Sirona SIROSONI L User manual

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Instructions for use
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Table of Contents Operating Instruction SIROSONIC/L/TL, PerioSonic
262 78 415 D3275.201.04.09.02
Table of Contents
1Before you begin … ........................................................................................ 6
1.1 Structure of the document ............................................................................................. 8
1.2 Service life of Sirona instruments.................................................................................. 10
2Safety information ........................................................................................... 12
3Technical description ...................................................................................... 15
3.1 Task............................................................................................................................... 15
3.2 Calculus detection - functioning .................................................................................... 15
3.3 Ultrasonic handpiece design ......................................................................................... 16
3.4 Technical data ............................................................................................................... 18
3.5 Power settings for ultrasonic tips................................................................................... 22
4Preparation ..................................................................................................... 25
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Operating Instruction SIROSONIC/L/TL, PerioSonic Table of Contents
62 78 415 D3275.201.04.09.02 3
4.1 Initial start-up and longer breaks in use ........................................................................ 25
4.2 Prior to starting the work day......................................................................................... 25
4.3 Before each patient ....................................................................................................... 25
5Operation ........................................................................................................ 27
5.1 Connecting the ultrasonic handpiece to the supply hose .............................................. 28
5.2 Detaching the ultrasonic handpiece from the supply hose............................................ 29
5.3 Inserting and removing the ultrasonic tip....................................................................... 31
5.4 Checking the ultrasonic tip for usability ......................................................................... 32
5.5 Adjusting the power for the ultrasonic tips..................................................................... 33
5.6 Adjusting the cooling spray ........................................................................................... 35
5.7 Treatment ...................................................................................................................... 37
6Follow-up ........................................................................................................ 64
6.1 After each treatment session......................................................................................... 64
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Table of Contents Operating Instruction SIROSONIC/L/TL, PerioSonic
462 78 415 D3275.201.04.09.02
7Conditioning.................................................................................................... 66
7.1 Conduct pre-disinfection................................................................................................ 66
7.2 Automated cleaning and disinfecting ............................................................................ 67
7.3 Manual cleaning and disinfection .................................................................................. 70
7.4 Sterilizing....................................................................................................................... 72
8Maintenance ................................................................................................... 74
8.1 Maintaining the water channel....................................................................................... 74
8.2 Cleaning the light guide surfaces .................................................................................. 75
8.3 Replacing the spray water cartridge.............................................................................. 76
8.4 Replacing the halogen lamp/LED.................................................................................. 78
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Operating Instruction SIROSONIC/L/TL, PerioSonic Table of Contents
62 78 415 D3275.201.04.09.02 5
9Spare parts and consumables ........................................................................ 80
10 Storage and transport conditions .................................................................... 92
11 Disposal .......................................................................................................... 94
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1Before you begin … Operating Instruction SIROSONIC/L/TL, PerioSonic
662 78 415 D3275.201.04.09.02
1Before you begin …
Complies withstate-of-the-arttechnology without generalstandards
SIROSONIC/L/TL / PerioSonic complies with state-of-the-art technical
regulations.
Read/observe_ general
1. Read the operating instructions prior to using SIROSONIC/L/TL /
PerioSonic.
2. Only use SIROSONIC/L/TL / PerioSonic for the applications
described in the operating instructions.
3. Observe the applicable hygiene standards, occupational safety
regulations and accident prevention measures for SIROSONIC/L/TL
/ PerioSonic.
Intended Use Scaler
SIROSONIC/L/TL / PerioSonic is used to treat dental disease. The
treatment is for the following uses:
● Supragingival removal of plaque and tartar (scaling)
● Subgingival removal of plaque and calculus (periodontology)
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Operating Instruction SIROSONIC/L/TL, PerioSonic 1Before you begin …
62 78 415 D3275.201.04.09.02 7
● Cleaning and biofilm management of implants as well as metallic
and ceramic restorations (implant cleaning tip)
● Irrigation of treated root channels (endo),
● liquefying of thixotropic composites (CEM),
● Micropreparation
● Retrograde root treatment (endo)
● Estimation of the working depth (tip with depth scale)
PerioSonic
PerioSonic is also used to generate a voltage signal for analysis in
PerioScan.
Contraindications - none
Contraindications None
Target group trained dental p ersonnel
This product is intended only for use by trained dental personnel in
dental practices and laboratories.
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1Before you begin … Operating Instruction SIROSONIC/L/TL, PerioSonic
862 78 415 D3275.201.04.09.02
1.1 Structure of the document
1.1.1 Labeling of information
Warnings ➢ To prevent injuries, please observe all warnings.
Warnings are labeled as follows:
DANGER! indicates a danger leading to death or serious injury if not
avoided.
WARNING! indicates a danger that may lead to death or serious
injury if not avoided.
CAUTION! indicates a danger that may lead to injury if not avoided.
Instructions for use ➢ To prevent material damage and additional expenses, please
observe all instructions for use.
Instructions for use are labeled as follows:
NOTICE! indicates measures for the prevention of material damage.
IMPORTANT: indicates information on the avoidance of additional
expenses and other important information.
Tip: indicates information for facilitating work.
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Operating Instruction SIROSONIC/L/TL, PerioSonic 1Before you begin …
62 78 415 D3275.201.04.09.02 9
1.1.2 Formats and symbols
The formats and symbols used in this document have the following
meaning:
✔ Prerequisite
1. First action step
2. Second action step
or
➢Alternative action
ªResult
➢Individual action step
Requests you to do something.
Use of formats and
symbols [ → 9].
Identifies a reference to another text
passage and specifies its page number.
● List Identifies a list.
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1Before you begin … Operating Instruction SIROSONIC/L/TL, PerioSonic
10 62 78 415 D3275.201.04.09.02
1.2 Service life of Sirona instruments
Service life5 + 3 years /3 + 1 1/2 years
When used as intended:
Standard_Sirona
● Non-moving parts of Sirona instruments have a typical service life of
approx. 5 years
● Moving parts of Sirona instruments have a typical service life of
approx. 3 years
No warranty claim can be inferred here, as wear may occur earlier or
later than indicated above depending on use, frequency of sterilization,
and frequency of maintenance.
Scaler sealingring
The sealing ring for SIROSONIC TL and PerioSonic must be replaced
annually.
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Operating Instruction SIROSONIC/L/TL, PerioSonic 1Before you begin …
62 78 415 D3275.201.04.09.02 11
1.2.1 Service time for the tips and torque wrench
After 12 months of service time, the tips and included torque wrench
have reached their wear limit and must be disposed of.
Exception: SIROIMPLANT IP1 reaches its service time after 1,000
treatments or 24 months.
Document and check the service time of the tips and torque wrench
based on the 4-digit alphanumeric serial number.
A 4-digit alphanumeric serial number Here: H6F1
B Tip number Here: no. 3L
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2Safety information Operating Instruction SIROSONIC/L/TL, PerioSonic
12 62 78 415 D3275.201.04.09.02
2Safety information
Obligationsof the user
Obligations of the user ● Use only fault-free materials that do not deviate from the specified
data [ → 18].
● Protect yourself, patients, and others against any foreseeable
dangers. To do this, follow the safety information.
● Comply with the Intended use of the equipment.
● You should always keep these operating instructions within reach for
further reference.
Scaler only withSirona
● Use SIROSONIC/L/TL / PerioSonic only with Sirona equipment.
● Only use the torque wrench included with each tip.
● Dispose of the torque wrench with the tip after a service time of 12
months.
Cross contami nation and spread of infect ions
Preventing the spread of infections and cross
contamination
Sterilization
Prevent the spread of infections and cross contamination between
patients, users, and third parties. Sterilize equipment after each patient.
Take the appropriate hygiene measures, e.g. wear protective gloves.
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Operating Instruction SIROSONIC/L/TL, PerioSonic 2Safety information
62 78 415 D3275.201.04.09.02 13
Eye damage
Prevention of eye damage The LED is in risk class 2 according to the IEC 62471:2006 standard.
The LED emits optical radiation that is potentially hazardous and may
be harmful to the eyes! Potential damage to the retina from the blue light
emission. Do not stare at the LED for longer periods of time while in
operation.
Improper use
Improper use Improper use may cause damage to the surface of the patient's teeth.
Malfunction/ Damage _ Scaler
Malfunction or damage Discontinue use immediately in case of malfunction, unusual or different
sounds or damage. Damaged ultrasonic handpieces and tips may
cause injury. Notify the dental depot or the manufacturer.
Potentialexplosion hazard
Potential explosion hazard Do not use this product in areas subject to explosion hazards.
Repair _ Scaler
Repair Do not repair the ultrasonic handpieces and tips on your own.
Accessory parts
Spare and accessory parts Use only original Sirona parts or parts approved by Sirona. Safe
operation is not guaranteed for parts that have not been approved by
Sirona.
Endo note for cofferdam scaler
Endontic work Use a cofferdam in patients for endodontic work.
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2Safety information Operating Instruction SIROSONIC/L/TL, PerioSonic
14 62 78 415 D3275.201.04.09.02
Pacemakers an d defibrillators
Cardiac pacemakers and implanted defibrillators Sirona does not recommend using ultrasonic scalers for patients and
equipment users with cardiac pacemakers and/or implanted
defibrillators.
Combination with trea tment centers
Combination with treatment centers Use the Sirona scalers only in combination with a Sirona treatment
center. There is a risk of injury when used in combination with treatment
centers from other manufacturers.
If you have any questions, please contact your dental dealer or the
manufacturer.
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Operating Instruction SIROSONIC/L/TL, PerioSonic 3Technical description
62 78 415 D3275.201.04.09.02 15
3Technical description
3.1 Task
SIROSONIC
The ultrasonic handpiece converts electrical energy into a translational
movement and transfers it to the ultrasonic tip, thus oscillating the distal
end of the ultrasonic tip.
3.2 Calculus detection - functioning
PerioScan
Calculus can be detected only with the SIROPERIO 4 PS ultrasonic tip
in combination with the PerioSonic handpiece on the Sirona PerioScan.
Detection: The physical vibration patterns of the ultrasonic tip are
analyzed and the contacted tooth surface is thus detected. The
substance or material of the tooth being examined, not the surface
structure, is detected here.
The detection mode is automatically activated when the PerioSonic
handpiece is removed from its holder on the PerioScan.
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3Technical description Operating Instruction SIROSONIC/L/TL, PerioSonic
16 62 78 415 D3275.201.04.09.02
When the software detects root surfaces the signal green lights up
green - if calculus is detected, the signal ring lights up blue. Observe the
notes in the operating instructions for PerioScan.
3.3 Ultrasonic handpiece design
SIROSONIC TL
SIROSONIC/L/TL design
A Tip mount
B Light aperture (for SIROSONIC L/TL only)
Control ring
D Hose nut
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Operating Instruction SIROSONIC/L/TL, PerioSonic 3Technical description
62 78 415 D3275.201.04.09.02 17
PerioSonic
PerioSonic design
A Tip mount
B Light aperture
Signal ring
D Control ring
E Hose nut
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3Technical description Operating Instruction SIROSONIC/L/TL, PerioSonic
18 62 78 415 D3275.201.04.09.02
3.4 Technical data
Scaler
Ultrasonic handpiece
SIROSONIC SIROSONIC L SIROSONIC TL PerioSonic
Oscillation frequency in kHz 25 - 32 25 - 32 25 - 32 25 - 32
Spray function x x x x
Spray water regulation at the
coupling
xxxx
Light function - x x x
Amplitude of the
instrument tip in µm
(100µm = 0.10mm)
~ 180 (with tip 4L) ~ 180 (with tip 4L) ~ 180 (with tip 4L) ~ 200 (with tip 4PS)
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Operating Instruction SIROSONIC/L/TL, PerioSonic 3Technical description
62 78 415 D3275.201.04.09.02 19
Treatment center
SIROSONIC SIROSONIC L1SIROSONIC TL
Lamp voltage in V, at the lamp - 3.6 ±0.1 -
Lamp current in A
Halogen lamp - - -
LED - 0.03 0.03
Spray water flow in ml/min (with fully-opened water
regulator)
60 60 60
Spray water pressure in bar (without tip) 2 ±0.2 2 ±0.2 2 ±0.2
Recommended water content in spray in ml/min > 30 ml/min > 30 ml/min > 30 ml/min
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3Technical description Operating Instruction SIROSONIC/L/TL, PerioSonic
20 62 78 415 D3275.201.04.09.02
PerioScan
1. Depending on the treatment center and its accessories
PerioSonic
Lamp voltage in V, at the lamp -
Lamp current in A
Halogen lamp -
LED 0.03
Spray water flow in ml/min (with fully-opened water regulator) 60
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