WH
WH
WH
SI-923 / SI-915
Contents
W&H Symbols ..................................................................................................................................................................................4 – 5
1. Introduction......................................................................................................................................................................................6 – 7
2. Electromagnetic compatibility (EMC) ..................................................................................................................................................8
3. Unpacking ..............................................................................................................................................................................................9
4. Equipment supplied ............................................................................................................................................................................10
5. Safety notes ................................................................................................................................................................................11 – 14
6. Description of front panel ....................................................................................................................................................................15
7. Description of rear panel ....................................................................................................................................................................16
8. Description of motor with cable ..........................................................................................................................................................17
9. Starting operation – General................................................................................................................................................................18
10. Starting operation – Foot control................................................................................................................................................19 – 22
11. Factory settings ..........................................................................................................................................................................23 – 25
12. Control unit operation..................................................................................................................................................................26 – 29
13. Error messages....................................................................................................................................................................................30
14. Hygienic maintenance ................................................................................................................................................................31 – 35
15. W&H Accessories ........................................................................................................................................................................36 – 38
16. Servicing ......................................................................................................................................................................................39 – 40
17. Technical data ..............................................................................................................................................................................41 – 42
18. Recycling and disposal........................................................................................................................................................................43
Consult Instructions for use Do not dispose of with REF Catalogue number
domestic waste
SN Serial number
5
1. Introduction
For your safety and the safety of your patients
These Instructions for Use explain how to use your W&H 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.
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, maxillo-facial surgery and endodontics for treatment of dental
hard tissue and mechanical rotating root canal preparation.
6
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
in the condition as supplied by us. This declaration does not apply to non-specified fittings, mountings etc.
> The Implantmed must be used in accordance with these Instructions for Use.
> The Implantmed has no components which can be repaired by the user. Assembly, modifications or repairs must only be
undertaken by an authorized service organization (see Page 51).
> 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.
7
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
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.
8
3. Unpacking
➌ Lift out insert with W&H packaging is environmentally friendly and can be
control unit. disposed of by industrial recycling companies.
9
4. Equipment supplied
Control unit
❍ green REF 04708900 (230 V)
❍ blue REF 04801300 (230 V)
❍ Foot control S-NU REF 04785700
❍ Motor with 1.8 m cable including 5 clips, REF 04720000
❍ Mains cable REF 01343700 (Europa)
❍ 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
❍ green REF 04691400 (115 V)
❍ blue REF 04801200 (115 V)
❍ Mains cable REF 02821400 (USA, CAN, J) / REF 03212700 (UK, IRL) / REF 02909300 (AUS, NZ) / REF 04280600 (CH)
❍ Foot control S-N1 REF 05046200
Optional accessories:
❍ W&H instruments
❍ Motor protective cover REF 04032600
❍ Sterilization cassette REF 04013500
❍ Transportation case REF 04013600
❍ Trolley white REF 04541900 / REF 04542100
❍ Trolley, stainless steel REF 04042600
10
5. 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.
Inappropriate use
Improper use, in addition to incorrect assembly, installation, modification or repairs of the Implantmed or non-compliance
with our instructions invalidates all claims under warranty and any other claims.
11
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 Implantmed Programs 4 and 5 are only designed to be used with the contra-angle handpieces WS-75 E/KM, WI-75 E/KM,
WI-75 LED G and WD-79 M 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.
12
Safety notes
Mains cable
Only connect to an earthed socket outlet.
Power failure
In the event of a power failure, if the Implantmed 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 Implantmed does not constitute a critical fault.
13
Safety notes
Coolant
The Implantmed 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.
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.
14
6. Description of front panel
P1 P2 P3 P4
OPEN
Program button Pump arm
ENDODONTIE
2:1
15
7. Description of rear panel
Stand holder
16
8. 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 transmission, the locking pin supplied can be pushed
into the designated hole (see illustration). The locking pin can only be used in combination with straight and contra-angle
handpieces that have corresponding holes.
Test run
> Start the motor.
> If you observe problems (e.g. vibrations, unusual noise, overheating, coolant supply failure or leakage), stop the motor
immediately and contact an authorized service organization (see Page 51).
17
9. Starting operation – General
18
10. Starting operation – Foot control S-NU
ORANGE
Change program
GREEN Implantology: Program 1 to 4
Endodontics: Endo mode E1 to E5
Pump
Implantology: ON / OFF
Endodontics: not in operation
YELLOW
Change motor direction
Implantology and Endodontics:
forward / reverse drive
BLACK
Start motor
Implantology: VARIABLE or ON / OFF
(Factory setting = variable)
Endodontics: ON / OFF
(Factory setting = ON / OFF)
19
Starting operation – Foot control S-N1
ORANGE
Change program
Implantology: Program 1 to 4
Endodontics: Endo mode E1 to E5
GREEN
Pumpe
Implantology: ON / OFF
Endodontics : not in operation YELLOW
Change motor direction
Implantology and Endodontics:
forward / reverse drive
GREY
Start motor
Implantology: VARIABLE or ON / OFF
(Factory setting = variable)
Endodontics: ON / OFF
(Factory setting = ON / OFF)
20
Starting operation – Foot control S-NU and S-N1
Changing program IMPLANTOLOGY
The Programs 1 – 4 can be selected in ascending sequence by operating the ORANGE button.
When changing from Program 4 to Program 1, a longer confirmation signal is heard.
With each program change, the motor direction is automatically set to forward operation.
Pump ON / OFF
Only when the motor is stationary can the pump be switched on or off by operating the GREEN 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 YELLOW 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.
21
Starting operation – Foot control S-NU and S-N1
To change from VARIABLE to ON / OFF
20:1
20:1
20:1
➌ Keep P3 depressed and carry out adjustment.
01 = VARIABLE (factory setting) – Press PLUS button
22
11. Reset factory settings
Factory setting always starts with Program 1 (P1).
1:1
➋ Keep P1 depressed and simultaneously
switch on the control unit
23
Factory settings Implantology (P1 – P4)
P1 P2 P3
1:1 20:1
P4 Forward P4 Reverse
24
Factory settings Endodontics (P5)
2:1
P5
Endo mode E1 E2 E3 E4 E5
Transmission ratio 2:1 2:1 2:1 2:1 2:1
Factory setting rpm 300 300 300 300 300
Motor direction forward forward forward forward forward
Factory setting Ncm 6.0 3.5 2.5 1.5 0.7
Pump off off off off off
25
12. Control unit operation – Changing the program (P1 – P5)
Activate the required Program for Implantology (P1 – P4) or Endodontics (P5) by pressing the corresponding Program
button. During selection an audible signal can be heard and the Program button is illuminated. On the display the selected
Program appears with the adjusted range in rpm, e.g. for P1:
rpm
Pump operation
ON / OFF
Error messages
> Motor temperature too high
> Motor connection
26
Control unit operation – Changing the speed (P1 – P3)
Keeping PLUS / MINUS depressed activates the repeat function and the values are continuously increased / decreased.
➋ Increase speed
➋ Decrease speed
27
Control unit operation – Changing the torque (P4)
Adjustable range from 5 up to 50 Ncm, intermediate stage 32 Ncm. Keeping PLUS / MINUS depressed activates the repeat
function and the values are continuously increased / decreased.
When changing from 5 to 50 Ncm and 50 to 5 Ncm, a longer confirmation signal is heard.
When the set torque in the the forward / reverse drive mode is reached, the motor switches off automatically.
28
Control unit operation – Changing the coolant flow (P1 – P4)
Factory setting 100%. Adjustable range 65%, 80% and 100 %.
Depressing PLUS / MINUS the values are continuously increased / decreased.
29
13. Error messages
If one of the error messages described above cannot be rectified by switching off the Implantmed and then switching it on
again, the equipment must be checked by an authorized service organization (see Page 51).
If a total failure of the equipment occurs caused by external circumstances, the equipment must be switched off and then on
again.
30
14. Hygienic maintenance
Follow your country-specific directives, standards and guidelines for cleaning, disinfection and sterilization.
Pre-disinfection
> If heavily soiled: Clean first with disinfectant cloths.
Only use disinfectants that have no protein-fixing effects.
32
Hygienic maintenance
Motor with cable
Manual cleaning
> Rinse under demineralized water (< 38 °C) with the aid of a brush (brush is not recommended in U.K.).
> Remove any liquid residues (absorbent cloth, blow dry with compressed air).
Manual disinfection
> Disinfection with surface disinfectants, wiping disinfection is recommended.
> Use only surface disinfectants which do not contain chlorine and which are certified by officially recognized institutes.
For USA: Use EPA registered surface disinfectants.
> Note the manufacturer’s specifications for the use of the surface disinfectants.
After manual cleaning and disinfection you must carry out a final sterilization (wrapped) in the class B or S steam sterilizer
(according to EN 13060).
33
Hygienic maintenance
Sterilization and storage
W&H recommends sterilization according to EN 13060, class B
For sterilization in sterilizers with a drying program we recommend you to remove the motor protective cover.
For sterilization in sterilizers without a drying program we recommend you to use the motor protective cover (see Page 32).
34
Hygienic maintenance
Approved sterilization procedures
or
35
Use only original W&H accessories / spare parts
15. W&H Accessories or accessories approved by W&H
36
W&H Accessories
Disposable article
2
04019000 04363600 04719400
Clips (5 pcs) Irrigation tubing set 2.2 m (6 pcs) Irrigation tubing set 2.2 m
37
W&H Accessories
04785700 04308700
Foot control S-NU Step wedge
for foot control S-NU
05046200 04653500
Foot control S-N1 Handle
for foot control S-N1
38
16. Servicing
Regular checking of Implantmed and accessories
Regular servicing of function and safety of the Implantmed including the accessories is necessary and should be carried out
at least once every three years, unless shorter intervals are prescribed by law. The inspection must be undertaken by a
qualified organization and needs to include the following procedures:
We recommend that only an authorized service organization (see Page 51) should undertake this servicing and checking.
39
Servicing
Motor with cable
The standard ISO 11498 stipulates a durability of at least 250 sterilization cycles. In the case of the motor with cable from W&H we
recommend you to carry out a regular servicing after 500 sterilization cycles, or one year.
Repairs
If a defect occurs, always return all the equipment, due to the fact that with motor malfunctions, an inspection of the electronic
controls is also necessary!
Returns
> Refer all questions to an authorized service organization (see Page 51).
> Always return equipment in the original packaging!
> Do not coil the cable around the motor and do not twist or kink the motor cable! (Risk of damage)
40
17. Technical data
Implantmed SI-923 SI-915
Physical characteristics
Temperature for storage: -40 °C (-40 °F) to +70 °C (+158 °F)
Air humidity for storage: 8 % to 80 % (relative), non-condensing at +40°C (+104 °F)
Ambient temperature during operation: +10 °C (+50 °F) to +40 °C (+104 °F)
Air humidity during operation: 15 % to 80 % (relative), non-condensing at +40°C (+104°F)
41
Technical data
Classification according to § 5 of the General Specifications for the Safety of Medical Electrical Equipment
according to IEC 60601-1 / UL 60601-1
Class II equipment
Motor REF 04720000 and the foot controls REF 04785700 and REF 05046200 conform to Class AP
according to IEC 60601-1 / UL 60601-1 in danger zone M.
The foot controls are water-tight according to IPX8, 1m depth of immersion, 1 hour (water-tight according to IEC 60529)
42
18. Recycling and disposal
Recycling
W&H considers that it has a special duty towards the environment. The Implantmed equipment along with its packaging has been
designed to be as environmentally friendly as possible.
43
Copy for the user / customer
C E R T IF IC AT ION OF T R A INING
essential for EU user / customer
The user / customer has been trained in all functions of the
surgical unit in accordance with current Instructions for use.
Particular attention was shown to Safety notes,
Cleaning, Disinfecting, Sterilization and Servicing.
W&H Surgical unit
Type SN
Name of the user / customer
Clinic, Department
Adress
Signature
Name of the instructor
Adress
Date Signature
✄
Clinic, Department
Adress
Signature
Name of the instructor
Adress
✄
Date Signature
Le t te r o f i n d e m n it y
This W&H product has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls
guarantee faultless operation. Please note that claims under warranty can only be validated when all the directions in the
instructions for use have been followed.
As manufacturer, W&H is liable for material or manufacturing defects within a warranty period of one year from the
date of purchase.
We accept no responsibility for damage caused by incorrect handling or by repairs carried out by third parties not authorized
to do so by W&H!
Claims under warranty – accompanied by proof of purchase – must be sent to the vendor or to an authorized W&H service
point. The provision of service under warranty extends neither the warranty period nor any other guarantee period.
12 m o nth s wa r ra nt y
Authorized service organizations
GB IRL M
W&H (UK) LIMITED, 6 Stroud Wood Business Centre, Park Street, St Albans, Herts AL2 2NJ,
t + 44 1727 874990, f + 44 1727 874628, E-Mail: technical.uk@wh.com
USA
W&H Impex Inc., 14300 Henn Rd., Dearborn, MI 48126, USA,
t + 1 800 2656277, + 1 519 9446739, f + 1 519 9746121, E-Mail: service.us@wh.com
CAN
W&H Impex Inc., 6490 Hawthorne Drive, Windsor, Ontario, N8T 1J9,
t + 1 800 2656277, + 1 519 9446739, f + 1 519 9746121, E-Mail: service.ca@wh.com
AUS NZ
A-DEC AUSTRALIA CO. INC., Unit 8, 5-9 Ricketty Street, Mascot NSW 2020,
t + 61 2 83324000, f + 61 2 83324099, E-Mail: a-dec@a-dec.com.au