HiLAN pneumatic trepan motor GA742R

1.

Applicable to

Compressed-air tubes

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

compatibility, see also www.extranet.bbraun.com

2.

the

Aesculap

Extranet

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 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.

3.

Product description

3.1

Scope of supply

Art. no.

Aesculap-Dräger system GA464R

3m

GA466R

5m

GA194R

Extension tube 3 m

GA195R

Extension tube 5 m

DIN connection GA461R

3 m, with diffuser

GA463R

3 m, without diffuser

GA465R

5 m, without diffuser

GA087

Extension tube 5 m

Motor tubes GA513R

3m

GA523R

2.3 m

GA505R

5m

GA194R

Extension tube 3 m

GA195R

Extension tube 5 m

3.3 Art. no.

Designation

GA742R

HiLAN pneumatic trepan motor

GB600820

STERILIT adapter

3.2

Components required for operation

Art. no.

Designation

–

Compressed-air supply with a minimum of 6 bar (0.6 MPa)

e.g., GA099

For compressed air supply from compressed air cylinders: Pressure reducer

GA521

Foot control

–

HiLAN pneumatic trepan motor

Designation

at

Intended use

The HiLAN pneumatic trepan motor is used as a drive unit for trepanning tools in neurosurgery.

3.4

Operating principle

3.4.1

HiLAN pneumatic trepan motor

The HiLAN pneumatic trepan motor converts the energy induced by the compressed-air supply into rotary movement. Only cranial perforators with a HUDSON coupling can be coupled to this device. The HiLAN pneumatic trepan motor is controlled via the foot control. The rotary speed of the HiLAN pneumatic trepan motor can be continuously adjusted between "ZERO" and "MAXIMAL" by applying more or less pressure on the control pedal. Note The operator is responsible for the compatibility and proper, safe use of the tools used with this applied part.

3

Aesculap® HiLAN HiLAN pneumatic trepan motor GA742R

3.4.2

Compressed-air tubes

4.1.1

Operation with central gas supply according to DIN 13260 and EN 737

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 motor.

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

8 bar

3.4.3

Maximum allowable operating pressure

10 bar

Minimum operating pressure

6 bar

Minimum gas-supply delivery

300 l/min

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. 3.4.4

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. In this way the HiLAN pneumatic trepan motor is stopped 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 – national regulations for installation and operation, – national regulations on fire and explosion protection. ► Prior to using the HiLAN pneumatic trepan motor and its accessories, check the motor and its accessories for visible damage. ► Use the HiLAN pneumatic trepan motor and its accessories only if they are in perfect condition.

4.1

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 trepan motor

5.1

System set-up

WARNING

Compressed-air supply

DANGER

CAUTION

4

4.1.2

Danger of fire and explosion when operating devices that run on oxygen! ► Do not operate the HiLAN pneumatic trepan motor with oxygen under any circumstances. ► Operate the HiLAN pneumatic trepan motor with compressed air or nitrogen. Damage to the HiLAN pneumatic trepan motor caused by operating pressure in excess of 10 bar! ► Set an operating pressure of between 6 bar and 10 bar.

Risk of injury and material damage caused by inadvertent activation of the motor! ► To avoid injuries caused by inadvertent starting of the motor, never connect the compressed-air tube directly to a compressed-air source without the foot control installed between the supply and the motor.

WARNING

Risk of infection and contamination! The HiLAN pneumatic trepan motor and its accessories are supplied in unsterile condition. ► Carry out sterile processing of the HiLAN pneumatic trepan motor and its accessories prior to putting them into operation.

DANGER

Risk of injury caused by inadvertent activation of the motor! ► Disconnect the HiLAN pneumatic trepan motor from the motor tube before carrying out any tool change.

5.2

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.

5.3

Connecting the HiLAN pneumatic trepan motor to the compressed-air supply

Long tubes may cause a backup of the exhaust air and may thus result in lower power of the HiLAN pneumatic trepan 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 Preparation. Note The HiLAN pneumatic trepan motor and the motor tube are sterile. Sterile separation takes place at the motor tube. 5.3.1

Connecting the HiLAN pneumatic trepan motor to the foot control

Coupling: ► Pull back unlocking sleeve 6 on the motor tube 8 and connect motor

tube with fast-lock coupling 5 to the compressed-air connector 4 on the HiLAN pneumatic trepan motor 3. ► Release unlocking sleeve 6. ► Insert plug 9 of motor tube 8 in socket 16 of the foot control so that it fully engages. Uncoupling: ► Pull back unlocking sleeve 6 at motor tube 8. ► Pull off fast-lock coupling 5 from HiLAN pneumatic trepan motor 3. ► Pull back unlocking sleeve 10 on plug 9 of motor tube 8. ► Pull out plug 9 from socket 16 of the foot control.

5.3.2

Connecting the foot control to the compressed air supply

Aesculap-Dräger system Coupling: ► Pull back unlocking sleeve 12 on connecting tube 14 and connect tube with fast-lock coupling 11 to plug 17 on the foot control. ► Release unlocking sleeve 12. ► Insert plug 9 of connecting tube 14 in Aesculap-Dräger socket 15 so that it fully engages. Uncoupling: ► Pull back unlocking sleeve 12 at connecting tube 14. ► Pull off fast-lock coupling 11 from foot control plug 17. ► Pull back unlocking sleeve 10 on plug 9 of connecting tube 14. ► Pull out plug 9 from Aesculap-Dräger socket 15. DIN connection Coupling: ► Pull back unlocking sleeve 12 on connecting tube 14 and connect tube

with fast-lock coupling 11 to plug 17 on the foot control. ► Release unlocking sleeve 12. ► Insert DIN connector 19 of connecting tube 14 in DIN socket 21 so

that it fully engages. Uncoupling: ► Pull back unlocking sleeve 12 at connecting tube 14. ► Pull off fast-lock coupling 11 from foot control plug 17. ► Pull back unlocking sleeve 22 on DIN socket 21. ► Pull out DIN connector 19 from DIN socket 21.

5

Aesculap® HiLAN HiLAN pneumatic trepan motor GA742R

5.3.3

Coupling a cranial perforator with HUDSON coupling to the HiLAN pneumatic trepan motor

WARNING

CAUTION

Risk of injury and material damage due to inappropriate use of the cranial perforators! ► Follow the instructions for use of the cranial perforators. Damage to the HiLAN pneumatic trepan motor and/or the cranial perforators! ► Couple/uncouple cranial perforators only with the motor inactive.

5.4

Function checks

► Always perform a dry run of the pneumatic motor system (HiLAN pneu-

matic trepan motor, foot control, tubes) prior to use. ► Make certain the HiLAN pneumatic trepan motor and the foot control

function properly. ► Make certain that all tubes are properly connected and free of leaks. ► Check that the cutting edges of the skull trepan are not showing any

mechanical damage. Test run ► Ensure that the perforator A is seated securely in the tool coupling C. ► Briefly run the trepan motor at maximum speed. Check for proper and

reliable functioning.

WARNING

5.5

Risk of burns to the patient, caused by blunt perforators or lack/inadequacy of maintenance of handpieces! ► Prior to each use and before clamping in place, check the perforator for any wear or damage.

Safe operation

Fig. 1

Risk of injury caused by inadvertent activation of the HiLAN pneumatic trepan motor! ► Always secure the HiLAN pneumatic trepan motor against inadvertent activation when it is not in active use. ► After use, disconnect the motor tube from the HiLAN pneumatic trepan motor.

Legend A Cranial perforator (ready for operation) B Tool shaft C Tool coupling 2 Unlocking sleeve 3 HiLAN pneumatic trepan motor

DANGER

Coupling the cranial perforator

WARNING

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

WARNING

Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

► Pull and hold back uncoupling sleeve 2. ► Insert tool shaft B into tool holder of the HiLAN pneumatic trepan

motor 3 as far as it will go. ► Release unlocking sleeve 2. ► Pull at cranial perforator A to check for secure seating. Uncoupling the cranial perforator ► Pull and hold back uncoupling sleeve 2. ► Remove cranial perforator A. ► Release unlocking sleeve 2.

6

► Press the foot control to set the speed of HiLAN pneumatic trepan

motor 3.

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.

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.

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.

6.3

Note If there is no final sterilization, then a virucidal disinfectant must be used.

6.4

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.

damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

6.2

General information

Dismantling prior to carrying out the reprocessing procedure

► Disassemble the product immediately after use, as described in the

respective instructions for use.

Preparations at the place of use

► Remove any visible surgical residues to the extent possible with a

6.5

Preparation before cleaning

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

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.

7

Aesculap® HiLAN HiLAN pneumatic trepan motor GA742R

6.6

Cleaning/disinfection

6.6.1

Product-specific safety instructions for the reprocessing procedure

CAUTION

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 high-grade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 60 °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.

6.6.2

Validated cleaning and disinfection procedure

Validated procedure

Special features

Manual cleaning and wipe disinfection

■ When cleaning instruments with movable hinges, ensure that these

■ HiLAN pneumatic trepan motor

Reference

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 or compressed air for medical purposes

■ 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

■ HiLAN pneumatic trepan motor

8

■ Insert the product in its proper position in the Eccos holder GB609R.

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

6.7

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.

6.7.1

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

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

compressed air), see Validated cleaning and disinfection procedure. 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.

9

Aesculap® HiLAN HiLAN pneumatic trepan motor GA742R

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. 6.8.1

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.

6.9

► Follow the instructions for use for the applied packaging and storage

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 the HiLAN pneumatic trepan motor with Aesculap-STERILIT oil

spray GB600 with adapter GB600820 for approx. 1 second. ► Check the product for any damage, abnormal running noise, overheat-

ing or excessive vibration. ► Inspect tools for broken, damaged or blunt edges. ► Set aside the product if it is damaged.

10

6.10 Packaging 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. ► 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

7.

Note The foot control must not be sterilized.

To ensure reliable operation, the product must be maintained as indicated on the maintenance label. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

Note The product may only be sterilized when dismantled.

Maintenance

► 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.

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

*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.

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

a dry, dark, temperature-controlled area.

11

Aesculap® HiLAN HiLAN pneumatic trepan motor GA742R

8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Motor not running

No compressed air

Gas cylinder empty Manometer set to "0"

Change cylinder

No compressed air at the wall outlet

Open valve

Motor tube/connecting tube not connected correctly

Fully connect the fast-lock coupling

Pedal movement too light or pedal not moving

Foot control defective

Have product repaired by the manufacturer

Insufficient air supply

Operating pressure too low (at least 6 bar)

Have compressed-air supply checked

Pressure reducer on gas cylinder defective

Have pressure reducer checked

Operating pressure setting at pressure reducer too low

Adjust to higher operating pressure setting

Connecting tube too long

Use shorter connecting tube

Connecting tube excessively buckled or crushed

Free the connecting tube

Exit-air ducting

Unblock diffuser/exit air channel

HiLAN pneumatic trepan motor defective

Have product repaired by the manufacturer

Insufficient power

Strong air resistance in connecting tube

Motor not running despite correct air supply HiLAN pneumatic trepan motor overheating HiLAN pneumatic trepan motor running jerkily

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

12

Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Or in the US: Aesculap Inc. 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

11. Technical data

Art. no.

Designation

Classification acc. to Directive 93/42/EEC

GA521

Foot control (accelerator pedal)

Art. no.

Designation

Class

GB459R

Eccos mounting set for holders

GA742R

HiLAN pneumatic trepan motor

IIa

GB564R

Eccos holder for motor tube

GB609R

Eccos holder for trepan motor

GB600

Aesculap STERILIT oil spray

GB600820

STERILIT adapter

JF213R

Tray (64 mm)

JK431

Container

Compressed-air tubes Art. no.

Designation

Nominal operating pressure

8 bar ± 2 bar

Max. operating pressure

10 bar

Air consumption

approx. 300 l/min

Max. permissible backup in the exit air

0.4 bar to 0.6 bar

Torque

>3 Nm

Weight

495 g

Size

∅ 39 mm x 130 mm

Aesculap-Dräger system GA464R

3m

GA466R

5m

GA194R

Extension tube 3 m

GA195R

Extension tube 5 m

DIN connection

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-

GA461R

3 m, with diffuser

GA463R

3 m, without diffuser

GA465R

5 m, without diffuser

GA087

Extension tube 5 m

Motor tubes GA513R

3m

GA523R

2.3 m

GA505R

5m

GA194R

Extension tube 3 m

GA195R

Extension tube 5 m

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

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

13