Synthes Maintenance Unit User manual

Instructions for Use
Maintenance Unit. For Electric Pen
Drive 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
2
3
8
10
11
12
13

2Synthes Maintenance Unit. For EPD and APD Instructions for Use
Introduction
Intended use
The Maintenance Unit 05.001.099 is an electrically- and
compressed air powered device for maintaining hand pieces
and attachments for Electric Pen Drive and Air Pen Drive.
Only use Synthes accessories to guarantee optimal function
of the Maintenance Unit and to guarantee operational
reliability of the Electric Pen Drive and the Air Pen Drive.
Location of device
The Synthes Maintenance Unit is only permitted for storage
and operation outside the operating theatre. It must not
be allowed to come into direct or indirect contact with the
patient.
Warning: The Synthes Maintenance Unit may not be stored
or operated in an explosive atmosphere.
Disposal of waste
According to WEEE 2002/96/EC the Maintenance Unit may
not be disposed in the normal waste, but must be sent back
to Synthes for recycling.
Warranty
The manufacturer assumes no warranty for damages arising
from 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 arises
from using attachments and tools of other manufacturers is
not covered by the warranty.
Scope of delivery
When ordering the Maintenance Unit (05.001.099) it will be
delivered ready to use, including the unit itself, pneumatic
connection, power supply, country specific power cord as
well as oil and filter.
General Information

Synthes 3
The Lubrication Process
1
Installation
Install the provided Power Supply in the power supply con-
nection, then connect the country specific Power Cord to the
Power Supply and to a plug socket.
First, applying slight pressure, plug the simple end of the
Pneumatic Connection into the air connector on the back of
the 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 and
APD (05.001.095), as described in the chapter Care and
Maintenance.
Note: To completly disconnect from AC mains disconnect
the power supply.
2
Start the Maintenance Unit
Push the ON/OFF button on the keypad to turn on the
Maintenance Unit. The POWER ON LED should stay lit up.
If the ERROR LED flashes or lights up, consult the chapter
Troubleshooting.

4Synthes Maintenance Unit. For EPD and APD Instructions for Use
The Lubrication Process
3
Connect the Electric Pen Drive handpieces
(05.001.010 and 05.001.011)
The connector for the handpiece is on the left. To connect
the Electric Pen Drive handpieces, open the release sleeve for
attachments on the handpiece and place one of the
handpieces with the coupling for attachments pointing
forward, then push the handpiece with light pressure
towards the connector fitting until the handpiece locks in
place.
Make sure that the cable for the Electric Pen Drive 90,000
rpm handpiece is positioned were the opening for the lid is
placed.

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Connect the Air Pen Drive handpiece (05.001.080)
To connect the Air Pen Drive handpiece, the Adapter for
Maintenance Unit for Air Pen Drive (05.001.089) has to be
used. Place the female side of the Adapter on the connector
on the left of the Maintenance Unit, making sure that the
pins on the connector engage in the slotted link on the
Adapter and then turn the Adapter clockwise. To apply the
handpiece, 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 in
the air hose coupling side of the handpiece and turn the
handpiece 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 attachments
The second, third and forth connector from the left can be
used for attachments. To connect the attachments, carefully
push the attachment with the cone coupling pointing to-
wards the connector fitting and turn the attachment coun-
terclockwise to lock it in place.
6Synthes Maintenance Unit. For EPD and APD Instructions for Use
The Lubrication Process
Connect the Burr Attachments XL and XXL 20°
To connect the Burr Attachment XL 20° (05.001.063) and
XXL 20° (05.001.055) the Adapter for Maintenance Unit for
Burr Attachments XL and XXL (05.001.064) has to be used.
Place the male side of the Adapter on the second connector
from the left, making sure that the pins on the Adapter
engage in the slotted link on the connector and then turn
the Adapter counterclockwise.

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5
Remove the handpieces and the attachments
To remove an Electric Pen Drive handpiece, turn the release
sleeve as indicated by the arrow and remove the handpiece.
To remove the Air Pen Drive handpiece, simply turn the
handpiece anticlockwise and remove from the Adapter.
When the Maintenance Unit is only used for maintaining the
Air Pen Drive it is possible to keep the Adapter in the Mainte-
nance Unit.
The attachments can be removed by turning them clockwise
in the connector and carefully pulling them out.
After the sterilizing process the handpiece and the attach-
ments will be ready to use.
4
Start the lubrication process
Before starting the lubrication process the Lid must be
closed. After closing the Lid, push the START button to start
the lubrication procedure. The lubrication procedure will take
approximately 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 chapter
Troubleshooting.
Note: Make sure the oil is filled up.

8Synthes Maintenance Unit. For EPD and APD Instructions for Use
Care and Maintenance
2
Change the filter
If oil can be seen in the filter in the inspection window, the
filter should be changed. We recommend changing the filter
every time the oil has to be filled up.
To change the filter, open the Lid, remove the old filter and
fit 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 national
regulations.
Note: The Maintenance Kit 05.001.094 contains 1 bottle of
Synthes Special Oil 05.001.095 and 1 spare filter.
1
Fill the oil tank
If the oil tank is empty, the ERROR LED will stay lit up; oil
should then be refilled. Open the oil tank by turning the
cap 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 and
APD, 05.001.095. Other oils can have a toxic effect and can
lead to sticking. In this case warranty claims will be invali-
dated.

Synthes 9
Maintenance
By 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 inserted
and tightened.
If the Maintenance Unit or the Adapters 05.001.064 and
05.001.089 are contaminated, they can be wiped with a
cloth 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 with
the unit itself.
The manufacturer shall assume no responsibility for damage
resulting from improper operation or unauthorised mainte-
nance.

10 Synthes Maintenance Unit. For EPD and APD Instructions for Use
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 the
Lid is closed.
A Burr Attachment (05.001.045–
05.001.050, 05.001.063 and
05.001.055) or Craniotome Attach-
ment (05.001.059) is placed on the
connectors, but the release sleeve
is in the unlock position. This blocks
the lubrication procedure.
The fixing bolts are not proper inserted
or tightened into the housing of the
Maintenance 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 lubricated
through the attachment coupling.
The Air Pen Drive is not set to the foot
switch position during lubrication.
The Maintenance Unit is faulty.
No handpiece or attachment is plugged
to 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 or
05.001.059) into lock position and
push the START button again.
Insert both fixing bolts proper and
tighten 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 lubricated
with the Adapter for Maintenance Unit
for Air Pen Drive (05.001.089) and
through the air inlet/outlet.
Set the Air Pen Drive to the foot switch
position during lubrication.
Send the Maintenance Unit to your
Synthes Service Centre.
Reconnect the handpiece or attach-
ments (entirely). Push the start button
again.
Problem Possible Causes Remedy

Synthes 11
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 Maintenance
Unit 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 60601-1/60601-1-1/60601-1-2/60601-1-4
IEC 61000-6-1/61000-6-2/61000-6-3/61000-6-4
Medical electrical equipment
With regard to electrical shock, fire, mechanical hazards, only
in accordance with UL 60601-1 and CAN/CSA C22.2
No.601.1
Environmental conditions
Operation Transport and
Storage
Temperature 10– 40°C –20–50°C
50–104°F –4–122°F
Relative humidity 30–75% 10–75%
Atmospheric pressure 500–1060 hPA 500–1060 hPA
0.5–1.06 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 cord
is supplied with each unit.

036.000.098 SE_017570 AC 41070017 © 06/2008 Synthes, Inc. or its affiliates All rights reserved Synthes is a trademark of Synthes, Inc. or its affiliates
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