W&H Implantmed Plus SI-1010 User manual

Instructions for Use
Edition USA
SI-1010 / SI-1015 / SI-1023

2
Contents
Symbols.......................................................................................................................................................................................................... 4
1. Introduction ............................................................................................................................................................................................... 8
2. Unpacking ................................................................................................................................................................................................ 10
3. Scope of delivery..................................................................................................................................................................................... 11
4. Safety notes .............................................................................................................................................................................................12
5. Description................................................................................................................................................................................................17
of front panel........................................................................................................................................................................................17
of rear panel........................................................................................................................................................................................ 18
of foot control S-N2/S-NW .................................................................................................................................................................. 19
6. Start-up .....................................................................................................................................................................................................21
7. Starting operation.................................................................................................................................................................................... 23
8. Control unit operation............................................................................................................................................................................. 24
Main menu........................................................................................................................................................................................... 24
Menue Navigation ............................................................................................................................................................................... 27
Documentation with USB stick........................................................................................................................................................... 33
ioDent®platform................................................................................................................................................................................. 35
Beacon ................................................................................................................................................................................................ 37
9. Error messages........................................................................................................................................................................................ 38

3
Contents
10. Hygiene and maintenance ................................................................................................................................................................... 41
General notes ...................................................................................................................................................................................... 41
Limitations on processing.................................................................................................................................................................. 42
Initial treatment at the point of use .................................................................................................................................................. 43
Manual cleaning.................................................................................................................................................................................. 44
Manual disinfection............................................................................................................................................................................ 45
Automated cleaning and disinfection ............................................................................................................................................... 46
Drying.................................................................................................................................................................................................. 47
Inspection, maintenance and testing ............................................................................................................................................... 48
Packaging............................................................................................................................................................................................ 49
Sterilization......................................................................................................................................................................................... 50
Storage ................................................................................................................................................................................................ 52
11. Servicing ................................................................................................................................................................................................ 53
12. W&H accessories and spare parts....................................................................................................................................................... 55
13. Technical data........................................................................................................................................................................................ 58
14. Data on electromagnetic compatibility according to IEC/EN 60601-1-2.......................................................................................... 60
15. Disposal ................................................................................................................................................................................................. 63
W&H course certificate............................................................................................................................................................................... 64
Explanation of warranty terms................................................................................................................................................................... 67
Authorized W&H service partners.............................................................................................................................................................. 68

4
WARNING!
(if persons could be injured)
ATTENTION!
(if property could be damaged)
General explanations, without
risk to persons or property
Medical Device
CE marking with identification
number of the Notified Body
XXXX
Manufacturer
Consult Instructions for Use
Catalogue number
Serial number
Do not dispose of with
domestic waste
DataMatrix code for product
information including UDI
(Unique Device Identification)
Date of manufacture
Symbols
Sterilizable up to the stated
temperature
Thermo washer disinfectable

5
Follow Instructions for Use
Symbols
Class II equipment
Foot control
On / Off
Electric fuse
Earth
Alternating current
Power consumption
of the control unit
Supply voltage
of the control unit
Supply current
Frequency of the
alternating current
MEDICAL – GENERAL MEDICAL
EQUIPMENT AS TO ELECTRICAL
SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE
WITH ANSI/AAMI ES60601-
1:2005/(R)2012 + A1:2012 +
C1:2009/(R)2012 + A2:2010/
(R)2012, ANSI/AAMI ES60601-
1:2005/A2:2021, CAN/
CSA-C22.2 No. 60601-1:14,
CAN/CSA-C22.2 No. 60601-
1:14/A2:22, IEC 80601-2-
60:2019. 25UX – Control No.
25UX

6
Revolutions per minute
(= rpm)
Symbols
This way up
Fragile, handle with care
Keep dry
Temperature limitation
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 %
Caution! According to
Federal law restricts this
device to sale by or on the
order of a physician, dentist,
veterinarian or with the
descriptive designation of any
other practitioner licensed by
the law of the State in which
the practitioner practices to
use or order the use of the
device.
Data structure in
accordance with Health
Industry Bar Code

7
Symbols
Sterilization with ethylene
oxide
Batch code
Not for re-use
Latex-freeUse by
Do not resterilize
Do not use when package is
damaged
Keep away from heat Single sterile barrier system

8
1. Introduction
For your safety and the safety of your patients
These Instructions for use explain how to use your medical device. 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) for treatment of dental hard tissue.
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 medical device.
We have based our developmed and design of the medical device on the »physician« target group.

9
Introduction
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device
when compliance with the following instructions is ensured:
> The medical device must be used in accordance with these Instructions for Use.
> The medical device 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 68).
> 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.
Improper use, unauthorized assembly, modification or repair to the medical device, non-compliance with our instructions or the use
of accessories and spare parts which are not approved by W&H, invalidates all claims under warranty and any other claims.
Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the
competent authority!

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2. 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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3. Scope of delivery
Control unit SI-1023 (230V)
30288000
SI-1015 (120V)
30289000
SI-1010 (100V)
30290000
REF 436360 Irrigation tubing set 2.2 m
(3 pcs, disposable) X
REF 07721800 Universal support X
REF 04005900 Irrigant support X
Mains cable country-specific X
Optional included in set
REF 3028100x EM-19 LC motor with electrical
contacts and 1.8 m or 3.5 m cable
REF 30185000 EM-19 motor without electrical
contacts with 1.8 m cable
REF 30264000 Foot control S-NW
REF 30285000 Foot control S-N2
REF 07759700 SPI dongle

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4. Safety notes
> Before using the medical device for the first time, store it at room temperature for 24 hours
> Check the medical device for damage and loose parts each time before using.
> Do not operate the medical device 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 units or instruments fail.
The medical device is not approved for operation in potentially explosive atmospheres.
The medical device is not approved for operation in oxygen rich Environment.

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Safety notes
> Use only original W&H fuses.
> Never touch the patient and the electrical contacts on the control unit simultaneously.
> Make sure that no computer viruses are transferred to the control unit by an external data medium (USB stick).
The connection of a USB hard drive with an external power source is not permitted.
The control unit is classed as “conventional equipment” (closed equipment without protection against the ingress of water).
Use the WS-75, WI-75 and SZ-75 (20:1) ratios exclusively with the 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 therefore
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.

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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.
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.
Note that when using or setting low speeds, the operation or run-down of rotary instruments is more difficult to detect.

15
Safety notes
Risks due to electromagnetic fields
The functionality of active implantable medical devices (AIMD) (e.g. cardiac pacemaker, ICD) can be affected by electric,
magnetic and electromagnetic fields.
> Find out if the patient has active implantable medical devices (AIMD) before using the medical device and inform about
the risks.
Follow the directions and safety notes in the Instructions for Use of the foot control, the elctric motors and the transmission
handpieces.

16
Safety notes
Coolant supply
The medical device 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.
Hygiene and maintenance prior to initial use
> Clean and disinfect the control unit, the universal support and the irrigant support.
> Sterilize the universal support.

17
5. Description
Connection for motor
Display
(touchscreen)
Pump cover
OPEN
Pump cover Irrigant support locator
of front panel

18
Description
Connection
for foot control
Fuse holder with 2 fuses
(2 x 250 V – T1.6 AH)
Connection for
mains cable
Irrigant support locator
USB
USB
Power switch
ON/OFF
of rear panel

19
Description
ORANGE
Change program
Change application
Locator
attach/detach
GREEN
Pump
ON/OFF
GREY
Start motor (pedal)
VARIABLE or ON/OFF
(Factory setting = variable)
YELLOW
Change motor direction
Forward operation/reverse operation
of foot control S-N2/S-NW

20
Description
ORANGE
S-N2 / S-NW: Change program
Press the ORANGE button to change programs in ascending order. The motor direction is automatically set to forward operation every
time the program is changed.
When changing from the last program to the first program a longer acoustic signal sounds (risk of injury).
GREEN – pump ON/OFF
Only when the motor is stationary can the pump be switched on or off by pressing the GREEN button of the foot control.
YELLOW – change motor direction
Forward operation/reverse operation
Press the YELLOW button to change from forward operation to reverse operation. A signal sounds on selection and the
“Forward/reverse operation mode” symbol flashes. Before the motor starts in reverse operation, 3 audible signals are given.
of foot control S-N2/S-NW