300 Executive Drive, Edgewood, NY 11717
1-800-243-7446 • Fax: 631-249-1242 • www.parkell.com • Email: [email protected]
European Authorized Representative: (Not a dealer/distributor)
EMERGO EUROPE, Molenstraat 15, 2513 BH, The Hague, The Netherlands
Tel: +31 (0)70 345 8570 Fax: +31 (0)70 346 7299
Troubleshooting the Digitest Pulp Vitality Tester
1) Display does not light when button is depressed.
a) Battery weak or dead – Needs replacement.
b) Unit damaged – Needs service.
2) Tooth Probe loose or rotating in Power Unit.
a) Tooth Probe base too loose—Adjust base with screwdriver.
3) Vitality test showing no response at “64” reading, while control tooth is normal.
a) Tooth is actually non-vital.
b) Tooth Probe not adequately contacting tooth – Apply toothpaste to probe and reapply to tooth.
c) Lip Clip Wire Assembly not connected to Power Unit while wearing gloves – Connect Lip Clip
and Wire Assembly as detailed above.
4) Vitality test showing immediate response at very low reading.
a) Tooth is hyperemic – recommend endodontic treatment.
b) If problem persists with all teeth tested, unit needs service.
Warranty
Parkell will repair or replace, at its option, a defective unit. This warranty does not cover repairs where
the only fault found is a weak or dead battery. Always replace the battery with a fresh one before
returning the unit for warranty service, to rule this out as the cause of the problem.
This warranty is
in lieu of all warranties of merchantability, fitness for purpose or other warranties, express or
implied.
Parkell does not accept liability for any loss or damage, direct, consequential or otherwise,
arising out of the use of or the inability to use the product herein described. Before using, the user
shall determine the suitability of the product for its intended use and the user assumes all risk and
liability whatsoever in connection herewith.
Device Description
The Digitest II™ 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 a rate preset by the
operator. 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 II Pulp Vitality Tester is intended to
be used as a diagnostic instrument to assist in the
determination of the vitality of the dental pulp.
Contraindications
This device 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.
Specifications
• Protection Against Electric Shock - Class 1,
Type B 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)
Conformance to Standards
Parkell’s quality system is certified to
ISO9001/ISO13485, and this device conforms
with IEC 60601-1, UL 60601-1:2003,
IEC 60601-1-2, CAN/CSA-C22.2 No. 60601-1-08
& Medical Device Directive 93/42/EEC.
The Digitest II kit includes (Figure 1)
(1) Digitest II Pulp Vitality Tester
(1) High-output alkaline battery (9-Volt)
(already installed in the tester)
(2) Autoclavable stainless steel standard size
tooth probes (anterior and posterior)
(2) Autoclavable stainless steel precision
size tooth probes, for testing small or
difficult-to-access labial or lingual surfaces
or accessible crown margins.
(1) Autoclavable Lip Clip with Wire Assembly
(1) Instructions for Use / Warranty Registration Card
(1) Durable Plastic Storage Case
CAUTION: RX ONLY
INSTRUCTIONS FOR USE:
Pulp Vitality Tester
(Stock No. D640)
A00653revD1015
Lip Clip
Digital Display
Stimulus Adjustment
Control Button
A
C
B
D
Autoclavable Probes
A. Posterior
B. Anterior
C. Precision Lingual
D. Precision Labial
Wire Assembly
Fig. 1
Type “BF”
Applied Part
Certified to MDD
93/42/EEC