Osstem OSM 2 User manual
Instructions for use
SI-923 / SI-915
2
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.
3
Contents
W&H Symbols ..............................................................................................................................................................2
1. Introduction ............................................................................................................................................................4 – 5
2. Unpacking ....................................................................................................................................................................6
3. Equipment supplied ....................................................................................................................................................7
4. Safety notes ........................................................................................................................................................8 – 10
5. Description of front panel ..........................................................................................................................................11
6. Description of rear panel............................................................................................................................................12
7. Description of motor with cable ................................................................................................................................13
8. Starting operation – General ......................................................................................................................................14
9. Starting operation – Foot control ......................................................................................................................15 – 17
10. Factory settings..................................................................................................................................................18 – 19
11. Control unit operation ........................................................................................................................................20 – 23
12. Error messages ..........................................................................................................................................................24
13. Disinfection, Cleaning, Sterilization....................................................................................................................25 – 27
14. W&H Accessories ..............................................................................................................................................28 – 29
15. Servicing ............................................................................................................................................................30 – 31
16. Technical data ....................................................................................................................................................32 – 33
Letter of indemnity ....................................................................................................................................................35
Certification of Training ........................................................................................................................................37, 39
Authorized W&H Service organizations ............................................................................................................41 – 43
4
1. Introduction
For your safety and the safety of your patients
These Instructions for Use explain how to use your product. 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 10.
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 OSM2 from
OSSTEM. We have based our development and design of the OSM2 on the "physician" target group.
5
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
– OSM2 SI-915 and
– OSM2 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 manufacturer can only accept responsibility for the safety, reliability and performance of the OSM2 when there
is compliance with the following directions:
– OSM2 must be used in accordance with these Instructions for Use.
– OSM2 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.
6
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 irrigation tubing
set.
➎Remove carton containing
motor, mains cable,
motor support and
instruments (optional).
7
3. Equipment supplied
❍Control unit REF 05191900 (230 V)
❍Foot control REF 04785700
❍Motor with 1.8 m cable including 5 clips, REF 04720024
❍Mains cable REF 01343700 (Europe)
❍Motor support REF 04735700
❍Stand REF 04005900
❍Locking pins REF 04006800 (2 pcs)
❍Irrigation tubing set REF 436360 (3 pcs, disposable)
Alternative specification:
❍Control unit REF 05192000 (115 V)
❍Mains cable REF 02821400 (USA, CAN, J) / REF 03212700 (UK, IRL) / REF 02909300 (AUS, NZ)
Optional accessories:
❍Motor protective cover REF 04032600
❍Sterilization cassette REF 04013500
❍Transportation case REF 04013600
❍Trolley white REF 04541900 / 04542100
❍Trolley, stainless steel, REF 04042600
8
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 OSM2 or
non-compliance with our instructions invalidates all claims under warranty and any other claims.
Cardiac pacemaker function
Use of the OSM2 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 OSM2 is
designed for the intermittent operating mode S3 with an operating time of 4 minutes and a pause time of 10 minutes.
9
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 OSM2 Program 4 is only designed to be used with the contra-angle handpieces WS-75 E/KM and
WI-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.
Mains cable
Only connect to an earthed socket outlet.
Power failure
In the event of a power failure, if the OSM2 is switched off, or when alternating between programs, the last values set are
saved and re-activated on power-up.
10
Safety notes
System failure
A total system failure of the OSM2 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.
Coolant
The OSM2 is designed for use with physiological saline solution. Use only suitable irrigation fluids and comply
with the medical data and instructions from the manufacturer. Use the W&H irrigation tubing set or accessories
approved by W&H. Coolant bottle or coolant bag can be obtained from a pharmacist.
Sterility of irrigation tubing set
Sterile irrigation tubing sets are supplied with the equipment. These irrigation tubings are disposable articles and
must be thrown away after each treatment! Please note the expiry date and the relevant regulations for disposal
of irrigation tubing.
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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