Important: These sensors are no longer manufactured, due to concerns about sexually transmitted diseases, especially AIDS. This chapter is provided as an historical document, and because many clinicians still have and use these "sterilizable" sensors. Continued use is at your own risk.
Manufactured by Farrall Instruments, Inc. Grand Island, Nebraska 68802 U.S.A.
Under License from Biotechnologies, Inc. Distributed by Farrall Instruments, Inc.
and Biotechnologies, Inc.
Strafford, Pennsylvania 19087 U.S.A.
Product Designations:
EPS-10 Standard Vaginal-size EMG perineometer sensor
EPS-20 Standard Anal-size EMG perineometer sensor
EPS-30 Like EPS-20, but with 1/4 axial catheter hole
for use with "rectal fullness" sensation balloon.
EPS-40 Like EPS-20, but without retaining bulb; sometimes
preferred for use with young children who cannot relax sphincter
on command. Secured in place with tape.
Update: "EPS-11" and "EPS-12" (etc.) represent manufacturing improvements over the original "EPS-10" model
Patented: The vaginal & rectal myographs are
patented in the United States (No. 4,396,019), Canada (No. 1191207),
United Kingdom (No. 2119516) and France (No. 2,507,076); and other
patents pending.
Purpose: The Electronic Perineometer™ brand vaginal and rectal myograph sensors are designed to provide electromyographic biofeedback from the pelvic musculature for the purpose of rehabilitation of weak muscles and the restoration of neuromuscular control. They are widely used in the treatment of urinary and fecal incontinence and certain sexual dysfunctions.. These sensors may be used with any standard brand, high quality EMG biofeedback instrument. The inventor of the sensor, Dr. John D. Perry, has established international standards for diagnostic testing and training with this device. Only instruments which meet his high standards are allowed to carry his endorsement.
Safety Considerations
1. Electrical Safety
The Electronic Perineometer™ sensor should only
be used with battery-powered electromyograph instruments (Most
commercially available biofeedback equipment is battery-powered)
or with computerized instruments which are expressly designed
and approved for use with human subjects. If it doesn't say so
in the manual, assume it isn't safe. Safe instruments have built-in
optical (or other) isolation for protection. Industrial-control
type computers are usually not safe for use with human subjects.
If you intend to utilize this device with any line-powered equipment,
including computers, polygraphs, strip-chart recorders, etc.,
you must consult a competent bio-medical engineer to ensure the
electrical safety of your clients. Special isolation amplifiers
must be employed in such instances.
2. Medical Precautions:
Normally, a routine gynecological or urological examination will be conducted prior to pelvic muscle evaluation and/or re-education. In some continence clinics, a urinanalysis is conducted to determine the presence of either red or white blood cells. If either is found, appropriate medical evaluation and/or treatment is required first. The Electronic Perineometer™ sensor should not be used in the presence of urinary or vaginal tract infection or irritation without a physician's advice. [There is no special danger to the patient, and the sensor is often used to treat recurrent infections. The admonition is for the protection of the biofeedback therapist.]
3. Recommendations for Disinfection
The Electronic Perineometer™ sensor is shipped
to you in clean, disinfected condition; it should be disinfected
prior to its first use, and whenever it is being used by a different
client. When it will be used by the client at home, the therapist
should carefully warn the client against loaning the sensor to
any other person, including other family members, because of the
dangers of transmission of infectious diseases
The following procedure for disinfection was provided
by the Nosocomial Infections Laboratory Branch, Hospital Infections
Program, Center for Infectious Diseases, Atlanta, Georgia for
control of AIDS, Syphilis, and Gonorrhea:
"The current recommendations for disinfecting
or sterilizing medical devices contaminated with putative agent
of Acquired Immune Deficiency Syndrome (AIDS) are the same as
those recommendations for devices contaminated by hepatitis B
virus."
Ordinarily, sporogenes (which require "sterilization"
or 10 hours in CIDEX) are not a concern for this type of device.
Therefore, it is usually not considered necessary to "sterilize"
the sensors and cables. "Disinfection" (10 minutes in
CIDEX) is the name of the technique that most authorities would
consider appropriate.
Based on the recommendations of the CDC and of Dr.
James Geer (1978), the manufacturer suggests the use of aqueous
CIDEX (2% glutaraldehyde) or, preferably the newer CIDEX-7, now
manufactured by Johnson and Johnson and readily available from
hospital and dental supply houses (but NOT ordinary drug stores).
Instructions for the use of CIDEX-7 are included with this manual
for your convenience; complete directions are also furnished with
the product. The CIDEX-7 formulation has a useful mixed life of
28 days. The most useful size is a package of four quart bottles.
Note: It is important to follow the directions on
the package for mixing the two solutions which make up the CIDEX
solution. Reports have been received which indicate that attempts
"partition" the solution into smaller volumes have resulted
in mixtures which failed to pass potency tests. DO NOT purchase
the "gallon" container size unless you really intend
to use a gallon at a time. Your supplier can readily obtain the
"quart" size bottle, which come packaged 4 qts to a
box. [Johnson and Johnson Product CODE 2783].
If the device is to be sent home with a patient,
it should be carefully disinfected, rinsed, dried, and furnished
to the patient in a sterile plastic bag. The connection cable,
including the pink plastic molded connector and the cable up to
the "instrument" end, should also be disinfected. The
sensor and cable should then be rinsed with water and carefully
and promptly air dried.
NOTE: DO NOT AUTOCLAVE! The Electronic Perineometer™
sensor is made of high-quality denture acrylic, and will be DESTROYED
if subjected to high temperatures. Please consult Farrall Instruments,
Inc. or Biotechnologies, Inc., before using any other sterilization
techniques. (One product, described by a competent technician
as "just like CIDEX", destroyed the smooth surface of
their sensor) Use of any product other than CIDEX will VOID your
warranty.)
NOTE: A number of hospitals prefer gas sterilization
techniques. We believe this is also safe for the product, and
are now including it within the product warrantee. Careful manual
cleaning is, of course, still required.
Sample Disinfection Procedure:
These procedures are suggested as a guide only; consult
the appropriate hospital or clinic official to establish your
own operating policy.
Safe handling of the sensors is not difficult, but
it does require good common sense and carefully controlled clinical
procedures. Obtain a pint or quart wide-mouth bottle from your
druggist and fill with CIDEX-7 to a level which will completely
cover the sensor and coiled connecting cable (leaving only the
instrument-end connector outside). Do not use a common food or
drinking container as the CIDEX might be mistaken for something
to drink. Mark the expiration date on the container.
In the office, the patient should be instructed to
remove the sensor and immediately rinse it off under warm running
tap water. Then place the sensor in a conventional plastic "baggie"
to take home or to return it to the therapist (or leave on the
counter in the restroom, if appropriately secure).
Wearing disposable rubber gloves, the therapist or
staff member can wash and rinse the sensor and cable and then
place them in the CIDEX without ever touching them with bear hands.
Baggies should never be used more than once. Keep the sensor and
cable in CIDEX for 10 or 15 minutes as determined by local policy.
I. Avoid getting the solution on the hands and clothing. It will
irritate the former and might stain the latter.
Common sense: If you add
a "dirty" sensor to a container of already-disinfected
sensors, the whole batch becomes "unclean" for at least
10 minutes!
After disinfection, wearing rubber gloves, rinse
the sensor and cable with quality tap water and air dry. (If in
doubt, tap water should be tested and certified safe to eat and
drink.) When dry, put each in a separate "baggie", and
label each with a pressure-sensitive (computer) label showing
the word "disinfected", the date, and the initials of
the person responsible. Seal the baggie with the label in such
a way that the label will be broken if the baggie is opened. Store
clean sensors and cables in a special location. (In certain circumstances,
a locked file cabinet would be appropriate.)
In multi-staff installations, the existence of written
instructions for the above procedures, including log sheets of
responsibility for disinfection on a daily basis, might be advisable.
They would certainly be helpful in the unlikely but not inconceivable
event of a "shotgun" lawsuit. Additional protection
could be obtained by keeping records of sensor utilization history.
(We have never heard of any therapist ever having had a problem
in this area, and we want to keep it that way!)
Patient Care of the Sensor at Home:
The Electronic Perineometer™ vaginal sensor should be washed with warm soapy water, rinsed, and dried after each use. You can store it, with the cable attached, in the bathroom, perhaps wrapped in a clean towel or in a clean baggie. When you are ready to use it again, wash your hands and rinse off any soap; then rinse the sensor to be sure it is clean and insert it as instructed (with the cable already attached). Under no conditions should any other person, family or friend, be allowed to use the sensor.
Warning: If irritation of the vaginal or rectal area
develops, discontinue use and consult your physician or therapist
for professional advice. Always be certain that all traces of
soap, detergent, and sterilizing solution have been rinsed from
the sensor before using it. Do NOT use petroleum jelly as a lubricant,
as it clogs the pores and interferes with normal vaginal lubrication.
{Additional, specific information for the Patient
to take home is provided in a separate section of this manual.}
This page is www.incontinet.com/articles/art_urin/HOPCHAP1.htm
Copyright 1996 by John D. Perry
Use your browser's back-arrow to return to previous page.
Click Here to return to our home page.