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

4
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.