Sirona SIROSONI L, PerioSonic, SIROSONI TL Operating Instructions Manual

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Instructions for use
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Table of Contents
1 Before you begin … ........................................................................................ 6
1.1 Structure of the document ............................................................................................. 8
1.2 Service life of Sirona instruments .................................................................................. 10
2 Safety information ........................................................................................... 12
3 Technical 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
4 Preparation ..................................................................................................... 25
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Operating Instruction SIROSONIC/L/TL, PerioSonic Table of Content s
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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
5 Operation ........................................................................................................ 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
6 Follow-up ........................................................................................................ 64
6.1 After each treatment session......................................................................................... 64
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7 Conditioning.................................................................................................... 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
8 Maintenance ................................................................................................... 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 Content s
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9 Spare parts and consumables ........................................................................ 80
10 Storage and transport conditions .................................................................... 92
11 Disposal .......................................................................................................... 94
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1 Before you begin …
Complies with state-of-the-art technology without general standards
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 …
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● 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 personnel
This product is intended only for use by trained dental personnel in dental practices and laboratories.
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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:
DA NGER ! 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 …
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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
ª Result ➢ 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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1.2 Service life of Sirona instruments
Service life 5 + 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 sealing ring
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 …
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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
Obligations of 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 with Sirona
● 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 contamination and spread of infections
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
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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.
Potential explosion 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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Pacemakers and 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 treatment 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
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3 Technical 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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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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PerioSonic
PerioSonic design
A Tip mount
B Light aperture
Signal ring
D Control ring
E Hose nut
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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 = 0.10 mm)
~ 180 (with tip 4L) ~ 180 (with tip 4 L) ~ 180 (with tip 4L) ~ 200 (with tip 4PS)
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Treatment center
SIROSONIC
SIROSONIC L
1
SIROSONIC 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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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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Operating Instruction SIROSONIC/L/TL, PerioSonic 3Technical description
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Operating conditions
Spray water pressure in bar (without tip) 1- 1.5
Recommended water content in spray in ml/min > 30 ml/min
PerioSonic
Ambient temperature 10°C - 40 °C (50°F - 104°F)
Relative humidity 30% - 95 %
Air pressure 700 hPa - 1060 hPa
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CE mark
This product bears the CE mark in accordance with the provisions of the Council Directive 93/42/EEC of June 14, 1993 concerning medical devices (MDD).
3.5 Power settings for ultrasonic tips
The tips can be used at the following maximum power:
0123
SIROSONIC SIROSONIC L SIROSONIC TL PerioSonic
Tip no. 1L 100% 100 % 100% 100 %
Tip no. 2L 100% 100 % 100% 100 %
Tip no. 3L ≤ 80% ≤ 80% ≤ 80% ≤ 80%
Tip no. 4L ≤ 70% ≤ 70% ≤ 70% ≤ 70%
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Operating Instruction SIROSONIC/L/TL, PerioSonic 3Technical description
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SIROPERIO PE 1 ≤ 70% ≤ 70% ≤ 70% ≤ 70%
SIROPERIO PE 2 100% 100 % 100% 100 %
SIROPERIO PE 3 100% 100 % 100% 100 %
SIROPERIO 4 PS ≤ 80% ≤ 80% ≤ 80% ≤ 80%
SIROPERIO PE 5 100 % 100% 100% 100 %
SIROPERIO PE 6 100 % 100% 100% 100 %
SIROPREP tips 100% 100% 100% 100 %
SIRORETRO tips 100% 100 % 100% 100 %
CEM tip ≤ 10% ≤ 10% ≤ 10% ≤ 30%
SIROSONIC SIROSONIC L SIROSONIC TL PerioSonic
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SIROIMPLANT IP 1
1
≤ 70% ≤ 70% ≤ 70% ≤ 70%
Endo tip no. 5 ≤ 4% ≤ 4% or Endo
function 1e - 5e
2
Endo function 1e ­5e
3
≤ 4%
1. in combination with SIROSON L ≤ 20%
2. in combination with the INTEGO/INTEGO PRO treatment center
3. in combination with the TENEO/SINIUS treatment center
SIROSONIC SIROSONIC L SIROSONIC TL PerioSonic
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Operating Instruction SIROSONIC/L/TL, PerioSonic 4Preparation
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4 Preparation
4.1 Initial start-up and longer breaks in use
Scaler
➢ An adequate normalization phase must be maintained following
transport before initial operation.
➢ Sterilize the scaler and accessory parts prior to startup [ → 72]. ➢ Clean and lubricate the scaler after longer breaks in use.
4.2 Prior to starting the work day
➢ Flush the water lines for 2 minutes.
4.3 Before each patient
Preparation _ Scaler without Siroair
1. Flush the water lines for 30 seconds.
2. Attach the ultrasonic handpiece [ → 28].
3. Insert the ultrasonic tip [ → 31].
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4. Check the ultrasonic tip for usability [ → 32].
5. Set a sufficient amount of cooling water (> 30 ml/min) [ → 35].
6. Use filtered water only (< 50 µm).
7. Check the nozzles for blockages and lime deposits, for example, and clean the nozzles if necessary.
8. Make sure the ultrasonic tip is fits tightly.
9. Perform an axial load test of the ultrasonic tip.
Tip: Use a cofferdam in patients for endodontic work.
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Operating Instruction SIROSONIC/L/TL, PerioSonic 5Operation
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5 Operation
Use only faultless tips
NOTICE! Tips wear out and can bend resulting in a performance loss and risk of breakage. Use only ultrasonic tips that are not worn or bent. Do not reshape bent tips.
Clamping tips
CAUTION! A loose ultrasonic tip can come loose from the thread or break off. This may cause injury! Use the ultrasonic handpiece only if the ultrasonic tip is firmly clamped in place.
Overheating at the preparation site _ flow rate
CAUTION! Insufficient cooling leads to overheating of the preparation site and damage to the tooth substance. Ensure that the flow rate is > 30 ml/min.
Puncture wound _ Tip
CAUTION! You can puncture your hand with an ultrasonic handpiece when the tip is inserted. This may cause injury! When the ultrasonic handpiece is not in use, remove the tip or attach the torque wrench for protection.
Harmful to eyes
CAUTION! Potentially hazardous optical radiation may cause harm to the eyes. Do not stare at the LED for longer periods of time while in operation.
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5.1 Connecting the ultrasonic handpiece to the supply hose
Attaching SIROSONIC/L
Connecting SIROSONIC/L
1. Compare the hole pattern in the handpiece with the small tubes in
the hose coupling.
2. Hold the hose nut (A) firmly and insert the ultrasonic handpiece until
it clicks audibly into place.
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Attaching SIROSONIC TL and PerioScan
Connecting SIROSONIC TL and PerioSonic
1. Align the Sirona logo with the recess on the hose coupling.
2. Hold the hose nut (A) firmly and insert the ultrasonic handpiece until
it clicks audibly into place.
5.2 Detaching the ultrasonic handpiece from the supply hose
Do not detach the scaler while it is in ope ration
CAUTION! Do not detach the ultrasonic handpiece from the supply hose while it is in operation. This may cause injury!
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