Instructions for use
SI-923 / SI-915
Contents
W&H Symbols ............................................................................................................................................................................................3 – 6
1. Introduction ........................................................................................................................................................................................7 – 8
2. Electromagnetic compatibility (EMC) .....................................................................................................................................................9
3. Unpacking ................................................................................................................................................................................................10
4. Scope of delivery .....................................................................................................................................................................................11
5. Safety notes ................................................................................................................................................................................... 12 – 16
6. Description of front panel ....................................................................................................................................................................... 17
7. Description of rear panel ........................................................................................................................................................................18
8. Description of foot control ......................................................................................................................................................................19
9. Description of motor with cable ............................................................................................................................................................ 20
10. Starting operation – General .................................................................................................................................................................. 21
11. Switch on / switch off Implantmed ....................................................................................................................................................... 22
12. Control unit operation .................................................................................................................................................................... 23 – 26
13. Foot control operation ...................................................................................................................................................................27 – 28
14. Factory settings ............................................................................................................................................................................. 29 – 31
15. Thread cutter function (chip breaker mode) .........................................................................................................................................32
16. Error messages .......................................................................................................................................................................................33
17. Hygiene and maintenance ............................................................................................................................................................34 – 39
18. W&H Accessories ........................................................................................................................................................................... 40 – 41
19. Servicing .........................................................................................................................................................................................42 – 43
20. Technical data ................................................................................................................................................................................ 44 – 45
21. Recycling and disposal .......................................................................................................................................................................... 46
Certification of training ............................................................................................................................................................................. 47, 49
Explanation of warranty terms .......................................................................................................................................................................51
Authorized W&H service partners ..................................................................................................................................................................52
2
W&H Symbols
Symbols in the instructions for use
WARNING!
(risk of injury)
Thermo washer disinfectable
For USA and Canada:
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.
(to prevent damage occurring)
up to the stated temperature
ATTENTION!
General explanations,
without risk to persons
or objects
W&H ServiceSterilizable
3
W&H Symbols
Symbols on the control unit
Follow instructions for use
Consult instructions for use
Class II equipment
Date of manufacture
Do not dispose of with
domestic waste
Foot switch
On / Off
Data matrix code for product
identification e.g. for hygiene
/ maintenance processes
REF
SN
V
AC
VA
Electric fuse
Not suitable for
intracardiac application –
Type B applied part
4
MEDICAL – GENERAL MEDICAL
EQUIPMENT WITH RESPECT TO
ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL60601-1:2006,
CAN/CSA-C22.2 No. 601.1-M90,
CAN/CSA-C22.2-No. 60601-1:08,
ANSI/AAMI ES 60601-1:2005
25UX (Control No.)
A
Hz
rpm
Catalogue number
Serial number
Supply voltage of the unit
Alternating current
Electric power input of the unit
Supply current
Frequency of the
alternating current
Revolutions per minute
-1
(rpm = min
)
W&H Symbols
Symbols on the packaging
This way up Caution: Federal law restricts
Temperature limit
this device to sale by or
on the order of a dentist,
physician or any other
practitioner licensed by the
Fragile, handle with care
Humidity limitation
law of the state in which he
or she practices to use or
order the use of the device
Keep away from rain
CE 0297 from
manufacturer
Der Grüne Punkt
Identification mark of Duales
System Deutschland AG
General symbol for
R
E
Y
recovery/recyclable
5
Symbols
Symbols on the irrigation tubing
Sterilization with
ethylene oxide
Not for re-use
Latex-free
Use by
Batch ID
Caution, please observe
accompanying documents
6
Consult instructions for use Caution: Federal law restricts
this device to sale by or
on the order of a dentist,
CE 0481 from manufacturer
Not sterile
Sterilizable at the
stated temperature
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
1. Introduction
For your safety and the safety of your patients
These instructions 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 that you observe the safety notes on pages 12 to 16.
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.
Misuse may damage the Implantmed and hence cause risks and hazards for patients, users and third parties.
Qualifications of the user
Only suitably qualified medical, technical and specialist trained staff may use the dental surgical unit Implantmed.
We have based our development and design of the Implantmed on the »physician« target group.
7
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 device and it applies to the
dental surgical units
> Implantmed SI-915 and
> Implantmed 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 Implantmed when it is used in compliance with the following directions:
> The Implantmed must be used in accordance with these Instructions for use.
> The Implantmed has no components that can be repaired by the user. Assembly, modifications or repairs must only be
undertaken by an authorized W&H service partner (see page 52).
> The electrical installation at the premises must comply with the regulations of IEC 60364-7-710 (»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. Electromagnetic compatibility (EMC)
Notes on electromagnetic compatibility (EMC)
Medical electrical equipment is subject to particular precautions with regards to EMC and must be installed and put into
operation in accordance with the EMC notes included.
W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories
and spare parts. The use of other accessories/other spare parts can lead to an increased emission of electromagnetic
interference or to a reduced resistance against electromagnetic interference.
You can find the current EMC manufacturer’s declaration on our website at
http://wh.com/en_global/emc
alternatively, you can obtain it directly from the manufacturer.
HF communication equipment
Do not use any portable and mobile HF communication equipment (e.g. mobile telephones) during operation.
These may affect medical electrical equipment.
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3. Unpacking
Lift out the insert with
the stand.
Lift out the insert with
the foot control.
Lift out the insert with the
control unit.
Remove the irrigation
tubing.
Remove the carton with
motor, accessories and
instruments (optional).
W&H packaging is environmentally friendly and can be
disposed of by industrial recycling companies.
However, we recommend that you keep the original packaging.
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4. Scope of delivery
Control unit
SI-923 REF 16929000 (230 V)
SI-915 REF 16929001 (115 V)
Mains cable
REF 01343700 (EU)
REF 02821400 (USA, CAN, J) / REF 03212700 (UK, IRL) / REF 02909300 (AUS, NZ) / REF 04280600 (CH) / REF 05901800 (DK)
Foot control S-N1 REF 06202400
Handle for foot control REF 04653500
Motor with 1.8 m cable REF 06631600 incl. 5 clips REF 04019000
Motor support REF 06177800
Stand REF 04005900
Locking pins REF 04006800 (2 pcs)
Irrigation tubing REF 436360 (3 pcs, disposable)
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5. Safety notes
Please observe the following instructions under all circumstances
> Before using the Implantmed for the first time, store it at room temperature for 24 hours.
> Only fit the straight and contra-angle handpieces when the motor is at a complete standstill.
> Never touch rotary instruments that are still rotating.
> Never touch the chuck mechanism of straight and contra-angle handpieces during operation or while they are still
running down.
> Always ensure correct operating conditions and that sufficient and adequate cooling is delivered.
> Avoid overheating at the treatment site.
> Check the Implantmed, the straight or contra-angle handpiece and the motor with cable for damage and loose parts
each time before using. Correct any faults or refer to an authorized W&H service partner (see page 52). Do not operate
the Implantmed if it is damaged.
> When changing the fuse, disconnect the unit from the power supply and only use W&H original fuses.
> Perform a test run prior to each treatment.
> Never touch the patient and the connections for the foot control simultaneously.
> Check the parameter settings every time the device is restarted.
> The ESD spring contact on the underside of the foot control must touch the floor during operation.
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.
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Inappropriate use
Improper use, in addition to incorrect assembly, installation, modification or repairs of the Implantmed or
failure to comply with our instructions invalidates all claims under warranty and any other claims.
Safety notes
Risks due to electromagnetic fields
The functionality of implantable systems, such as cardiac pacemakers and ICD (implantable
cardioverter defibrillator) can be affected by electric, magnetic and electromagnetic fields.
> Find out if patients and users have an implanted device before using the product and consider the applications.
> Weigh the risks and benefits
> Keep the product away from implanted devices.
> Make appropriate emergency provisions and take immediate action on any signs of ill-health.
> Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker or
ICD (implantable cardioverter defibrillator).
13
Safety notes
Danger zones M and G
In accordance with IEC 60601-1/ANSI/AAMI ES 60601-1, the control unit and the motor with cable are not suitable for use in
potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or
nitrous oxide.
Implantmed is not suitable for use in oxygen-enriched atmospheres.
Foot control
is in accordance with IEC 60601-1/ANSI/AAMI ES 60601-1 approved for use in zone M (AP). Zone M is defined as a »medical
environment« and constitutes the part of a room in which potentially explosive atmospheres may form due to the use of
anaesthesia or medical antiseptics and antibacterial soaps; such atmospheres are limited and only occur very briefly.
Please note that at low speeds, it is more difficult to determine that the motor is running.
Control unit
The control unit is classed as »conventional equipment« (closed equipment without protection against the ingress of water).
When using the transmission settings 20:1, Implantmed must only be employed with the following W&H-
approved surgical contra-angle handpieces: WS-75 E/KM, WS-75 LED G, WI-75 E/KM and WI-75 LED G. Use of
other contra-angle handpieces may result in deviation from the indicated torques and is the user’s responsibility.
The specified transmission ratios for the programs 1 to 5 must always be taken into consideration.
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Safety notes
Mains cable
Only use the mains cable supplied.
Only connect to a grounded socket outlet.
Set up the device so that the power switch is easily accessible.
In dangerous situations, the device can be disconnected from the power supply using the power switch or power cable.
The power switch can also be used to safely stop the device.
Power failure
In the event of a power failure, if the Implantmed is switched off, or when switching between programs, the last values set are saved
and re-activated on power-up.
System failure
A total system failure does not constitute a critical fault.
Simply switch the unit off and then on again.
Intermittent operating mode S3 (3 min/10 min)
The Implantmed is designed for intermittent operating mode S3 with an operating time of 3 minutes and an idle time of 10
minutes.If the operating mode specified is observed no overheating of the system and therefore no injury to the patient,
user or third persons arises. The responsibility for the use and timely shutdown of the system lies with the user.
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Safety notes
Coolant
The Implantmed is designed for use with physiological saline solution. Use only suitable irrigation fluids and follow the
manufacturer’s medical data and instructions. Use the W&H irrigation tubing set or accessories approved by W&H.
You can purchase the coolant bottle or the coolant bag at a drugstore.
Sterility of irrigation tubing set
Sterile irrigation tubing sets are supplied with the equipment. The irrigation tubing is a disposable article and must be
discarded after each treatment. Please note the expiry date and the relevant regulations for disposal of irrigation tubing.
Only use disposable irrigation tubing with undamaged packaging.
Rotational energy
As a result of the rotational energy stored in the drive system – compared to the value set – fast deceleration of the bur can
cause the selected torque to be significantly overloaded, at times.
Observe the individual manufacturer’s instructions for use when adjusting superstructure screws. We would
point out that adjusting these screws with an electric motor presents a potential risk as described above.
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6. Description of front panel
Program buttons
P1
P2 P3 P4 P5
Pump arm
Display
Motor connection socket
Stand holder
Pump arm
OPEN
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