W&H OsseoSet 200 User manual

Instructions for use
SI-923 / SI-915

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W&H Symbols
WARNING!
(Risk of injury)
ATTENTION!
Important notes!
(to prevent damage occurring)
General explanations,
without risk to
persons or objects
W&H ServiceSterilizable
up to the stated temperature
Thermo washer disinfectable
Only for USA
Caution: Federal law restricts this device to sale by or on the order of a dentist, physician or any other practitioner
licensed by the law of the state in which he or she practices to use or order the use of the device.

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Contents
W&H Symbols ..............................................................................................................................................................2
1. Introduction ............................................................................................................................................................4 – 5
2. Unpacking ....................................................................................................................................................................6
3. Equipment supplied ....................................................................................................................................................7
4. Safety notes ........................................................................................................................................................8 – 11
5. Description of front panel ..........................................................................................................................................12
6. Description of rear panel............................................................................................................................................13
7. Description of motor with cable ................................................................................................................................14
8. Starting operation foot control ..........................................................................................................................15 – 20
9. Starting operation – General ......................................................................................................................................21
10. Factory settings..................................................................................................................................................22 – 23
11. Control unit operation ........................................................................................................................................24 – 27
12. Error messages ..................................................................................................................................................28 – 29
13. Disinfection, Cleaning, Sterilization....................................................................................................................30 – 32
14. Accessories ..............................................................................................................................................................33
15. Servicing ............................................................................................................................................................34 – 35
16. Technical data ....................................................................................................................................................36 – 37
Letter of indemnity ....................................................................................................................................................39
Certification of Training ........................................................................................................................................41, 43
Authorized W&H Service organizations..............................................................................................................45 – 47

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1. Introduction
For your safety and the safety of your patients
These Instructions for Use explain how to use your OsseoSetTM 200. However, we must also warn against
possible hazardous situations. Your safety, the safety of your team, and of course, the safety of your patients are
of paramount importance to us.
It is therefore essential to read the safety notes on Pages 8 to 11.
Intended use
Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964
(DIN 13.940).
The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard
tissue.
Qualifications of the user
Only suitably qualified medical, technical and specialist trained staff may use the dental surgical unit OsseoSetTM 200.
We have based our development and design of the OsseoSetTM 200 on the "physician" target group.

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Introduction
Production according to EU Directive
EU Directive 93/42/EEC has been used as a basis in the design and manufacture of this medical product and
this applies to the dental surgical units
– OsseoSetTM 200 SI-915 and
– OsseoSetTM 200 SI-923
in the condition as supplied by us. This declaration does not apply to non-specified fittings, mountings etc.
Responsibility of the manufacturer
The W&H Dentalwerk (dental factory) in Bürmoos can only accept responsibility for the safety, reliability and
performance of the OsseoSetTM 200 when there is compliance with the following directions:
– OsseoSetTM 200 must be used in accordance with these Instructions for Use.
– OsseoSetTM 200 has no components which can be repaired by the user. Assembly, modifications or repairs
must only be undertaken by skilled personnel authorized by W&H.
– The electrical installation at the premises must comply with the regulations of ÖVE-EN 7 ("Installation of
electrical equipment in rooms used for medical purposes") or with the regulations applicable in your country.
– Unauthorized opening of the equipment invalidates all claims under warranty and any other claims.

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2. Unpacking
The packaging is environmentally friendly and can be
disposed of by industrial recycling companies.
However, we recommend that you keep the original
packaging.
➊Lift out insert with stand.
➋Remove foot control and
insert.
➌Lift out insert with control
unit.
➍Remove carton with mains
cable.
➎Remove carton containing
motor, motor support,
drill gauge, locking pins
and instrument.

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3. Equipment supplied
❍Control unit REF NB05018200 (230 V)
❍Foot control S-NU 1, REF NB04491600
❍Motor with 1.8 m cable including 5 clips, REF NB04720016
❍Mains cable REF NB01343700 (Europe) / REF NB03212700 (UK, IRL) / REF NB02909300 (AUS, NZ)
❍Motor support REF NB05028500
❍Stand REF NB04005900
❍Locking pins REF NB04006800 (2 pcs)
❍Clips REF NB04019000 (5 pcs)
❍Drill gauge REF NB02139800
❍Contra-angle handpiece
Alternative specification:
❍Control unit REF NB05018300 (115 V)
❍Mains cable REF NB02821400 (USA, CAN, J)

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4. Safety notes
Please ensure that you carry out the following instructions
– Only fit the handpieces when the motor is at a complete standstill.
– Never touch rotary instruments which are still rotating.
– Never touch the chuck mechanism of straight and contra-angle handpieces while they are still running.
– Always ensure correct operating conditions and that sufficient and adequate cooling is delivered.
– Avoid overheating at the treatment site.
Use only suitable and serviceable tools
Ensure that you comply with the manufacturer's instructions for surgical straight and contra-angle handpieces
with respect to maximum speed, maximum torque, forward and reverse movement.
Inappropriate use
Improper use, in addition to incorrect assembly, installation, modification or repairs of the OsseoSetTM 200 or
non-compliance with our instructions invalidates all claims under warranty and any other claims.
Cardiac pacemaker function
Use of the OsseoSetTM 200 involves the generation of magnetic fields, which are below the interference threshold limit
according to EN 50061 Ad1. Even under adverse conditions, there is no likelihood of serious harm to the patient.
The OsseoSetTM 200 is designed for the intermittent operating mode S3 with an operating time of 4 minutes and a pause
time of 10 minutes.

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Safety notes
Danger zones M and G
In accordance with IEC 60601-1 / UL 60601-1, the control unit is not suitable for use in potentially explosive
atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide.
Control unit
The control unit is classed as "conventional equipment" (closed equipment without protection against the ingress of
water).
The OsseoSetTM 200 Programs 4 and 5 are only designed to be used with the contra-angle handpieces
WI-75 E/KM and WS-75 E/KM approved by W&H. Use of other contra-angle handpieces may result in deviation
from the indicated torques and is under the user’s responsibility. The specified transmission ratios for the
Programs 1 to 5 must always be considered.
Motor and foot control
The motor and foot control are approved for use in zone M (AP).
Please note that at low speeds, it is more difficult to determine that the motor is running.

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Safety notes
Mains cable
Only connect to an earthed socket outlet.
Power failure
In the event of a power failure, if the OsseoSetTM 200 is switched off, or when alternating between programs, the last
values set are saved and re-activated on power-up.
System failure
A total system failure of the OsseoSetTM 200 does not constitute a critical fault.
Intermittent operating mode S3 (4min/10min)
When there is a current consumption of max. 0.8 A for SI-923 and 1.6 A for SI-915 (with pump switched on),
the permissible relative load time is 4 minutes to 10 minutes pause time.

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Safety notes
Coolant
The OsseoSetTM 200 is designed for use with physiological saline solution. Use only suitable irrigation fluids and
comply with the medical data and instructions from the manufacturer. Coolant bottle, coolant bag and sterile
fittings can be obtained from a pharmacist.
Rotational energy
Fast deceleration of the bur can, at times, cause the selected torque to be overloaded as a result of the rotational
energy stored in the drive system.
We therefore advise compliance with the individual manufacturer's instructions for use, particularly when adjusting
superstructure screws.
For safety reasons, these should be screwed in very carefully by hand, or by using a torque wrench.
We would point out that adjusting these screws with an electric motor represents a potential risk as described
above.

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5. Description of front panel
Motor connection socket
Display
OPEN
Pump arm
P5
Program buttons
P1 P2 P3
P4
Pump arm Stand holder

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6. Description of rear panel
Connecting socket
for foot control
Fuse holder with 2 fuses REF 04014700
(250 V – 1.25A slow-blow)
Power socket
Power switch
ON / OFF
Stand holder

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7. Description of motor with cable
The motor may not be dismantled!
The motor bearings are lubricated for life. No oil lubrication or other maintenance is necessary.
To prevent the instrument on the motor attachment from turning during the transmission, the locking pin supplied
can be pushed into one of the two holes (see illustration). The locking pins can only be used in combination with
straight and contra-angle handpieces that have corresponding holes.
Test run
– Start the motor.
– If you observe dysfunctions (e.g. vibrations, unusual noise, overheating, coolant supply failure or leakage) contact your
authorized service organization (see Page 45 – 47).
Made in
AUSTRIA

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8. Starting operation foot control – Fitting / Removing the handle
Fitting the handle
For easy fitting of the handle rotate the foot control by 180°.
➊Remove the protective cap from the handle hole.
➋Locate the guide pin of the handle in the recess in the hole within the foot control.
➌Press the handle until it audibly engages into the recess.
Swivel the handle upwards into the desired position.
Removing the handle
Turn the handle to the rear and pull out.

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Starting operation foot control – Disassembly of foot control
Disassembly of foot control – removing the pedal
for disinfection and cleaning (see Page 30)
– Remove the handle from the foot control.
– Press on one of the two guide pins with the tool provided and lift the pedal slightly.
– Press on the second guide pin with the tool and remove the pedal.
– Take out and retain the springs.

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Starting operation foot control – Reassembly of foot control
– Make sure that both springs are inserted in the appropriate recess.
– Position the pedal at the end of the foot control into the mounting plate.
– Press the two guide pins in front of the foot control at the same time and allow the pedal to engage.
– Refit the handle.

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Starting operation foot control – Description of pedal
LIGHT-GREY
Pump
ORANGE
Change program
DARK-GREY
Change motor direction
BLACK
(Pedal)
Motor start
Function
BLACK = VARIABLE or ON / OFF (Factory setting = variable)
LIGHT-GREY = Pump ON / OFF
ORANGE = Program 1 to 5
DARK-GREY = Motor forward / reverse drive

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Starting operation foot control – Description of pedal
Changing program
The Programs 1 – 5 can be selected in ascending sequence by operating the ORANGE button.
When changing from Program 5 to Program 1, a longer confirmation signal is heard.
With each program change, the speed is automatically set to forward operation.
Pump ON / OFF
Only when the motor is at a complete standstill can the pump be switched on or off by operating the LIGHT-GREY button
of the foot control. When pump operation is active, the pump symbol appears on the display.
Reverse operation
You can switch between forward and reverse operation by pressing the DARK-GREY button. On selecting reverse
operation, an audible signal can be heard and the selected Program button flashes. Before the motor starts in reverse
operation, 3 audible warning signals are given.

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Starting operation foot control –
To change from VARIABLE to ON / OFF
Keep Program button P3 depressed throughout this procedure!
➊Press P3 for approx. 4 seconds
➋Keep P3 depressed and simultaneously press
PLUS and MINUS
➌Keep P3 depressed and carry out adjustment.
01 = VARIABLE (factory setting) – Press PLUS button
00 = ON / OFF – Press MINUS button
After changeover the Program button P3 illuminates and is active!