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Description:
Jelly Tab™ sensors are disposable, single-use tab electrodes that come in a set of three.
Flexicouplers® are a single patient use, disposable, self-adhesive, circumaural
earphone with a transparent upper surface designed and sized specifically for use with
infants. The Flexicoupler ear couplers are soft, flexible, single-wall ear couplers. The
circumaural ear couplers are designed to reduce the effects of ambient noise during
auditory brainstem response hearing screening.
The Jelly Tab sensors and Flexicoupler come packaged together in a combination
package for ease of use, although the Jelly Tab sensors are also available without the
sensor-Flexicoupler combination pack.
Intended Use:
Jelly Tab Sensors
The Jelly Tab sensors provide a means for establishing electrical contact between the
skin and biomedical recording equipment. The sensors conduct the electrical signals
generated by nerve and muscle tissue from the skin to the recording device using
an attached lead. The intended use of Jelly Tab sensors is for conducting auditory
brainstem response (ABR) monitoring for hearing screening purposes. The sensors are
for single patient use.
Flexicoupler
The Flexicoupler is a disposable, non-sterile earphone device intended to be used as
an accessory to hearing screening systems. The ear couplers are connected to the
device with a transducer cable (ATA cable) to provide an acoustic coupling (sound
connection path) between the transducer and the patient’s ear. Thus, the Flexicoupler
performs as the means for delivering the auditory stimulus from the hearing screening
system’s auditory stimulator to the patient’s ear while reducing the effects of ambient
noise during the test. The device is especially indicated for use in the auditory-evoked
response screening of newborn infants because the Flexicouplers are circumaural; they
can be placed over the entire ear of the infant, and nothing has to be placed into the
ear canal.
Intended Users and Patient Target Group:
These Jelly Tab sensors and Flexicouplers are to be used or sold only under the direct
supervision or order of a licensed practitioner.
The target population is an infant who is undergoing hearing screening.
Clinical Benefits:
The Flexicouplers and Jelly Tab sensors are used during ABR hearing screenings. Use
of the Flexicouplers and Jelly Tab sensors for hearing screening purposes is at the
discretion of the clinical provider.
Contraindications and Side Effects:
There are no known contraindications or side effects for procedures performed with
the Flexicouplers and Jelly Tab sensors.
Operating Instructions:
IMPORTANT!
If the Jelly Tab sensors or Flexicouplers appear discolored or hard or are
not sticky when removed from the package, dispose of the ear couplers and/or the
Jelly Tab sensors and use new ones. Do not use damaged or expired ear couplers or
expired electrodes.
Apply Jelly Tab sensors and Flexicoupler disposable earphones when using a transducer
(ATA) cable for ABR screenings.
Applying Electrodes:
1. If needed, thoroughly clean and dry the areas to which the electrodes will be
applied.
2. Prepare the skin by briskly rubbing the area with your preferred electrode skin
prep product, being careful not to damage the skin.
3. If a moist skin prep product is used, be sure to remove any residue to ensure good
adhesion of the electrode to the skin.
4. Tear open the sealed electrode foil pack.
5. Squeeze the clip of the electrode lead and attach it to the purple area of the tab on
the electrode. Note: Do not allow the clip to come into contact with the hydrogel/
sticky part of the electrode.
6. Repeat step #5 for all electrodes required for the test.
7. Carefully peel an electrode from the backing card.
8. Apply the electrode, adhesive-side down, onto the appropriate skin site keeping
the electrode leads directed to one side if possible and in a comfortable
orientation for the patient.
9. To adhere the hydrogel to the skin securely, press gently but firmly over the entire
surface of the electrode.
10. Repeat steps #7-#9 for all electrode sites.
Note:
• Be sure to review the information regarding proper placement of the electrodes
into the cable as indicated on the label of the interface cable or refer to the user
manual for the specific application you are using. Always connect the cable to
the device prior to connecting the electrodes to the cable.
• Use the electrodes before the expiration date.
• Unused electrodes that have not been removed from the backing card can be
placed back in the package. Be sure to close the package opening to minimize
airflow into the foil pack. Use these as soon as possible.
Affixing Flexicouplers to the Acoustic Cable:
1. Open the earphone pouch by tearing the notch in the corner. Leave the earphones
on the liner.
2. With the earphones on their liner, attach the colored transducers to the earphones
by inserting the acoustic transducer into the round openings and clicking it
into place along the side of the earphone. To facilitate the attachment of the
transducers to the earphones place your fingers through the holes on the back of
the liner.
Earphone connector
Earphone tab
Earphone liner
Example of Flexicouplers attached to the colored transducers.
3. One at a time, remove an earphone from the liner and place it over the patient's
ear. The blue transducer on the left ear and the red transducer on the right ear.
4. Position the earphone tab at the back of the ear with the cable emerging either
toward the top of the head or toward the patient's body. Roll the earphone from
the back of the ear to the front as you attach it to the patient. The earphone must
completely enclose the external ear and form a good seal all the way around.
Avoid applying earphones to hair if possible.
Understanding Caution Statements:
CAUTION
Refers to a hazardous situation that could result in minor or moderate injury or
material damage if not avoided.
Precautions:
CAUTION
Flexicouplers: Potential high-intensity changes to either too high or too low
• Any use of the earphones or the earphone cable other than described here may
result in screening at unknown and uncontrolled decibel levels.
• Never apply pressure to the ear canal or compress the tragus (the prominence in
front of the external opening of the ear).
• Always ensure the transducer cable is coupled to a coupler and not in direct
contact with the ear canal.
