Medizintechnik Gulden PERIOTEST M User manual

PERIOTEST M
Operating Instructions
English
PERIOTEST M

Medizintechnik Gulden e.K.
Operating Instructions
Electrical measuring instrument for dentistry and dental implantology
Page 2

Operating Instructions
English
PERIOTEST M
Electrical measuring instrument for dentistry and dental implantology
Page 3

Dear Customer,
Symbols used in the
Operating Instructions
NOTE
CAUTION
WARNING
About this document
Thank you for purchasing the Medizintechnik Gulden
Periotest M.
The technical documentation supplied is part of the
product and always must be kept within easy reach.
Please read these Operating Instructions carefully
and familiarize yourself with the Periotest M.
If you encounter unsolvable problems after
thoroughly studying the Operating Instructions,
please contact your dental depot or the
manufacturer.
To prevent any personal injury or material damage,
please observe the warning and safety information
provided in the present operating instructions. All
such information is highlighted as follows:
Additional information, explanation or supplement.
The information provided unter this keyword directly
concerns the functioning of the product and / or
warns against possible operating errors.
The warning symbol warns against possible hazards
for the product or the user.
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Symbols used in these
Operating Instructions as well
as on the product and the
package
VAC
VDC
f
N
M
h
(volts alternating current): Alternating current in volts.
(volts direct current): Direct current (DC) in volts.
Serial number of the unit
Electrical protection class: II (double insulation,
complies with the requirements of IEC 60601-1.
Part applied to patient: Type B.
Manufacture date: Date written as year-month.
Name and address of the manufacturer.
Disposal: This product must not be disposed with
household garbage.
Order number / item number
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Storage and transport
conditions
p
C0366
Item number and Version of
Operating Instructions
Temperature: The product must not be stored and
transported at temperatures ranging outside of
-20 °C and +50 °C (-4 °F and +122 °F).
Air pressure: Permissible atmospheric pressure: 500
to 1060 hPa.
Humidity: Permissible relative humidity: 20 to 90 %.
Observe information in accompanying documents.
Fragile; handle with care.
Protect from moisture.
This product bears the CE mark in accordance with
the provisions of Council Directive 93/42/EEC of
June 14, 1993 concerning medical devices.
REF 8920165
Version 2015-03-17
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Contents Page
1. Warning and safety information
1.1 General safety information 8
2. Technical information
2.1 Technical description 11
2.2 Technical data 12
2.3 Service life of Periotest instruments 14
3. Scope of supply 14
4. Installing the Periotest M 15
5. Controls and functional elements 17
6. Operation
6.1 Putting the unit into operation 18
6.2 Functional test 19
7. Conducting measurements with the Periotest M
7.1 Sitting position of the patient 20
7.2 Point of application at the tooth / implant 20
7.3 Posture of the Periotest M 21
7.4 Measurement procedure 23
7.5 Point in time of measurements at dental implants 24
7.6 Measurement of the occlusal load 24
8. Meaning of the Periotest values 25
9. Care and cleaning
9.1 Cleaning and disinfection 27
9.2 Sterilization of the Periotest M probe 29
10. Battery
10.1 Charging the battery 30
11. Maintenance 31
12. Electromagnetic compatibility 32
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Retention of documentation
Read carefully before
starting!
Intended use
Modification of the device
Disclaimer
1 Warning and safety information
1.1 General safety information
It is very important to make sure that this manual is
stored together with the unit so that it will also be
available at any time in the future. In case the unit is
sold or the right to use is transferred to a different
owner, make sure that the manual always remains
located near the unit. This is necessary to ensure
that the new owner can use the unit properly and
has all required information.
These instructions serve to promote safety. Be sure
to read them carefully before installing and using the
unit.
This symbol is attached at the Periotest M to remind
the user to observe the manual.
Medical electrical devices may be used with
reference to the risk of electrical shock, fire or
mechanical hazards, according to IEC 60601-1 only.
The Periotest M is an electrical measuring
instrument for dentistry and dental implantology. It
may be used only by qualified dental personnel.
The device must not be modified without the
permission of the manufacturer.
The manufacturer assumes no liability whatsoever in
cases involving:
- work or repairs performed by any personnel not
authorized by the manufacturer or importer
- an application which does not correspond to the
ones described in this manual
- the use of non-OEM components or any
components not described in the section entitled
Scope of supply.
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Electromagnetic compatibility
Operating environment
Malfunction or damage
Connected devices
Sterilization
To prevent potential risks from electromagnetic
interference, no medical devices or other electronic
devices may be operated in the immediate vicinity of
the Periotest M (see Chapter 12 for recommended
working clearances between Periotest M and
portable and mobile RF communication devices).
The device meets the currently applicable guidelines
for electromagnetic compatibility (IEC 60601-1-2).
This unit does not cause any harmful interference.
However, it can receive interference from other
devices, such as wireless transmitters, mobile
communication devices, and other household
appliances, including interference that may lead to
undesirable functions. Special EMC precautions are
required for the installation and operation of the
Periotest M. These Operating Instructions contain
the corresponding EMC information.
Never use this unit in the presence of flammable
anesthetics or anesthetic agents mixed with air,
oxygen or nitrogen.
In case of malfunction or damage of the unit, stop
using it immediately. Damaged instruments can
cause injuries. Contact your dental dealer or the
manufacturer.
The Periotest M may be used only with the supplied
probe. The use of a different probe may lead to
wrong readings.
Maximum sterilization temperature for the probe:
134 °C (273 °F).
5
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Power supply
Battery
Side effects
Return shipment for repair
Disposal
The Periotest M is powered by a storage battery.
The supplied power supply unit and the charger unit
are used only to charge the battery, but not to
operate the Periotest M. Do not use other charging
devices than the supplied power supply unit and the
supplied battery charger.
The Periotest M is equipped with a built-in battery.
Do not try to open the Periotest M casing and
change the battery by yourself. The battery may only
be replaced by an authorized dealer or the
manufacturer.
Until now, no side effects (e.g. necrosis) have been
determined in connection with clinical use of the
Periotest M.
Parts returned for repair must always be disinfected
prior to shipment to ensure that no innocent
bystander is infected when unpacking and
transporting them.
It generally applies that any disposal of this product
must comply with the relevant national regulations.
Please observe the regulations applicable in your
country. Within the European Economic Community,
Council Directive 2002/96/EU (WEEE) requires
environmentally sound recycling / disposal of
electrical and electronic devices. Your product is
marked with the adjacent symbol. Disposal of your
product with domestic refuse is not compatible with
the objectives of environmentally sound recycling /
disposal. The black bar underneath the „garbage
can“ symbol means that it was put into circulation
after August 13, 2005 (see EN 50419:2005). Please
note that this product is subject to Council Directive
2002/96/EU (WEEE) and the applicable national law
of your country and must be recycled or disposed in
an environmentally sound manner. Please contact
your dental depot if final disposal of your product is
required.
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2 Technical information
2.1 Technical description
The Periotest M is an electrical measuring instrument for use in dental practices. It is
designed for the following range of applications:
- Assessment of the osseointegration of dental implants
- Diagnosis and assessment of periodontopathies. The Periotest M measures the damping
characteristics of the periodontium and, indirectly, tooth mobility, which it outputs in the
form of a Periotest value.
- Assessment of the occlusal load
- Control of the treatment‘s progress.
The instrument‘s scale ranges from -8.0 to +50.0. The unit of measure is „Periotest
values“. Periotest values correspond to the contact time of the probe with the measured
object (tooth, implant). A short contact time corresponds to a low Periotest value, while a
long contact time corresponds to a high Periotest value.
The Periotest M is the result of a cooperation between experienced dental technicians and
many years of experience in high-end electronics. It represents the state of the art in
dental research technology.
Contraindications
The Periotest M should not be applied in the following cases:
- All types of acute apical periodontitis
- Acute trauma (dislocation, root fracture, alveolar process fracture).
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2.2 Technical data
Manufacturer
Model Periotest M type 3218
Periotest M hand unit data
Dimensions Approx. 180 x 31 x 40 mm
Material
Housing (white parts) ABS (Flammability HB)
Housing (blue parts) TPE (Flammability HB)
Probe sleeve Brass, nickel and chrome plated
Tapping head Stainless steel X8CrNiS18-9
Weight incl. battery Approx. 153 g
Noise level < 65 dBA
Power supply Battery driven device
Power consumption from
battery charger during charging max. 225 mA
Battery
type Lithium-ion polymer
Voltage nominal 7.4 VDC
Capacity typical 250 mAh
Protection against electrical shock
Protection class Internal power supply
Degree of protection against
electrical shock Applied part: type B
Operating mode Intermittent operation: ON 4 sec. / OFF until
next measurement
Housing IP class IP20
Medizintechnik Gulden e.K.
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2.2 (continued): Technical data
Energy transfer from the tapping head
to the measured object (tooth, implant) Max. 0.00018 Joule
Weight of the tapping head Approx. 9 g
Range of the Periotest value scale -8.0 to +50.0
Unit of measure Periotest values
Accuracy of measure Scale range -8 to +19: +/- 1.0 Periotest value
Scale range +20 to +50: +/- 2.0 Periotest value
Display resolution 0.1 Periotest value
Operating conditions Temperature: 15 to 30 °C (59 to 86 °F)
Relative humidity: 20 to 90 %
Air pressure: 700 to 1060 hPa
Transport and storage conditions Temperature: -20 to 50 °C (-4 to 122 °F)
Relative humidity: 20 to 90 %
Air pressure: 500 to 1100 hPa
Periotest M battery charger data
Input voltage 12 VDC
Housing IP class IP20
Protection class II
Item number / order number REF 8916793
Switch mode power supply unit data
Manufacturer Friwo
Type FW7660M/12
Input voltage 100 to 240 VAC
Mains frequency 50 to 60 Hz
Output voltage 12 VDC
Output current 800 mA
Housing IP class IP40
Item number / order number REF 8919610
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2.3 Service life of Periotest M instruments
When used as intended, the non-moving parts of Periotest M instruments have a typical
service life of 5 years. Moving parts of Periotest M instruments have a typical service life
of 3 years. However, 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.
If your Periotest M (the unit as a whole, or in parts) or the accessories shall not be used
any more, do not dispose the product or the parts with household garbage. They can be
posing a risk to the environment. Please return these parts to the manufacturer.
Alternatively, there may be local recycling or collection points.
3 Scope of supply
- Periotest M including probe REF 8917140
- Lithium-ion polymer battery (built-in) REF 8917025
- Switch mode power supply unit REF 8919610
- Battery charger REF 8916793
- Test sleeve REF 5950027
- Cleaning brush REF 5245758
- Operating Instructions REF 8920165
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4 Installing the Periotest M
Remove the Periotest M and its accessories from the box and lay everything on a table.
Before installing the Periotest M inspect everything for damage. Any damage which may
have occurred during transport must be reported to the dealer within 24 hours after
receipt of the goods. Check the contents of the box for completeness as described in
section 3 (Scope of supply).
CAUTION
- This product is intended only for use by trained dental personnel.
- Do not install the Periotest M near direct or indirect sources of heat.
- Prior to initial use, all components of the Periotest M must be disinfected (see section 9).
- The packaging of the unit or its accessories must not be used for sterilization.
- While the battery is charging, make sure that the power supply plug can be easily
reached to enable quick and easy disconnection from the mains supply.
The charger should be placed on a level and sturdy surface. Make sure that the charger
is in a secure position. Plug the supplied test sleeve into its holder on the rear side of the
charger. Connect the charger with the power supply unit. Then plug the power supply unit
into a mains socket. The LEDs on the charger and on the power supply unit will both light
up green.
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WARNING
- The charger must not be placed in the patient environment while it is connected with the
power supply unit.
- Never touch the charging contacts AND the patient.
Place the Periotest M into the charger. The Periotest M battery is being charged. The
green LED at the charger starts blinking. Once the battery is fully charged, the LED stops
blinking and lights up green constantly.
PERIOTEST M
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5 Controls and functional elements
1 - Power supply unit 6 - Tip of the probe
2 - Battery charger 7 - Mounting ring
3 - Periotest M hand unit 8 - Start button
4 - Test sleeve 9 - LCD
5 - Cleaning brush
PERIOTEST M
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6 Operation
6.1 Putting the unit into operation
The Periotest M is intended solely to be driven by battery. It is not designed for mains
operation (100 - 240 VAC).
WARNING
The Periotest M must not be connected with the mains supply (via charger and power
supply) during operation.
The Periotest M is disconnected from the mains supply by pulling the power supply unit
out of the wall socket. Press the start button to switch on the unit. All segments on the
display light up for approx. 2 seconds. Then a short melody plays, the display shows - - . -
and the Periotest M is ready to conduct measurements.
NOTE
The Periotest M does not have a switch off button. The device switches off automatically
after approx. 3 minutes of idle state.
If you have terminated your measurements, put the Periotest M back into the charger.
PERIOTEST M
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6.2 Functional test
With the functional test as described hereinafter you verify the correct function and
readings of the Periotest M. Please carry out the functional test every time before you
take any measurement at a patient.
Visually inspect the device. If you observe damage which could lead to a hazardous
situation do not use the device. Contact your dental depot or the manufacturer first.
The functional test is done by measuring the supplied test sleeve. Remove the Periotest
M from the charger. Fit the test sleeve onto the tip of the probe. Press the start button to
switch on the unit. After 2 seconds a melody plays and the unit is ready to measure. Hold
the Periotest M horizontally and press the start button again. The measuring process
starts.
After the measuring cycle (approx. 4 seconds - 16 impulses) is finished, the short melody
plays again and the reading is indicated on the display. The reading should match the
value indicated on the test sleeve. A deviation of +/- 2.0 Periotest values is acceptable. In
case of a higher deviation, or in case no reading at all is indicated, the Periotest M does
not measure properly. Please observe the instructions in section 9.1 (Care and cleaning).
Above all, the probe must be clean and dry, enabling the tapping head to move easily. If
cleaning of the probe does not solve the problem, please contact your dealer.
Remove the test sleeve from the tip of the probe and plug it onto the holder on the rear
side of the charger.
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7 Conducting measurements with the Periotest M
7.1 Sitting position of the patient
Most favourable is an upright sitting position of the patient with a corresponding vertical
position of the teeth / implants. But it is also possible to conduct measurements on
patients in a lying position.
The teeth of the maxilla and the mandible must not have contact to each other.
However, the patient should open his mouth only a little bit and not too wide to enable
an easy access to the molar area.
7.2 Point of application at the tooth / implant
To measure natural teeth, the Periotest M must be positioned from vestibularly
(buccally, labially) in direction of lingually / palatinally. The tapping head should hit the
center of the lateral surface of the tooth.
To measure dental implants, two measuring directions are relevant:
1. Accordingly to the measurement of natural teeth: Position of the Periotest M from
vestibularly in direction of lingually / palatinally. Mainly the lingual wall is measured.
2. Alternatively, if anatomically possible and accessible: Position of the Periotest M from
lingually / palatinally in direction of vestibularly. Mainly the vestibular wall is measured.
One-piece implants are measured at the upper end of the implant (ball head or similar).
Two-piece implants are not measured at the implant itself, but at the implant abutment,
the gingiva former or the final crown. The preferred hitting point is right above the
gingiva.
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