Mobile rack GA415 and GA411

Contents 1. 2. 3. 3.1 3.2 3.3 3.4 4. 4.1 5. 5.1 5.2 5.3 6. 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 7. 8. 9. 10. 11. 12. 13.

1.

2.

Applicable to Safe handling Product description Scope of supply Components required for operation Intended use Operating principle Preparation and setup Preparation Using the mobile rack System set-up Function checks Safe operation Validated reprocessing procedure General safety instructions Single-use products Reusable products General information Dismantling prior to carrying out the reprocessing procedure Preparations at the place of use Preparation before cleaning Cleaning/disinfection Wipe disinfection for electrical devices without sterilization Inspection, maintenance and checks Maintenance Troubleshooting list Technical Service Accessories/Spare parts Technical data Disposal Distributor in the US/Contact in Canada for product information and complaints

3 3 4 4 4 4 4 5 5 5 5 8 8 9 9 9 9 9 10 10 10 10 11 11 11 11 12 12 13 13 13

Applicable to

Safe handling

CAUTION Federal law restricts this device to sale by or on order of a physician! ► 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. ► Make certain that the mobile rack does not tip when rolled over cables or uneven surfaces. Single-use products

WARNING

Risk of infection for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product.

The following products must only be used once: Designation

Art. no.

Tube set

GA391/GA391SU

Sterile sheet

GA414

These products have been radiation-/EO-/steam-sterilized and are supplied in sterile packaging. They must not be reused. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not re-sterilize the product. ► Do not use the product after its use-by date.

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

compatibility, see also www.extranet.bbraun.com

the

Aesculap

Extranet

at

3

Aesculap® Mobile rack GA415 and GA411

3.

Product description

3.1

Scope of supply

Designation

Art. no.

Mobile rack

GA415, GA411

Wrench SW 6

TA004545

Instructions for use

TA007503

3.2

Components required for operation

Operation with sterile screen and rinsing

GA415

GA411

Designation

Art. no.

Art. no.

Sterile sheet

GA414

GA414

Textile cover sheet

GA412

GA412

Foot control

GA188, ...

GD668, GD671

Control unit/motor

GA830, ...

GD670

Motor cable/flexible shaft

GA176

GD672, GD673

Tube set

GA391

GA391SU

Spray nozzles

GD460, ...

GB761SU, ...

Operation without sterile screen

GA415

GA411

Designation

Art. no.

Art. no.

Motor system

Mobile rack

Foot control

GA188, ...

GD668, GD671

Designation

Art. no.

Control unit/motor

GA830, ...

GD670

ELAN EC (e.g. GA830)

GA415

Motor cable/flexible shaft

GA176, ...

GD672, GD673

microspeed uni (e.g. GD670)

GA411

Operation with sterile screen, without rinsing

GA415

GA411

Designation

Art. no.

Art. no.

Sterile sheet

GA414

GA414

Textile cover sheet

GA412

GA412

Foot control

GA188, ...

GD668, GD671

Control unit/motor

GA830, ...

GD670

Motor cable/flexible shaft

GA176

GD672, GD673

Irrigation fluid container

For information on the accessories and possible dimensions of the baskets, see Accessories/Spare parts.

3.3

Intended use

The mobile rack is used for providing mobile availability of equipment in the operation room. It is employed with electric motors and in all branches of operative medicine. The universal design of the appliance rest allows the Aesculap surgical motor ELAN EC or the control units microspeed EC/ microspeed uni to be fastened to it.

3.4

Operating principle

The rack offers the following functions: ■ As the rack runs on wheels, it can be placed at any location ■ Its height is continuously adjustable from 130 cm to 165 cm ■ The universal attachment elements allow the safe and secure fixation of devices ■ The sterile screen/basket holder allows the sterile preparation of devices/accessories

4

4.

Preparation and setup

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

4.1

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. Assembling the mobile rack ► Insert the guide peg of the column 15 into the matching hole in the

chassis 5, making sure that the column 15 is in the right position. ► Insert the four fastening screws 27 with their washers in the underside of the chassis 5 and tighten them with the wrench SW 6. The column 15 is now mounted on the mobile rack 1. Presetting the correct voltage The mains voltage must correspond to the voltage indicated on the type plate at the back of the unit. The correct voltage for the control unit is indicated in the window located at the back of the device. The standard voltage for the unit in Europe is: 230 V. ► If the indicated voltage does not correspond to the actual mains voltage, change the setting at the rear panel of the power unit: – Unlock the fuse holder. – Pull out the voltage selection element under the fuse holder. – Reinsert the voltage switching insert so that the desired voltage is legible. – Reinsert the fuse holder.

5.

Using the mobile rack

5.1

System set-up

Mounting the device on the mobile rack Only one device may be mounted on the mobile rack at any time, always taking into consideration the stability of the mobile rack. ► Remove the caps from the stacking cones 37. ► Unscrew the feet from the device to be mounted, either by hand or by means of a screwdriver. ► Move stacking cones 37 to the correct mounting positions by turning locking screw 36 counterclockwise as far as it will go, using a screwdriver. ► Rest the device on the mobile rack 1 so that the front edge is flush with the appliance rest 18 and the stacking cones 37 sit in the holes provided in the appliance rest 18, see Fig. 1. ► Secure the device by turning locking screw 36 clockwise as far as it will go. ► Lift the device slightly in order to check if is securely connected to the appliance rest 18. The device is now mounted onto the mobile rack.

1 36 37 18

Fig. 1 Legend 1 Mobile rack 18 Appliance rest 36 Locking screw 37 Stacking cones

5

Aesculap® Mobile rack GA415 and GA411

Dismounting the device from the mobile rack

Connecting the power supply

► Use a screwdriver to turn locking screw 36 counterclockwise as far as

it will go. ► Lift off the device. ► Screw on the feet of the device, either by hand or by means of a screwdriver. Connecting the accessories

DANGER

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. Also note that any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment, IEC/DIN EN 60601-1 for electromedical devices). All configurations must comply with basic standard IEC/DIN EN 60601-1. Any individual connecting devices with one another is responsible for such configuration and must ensure compliance with basic standard IEC/DIN EN 60601-1 or applicable national standards. ► Please contact your B. Braun/Aesculap partner or Aesculap Technical Service (address: see Technical Service) with any inquiries in this respect. ► Connect the cold-appliance plug of the mains cable 17 from the mobile rack to the mains socket at the device. ► Connect the control cable plug 16 from the mobile rack to the control cable socket of the device. ► Connect the cold-appliance plug of the mains cable from the device to the mains socket 35 of the mobile rack1. ► Wind the mains cable around the cable bobbins 32. ► Insert the plug of the foot control cable into the control socket 34 at the mobile rack 1. ► Put the foot switch onto the chassis 5. ► Wind the foot control cable around the cable bobbins 32. ► For devices comprising a pump: Hang the bottle holder into the adapter at the back of the device. ► For reusable tube fittings: Connect the punching spike with the rinsing tube.

DANGER

► Connect the mains cable to the power supply. ► If necessary, connect the potential compensation line with the poten-

tial compensation pin 33 and with the potential compensation bar installed in the operating room. ► Switch on the device (observing its instructions for use). The mobile rack is operational now, if used without the sterile screen/basket holder. Sterile set-up of the mobile rack

WARNING

Risk of infection and contamination! The sterile screen, the textile cover sheet GA412, and the basket holder are delivered in an unsterile condition. ► Prior to use, sterilize the sterile screen, the textile cover sheet GA412 and the basket holder.

► Take hold of the handle 6 and lift the sterile screen 6 out of its con-

tainer. ► Fit the sterile screen 8 with the pegs 9 into the adapter sockets 29 of

the mobile rack 1. Drop latch 30 locks pegs 9. ► Pull handle 6 to make sure that sterile screen 8 is locked in position, see Fig. 2.

30

8

6

29 Fig. 2

6

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

9

12

► Turn out the arms 12 of sterile screen 8.

► Insert the basket 4 into the basket holder 19 by lifting the basket 4 at

► Fasten the sterile sheet/textile cover sheet 3 to the buttons 13 of the

its front and pushing it under the hooks 21, see Fig. 5.

sterile screen 8, see Fig. 3. 13

12

3

19

4 21

Fig. 3 ► Hang basket holder 19 with guide pegs 20 into the adapter for the

basket holder14 of sterile screen 8, see Fig. 4.

Fig. 5 ► Install the tube fittings. ► Swivel the sterile screen 8, see Fig. 6:

– Push the bolt 10 of the sterile screen 8 up through the sterile sheet 3. – Pull handle 6.

8

8

6

20

14

19

Fig. 4 10

Fig. 6

7

Aesculap® Mobile rack GA415 and GA411

► Insert the tube fittings with the groove 26 in the holding slot 11 in the

sterile screen 8, so that the rinsing tube 24 points to the device, see Fig. 7. 11

Disassembling the mobile rack Note Prior to dismounting components, decouple the motor cable/flexible shaft from the device at the plug and the motor coupling respectively. ► Unhinge the basket 4 from the basket holder 19. ► Remove the basket holder 19 with the guide pegs 20 at the adapter

for the basket holder 14 of the sterile screen 8. ► Pull off the sterile sheet/textile cover sheet 3 from the sterile screen 8.

26

► Push up the latch 10 at the sterile screen 8 and turn the sterile

8

screen 8 to one side, holding it at the handle 6. ► Remove the tube fittings from the pump and the sterile screen 8. ► Swivel back sterile screen 8 until it clicks into position. ► Lift drop latch 30 and pull sterile screen 8 out to the front, holding it at handle 6. 24

5.2 Fig. 7 The following steps are carried out by the unsterile person: ► Insert pump tube into the pump (observing the instructions for use of

the device). ► Tube set: – Remove the protective cap from the punching spike. – Insert the punching spike into the irrigation liquid container, observing sterility. ► Hang the irrigation liquid container on the bottle holder. ► Open valve. ► Remove rinsing tube 24 from the swiveling range of sterile screen 8. The following steps are carried out by the sterile person: ► Turn sterile screen 8 to its rest position and let it click into place. If

necessary, lift sterile screen 8 slightly.

Function checks

► Before using the device, always perform a test run with the complete

set-up and check its proper and reliable functioning. ► Check the height adjustment of the sterile screen 1. ► Check the fastenings of the device. ► Perform a function check on the device used.

5.3

Safe operation

WARNING

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

► Ensure that the motor cable/flexible shaft does not get into the unster-

ile area during operation. ► Turn the turning handle 31 counterclockwise, until it turns easier.

► Pull handle 6 to make sure that sterile screen 8 is locked in position.

► Move the device to the required height.

► Connect the motor cable/flexible shaft at the plug and the motor cou-

► Tighten the turning handle 31 by turning it clockwise.

pling on the device. ► Secure the supply tube on the motor cable/flexible shaft by means of clips. ► Roll mobile rack 1 to the intended place of operation, ensuring that the wheels are not jammed.

► Follow the instructions for use of the Aesculap surgical motor ELAN EC

8

and the control units microspeed EC/microspeed uni.

6.

Validated reprocessing procedure

6.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

6.2

Single-use products

WARNING

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product!

Designation

Art. no.

Tube set

GA391/ GA391SU

Sterile sheet

GA414

6.3

Reusable products

Designation

Art. no.

Motor cable, flexible shaft

GD656, GA176, ...

Textile cover sheet

GA412

6.4

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.

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Aesculap® Mobile rack GA415 and GA411

6.5

Dismantling prior to carrying out the reprocessing procedure

► Prior to cleaning, dismount all parts attached to the mobile rack, see

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.

Disassembling the mobile rack.

6.6

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.

6.7

Preparation before cleaning

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

CAUTION

6.8

Cleaning/disinfection

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.

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for plastic material and highgrade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time.

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Wipe disinfection for electrical devices without sterilization

■ Clean the surfaces of the mobile rack with a sponge or cloth moist-

Chapter Wipe disinfection for electrical devices without sterilization

10

ened with clean water, or with an alcohol solution.

■ Follow the disinfectant manufacturer’s instructions.

6.9

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

6.10 Inspection, maintenance and checks

► Remove any visible residues with a disposable disinfectant wipe.

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

► Wipe all surfaces of the optically clean product with a fresh, disposable

disinfectant wipe. ► Observe the specified application time (1 min minimum).

7.

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

Maintenance

For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service. ► Lubricate the wheels of the mobile rack.

8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

The wheels of the mobile racks are jammed

The mobile rack is rough-running

-

Have product repaired by the manufacturer

Screen cannot be coupled

-

Pegs are damaged

Have product repaired by the manufacturer

Adapter sockets on the mobile rack are damaged Screen cannot be swiveled

Latch/pegs are damaged

Screen cannot be unlocked

Latch/pegs are damaged

Screen cannot be locked in position Have product repaired by the manufacturer

Hinge has been bent Rinsing tube is trapped

Have product repaired by the manufacturer

Position the rinsing tube so that it will not be trapped

11

Aesculap® Mobile rack GA415 and GA411

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/

Aesculapagency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Or in the US: Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420 Other service addresses can be obtained from the address indicated above.

12

10. Accessories/Spare parts Art. no.

Designation

GA412

Textile cover sheet

GA414

Sterile sheet, single-use

GA391

Tube set, single-use ELAN EC

GA391SU

Tube set, single-use microspeed uni

TA020537

Potential-compensation line

GA409

Mounting

Suitable baskets Art. no.

Dimensions, in mm

JF012R

406 x 254 x 50

JF112R

243 x 253 x 56

JF212R

485 x 253 x 56

JF222R

540 x 253 x 56

JF252R

406 x 253 x 56

JF489R

254 x 257 x 50

JF499R

485 x 257 x 50

JF690R

540 x 254 x 50

JG112R

243 x 253 x 44

JG212R

485 x 253 x 44

JG222R

540 x 253 x 44

JG252R

406 x 253 x 44

11. Technical data Voltage

100–240 V

Mains frequency

50-60 Hz

Protection class (acc. to IEC/DIN EN 60601-1)

1

Max. current

6A

Weight

approx. 40 kg

Payload

max. 10 kg

Dimensions (L x W x H)

500 x 500 x 1 300 mm (1 650 mm)

12. 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.

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

13

- 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. 007503 Änd.-Nr. 50788

07/14

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