DEVICE DESCRIPTION
The
Gentle Pulse™ Pulp Vitality Tester
is a hand-held, battery-powered dental diagnostic
device that identifies a living tooth by stimulating it with a weak electric current. As the operator
turns the intensity knob higher, the strength of the electrical signal delivered to the tooth
increases. The unique “Gentle Pulse” stimulus is designed to reliably trigger a patient response in
a vital tooth with minimal discomfort. To prolong battery life, a battery-saver feature automatically
turns the device off after 5-6 minutes of inactivity.
INTENDED USE/INDICATIONS
The Gentle Pulse is indicated as a diagnostic aid in establishing the vitality of the dental pulp.
CONTRAINDICATIONS
This device is contraindicated for use on a patient 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 and endanger the patient and
the operator. Any modification will void the warranty.
ADVERSE EVENTS
None known.
CONFORMANCE TO STANDARDS
Parkell’s quality system is certified to ISO9001/ISO13485, and conforms with IEC60601-1,
IEC60601-1-2 & Medical Device Directive 93/42/EEC.
HOW SUPPLIED
• 1 – Gentle Pulse Pulp Vitality Tester
• 1 – High-output (9-volt) alkaline battery —already installed in the Tester
• 2 – Autoclavable stainless steel tooth probes (anterior and posterior)
• 1 – Lip Clip Wire Assembly
• Instructions for use
PULP VITALITY TESTER
INSTRUCTIONS FOR USE
STOCK NO. D624MS
24-HOUR SAFETY HOTLINE
1-800-535-5053
RX ONLY
(9) Output Control Knob
(8) Power Unit
(7) Anterior
Tooth Probe
(6) Posterior
Tooth Probe
Lip Clip
Wire Assembly
(3) Body
(11) Pin
(1) Screw
(2) Sheath
(10) Indicator Light
Gentle Pulse Components
Figure 1
A00095revJ1216