General Description: The Clinical Perineometer™ instrument is an advanced electronic EMG diagnostic
and treatment center. Model CP-400 is supplied in a "transportable" case for easy movement from one
location to another. (Model CP-100 is no longer available) Its features are optimized for use with the
Electronic Perineometer™ sensor in the therapy of pubococcygeus muscle deficiencies, but it can also be
used in any application in which a laboratory-grade EMG biofeedback instrument might be employed. It
features direct digital read-out of both peak and 10-second integrated EMG levels, as well as automatic
timing of muscle endurance, and simultaneous strip-chart recording of electrical activity for visual
inspection, educational use with patients, and documentation for third party payers.
The unique patient remote unit includes a circular display of 20 Light Emitting Diodes for visual biofeedback and an adjustable speaker for audio feedback. The unit operates from 120 volt 50-60 Hz line power, and includes both isolation transformer and isolation amplifier for double safety protection of patients. It is furnished in an attractive solid-wood cabinet. It is manufactured entirely by Farrall Instruments, Inc. of Grand Island, Nebraska, a leading producer of medical and scientific instruments for over a quarter-century.
Summary of Contents
Quick Test and Verification of Operation
Initial Set-Up.
First Test: Power On.
Second Test: Sensor Noise
Third Test: Sensor/Cable Integrity
"Manual" Sensor Test
Fourth: Visual & Auditory Feedback.
Fifth Test: Strip Chart Recorder
Sixth Test: Peak Readings
Seventh Test: 10-Second Integrated Readings
Eighth Test: Tonic Endurance Test
Detailed Description of Controls & Gages
Using the Clinical Perineometer with Patients
References
User's Comments
Note: The CP-400 includes sophisticated diagnostic testing circuits which should be thoroughly understood before utilizing the device to treat patients. Since many users wish to "try out" equipment immediately upon arrival, the following sequence of steps is provided. Upon completion, please read the entire instruction manual fully and carefully before using the CP-400 with patients!
Quick Test of CP-400 Features
Initial Setup: Upon arrival and before testing, the various panel switches should be set as follows (starting in lower left):
1. Power - OFF
2. Chart - OFF
3. Reset Timer - (down)
4. Audio Threshold - fully clockwise
5. Audio Volume - fully counter-clockwise
6. Sensor Circuit - SHORTED position
7. Pen Heat - mid-range (index marker UP)
8. Position - mid-range (index marker UP)
9. Chart Speed - 1 mm/Sec.
10. Function - TIME position
11. Full Scale Microvolts - 100
12. Peak Clear - (down = "measure")
13. Manual/Automatic - OFF (center position)
Then:
1. Plug remote unit into socket (6-pin) on rear panel.
2. Plug Electronic Perineometer sensor into the insulated socket (3-pin) in lower right corner of front panel.
3. Connect power cord to a properly grounded (three-wire) electrical outlet.
First Test: Power On
Turn main power switch (lower left) "on". You should observe the Red "relax" lights illuminated on both the remote unit and the console, and the "microvolts" display should show "00.5" or less; this is the "internal noise level" of the EMG amplifier. When the power was first applied, some of the LEDs of the circular display may blink on momentarily, and the strip chart pen may change position. The audio feedback tone may come on momentarily as well.
Safety Note: As with any advanced electronic equipment, DO NOT turn the power switch on and off in rapid sequence, as this can cause damaging power surges. Always wait 30 seconds before turning the unit back "on".
Second Test: Sensor Noise
Turn the Sensor Circuit Selector switch to bilateral. You should observe momentary changes in the Circular Display, the Strip Chart Pen, and Audio tone. Note the emg microvolts display, which should show a higher reading. (How much higher will depend on the electrical noise characteristics of the room, the placement of the sensor, etc.)
Third Test: Sensor/Cable Integrity
Alternately place a finger on first one and then another of the silver pads on the Electronic Perineometer.
Contact with two of these sensors will drive the light, pen, and audio displays to their maximum limit,
while the third will show very little response. This "unresponsive" sensor is the "ground" or "reference"
electrode. You should note its position with respect to the sensor's connecting cable: all readings are
(normally) taken between the other two sensors.
Normally, the sensor will be inserted so that the reference electrode is "down" or at the 6 o'clock position, i.e., closest to the coccyx bone. The Sensor Circuit Selector switch on the front panel allows the user to determine which pair (right or left) will be "active" (and which one will be the "reference" electrode). This feature is invaluable in assessing the effects of unilateral injury, such as an episiotomy that reached into the muscle body. Normally RIGHT and LEFT readings will be similar, and not too different from bilateral; large differences should be noted.
Return the SENSOR SELECTOR to shorted before continuing.
"Manual" Test of the Electronic Perineometer Sensor
You can test the sensor by holding it in the crouch of your hand. Encircle the sensor's silver pads with your thumb and forefinger, and hold the sensor against the muscle at the base of your thumb by light pressure from the other three fingers. You must (1) moisten the area first; saliva works best and (2) you must ensure that all three (3) silver pads are making solid contact with pre- moistened skin. Like an EKG, this instrument is designed to measure the voltage differences between two electrodes while using a third "reference" electrode for common-mode rejection. It simply will not work meaningfully unless all three pads are touching the skin; otherwise, random noise will be charted and displayed. When "contracting", be sure to contract the thumb muscles in the hand, and not necessarily the fingers. When relaxing, make sure that you do not lose contact of the skin with any of the three silver pads. REMEMBER, EMG WORKS BY ELECTRICAL PICK-UP FROM MUSCLES -- PHYSICAL PRESSURE HAS NOTHING TO DO WITH THE READINGS!
Fourth Test: the Visual and Auditory Feedback Displays
1. Set the Full Scale MICROVOLTS switch to 60. In this position, each LED represents 3 microvolts of EMG (20 x 3 = 60 Full Scale).
2. Hold the sensor in one hand as described immediately above, and with your other hand switch the Sensor Circuit to bilateral.
3. Alternately tightening and relaxing the thumb muscles should produce maximum (up to 20 LEDs) and minimum illumination of the CIRCULAR DISPLAY, rising and falling AUDIO TONE, pen deflection, and, of course, a change in the MICROVOLTS display. In general, you should obtain contraction readings of 100 microvolts or more, and relaxation readings of 2 or 3 microvolts -- or less.
If the Clinical Perineometer does not respond as indicated, the most likely cause is poor electrical contact
with the hand. The surface of the skin MUST BE MOIST. In addition, some persons' hands are heavily
calloused and no amount of moisture will help. It is an element of professional training to understand the
importance of good electrode contact, and the techniques of skin preparation are outside the scope of
these instructions. For further information, consult any general EMG biofeedback manual or biomedical
engineering guide.
A note on office style
It is good office practice to ALWAYS return the Sensor Circuit Selector to shorted before letting go of the sensor, and whenever the sensor is not actually in its normal location in the vagina (where all three sensors are, of necessity, making good electrical contact with the skin). The reason for this is to avoid confusing persons who are unfamiliar with EMG and similar instruments. In our experience, many persons are startled by the appearance of "higher readings" when the sensor is merely touched with the finger, etc. You could explain the way "differential operational amplifiers" function --- but it would be easier just to avoid such situations. A cardiologist would never show the EKG which results when one lead is dangling in the air! For the sake of patients' peace of mind, avoid sloppy office procedures.
Fifth Test: Strip Chart Recorder
1. Check that the "Sensor Circuit" switch is set to shorted position.
2. Turn the CHART ON switch ON (up) and observe that the paper is beginning to move.
3. Use "PEN POSITION" knob to move pen tracing right and left; then leave it set on the left-most heavy line of the chart.
4. Adjust "PEN HEAT" for a firm but not blurred line.
5. Holding the sensor in one hand as described above, switch the "Sensor Circuit" to the "bilateral" setting.
Alternately squeezing and relaxing the hand muscles should be reflected in the pen defection. Properly
done, full scale defection (i.e., 60 microvolts) should be easily accomplished. You should, perhaps with
practice, be able to relax to 3, 2, or even 1 microvolt without dropping the sensor or breaking contact.
6. Momentarily raise the RELAX-CONTRACT LIGHT SWITCH from its neutral position to MANUAL
position. Note that whenever the GREEN CONTRACT light is on, a black mark is written in the left margin
of the strip chart paper. This feature allows you to observe the correspondence between the instruction
given (con tract or relax) and the client's response (high or low EMG levels).
7. Experiment with different settings of the FULL-SCALE MICROVOLTS SWITCH. Observe, for instance, that a contraction of 30 microvolts on the emg microvolts DISPLAY or CIRCULAR DISPLAY will give a pen defection of 5 major divisions (out of 10 on the paper) when Full Scale is set at 60; the same contraction should register as 3 major divisions when Full Scale is set to 100. Similarly, it will be off the right side of the paper when you turn to Full Scale SWITCH to 20 or 10 uV.
Normally, the FULL-SCALE switch is used at 20 for weak muscles and 60 for stronger muscles. At these settings the Full Scale (i.e., 10 major divisions on the paper) of the STRIP CHART corresponds to Full Scale (i.e., all 20 LEDs) of the CIRCULAR DISPLAY as well. The "10" scale is useful for demonstrating muscle spasms or tension when a client is trying to "relax"; the "100" scale is useful for stronger muscles which would otherwise go "off scale". In addition, "100" is "standardized" in the sense that each major division represents 10 uV, so it is "direct-reading". Some practitioners like to do all diagnostic testing at the same setting, to facilitate rapid and accurate analysis. We suggest you settle on 60 or 100 and use your choice consistently.
8. Turn the CHART SPEED to 5 mm/Sec setting, and observe that (1) the paper moves much faster and (2) the tracing shows considerably more detail. At slow speed the tracing is "smoothed" electrically, whereas at fast speed it is less filtered.
9. Return CHART SPEED to 1 mm/Sec to conserve paper, and remember to turn CHART OFF when finished with this section. Then turn SENSOR SELECTOR to shorted before releasing the sensor.
Sixth Test: Peak Readings
1. Check that SENSOR SELECTOR is set to shorted.
2. Move the FUNCTION switch to PEAK.
3. Grasp the Electronic Perineometer sensor in one hand as described above; with the other hand, move Sensor Circuit switch to bilateral, and momentarily flick the PEAK CLEAR switch up to clear and reset the peak reading circuit, and then down to MEASURE the peak. Note the number shown on the emg microvolts display.
4. Slowly squeeze the sensor and relax again; note that the emg microvolts display shows a high reading which does NOT go back down when you relax. This is the peak, or highest reading since the last resetting of the PEAK CLEAR switch.
5. Alternately squeeze a little harder each time and relax in between. Note the increasing PEAK readings displayed. Practice resetting the PEAK CLEAR switch and recording new sequences of peaks.
The highest reading that can accurately be displayed on the MICROVOLTS display is set by the "Full Scale MICROVOLTS SWITCH". This is not a problem for normal pelvic muscle measurement, but you will be able to generate much higher readings from the hand. With Full Scale set to 100, you can be certain of accuracy only to 100 microvolts, even though the digital display will read up to 199.9 microvolts. If the EMG input exceeds 200 uV, the display will show only 1 followed by blanks to signify the over- range condition. On the TIME function the over-range condition is self-clearing; on the PEAK function, the over-range must be cleared by resetting the PEAK CLEAR lever switch.
Remember to turn the SENSOR SELECTOR switch to shorted position before releasing the sensor at the end of the test.
Seventh Test: 10-Second Integrated Measure
1. Move the FUNCTION switch to TIME position.
2. Grasp the sensor in one hand as described above, and move the SENSOR SELECTOR to bilateral. Verify that you have a good skin contact and a relaxed hand by observing a low (2 or 3 uV) reading on the MICROVOLTS display and/or LED circular display.
3. Turn the FUNCTION switch to INTEGRATE position. The RED RELAX light will go off, the GREEN CONTRACT light will come on. Make and try to hold a consistent level of muscular contraction by observing the CIRCULAR LIGHT display. Hold this contraction as long as the GREEN CONTRACT light is on -- 10 seconds. At this point the emg microvolts display will be meaningless (showing the reading of the last time that that function was used).
4. When the RED RELAX light comes on after 10 seconds, STOP contracting and let your hand relax, but
do not let go. Observe the CONTRACT INTEGRATION LED is lit, indicating that the emg microvolts
display is showing a valid value. This value of perhaps 10 and 100 microvolts you will notice is the average
EMG reading of all ten seconds during the trial. For example, if your contraction was about 60 microvolts
for the first five seconds, and about 40 microvolts for the last five seconds, the DISPLAY should show a
number around 50 microvolts as the 10- second average CONTRACT INTEGRATION value. Other
combinations will, of course, give other results. The INTEGRATION value shown is a much more accurate
calculation of the "work" done in the contraction than you could possibly make by eye-balling the display
and mentally guestimating, which is why we have produced this advanced instrument for accurate diagnostic
work.
5. While trying to observe and understand the above, also notice the approximate EMG level indicated by the CIRCULAR DISPLAY during the 10 seconds that the RED RELAX light is on.
6. When the GREEN CONTRACT light comes on again, contract your hand as you did above in step three, and try to hold a steady contraction. At the same time, observe the RELAX INTEGRATION LED is lit, and a new value is shown on the emg microvolts DISPLAY; this now represents the average integrated value of each of the ten seconds during the rest period which you observed in step 5.
OBVIOUSLY, It is difficult to monitor all of these things at once, so you will want to repeat this section many times, perhaps every day for a week, until you fully understand what the instrument is doing, and can obtain consistent and understandable results. This is only a training and practice session, and it will be much easier if one person is doing the contractions in response to the signal lights, while a different person is observing the displays.
THE MOST IMPORTANT THING to understand is that the INTEGRATE function displays the 10-second average of the previous 10-second period. Every 10 seconds the DISPLAY is "up-dated" to show the calculations for the previous period, even while another electronic circuit is gathering data about the current period. The RELAX INTEGRATION and CONTRACT INTEGRATION lights -- which run one cycle behind the RELAX and CONTRACT lights, are there to remind you which data is being displayed.
7. Repeat this CONTRACT-RELAX cycle several times, trying to obtain as low as possible a reading during the RELAX periods, and a predictably high reading during the CONTRACT periods. Observe that the CIRCULAR DISPLAY operates in "real time" regardless of the FUNCTION SWITCH; that is, it always displays the current, immediate contraction level in EMG microvolts.
8. Next, repeat the above cycle, but include the AUDIO feedback by turning the AUDIO VOLUME level up.
Observe also that the AUDIO THRESHOLD can be set to "come on" at any level; i.e., with any number of
LEDs illuminated. In therapeutic practice, both the pitch (higher-lower tone) and the THRESHOLD (or
starting point can be manipulated to reward the client for performance at or above a given level, according
to the principles of psychological learning theory.
9. Finally, repeat the above process, adding the STRIP CHART RECORDER. Refer to "FIFTH TEST" above, for sequence of steps. Observe that the STRIP CHART, like the CIRCULAR DISPLAY, operates in "real time" and plots the current EMG level, regardless of the setting of the FUNCTION SWITCH. Observe also that the "event marker" device lays down a black line in the left margin of the paper tape whenever the CONTRACT light is on. This is to allow observation of the "latency" or delay between the command to contract and the client's ability to effect that response.
10. When you have mastered the above, try to run the standard 6 pairs of 10-second trials as described by
Perry in the biofeedback literature. Using all three feedback indicators -- CIRCULAR DISPLAY, AUDIO
FEEDBACK, and STRIP CHART RECORDER, run through a series of six CONTRACT-RELAX cycles or
trials. You should be able to produce a series of six "square-wave" humps on the paper tape, each
corresponding to a black line mark in the left margin when the GO light was ON. Observe the consistency
of the recordings. Recall the ZEN aphorism "When you sit, sit; when you stand, stand? Notice if relaxed is
really relaxed (a relatively smooth line) and if contracted is consistently contracted, or if there are
fluctuations.
Save the Strip Chart records of this session! There is no widely accepted scientific basis yet for deciding what level of consistency is appropriate to expect from the pelvic muscles. There is clinical data, however, that shows that many "sexual athletes" can exert the same degree of control over their pelvic muscles that normal people can exert over their hand muscles. Recall that the Great Houdini is reported to have practiced tying and untying bows in pieces of string with his toes, in order to accomplish his "magic" tricks. There is also considerable clinical evidence that "patients" -- i.e., persons who present themselves with symptoms of urinary stress incontinence, dysmenorrhea, chronic pelvic tension (low back pain), or similar problems often have NO CONTROL over these muscles. The level of muscular control to be considered "normal" or "healthy" is obviously somewhere between the extremes, and a function of the patient's chosen goals -- NOT the therapist's goals!
11. Having mastered the "normal" diagnostic testing sequence, you should next attempt to replicate the
"simulated chart recordings" published in the promotional literature for this instrument (Farrall Instruments
CP-10/82, and elsewhere). See if you can replicate, with your hand muscles, the conditions of
WEAKNESS, CHRONIC TENSION, ABSENCE OF CONTROL, FATIGUE, and LEARNING that are
illustrated there. Observe the physical effort required to produce a 10 uV INTEGRATED 10-Second
reading --- that is very close to the strongest contraction that the average American woman is able to
register with her pelvic muscles! Observe the effort required to sustain a 30 microvolt contraction for
several minutes, and imagine what it would be like to have a muscle that tense for several hours, as in
dysmenorrhea.
Return all switches to their "initial" positions (see page 28) at the completion of each test.
Eighth Test: Tonic Endurance Test
1. Set the FUNCTION SWITCH to PEAK, and Full Scale to 100.
2. Grasp the Electronic Perineometer sensor as above, and switch the SENSOR SELECTOR to bilateral.
3. Flip the PEAK CLEAR SWITCH - UP to clear and reset the PEAK circuit and then DOWN to MEASURE a new peak. Flip the RELAX- CONTRACT light to MANUAL to illuminate the CONTRACT light, and then make a very strong contraction; release the MANUAL switch and relax. Observe the emg microvolts DISPLAY; this is the current PEAK reading.
4. Move the PEAK switch to its middle or HOLD position; this automatically enters one-half the current PEAK reading into the TIMER circuit.
5. Turn the FUNCTION SWITCH to TIME position.
6. Observe that the hand is relaxed (less than 2 or 3 microvolts, preferably). If not, try to relax without
dropping the sensor.
7. Flip the RESET TIMER switch UP, and observe that the YELLOW TIMING light has come on, indicating the instrument is ready to begin an endurance test. When you are ready, begin to make the same very strong contraction as in step three, except this time attempt to HOLD the highest level you can for as long as you can without letting go. You will observe that the TIME IN SECONDS display will start ticking off in 1/10 second units when you go ABOVE the THRESHOLD level obtained in step 4 (1/2 the PEAK in 3) on the way up to maximum, and will continue to count until the EMG level drops BELOW that threshold again. When the EMG drops below that pre-determined level, even for an instant, the RED FINISHED light will come on and the timer will stop advancing. Write down the number of seconds obtained as the score for the endurance test.
8. Practice the preceding steps several times and experiment with "trying really hard" verses being "lazy"; get a sense of how the test is used, and what its limitations are.
NOTE: Arnold Kegel, inventor of the Perineometer, apparently never considered the "tonic" component of muscle strength; he only reported "phasic" strength, as measured by relatively short (1-2 second) contractions. Yet his published data shows that, with practice, PC contractions always got longer as well as stronger. And, recent research suggests that the tonic component of the muscle (the ability to HOLD a contraction) may be even more important a diagnostic category than the phasic component. We suggest that, until more is known about effective exercise for the pelvis, ALL THREE TESTS (peak, hold, and endurance) be used for all patients. When only one test is possible, it should be the HOLD, or 10-Second INTEGRATION test, which includes or integrates BOTH strength and time.
9. After mastering the Timing Test, repeat it several times with the STRIP CHART added to your sequence, as described above. You should be able to reproduce the "fatigue" chart described above; a strong beginning, which gradually tapers off. Note that the timer does NOT come back on after even a momentary dip below threshold setting. Obviously, if it is suspected that the obtained score is not representative due to early giving up (or misunderstanding the instructions), the time test may be repeated after a brief rest period.
Clinical Perineometer Controls & Displays
1.0 The Front Panel
The front panel controls are organized in functional clusters to simplify operation. They are:
A. Lower Left - Power Switches
B. Upper Left - EMG Digital Display & Controls
C. Upper Center - Timer
D. Lower Center - Audio Biofeedback Controls
E. Right Side - Strip Chart Controls
The functions of each switch are as follows:
1. MAIN POWER SWITCH. Connects the CP-400 to the A.C. power line; up is ON.
2. CHART MOTOR SWITCH. Controls the paper-feed motor of the strip chart recorder; up is ON. (See also CHART SPEED.)
3. RESET TIMER. Momentary-type; raise the lever UP (and release) to reset and begin a TIME measurement sequence for the Tonic Endurance Test.
4. AUDIO THRESHOLD CONTROL. The audio feedback signal (through the speaker in the patient remote unit) can be set to come on at any EMG level (the "threshold"); above the threshold, the tone rises from low to high frequency in linear relationship to the EMG level. Rotate clockwise to LOWER the threshold level. The control is generally set so that there is NO tone when the patient is relaxed.
5. AUDIO VOLUME. This control adjusts the volume in the patient feedback speaker; full clockwise is OFF, full counter-clockwise is the loudest setting. Adjust for a comfortable level. Since the remote unit is designed to be held by the patient or placed very near, the speaker is not very loud.
7. Sensor Circuit Selector. This four-position switch has two basic functions. The left-most setting,
shorted, connects all three silver sensor wires together and thus silences the instrument. It is used during
every session to make certain that spurious noise does not give false or misleading readings. Always leave
this switch on shorted except when the Electronic Perineometer sensor is in place.
The bilateral setting is normally used for all regular testing and training situations. Refer to the "Third Test" above for procedures to determine which silver sensor is the "reference" electrode in the bilateral position, and always instruct the patient to insert the sensor with this sensor towards the coccyx bone.
In the LEFT and RIGHT positions, the "reference electrode" is electronically switched to become the opposite (from switch label) sensor, and the remaining pair on the LEFT or RIGHT side become the "active" ones used for measurement. When the sensor is correctly inserted, any significant difference between LEFT and RIGHT side readings should be carefully considered. Such an imbalance may reflect past surgical or disease damage which should be carefully evaluated with gynecological consultation. At this point not enough is known about the effectiveness of exercise in overcoming the limitations imposed by such major injuries. Effective clinical use of this option may provide the needed information for practitioners.
8. PEN HEAT. This control determines how hot the chart stylus becomes. It should be set to write a clear, dark tracing on the heat-sensitive paper; if too hot, the tracing will become blurred. It is sometimes necessary to raise the setting at faster chart speeds. Normally you can set and forget it.
9. PEN POSITION. When the Sensor Circuit Selector is on shorted, use this control to set the pen on the left-most heavy division of the paper chart, so that the EMG level can be read directly. (EMG level equals number of divisions times value of each division. With Full Scale set at 100, each small division is equal to 2 uV.)
10. CHART SPEED. The normal chart speed setting is 1 (one mm per second); at this setting, the raw EMG signal is "smoothed" electronically to provide a clear diagnostic picture without using a lot of paper. The 5 setting (five mm per second) has less electronic "smoothing", so it provides a more detailed picture of pelvic muscle activity. This detailed setting is most often used to look for the sharp "spikes" which appear as a result of muscle spasms during attempted relaxation. Such spikes are common, with the patient's awareness of acute pain, in dysmenorrhea. On the other hand, spikes are often present but without the patient's awareness in psychogenic anesthesia.
11. FUNCTION SWITCH. This is the main operational switch and determines which of the major portions of the CP-400 will be used at any given time. The TIME setting is used for both the normal tonic muscle endurance test (with the TIME IN SECONDS digital display) and also for plain, ordinary direct reading EMG biofeedback such as is available on regular EMG biofeedback devices from other manufacturers. The TIME setting works in this "ordinary" fashion until and unless the "RESET TIMER" switch is activated. In the TIME position, the VISUAL and AUDIO feedback systems on the Patient Remote Unit, and the digital emg microvolts DISPLAY are all working. The Strip Chart pen also operates, but not necessarily the paper-feed motor unless it is separately turned on.
In the INTEGRATE position, the automatic 10-second EMG integrator circuit is available for use. The remote VISUAL and AUDIO feedback and STRIP CHART work as in the TIME function, but the emg microvolts display is changed. In this position, when the AUTOMATIC 10 SECOND SWITCH is activated, the emg microvolts display shows the previous 10-Second integrated average. The LEDS on either side of the display remind you which period is being shown. (When you first switch to INTEGRATE, the display is meaningless, based on old data.)
In the PEAK position, the automatic peak-reading circuit is available for use [providing that the PEAK switch is set at MEASURE as well.] (When you first switch to PEAK, the MICROVOLTS display is meaningless, until it is cleared and reset with the PEAK CLEAR momentary-action switch.) At this setting, the remote VISUAL and AUDIO feedback systems and the STRIP CHART operate normally, but the emg microvolts DISPLAY now shows only the highest reading obtained since the PEAK CLEAR SWITCH was last reset.
12. FULL-SCALE MICROVOLTS SWITCH. This is a sensitivity switch, and controls the range of
measurement possible for the various measurement systems which make up the instrument. It has three
different effects, which will be discussed separately.
VISUAL and AUDIO FEEDBACK (patient remote unit): The four FULL-SCALE SWITCH positions
actually provide only two ranges, high and low sensitivity, which (not coincidentally) correspond to the two
ranges available on our Personal Perineometer patient take-home instrument. (This design choice was
made to prevent patient confusion in transferring from one instrument to the other.) When the
FULL-SCALE SWITCH is set for either 10 or 20 microvolts, the individual LEDs that make up the
CIRCULAR DISPLAY each have a value of exactly one microvolt; full-scale here is "20". When the
FULL-SCALE SWITCH is set at either 60 or 100 each LED has a value of 3 microvolts, so full-scale is 20
x 3 or 60 uV. The AUDIO feedback corresponds to the CIRCULAR DISPLAY.
STRIP CHART RECORDER: Once the pen has been "zero'd" on the left-most heavy line, the
FULL-SCALE SWITCH determines the numerical value of the right-most heavy line, and consequently, of
each division on the Chart Paper, as well. On "10", for example, each major division to the right of the
baseline is worth one microvolt; on "100", each is worth ten. On "20", each major division is two. On "60"
the reading is less easy to calculate, since each major division has a value of six.
emg microvolts DISPLAY: The FULL-SCALE SWITCH also determines the upper limit of reliability for the digital emg microvolts DISPLAY. That is, the display is only guaranteed to be linear and accurate up to the value set, even though it can display higher numbers. With the switch set for "10", 10 microvolts is the highest value that you can be certain is accurate. Values to 110% of the switch setting are probably reasonably accurate, but more than that the digits displayed are certain to be not accurate and should never be trusted. From a theoretical point of view, the FULL-SCALE SWITCH should be set high enough to include the highest value produced, but not much more. [When you are also using the STRIP CHART, this limitation will be self-evident, as the pen will be "off-scale" at its upper limit. It is not considered good form to collect tracings that include any substantial portion of "off-scale" lines.]
13. TIME IN SECONDS DISPLAY. This digital clock circuit displays the time, in seconds and tenths, that a contraction is above the 50%-of-peak "threshold" setting. This is a standard (physical therapy) measure of the "tonic", or long-term endurance strength, of a muscle system. The YELLOW TIMING LED on the left side of the digital display indicates when the timer is ready to start counting; the digits themselves do not appear until the contraction level goes above the threshold setting. After counting has begun, the display freezes and the RED FINISHED LED comes on as soon as the contraction level drops below the threshold setting. The Clinical Perineometer is the only EMG instrument in the world to provide this standard evaluative test in automatic form.
[Note: The Timer can be utilized as a stopwatch or telephone call timer. Set FUNCTION to TIME, SENSOR to shorted, and reset the RESET TIMING function. (If the clock does not start, momentarily move the SENSOR off shorted position.) To stop timing, momentarily move the SENSOR off shorted (again).]
14. emg microvolts DISPLAY. This portion of the instrument is an advanced digital voltmeter which displays either (1) the current, "on-line", EMG level (when FUNCTION is set for TIME); (2) the highest EMG level obtained since the PEAK CLEAR switch was last reset Upwards (when FUNCTION is set for PEAK); or (3) the average "integrated" EMG level obtained during the preceding 10-second period (when FUNCTION is set for INTEGRATE).
The accuracy of the DISPLAY is limited to the Full Scale MICROVOLTS SWITCH setting, as discussed in the fourth paragraph preceding. For practical purposes, the DISPLAY is useful up to 110% of the setting of the Full Scale SWITCH. Good clinical practice requires matching the setting to the expected range of data to be collected.
15. SENSOR. The Electronic Perineometer sensor cable is connected to the 5-pin plug on the lower right front panel. Note that the socket is insulated from the metal panel for added patient safety.
Rear Panel Controls.
1. Power Cord. The AC power cord plugs into its socket at the lower right rear of the cabinet. The plug must only be inserted in a properly grounded 110 volt electrical outlet. If you are less than 100 percent certain that the outlet is grounded correctly, obtain the judgement of an expert electrician. Alternatively, several manufacturers (including Radio Shack) have recently introduced grounded outlet checkers for $6-7. These consist of a moulded 3- blade plug containing a set of three neon lights that glow in a specific pattern if and only if the outlet is correctly wired. The use of such a device is cheap insurance against improper electrical connections.
2. Circuit Breaker: located above the power cord socket is a circuit breaker which will pop out and display a red portion if overload occurs. If resetting the circuit breaker does not restore power, please contact the factory for advice.
3. Remote Unit Socket. This 6-pin socket is for the Patient Remote unit. Observe that the plug must be correctly oriented to be inserted. Do NOT force the plug; damage will result. ALWAYS make sure the POWER is OFF before inserting or removing the Remote Unit plug; otherwise the unit may be damaged.
SAFETY NOTE: In the event that research laboratory layout requires Remote Unit or Sensor cables of different lengths than those supplied, please contact the factory for advice. All warranties, guarantees and assurances are null and void, and Farrall Instruments, Inc., can assume no responsibility in the event of the use of non-approved accessories. Professional ethics and patient safety require that a biomedical engineer be consulted prior to any modifications or alterations to this equipment or its instructions.
Using the Clinical Perineometer with Patients
"I wouldn't ask you to do anything I wouldn't do myself."
Manual Testing of the CP-400 features (as described above) is the quickest, easiest and safest way for the professional to become familiar with the proper operation of the instrument. Before using the Clinical Perineometer with patients, however, we recommend two additional stages of familiarization.
Next, the clinician or researcher should repeat the integrated, peak, and endurance tests himself or herself, using the vaginal or anal size sensor as appropriate. Assuming no pathology is present, this will provide invaluable insight into the normal response to instructional sets. If it takes you, the expert, X seconds to execute the instructions, comparable latencies should be incorporated into your expectations of patients.
Finally, we consider a few "demonstration runs" with non-patients to be invaluable self-training. Select a few staff members or colleagues to run through the procedures with. Ideally every staff member who will have contact with Perineometer patients should have personal experience with the device. The resistance that staff members will likely show to such an invitation is important data for understanding patient reactions. Remember that many women are as sensitive about their pelvic muscle strength as many men are about penis size. Immensely valuable but not always possible is the opportunity to conduct a standard diagnostic evaluation on a sexual partner or other person of whom one has intimate personal knowledge of pelvic muscle control and strength. The original development and testing of the Electronic Perineometer was greatly aided by the generosity of dozens of professional women (nurses, doctors, sex therapists and social workers) who were willing to candidly discuss their most personal muscles with researchers. The ability to recognize and refine therapeutic applications of the device may be credited to the courage of these women. Ideally, you should seek the opportunity to evaluate non-patient volunteers with the following characteristics:
(1) a person with urinary stress incontinence [i.e., weak muscles
(2) a person with no such history [i.e., hopefully, "average"] and
(3) a person who has frequent multiple orgasms during sex [i.e., a person with well-developed pelvic muscles].
The Clinician who practices with such research volunteers before attempting to treat patients will act with greater confidence and skill than one who does not.
General Instructions: The general procedures for pelvic muscle diagnosis and therapy are given in Chapter I, "General Electronic Perineometer" Instructions" which should be read in its entirety before beginning to use the Clinical Perineometer with patients.
Specific Instructions: The three diagnostic tests described in the Electronic Perineometer instructions are designed into the Clinical Perineometer instrument.
1. Pre-set the instrument switches as listed on page 27; be sure to have the FUNCTION set for TIME, FULL-SCALE at 100 (or 60 if that is your practice), and Sensor Circuit on shorted.
2. Instruct the patient fully, as described in the Chapter I. When the patient returns and is seated or lying down comfortably, connect the gray sensor cable to the CP-400 and turn on the POWER SWITCH.
3. Move the SENSOR SELECTOR to bilateral and ask the patient to make a few "Kegel-type" contractions to verify that the instrument-sensor-patient are correctly connected. Most users will also want to turn the CHART ON at this point and leave it on for the duration of diagnostic testing.
4. Move the FUNCTION SWITCH to PEAK, reset the PEAK CLEAR and leave it on MEASURE and use the MANUAL CONTRACT LIGHT SWITCH to signal the patient to make a strong "flick" contraction. (It is probably best to use BOTH verbal instructions and the CONTRACT LIGHT signal, especially at first.)
Note, however, that if you do use verbal instructions you should try to "standardize" the wording so that you can make valid comparisons later. It would not be correct, for example, to compare Ms. A's peak readings with Ms. B's, if one were told to "squeeze your muscles very, very tightly", and the other were told to "make a Kegel flick". We suggest you try a variety of wordings at first, and then WRITE DOWN the patterns that seem both natural to you and universally appropriate for all your patients.
Be sure to repeat the PEAK or "Flick" test a standard number of times (minimum of three, maximum of six are suggested), and record the obtained readings either on the patient's chart or directly on the strip chart paper itself.
5. Move the FUNCTION SWITCH to INTEGRATE and run through a sequence of six 10-second "Hold"
contractions as described above. Remember to use the AUTOMATIC 10 SECOND SWITCH to signal the
patient when to contract and when to relax. Be sure to record the numerical values of both the contract and
relaxed intervals on the patient chart or strip chart itself. Remember to observe and mentally note the
latency, or time interval, between the turning on the the CONTRACT LIGHT and the onset of the actual
contraction. Equally important is the latency in "letting go" at the end of the 10 seconds. The tracing should
return to baseline levels during the 10 second rest period; often it does not. If the discrepancy between
initial baseline and inter-interval rests is more than 1 or 2 microvolts, it should be noted for later training
in relaxation.
A NOTE ON FALSE NEGATIVES: In general, the ability to contract and relax the pubococcygeus muscle voluntarily is accepted as a valid diagnostic test of muscle strength and control. However, we have observed exceptions; for example, a woman with exceptionally strong muscles had great difficulty learning to do the Kegel "Hold" contractions. In the course of discussion, it became clear that the research subject was accustomed to extensive muscular activity in the course of sexual play, and that she had conscious control only in a sexual context. An hypnotic trance model was hypothesized and seemed appropriate. She wanted to do "one minute" contractions and relaxations. [To do this on the CP-400, simply override the CONTRACT-RELAX lights with VERBAL instructions, and later calculate the average of six 10 second intervals.]
SHOULD I ALLOW PRACTICE SESSIONS? Sometimes patients will want to "practice" contractions before the "real" testing begins. Clinical judgement is necessary at this point. In general, our advice is to NOT allow any warm-up period in order to obtain a truer "initial" evaluation. At the end of the first testing sequence therapeutic instruction and practice may be given, and (allowing for some rest) a second sequence of testing can be obtained at the end of the first session. Some patients will show dramatic changes within this first session, while others will show no change, or even the effects of fatigue. All of this is important clinical data which will be taken into account in forming a clinical judgement.
6. Move the FUNCTION SWITCH to PEAK and CLEAR PEAK by raising the level; return to MEASURE and obtain a new PEAK reading. Then capture the new PEAK reading by moving the switch lever to HOLD PEAK position.
Then move the FUNCTION SWITCH to TIME position, and start the endurance test by flicking the RESET TIMING SWITCH up. Then use the MANUAL CONTRACT LIGHT SWITCH to signal the patient. Obviously, you should explain the nature of the test, using words to this effect: "This time I want you to make your strongest possible contraction, and to hold it as hard as you can for as long as you can without letting go even for an instant." Be certain to tell the patient to relax once you observe that the timer FINISHED light has come on. Record the data in the appropriate chart.
7. Clinical Test for Control. Chapter I suggests playing a few rounds of "Follow my finger" to assess and train neurological muscle control. A variation of this for the CP-400 (if lighting and vision are adequate) is to call out the numbers next to randomly chosen lights: "Give me a 6 -- give me a 15", etc. You might wish to set the Full Scale to 20 microvolts for this activity, so that the numbers will be "direct reading" in microvolts. If convenient, move to the patient's side to share in the activity and make it almost "fun".
WHERE TO PUT THE REMOTE UNIT. The CP-400 REMOTE UNIT was designed so that it could be hand-held by the patient during use. It can also be place on a table or other stand, if near enough to be clearly seen. The VISUAL BIOFEEDBACK circular display is intentionally designed to be readily visible at all times when the patient's attention is focused on the RELAX-CONTRACT lights. In this sense --- with constant biofeedback --- every diagnosis session is also a training session. Defeating this function (by concealing the REMOTE UNIT, for example) should only be done as a matter of professional judgement for good reason. The ever- present biofeedback signal is one reason why it is so quick and easy to learn pelvic muscle control and exercise with the CP-400.
SHAPING BEHAVIOR AND LEARNING PRINCIPLES. The clinician should remember the rich body of knowledge in psychological learning theory that underlies the field of biofeedback. In particular, recall that behavior should be quickly rewarded for small steps in the right direction. For example, if the patient can reach 10 microvolts, ask for 12, and say "That's it, terrific" when she does. The goal at any given time should be only a small and plausible step away.
Therapeutic and Diagnostic Sessions
In the course of development of the Electronic Perineometer and the Clinical Perineometer instruments, we developed a standard office procedure for PC patients. No formal research has yet been done to validate this (or any other) protocol; it is offered here for professional consideration.
At the first session, one and a half hours is allocated. The first third is for obtaining a general history and establishing rapport; the second is for specific discussion of the PC and its function (sexual, urinary control, or both) in the patient's life. In the third half-hour, actual testing and training is begun. In sessions after the first, only the second and third parts are needed.
Each Perineometer session consists of three parts: a set of evaluative trials (Peak, Integrate, and Time), followed by specific instructions and therapeutic exercises with patient observation, education, and ample time for practice, followed by a repeat of the first evaluative trials.
If the patient will be using a take-home trainer such as the PP-200 Personal Perineometer, it should be handed to the patient and some opportunity provided to practice with it before ending the session.
In general, weekly training sessions are sufficient. Since at- home practice is probably the greatest stumbling block to patient progress, some means of monitoring it is in order. A written log of exercise periods, number of contractions, time allocated and actually spent, etc. is often helpful. In difficult cases, daily telephone calls to (or from) office personnel may be necessary. Indications of non-compliance should be noted and followed up, as they may indicate the presence of social (partner or family) or psychological resistance to self-improvement.
REFERENCES
A. General
Leslie Cromwell, Fred J. Weibell, and Erich A. Pfeiffer, Biomedical Instrumentation and Measurements. Prentice-Hall, Inc., Englewood Cliffs, New Jersey 07632, 1980. (2nd edition)
James H. Geer. "Sterilization of Genital Devices". Psychophysiology, 15, 4, 1978, p. 385.
George D. Fuller, Ph.D. Biofeedback: Methods and Procedures in Clinical Practice. Biofeedback Institute of San Francisco, California, 1977.
Robert J. Gatchel and Kenneth P. Price. Clinical Applications of Biofeedback: Appraisal and Status. Pergamon Press, New York,1979.
Kenneth R. Gaarder and Penelope S. Montgomery. Clinical Biofeedback: A Procedural Manual. The Williams & Wilkins Company, Baltimore, 1977.
B. The Pubococcygeus Muscle
Benjamin Graber, ed. Circumvaginal Musculature and Sexual Function, (New York: S. Karger, 1982)
Benjamin Graber and Georgia Kline-Graber, "Female Orgasm: Role of the Pubococcygeus Muscle". Journal of Clinical Psychiatry, Vol. 40, No. 8, August, 1979, p. 33-39.
Georgia Kline-Graber and Benjamin Graber, Women's Orgasm. New York: Popular Library, 1975.
Arnold H. Kegel, M.D., "Sexual Functions of the Pubococcygeus Muscle". Western Journal of Surgery, Obstetrics and Gynecology, Vol. 60, 1952, p. 521-524.
C. Biofeedback and Sex Therapy
Alice K. Ladas, Berverly Whipple, & John D. Perry. The G Spot and Other Recent Discoveries About Human Sexuality (New York: Holt, Rinehart & Winston, 1982; Dell (paperback) 1983).
John D. Perry and Michael Price, "Task Force Report on the Use of Biofeedback as an Adjunct to Sex Therapy". Biofeedback Society of America, Denver, CO, March, 1978.
John D. Perry, "The Vaginal Myograph: Measurement in the Second Stage of Sexual Arousal", invited paper
presented at the Annual Meeting of the Biofeedback Society of New England, Wakefield, Massachusetts,
November 27, 1978.
User's Feedback
Although parts of these instructions are now in their sixth edition, there is always room for improvement. We welcome and solicit your feedback about the accuracy, completeness, and usefulness of these instructions. Below are some suggested topics -- but feel free to tell us anything that you think might be helpful to us and especially to other users.
-- John D. Perry, PhD, ACS, BCIA
Send to: John D. Perry, President
Biotechnologies, Inc.
Strafford, PA 19087-2454
WHAT QUESTIONS REMAIN IN YOUR MIND AFTER READING THE MANUAL?
WHAT PROCEDURES ARE MOST CLEAR? MOST UNCLEAR?
DID YOU FIND ANY ACTUAL ERRORS (INCLUDING TYPOGRAPHICS)?
WHAT DO YOU CONSIDER THE BEST PART OF THE MANUAL? THE WORST?
WHAT TOPICS OR DETAILS SHOULD BE SPELLED OUT MORE COMPLETELY?
PLEASE give your name & a telephone where we can reach you for further clarification if necessary! We value your comments!
This page is www/incontinet.com/articles/art_urin/HOPCLIN.htm
Copyright 1996 by John D. Perry
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