Denjoy DY310 User manual

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USER’S MANUAL
DY310 Pulp Tester
The unit must be installed by a qualified dental engineer.
The unit is only for use by dental professionals.
Read this operation manual carefully before operation.

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CONTENTS
SECTION I. CONTACT INFORMATION
SECTION II. DESCRIPTION
SECTION III. COMPONENTS AND FEATURES
SECTION IV.SYMBOL
SECTION V. MAIN TECHNICAL INDEX
SECTION VI. OPERATION
SECTION VII. SAFETYPRECAUTIONS
SECTION VIII. MAINTENANCE
SECTION IX: TOUBLESHOOTING GUIDE
SECTION X. PACKING LIST
SECTION XI. STORAGE &TRANSPORT
ENVIRONMENT
SECTION XII. WARRANTY STATEMENT
REMARKS:
The pictures here are for reference only.
Real products shall prevail. The parameters
and pictures in this manual are subject to
change without prior notice.

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SECTION I. CONTACT INFORMATION
Thank you for purchasing our device. Before operating the
device, please fully read the manual and this manual
should be saved for later use.
DENJOY DENTAL CO., LTD will take the responsibility for
the security, reliability, capability under the following
conditions:
1. The installation, debugging, maintenance should be
adjusted by the approbatory technician by our company
or obtained related nation quality level license
professions.
2. The power supply shall be in conformity with the
relevant provisions of the state and the use requirements
of device itself.
3. The device should be operated by licensed dental
professionals with medical applied skill. The whole
operation process should follow user’s manual strictly.
DENJOY DENTAL CO., LTD has right to improve shape and
structure of the device, change any information and
technical specification of this manual all the time, and no
need to notice the user in advance.

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CONTACT INFORMATION
The device is manufactured by:
DENJOY DENTAL CO., LTD
Address: F4, Building A4, Lugu Medical Device Park,
No.229 Guyuan Road, Changsha, 410205 P. R. China
Authorized European Representative:
Company name: LANDLINK GMBH
Address: DORFSTRASSE 2/4, 79312 EMMENDINGEN,
GERMANY
SECTION II. DESCRIPTION
Pulp Tester DY310 is a device to examine the vitality of
dental pulp using the electrical stimulation. During the
pulp test, the current stimulates intradental nerve, and
give severe pain to patients. Some studies were
accomplished to measure the responses of subjects by
stimulating over the sensory threshold to determine
whether the nerve of pulp in the tooth remains alive. So It
can accurately read the pulp’s livingness in a very highly
efficiency way.

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SECTION III. COMPONENTS AND FEATURES
A. Test electrode B. Stainless hook
C. Control part D. Probe cable
Test electrode 2pcs, Stainless hook 4pcs,
Probe cable 1pc

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Press ON/OFF button for 2S to turn on the device.
Press MODE button to set the speed of number change.

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“High” “Mid” “Low” stands for different modes for
speed of number change.
Features
● Preset speed mode (high-mid-low speed)
A gentle, pulsed stimulus begins to increase at a
rate of high-mid-low speed
● Specifically designed for patient comfort
If the patient indicates perception, simply release the
button. The stimulus stops immediately, but the numbers
remain frozen on the face for about 3 minutes.
● Convenient to operate
Peak of stimulus current reaction numerical
value---80.
Between 0-39, the patient feels ache and anesthesia,
it means alive teeth nerve
Between 40-79, with above-mentioned reaction, it
means part of teeth nerve dead
Reach 79, no above-mentioned reaction, dead teeth
nerve

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● The device turns itself off three minutes later after
operation (No wasted batteries.)
SECTION IV. SYMBOL
The following symbols may appear in this manual, on the
label, or on it’s accessories. Some of the symbols
represent standards and compliances associated with the
endo motor and its use.
Consult accompanying documents
Cautions
Authorized Representative in the
European Community
CE Mark: conforms to essential
requirements of the Medical Device
Directive 93/42/EEC.
Sterilizable up to the temperature
specified at most

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Date of manufacture.
Manufacturer
SN
Specifies serial number
Type BF applied part
Refer to instruction manual / booklet
Direct current
The device should not be used after the
end of the shown or the day
DISPOSAL: Do not dispose this product as
unsorted municipal waste. Collection of
such waste separately for special
treatment is necessary.
SECTION V. MAIN TECHNICAL INDEX
Model Name DY310
Anti-shock type internally powered equipment

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Anti-shock level Class BF
Degree of protection from ingress of liquids: None
Operation mode Continuous Operation
Rated voltage: 9.0V DC
Net weight: about 100g
Gross weight: about 350g
SECTION VI. OPERATION
1. Make the probe cable link with the cable socket of
the control part; afterwards insert the stainless hook and
the test electrode into the interface of the device.
2. Strictly separate the tooth which will be measured
from the saliva , blow the surface of the tooth until it is
dry , so as to forbid the stimulation electric current to
conduct from the gum, or else there will appear a false
stimulus current. You have to particularly pay attention to
the near joint's dryness, for forbidding the current
conduct from the near joint to the near tooth, or else
there will appear a false stimulation current signal.
3. Hang the stainless hook on any side of the mouth,
then select different speed mode (different speed: high
means high speed, mid means middle speed, low means

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low speed)
4. Paste a spot of conducting glue or toothpaste on
the contact interface (1/3 slice side) between test
electrode and selected tooth.
Then press the power switch.
Then lay the test electrode on the on the surface of
selected tooth. Afterwards, the unit will be activated and
simultaneously the figure keeps rising on the screen.
5. When the patient slightly feels toothache, or
anesthesia, you should take the test electrode away from
the tooth and observe the figure on the screen in order to
record it; this figure is the tooth's stimulation current
reaction number.
6. Peak of stimulus current reaction numerical value is
80. Between 0-40, the patient who has the reaction of
ache and anesthesia, the dentist can be sure that the
nerve is still alive. Only the numerical value go up to 40-80,
the patient has the above-mentioned reaction, the dentist
can be sure that part of the teeth nerve has been dead!
When the numerical value has reached 80, but the tooth
has no above-mentioned reaction, this shows the nerve
has already been dead!
7. After operation, the measuring result remains frozen

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on the surface of LCD screen for 3 minutes and then the
unit will switch off automatically.
* After switch the machine on, while the display screen
shows LO, its means the battery needs to be charged.
SECTION VII. SAFETYPRECAUTIONS
a). Before operation, you have to read this usage manual
carefully.
b). CAUTION: Persons having a history of
photosensitive reactions or who are using
photosensitizing drugs should not be exposed to light
from this unit.
c). CAUTION: Set the battery in a properly way
connecting positive with negative pole.
d) CAUTION: Keep away from bump into hard
stuff!
e) CAUTION: Equipment not suitable for use in

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the presence of flammable anesthetic mixture with air or
nitrous oxide.
f). To keep the safety operation, we suggest that
check your local AC power supply voltage before you buy
this product oversea.
g). CAUTION: Persons having a history of
photosensitive reactions or who are using
photosensitizing drugs should not be tested by pulp
tester.
h). CAUTION: Only experienced professional and
well-trained operator can use this machine.
i) The pulp tester should be placed in the
original packing box in a dry and clean cupboard. Please
take out the battery of the unit during the long period of
nonuse!

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SECTION VIII. MAINTENANCE
1. This device cannot be dismantled privately;
otherwise the unit will be damaged wholly.
2. Please use the original charger, any other
charger may result in the damage of the battery and
the controlled electric circuit; even the machine will
be greatly damaged.
3. After using this unit, the dental professionals must
cover the machine with sterilized sheet.
4. The unit should be scrubbed by pure water or
ethanol and follow the standard disinfection procedure to
disinfect the materials. Then the pulp tester should be
placed in the original packing box in a dry and
clean cupboard, in case of its drop onto the floor.
SECTION IX: TOUBLESHOOTING GUIDE
When trouble is found, check the following again before
contacting your dealer. If none of these are applicable or
the trouble is not remedied even after action has been
taken, the product may have failed. In this case, please
contact your dealer.
Problems
Cause & Solution
The device
can not be
The batteries out of power. Charge the
batteries

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turned on.
Batteries disorder. Reinstall the batteries.
The light
indicator has
no changes
Button of speed mode (high-mid-low
speed) is broken.
The device
can not work
normally
during the
operation.
Make sure that connection plug of
probe cable is in good contact with
cable socket of control part.
Make sure that all connection cables are
in good order.
Make sure that test electrode
connection is well and stable. The front
part of test electrode can seamlessly
contact with teeth facing.
Make sure that stainless hook
connection is well and stable.
Make sure that the preparation
treatment of teeth has been made
before operation.
SECTION X. PACKING LIST
Standard accessories contain:
．Control part
1pc
．Test electrode
2pcs
．Probe cable
1pc

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．Stainless hook
4pcs
．User manual
1pc
SECTION XI. STORAGE & TRANSPORT
ENVIRONMENT:
OPERATING CONDITIONS
Ambient temperature: 5℃~ 40℃
Relative humidity range: ≤80%
Atmospheric pressure: 70kPa ~ 106kPa
STORAGE AND SHIPPING CONDITIONS
Ambient temperature: -40℃~ 55℃
Relative humidity range: ≤80%
Atmospheric pressure: 50kPa~ 106kPa
Equipment is not suitable for storage in the presence
of sunlight, rain, dust, corrosive gasoline and volatile
without poor ventilation.
Transportation is applicable to all common methods.
SECTION XII. WARRANTY STATEMENT
This device described below has been fully inspected
and confronts to the current products specification.

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This device is guaranteed for its designated use, against
original defects in materials and workmanship for a period
of 12 months from date of purchase.
Products warranty or service will not be extended if
(1) The product is repaired, modified, misused,
disassembled, or using the parts are not provided by the
manufacturer. (2) The serial number of the product is
defaced or missing.
The guarantee for accessories is 6 months. All
accessories of the device are damaged or needed to be
renewed, the user can purchase new accessories from the
seller.
WARNING
The device is not repairable by user and contains no user
serviceable parts. No modification of this equipment is
allowed. The user must check that the equipment
functions safely and see that it is in proper working
condition before being used. The manufacturer does not
require such preventive inspections by other persons.
Please contact the sales distributor directly from
whom you have purchased this device for user’s
record and further after-sale service.

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Table 1
Guidance and manufacturer’s declaration -
electromagnetic emissions
The [DY310] is intended for use in the electromagnetic
environment specified below. The customer or the user of
the [DY310] should assure that it is used in such an
environment
Emissions
test
Compliance
Electromagnetic
environment -
guidance
RF
emissions
CISPR 11
Group 1
The [DY310] uses RF
energy only for its
internal function.
Therefore, its RF
emissions are very low
and are not likely to
cause any interference
in nearby electronic
equipment.
RF
emissions
CISPR 11
Class [B]
The [DY310] is suitable
for use in all
establishments other
than domestic, and may
be used in domestic
Harmonic
emissions
Class A

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establishments and
those directly connected
to the public low-voltage
power supply network
that supplies buildings
used for domestic
purposes, provided the
following warning is
heeded:
Warning: This
equipment/system is
intended for use by
healthcare
professionals only. This
equipment/ system may
cause radio interference
or may disrupt the
operation of nearby
equipment. It may be
necessary to take
mitigation measures,
such as re-orienting or
relocating the [DY310]
or shielding the location.
IEC
61000-3-2
Voltage
fluctuations/
flicker
emissions
IEC
61000-3-3
Complies

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Table 2
Guidance and manufacturer’s declaration -
electromagnetic emissions
The [DY310] is intended for use in the electromagnetic
environment specified below. The customer or the user of
the [DY310] should assure that it is used in such an
environment
Immunity
Test
IEC
60601
Test level
Complian
ce level
Electromagne
tic
environment -
guidance
Electrostatic
discharge
(ESD)
IEC
61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should
be wood,
concrete or
ceramic tile. If
floors are
covered with
synthetic
material, the
relative
humidity
should be at
least 30 %
Electrical
fast
±2 kV for
power
±2 kV for
power
Mains power
quality should