HiLAN irrigation pump

Aesculap® HiLAN irrigation pump

Legend 1 HiLAN Irrigation pump GA530 2 Indicator light, power ON 3 Power ON switch 4 Power OFF switch 5 Socket 6 Pump ON indicator 7 Decrease delivery rate key 8 Coolant pump display 9 Increase delivery rate key 10 Release keys 11 Coolant pump 12 Bottle holder 13 Bottle holder mount 14 Potential equalization plug (socket for potential equalization) 15 Fuse holder 16 Device connector 17 Ventilation slots 18 Plug 19 Device foot 20 Stacking cones 21 Fixation screw 22 Connecting tube (to foot control) 23 Fast-lock coupling quick release coupling 24 Sleeve (coupling-side) 25 Coupling 26 Plug 27 Sleeve (plug-side) 28 Socket foot control 29 Plug foot control 30 Foot control GA521 31 Connecting tube (to compressed-air source) 32 DIN connector 33 Schrader connector 34 Socket system Aesculap-Dräger 35 Socket system DIN coupling 36 Socket system Schrader 37 Motor tube 38 Coupling 39 Sleeve (motor-side) 40 Fast-lock coupling (motor-side) 41 Tube connection 42 HiLAN pneumatic motor

2

HiLAN irrigation Aesculap® pump

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product Follow the instructions for use

Type B application component

Input from irrigation bottle (coolant pump)

Outlet to handpiece (coolant pump)

Pumping direction (coolant pump) Terminal for equipotential bonding conductor

Fuse Alternating current Label according to DIN EN ISO 5359 Gas approved for running surgical tools: Air Label according to DIN EN ISO 5359 Gas approved for running surgical tools: Nitrogen Labeling of electrical and electronic devices according to Directive 2002/96/EG (WEEE), see Disposal

LOT

Manufacturer’s batch designation

Manufacturer’s serial number

Manufacturer’s article number Date of manufacture

Contents 1. 2. 2.1 2.2 2.3 2.4 3. 3.1 3.2 3.3 3.4 4. 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.2 4.3 5. 5.1 5.2 5.3 5.4 5.5 5.5.1 5.5.2 5.6 5.7 6. 7. 7.1 7.2 7.3 8. 9. 9.1 9.1.1 9.1.2

Safe handling Product description Scope of supply Components required for operation Intended use Operating principle Preparation and setup First use Stacking of units Operation with central gas supply according to DIN EN ISO 7396-1 Operation with compressed gas cylinders according to DIN EN ISO 11117 Working with the HiLAN irrigation pump GA530 System set-up Connecting the accessories Connecting the power supply Connecting the compressed-air supply Connecting the HiLAN pneumatic motor Connecting the tube set Activating/deactivating the HiLAN irrigation pump 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 Cleaning/disinfection Product-specific safety instructions for the reprocessing procedure Validated cleaning and disinfection procedure Wipe disinfection for electrical devices without sterilization Inspection, maintenance and checks Maintenance Troubleshooting list Malfunctions with error display Other malfunctions Fuse replacement Technical Service Accessories/Spare parts Accessories Mains power cord Equipotential bonding lead

3 4 4 4 4 4 4 5 5

9.1.3 9.1.4 9.1.5 10. 10.1 11. 12.

1. 5 5 5 5 6 6 6 7 8 8 8 9 9 9 10

Rinsing Compressed-air system Replacement parts Technical data Ambient conditions Disposal Distributor in the US/Contact in Canada for product information and complaints

14 14 15 15 15 15 15

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician!

DANGER

WARNING

Risk of fatal injury from electric shock! ► Do not open the product. ► Connect the product only to a grounded power supply. Risk of injury and damage to property due to improper handling of the product! This product is an accessory of a medical device. ► Follow the instructions for use of the medical device (HiLAN pneumatic motor). ► Follow the instructions for use of all products used.

► Prior to use, check that the product is in good working order. ► Observe “Notes on Electromagnetic Compatibility (EMC)“, see

10 10 10 10 11 11 11 11 12 12 13 13 14 14 14 14 14

TA022130. ► 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 electrical facilities in the room in which the device is being used conform to IEC/DIN EN norms. – When operating the product with a central compressed-air supply system, adhere to the relevant national standards (DIN EN ISO 7396-1). – When operating the product with compressed-gas cylinders, adhere to the relevant national standards (DIN EN ISO 11117). ► 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. ► Disconnect from the power supply only by pulling on the plug, never on the power cord.

3

Aesculap® HiLAN irrigation pump

2.

Product description

2.1

Scope of supply

Art. no.

Designation

GA530

HiLAN irrigation pump

GD412804

Bottle holder

TA022140

Instructions for use

TA022130

Notes on electromagnetic compatibility (EMC)

2.2

Components required for operation

■ HiLAN irrigation pump GA530 ■ Mains power cord ■ Compressed-air supply (only compressed air or nitrogen) – when using gas cylinder pressure reducer (e.g. GA099)

■ Compressed-air tubes – from the supply to the HiLAN irrigation pump (or, if applicable, to the foot control unit and to the HiLAN irrigation pump) – from the HiLAN irrigation pump to the motor ■ HiLAN pneumatic motor ■ Handpiece with tool ■ Foot control (for use with a motor without hand control) ■ Disposable tube set and silicone clips for tube set ■ Spray nozzle

2.3

Operating principle

The HiLAN irrigation pump GA530 is installed between the compressedair source and the HiLAN pneumatic motor 42. A flow switch in the irrigation pump detects the activation of the HiLAN pneumatic motor 42 and unlocks the coolant pump 11 for operation. The HiLAN irrigation pump 1 has been designed for the mains voltage range 100 V to 240 V / 50 Hz to 60 Hz. The mains voltage is transformed to safety low voltage, which powers coolant pump11. The HiLAN irrigation pump 1 performs a power-on check after switch-on with the power ON switch 3. During this time all indicator light elements (2, 6 and 8) are illuminated. Activation of the HiLAN pneumatic motor 42 during the test period will trigger an error message. Any detected error will be indicated for the user on coolant pump display 8, see Troubleshooting list. Operation of coolant pump 11 will be interlocked until the error is remedied. After successful completion of the power-on check, pump ON indicator light 6 will light up. Coolant pump display 8 indicates the selected dosage setting. The dosage setting can be changes via Decrease rate of delivery key 7 and Increase rate of delivery key 9. The delivery rate can be adjusted to 21 settings. In dosage settings 1 to 5, the HiLAN irrigation pump 1 operates in intermittent mode; in settings 6 to 21 it operates in continuous mode. At each restart, the device is set to default dosage setting 15. Coolant pump 11 only works if HiLAN pneumatic motor 42 is active. The following settings can be adjusted even when HiLAN pneumatic motor 42 is active: ■ Dosage setting ■ Switching coolant pump 11 on and off Once the HiLAN pneumatic motor 42 has been active for more than two seconds, a special drive control prevents further coolant from dripping out.

Intended use

The HiLAN irrigation pump GA530 serves exclusively for cooling or irrigating the tools of Aesculap-HiLAN pneumatic motors. For the coolant, we recommend infusion solutions up to 1000 ml, e.g. NaCl 0.9 % by B. Braun. The device meets the type B requirements according to IEC/ DIN EN 60601-1. Operation Indoors, outside of the explosion-hazard area. Set-up location Table, equipment cart or mobile stand in the non-sterile area. Type and fields of application The scope of application depends on the motor, handpiece and tool being used and is specified in the corresponding instructions for use.

4

2.4

3.

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, – the national regulations on fire and explosion protection, – national legal regulations pertaining to compressed air supply, – Instructions for use according to IEC/DIN EN regulations.

Note For the safety of patients and users it is essential that the mains power cord and, especially, the protective earth connection are intact. In many cases defective or missing protective earth connections are not registered immediately.

3.3

Operating pressure

6-10 bar

► Connect the device via the potential equalization terminal at the rear

Maximum allowable operating pressure

10 bar

Maximum allowable backup pressure in exit air conduit while motor is operating (with exit air recycling)

0.7 bar

panel of the device to the potential equalization system of the room used for medical purposes. Note The potential equalization lead can be ordered from the manufacturer as art. no. GK535 (4 m length) or TA008205 (0.8 m length). The foot control circuit for the compressed air is ignition-safe and approved for operation in medical environments acc. to IEC/DIN EN.

DANGER

DANGER

CAUTION

3.1

Danger of fire and explosion when operating devices powered by oxygen! ► HiLAN pneumatic motor must only be operated with compressed air or nitrogen. Damage to the HiLAN irrigation pump and the HiLAN pneumatic motor caused by operating pressure in excess of 10 bar! ► Set an operating pressure of between 6 bar and 10 bar.

First use

WARNING

3.2

Fire and explosion hazard! ► Do not operate the device in explosion-hazard areas.

Operation with central gas supply according to DIN EN ISO 7396-1

The gas supply must provide clean, dry air and must be set as follows:

3.4

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 reduced to operating pressure of 6-10 bar through a pressure reducer (e.g. GA099)

4.

Working with the HiLAN irrigation pump GA530

4.1

System set-up

WARNING

Risk of injury and/or product malfunction due to incorrect operation of the electromedical system! ► Adhere to the instructions for use of any medical device.

Stacking of units

Note The device can be mounted on a Aesculap mobile stand for surgical devices GD416M.

WARNING

Risk of infection and contamination! ► Carry out sterile processing of the compressedair tube, motor, handpiece and tools according to the instructions for use prior to putting them into operation. ► Make certain that the packaging of sterile products is undamaged. Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. Injury to the operator and damage to the device components can result from accidentally putting the HiLAN pneumatic motor into operation! ► Follow the instructions for use of the HiLAN pneumatic motor.

Note Do not stack other devices on top of the device. ► Assembly/disassembly on mobile stands according to the instructions

for use of the mobile stand. ► Make certain the device is set up on a sufficiently stable support (table, equipment cart). ► Ensure that the console is set up in a stable position. 5

Aesculap® HiLAN irrigation pump

CAUTION

4.1.1

Lack of performance of the HiLAN pneumatic motor/bursting of damaged compressed-air hoses! ► Lay compressed-air hoses only through unobstructed areas. ► Do not squeeze or block open hose ends or diffusers. ► Do not coil up compressed-air tubes to tightly (minimum coil diameter 20cm). ► Do not kink, squeeze or clamp compressed-air hoses. ► Verify that the compressed-air hoses are not damaged (e.g. by scalpels) or loaded with sharp objects (e.g. cloth clips).

Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device.

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. All configurations must meet the basic standard IEC/DIN EN 60601-1. The person connecting the devices is responsible for the configuration and must ensure that the basic standard IEC/DIN EN 60601-1 or the corresponding national standards are met. ► Please contact your B. Braun/Aesculap partner or Aesculap Technical Service (address: see Technical Service) with any inquiries in this respect. Connecting the power supply

DANGER

Risk of fatal injury from electric shock! ► Connect the product only to a grounded power supply.

The mains voltage must correspond to the voltage indicated on the type plate at the back of the unit. ► Plug in the mains power cord at device socket 16. ► Connect power supply by inserting into a wall socket.

6

Connecting the compressed-air supply

Note When using a HiLAN pneumatic motor without hand control, foot control GA521 must be connected between the HiLAN irrigation pump and the compressed-air source! ► Make certain that the requirements concerning the central gas supply

or the compressed-gas cylinder are fulfilled, see Preparation and setup. ► Keep to the possible combinations of motor, compressed-air supply

and hose variants (see foldout pages) and choose the appropriate combination. 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 the tubes are not kinked or squeezed in.

Connecting the accessories

DANGER

4.1.2

4.1.3

Connecting the HiLAN irrigation pump to the compressed-air supply for use with a foot control Connecting the HiLAN irrigation pump to foot control GA521 Coupling: ► Pull back sleeve (coupling-side) 24 on connecting tube 22 and connect fast-lock coupling 23 to plug 18 on the rear panel of the HiLAN irrigation pump 1. ► Release sleeve (coupling-side) 24. ► Pull at coupling 25 to check for correct coupling. ► Insert plug 26 of connecting tube 22 in socket at foot control 28 so that it fully engages. Uncoupling: ► Pull back sleeve (coupling-side) 24 on connecting tube 22 and remove fast-lock coupling 23 from plug 18 of the HiLAN irrigation pump 1. ► Pull back sleeve (plug-side) 27 on plug 26 of the connecting tube 22 and remove plug 26 from the socket on the foot control 28. Connecting the foot control to the compressed-air supply Aesculap-Dräger system Coupling: ► Pull back sleeve (coupling-side) 24 on the connecting tube (to the compressed-air source) 31 and connect fast-lock coupling 23 to the foot control plug 29. ► Release sleeve (coupling-side) 24. ► Pull at coupling 25 to check for correct coupling. ► Insert plug 26 of the connecting tube (to the compressed-air source) 31 into Aesculap-Dräger socket 34, until it engages.

Uncoupling: ► Pull back sleeve (plug-side) 27 of the connecting tube (to the com-

pressed-air source 31 and remove plug 26 from the Aesculap-Dräger socket 34. ► Pull back sleeve (coupling-side) 24 on the connecting tube (to the compressed-air source) 31 and remove fast-lock coupling 23 from the foot control plug 29. DIN or Schrader connection Coupling: ► Pull back sleeve (coupling-side) 24 on the connecting tube (to the compressed-air source) 31 and connect fast-lock coupling 23 to the foot control plug 29. ► Release sleeve (coupling-side) 24. ► Pull at coupling 25 to check for correct coupling. ► Insert DIN connector 32 or Schrader connector 33 of the connecting tube (to the compressed-air source) 31 into DIN socket 35 or Schrader socket 36, until it engages. Uncoupling: ► Pull back the sleeve on the DIN socket 35 or Schrader socket 36 and remove the DIN connector 32 or Schrader connector 33 of the connecting tube (to the compressed-air source) 31 from the DIN socket 35 or Schrader socket 36. ► Pull back sleeve (coupling-side) 24 on the connecting tube (to the compressed-air source) 31 and remove fast-lock coupling 23 from the foot control plug 29. Connecting the HiLAN irrigation pump to the compressed-air supply when using a HiLAN pneumatic motor with hand control Connecting the connecting tube (to the compressed-air source) to the HiLAN irrigation pump Coupling: ► Pull back sleeve (coupling-side) 24 on connecting tube (to the compressed-air source) 31 and connect fast-lock coupling 23 to plug 18 of the HiLAN irrigation pump 1 (on the rear panel). ► Release sleeve (coupling-side) 24. ► Pull at coupling 25 to check for correct coupling. Uncoupling: ► Pull back sleeve (coupling-side) 24 on connecting tube (to the compressed-air source) 31 and remove fast-lock coupling 23 from plug 18 of the HiLAN irrigation pump 1.

Connecting the connecting tube (to the compressed-air source) at the compressed-air source Aesculap-Dräger system Coupling: ► Insert plug 26 of the connecting tube (to the compressed-air source) 31 into Aesculap-Dräger socket 34, until it engages. Uncoupling: ► Pull back sleeve (plug-side) 27 on the connecting tube (to the compressed-air source) 31 and remove plug 26 from the Aesculap-Dräger socket 34. DIN or Schrader connection Coupling: ► Insert DIN connector 32 or Schrader connector 33 of the connecting tube (to the compressed-air source) 31 into DIN socket 35 or Schrader socket 36, until it engages. Uncoupling: ► Pull back the sleeve on the DIN socket 35 or Schrader socket 36 and remove the DIN connector 32 or Schrader connector 33 of the connecting tube (to the compressed-air source) 31 from the DIN socket 35 or Schrader socket 36. 4.1.4

Connecting the HiLAN pneumatic motor

Note The HiLAN pneumatic motor and the motor tube are sterile! Sterile separation takes place at the motor tube. Coupling: ► Pull back sleeve (motor-side) 39 on the motor tube 37 and connect fast-lock coupling (motor-side) 40 to the tube connection 41 on the HiLAN pneumatic motor 42. ► Release sleeve (motor-side) 39. ► Pull at coupling 38 to check for correct coupling. ► Insert plug 26 of motor tube 37 in socket 5 on the front panel of the HiLAN irrigation pump 1 so that it fully engages. Uncoupling: ► Pull back sleeve (motor-side) 39 on the motor tube 37 and remove fast-lock coupling (motor-side) 40 from the HiLAN pneumatic motor 42. ► Pull back sleeve (plug-side) 27 on plug 26 of the motor tube 37 and remove plug 26 from the socket 5 on the front panel of the HiLAN irrigation pump 1.

7

Aesculap® HiLAN irrigation pump

4.1.5

Connecting the tube set

Note The tube set is sterile! Sterile separation is carried out on the tube set.

WARNING

Risk of injury to the user by crushing a finger in the pump housing while the coolant pump is active! ► Insert the tubing only with the coolant pump deactivated. ► Close the pump housing.

► Insert bottle holder 12 into the bottle holder mount 13. ► To open coolant pump11: Simultaneously press release buttons 10. ► Insert tube set: Insert the pump tube with the tube nipple into the

recess B, see Fig. 1. ► Close coolant pump 11: Push together the pump housing until it clicks

into position (arrows A). When doing so, ensure that the pump housing is completely closed, both at the inlet (from the irrigation bottle) and at the outlet (to the handpiece). ► Insert the punching spike into the sterile fluid bottle. ► Mount the sterile fluid bottle at bottle holder 12. ► Fixate the tube set with silicone clips GA526P to the compressed-air tube in accordance with the instructions for use of the tube set. 11 A

10

10

B

B

A

Fig. 1 Legend A Pump housing B Recesses 10 Release buttons 11 Coolant pump 4.1.6

Activating/deactivating the HiLAN irrigation pump

► Switch on HiLAN irrigation pump 1 with the power ON switch 3.

Power ON indicator light 2 will be illuminated. HiLAN irrigation pump 1 performs a power-on check every time after switch-on. During this self-test, all indicator elements will light up. 8

Any detected error will be indicated for the user on coolant pump display 8, see Troubleshooting list. ► Switch off HiLAN irrigation pump 1 with the power OFF switch 4. Power ON indicator light 2 goes off.

4.2

Function checks

► Prior to each use, check that the entire unit is in good working order. ► verify that

– all components to be used function properly and are properly connected. – the parameters and operation are carried out in accordance with the instructions for use and safety information for all components used. ► Carry out a functional check of the components/accessories according to the corresponding instructions for use. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Switch on the device. ► Irrigation pump performs a power-on check after switch-on. During this time all indicator elements (2, 6 and 8) must be fully illuminated. ► HiLAN pneumatic motor is then to be activated. The coolant pump is started. Once the motor was active for more than two seconds, a special drive control prevents further coolant from dripping out.

4.3

Safe operation

WARNING

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Note HiLAN irrigation pump 1 is unsterile! HiLAN irrigation pump 1 is operated in the unsterile area!

5.

Validated reprocessing procedure

5.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

Note After an operation, HiLAN irrigation pump 1 must be separated from the compressed-air by uncoupling the compressed-air tube at source!

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 Coolant pump 11 only works if HiLAN pneumatic motor 42 is running. Once the HiLAN pneumatic motor 42has been active for more than two seconds, a special drive control prevents further coolant from dripping out.

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

Selecting the dosage setting or delivery rate of the coolant pump Note The delivery rate can be adjusted while HiLAN pneumatic motor 42 is running. The delivery rate can be adjusted to 21 settings. In dosage settings 1 to 5, the pump operates in intermittent mode; in settings 6 to 21 it operates in continuous mode. ► To increase the delivery rate: Press Increase delivery rate key 9. ► To reduce the delivery rate: Press Decrease delivery rate key 7.

Switching the coolant pump on and off

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.

Note Coolant pump 11 can be switched on and off while HiLAN pneumatic motor 42 is running or connected. To switch off coolant pump 11: ► Simultaneously press Increase delivery rate key 9 and Decrease delivery rate key 7 for 1 second. Pump ON indicator light 6 goes off. To switch on coolant pump 11: ► Simultaneously press Increase delivery rate key 9 and Decrease delivery rate key 7 for 1 second. Pump ON indicator light 6 will be illuminated.

9

Aesculap® HiLAN irrigation pump

5.2

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.

5.3

Dismantling prior to carrying out the reprocessing procedure

► Disconnect the product from mains power supply immediately after

use. ► Remove the components/accessories after use according to the instructions.

10

5.4

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.

5.5

Cleaning/disinfection

5.5.1

Product-specific safety instructions for the reprocessing procedure

DANGER

Risk of electric shock and fire hazard! ► Unplug the device before cleaning. ► Do not use flammable or explosive cleaning or disinfecting solutions. ► Ensure that no fluids will penetrate the product.

CAUTION

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.

5.5.2

Validated cleaning and disinfection procedure

Validated procedure

Special features

Reference

Wipe disinfection for electrical devices without sterilization

■ Keep coolant pump open for cleaning. Close after cleaning.

Chapter Wipe disinfection for electrical devices without sterilization

5.6

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:

Room temperature

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).

5.7

Inspection, maintenance and checks

► Inspect the product after each cleaning and disinfecting cycle to be

sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged.

6.

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.

11

Aesculap® HiLAN irrigation pump

7.

Troubleshooting list

7.1

Malfunctions with error display

When an error condition is detected, this is indicated to the user by flashing display 8 on coolant pump 11. The display will keep flashing until the respective error condition is resolved. Operation of coolant pump 11 will be interlocked until the error is remedied. If the malfunction cannot be remedied as described below: Have the product repaired by the Aesculap Technical Service, see Technical Service. Malfunction

Cause

Remedy

Error 1

Continuous actuation of a key: Key has been pressed for longer than 7 seconds

Press key for no longer than 7 seconds

Error 2

"Air flow" at power-on: HiLAN pneumatic motor activated during power-on check (automatic self-test)

Release foot control pedal or hand lever of he motor

Flow switch defective

Have the product repaired by the Aesculap Technical Service, see Technical Service

Error 3

Monitoring of the internal supply voltage Error 24 V supply

Switch off the device and switch it on again If the error reoccurs, have the product repaired by the Aesculap Technical Service, see Technical Service

Error 4

Error current output stage

Switch off the device and switch it on again If the error reoccurs, have the product repaired by the Aesculap Technical Service, see Technical Service

Error 5

Coolant pump blocked

Check position of the tubing

Error 6

Coolant pump cannot be powered

Switch off the device and switch it on again If the error reoccurs, have the product repaired by the Aesculap Technical Service, see Technical Service

Error 7

Internal error

Switch off the device and switch it on again If the error reoccurs, have the product repaired by the Aesculap Technical Service, see Technical Service

12

Display/Light-strip indicator

7.2

Other malfunctions

Malfunction

Detection

No coolant

Device not connected to mains Device not powered power or not switched on Power ON indicator light 2 not illuminated

Connect device to mains power and switch it on

Power ON indicator light 2 not illu- Fuses blown minated

Replace fuses, see Fuse replacement

Pump ON indicator light 6 not illu- Coolant pump 11 deactivated minated

Activate coolant pump: Simultaneously press Decrease delivery rate key 7 and Increase delivery rate key 9

HiLAN pneumatic motor not running

Tube coupling not coupled correctly

Couple tube couplings correctly (coolant pump 11 only works if the HiLAN pneumatic motor is running)

Coolant pump 11 not closed correctly

Tubing inserted incorrectly

Fully close coolant pump 11, see Connecting the tube set

Irrigation tube not coupled to spray nozzle

–

Couple irrigation tube to spray nozzle

Coolant pump 11 running

Spray nozzle/irrigation tube blocked

Replace spray nozzle/tube set

Tube set blocked/defective

Sterile fluid bottle not vented prop- Use new tube set or vent bottle erly properly

Irrigation tube kinked or squeezed

–

Unkink or free irrigation tube

Pump housing not closed correctly at input (from irrigation bottle) or output (to handpiece) side

Coolant pump 11 not closed correctly

Fully close coolant pump 11, see Connecting the tube set

No coolant or insufficient coolant at spray nozzle

Coolant flowing continuously

7.3

Cause

Remedy

Fuse replacement Risk of fatal injury from electric shock! ► Unplug the device before changing the fuses!

DANGER Specified fuses: 2 x IEC 127 - T 2,5 A breaking capacity H (1 500 A) ► Use a small screwdriver to release the clip on the fuse holder 15. ► Remove fuse holder 15. ► Replace both fuses. ► Reinsert fuse holder 15 so that it audibly snaps into place. Note If the fuses burn out frequently, the device is faulty and should be repaired, see Technical Service.

13

Aesculap® HiLAN irrigation pump

8.

Technical Service

9.1.3

Rinsing

Art. no.

Designation

GA391SU

Disposable tube set for power system sterile

GA526P

Silicon clips for tube set for GA523R

► For service and repairs, please contact your national B. Braun/

GB550SU

Hi-Line single-use spray nozzle I

Aesculapagency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses.

GB551SU

Hi-Line single-use spray nozzle II

GB552SU

Hi-Line single-use spray nozzle III

Service addresses

GB767SU

Hi-Line XS single-use spray nozzle for GB740R

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.

GB761SU

Hi-Line XS single-use spray nozzle I

GB762SU

Hi-Line XS single-use spray nozzle II

GB763SU

Hi-Line XS single-use spray nozzle III

GB764SU

Hi-Line XS single-use spray nozzle XL-I

GB765SU

Hi-Line XS single-use spray nozzle XL-II

GB766SU

Hi-Line XS single-use spray nozzle XL-III

GD412804

Bottle holder

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

9.

Accessories/Spare parts

9.1

Accessories

9.1.1

Approvals

Color

Compressed-air system

Art. no.

Designation

GA521

Foot control for HiLAN pneumatic motor

GA523R

Motor tube system Aesculap-Dräger (2.3 m)

GA513R

Motor tube system Aesculap-Dräger (3 m)

GA505R

Motor tube system Aesculap-Dräger (5 m)

GA464R

Compressed-air tube system Aesculap-Dräger (3 m)

GA466R

Compressed-air tube system Aesculap-Dräger (5 m)

GA194R

Extension tube system Aesculap-Dräger (3 m)

Length (in m)

GA195R

Extension tube system Aesculap-Dräger (5 m)

GA461R

Compressed-air tube system DIN with diffuser (3 m)

Mains power cord

Art. no.

9.1.4

TE780

Europe

black

1.5

GA463R

Compressed-air tube, system DIN (3 m)

TE730

Europe

black

5.0

GA465R

Compressed-air tube, system DIN (5 m)

TE734

Great Britain

black

5.0

GA087

Extension tube, system DIN (5 m)

TE735

USA, Canada, Japan

gray

3.5

GA468R

Compressed-air tube system Schrader with diffuser (5 m)

9.1.2

Equipotential bonding lead

GA099

Pressure reducer with fast-lock coupling

Art. no.

Designation

GK535

Equipotential bonding lead 4.0 m

TA008205

Equipotential bonding lead 0.8 m

14

9.1.5

10.1 Ambient conditions

Replacement parts

Art. no.

Designation

Operation

TA020005 Miniature fuse links T 2.5 A

Temperature

10. Technical data

Relative humidity

Storage and transport

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

Designation.

Class

GA530

HiLAN irrigation pump 100–240 V

IIa

Atmospheric pressure

GA530 Mains voltage ranges (Current intake)

100 V~–120 V~ (0.2 A–0.15 A) 220V~–240 V~ (0.14 A–0.12 A)

Frequency

50-60 Hz

Safety rating (in accordance with IEC/DIN EN 60601-1)

I

Device protection

T 2.5 A

Breaking capacity

H (1 500 A at 250 V/50 Hz)

Delivery rate of cooling pump (at maximum dosage setting)

100 ml/min (±25 %)

Allowable pressure medium (compressed-air connection)

Compressed air Nitrogen

Max. operating pressure

10 bar

Max. permissible backup in the exit air

0.7 bar

Switching point

approx. 70 to 80 norm-liters/min

Weight

5.8 kg

Dimensions (L x W x H)

305 mm x 305 mm x 125 mm

Applied part

Type B

EMC

IEC/DIN EN 60601-1-2

Conforming to standard

IEC/DIN EN 60601-1

11. Disposal Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. Adhere to national regulations when disposing of or recycling the product, its components and its packaging! The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a free-of-charge service. ► Detailed information concerning the disposal of the product is avail-

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

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

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. 022140 Änd.-Nr. 48875

05/14

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