W&H Implantmed User manual

Instructions for Use
SI-915 / SI-923

2
Contents
Symbols.......................................................................................................................................................................................................... 4
1. Introduction ............................................................................................................................................................................................... 9
2. Electromagnetic compatibility (EMC)................................................................................................................................................... 11
3. Unpacking .................................................................................................................................................................................................12
4. Scope of delivery......................................................................................................................................................................................13
5. Safety notes .............................................................................................................................................................................................14
6. Description
of front panel........................................................................................................................................................................................21
of rear panel........................................................................................................................................................................................22
of foot control ..................................................................................................................................................................................... 23
of motor with cable ............................................................................................................................................................................. 24
7. Start-up..................................................................................................................................................................................................... 25
8. Implantmed.............................................................................................................................................................................................. 26
9. Control unit operation
changing program (P1 – P5)............................................................................................................................................................. 27
change speed (P1 – P3) .................................................................................................................................................................... 28
change torque (P4 – P5).................................................................................................................................................................... 29
change coolant volume (P1 – P5)..................................................................................................................................................... 30
10. Operation................................................................................................................................................................................................ 31
11. Restore factory settings....................................................................................................................................................................... 33
12. Thread cutter function (chip breaker mode) ...................................................................................................................................... 36
13. Error messages...................................................................................................................................................................................... 37
14. Hygiene and maintenance
General notes...................................................................................................................................................................................... 38
Limitations on processing.................................................................................................................................................................. 39

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Contents
Initial treatment at the point of use .................................................................................................................................................. 40
Manual cleaning.................................................................................................................................................................................. 41
Manual disinfection............................................................................................................................................................................42
Automated cleaning and disinfection ............................................................................................................................................... 43
Drying.................................................................................................................................................................................................. 44
Inspection, Maintenance and Testing................................................................................................................................................ 45
Packaging............................................................................................................................................................................................46
Sterilization......................................................................................................................................................................................... 47
Storage ................................................................................................................................................................................................ 48
15. Servicing ................................................................................................................................................................................................ 49
16. W&H accessories and spare parts ...................................................................................................................................................... 51
17. Technical data ........................................................................................................................................................................................ 53
18. Disposal ................................................................................................................................................................................................. 55
W&H course certificate............................................................................................................................................................................... 57
Explanation of warranty terms....................................................................................................................................................................61
Authorized W&H service partners.............................................................................................................................................................. 62

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Symbols
WARNING!
(if persons could be injured)
ATTENTION!
(if property could be damaged)
General explanations,
without risk to persons or property
Call customer serviceSterilizable
up to the stated temperature
Thermo washer disinfectable
in the Instructions for Use

5
Symbols
Follow Instructions for Use Class II equipment
Date of manufacture
Catalogue number
Serial number
Revolutions per minute (= rpm)
Alternating current
Electric power consumption
of the unit
Electric fuse
Supply voltage of the unit
Supply current
Frequency of the
alternating current
Data Matrix code
for product information
including UDI (Unique
Device Identification)
Type B applied part (not suitable
for intracardiac application)
Foot control
Do not dispose of with
domestic waste
On / Off
Consult Instructions for Use
The medical device with reference to electrical safety, mechanical safety
and fire prevention conforms to UL 60601-1:2006,
CAN/CSA-C22.2 No.601.1-M90:2005, CAN/CSA-C22.2 No. 60601-1:2008,
ANSI/AAMI ES 60601-1:2005 25UX (Control No.)
CE marking
with identification number
of the Notified Body
XXXX
on the control unit

6
Symbols
Catalogue number
Serial number
Date of manufacture
UL Component Recognition
Mark indicates compliance
with Canadian and
U.S. requirements
Do not dispose of with
domestic waste
Data Matrix code
for product information
including UDI (Unique
Device Identification)
CE marking
with identification number
of the Notified Body
XXXX
on the foot control
Category AP equipment
AP

7
Symbols
This way up
Caution! According to Federal law, this medical
device may only be sold by or on the order of a
dentist, physician or any other medical practitioner
licensed by the law of the State in which he or she
practices and intends to use or order the use of this
medical device.
Fragile, handle with care
Keep dry
Permitted temperature range
Humidity,
limitation
»Der Grüne Punkt« (The Green Dot)
trademark of Duales System
Deutschland GmbH
Trademark of RESY OfW GmbH
for identification of recyclable
transport and outer packaging
of paper and cardboard
-40 °C (-40°F) Min.
+70 °C (+158°F) Max.
8 %
80 %
CE marking
with identification number
of the Notified Body
XXXX
Data structure in accordance with
Health Industry Bar Code
Data Matrix code
for product information including UDI
(Unique Device Identification)
on the packaging

8
Symbols
Sterilization with
ethylene oxide
Consult Instructions for Use
Caution! According to Federal law, this medical device may only be sold
by or on the order of a dentist, physician or any other medical practitioner
licensed by the law of the State in which he or she practices, and who
intends to use or order the use of this medical device.
Batch code
Not for re-use Latex-free
Use byCE marking
with identification number
of the Notified Body
XXXX
on the irrigation tubing set

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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.
Observe the safety notes.
Intended use
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN 13940)
compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF).
Misuse may damage the medical device 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 W&H Implantmed.
We have based our developmed and design of the Implantmed on the »physician« target group.

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Introduction
Production according to EU Directive
The medical device complies with the regulations of Directive 93/42/EEC.
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the Implantmed
when compliance with the following instructions is ensured:
> The Implantmed must be used in accordance with these Instructions for Use.
> The Implantmed has no components that can be repaired by the user.
> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 62).
> The electrical installation at the premises must comply with the regulations laid out in 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 control unit invalidates all claims under warranty and any other claims.
In addition to unauthorized assembly, installation, modification of or repairs to the control unit, motor with cable,
transmission instrument and non-compliance with our instructions, improper use will void the warranty and release us
from all other claims.

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2. Electromagnetic compatibility (EMC)
Medical electrical device 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 only guarantees compliance of the control unit with the EMC Directives when it is used with original W&H
accessories and spare parts. The use of accessories and spare parts that have not been approved by W&H may lead
to increased emission of electromagnetic interference or to reduced resistance to electromagnetic interference.
You can find the current EMC manufacturer’s declaration on our website at http://wh.com
or, alternatively, you can also request a copy 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 device.

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3. Unpacking
Remove the packaging.
Remove the motor with cable.
Remove the foot control,
Instructions for Use and
accessories.
Lift out the insert with the
control unit. Remove the
mains cable, irrigant support,
universal support, irrigation
tubing set and Instructions
for Use.
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
REF Description
30286000 Control unit SI-923 (230 V)
30287000 Control unit SI-915 (115 V)
30185000 EM-19 motor without electrical contacts with 1.8 m cable incl. 5 hose clips
04363600 Irrigation tubing set 2.2 m (3 pcs, disposable)
07721800 Universal support
04005900 Irrigant support
30285000 Foot control S-N2
01343700 Mains cable EU
02821400 Mains cable USA, CAN, J
03212700 Mains cable UK, IRL
04280600 Mains cable CH
05901800 Mains cable DK

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5. Safety notes
> Before using the Implantmed for the first time, store it at room temperature for 24 hours.
> Check the control unit and the motor with cable for damage and loose parts every time before use.
> Do not operate the control unit and the motor with cable if it is damaged.
> Check the parameter settings every time the device is restarted.
> Perform a test run prior to every treatment.
> The responsibility for the use and timely shutdown of the system lies with the user.
> Ensure that it is possible to complete the operation safely should the control units or instruments fail.
The Implantmed is not approved for operation in potentially explosive atmospheres.
Do not twist or kink the motor cable! Do not coil it too tightly!
Moisture in the motor with cable may cause a malfunction! (Risk of short circuit)
Control unit / Motor

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Safety notes
> Use only original W&H fuses
> Never touch the patient and the electrical connections on the control unit simultaneously.
The control unit is classed as “conventional equipment” (closed equipment without protection against the ingress of water).
Use the control unit in P4 and P5 programs exclusively with the surgical contra-angle handpieces approved by W&H. Use of
other contra-angle handpieces may result in deviation from the indicated torque. The user alone is responsible for the above.
The manufacturer does not accept any liability.
Power failure
In the event of a power failure, if the control unit 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.
Control unit

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Safety notes
Mains cable / Power switch
> Only use the mains cable supplied.
> Plug the mains cable only into an earthed power socket.
> Set up the control unit so the power switch and the socket are easily accessible at all times.
Disconnect the control unit from the power supply in case of danger.
> Turn off the control unit at the power switch.
> Pull the power plug out of the socket.
Rotational energy
Deceleration of the bur can, cause the selected torque to be temporarily exceeded,
compared to the value set, as a result of the rotational energy stored in the drive system.
Observe the manufacturer’s speed and torque specifications for retaining screws for superstructures.
Adjusting these retaining screws with an electric motor presents a potential risk as described above.
Control unit / Motor

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Safety notes
Risks due to electromagnetic fields
The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (ICD)
can be affected by electric, magnetic and electromagnetic fields.
> Find out if patient and user have implanted systems before using the medical device and consider the application.
> Weigh the risks and benefits.
> Keep the medical device away from implanted systems.
> Do not place the motor on the patient’s body.
> 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.
Control unit / Motor / Foot control

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Safety notes
Follow the directions and safety notes in the Instructions for Use of the foot control.
The foot control is approved for operation in potentially explosive atmospheres (AP).
> Note that when using or setting low speeds, the operation or run-down of rotary instruments is more difficult to detect.
> The ESD spring contact on the bottom of the foot control must be in contact with the ground during operation.
ESD is the abbreviation for “electrostatic discharge”.
Foot control S-N2

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Safety notes
The Implantmed is designed for use with physiological saline solution.
> Always ensure correct operating conditions and that sufficient and adequate coolant is delivered.
> Always provide sufficient coolant and ensure the appropriate suction.
> Use only suitable coolants and follow the manufacturer’s medical data and instructions.
> Use the W&H irrigation tubing set or accessories approved by W&H.
Irrigation tubing set
Sterile disposable irrigation tubing sets are supplied with the equipment.
> Note the expiration date and only use disposable irrigation tubing with undamaged packaging.
> Replace the disposable irrigation tubing immediately after every treatment.
> Follow your local and country-specific laws, directives, standards and guidelines for disposal.
Coolant supply

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Safety notes
Transmission instrument
> Follow the directions and safety notes in the Instructions for Use of the transmission instrument.
> Only use transmission instruments with an ISO 3964 (DIN 13940) compatible coupling system and manufacturer
approved transmission instruments.
> Follow the directions of the manufacturer of transmission instrument with reference to transmission ratio, maximum
speed and maximum torque.
Hygiene and maintenance prior to initial use
> Clean and disinfect the control unit, the motor with cable, the universal support and the irrigant support.
> Sterilize the motor with cable and the universal support.