Process Modeling, Simulation, and Control For Chemical Engineers 2nd Ed (McGraw-Hill Chemical Engineering Series) - William L. Luyben

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Instructions for use
Micro handpieces
92-020 | 92-021 | 92-112
DocNr.: 03-2002_R02.01 | 16.04.2015 | en-US 0123

Handpiece 92
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2 Micro handpieces | DocNr.: 03-2002_R02.01 | 16.04.2015 | en-US

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
4 Transport and storage..................................................................................13
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
DocNr.: 03-2002_R02.01 | 16.04.2015 | en-US | Micro handpieces 3

Table of contents
7 Preventive maintenance ..............................................................................28

7.1 Faults................................................................................................28
7.2 Safety check.....................................................................................29
7.3 Preventive maintenance ................................................................29
7.4 Repairs .............................................................................................29
8 Disposal .........................................................................................................31
9 Technical data ...............................................................................................32
Index ..............................................................................................................33

Introduction
Information about these instructions for use
1 Introduction
1.1 Information about these instructions for use

These instructions for use are intended to help you use the Micro handpiece in an op-
timum manner. Assembly and disassembly of the Micro handpiece and reprocessing
after use are described in detail. Medical application is not described. Find out about
the medical applications and their side effects. The relevant information can be found
in the specialist literature.
These instructions for use are included with the Micro handpiece. Please read the in-
structions for use completely before using the Micro handpiece. Please keep these in-
structions for use for future reference.
The Micro handpiece is only approved for use with a Söring ultrasonic generator and
Söring accessories. Please also observe the instructions for use for the ultrasonic gen-
erator and the accessories that are used.
If you have further questions on the content of these instructions for use or use of the
Micro handpiece, please contact Söring GmbH (contact data on back page) or an au-
thorized distributor.
1.2 Typographical conventions

In these instructions for use, warnings are indicated by a signal word. Hazards are cat-
egorized into hazard levels with consequences of differing severity.
Signal word Consequences
The consequences are death or severe injury.
The consequences may be death or severe injury.
The consequences may be minor injury.
This could result in material damage.
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
1.3 General conditions

Ensure that the following conditions are met when working with the Micro hand-
piece:
 The instructions for use must be read before the Micro handpiece can be used.
 The Micro handpiece must be processed according to the instructions given in
these instructions for use before it can be used for the first time (see Chapter ”Re-
processing” on page 23).
 Report any recurring faults or problems to Söring GmbH or an authorized distrib-
utor.
Söring GmbH does not accept liability for any damage or personal injury arising from:
 Modification or manipulation of the Micro handpiece
 Improper use
 Use of an unauthorized ultrasonic generator
 Use of accessories other than the recommended ones
 Improper handling
 Non-compliance with these instructions for use
1.4

Safety
Intended use
2 Safety
2.1 Intended use

The micro handpiece is intended solely for use on the central nervous system, in neu-
rosurgery and in spine surgery on humans. The micro handpiece is used for selective
dissection of tissue. Intracranial tumours (e.g. meningeomas, gilomas, neurinomas) in-
tracranial metastases as well as spinal soft tissue (intradural extramedullary tumors,
intradural intramedullary tumors and extradural tumors) may be treated.
The micro handpiece is not intended for use directly on the eye or circulatory system.
For the desired tissue effect to be achieved with the micro handpiece, sufficient irriga-
tion solution must be used. Only physiological saline solution or Ringer's solution is
approved as an irrigation solution.
As no definitive information is available for the treatment of at risk patients – primar-
ily pregnant women and hemophiliacs as well as infants and children up to 13 years
of age – the attending surgeon must weigh the risks of the treatment particularly
carefully against the benefits.
In each case, the surgeon providing treatment is responsible for weighing the risks of
treatment against the benefits.
The micro handpiece may only be used in medical procedures and operating rooms.
In close vicinity to the operating field, the atmosphere must not be oxygen enriched
nor must there be any danger of explosion.
Only qualified surgeons may operate on patients with the micro handpiece.
Any other use of the micro handpiece in accordance with the intended use – e.g. for
operation and reprocessing – is only permitted for qualified specialists such as oper-
ating room staff and sterilization department staff possessing the required education,
training or knowledge as well as sufficient experience.
In general, the micro handpiece may only be used by individuals properly instructed
in its handling. The manufacturer or a person authorized by the operator must pro-
vide instruction in the handling of the micro handpiece with the help of these instruc-
tions for use.
The micro handpiece is authorized for use with the following Söring ultrasonic gener-
ators only:
 SONOCA 300
 SONOCA 400
Under normal conditions, the micro handpiece is intended for use of no longer than
60 minutes in total.
The specified ambient temperature, relative humidity and air pressure conditions
must be maintained at all times during operation as well as during transport and stor-
age.
Any use other than that specified is considered to be improper use.

Safety
General warnings
2.2 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.
Contaminated micro handpiece

Use of a contaminated micro handpiece may result in life-threatening infections in
both patients and users.
 Only use a sterile micro handpiece.
 Only use a sterile instrument cable.
 Only use a sterile double tubing from undamaged packaging.
Damaged instrument cable

Damaged insulation on the instrument cable may cause electric shock and result in
severe injury or death.
 Check the instrument cable for damage.
 If the instrument cable is damaged, immediately switch off the power supply (or
do not switch it on).
 Replace the instrument cable if damaged.
 Only use an undamaged instrument cable.

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).
Use outside of the specified ambient conditions

Use of the micro handpiece outside the specified ambient temperature, relative hu-
midity and air pressure conditions can have incalculable consequences.
 When operating the micro handpiece, ensure that the specified ambient condi-
tions are maintained.
 During transport and storage, ensure that the specified ambient conditions are
maintained.
Treatment of at risk patients

The treatment of at risk patients may lead to death or severe injury. At risk patients in-
clude pregnant women, hemophiliacs as well as infants and children up 13 years of
age.
 Weigh the medical benefits of the treatment against the risks.
 Prior to beginning treatment, ensure that all measures for lessening risks have
been taken.

Overview
Overview of micro handpiece
3 Overview
3.1 Overview of micro handpiece
1 2
3
5
6
8 7
Fig. 3.1 Micro handpiece
1 Sonotrode 5 Luer lock port for the aspiration

2 Cover (disposable accessory) 6 Luer lock port for the irrigation
3 Nose cone 7 Connector socket for the instrument cable
4 Handpiece body with ultrasonic transducer 8 Type designation and serial number
1
2
Fig. 3.2 Individual parts of micro handpiece
1 Cover (disposable accessory) 3 Handpiece body with ultrasonic transducer

2 Nose cone 4 Sonotrode

Overview
Scope of delivery
3.2 Scope of delivery

The micro handpiece is delivered without other accessories.
For the use of the micro handpiece, the following accessories are necessary:
 An instrument cable
 A double tubing (disposable accessory)
Only use approved accessories. Approved accessories are listed in the catalogue.
For the latest information regarding accessories, please visit our website:
www.soering.com
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 of type BF (Body Floating).
Indicates a medical device with an article number in order to identify and re-
order it.
Indicates the batch of the medical device.
Indicates who is the manufacturer of the medical device.
Indicates when the medical device was manufactured.
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
3.4 System overview

The micro handpiece is connected to an ultrasonic generator with irrigation and aspi-
ration. A single foot switch on the ultrasonic generator is used for simultaneously acti-
vating the ultrasonic power as well as the irrigation and the aspiration.
INFORMATION
Fig. 3.3 Micro handpiece in the entire system
1 Ultrasonic generator 4 Micro handpiece

2 Double tubing (disposable accessory) 5 Cover (disposable accessory)
3 Instrument cable 6 Single foot switch
3.5

Transport and storage
4 Transport and storage

For transport and storage of the Micro handpiece, use packaging which protects it
from damage and contamination.
Always store the sterilized Micro handpiece in sterile packaging in accordance with
ISO 11607.
The storage environment must be dry, clean and dust-free.
 Storage temperature: between –25 °C and 70 °C (–13 °F and 158 °F).
 Relative humidity: between 10 % and 95 %, non-condensing.
 Air pressure: between 500 hPa and 1060 hPa (7.25 psi and 15.37 psi).
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
5.1 Preparing for treatment

First the Micro handpiece must be connected to the ultrasonic generator. A visual in-
spection must then be performed. Finally, functional testing must be performed and
the power settings on the ultrasonic generator checked. Only then may treatment be
started.
5.1.1 Connecting the micro handpiece to the ultrasonic generator
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.
Liquid on the contacts

The connector socket may melt due to liquid on the contacts of a connector socket or
the instrument cable. This leads to malfunctions of the micro handpiece and of the ul-
trasonic generator. Treatment must be performed with a redundant system, thereby
lengthening the treatment duration.
 Make sure the contacts on the connector sockets and on the plugs are dry.
 Observe the specified sequence of the steps so no liquid gets onto the contacts.

Operation
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.
– The instrument cable engages in the connector socket.

– The OK indicator light on the ultrasonic generator lights.
5. Connect the double tubing with the luer lock ports of the micro handpiece.
Hand tighten only.
Observe the instructions for use of the ultrasonic generator for using the irriga-
tion bottle and the aspiration canister.
– The micro handpiece has been connected to the ultrasonic generator.

Operation
5.1.2 Functional testing
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
5.2 Starting treatment

A single foot switch on the ultrasonic generator is used for simultaneously activating
the ultrasonic power as well as the irrigation and the aspiration.
It is crucial for the treatment result that the power settings are correct. The tissue ef-
fect is controlled primarily with the ultrasonic power and the aspiration capacity. The
higher the ultrasonic power and the aspiration capacity is set, the stronger the tissue
effect.
Always begin the treatment with a low ultrasonic power to prevent an unintention-
ally strong effect. Then slowly increase the ultrasonic power.
For the desired tissue effect to be achieved with the micro handpiece, sufficient irriga-
tion solution must be used. Only physiological saline solution or Ringer's solution is
approved as an irrigation solution.
Only when sufficient irrigation solution is directed to the sonotrode tip will the so-
notrode tip not clog. Sufficient irrigation solution also prevents the micro handpiece
from becoming excessively hot when activated for a long time. Thus check the so-
notrode tip continuously over the course of the treatment to determine that it is
being supplied with sufficient irrigation solution. For the irrigation solution to be aspi-
rated again, the aspiration capacity must be set accordingly high.
Sufficient irrigation solution is important to achieve the desired tissue effect. How-
ever, too much irrigation solution can impair the view of the operating field. The irri-
gation solution must be aspirated.
Do not set the aspiration capacity too low. Instead, increase the irrigation capacity in
order to prevent the sonotrode and the double tubing from blocking.
Due to the friction heat, it is also crucial for the treatment result that the correct pres-
sure is applied to the tissue and the movement of the sonotrode tip is correct over
the tissue.
Always use the micro handpiece with care so the sonotrode is not damaged. Do not
bend the sonotrode or touch any metal objects with it.
Observe the course of the instrument cable and the double tube during the treat-
ment. The staff must not be impeded. They could fall and patients be injured by the
sudden movement from the fall.

Operation
Starting treatment
Contaminated micro handpiece

Use of a contaminated micro handpiece may result in life-threatening infections in
both patients and users.
 Only use a sterile micro handpiece.
 Only use a sterile instrument cable.
 Only use a sterile cover from undamaged packaging.
 Only use a sterile double tubing from undamaged packaging.
Metal objects in the vicinity of the sonotrode

Contact of the sonotrode with metal objects can cause sparking. This may result in ex-
plosions and fires. The sonotrode can also be damaged, in turn leading to the possi-
bility of severe injury to patients.
 Do not touch any metal objects with the sonotrode.
 Do not use anaesthetic gas or oxygen in the immediate vicinity of the operating
field.
 Do not use any explosive or flammable materials in the immediate vicinity of the
operating field.
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
Micro handpiece incorrectly set down

A micro handpiece that is not in use can be accidentally activated. If the micro hand-
piece is set down on a patient, this can result in severe injury to the patient due to ac-
cidental activation.
 Always set an unused micro handpiece down on a utility table.
 Never set the micro handpiece down on a patient when not in use.
Treatment without cover

The sonotrode can become hot during the treatment. The cover prevents direct con-
tact of the sonotrode edges with the surrounding tissue and directs the irrigation so-
lution to the sonotrode tip. If no cover is used, this can result in burning of the
surrounding tissue
 Always use a cover.
 Only touch the tissue with the sonotrode tip.
 Never touch tissue with the sonotrode edge.

Operation
Ending treatment
5.3 Ending treatment

After treatment the Micro handpiece must be disconnected from the ultrasonic gen-
erator and disassembled into its constituent parts. Disposable accessories must be
disposed of immediately.
The Micro handpiece and the instrument cable must then be reprocessed (see Chap-
ter ”Reprocessing” on page 23).
5.3.1 Disconnecting the micro handpiece from the ultrasonic generator
Requirements
 The ultrasonic generator is switched off.
Procedure
1. Pull the cover off the nose cone and dispose of properly.
2. Disconnect the instrument cable from the micro handpiece.

To do this, only pull on the grip sleeve of the instrument cable.
3. Disconnect the instrument cable from the ultrasonic generator.

To do this, only pull on the grip sleeve of the instrument cable.

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).
6.1 Disassembling the micro handpiece

Requirements
 The micro handpiece has been disconnected from the ultrasonic generator.
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
6.2 Manually pre-cleaning the micro handpiece

If the handpiece body, the nose cone or the instrument cable are heavily soiled, they
must be pre-cleaned manually.
The information in the table describes the reprocessing procedure recommended by
Söring for manual pre-cleaning. If you want to use other methods and parameters,
you can determine the material compatibility from the reprocessing procedure rec-
ommended by Söring.
Manual pre-cleaning Water type Temperature Process chemical Duration

In water bath Tap water Cold – > 1 minute
With brushes Tap water Cold Alkali > 2 minutes
With water jet Tap water Cold – 10 seconds
In ultrasonic bath Tap water Cold Alkali > 3 minutes
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
6.3 Automatically clean and disinfect the micro handpiece

A washer-disinfector must be used for the cleaning and disinfection of the handpiece
body, the nose cone and the instrument cable.
The information in the table describes the reprocessing procedure validated by
Söring for the mechanical cleaning and disinfection. If you want to use another pro-
cess chemical, other methods or parameters, you can determine the material compat-
ibility from the reprocessing procedure validated by Söring.
For the validation, Neodisher Mediclean forte was used as the process chemical.
The reprocessing procedure recommended by Söring includes the following program
steps.
Program steps Water type Temperature Process chemical Duration

Pre-rinsing Tap water –
Cleaning Tap water 55 °C (131 °F) Alkali 10 minutes
Double neutralization Tap water –
Thermal disinfection VE water 93 °C (199.4 °F) – 5 minutes
Drying – > 90 °C (194 °F) – 40 minutes
Minimum requirement for the thermal disinfection: A0value > 3000.
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
6.4 Reassembling the micro handpiece

Requirements
 All individual parts of the micro handpiece and the instrument cable have been
automatically cleaned and disinfected and are dry.
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.
– The micro handpiece has now been reassembled.

Reprocessing
Sterilizing the micro handpiece
6.5 Sterilizing the micro handpiece

A steam sterilizer and special packaging conforming to ISO 11607 must be used for
sterilizing the micro handpiece and the instrument cable.
The information in the table describes the reprocessing procedure validated by
Söring for the sterilization. For the validation, simple packaging was used. If you want
to use other methods and parameters, you can determine the material compatibility
from the reprocessing procedure validated by Söring.
Settings on the steam sterilizer Pressure Temperature Duration

Sterilization 3 bar (43.51 psi) 134 °C (273.2 °F) 3 minutes
Drying 10 minutes
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
Use despite the presence of a fault

Use of the micro handpiece when a fault condition exists may lead to malfunction
and result in life-threatening injury to patients.
 Immediately eliminate the cause of the fault.
 Report any recurring faults to the manufacturer or an authorized distributor.
Fault Possible cause Remedy

A clanking noise can be heard The sonotrode is not firmly Send in the micro handpiece
when the micro handpiece is screwed to the ultrasonic for repair.
activated. transducer.
The micro handpiece is exces- Either the ultrasonic trans- Send in the micro handpiece
sively hot. ducer or the sonotrode is de- for repair.
fective.
The achieved tissue effect is The instrument cable is defec- Replace the instrument cable.
insufficient. tive.
Either the ultrasonic trans- Send in the micro handpiece
ducer or the sonotrode is de- for repair.
fective.
There is no irrigation solution. The roller clamp on the double Release the roller clamp on the
tubing is engaged. double tubing.
The irrigation bottle is empty. Use a new irrigation bottle.
The OK indicator light on the The instrument cable is defec- Replace the instrument cable.
ultrasonic generator is not lit. tive.
The ERROR indicator light on The micro handpiece is over- Wait for 10 seconds and acti-
the ultrasonic generator is lit. loaded or damaged. For safety vate the micro handpiece
The micro handpiece cannot purposes, the ultrasonic gen- again.
be activated. erator no longer outputs any If the fault persists, the micro
ultrasonic power. handpiece is defective and may
no longer be used.

Safety check
7.2 Safety check

A safety check must be performed on the Micro handpiece at least once every 12
months. The safety check may only be performed by competent individuals autho-
rized by the manufacturer using suitable measuring and testing devices. The type and
scope of the safety check are prescribed by the manufacturer. The procedure and re-
sults of this safety check must be recorded in a report.
7.3 Preventive maintenance

Regular maintenance of the Micro handpiece lengthens the expected service life. It is
recommended to perform preventive maintenance once every twelve months or
after 150 reprocessing cycles.
Preventive maintenance may only be performed by the manufacturer. Regular pre-
ventive maintenance preserves the leak-tightness of the handpiece body.
7.4 Repairs
Unauthorized repairs or modifications

Improper repairs, modifications and manipulations can lead to malfunctions and re-
sult in life-threatening injury to patients.
 Only have repairs performed by the manufacturer or by qualified service person-
nel authorized or trained by the manufacturer.
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.
Spare part Article number

Titanium part of the nose cone including O-ring 612S0024
O-ring for the titanium part 510N0053
Plastic part of the nose cone including O-ring 612S0031
O-ring for the plastic part 510N0054
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.

Repairs
A defective micro handpiece can be sent to the manufacturer or an authorized dis-

tributor for inspection and repair. Also send the instrument cable along with the in-
strument if possible. Only send in a disinfected micro handpiece with certificate of
disinfection; otherwise additional costs will be incurred. Enclose a detailed error de-
scription that also notes the serial number of the micro handpiece.
If the micro handpiece is irreparable, please send it to the manufacturer, an autho-
rized distributor or a disposal company for proper disposal (see Chapter ”Disposal” on
page 31).

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.
Contaminated Micro handpiece

An improperly disposed of contaminated Micro handpiece or instrument cable can
lead to life-threatening infections in people and damage to the environment.
 Only a cleaned and disinfected Micro handpiece or instrument cable will be ac-
cepted for disposal.
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
C Functional testing, carrying out 17

Cavity, see Lumen H
Check Handling the Micro handpiece, conditions for 6
regular 29
safety 29 I
Classification 32 Instructions for use
for the Micro handpieces 5
Cleaning 24, 25
for the ultrasonic generator 5
Conditions, for handling the Micro handpiece 6
Instrument, see Micro handpiece
Connector socket 10
Instrument cable
Contamination, see Cleaning connecting 15
Cover 10, 12, 20 contaminated 8, 19
damaged 8
D disconnecting 21
Disassembly 23 Intended use 7
Disinfectants, recommended 23 L
Disinfection 25 Luer lock port 10
Disposal 31 Lumen 25
Disposal company 31

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
Power settings, checking 17 Treatment

benefits of 14
Pre-vacuum, fractionated 27 ending 21
Preventive maintenance 28, 29 preparing 15
risks of 14
Procedure time 32
starting 18
Purpose 7 tasks prior to 14, 15
Type designation 10

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

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April 2015 7:35 07

Instructions for use

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4 Transport and storage..................................................................................13

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7 Preventive maintenance ..............................................................................28

9 Technical data ...............................................................................................32

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1.1 Information about these instructions for use

1.2 Typographical conventions

Signal word Consequences

The consequences are death or severe injury.

The consequences may be death or severe injury.

The consequences may be minor injury.

This could result in material damage.

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1.3 General conditions

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2.1 Intended use

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2.2 General warnings

Contaminated micro handpiece

Damaged instrument cable

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Use outside of the specified ambient conditions

Treatment of at risk patients

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3.1 Overview of micro handpiece

1 Sonotrode 5 Luer lock port for the aspiration

Fig. 3.2 Individual parts of micro handpiece

1 Cover (disposable accessory) 3 Handpiece body with ultrasonic transducer

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3.2 Scope of delivery

Indicates a medical device of type BF (Body Floating).

Indicates the batch of the medical device.

Indicates who is the manufacturer of the medical device.

Indicates when the medical device was manufactured.

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3.4 System overview

Fig. 3.3 Micro handpiece in the entire system

1 Ultrasonic generator 4 Micro handpiece

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Transport and storage

4 Transport and storage

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14 Micro handpieces | DocNr.: 03-2002_R02.01 | 16.04.2015 | en-US

5.1 Preparing for treatment

5.1.1 Connecting the micro handpiece to the ultrasonic generator

Liquid on the contacts

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– The instrument cable engages in the connector socket.

– The micro handpiece has been connected to the ultrasonic generator.

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5.1.2 Functional testing

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5.2 Starting treatment

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Contaminated micro handpiece

Metal objects in the vicinity of the sonotrode

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Micro handpiece incorrectly set down