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Micro handpieces
92-020 | 92-021 | 92-112
Table of contents
Table of contents
1 Introduction .................................................................................................... 5
1.1 Information about these instructions for use................................. 5
1.2 Typographical conventions ............................................................. 5
1.3 General conditions............................................................................ 6
2 Safety ............................................................................................................... 7
2.1 Intended use...................................................................................... 7
2.2 General warnings .............................................................................. 8
3 Overview........................................................................................................10
3.1 Overview of micro handpiece ........................................................10
3.2 Scope of delivery.............................................................................11
3.3 Pictograms.......................................................................................11
3.4 System overview .............................................................................12
5 Operation ......................................................................................................14
5.1 Preparing for treatment .................................................................15
5.1.1 Connecting the micro handpiece to the ultrasonic generator.............15
5.1.2 Functional testing .................................................................................................17
5.2 Starting treatment ..........................................................................18
5.3 Ending treatment............................................................................21
5.3.1 Disconnecting the micro handpiece from the ultrasonic generator..21
6 Reprocessing .................................................................................................23
6.1 Disassembling the micro handpiece .............................................23
6.2 Manually pre-cleaning the micro handpiece ................................24
6.3 Automatically clean and disinfect the micro handpiece .............25
6.4 Reassembling the micro handpiece ..............................................26
6.5 Sterilizing the micro handpiece.....................................................27
Table of contents
8 Disposal .........................................................................................................31
Index ..............................................................................................................33
Introduction
Information about these instructions for use
1 Introduction
All warning information is structured according to the same model. The source of the
hazard is stated after the signal word. Then the effects of the hazard and its conse-
quences are described. Finally the steps that must be taken to eliminate the hazard
are given.
Introduction
General conditions
1.4
Safety
Intended use
2 Safety
Safety
General warnings
Electromagnetic fields
Electromagnetic fields, such as those generated by a magnetic resonance tomograph,
can influence the function of the micro handpiece and cause severe injury to patients.
Do not use the micro handpiece in the area of influence of electromagnetic fields.
Ensure electromagnetic compatibility of other electrical devices.
Only use medical electrical devices that have a CE mark with identification num-
ber of the notified body.
Safety
General warnings
Incorrect accessories
Use of unauthorized accessories may lead to malfunction and cause severe injury to
patients as well as operators.
Only use approved accessories (see catalogue or our website: www.soering.com).
Overview
Overview of micro handpiece
3 Overview
1 2
3
5
6
8 7
Fig. 3.1 Micro handpiece
1
2
Overview
Scope of delivery
3.3 Pictograms
In connection with the Micro handpiece, standardized symbols are used. In particular,
the packaging of the required accessories is marked with these symbols.
Pictogram Meaning
Indicates that the instructions for use must be read and followed.
Indicates a medical device with an article number in order to identify and re-
order it.
Indicates the date until which the medical device may be used.
Indicates a medical device that may not be used if the packaging is damaged
or already open.
Indicates a medical device that has been sterilized with ethylene oxide.
Indicates a medical device that must be stored in a dry place and protected
from humidity.
Indicates a medical device that must be protected from sunlight and light
sources.
Indicates the temperature to which the medical device can be safely exposed.
Indicates a medical device that may not be reused and is only intended for
single use on an individual patient during a single treatment.
Overview
System overview
INFORMATION
3.5
4.1
Operation
5 Operation
Only qualified surgeons may operate on patients with the micro handpiece. Any
other use of the micro handpiece in accordance with the intended use is only permit-
ted for qualified specialists.
The surgeon providing treatment is responsible for weighing the risks of treatment
against the benefits.
Prior to the first treatment – and prior to any further treatment – the micro handpiece
and the instrument cable must be cleaned, disinfected and sterilized (see Chapter
”Reprocessing” on page 23).
Please also observe the instructions for use supplied with the ultrasonic generator.
They contain information regarding the assembly of the required accessories and the
connection of the micro handpiece to the ultrasonic generator.
Functional testing must always be performed on the ultrasonic generator with the
micro handpiece prior to treatment (see Chapter ”Functional testing” on page 17).
Please also observe the instructions for use supplied with the ultrasonic generator
when performing this test.
During the treatment keep a redundant system ready for use in case the first one fails.
After treatment, properly dispose of the double tubing. The micro handpiece and the
instrument cable must be reprocessed (see Chapter ”Reprocessing” on page 23).
Operation
Preparing for treatment
Requirements
The micro handpiece is sterile.
The instrument cable is sterile.
An irrigation bottle, an aspiration canister and a sterile double tubing are at hand.
The ultrasonic generator is turned on.
Procedure
1. During a visual inspection, ensure that the handpiece body, the sonotrode and
the nose cone are in perfect condition.
2. Place the cover over the sonotrode and slide onto the nose cone.
Operation
Preparing for treatment
3. Insert the instrument cable plugs into the connector socket on the ultrasonic gen-
erator.
Heed the markings.
– The instrument cable engages in the connector socket.
4. Insert the instrument cable into the connector socket on the micro handpiece.
Heed the markings.
Operation
Preparing for treatment
Functional testing must always be performed on the ultrasonic generator with the
micro handpiece prior to treatment. The irrigation function and the ultrasonic func-
tion are checked during the functional testing and the suctioning function.
Finally, the power settings on the ultrasonic generator must be checked and ad-
justed. The ultrasonic power as well as the aspiration capacity and the irrigation ca-
pacity must be ensured.
Requirements
The micro handpiece has reached the permissible temperature for use (between
10 °C and 40 °C (50 °F and 104 °F)).
The micro handpiece has been connected to the ultrasonic generator.
The OK indicator light on the ultrasonic generator lights.
Procedure
1. Press and hold the button on the ultrasonic generator for filling with irrigation so-
lution until irrigation solution exits from the sonotrode on the micro handpiece
and there is no more air trapped in the double tubing.
2. Ensure the connections between the double tubing and micro handpiece and be-
tween the double tubing and irrigation bottle do not leak.
3. Activate the micro handpiece with the foot switch and immerse the sonotrode in
sterile liquid.
– The sterile liquid begins to make a noise; this is a sign that ultrasonic power is
being supplied.
4. Release the foot switch.
– The aspiration pump continues to run for another 30 seconds.
5. As long as the aspiration pump continues to run, immerse the sonotrode in sterile
liquid again.
– The liquid is suctioned off which is visible in the transparent part of the double
tubing.
– Functional testing has been performed.
6. Check and adjust the power settings on the ultrasonic generator (irrigation capac-
ity, ultrasonic power and aspiration capacity).
– All power settings have been adjusted.
– Treatment can be carried out.
Operation
Starting treatment
Operation
Starting treatment
Hot sonotrode
The sonotrode can heat up during the operation. Contact with the hot sonotrode can
damage tissue, even if the micro handpiece is not activated.
Do not touch tissue that is not to be operated on with the sonotrode.
Operation
Starting treatment
Operation
Ending treatment
Requirements
The ultrasonic generator is switched off.
Procedure
1. Pull the cover off the nose cone and dispose of properly.
Operation
Ending treatment
4. Disconnect the double tubing from the luer lock ports of the micro handpiece.
5. Disconnect the double tube from the ultrasonic generator and properly dispose
of it.
– The micro handpiece has been disconnected from the ultrasonic generator.
Do not allow any secretions or tissue residues to dry on the instrument. If the micro
handpiece cannot be disassembled and reprocessed immediately, place it in a closed
jar with cleaning and disinfectant solution. The jar protects the micro handpiece dur-
ing transport and prevents contamination of the environment.
You can completely immerse the micro handpiece in a cleaning or disinfectant solu-
tion. Do not use a physiological saline solution. Please observe the manufacturer's in-
formation regarding cleaning and disinfecting solution temperatures, contact times
and concentrations.
Reprocessing
Disassembling the micro handpiece
6 Reprocessing
The Micro handpiece (handpiece body and mouthpiece) and the instrument cable
must be reprocessed after each treatment to prevent infections.
Reprocessing of the Micro handpiece and the instrument cable essentially consists of
three steps:
Cleaning
Disinfection
Sterilization
Only use disinfectants recommended by the Association for Applied Hygiene (VAH).
Also observe the guidelines of the Robert Koch Institute (RKI).
Procedure
1. Unscrew the nose cone and remove from the sonotrode.
– The micro handpiece has now been disassembled into its two individual parts.
Reprocessing
Manually pre-cleaning the micro handpiece
Requirements
The micro handpiece has now been disassembled into the handpiece body and
nose cone.
Procedure
1. Place the handpiece body, nose cone and instrument cable in a cold water bath
(see table).
If the water is too warm, residues can deposit on the individual parts.
2. Brush off visible dirt with a soft brush in the water bath with process chemicals
(see table).
3. Rinse out the nose cone with a water jet at a water pressure of 1.8 bar (26.11 psi)
(see table).
4. Clean the handpiece body, nose cone and instrument cable in the ultrasonic bath
with process chemical.
– The handpiece body and the nose cone of the micro handpiece and the instru-
ment cable are ready to be pre-cleaned manually and cleaned and disinfected
mechanically.
Reprocessing
Automatically clean and disinfect the micro handpiece
Requirements
The handpiece body and the nose cone of the micro handpiece and the instru-
ment cable are ready to be cleaned and disinfected mechanically.
Procedure
1. Place the handpiece body and the connection cable in a suitable stainless steel
basket.
2. Load the stainless steel basket into the washer-disinfector.
Connect the luer lock ports on the micro handpiece to an irrigation device.
Make sure the lumens are clear and can be sufficiently flushed through.
3. Insert the nose cone on a flushing cannula of the washer-disinfector.
4. Clean and disinfect all individual parts in the washer-disinfector.
The cleaning and disinfection according to the reprocessing procedure validated
by Söring (see table) is recommended.
– The handpiece body and the nose cone of the micro handpiece and the instru-
ment cable have been automatically cleaned and disinfected.
Reprocessing
Reassembling the micro handpiece
Procedure
1. Perform a visual inspection to check that the handpiece body, the sonotrode and
the nose cone are not visibly damaged.
– The handpiece body, the sonotrode and the nose cone are in perfect condition.
2. Position the nose cone on the sonotrode and screw on tightly.
Reprocessing
Sterilizing the micro handpiece
Requirements
The micro handpiece and the instrument cable have been cleaned and disin-
fected.
The cleaned and disinfected micro handpiece has now been reassembled.
Procedure
1. Place the micro handpiece in packaging.
2. Place the instrument cable in different simple packaging.
3. Sterilize the packaged micro handpiece and the packaged instrument cable in a
steam sterilizer with a fractionated pre-vacuum.
4. Store the micro handpiece and the instrument cable in accordance with the in-
structions (see Chapter ”Transport and storage” on page 13).
– The micro handpiece and the instrument cable have now been sterilized and
can be used for treatment.
6.6
Preventive maintenance
Faults
7 Preventive maintenance
The Micro handpiece undergoes natural wear due to thermal, chemical and mechani-
cal strain even if used according to its intended use and handled with care. This wear
has an effect on individual component service life. Regular maintenance of the Micro
handpiece lengthens the expected service life.
Maintenance of the Micro handpiece entails checking the condition of the Micro
handpiece and the extent of wear at regular intervals. A safety check must be per-
formed on the Micro handpiece once every 12 months.
You can remedy some faults occurring during use yourself. However, you must not
perform repairs yourself. You may only replace the mouthpiece yourself.
7.1 Faults
Preventive maintenance
Safety check
7.4 Repairs
Do not attempt to repair the micro handpiece yourself. You can only replace the nose
cone or a part of the nose cone yourself if it is visibly damaged or has been lost.
Please contact the manufacturer or an authorized distributor to order a new spare
part.
If you want to use a spare part, first mechanically clean and disinfect, then sterilize the
micro handpiece and the new spare part. After assembly, the micro handpiece must
be sterilized again.
Preventive maintenance
Repairs
Disposal
8 Disposal
As soon as the Micro handpiece or the instrument cable has reached the end of its
service life, it must be properly disposed of.
Give the Micro handpiece or the instrument cable to a disposal company or send it to
the manufacturer or an authorized distributor.
8.1
Technical data
9 Technical data
Micro handpiece
Materials: Titanium, plastic
Total length: 92-020: 222 mm
92-021: 285.5 mm
92-112: 296.5 mm
Working length: 92-020: 35 mm
92-021: 96.5 mm
92-112: 107.5 mm
Sonotrode tip diameter: 92-020: 2.0 mm
92-021: 2.0 mm
92-112: 2.3 mm
Irrigation: External
Aspiration: Interior
Weight: 92-020: 81 g
92-021: 82 g
92-112: 83 g
Working frequency: 35 kHz
Compatibility: SONOCA 300, SONOCA 400,
software version 4.53 and higher
Temperature: Operation: 10 °C to 40 °C (50 °F to 104 °F)
Transport and storage: –25 °C to 70 °C (–13 °F to 158 °F)
Relative humidity: Operation: 20 % to 80 %, non-condensing
Transport and storage: 10 % to 95 %, non-condensing
Air pressure: Operation: 700 hPa to 1060 hPa (10.15 psi to 15.37 psi)
Transport and storage: 500 hPa to 1060 hPa (7.25 psi to 15.37 psi)
Activation: Foot switch
Procedure time: During treatment:
Not more than 60 minutes in total
Classification: Type BF (in accordance with IEC 60601-1)
Class III (in accordance with the Medical Devices and Directive
93/42/EEC, Annex IX)
Annex I (German Ordinance on the Installation, Operation and
Use of Medical Products (MPBetreibV))
9.1
Index
Index
A Double tubing 12
Accessories 11 connecting 15
improper 9
E
Activation 32 Electromagnetic compatibility 8
Ambient conditions 9, 32 Electromagnetic fields 8
Application, see Intended use End of service life, of the Micro handpiece 31
Article number 29
F
Assembly 26
Fail-safe operation 14
Association for Applied Hygiene (VAH) 23
Faults 28
At risk patients 7, 9 use despite 28
Autoclaving, see Sterilization Foot switch 12
Index
M Q
Magnetic fields 8 Qualification 7
Magnetic resonance tomograph 8
R
Micro handpiece Repair 29
assembling 26
automatic cleaning 25 Reprocessing 23
checking 29 prior to initial use 14
cleaning 24, 25 Reprocessing cycles 29
connecting 15
Robert Koch Institute (RKI) 23
contaminated 8, 19, 31
detaching 23 S
disassembling into individual parts 23
disconnecting 21 Safety check 29, see Safety check
disinfecting 25 Safety notice, see Warning
incorrectly set down 20
Scope of delivery 11
manually pre-cleaning 24
operating 14 Serial number 10
reassembling 26 Service life 28, 29
sterilizing 27
Signal word 5
Micro handpieces, overview of 10
Sonotrode 10, see Sonotrode, see Sonotrode
MRT 8 contaminated 8
hot 19
N
incorrectly fitted 28
Noise, clanking 28
Sonotrode tip 10
Nose cone 10, 29
Spare part 29
Numeric code, on the ultrasonic generator 28
Specialist staff, qualified 7
O Stainless steel basket 25, see Stainless steel basket,
O-ring 29 see Stainless steel basket
Operation 14 Steam sterilization, see Sterilization
Overview 10 Steam sterilizer 27
Sterilization 27
P
Packaging 13 Storage 13, see Storage
for sterilization 27
T
Pictogram Technical data 32
on the Micro handpiece 11
on the packaging 11 Transport 13
Index
U V
Ultrasonic transducer 10, see Ultrasonic transducer, Visual inspection 15, 26
see Ultrasonic transducer, see Ultrasonic transdu-
cer W
Usage, see Intended use Warning 5
general 8
Use
intended 7 Washer-disinfector 25, see Washer-disinfector
of incorrect accessories 9 Wear 28
of the Micro handpiece 23
Working length 32
Index
Söring GmbH
Justus-von-Liebig-Ring 2
D-25451 Quickborn
Tel.: +49 (0)4106-6100-0
Fax: +49 (0)4106-6100-10 Content management
Email: info@soering.com ZINDEL AG
Internet: www.soering.com www.zindel.de