Instructions for Use - bucmedi.com Maintenance Unit. For Electric Pen.pdfFor EPD and APD Instructions for Use Introduction Intended use The Maintenance Unit 05.001.099 is an electrically-

Instructions for Use

Maintenance Unit. For Electric PenDrive and Air Pen Drive.

Synthes 1

Table of Contents

Introduction

The Lubrication Process

Care and Maintenance

Troubleshooting

Explanation of Symbols Used

System Specifications

Ordering Information

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2 Synthes Maintenance Unit. For EPD and APD Instructions for Use

Introduction

Intended useThe Maintenance Unit 05.001.099 is an electrically- andcompressed air powered device for maintaining hand piecesand attachments for Electric Pen Drive and Air Pen Drive.Only use Synthes accessories to guarantee optimal functionof the Maintenance Unit and to guarantee operational reliability of the Electric Pen Drive and the Air Pen Drive.

Location of deviceThe Synthes Maintenance Unit is only permitted for storageand operation outside the operating theatre. It must notbe allowed to come into direct or indirect contact with thepatient.

Warning: The Synthes Maintenance Unit may not be storedor operated in an explosive atmosphere.

Disposal of wasteAccording to WEEE 2002/96/EC the Maintenance Unit maynot be disposed in the normal waste, but must be sent backto Synthes for recycling.

WarrantyThe manufacturer assumes no warranty for damages arisingfrom improper use or unauthorized servicing.

Only use Synthes Special Oil, for EPD and APD, 05.001.095.Other oils can have a toxic effect and can lead to sticking.In this case warranty claims are invalid.

Only use original products from Synthes intended for use together with the Maintenance Unit. Damage that arisesfrom using attachments and tools of other manufacturers isnot covered by the warranty.

Scope of deliveryWhen ordering the Maintenance Unit (05.001.099) it will bedelivered ready to use, including the unit itself, pneumaticconnection, power supply, country specific power cord aswell as oil and filter.

General Information

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1Installation

Install the provided Power Supply in the power supply con-nection, then connect the country specific Power Cord to thePower Supply and to a plug socket.

First, applying slight pressure, plug the simple end of thePneumatic Connection into the air connector on the back ofthe module; then connect the nipple for the Pneumatic Connection to the air supply.

Fill the oil tank with Synthes special oil 50 ml for EPD andAPD (05.001.095), as described in the chapter Care andMaintenance.

Note: To completly disconnect from AC mains disconnectthe power supply.

2Start the Maintenance Unit

Push the ON/OFF button on the keypad to turn on theMaintenance Unit. The POWER ON LED should stay lit up.

If the ERROR LED flashes or lights up, consult the chapterTroubleshooting.



3Connect the Electric Pen Drive handpieces(05.001.010 and 05.001.011)The connector for the handpiece is on the left. To connectthe Electric Pen Drive handpieces, open the release sleeve forattachments on the handpiece and place one of thehandpieces with the coupling for attachments pointingforward, then push the handpiece with light pressuretowards the connector fitting until the handpiece locks inplace.

Make sure that the cable for the Electric Pen Drive 90,000rpm handpiece is positioned were the opening for the lid isplaced.

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Connect the Air Pen Drive handpiece (05.001.080) To connect the Air Pen Drive handpiece, the Adapter forMaintenance Unit for Air Pen Drive (05.001.089) has to beused. Place the female side of the Adapter on the connectoron the left of the Maintenance Unit, making sure that thepins on the connector engage in the slotted link on theAdapter and then turn the Adapter clockwise. To apply thehandpiece, set the adjustment sleeve to the foot switch posi-tion. Then fit the air hose side of the handpiece to the con-nector by fitting the pins on the Adapter into the grooves inthe air hose coupling side of the handpiece and turn thehandpiece clockwise.

Caution– The Air Pen Drive must be set to foot switch position

during the lubrication process!– The Air Pen Drive has to be lubricated through the air

inlet/outlet, not through the attachment coupling!

Connect the attachmentsThe second, third and forth connector from the left can beused for attachments. To connect the attachments, carefullypush the attachment with the cone coupling pointing to-wards the connector fitting and turn the attachment coun-terclockwise to lock it in place.



Connect the Burr Attachments XL and XXL 20°To connect the Burr Attachment XL 20° (05.001.063) andXXL 20° (05.001.055) the Adapter for Maintenance Unit forBurr Attachments XL and XXL (05.001.064) has to be used.Place the male side of the Adapter on the second connectorfrom the left, making sure that the pins on the Adapter engage in the slotted link on the connector and then turnthe Adapter counterclockwise.

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5Remove the handpieces and the attachments

To remove an Electric Pen Drive handpiece, turn the releasesleeve as indicated by the arrow and remove the handpiece.

To remove the Air Pen Drive handpiece, simply turn thehandpiece anticlockwise and remove from the Adapter.When the Maintenance Unit is only used for maintaining theAir Pen Drive it is possible to keep the Adapter in the Mainte-nance Unit.

The attachments can be removed by turning them clockwisein the connector and carefully pulling them out.

After the sterilizing process the handpiece and the attach-ments will be ready to use.

4Start the lubrication process

Before starting the lubrication process the Lid must beclosed. After closing the Lid, push the START button to startthe lubrication procedure. The lubrication procedure will takeapproximately three minutes when all connectors are filled.

The READY LED will light when the lubrication loop is successfully completed.

If the ERROR LED flashes or lights up, consult the chapterTroubleshooting.

Note: Make sure the oil is filled up.


Care and Maintenance

2Change the filter

If oil can be seen in the filter in the inspection window, the filter should be changed. We recommend changing the filterevery time the oil has to be filled up.

To change the filter, open the Lid, remove the old filter andfit the new filter into the bottom of the Maintenance Unit.

The oily filter and the empty bottle of Synthes special oil,for EPD and APD, should be disposed according to nationalregulations.

Note: The Maintenance Kit 05.001.094 contains 1 bottle of Synthes Special Oil 05.001.095 and 1 spare filter.

1Fill the oil tank

If the oil tank is empty, the ERROR LED will stay lit up; oilshould then be refilled. Open the oil tank by turning thecap counterclockwise and refill only with Synthes Special Oil,50 ml, for EPD and APD, 05.001.095.

Note: Only use the provided Synthes Special Oil, for EPD andAPD, 05.001.095. Other oils can have a toxic effect and canlead to sticking. In this case warranty claims will be invali-dated.

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MaintenanceBy unscrewing the fixing bolts on both sides it is possible to remove the Lid for better cleaning. When mounting the lid again, make sure that both fixing bolts are proper insertedand tightened.

If the Maintenance Unit or the Adapters 05.001.064 and05.001.089 are contaminated, they can be wiped with acloth soaked in detergent and / or disinfectant.

Note: The Maintenance Unit may not be sterilized!Do not allow moisture to penetrate the unit.

In case of damage, please contact your Synthes representa-tive. If the Maintenance Unit has to be sent in for repair,make sure that all cables and hoses are sent in together withthe unit itself.

The manufacturer shall assume no responsibility for damageresulting from improper operation or unauthorised mainte-nance.


Troubleshooting

After pushing the start button the ERROR LED lights up.

The Maintenance Unit stops during the lubrication procedure and the ERROR LED lights up.

ERROR LED stays lit.

ERROR LED flashes.

Lubrication procedure does not start, despite pushing the start button.The POWER ON LED lights up.

The START button only works when theLid is closed.

A Burr Attachment (05.001.045–05.001.050, 05.001.063 and05.001.055) or Craniotome Attach-ment (05.001.059) is placed on theconnectors, but the release sleeve is in the unlock position. This blocksthe lubrication procedure.

The fixing bolts are not proper insertedor tightened into the housing of theMaintenance Unit.

The Lid has been opened during the lubrication procedure.

The air pressure falls (<4.5 bar) during the lubrication procedure.

The oil level is too low.

The air pressure is too low (<4.5 bar).

The Air Pen Drive is being lubricatedthrough the attachment coupling.

The Air Pen Drive is not set to the footswitch position during lubrication.

The Maintenance Unit is faulty.

No handpiece or attachment is pluggedto the Maintenance Unit or is detected.

Close the Lid and push the START button again.

Turn the release sleeve of the attach-ment (05.001.045-05.001.050,05.001.063 and 05.001.055 or05.001.059) into lock position andpush the START button again.

Insert both fixing bolts proper andtighten them.

Close the Lid and repeat the lubrication procedure.

Open the Lid, set the pressure to 5–10 bars and close the Lid.Push the START button again.

Fill up oil.

Set the air pressure to 5 – 10 bars.

The Air Pen Drive has to be lubricatedwith the Adapter for Maintenance Unit for Air Pen Drive (05.001.089) andthrough the air inlet/outlet.

Set the Air Pen Drive to the foot switchposition during lubrication.

Send the Maintenance Unit to yourSynthes Service Centre.

Reconnect the handpiece or attach-ments (entirely). Push the start buttonagain.

Problem Possible Causes Remedy

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Important information in the enclosed documents.Please read before using the device.

The product is double insulated.

Indoor use only.

Air intake.

Polarity of the supply voltage connector.

The product is UL certified.

The product is CE marked.

This is a recognised component by UL.

According to WEEE 2002/96/EC the MaintenanceUnit may not be disposed in the normal waste, but must be sent back to Synthes for recycling.

Explanation of Symbols Used

Technical data

Maintenance Unit

Weight: ~ 4700 g

Dimensions: 330 mm / 200 mm / 165 mm

Operating voltage: 24 VDC

Degree of protection: IP X0

Intake air pressure: 5–10 bar / 70–145 psi

Intake air quality: Filtered air 5 μm, unoiled

Power Supply

Weight: ~130 g (including cable)

Dimensions: 92 mm / 40 mm / 28 mm

Operating voltage: 100 VAC – 240 VAC, 50/60 Hz

Output voltage: 24 VDC

Output current: 500 mA

Degree of protection: IP X0

Caution– The Maintenance Unit may not be sterilized.– The Maintenance Unit may not be stored or operated in

an explosive atmosphere.– Do not allow moisture to penetrate the unit.

The device complies with the following standards:IEC 60601-1/60601-1-1/60601-1-2/60601-1-4IEC 61000-6-1/61000-6-2/61000-6-3/61000-6-4Medical electrical equipment

With regard to electrical shock, fire, mechanical hazards, onlyin accordance with UL 60601-1 and CAN/CSA C22.2No.601.1

Environmental conditions

Operation Transport andStorage

Temperature 10 – 40 °C –20 – 50 °C50 – 104 °F –4 – 122 °F

Relative humidity 30–75% 10–75%

Atmospheric pressure 500–1060 hPA 500–1060 hPA0.5–1.06 bar 0.5–1.06 bar

System Specifications

Ordering Information

Maintenance unit and adapters

05.001.099 Maintenance Unit, for EPD and APD (includes 05.001.094)

05.001.094 Maintenance kit with oil and filter, for EPD and APD

05.001.089 Adapter, for Maintenance Unit, for APD

05.001.064 Adapter, for Maintenance Unit, for Burr Attachment XL and XXL

Spare parts

50160469 Lid, for Maintenance Unit 05.001.099

50160470 Fixing bolt, for Maintenance Unit 05.001.099

50160473 Pneumatic connection, for Maintenance Unit 05.001.099

50160471 Oil cap, for Maintenance Unit 05.001.099

50161414 Power Supply

05.001.130 Power Cord, two-pole (AT, BE, BG, CH, CN, CZ, DE, DK, ES, FI, FR, GR, HU, ID, IT, NL, NO, PL, PR, PT, RO, RU, SE, SK, TR)

05.001.131 Power Cord, two-pole (Argentine, Brazil, Canada, Colombia, Korea, Mexico, Taiwan, USA)

05.001.132 Power Cord, two-pole (Great Britain, Ireland, Hong Kong, Malaysia, Singapore)

05.001.133 Power Cord, two-pole (Australia, New Zealand, Uruguay)

05.001.134 Power Cord, two-pole (Japan)

05.001.135 Power Cord, two-pole (India, South Africa)

Caution: The device shall only be operated with the country specific Power Cord provided by the supplier! One power cordis supplied with each unit.

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Documents

Instructions for Use - bucmedi.com Maintenance Unit. For Electric Pen.pdfFor EPD and APD Instructions for Use Introduction Intended use The Maintenance Unit 05.001.099 is an electrically-