Instructions for use

KaVo PiezoLED Scaler handpiece and tips

Table of contents

1. Before Use .......................................................................................................... 3

1.1. Intended Use ................................................................................................. 4
1.2. Indications ..................................................................................................... 4
1.3. Intended users ............................................................................................... 4
1.4. Intended patient population ........................................................................... 4
1.5. Undesirable side effects and contraindications ............................................. 4
1.6. Compatibility .................................................................................................. 5
1.7. Recommendations and safety precautions .................................................... 5
2. Installation ........................................................................................................... 8
2.1. KaVo PiezoLED Products ............................................................................. 8
1.1.1. Kits .......................................................................................................... 8
1.1.2. Accessories and consumables................................................................ 9
2.2. Preparation .................................................................................................... 9
2.2.1. Attaching and removing the handpiece ................................................. 10
2.2.2. Attaching and removing the tips ............................................................ 10
2.2.3. Attaching and removing a file ................................................................ 11
2.2.4. Patient and dental professional precautions ......................................... 12
3. Treatment .......................................................................................................... 13
3.1. PiezoLED treatment .................................................................................... 13
3.2. End of the treatment .................................................................................... 14
4. Cleaning and reprocessing ................................................................................ 15
Prepare ................................................................................................................. 16
Clean, disinfect and dry ..................................................................................... 17
Clean ................................................................................................................. 17
 Disinfection ........................................................................................................ 18
Dry ..................................................................................................................... 18
Inspection before sterilisation ............................................................................ 18
Reassembly and packaging for sterilisation ...................................................... 19
Sterilisation ........................................................................................................ 20
Storage .............................................................................................................. 20
Service life ......................................................................................................... 21
5. Maintenance and troubleshooting ..................................................................... 22
5.1. General maintenance .................................................................................. 22
5.1.1. PiezoLED light guide sleeve check & replace ....................................... 22
5.1.2. Wear ..................................................................................................... 22
5.2. Troubleshooting ........................................................................................... 22
6. Sustainability ..................................................................................................... 23
6.1. Disposal of waste parts ............................................................................... 23
6.2. Sustainable design ...................................................................................... 24
7. Warranty ............................................................................................................ 24
8. Technical description ......................................................................................... 24
8.1. Symbols ....................................................................................................... 25
8.2. Electromagnetic compatibility ...................................................................... 25
 1. Before Use

Before using this product, please carefully read and follow the recommendations of
the instruction manuals originally delivered with your device and system. Please pay
special attention to the safety precautions.

Any serious incident that has occurred in relation to the device should be reported to
the manufacturer and the competent authority of the Member State in which the user
and/or patient is established.

Always keep these Instructions close at hand. These Instructions are only applicable
to the equipment they were delivered with.

To prevent injury to persons or damage to property, please observe the corresponding

directives and symbols.

DO NOT modify products. No modification of any part is allowed.

Translations in this manual are based on the English version. Thus the English text will
be referred to in case of discrepancy.

The Instructions for Use of the device is provided in electronic format and
are part of the product documentation. However, if you want these in hard
copy, you can request one set free of charge on our website, by telephone or in writing,
and receive it within 7 days.

• The Instructions for Use of the device is available for download in PDF format
at www.kavo.com/download. A PDF reader is required and, in case of need, it
can be downloaded from the same web site.
• It is essential to first read and understand all the Instructions for Use of the
device before operating it and using the related accessories.
• We recommend that you visit the website regularly to consult and/or download
the latest version of the documentation for your device at
www.kavo.com/download
• Please contact KaVo technical support for further information and support.
 1.1. Intended Use

KaVo PiezoLED module, handpiece and tips are intended to be integrated in a KaVo
dental treatment unit for the purpose of removing supragingival and subgingival1
calculus:

- From primary1 and secondary teeth

- From dental hard tissues: enamel, dentine1 and cementum1

- From restorations1, prosthetics and dentures.

- Around implants1

- Around orthodontic appliances1

1.2. Indications
KaVo PiezoLED products are indicated to remove calculus supragingivally and
subgingivally1 up to 10mm1.

1.3. Intended users

KaVo PiezoLED products are intended to be used by dental professionals.

1.4. Intended patient population

KaVo PiezoLED products are intended to be used on patients regardless of age,
including children; however, some instruments can only be used in populations with
secondary teeth1.

1.5. Undesirable side effects and contraindications

Contraindications: N/A

Undesirable side effects: The noise produced during the ultrasonic treatment may
result in transient tinnitus.

1 some intended uses are restricted depending on the instrument used.

 1.6. Compatibility
KaVo PiezoLED module, FS-369, is compatible only with KaVo PiezoLED
accessories:

− Piezo Tips: DS-401A, DS-410A, DS-411A, DS-416A, DT-465A

− PiezoLED handpiece: EN-063

There is a risk of confusing Piezo tips with other ones.

1.7. Recommendations and safety precautions

Only use KaVo PiezoLED products together.

The use of any other accessories could lead to patient injury, malfunction or
damage to the device

KaVo PiezoLED products (handpieces and tips) are reusable, but they shall be
reprocessed before use: cleaned, disinfected and sterilised. Not reprocessed
handpieces and accessories may cause bacterial or viral infections.

Follow the “Cleaning and reprocessing” instructions and the present-day

regulations on reprocessing enforced in your country.
 Never work dry with PIEZO instruments (unless otherwise specified). The tip of the
instrument immediately heats up when used dry. Always make sure there is enough
irrigation.

Only use this product for the intended indications. Please refer to PiezoLED treatment
chapter. Carefully read these operating instructions before using the product. This also
applies to any product used with this system. Failure to observe the operating
instructions may result in the patient or user suffering serious injury or the product
being damaged.

DO NOT use this device in the presence of flammable anaesthetics or oxidising

gases (such as nitrous oxide (N2O) and oxygen) or in close proximity to volatile
solvents (such as ether or alcohol), as explosion may occur.

DO NOT use the instruments on metal or ceramic restorations, neither on prosthesis

units as they might be damaged (unless otherwise specified).

Always examine your PiezoLED system for damage before starting treatment.
Damaged accessories or a damaged product must not be used and must be replaced.
Only use original KaVo PiezoLED spare parts and accessories.

Special considerations where clinicians must use their own discretion or consent
from the physician.

- Antiresorptive therapy that reduces bone loss (i.e. therapy with bisphosphonates or
denosumab).
- Contagious patients or patients with a risk of infection: suitability for PIEZO treatment
needs to be assessed individually by the clinician according to the medical condition
present and in accordance with practitioner protection level, patient risk assessment
and specific country regulations.
- Patient with cardiac pacemakers, defibrillators and other active implantable medical
devices, can be treated with PIEZO devices with a safe workable distance of at least
23cm between the mouth and the respected implantable device (which is the distance
between the mouth and the device during treatment).
- There are a variety of pacemakers and other medically implanted devices on the
market. Clinicians should get the patient’s physician consent on the prophylaxis
treatment with PIEZO before any treatment for detailed information about the device.
- Keep the device, cables and handpiece as far as possible from the implanted device
(at least 23cm)
- Implantable electronic devices such as insulin pump and hearing aids are
recommended to be switch off or removed during treatment.

Listen for a noise change: a suspicious noise during contactless activation may be
a sign of possible damage to the system or improper screwing of the instrument. In this
case, check the correct screwing with the PIEZO Scaler Tip torque, then the condition
of the instrument. If in doubt, contact the support service.
 Most dental procedures involve contaminated aerosols which could represent a risk
factor. Follow the recommendations of treatment and patient and dental professional
precautions, in order to minimise the risk.
2. Installation
2.1. KaVo PiezoLED Products
1.1.1. Kits

Logistic
Product name Reference
reference
Installation Kit PiezoLED FS-349 1.007.3994

Number Product name Reference Logistic reference

1 Steri-Box EL-270B 1.007.3997 or 1.007.3998
2 PIEZO Scaler Tip torque wrench EL-431/A 1.007.3004
3 PIEZO Tubing R1300 EM-122A/A 1.007.4002
4 PiezoLED Handpiece EN-063/A 1.007.3995
5 PIEZO Scaler Tip 201 DS-401 1.007.4024
PIEZO Scaler Tip 202 DS-411 1.007.4026
PIEZO Scaler Tip 203 DS-416 1.007.4028
6 Instructions for use FB-697 N/A
(electronic or
paper)
PIEZO wear indicator card FA-331/EN 1.007.4016

Logistic
Product name Reference
reference
PIEZO Scaler Tip Set FS-354 1.007.4004

Number Product name Reference Logistic reference

1 Steri-Box EL-270B 1.007.3997 or 1.007.3998
2 PIEZO Scaler Tip torque EL-431/A 1.007.3004
3 PIEZO Scaler Tip 201 DS-401 1.007.4024
PIEZO Scaler Tip 202 DS-411 1.007.4026
PIEZO Scaler Tip 203 DS-416 1.007.4028
4 Instructions for use FB-697 N/A
(electronic or
paper)
PIEZO wear indicator card FA-331/EN 1.007.4016

Logistic
Product name Reference
reference
PIEZO Implant Tip Set FS-361 1.007.4008

Number Product name Reference Logistic reference

1 PIEZO Endo Tip 222 DS-410 1.007.4043
2 PIEZO Implant Refill Tip set DT-465 1.007.4014
3 PIEZO Endo Tip Key DT-018A 1.007.4020
 1.1.2. Accessories and consumables

Product name Reference Logistic reference

PIEZO Scaler Tip Set FS-354 1.007.4004
PIEZO Scaler Tip 201 DS-401 1.007.4024
PIEZO Scaler Tip 202 DS-411 1.007.4026
PIEZO Scaler Tip 203 DS-416 1.007.4028
PIEZO wear indicator card FA-331/EN 1.007.4016
PIEZO Scaler Tip torque wrench EL-431/A 1.007.3004
PIEZO Tubing R1300 EM-122A/A 1.007.4002
PiezoLED Handpiece EN-063/A 1.007.3995
Steri-Box EL-270B 1.007.3997 or 1.007.3998
PiezoLED Sleeve AD-644 1.007.4917
PiezoLED light guide sleeves FV-066 1.007.4021
PIEZO Flat Seal AB-348/A 1.007.4916
PIEZO Implant Tip Set FS-361 1.007.4008
PIEZO Endo Tip 222 DS-410 1.007.4043
PIEZO Implant Refill Tip set DT-465 1.007.4014
PIEZO Endo Tip Key DT-018A 1.007.4020
O'ring Ø 1.15x1.00 BC-077 1.007.6959
PIEZO Endo Tip 222 nut AD-147 1.007.4793
O-ring Ø1.50 x 1.00 BC-083 1.007.4794

2.2. Preparation

KaVo PiezoLED handpieces and tips are reusable, but they shall be reprocessed
before use: cleaned, disinfected and sterilised. Not reprocessed handpieces and
accessories may cause bacterial or viral infections.

Follow the “Cleaning and reprocessing” instructions and the present-day

regulations on reprocessing enforced in your country.

Check tip length and tip thread using the PIEZO wear
indicator card – FA-331/EN - 1.007.4016.

If tip extremity reaches or is shorter than the limit

indicated by the red line, it can have excessive and
uncontrolled vibration. Replace the tip.
 2.2.1. Attaching and removing the handpiece

Connect the PiezoLED Handpiece to the

Attaching hose PIEZO Tubing R1300.
the
handpiece

Disconnect the PiezoLED Handpiece from

Removing the hose.
the
handpiece

2.2.2. Attaching and removing the tips

In order to ensure perfect electronic connection, the individual components must be

dry.

Mount the tip using the PIEZO Scaler Tip

torque.

Only use the PIEZO Scaler Tip torque

to tighten the KaVo Tip on the PiezoLED
Handpiece to the correct torque to avoid
Attaching tip unscrewing or breaking.
the tips
Once the tip is screwed all the way in,
give an extra quarter of a turn to obtain the
required torque and remove the PIEZO
Scaler Tip torque .

Place the PIEZO Scaler Tip torque on the

tip, and unscrew it anticlockwise

Removing
the tips
 2.2.3. Attaching and removing a file

In order to ensure perfect electronic

connection, the individual components
must be dry.
Screw the PIEZO Endo Tip 222 onto the
PiezoLED Handpiece.

Attach the PIEZO Endo Tip 222 to the

handpiece with the PIEZO Endo Tip Key.

Slide the file into the PIEZO Endo Tip

Attaching a 222 up to an overall length of 14 mm.
file
Do not tighten the chuck nut when no
file or instrument is installed as this may
damage it.
Verify that the plastic coating is not
worn or damaged before use.

Gently tighten the union nut screwed

sleeve with the PIEZO Endo Tip Key.

Unscrew the tip from the PIEZO Endo

Tip 222.

Removing a
file
Unscrew the PIEZO Endo Tip 222 from
the PiezoLED Handpiece.
 2.2.4. Patient and dental professional precautions

For your protection and the protection of your patient, start by gargling patient mouth
with a mouthwash available in your country.

Patient preparation

Eye protection is mandatory.

It is also recommended to remove the patient‘s glasses and optical lenses.

OptraGate for lip and cheek retractor protection is mandatory.

Dental professional preparation

Protect yourself with the following measures:

Wear protective Wear protective Wash your hands Wear protective

mask glasses gloves

High vacuum suction (HVS) and saliva ejector are mandatory for PiezoLED technology.
 3. Treatment

3.1. PiezoLED treatment

KaVo PIEZO Tips vibrate in a controlled back and forth oscillation. During treatment,
always hold the instrument parallel to the tooth surface adapting the lateral side of the
instrument.

Do not direct the instrument straight to the enamel surface. Never point the tip of
the instrument to the tooth surface (unless otherwise specified).

PIEZO Scaler Tip 201

Removes supragingival calculus:
- From secondary teeth
- From dental hard tissues: enamel
Use a low to medium power setting. In case of hard calculus
use a higher power.
Use a medium to high water flow rate.

PIEZO Scaler Tip 202

Removes supragingival and subgingival up to 4mm calculus:
- From secondary teeth
- From dental hard tissues: enamel
Use a low to medium power setting. In case of hard calculus
use a higher power.
Use a medium to high water flow rate.

PIEZO Scaler Tip 203

Removes supragingival and subgingival up to 10mm
calculus:
- From primary and secondary teeth
- From dental hard tissues: enamel, dentine and cementum
- From restorations, prosthetics and dentures.
- Around orthodontic appliances
Use with low and high-power settings depending on the
treatment area.
Use a medium to high water flow rate.
PIEZO Implant Tip
Removes supragingival and subgingival up to 3mm calculus:
- From primary and secondary teeth
- From dental hard tissues: enamel and dentine
- From restorations, prosthetics and dentures.
- Around implants
- Around orthodontic appliances
Must be used with the PIEZO Endo Tip 222.
Adjust the instrument to a length 14mm.
Use low to medium power setting.
Use a medium to high water flow rate.

Verify that the plastic coating is not worn or damaged before use.

3.2. End of the treatment

Fluoride protection

After completion of treatment, the patient can do a final rinse.

After the treatment, the teeth are practically free from mucin. It is thus advised to carry
out a topics application of fluoride. It is then important to use a colourless fluoride.

Post-treatment recommendations

Treatment cleans the teeth but also eliminates the pellicle acquired by the patient.
Since the restoration by salivary proteins takes time, the teeth are left without natural
protection against colouration for 1 hour.
 4. Cleaning and reprocessing

The legal manufacturer recommends the use of cleaning, disinfection, packaging for
sterilisation and sterilisation procedures accordingly with ISO 17664.

Always report adverse events related to device reprocessing directly to EMS.

Reusable products must be cleaned, disinfected and, if applicable, sterilised before

first use and before any reuse. Do not reprocess the products over the allowed number
of sterilisation cycles, but replace: refer to the “Service life” section of the “Technical
description” chapter.

Concentrations and contact times specified by the manufacturer of the cleaning and
disinfection agent must be followed.

Remember that sterilisation cannot be achieved unless the elements of the

assembly are cleaned and disinfected first.

If there is anything in the following instructions that is not clear or seem to be

inadequate, do not hesitate to contact/inform KaVo.

The following instructions have been validated as being capable of preparing for re-
use the KaVo PiezoLED products: handpiece, tips, Torque wrench and tip wrench. It
remains the responsibility of the user to ensure that the processing as actually
performed using equipment, materials and personnel in the processing facility achieve
the desired result. This requires validation and routine monitoring of the process.
Likewise any deviation by the processor from the instructions provided should be
properly evaluated for effectiveness and potential adverse consequences.
The user shall also observe any applicable legal requirements in their country as well
as the hygiene regulations of the hospital or clinic. This applies especially with regard
to the additional requirements for the inactivation of prions.

Prepare
Manual pre-cleaning is required:

At the point of use: Immediately after use, rinse the lumen(s) line of the
handpiece/instrument with cold tap water. Coarse soiling must be removed.

Place the products on an appropriate rack to transport them to the reprocessing area
to avoid any product damage and contamination to the environment and people
involved in the reprocessing process.

Cleaning is to be performed within 1 hour from use.

Wear personal protective equipment according to the type of preparation.

PiezoLED handpiece:

• Remove any installed instrument.

• Remove the PiezoLED Sleeve and separate aside the PiezoLED light guide
sleeve and the O-ring.

PIEZO Endo Tip 222:

• Remove any installed file.

• Remove the screw and separate aside the small O-ring.

PIEZO Scaler Tips with PIEZO Scaler Tip torque:

• Separate the PIEZO tip and the PIEZO Scaler Tip torque but keep them together
throughout their life.
Any part must be cleaned manually or automatically by washer or disinfector. The legal
manufacturer recommends the use of an ISO 15883 compliant automatic washer-
disinfector (WD) for an optimal effectiveness and part service life.

KaVo PiezoLED products must not be lubricated or otherwise exposed to oil

whether directly or indirectly.

AUTOMATIC MANUAL
Clean, disinfect and dry Clean
The washer-disinfector must comply The following process can be used with and
with ISO 15883, must have suitable without ultrasound.
baskets to hold small products and must DO NOT use any ultrasound bath cleaning
have rinsing connections with diameter of procedure with the handpieces: it may destroy
approximately 16mm for the attachment to the products. It is ONLY intended to be used
product lumen. with PIEZO Tips and PIEZO Endo Tip. In case
of ultrasound bath cleaning, place products in
Correctly place the product into a suitable a metal sieve and sonicate 10 minutes.
rack, connect all lumens to the rinsing
connectors and start the automated Brush the products 5
in a cleaning solution of
cleaning. 0.5% neodisher in deionised water at 40°C
with a suitable soft bristled brush6 until all
visible residue has been removed.
Instructions of the manufacturer of the For products with lumens, flush all
washer disinfector must also be observed. 15 s
lumens with a spray gun (water jet
gun, with a static water pressure
Carefully follow the instructions
of 2 bar) with cold tap water.
provided by the disinfection solution
manufacturer.
15 min Place the product in 0.5% solution
of neodisher5 with deionised water
The following automated process2 can be (10 min with
used to achieve an A0 Level of 3000: ultrasounds)at 40°C. Make certain that all
lumens are filled with cleaning
solution (use a syringe if needed).
3
2 min Pre-clean with cold tap water .
15 s Rinse all lumens by flushing with
Drain a spray gun (water jet gun, with a
static water pressure of 2 bar) with
3
5 min Clean at 55°C with tap water cold deionised water.
and 0.5% cleaning solution5.
10 s Rinse the whole product under
Drain cold running deionised water.

3 min Rinse and neutralise with cold

demineralised water4.

2 For example: Miele Professional G 7836 CD with Miele Rack E429

3 Cold tap water = 16°C +/- 2°C
4 Cold demineralised water = 20°C +/- 2°C
5 For example: MediClean Dental, Dr. Weigert Hamburg
6 Medisafe MED100.33
 Drain Disinfection
ASP CIDEX® OPA solution must be used
2 min Rinse with cold demineralised undiluted, within its useful and shelf life, and in
water4. compliance with the manufacturer’s warnings
and instructions for use.
Drain

3 min Perform thermal disinfection 5 min Immerse the product completely

into CIDEX® OPA solution at
(final rinse) with deionised
minimum 20°C. Make certain that
water at 93°C minimum.
all lumens are filled with
Drain disinfectant solution (use a syringe
if needed).
20 min Dry at 100°C. ®
(at least) 1 min The ASP CIDEX OPA disinfectant
(each requires a total of three rinses :
rinse) keep the product totally immersed,
and use a large volume7 of fresh
water.

Do not reuse the water for rinsing or any other

purpose. Residues of disinfectant may cause
serious side effects

Dry
At room temperature (15-25°C), use an air
pistol (compressed air, max. 3 bars) to fully dry
the lumen and the whole product until no more
residues of water are present (visible or
detectable).

Example of correct placement of the parts

in the WD Miele Professional G 7836 CD
using the Mobile Injector Unit (Rack) Miele E429

Inspection before sterilisation

If stains are still visible on the product after cleaning/disinfection, the entire cleaning/
disinfection procedure must be repeated. Products with visible damage, chip/flake loss,
corrosion or deformation must be disposed of (no further use is permissible). Check
also the integrity of O-rings and gaskets and replace if damaged or deformed.

Verify the part to be fully dry. In case of detection of residues of water, remove
these using an air pistol (clean compressed air). Fully dry the lumen and the whole part
until no more residues of water are present (visible or detectable).

7 e.g. 2 gallons
Reassembly and packaging for sterilisation
Only previously cleaned and disinfected products can be sterilised.

Effective sterilisation can take place only on fully dry products. Ensure each part
(internal lumens and any surface) to be perfectly dry before reassembling and packing.

Prior to sterilisation, the products need to be reassembled for ready use and placed in
suitable sterilisation packaging.

PiezoLED handpiece:

• Reinstall the O-ring first, then put the PiezoLED light guide sleeve into the
PiezoLED Sleeve and screw it on the handpiece.

PIEZO Endo Tip 222:

• Reinstall the small O-ring (gasket) first, and then gently screw the retention bolt
without tightening it.

PIEZO Scaler Tips with PIEZO Scaler Tip torque:

• Reinstall the original Instrument with its Torque wrench.

Package your products with a single or double pouch:

• suitable for prevacuum moist heat sterilisation,

• compliant with ISO 11607-1 or EN 868,
• resistant to 138°C
• and with adequate steam permeability (e.g. Wipak STERIKING flat rolls Type
R43 and R44).
Sterilisation
Sterilisation must be performed immediately after cleaning-disinfection.

The loading pattern defined by the autoclave manufacturer must be followed.

DO NOT exceed
• the maximum number of sterilisation cycles allowed.
• a sterilisation temperature of 138°C and a holding time of 20 min.
DO NOT use hot-air sterilisation and radio-sterilisation procedures: they destroy the
products.

EMS recommends not to use class N sterilisers to reprocess PiezoLED handpieces

unless they include at least 20 minutes of drying cycle. The PiezoLED Handpiece
lifetime can be reduced.

Moist heat sterilisation of products shall be performed according to ISO 17665 and in
compliance with respective country requirements.

The prevacuum moist heat (steam) process can be used with any EMS product
packaged in appropriate single or double pouches:

Parameters for the prevacuum moist heat cycle:

• 3 prevacuum phases
• Pressure of 3 bar8
• Humidity of 100%
• Minimum temperature of 132°C
• 3 min Hold time (full cycle)
(minimum)
• 20 min Dry
(minimum)

Users must ensure that the reprocessing processes, including resources, materials
and personnel, are capable to reach the required results and maintained over time: it
is the user's responsibility to ensure that validation of the reprocessing procedures is
kept up to date at all times.

Storage
Store the sterilised products at a temperature up to 40°C in a:

• dry,
• clean
• and dust-free environment.

8 Absoluter Druck
Service life
If the number of permissible re-sterilisation cycles is restricted, this will be stated in
the product’s specific Instructions for Use (if any) and/or in the “Service life” section of
the “Technical description” chapter.

The products have been designed for a large number of sterilisation cycles. The
materials used in their manufacture were selected accordingly. However, with every
renewed preparation for use, thermal and chemical stresses will result in the ageing of
the products.

Always replace products that present sign of worn-out or of early degradation,

regardless of the number of sterilisation cycles left unused.

DO NOT expose the products to temperature exceeding the 138°C.

 5. Maintenance and troubleshooting
5.1. General maintenance
5.1.1. PiezoLED light guide sleeve check & replace

The PiezoLED light guide sleeve loses its transparency after undergoing repeated
reprocessing cycles. Check the transparency of the PiezoLED light guide sleeve every
month and do the following:

1. Remove the tip and unscrew the PiezoLED sleeve by hand.

2. Take off the PiezoLED light guide sleeve and inspect it.
3. Place in a new PiezoLED light guide sleeve .
4. Screw the PiezoLED sleeve on again, by hand only.

5.1.2. Wear

KaVo PIEZO Tips must be checked regularly using the PIEZO wear indicator card.
Ultrasound instruments wear during use and become shorter. Worn instruments are
ineffective and are a cause of discomfort to the patient.

For precautionary reasons, do not exceed the validated lifespan of the components
(see the “Technical description” chapter).

Always use KaVo original parts. Using non original components may damage the
equipment, and practitioner or patient may be injured.

5.2. Troubleshooting

White PiezoLED is not working

1° Clean and dry the handpiece connection and try again.
2° Your PiezoLED Handpiece might have been switched off by activity
time-outs:
- after 10 minutes of continuous operation,
- or after 20 seconds of inactivity off the holder.
In both cases, put back the PiezoLED Handpiece into the holder, wait
1 minute and try again.
3° If still not solved, contact KaVo aftersales service.
 Insufficient lighting
1° Check the PiezoLED light guide sleeve and replace if necessary.
2° If the light is still weak, replace the PiezoLED Handpiece.
Damaged light guide
Replace the PiezoLED light guide sleeve .
Low or no mechanical power delivered by PIEZO or vibration
perceived
1° Make sure that the PIEZO tip is correctly screwed on (use the
Torque wrench).
2° Check the wear of the tip and replace it if necessary.
3° Clean and dry the PiezoLED Handpiece and the PIEZO Tubing
R1300 electric connections.
4° Replace the PiezoLED Handpiece first.
5° Replace the PIEZO Tubing R1300.
6° If still not solved, contact KaVo aftersales service.
No or low irrigation flow
Check if the instrument is blocked. Blow compressed air through the
instrument to unblock it
Use another PiezoLED Handpiece to check if the PiezoLED
Handpiece is blocked
If the obstruction cannot be removed, the PiezoLED Handpiece must
be sent to an approved KaVo repair centre

6. Sustainability

6.1. Disposal of waste parts

The device must not be discarded in domestic household

waste. Should you wish to definitively dispose of the device,
please comply with the regulations that apply in your country.

Other parts of this device, including tips/inserts, and chemicals

must be disposed of according to your country’s regulations.

Waste Electrical and Electronic Equipment belonging to

customers located in the European Union may be shipped to
EMS for recycling in accordance to the WEEE regulations. The
costs of recycling, exclusive of shipping fees, are covered by
EMS.

Keep the original packaging until the device is to be disposed

of permanently. It can be used for shipping or storing.
 6.2. Sustainable design

Packaging cardboards are recycled and recyclable.

7. Warranty

Warranty is void if the device has been used with non-original KaVo PiezoLED
products. Warranty is void if the device has been opened.

EMS and the distributor of this device accept no liability for direct or consequential
injury or damage resulting from improper use, arising in particular through non-
observance of the instructions for use, or improper preparation and maintenance.

EMS declines the responsibility for the safety of the device and declares the warranty
null and void if service or repair is carried out by an unauthorised third party or if non-
genuine spare parts are used.

8. Technical description

Legal manufacturer EMS ELECTRO MEDICAL SYSTEMS SA, CH-1260 Nyon, Switzerland
Classification IEC Electrical Insulation Class-I
60601-1 Applied part Type B
Humidity protection class: IP X0

Classification EU Medical Device Class IIa

MDD 93/42/EEC
Essential This medical device, in the meaning of the EU MDD 93/42 has no
Performance Essential Performance
Operating mode Continuous operation
Power supply 24 VAC ± 10% or 24-32 VDC ± 10%
Power consumption Max: 18VA
Ultrasonic module Max Output Power: 8W under fully-loaded mechanical condition.
Frequency: 24-32kHz.
Weight Module: ~ 80 g
Dimensions Module: 34 x 60 x 50mm (without connectors)
Operating conditions Temperature: 10°C to 35°C
Humidity: 30% to 75%
Storage conditions see individual packaging
 Input fluids Water: 1.0 – 2.0 bar (100 – 200 kPa / 15 – 29 PSI)
Adjustable flow rate 0-50 ml/min ±10
Lifetime PiezoLED Handpiece (main bodies): 1000 sterilisation cycles
PIEZO Scaler Tip torque wrench: 1000 sterilisation cycles
Steri-Box: 2000 sterilisation cycles

8.1. Symbols

General Warning
Read the operation instructions
Electronic instructions for use
Mandatory action
Expiration date
Do not do.
Disposal of old electronic equipment (European Union & other
countries with separate collection systems)
Sterilisable at up to 135°C in the autoclave
Thermal disinfection
Input
Output
Fuse
Wired foot pedal connection
Protection against water permeability
Applied part, type B
Manufacturer
Manufacturing date
Serial number
Catalogue number / Product reference
Medical Device compliant with EU Directive 93/42/EEC
Number of the Notified Body
Medical device

8.2. Electromagnetic compatibility

The electromagnetic compatibility has been validated on the final system composed of
the dental unit, the integrated PiezoLED scaler and its related accessories. Therefore,
for any information regarding electromagnetic compatibility, please refer to the
instructions for use of the dental unit.
ELECTRO MEDICAL SYSTEMS SA
Chemin de la Vuarpillière 31
CH - 1260 Nyon
www.ems-dental.com/en/contact
T. +41 22 99 44 700
F. +41 22 99 44 701

Distributed by
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Phone +49 (0) 7351 56-0
Fax +49 (0) 7351 56-1488

1.015.1361 Fk 20220902 - 1 · en (FB-697/EN-GB rev.A ed.2022/07)