parkell GentlePulse D624MS User Manual

DEVICE DESCRIPTION
The Gentle Pulse™ Pulp Vitality Testerisahand-held,battery-powereddentaldiagnostic
devicethatidenties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debrillator,insulinpump,etc.),oranypersonal
electronic monitoring device.
WARNING
Donotmodifythisdevice.Modicationmayviolatesafetycodesandendangerthepatientand
theoperator.Anymodicationwillvoidthewarranty.
ADVERSE EVENTS
Noneknown.
CONFORMANCE TO STANDARDS
Parkell’squalitysystemiscertied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

T
ooth Probe
(6)Posterior
T
ooth Probe
Lip Clip
Wire Assembly
(3)Body
(11)Pin
(1)Screw
(2)Sheath
(10)IndicatorLight
Gentle Pulse Components
Figure 1
A00095revJ1216

parkell GentlePulse D624MS Specifications

General

Brand	parkell
Model	GentlePulse D624MS
Category	Test Equipment
Language	English