proxeo PL-40 HW Instructions for Use Rev 003

Contents 1. Introduction... 7 2. Scope of delivery... 9 3. Safety notes... 10 4. Description... 15 Handpiece drive... 15 Foot control C-NW... 16 Status LED handpiece drive...17 Status LED foot control... 18 5. Start-up... 19 Charging the battery... 19 Query battery status... 20 Pairing...21 Assembly/removal of the handpiece-/contra-angle head... 23 6. Handpiece drive ... 24 Operation... 24 7. Hygiene and maintenance... 26 General notes... 26 Limitations on processing... 27 Initial treatment at the point of use... 28 Manual cleaning... 29 Manual disinfection... 30 Automated cleaning and disinfection... 31 Drying... 32 Inspection, Maintenance and Testing... 33 8. Replacing the O-ring... 34 2

Contents 9. Servicing... 35 10. Accessories, consumables, spare parts and other recommended medical devices by W&H... 37 11. Technical data... 39 12. Data on electromagnetic compatibility according to IEC/EN 60601-1-2... 42 13. Disposal... 45 Explanation of warranty terms... 46 Authorized W&H service partners... 47

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Symbols WARNING! (risk of injury)

4

XXXX

CE mark with identification number of the Notified Body

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Not for re-use

ATTENTION! (to prevent damage occurring)

Medical device

Non-ionizing electromagnetic radiation

General explanations, without risk to persons or objects

Thermo washer disinfectable

Catalogue number

Follow instructions for use

Sterilizable up to the stated temperature

Serial number

Manufacturer

Non-sterilizable

DC – direct current

Date of manufacture

Class II medical electrical equipment

Do not dispose of with domestic waste

Symbole Not suitable for intracardiac application – Type BF appliance 25UX

Data Matrix code for product information including UDI (Unique Device Identification) Data structure in accordance with Health Industry Bar Code

This way up

MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES606011:2005/(R)2012 + A1:2012 + C1:2009/(R)2012 + A2:2010/ (R)2012, ANSI/AAMI ES606011:2005/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.

Fragile, handle with care

+60 °C (+140°F) Max.

Temperature limitation

-20 °C (-4°F) Min.

Keep dry

80 %

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

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.

8%

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Symbols RCM – Australian / New Zealand

ANATEL – Brazil

R 209 - J00204

GITEKI (MIC) – Japan

FCC / IC – USA / Canada

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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 PL-40 HW: Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings.

Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. Qualifications of the user We have based our development and design of the medical device on the target group “dentist, dental hygienist, dental employees (prophylaxis) and dental assistants”.

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Introduction Hereby, W&H declares that the medical device 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 medical device when it is used in compliance with the following directions: > > > >

The medical device must be used in accordance with these instructions for use. Only the components approved by the manufacturer may be replaced (O-ring). Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 47). 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 medical device 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. Scope of delivery REF

Description

30410000

Handpiece drive

07969610

Charger with adaptor

05882600

Handpiece holder

Optional included in set 30316000

Foot control C-NW with Stick

30096000

PL-66 W Contra-angle head System LatchShort

30097000

PL-64 Contra-angle head System Screw-in Young

30098000

PL-44 Handpiece head System Doriot

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3. 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. > Always ensure the correct operating conditions. > Perform a test run each time before using. > Never touch the patient and the electrical contacts on the medical device simultaneously.

> Do not expose the medical device to any violent mechanical impacts. > The handpiece drive must not be disassembled.

Battery > Do not charge the battery unattended. > As soon as the charging cycles start to deteriorate send the medical device to an authorized W&H service partner. > Defective or worn-out batteries must only be replaced by an authorized W&H service partner.

> Charge the battery of the medical device as soon as the status LED flashes. > Incorrect use of the rechargeable battery can cause fire or corrosion.

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Safety notes The medical device is classed as “conventional equipment” (closed equipment without protection against the ingress of water). The medical device is not approved for operation in potentially explosive atmospheres. Charger > Only use chargers approved by W&H. Hygiene and maintenance prior to initial use > Clean and disinfect the medical device. System failure A total system failure does not constitute a critical fault. Simply switch the unit off and then on again.

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Safety notes Risks due to electromagnetic fields This medical device is suitable for use on patients with cardiac pacemakers, if a safety distance between the medical device and the cardiac pacemaker of at least 15 cm (5,9 inch) is maintained. The functionality of other active implantable medical devices (AIMD) (e.g. ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if the patient has other active implantable medical devices (AIMD) before using the medical device and inform about the risks. > Do not place the applied part on the patient’s body.

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Safety notes The patient environment (see diagram) encompasses the area up to 2.50 m above the patient and 1.83 m in all horizontal directions. 2,5 m

The charger must not be used within the patient environment.

3m

1,83 m

1,8

1,83 m

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Safety notes

Handpiece-/contra-angle head

> Use only the handpiece drive with the handpiece-/contra-angle head PL-44, PL-66 W, PL-64. > Follow the directions and safety notes in the Instructions for Use of the handpiece-/contra-angle head.

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4. Description

Handpiece drive W&H coupling for handpiece-/contra-angle head Status LED handpiece drive (see page 17) Status LED foot control (see page 18)

Charging socket ON/OFF button

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Description

Foot control C-NW

Stick

Charging LED (orange) (see page 18 – 19)

Status LED (green) (see page 18, 21) Charging socket Reset button

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Pairing button

Description

Status LED handpiece drive Standby mode > The handpiece can be activated with the ON/OFF button. > If the handpiece drive is not used for longer than 4 minutes, it returns to standby mode automatically.

LED

steady

GREEN

e Battery is 25–100 % charged e Pairing successful > Handpiece drive is ready for operation (charging cable must be disconnected) e Battery is charging > Not ready for operation

ORANGE

RED

flashes

flashes intermittently

e Pairing active

e Battery is 2–25 % charged e Battery is 1 % charged > Complete the treatment > Charge the battery > Do not start any further treatment > Charge the battery e Error message > Contact an authorised W&H service partner 17

Description LED

ORANGE

Status LED foot control flashes

flashes alternately

e Battery of foot control is flat e Pairing unsuccessful > Complete the treatment > Troubleshooting with pairing problems > Charge the battery of the foot control (see page 22) Standby mode > The foot control can be activated by pressing.

LED

steady

GREEN

e Connection to paired medical device established

ORANGE * The LED flashes for 40 milliseconds every 4 seconds

18

steady

e Battery is charging

flashes

flashes intermittently*

e Foot control is attempting to establish a connection to the paired medical device

e Battery is flat > Charge the battery

5. Start-up

Charging the battery

Charge the medical device fully before you use them for the first time.  Attach the adaptor to the power supply unit.

 Connect the charging cable into the foot control charging socket.

 Plug the charger into an power socket.

LED orange: Battery is charging. LED off: Battery is charged.

click!

 Insert the charging cable into the handpiece drive charging socket until it audibly engages. LED orange: Battery is charging. LED green: Battery is charged. The handpiece drive does not switch to standby mode and it is not ready for operation until it is connected to the charging cable. 19

Start-up

Query battery status

You can query the battery status when the handpiece drive is switched on and during the charging process.

> Briefly press the ON/OFF button: LED

20

flashes

Battery status

3 x green 2 x green 1 x green orange

75–100 % 50–75 % 25–50 % 2–25 %