parkell Digitest II User Manual

Device Description
The Digitest
®
II Pulp Vitality Tester is a hand-held,
battery-powered dental diagnostic device that
identi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 a rate preset by the op-
erator. 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 debrillator, insulin pump, etc.), or any
personal electronic monitoring device.
Warning
• Do not modify this device. Modication may
violate safety codes, endanger the patient
and the operator, and void the warranty.
• This device should only be used by licensed
dental professionals qualied in the use of
the unit.
• Read and understand all instruction manuals
before using the device.
Specications
• Protection Against Electric Shock - Class 1,
Type BF applied part
• Equipment not suitable for use in the presence
of 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)
Conformance to Standards
Parkell’s quality system is certied to ISO13485, and
this device conforms with IEC 60601-1, UL 60601-1,
IEC 60601-1-2, CAN/CSA-C22.2 No. 60601-1 &
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
difcult-to-access labial or lingual surfaces
or accessible crown margins.
(1) Autoclavable Lip Clip with Wire Assembly
(1) Instructions for Use
Rx Only
INSTRUCTIONS FOR USE: Pulp Vitality Tester
(h D640)
A00653revF0819
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
EN
Fig. 1

parkell Digitest II Specifications

General

Brand	parkell
Model	Digitest II
Category	Test Equipment
Language	English

Summary

Device Description and Indications

Intended Use

The Digitest II Pulp Vitality Tester is a diagnostic instrument for determining dental pulp vitality using electrical stimulation.

Contraindications

Device is contraindicated for patients with pacemakers or other internal electronic devices.

General Warnings

Do not modify the device. Use only by licensed dental professionals. Read all manuals before use.

Specifications and Standards

Product Specifications

Details electric shock protection, operating conditions, and liquid ingress protection (IPX0).

Conformance to Standards

Device conforms to IEC 60601-1, UL 60601-1, IEC 60601-1-2, and MDD 93/42/EEC.

Digitest II Kit Contents

Included Kit Components

Lists the Digitest II tester, battery, autoclavable probes (standard/precision), lip clip, and instructions.

Cleaning, Maintenance, and Setup

Cleaning and Infection Control

Instructions for cleaning the power unit and sterilizing probes/accessories.

Service and Maintenance

Covers battery removal, device care, and probe tightening/replacement.

Changing the Battery

Step-by-step guide for replacing the 9-Volt battery.

Digitest II Setup

Procedure for preparing the device and patient for pulp vitality testing.

Pulp Vitality Testing Procedure

Performing the Test

Detailed steps for activating the unit, setting stimulus rate, and applying stimulation.

Clinical Observations and Interpretation

Guidance on interpreting results, comparing to control teeth, and factors affecting thresholds.

Troubleshooting and Warranty Information

Troubleshooting Common Issues

Addresses display problems, loose probes, and no/immediate response during testing.

Warranty and Terms of Use

Information on product warranty and terms of use, referencing parkell.com.

Explanation of Symbols Used

Key Symbols and Meanings

Defines symbols related to product use, sterilization, temperature, and packaging.