Foot Control S-NW , S-N2 and S-N1 Instructions for Use Rev 008

Contents Symbols... 3 1. Introduction... 6 2. Scope of delivery... 8 3. Safety notes... 9 4. Attaching - detaching the locator...12 5. Foot control S-NW...13 Inserting and replacing batteries...13 Replacing the O-ring...14 Connecting and disconnecting the CAN dongle... 15 Description of CAN dongle... 16 Connecting and disconnecting the SPI dongle...17 Description of SPI dongle... 18 Assistance with pairing problems... 19 6. Foot control S-N2 / S-N1... 20 7. Hygiene and maintenance...21 General notes...21 Manual cleaning... 22 Manual disinfection... 23 8. Servicing... 24 9. A ccessories, consumables, spare parts and other recommended medical devices by W&H... 25 10. Technical data... 26 11. D  ata on electromagnetic compatibility according to IEC/EN 60601-1-2... 28 12. Disposal... 31 Explanation of warranty terms... 32 Authorized W&H service partners... 33 2

Symbols WARNING! (if persons could be injured)

CE marking with identification number of the Notified Body

Consult Instructions for Use

ATTENTION! (if property could be damaged)

Manufacturer

Do not dispose of with domestic waste

General explanations, without risk to persons or property

Date of manufacture

DataMatrix code for product information including UDI (Unique Device Identification)

Foot control

Catalogue number

Medical Device

Serial number

XXXX

AP

Category AP equipment

UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements 3

Symbols Non-ionizing electromagnetic radiation

80 %

Humidity limitation

8%

4

+70 °C (+158°F) Max.

Temperature limitation

-40 °C (-40°F) Min.

Battery compartment closed

“Der Grüne Punkt” (The Green Dot) trademark of Duales System Deutschland GmbH

Battery compartment open

Data structure in accordance with Health Industry Bar Code

This way up

Keep dry

Fragile, handle with care

Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard

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.

Symbols R

007 - AB0103

GITEKI (MIC) – Japan

KCC-CRM-BGT-BLE113

S-NW: CCAH19LP2780T2 CAN dongle: CCAH19LP2790T5 SPI dongle: CCAH19LP2800T8

ANATEL – Brazil 01237-16-03402

IC – South Korea

NCC – Taiwan

Complies with IMDA Standards DA103787

IMDA – Singapur*

RCM – Australian / New Zealand

*Symbol only in IFU

FCC / IC – USA / Canada

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: > Reorient or relocate the receiving antenna. > Increase the separation between the equipment and receiver. > Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. > Consult the dealer or an experienced radio/TV technician for help.

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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 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.

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Introduction Hereby, W&H declares that the medical product is in compliance with Directive 2014/53/EU (RED). The full text of the EU declaration of conformity is available at the following internet address https://wh.com Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the foot control when 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 33). Unauthorized opening of the foot control invalidates all claims under warranty and any other claims.

The respective foot control may only be used with the control unit listed in the scope of delivery. 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. Scope of delivery Foot control

Incl. dongle

Compatible with control unit*

S-NW, REF 30264000 S-NW, REF 30264003

REF 07759700

SI-1010/SI-1015/SI-1023, M-UK1010/ M-UK1015/M-UK1023, SA-430 M/SA-435 M Built-In Solution (to be agreed with the system assembler)

S-NW, REF 30264001

REF 07795800

SA-320, SA-310, SI-915/SI-923 (REF 16929000/16929001)

S-N2, REF 30285000 S-N2, REF 30285002 S-N1, REF 05046200

SI-1010/SI-1015/SI-1023, SI-915/SI-923 (REF 30286xxx, 30287xxx) M-UK1010/M-UK1015/M-UK1023, SA-430 M/SA-435 M Built-In Solution (to be agreed with the system assembler) SI-915/SI-923 (REF 009001xx)

S-N1, REF 06202400

SA-310 SI-915/SI-923 (REF 16929000/16929001)

S-N1, REF 07004400

SA-320

S-N1, REF 06382200

PA-123, PA-115

Locator, REF 04653500

For all listed foot controls

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

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3. Safety notes

General

> 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 each time before using. > Do not operate the foot control if it is damaged. > Replace the foot control as soon as the resistance is noticeably reduced. > Never touch the patient and the electrical contacts on the medical device 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 use in explosive areas (AP).

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Safety notes

General

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.

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Safety notes

Foot control S-NW

Keep the orange/middle button pressed and switch between the control units/applications. 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 faulty or flat batteries immediately and correctly via recycling systems. Do not dispose 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. 11

4. 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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5. Foot control S-NW

Inserting and replacing batteries

Open battery compartment

Remove batteries  Open the battery compartment.

 Pull the red thread to remove the batteries.

Note the symbols!

Insert batteries

Lock battery compartment Reposition the red thread before inserting batteries.

 Lock the battery compartment.

 Insert the batteries. Pay attention to the positioning!

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Foot control S-NW

Replacing the O-ring 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.

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Foot control S-NW

Connecting and disconnecting the CAN dongle

Connecting CAN dongle  Plug in the CAN dongle. Pay attention to the positioning!

Removing CAN dongle  Press the side lock and remove the CAN dongle.

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Foot control S-NW

Description of CAN dongle

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 Instructions for Use Implantmed/system assembler) and follow the directions. > Press and hold the green/left and orange/middle buttons simultaneously on the S-NW foot control for at least 3 seconds. Disable pairing Press and hold all three buttons simultaneously on the foot control S-NW for at least three seconds. Switching between multiple control units Press the orange/middle button for 3 seconds. Change application Press the orange/middle button for 3 seconds until an acoustic signal sounds. 16

Foot control S-NW

Connecting and disconnecting the SPI dongle

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.

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Foot control S-NW

Description of SPI dongle

Green – SPI dongle activated LED on if the SPI dongle is connected and the control unit is switched on. Orange – battery LED flashes if the batteries on the foot control need to be replaced. Blue – pairing The foot control S-NW and the SPI dongle are paired in default status. If pairing is active: LED indicator flashes If pairing is inactive:  Press and hold the button on the SPI dongle for 4 seconds.  LED indicator flashes. SPI dongle is in pairing mode for 30 seconds.  Press and hold the green and orange buttons simultaneously on the S-NW foot control.  LED flashes three times when pairing is successful. Disable pairing Press and hold the green, orange and yellow buttons simultaneously on the foot control S-NW for at least three seconds. Switching between multiple control units Press the orange/middle button for 3 seconds. 18

Foot control S-NW > > > > > >

Assistance with pairing problems

Check the plug-in connection of the dongle. Remove metallic objects between foot control, control unit and dongle. Change the position of the foot control. Eliminate any sources of interference (e.g. brush motors, mobile telephones, radios, WLAN, ...). Replace the pairing and repeat the pairing process. Remove and replace the batteries.

If the pairing problem cannot be remedied using the steps described above, the unit will need to be inspected by an authorized W&H service partner.

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6. Foot control S-N2 / S-N1

Connecting / disconnecting

Pay attention to the positioning!

 Plug in the foot control S-N2 / S-N1 or disconnect the foot control from the control unit.

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