parkell A00095 Gentle Pulse Pulp Vitality Tester Instruction Manual

: June 1, 2024
: parkell

Table of Contents

parkell A00095 Gentle Pulse Pulp Vitality Tester
Product Usage Instructions
DEVICE DESCRIPTION
AVAILABLE AS AN OPTION
CLEANING AND INFECTION CONTROL OF THE GENTLE PULSE
CHANGING THE BATTERY
Frequently Asked Questions (FAQ)
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

parkell A00095 Gentle Pulse Pulp Vitality Tester

Product Specifications

Product Name: Gentle Pulse Pulp Vitality Tester
Model Number: D624MS
Power Source: Battery-powered (9-volt alkaline battery)
Intended Use: Diagnostic aid for establishing dental pulp vitality
Features: Output control knob, posterior and anterior tooth probes, indicator light
Certifications: ISO9001/ISO13485, IEC60601-1, IEC60601-1-2,Medical Device Directive 93/42/EEC

Product Usage Instructions

Changing the Battery

To change the battery of the Gentle Pulse:

Remove screw (1) and lift off the stainless steel sheath (2).
Replace the weak battery with a new 9-volt alkaline battery by snapping it onto the connector (4).
Insert the battery properly and ensure the ribbon (5) is correctly positioned.
Reattach the sheath (2) and tighten screw (1) gently.

Note: Dispose of used batteries in accordance with environmental laws.

Prior to Performing Pulp Vitality Testing

Always use the Lip Clip and wire to ensure a complete electrical circuit.
Select the appropriate metal probe and insert it into the power unit (8).
Apply a small amount of toothpaste to the probe tip for good electrical contact with the tooth.
Hold the unit with the output control knob (9) near your thumb and ensure the indicator light (10) is visible.
Turn the output control knob (9) clockwise to activate the unit. The blinking indicator light (10) indicates readiness.

INSTRUCTIONS FOR USE
STOCK NO. D624MS
24-HOUR SAFETY HOTLINE
1-800-535-5053

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

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AVAILABLE AS AN OPTION

Precision Probe Set (Stock No. D636. See Figure 2) 2 Autoclavable stainless steel tooth probes for testing small or difficult-to-access labial or lingual surfaces or accessible crown margins.

CLEANING AND INFECTION CONTROL OF THE GENTLE PULSE

Do not autoclave the GentlePulse Power Unit, as this will cause damage to it.
Autoclaving and disinfecting do not remove accumulated debris. Before autoclaving or disinfecting accessories: Rinse the accessories under warm running water for 30 seconds to remove any external or internal soil or debris. Using a soft soapy cleaning brush to assist in the cleaning, if necessary. Use non-ammoniated detergent or dishwashing soap. Do not use ammoniated cleansers or disinfectants. Rinse the item again under warm running water for 30 seconds to remove any residual soap and blot dry with a dry lint-free towel.
The Power Unit should be protected using properly-sized disposable plastic barrier sleeves.
Since the Gentle Pulse incorporates sophisticated electronic circuitry, it should not be directly sprayed with or soaked in disinfectant. The device may be disinfected by wiping it with a lint-free towel moistened with an EPA-approved disinfectant containing not more than 30% alcohol, alcohol-free surface disinfectant wipes, or disinfecting wipes containing 3-5%Hydrogen Peroxide. Any disinfectant used on the housing should eventually be wiped off as per the instructions given on disinfectant labeling to remove chemical residue.
Follow the surface disinfecting protocol specified by the disinfectant manufacturer.
For further information, consult the Centers for Disease Control website at www.CDC.gov, referencing the most recent version of the “Guidelines for Infection Control in Dental Health-Care Settings”.
The Tooth Probes, Ground Clip and Lead Wire may be sterilized in any conventional steam autoclave (130º-134º C for 15 min for Gravity Displacement units, or 4 minutes for Pre-vacuum Cycle units, followed by a 15-minute minimum cool down interval). Comply with the autoclave manufacturer’s recommended procedure, if different. These items can be autoclaved for 250 cycles before requiring replacement.
Avoid dropping the Power Unit or subjecting it to physical shock.
To maintain battery life, unit should be switched off when not in use. Battery should be removed if unit is to be stored unused for more than 30 days.
The indicator light blinks continuously in normal use. If it fails to blink when the unit is switched on or during use, it is likely that the battery is exhausted. Remove the old battery and replace it as explained in “Changing the Battery” instructions.

CHANGING THE BATTERY

(REFER TO FIGURES 1 AND 3)

The Gentle Pulse Power Unit (8) comes with a 9-volt alkaline battery installed at the factory. To replace a weak battery, remove screw (1) and carefully lift off the stainless steel sheath (2) by gently pulling it upwards from the body (3). The replacement battery (Duracell® No. MN1604 or equivalent 9-volt) should be snapped onto the connector (4), which is designed to be attached in only one way. Insert the battery so the front end attached to the connector is placed forward into the opening as shown, taking care to position the ribbon (5) properly. Slight pressure on the bottom of the battery will help it to slide home. Replace the sheath (2) and tighten screw (1) gently.

NOTE: Used batteries must be disposed of in accordance with all applicable environmental laws.

PRIOR TO PERFORMING PULP VITALITY TESTING

Standard infection control protocol should be followed during pulp testing by wearing disposable rubber, vinyl or nitrile gloves. When wearing gloves, you must complete the circuit by using the autoclavable Lip Clip wire assembly, which is included in the Gentle Pulse kit.
To use, plug one end of the wire assembly onto the pin (Figure 1, Item 11) on the side of the Gentle Pulse, and insert the Lip Clip into the other socket. Place a small amount of toothpaste on the lip to enhance electrical conductivity, and place the Lip Clip over the patient’s toothpaste-coated lip, making good contact with the oral mucosa.
Remember that to accurately diagnose the condition of the tooth, pulp testing must be performed on a patient who has not been anaesthetized or received gas analgesia. Make sure to use the Gentle Pulse tester BEFORE you administer local anaesthesia or gas analgesia.
The tooth to be tested and the adjacent teeth must be clean and dry. Interproximal embrasures should be made free of any impacted food debris, saliva, water or plaque by flossing or scaling with an instrument and air-drying before testing.
It is often useful to electrically isolate the tooth being tested from its neighbors by surrounding it with a clear mylar strip, such as those used in fabricating Class III
composite restorations.
A dry cotton roll should be placed in the buccal vestibule to isolate the tooth from the lip and cheek. A plastic mirror should be used to keep the tongue off of the tooth during testing.
Metal or ceramic surfaces cannot be used as contact points for the pulp testing probes. Teeth selected for pulp testing must possess enough exposed enamel or dentin to allow the probe to make contact without contacting the gingiva or a metal restoration. In certain cases, this may necessitate the use of the Precision Probe Set (available separately).
Fully instruct the patient as to what you will be doing so they are not surprised during the test. It may be helpful to avoid the use of the word “pain” in your instructions.

PULP TESTING PROCEDURE

Always use the Lip Clip and wire to ensure a complete electrical circuit.
Select the appropriate metal probe and insert it into the open end of the power unit (8).
To ensure good electrical contact between the probe and the tooth, apply a small amount of toothpaste to the exposed tip of the metal probe.
Hold the unit in your hand so that the output control knob (9) is in close proximity to your thumb. The indicator light (10) should be visible to you. The probe may be rotated to any convenient angle.
Click the output control knob (9) to the “ON” position by turning it clockwise to activate the unit. The indicator light (10) will begin to blink continuously, indicating that the Gentle Pulse stimulus is ready to be applied to the tooth.
Set the dial to the lowest setting, and apply the probe tip to the middle of the labial or lingual surface of the tooth being tested. Avoid soft tissue and restorations such as crowns, amalgams or composites.
The power should be slowly increased by turning the output control knob clockwise until the patient becomes aware of the stimulus. At the first sign of a response, remove the probe from the tooth and make a note of the reading on the dial.
As a check of the reading obtained, a corresponding control tooth in the same arch should be tested for comparison, if possible. Molars should be matched to molars, premolars to premolars, cuspids to cuspids, and incisors to incisors. If this is not possible because teeth are absent, endodontically treated, or have full coverage restorations, a similar tooth in the opposite arch is always a better control than no control at all.
To preserve the battery, the device should be turned off immediately after use by rotating the control knob counter-clockwise until a click is heard. Should the operator forget to turn the power off, the instrument will shut itself off after 5-6 minutes. To reactivate the device after an automatic shut off, simply turn off the device and turn it on again.

CLINICAL OBSERVATIONS
There are many factors that can affect the response of teeth to electric pulp testing. Among these are patient age and gender, pain threshold, previous pain history, tooth trauma, presence of pathology, use of prescription and non- prescription medications, or illicit drug use. In general, thick teeth like molars require a greater stimulus than anterior teeth. Additionally, enamel will require a greater stimulus than dentin or cementum.
It is impossible to prepare a “table of normal values” for pulp tester readings because THERE IS NO “NORMAL” IN PULP TESTING. Rather, the clinician should perform sequential comparisons between the subject tooth and the control tooth at consecutive office visits, observing how the readings are changing as time progresses. By utilizing electric pulp testing, along with all available diagnostic information, it is often possible to predict where the tooth’s vitality is heading. This allows the clinician to make informed decisions as to whether endodontic therapy is appropriate, or whether it is prudent to simply watch and wait.

ADDITIONAL SPECIFICATIONS

Protection against electric shock – Class 1, Type B applied part
Equipment not suitable for use in the presence of a flammable anesthetic mixture (when used with air or oxygen)
Protection against ingress of liquids – Pulp Tester – IPX0 (Ordinary)
Mode of operation of equipment – Continuous
Operating conditions: 59°-95°F / 15-35°C – 10-80% RH (non-condensing)
Transport and storage conditions: 50°-104°F / 10-40°C – 10-80% RH (non-condensing)

WARRANTY AND TERMS OF USE:
For full Warranty and Terms of Use information, please see www.parkell.com. Parkell’s Quality System is certified to ISO 13485. If you have any questions, please email our Technical Support Service at techsupport@parkell.com

If you have any questions or problems call our Technical Support Service at 1-800-243-7446, M-F from 9:15 AM to 5:15 PM EST or E-mail techsupport@parkell.com

This precision dental device was designed, manufactured and is serviced in the United States of America by:

Parkell, Inc.,
300 Executive Dr., Edgewood, NY 11717 USA +1-800-243-7446 • www.parkell.com