parkell DIGITEST 3 Gebrauchsanweisung

Rx Only (product intended for use by a
Licensed dental professional).
Instructions for Use
DEVICE DESCRIPTION
The Digitest 3 Pulp Vitality Tester is a hand-
®
held, battery-powered dental diagnostic device
that identifi es a living tooth nerve by stimulating
it with a weak electric current. When the operator
depresses the button, the strength of the electrical
stimulus automatically increases at one of three
preset rates. The unique waveform is designed to
trigger a patient response in a vital nerve with a
minimal amount of discomfort.
INTENDED USE/INDICATIONS
The Digitest 3 Pulp Vitality Tester is intended to
be used as a diagnostic instrument to assist in
the determination of the vitality of the dental pulp.
It is indicated for use on vital and non-vital adult
human teeth.
CONTRAINDICATIONS
This Digitest 3 Pulp Vitality Tester is contraindi-
cated for use on a patient or by an operator wearing
a cardiac pacemaker or any other intra-corporeal
electronic device (internal defibrillator, insulin
pump, etc.), or any personal electronic monitor-
ing device.
WARNING
• Do not modify this device. Modification may
violate safety codes, endanger the patient and
the operator, and void the warranty.
• This device should only be used by licensed
dental professionals qualifi ed in the use of
the unit.
• Read and understand all instruction manuals
before using the device.
• Portable RF communications equipment (includ-
ing peripherals such as antenna cables and exter-
nal antennas) should be used no closer than 30
cm (12 inches) to any part of the Digitest 3 unit,
including cables specifi ed by the manufacturer.
Otherwise, degradation of the performance of this
equipment may result.
• Use of this equipment adjacent to, or stacked with
other equipment, should be avoided because it
may result in improper operation.
• This device is to be operated with Parkell acces-
sories only. Use of accessories other than
those specifi ed, or provided by Parkell Inc., may
result in increased electromagnetic emissions
or decreased electromagnetic immunity of this
equipment or improper operation.
SPECIFICATIONS
• Protection Against Electric Shock: Type BF
applied part.
• Equipment not suitable for use in the presence
of fl ammable or explosive gases. Use of dental
nitrous oxide/oxygen analgesia is acceptable.
• Protection Against Ingress of Liquids:
Pulp Tester - IPX0 (Ordinary).
• Mode of Operation of Equipment: Continuous.
• Operating Conditions: 15-40°C, 10-80% RH
(non-condensing).
• Transport and Storage Conditions: 10-40°C,
10-80% RH (non-condensing).
• Stimulator Output: The voltage output at the
electrode can be characterized as discretely
pulsed voltage packets that gradually increase
in amplitude as the display count is incremented.
The output voltage is purely AC and contains no
DC component. For further electrical specifi ca-
tions, see below.
ELECTRICAL SPECIFICATIONS
• Maximum DC Component Amplitude: None
• Maximum AC Component Amplitude:
500 V peak to peak
• Peak Output Current Maximum: 250uA
• Pulse Durations (Packet Width):
High (3 bars): 60.5ms
Medium (2 bars): 100ms
Low (1 bar): 124ms
• Pulse Repetition Period:
High (3 bars): 140ms
Medium (2 bars): 228ms
Low (1 bar): 284ms
• Average Voltage Increment: 7 V
• The tooth enamel of a patient is simulated using
a 2 Megaohm resistive load. Using this load as
a reference, the absolute maximum voltage that
can appear at the electrode is 500V at a maximum
output current of 250uA.
CONFORMANCE TO STANDARDS
• Parkell's quality system is certifi ed to ISO 13485,
and this device conforms with IEC 60601-1, IEC
60601-1-2, CAN/CSA-C22.2 No. 60601-1 and
IEC 60601-2-40.
1
EN
Pulp Vitality Tester
( hD655, hD655E)
A01095revA0221