W&H S-NW User manual

Instructions for Use
Foot control
variable
S-NW, S-N2, S-N1

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Contents
Symbols.......................................................................................................................................................................................................... 3
1. Introduction ............................................................................................................................................................................................... 7
2. Electromagnetic compatibility (EMC)..................................................................................................................................................... 9
3. Scope of delivery..................................................................................................................................................................................... 10
Scope of delivery......................................................................................................................................................................................... 11
4. Safety notes .............................................................................................................................................................................................12
5. Attaching - detaching the locator........................................................................................................................................................... 15
6. Foot control S-NW .................................................................................................................................................................................... 16
Inserting and replacing batteries ...................................................................................................................................................... 16
Replacing the O-ring.............................................................................................................................................................................17
Connecting and disconnecting the CAN dongle ................................................................................................................................ 18
Description of CAN dongle .................................................................................................................................................................. 19
Connecting and disconnecting the SPI dongle.................................................................................................................................. 20
Description of SPI dongle.....................................................................................................................................................................21
Assistance with pairing problems ..................................................................................................................................................... 22
7. Foot control S-N2 / S-N1.......................................................................................................................................................................... 23
Connecting / disconnecting ............................................................................................................................................................... 23
8. Hygiene and maintenance...................................................................................................................................................................... 24
9. Servicing .................................................................................................................................................................................................. 25
10. W&H accessories and spare parts....................................................................................................................................................... 26
11. Technical data........................................................................................................................................................................................ 27
12. Disposal ................................................................................................................................................................................................. 29
Explanation of warranty terms................................................................................................................................................................... 30
Authorized W&H service partners.............................................................................................................................................................. 31
Manufacturer’s declaration......................................................................................................................................................................... 32

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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
in the Instructions for Use
Foot control

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Symbols
UL Component Recognition
Mark indicates compliance
with Canadian and U.S.
requirements
Non-ionizing electromagnetic
radiation
Battery compartment closed
Do not dispose of with
domestic waste
Battery compartment open
Catalogue number
Serial number
Date of manufacture
Data Matrix code
for product information
including UDI (Unique Device
Identification)
CE marking
with identification number
of the Notified Body
XXXX
Regulatory Compliance Mark
(RCM) indicates compliance
with the Australian and New
Zealand electrical safety, EMC,
EME and telecommunications
requirements
on the foot control S-NW
Category AP equipment
AP
This medical device does
not claim to protect against
interference but must not
cause any interference on
properly authorised systems.
GITEKI (MIC) -
Japan Radio symbol
This medical device complies with part
15 of the FCC Rules. Operation is subject
to the following two conditions: (1) this
medical device may not cause harmful
interference, and (2) this medical device
must accept any interference received,
including interference that may cause
undesired operation
NCC – Taiwan Radio symbol
R

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Symbols
UL Component Recognition
Mark indicates compliance
with Canadian and U.S.
requirements
Do not dispose of with
domestic waste
Catalogue number
Serial number
Date of manufacture
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 S-N2 / S-N1
Category AP equipment
AP

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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

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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
Foot control for operation of medical electrical equipment.
Misuse may damage the foot control and hence cause risks and hazards for patients, users and third parties.
Qualifications of the user
We have based our development and design of the foot control for the physician, dental hygienists, dental employees (prophylaxis)
and dental assistants target group.
1. Introduction

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Introduction
Production according to EU Directive
The foot control S-N1 and S-N2 is a medical device as defined by EU Directive 93/42/EEC.
The foot control S-NW is a medical device as defined by EU Directive 93/42/EEC and RED Directive 2014/53/EU.
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the foot control
if it is used in compliance with the following directions:
> The foot control must be used in accordance with these Instructions for Use and with the instructions
> for use of the drive unit.
> The foot control 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 31).
> Unauthorized opening of the foot control invalidates all claims under warranty and any other claims.
The foot control must be used only with the control unit listed in the equipment supplied.
In addition to unauthorized assembly, installation, modification of or repairs to the foot control or non-compliance
with our instructions, improper use will invalidate all claims made under warranty or otherwise.

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2. Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to particular precautions in regard 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 accessories and spare parts not approved by W&H can lead to an increased emission of
electromagnetic interference or to a reduced resistance against electromagnetic interference.
HF communication equipment
Portable HF communications equipment (including peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical
device could result.
The medical device may be interfered by other equipment, even if these other devices comply with CISPR (International
special committee on radio interference) emission requirements.
Use of this medical device adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this medical device and the other equipment should be observed to verify that
they are operating normally.
The medical device is not intended for use in the vicinity of HF surgical devices.

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3. Scope of delivery
Foot control Incl. dongle Compatible with control unit*
S-NW, REF 30264000 REF 07759700 Implantmed SI-1010, Implantmed SI-1015, Implantmed SI-1023
Amadeo Medical M-UK 1023, M-UK1015, M-UK1010
S-NW, REF 30264001 REF 07795800 Piezomed SA-320, Elcomed SA-310, Implantmed REF 16929000 / 16929001
S-N2, REF 30285000
Implantmed SI-1010, Implantmed SI-1015, Implantmed SI-1023
Implantmed SI-923, SI-915 (REF 30286xxx, 30287xxx)
Amadeo Medical M-UK 1023, M-UK 1015, M-UK 1010
S-N1, REF 05083300 SI-95 (Implantmed, DU900, OsseoSetTM 100, Frios® Unit S)
SA-200, SA-200 C (Elcomed)
S-N1, REF 05046200
SI-923, SI-915 (Implantmed REF 00900100 / 00900101 / 00900102 / 00900103 /
00900104 / 00900105 / 00900106 / 00900107), BTI DrillTech®, Implant Unit, Ism,
Surgical Motor System, OSM2, MIS MCU, DU1000, Frios® Unit S/i, OsseoSet 200,
Osscora instrument set)
S-N1, REF 06202400 SA-310 (Elcomed)
SI-923, SI-915 (Implantmed REF 16929000 / 16929001)
S-N1, REF 07004400 SA-320 (Piezomed)
S-N1, REF 06382200 PA-123, PA-115 (Tigon+)
Locator, REF 04653500 For all listed foot controls

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Foot control S-NW
3 disposable batteries AA / Mignon / LR6 / 1.5V
* Not included
Scope of delivery

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4. Safety notes
> Before using the foot control for the first time, store it at room temperature for 24 hours.
> Check the foot control for damage and loose parts before every use.
> Do not use the foot control if it is damaged.
> Replace the foot control if the resistance of the pedal is noticeably reduced.
> Never touch the patient and the connections for the foot control on the control unit simultaneously.
> 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”.
The foot control is approved for operation in potentially explosive atmospheres (AP).
General

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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 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.
> 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.
Safety notes General

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Safety notes
Keep the ORANGE button depressed and switch between the control units.
Disposable batteries
> Replace the disposable batteries at the first prompt (battery icon on display or LED on dongle).
> Replace batteries outside explosive atmospheres only.
> Pay attention to the battery icon on the display before and after each treatment.
> Dispose of faulty or flat batteries immediately and correctly via recycling systems. Do not dispose of batteries in
domestic waste.
> Use only high-quality disposable alkaline AA / Mignon / LR6 / 1.5 V batteries. Risk of explosion if the wrong type of
battery is used.
> Do not mix new, old or different types of disposable batteries.
> Do not use rechargeable batteries.
> When inserting disposable batteries make sure that they are correctly oriented.
> Check the O-ring of the battery cover for damage. Replace a faulty or leaking O-ring immediately.
> Always keep spare batteries on hand.
Disposable batteries may cause damage due to leakage or corrosion.
> Remove the disposable batteries if you are not going to use the foot control for a longer period.
> See the safety notes of the battery manufacturer.
Foot control S-NW

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5. Attaching - detaching the locator
Attaching and detaching the locator
> Push it right in until the locator reaches the stop.
> Pull the locator out.

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Open the battery compartment.
Note the symbols!
6. Foot control S-NW
Pull the red thread to remove
the batteries.
Open battery compartment Remove batteries
Inserting and replacing batteries
Lock the battery compartment.
Insert batteries
Reposition the red thread before
inserting batteries.
Insert the batteries.
Pay attention to
the positioning!
Lock battery compartment

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Foot control S-NW
Do not use sharp tools!
Firmly squeeze the O-ring between your thumb and
index finger so that it forms a loop.
Pull off the O-ring.
Push the new O-ring on in its place.
Replacing the O-ring

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Plug in the CAN dongle.
Pay attention to the positioning!
Press the side lock and remove the CAN dongle.
Foot control S-NW
Connecting CAN dongle
Removing CAN dongle
Connecting and disconnecting the CAN dongle

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Foot control S-NW
CAN dongle activated
Icon visible on display
> CAN dongle inserted
> Control unit switched on
> Foot control actuated
Pairing
The foot control S-NW and the CAN dongle are paired by default.
If pairing is inactive, you can activate pairing on the control unit (see Implantmed instructions for use)
and follow the directions.
Press and hold the green and orange buttons simultaneously on the S-NW foot control for at least 3 seconds.
Disable pairing
Press and hold the green, orange and yellow buttons simultaneously on the foot control S-NW for at least three seconds.
Using multiple W&H control units simultaneously
Press and hold the orange button on the foot control S-NW for 3 seconds to switch between the various control units.
Description of CAN dongle

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Foot control S-NW
Connecting and disconnecting the SPI dongle
Pay attention to the positioning!
Plug in the SPI dongle or disconnect the SPI dongle from the control unit.
Attach the SPI dongle to the irrigant support or remove the SPI dongle from the irrigant support.
Connecting and disconnecting the SPI dongle