KaVo PIEZOlux 0.571.5211 User manual

Instructions for use
PIEZOlux (0.571.5211 - 1.001.8522)
Always be on the safe side.

Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Tel. [phone]
Fax [phone]
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com

Contents
Contents 1
1 User instructions 2
1.1 User guide 2
1.1.1 Abbreviations 2
1.1.2 Symbols 2
1.1.3 Target group 3
1.2 Service 3
1.3 Transportation and storage 3
2 Safety 4
2.1 Description of safety instructions 4
2.1.1 Warning symbol 4
2.1.2 Structure 4
2.1.3 Description of danger levels 4
2.2 Purpose – Proper use 4
2.2.1 General information 4
2.2.2 Product-specific 5
2.3 Safety 5
2.3.1 Product-specific safety instructions 5
3 First use 6
3.1 Exchanging tips 6
3.1.1 Screw out the tip 6
3.1.2 Screw in the tip 6
3.2 Load test for early recognition of tip breakage 6
4 Operation 7
4.1 Using the PIEZOlux 7
5 Preparation methods DIN EN ISO 17664 8
5.1 Cleaning 8
5.1.1 Cleaning the instrument 8
5.1.2 Cleaning the grip sleeve 9
5.1.3 Cleaning the ZEG tips 9
5.2 Disinfection 10
5.2.1 Disinfecting the instrument 10
5.2.2 Disinfecting the grip sleeve 10
5.2.3 Disinfecting the ZEG tips 11
5.3 Sterilisation 11
5.3.1 Sterilising the grip sleeve 12
5.3.2 Sterilising the ZEG tips 12
5.4 Service and Care 13
5.4.1 Replace the high-pressure lamp 13
5.4.2 Care of ZEG tips 13
5.5 Control and function test 13
5.5.1 Check the calculus remover tips with a measuring card 14
6 Tools 15
Instructions for use PIEZOlux (0.571.5211 - 1.001.8522)
Contents
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1 User instructions
1.1 User guide
Requirement
Read these instructions prior to first use to prevent misuse and damage.
1.1.1 Abbreviations
Abbre‐
viation
Explanation
GA Instructions for use
PA Care instructions
REC Assembly instructions
TA Technician's instructions
STK Safety checks
IEC International Electrotechnical Commission
RA Repair instructions
EMC Electro magnetic compatibility
1.1.2 Symbols
Refer to chapter Safety/Warning
Important information for users and technicians
KaVo products with this symbol can be sterilised in autoclaves up to 138°C.
Action request
Material number
CE mark according to EC Directive 93/42 for medical devices
Disposal instructions, proper use
Read and note the content of accompanying documents.
Follow the instructions for use
Classification
Type B application parts
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1.1.3 Target group
This document is for dentists and office personnel.
1.2 Service
Service hotline:
[phone]
[email protected]
Please indicate the product serial number in all requests.
Additional information can be obtained at: www.kavo.comAdditional information can
be obtained at: www.kavo.com
1.3 Transportation and storage
CAUTION
It is hazardous to start up the medical device after it has been stored refrigerated.
This can cause the medical device to malfunction.
▶Prior to start-up, very cold products must be heated to a temperature of 20°C
to 25°C (68°F to 77°F).
Temperature: -20°C to +70°C (-4°F to +158°F)
Relative humidity: 5% to 95%, non-condensing
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture
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2 Safety
2.1 Description of safety instructions
2.1.1 Warning symbol
Warning symbol
2.1.2 Structure
DANGER
The introduction describes the type and source of the danger.
This section portrays the possible consequences of non-observance.
▶The optional step covers necessary measures for avoiding hazards.
2.1.3 Description of danger levels
Safety instructions with three hazard levels are used in this document for avoiding
personal and property damage.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property, or mild or
moderate physical harm.
WARNING
WARNING
indicates a hazardous situation that can cause death or serious injury.
DANGER
DANGER
indicates the maximum hazard level. indicates a directly hazardous situation that
can cause death or serious injury.
2.2 Purpose – Proper use
2.2.1 General information
The overarching guidelines and/or national laws, national regulations and the rules
of technology applicable to medical devices for start-up and use of the KaVo product
for the intended purpose are to be applied and complied with.
This KaVo product is intended only for use in the field of dentistry. The product may
not be used for a purpose for which it was not intended.
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"Proper use" includes following all the instructions for use and ensuring that all in‐
spections and service tasks are performed.
During use, national legal regulations must be observed, in particular:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
Users have a duty to:
▪ Only use equipment that is operating correctly
▪ to protect himself, the patient and third parties from danger.
▪ to avoid contamination from the product
2.2.2 Product-specific
Note
Do not use the ZEG (calculus remover) tips on other brands.
The PIEZOlux scaler tips are intended for effective and gentle calculus removal.
The PIEZOlux Paro tips are used in periodontology (gentle cleaning).
PIEZOlux cem tips are used for the insertion of inlays (in the semi-liquid composite
and quickly liquefies).
Note
KaVo PIEZOlux tips can also be used with the KaVo SONOsoft.
2.3 Safety
2.3.1 Product-specific safety instructions
CAUTION
Sharp-edged tip.
Injury hazard.
▶When not in use, leave the provided torque wrench on the PIEZOlux.
CAUTION
Risks from electromagnetic fields.
The functions of implanted systems (such as pacemakers) can be influenced by
electromagnetic fields.
▶Ask patients before treatment!
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3 First use
Note
Before the first use of the PIEZOlux handpiece, sterilise the removable sleeve.
3.1 Exchanging tips
3.1.1 Screw out the tip
▶ Place the torque wrench on the tip, and unscrew it counterclockwise.
3.1.2 Screw in the tip
Note
Before initial use, sterilise the tips.
▶ Insert the tip into the torque wrench and screw it into the handpiece by turning
it clockwise.
The tip is tightly seated when the torque wrench clicks.
3.2 Load test for early recognition of tip breakage
10 N ▶ Mechanically approximately 10 N to the instrument insert.
(10 N corresponds to a weight of 1 kg).
See also:
4.1 Using the PIEZOlux, Page 7
5.5 Control and function test, Page 13
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4 Operation
4.1 Using the PIEZOlux
See also: Instructions for use for the KaVo treatment unit
The KaVo ZEG PIEZOlux can gently remove calculus and plaque as well as excess
cement from natural teeth without pain at a vibrational frequency of 30 kHz.
CAUTION
Instrument inserts can be damaged from long-term use, or when dropped or bent.
They cannot be guaranteed to function properly.
Potential injury from insert breakage.
▶Check the instrument inserts before each use.
▶In the case of frequent use, replace the instrument inserts every 9 - 12 months.
▶Before each use, apply approx. 10 N of pressure to instrument inserts as an
additional safety precaution. (10 N corresponds to weight of 1 kg).
See also: 3.2 Load test for early recognition of tip breakage, Page 6
▶ Select the spray on the foot control or the electronics.
Note
The water is supplied through the working tip and can be adjusted corresponding
to the tip on the water control.
The water flow should be adjusted so that the instrument tip sprays the water with
its vibration.
Water cock
▶ Control the intensity using a foot control or the electronics.
▶ Remove calculus, plaque or excess cement with light, painting movements fol‐
lowing the tooth surface.
Make sure that the movement of the tip is in line with the handpiece axis. (The
optimum removal occurs at a vibration width of 0.05 mm to 0.07 mm with a fre‐
quency of 30 kHz.)
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5 Preparation methods DIN EN ISO 17664
CAUTION
Damage from improper cleaning and disinfection
Using of improper cleaners and disinfectants can restrict function or damage the
unit.
▶Only clean the outer surface.
▶Only use a soft cloth and tap water.
▶Do not use solvents or aggressive chemicals.
CAUTION
Damage from liquid inside the device.
If the cleansers and disinfectants are improperly handled, liquid in the interior of
the unit can cause malfunctions or destruction.
▶Make sure that no liquid cleanser or disinfectant enters the device.
▶Do not place the medical device in disinfectant baths.
Note
Improper service and care can cause premature wear and malfunctioning.
KaVo only guarantees that its products will function properly when disinfectants are
used that are listed by KaVo since they were tested for proper use on KaVo prod‐
ucts.
Infection protection
For treatments that are a "critical treatment according to RKI," KaVo recommends
using an infection protection system to prevent contamination of the tip thread.
▶ Use finger stalls that are approved for medical use.
▶ Place the fingerstall over the handpiece after the tip has already been attached.
The handpiece is ready to use.
KaVo recommends the following product, for example:
▪ Disposable fingerstalls, powder-free, size: small, order number: 01271
KaVo recommends setting up the instruments as soon as they are used.
5.1 Cleaning
5.1.1 Cleaning the instrument
Manual cleaning
Required accessories:
▪ Tap water 30°C ± 5°C (86°F ± 10°F)
▪ Brush such as a medium hard toothbrush
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▶ Switch main device switch off.
▶ Clean the instrument and instrument with a moist, clean cotton cloth until no
residual soiling can be seen.
Automatic cleaning
Not applicable.
5.1.2 Cleaning the grip sleeve
Manual cleaning
▶ Brush off the grip sleeve under flowing, cold tap water until no visible contami‐
nation can be seen.
Automatic cleaning
CAUTION
Ultrasonic cleaning devices
Malfunctions from cleaning in ultrasonic cleaning devices
▶Do not place the medical device in an ultrasonic cleaning device!
▶ Clean the grip sleeve in a thermodesinfector by Miele, for example.
▶ Use according to the manufacturer's instructions for use.
5.1.3 Cleaning the ZEG tips
Manual cleaning
▶ Brush off the ZEG tips under flowing, cold tap water until no visible contamination
can be seen.
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Automatic cleaning
CAUTION
Ultrasonic cleaning devices
Malfunctions from cleaning in ultrasonic cleaning devices
▶Do not place the medical device in an ultrasonic cleaning device!
▶ Clean the ZEG tips in a thermodesinfector by Miele, for example.
▶ Use according to the manufacturer's instructions for use.
▶ After automatically cleaning the outside of the ZEG tips, immediately remove
them and sterilise them to prevent the tips from corroding.
5.2 Disinfection
CAUTION
Damage from liquid inside the device
If cleansers and disinfectants are improperly handled, disinfectants can enter the
device and cause malfunctions or destruction.
▶Make sure that no disinfectants into the device
▶Do not place the medical device in disinfectant baths.
5.2.1 Disinfecting the instrument
Manual disinfection
KaVo recommends the following products based on material compatibility. The mi‐
crobiological efficacy must be ensured by the disinfectant manufacturer.
Permissible disinfectants:
▪ AF liquid
▪ S&M Microcide
▪ Dürr FD 322
▶ Use disinfectants according to the manufacturer's instructions for use.
Automatic disinfecting
Not applicable.
5.2.2 Disinfecting the grip sleeve
Manual disinfection
KaVo recommends the following products based on material compatibility. The mi‐
crobiological efficacy must be ensured by the disinfectant manufacturer.
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Permissible disinfectants:
▪ AF liquid
▪ S&M Microcide
▪ Dürr FD 322
▶ Use disinfectants according to the manufacturer's instructions for use.
Automatic disinfecting
KaVo recommends thermodisinfectors in accordance with ISO 15883-1,
e.g. Miele G 7781/G 7881
(Validation was performed with the program "VARIO-TD", the cleaner "neodisher®
mediclean", the neutraliser "neodisher® Z" and rinse "neodisher® mielclear" and only
refers to the material compatibility with KaVo products.)
▶ The program settings and cleansers and disinfectants that must be used can be
found in the instructions for use of the thermodisinfector.
5.2.3 Disinfecting the ZEG tips
Manual disinfection
KaVo recommends the following products based on material compatibility. The mi‐
crobiological efficacy must be ensured by the disinfectant manufacturer.
Permissible disinfectants:
▪ AF liquid
▪ S&M Microcide
▪ Dürr FD 322
▶ Use disinfectants according to the manufacturer's instructions for use.
Automatic disinfecting
KaVo recommends thermodisinfectors in accordance with ISO 15883-1,
e.g. Miele G 7781/G 7881
(Validation was performed with the program "VARIO-TD", the cleaner "neodisher®
mediclean", the neutraliser "neodisher® Z" and rinse "neodisher® mielclear" and only
refers to the material compatibility with KaVo products.)
▶ The program settings and cleansers and disinfectants that must be used can be
found in the instructions for use of the thermodisinfector.
5.3 Sterilisation
Note
The PIEZOlux handpiece cannot be sterilised.
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5.3.1 Sterilising the grip sleeve
Requirement
Remove the grip sleeve from the handpiece.
▶ Seal the grip sleeve in sterile goods packaging.
▶ Sterilise the grip sleeve an autoclave.
Depending on the device, select a suitable method from the following sterilisation
methods.
Autoclave with a triple pre-vacuum for least four minutes at 134°C ± 1°C (273°F ±
1.8°F)
Autoclave using the gravitational method: sterilise for at least 10 min. at 134°C ±
1°C (273°F ± 1.8°F)
Autoclave using the gravitational for at least 60 min. at 121°C ± 1°C (250°F ± 1.8°F)
Follow the manufacturer's instructions for use.
CAUTION
Overheating.
Damage to the on the grip sleeve.
▶140°C (284 °F) Do not exceed even when drying.
▶Immediately remove the parts from the steriliser after the sterilisation cycle.
5.3.2 Sterilising the ZEG tips
CAUTION
Contact corrosion
Contact corrosion can damage the tips or cause them to break.
▶Do not place tips in the drill bit bath or disinfection bath.
▶ Screw off the tips from the instrument using a torque wrench.
▶ Pack the tips by itself in a STERIclave bag.
Note
The STERIclave bag must be large enough so that the bag is not stretched.
▶ Sterilise calculus remover tips in autoclaves.
Depending on the device, select a suitable method from the following sterilisation
methods.
Autoclave with a triple pre-vacuum for least four minutes at 134°C ± 1°C (273°F ±
1.8°F)
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Autoclave using the gravitational method: sterilise for at least 10 min. at 134°C ±
1°C (273°F ± 1.8°F)
Autoclave using the gravitational for at least 60 min. at 121°C ± 1°C (250°F ± 1.8°F)
Follow the manufacturer's instructions for use.
5.4 Service and Care
Note
Only trained technicians may perform the necessary repairs.
5.4.1 Replace the high-pressure lamp
CAUTION
Danger due to hot bulb.
Burning hazard.
▶Do not touch the bulb after it has been used. Let the bulb cool off.
▶ Screw off the hose casing① and remove the hose coupling ② from the hand‐
piece.
▶ Pull the high-pressure lamp (Mat. no. 1.002.2912) ③ out of the socket and re‐
placed with a new one. Ensure that the position of the contacts is correct.
▶ Connect the hose coupling ② to the handpiece and screw it to the hose casing.
5.4.2 Care of ZEG tips
▶ If needed, open the water passage of the tips using a nozzle needle.
5.5 Control and function test
CAUTION
Instrument inserts can be damaged from long-term use, or when dropped or bent.
They cannot be guaranteed to function properly.
Potential injury from insert breakage.
▶Check the instrument inserts before each use.
▶In the case of frequent use, replace the instrument inserts every 9 - 12 months.
▶Before each use, apply approx. 10 N of pressure to instrument inserts as an
additional safety precaution. (10 N corresponds to weight of 1 kg).
See also: 3.2 Load test for early recognition of tip breakage, Page 6
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5.5.1 Check the calculus remover tips with a measuring card
Wear to the calculus remover tips from frequent use. Check the permissible length
using the measuring card Mat. no. 1.001.6958. If the end of the calculus remover
tips are in the red range, they need to be discarded.
▶ Dispose of damaged instrument inserts.
▶ Dispose of worn instrument inserts.
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6 Tools
Note
Available from dental suppliers:
Designation Material number
PIEZOlux Scale tip No. 9 Mat. no. 0.571.5822
PIEZOlux Scaler tip No. 10 Mat. no. 0.571.5832
PIEZOlux Scaler tip No. 11 Mat. no. 0.571.5852
PIEZOlux Perio tip No. 63 Mat. no. 1.000.2222
PIEZOlux Perio tip No. 64 Mat. no. 1.000.2223
PIEZOlux Perio tip No. 65 Mat. no. 1.000.2224
PIEZOlux cem tip No. 47 Mat. no. 0.571.6961
Torque wrench Mat. no. 1.000.4887
Nozzle needle Mat. no. 0.410.0911
High-pressure bulb Mat. no. 1.002.2912
Grip sleeve Mat. no. 0.571.5622
Measuring card Mat. no. 1.001.6958
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1.005.5901 · kb · 20100125 - 02 · en