Slide 18 on hand lever 17 set to "0"
Schieber 18 in Stellung schieben
Tubes not correctly connected
Attach fast-lock coupling (motorside) 2 fully
Pedal can be easily pressed or can- Foot control switch defective not be pressed at all
Have product repaired by the manufacturer
Hand lever 17 can be easily pressed or cannot be pressed at all
Hand lever 17 defective
Have product repaired by the manufacturer
Safety stop 20 not set to "I"
Insufficient air supply
Turn safety stop 20 to "I"
Operating pressure of 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
Tube too long
High air resistance in the tube
Use shorter tubes
Tubes excessively buckled or crushed
Do not buckle or crush tubes
Exit-air ducting
Unblock diffuser and exit-air duct
Motor does not run in spite of cor- HiLAN pneumatic motor defective rect compressed-air supply
Have product repaired by the manufacturer
HiLAN pneumatic motor heats up
Have product repaired by the manufacturer
HiLAN pneumatic motor not running smoothly
Have product repaired by the manufacturer
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Aesculap® HiLAN HiLAN pneumatic motor GA519/GA520R/GA529
9.
Technical Service Risk of injury and/or malfunction! ► Do not modify the product.
WARNING ► For service and repairs, please contact your national B. Braun/
Aesculapp agency. 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.
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10. Accessories/Spare parts Art. no.
Designation
GB600
STERILIT Power Systems oil spray
GB600820
STERILIT Power Systems adapter
GA059
Special oil
GA530
HiLAN irrigation pump
GA513R (3 m) GA523R (2.4 m) GA505R (5 m)
Motor tube for Aesculap Dräger system
GA506R (5 m)
Motor tube for Aesculap Schrader system
GA507R (5 m)
Motor tube for Aesculap standard system
GA521 (gas pedal)
Foot control switch
GA194 (3 m) GA195 (5 m)
Extension tube for Aesculap Dräger system
GA087 (5 m)
Extension tube for Aesculap standard system
GA464 (3 m) GA466 (5 m)
Connecting tube for Aesculap Dräger system
GA461 (3 m) GA463 (3 m) GA465 (5 m)
Connecting tube for Aesculap standard system
GA468 (5 m)
Connecting tube for Aesculap Schrader system
GA508R
Angled tube adapter for GA519, GA529
GB577R
Storage (for HiLAN pneumatic motor with angled tube adapter mounted)
GB559R
Storage for motor GA519, GA529
GB560R
Storage for motor GA520R
GB564R
Storage for motor tube GA513R, GA523R, GA505R
GB575R
Storage for motor tube GA506R
GB576R
Storage for motor tube GA507R
JF213R (64 mm)
Tray
JK431
Container
GB473
Eccos storage mounting set
11. Technical data Motor type
GA519
GA520R
GA529
Operating pressure
8 ± 2 bar
8 ± 2 bar
8 ± 2 bar
Max. operating pressure
10 bar
10 bar
10 bar
Air consumption
approx. 200 l/min
approx. 200 l/min
approx. 200 l/min
Max. permissible backup in the exit air
0.7 bar
0.7 bar
0.7 bar
Speed
max. 100 000 1/min
max. 100 000 1/min
max. 110 000 1/min
Noise
< 70 dB(A) at 1 m distance
< 70 dB(A) at 1 m distance
< 70 dB(A) at 1 m distance
Weight
approx. 95 g
approx. 170 g
approx. 132 g
Size
∅ 21 mm x 80 mm
∅ 21 mm x 120 mm
∅ 21 mm x 80 (105) mm
11.1 Ambient conditions Operation
Storage and transport
Temperature
Relative humidity
13. Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA
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.
15
- 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. 009530 Änd.-Nr. 48673
01/14
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