54 Pages
Preview
Page 1
Instructions for use
PL-40 H
Contents Symbols... 4 1. Introduction... 9 2. Scope of delivery... 11 3. Safety notes...12 4. Description...17 Handpiece drive...17 Foot control... 18 Status LED handpiece drive... 19 Status LED foot control... 20 5. Start-up...21 Charging the battery...21 Query battery status... 22 Pairing... 23 Assembly/removal of the barrier sleeve and Prophy Angle... 25 6. Handpiece drive ... 26 Switch on/off... 26 Test run... 27 7. Hygiene and maintenance... 28 General notes... 28 Limitations on processing... 29 Initial treatment at the point of use... 30 Manual cleaning... 31 Manual disinfection... 32 Automated cleaning and disinfection... 33 Drying... 34 Inspection, Maintenance and Testing... 35 Packaging... 36
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Contents Sterilization... 37 Storage... 39 8. Replacing the O-ring... 40 9. Servicing... 41 10. W&H Accessories and spare parts... 43 11. Technical data... 44 12. Data on electromagnetic compatibility according to IEC/EN 60601-1-2... 47 13. Disposal... 51 Explanation of warranty terms... 52 Authorized W&H service partners... 53
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Symbols
in the instructions for use
WARNING! (risk of injury)
ATTENTION! (to prevent damage occurring)
2 Not for re-use
4
Class II medical electrical equipment
General explanations, without risk to persons or objects
Symbols Follow instructions for use
Non-sterilizable
Catalogue number
Date of manufacture
Sterilizable up to the stated temperature
Serial number
Do not dispose of with domestic waste
Thermo washer disinfectable
DC – direct current
Data Matrix code for product information including UDI (Unique Device Identification)
Not suitable for intracardiac application – Type BF appliance
Medical Device
CE mark XXXX with identification number of the Notified Body
25UX
on the handpiece drive / handpiece sleeve
Non-ionizing electromagnetic radiation
MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005, ANSI/AAMI ES60601-1: A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012, CAN/CSA-C22.2 No. 60601-1:2008, CSA CAN/CSA-C22.2 NO. 60601-1:2014. 25UX – Control No. 5
Symbols
on the foot control
CE mark XXXX with identification number of the Notified Body Do not dispose of with domestic waste
Data Matrix code for product information including UDI (Unique Device Identification) UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements Manufacturer
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IPX1
Non-ionizing electromagnetic radiation
Catalogue number
DC – direct current
Serial number
Protection against dripping water
Date of manufacture
Foot control cordless C-NW
Reset
Symbols R 209 - J00204
radio symbol on the handpiece drive / foot control GITEKI (MIC) – Japan
FCC / IC – USA / Canada*
ANATEL – Brazil
RCM – Australian / New Zealand
* 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. 7
Symbols
on the packaging
CE mark with identification XXXX number of the Notified Body
Data Matrix code for product information including UDI (Unique Device Identification)
This way up
Data structure in accordance with Health Industry Bar Code Fragile, handle with care +60 °C (+140°F) Max.
Keep dry
-20 °C (-4°F) Min.
80 %
“Der Grüne Punkt” (The Green Dot) trademark of Duales System Deutschland GmbH Date of manufacture Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard 8
Temperature limitation
Humidity limitation
8%
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.
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. Indications for use PL-40 H: Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings. C-NW: Foot control for operation of medical electrical equipment. 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 foot control 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 53). The foot control has no components that can be repaired by the user. 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! 10
2. Scope of delivery REF
Description
30317000
Handpiece drive
30316000
Foot control C-NW with Stick
07969610
Charger with adaptor
05882600
Handpiece holder
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3. Safety notes
Handpiece drive / Foot control
> 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 that the correct operating conditions are provided. > Perform a test run each time before using. > Never touch the patient and the electrical contacts on the medical device simultaneously. > Only put the medical device into operation when the handpiece sleeve is attached. > Keep the foot control away from magnetic fields. > Replace the foot control as soon as the resistance is noticeably reduced. > Do not expose the medical device to any violent mechanical impacts. 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
Handpiece drive / Foot control
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 handpiece drive and the foot control. > Sterilize the handpiece sleeve. 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
Handpiece drive / Foot control
Handpiece drive Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (ICD) can be affected by electric, magnetic and electromagnetic fields. This medical device is suitable for use on patients with unipolar and bipolar pacemakers or ICD, if a safety distance between the medical device and the cardiac pacemaker or ICD of at least 7 cm (2,76 inch) is maintained. > Find out if patient or user have implanted systems before using the medical device and consider the application. > Weigh the risks and benefits. > Make appropriate emergency precautions 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. Foot control > Keep the foot control away from implanted systems.
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Safety notes
Handpiece drive / Foot control 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 2,5 m m
The charger must not be used within the patient environment. 1,83 1.83m m
1,.8 3m
1,83 m m 1.83
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Safety notes
2
Prophy Angle / Barrier sleeve
The Prophy Angles and barrier sleeves are disposable articles.
> Use only Prophy Angles which are in perfect condition. Follow the operating instructions of the manufacturer. > Insert the Prophy Angle only when the medical device is stationary. > Never touch the Prophy Angle while it is still rotating. > Use a new disposable barrier sleeve for each application to prevent contamination of the handpiece drive. > Attach or remove the disposable barrier sleeve only when the medical device is stationary. > Only use Prophy Angles with plastic shanks for the Doriot system. Prophy Angles with metal shanks damage the clamping chuck system.
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4. Description
Coupling for Prophy Angle
Handpiece drive
Handpiece sleeve Status LED handpiece drive (see page 19) Status LED foot control (see page 20)
Nose Charging socket ON/OFF button
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Description
Foot control
Stick
Charging LED (orange) (see page 20 - 21)
Status LED (green) (see page 20, 23) 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 authorized W&H service partner 19
Description
Status LED foot control
LED
ORANGE
flashes
flashes alternately
e Battery of foot control is flat > Complete the treatment > Charge the battery of the foot control
e Pairing unsuccessful > Troubleshooting with pairing problems (see page 23)
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
20
steady
flashes
flashes intermittently*
e Foot control is attempting e Battery is flat to establish a connection to > Charge the battery the paired medical device e Battery is charging