Rx Only (product intended for use by a Licensed dental professional). Instructions for Use Pulp Vitality Tester ( hD655, hD655E) A01095revA0221 DEVICE DESCRIPTION or decreased electromagnetic immunity of this equipment or improper operation. The Digitest ® 3 Pulp Vitality Tester is a handheld, 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. 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). INTENDED USE/INDICATIONS • Mode of Operation of Equipment: Continuous. 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. • 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. 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. ELECTRICAL SPECIFICATIONS • Maximum DC Component Amplitude: None • Maximum AC Component Amplitude: 500 V peak to peak • Do not modify this device. Modification may violate safety codes, endanger the patient and the operator, and void the warranty. • Peak Output Current Maximum: 250uA • Pulse Durations (Packet Width): High (3 bars): 60.5ms Medium (2 bars): 100ms Low (1 bar): 124ms • 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. • Pulse Repetition Period: High (3 bars): 140ms Medium (2 bars): 228ms Low (1 bar): 284ms • 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. • 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. • 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 • Parkell’s quality system is certified to ISO 13485, and this device conforms with IEC 60601-1, IEC 60601-1-2, CAN

Stimulus Adjustment / Control Button Digital Display Ground Clip Lead Wire Posterior Autoclavable Probe Anterior Autoclavable Probe Precision Labial Autoclavable Probe Precision Lingual Autoclavable Probe • For further information, consult the Centers for Disease Control website at CDC.gov, referencing the most recent version of the “Guidelines for Infection Control in Dental Health-Care Settings”. • (1) Digitest 3 Pulp Vitality Tester • (4) Autoclavable Stainless Steel Tooth Probes • (1) Lead Wire • The Tooth Probes, Ground Clip and Lead Wire may be sterilized in any conventional steam autoclave...

• Discard and replace any Tooth Probe if the metal or the insulation becomes damaged during use. INSTALLING / REPLACING THE BATTERY • The Digitest 3 Pulp Vitality Tester comes with a high-output, 9-Volt alkaline battery. • To install the battery, remove screw (Figure 3) and carefully lift off the plastic battery door by gently pulling it away from the Power Unit (Figure 4). Withdraw the old battery from the battery enclosure, and unsnap it from the wire battery connector (Figure 5). Discard in accordance with applicable laws. • The tooth to be tested and the adjacent teeth must be clean and dry....

• Insert Tooth Probe into the open end of the Power Unit (Figure 13). To enhance electrical conductivity and contact between tooth and the probe, apply a small amount of toothpaste to the metal tip. 6. The maximum stimulus reading is 64. Even if there is no response at this level, there is still the possibility that the tooth is vital. No sensation at this number may simply indicate that the tooth is non-responsive at the time of the test, possibly from trauma. However, since teeth have been known to recover from traumatic injury many days after presenting with a “non-vital” reading, follow up...

TROUBLESHOOTING THE DIGITEST 3 PULP TESTER ■ Display does not light when button is depressed. • Battery weak or dead – needs replacement. • Unit damaged – needs service. • Ground wire not in use. ■ Tooth Probe loose or rotating in Power Unit. • Tooth Probe base too loose—adjust base with screwdriver (See Figure 2). ■ Vitality test showing no response at “64” reading, while control tooth is normal. • Tooth is non-vital. • Tooth Probe not adequately contacting tooth – apply toothpaste to probe and reapply to tooth. • Ground Clip Lead Wire not connected to Power Unit. • Patient not holding “Ground...