parkell Digitest 3 Gebrauchsanweisung

EN
INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
The Digitest 3 Pulp Vitality Tester is a hand-held,
®
battery-powered dental diagnostic device that
identifies 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
contraindicated 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 monitoring 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 qualified in the use of
the unit.
• Read and understand all instruction manuals
before using the device.
• Portable RF communications equipment
(including peripherals such as antenna cables
and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
Digitest 3 unit, including cables specified 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
accessories only. Use of accessories other than
those specified, 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 flammable 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 specifications, 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 certified 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
Pulp Vitality Tester
Rx Only •
hD655
A01095revA0620