parkell Digitest II Manual Del Usuario

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 and Terms of Use:
Parkell will repair or replace, at its option, a defective unit. This warranty is in lieu of all warranties
of merchantability, fitness for purpose or other warranties, express or implied. Please note that any
unauthorized alteration, misuse, abuse, or failure to follow operating instructions supplied with this
unit will automatically void all warranties associated with the unit.
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.
If you purchased this product directly from Parkell, your unit is automatically registered. Your invoice
is your "Warranty Registration" receipt. If you purchased this product from a domestic or overseas
dealer, please register your product via the Internet at www.parkell.com. Locate and complete the
online form, print a copy for your records, and click the "Submit" button. Store the printout in a safe
place. Full Warranty and Terms of Sale information can be found online at www.parkell.com.
Certified to MDD Type "BF"
93/42/EEC Applied Part
If you have any questions or problems call Technical Support Service
at 1-800-243-7446, M-F from 9:15 AM to 5:15 PM EST.
THIS PRECISION DENTAL DEVICE WAS DESIGNED, MANUFACTURED
AND IS SERVICED IN THE UNITED STATES OF AMERICA BY:
300 Executive Drive, Edgewood, NY 11717
1-800-243-7446 • Fax: 631-249-1242 • www.parkell.com • Email: info@parkell.com
European Authorized Representative (Not a dealer/distributor):
Directa AB - P.O. Box 723, Finvids väg 8
SE-194 27 Upplands Väsby - Sweden
CAUTION: RX ONLY
INSTRUCTIONS FOR USE:
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.
Fig. 1 Stimulus Adjustment
Control Button
A
B
Digital Display
C
Lip Clip
D
Autoclavable Probes
A. Posterior
B. Anterior
C. Precision Lingual
D. Precision Labial
Pulp Vitality Tester
(Stock No. D640)
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
Wire Assembly
A00653revE1216