peritron_owner_s_manual_ver_5-0_sept_2012.pdf
Page 1
Owner’s Manual
LABORIE
Page 2
Trademarks
Peritron is a trademark of LABORIE MEDICAL TECHNOLOGIES INC.
Windows is a registered trademark of Microsoft Corp.
Copyright
All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior written permission of
LABORIE.
© Copyright 2012 LABORIE
All information current at time of publishing. Published in Canada.
Document Number: PERI-UM01
Version Number: 5.0
Release Date: September 4, 2012
Issued By: R.A
Published in Canada.
Page 3
Contents
INTRODUCTION .................................................................................................................................................... 1
CONTROLS AND OPERATING QUICK START GUIDE ....................................................................................................... 3
ABOUT THE SENSORS ............................................................................................................................................ 6
BATTERY INSTALLATION ......................................................................................................................................... 8
HOW TO USE THE PERITRON .................................................................................................................................. 9
HOW TO KNOW WHICH MUSCLES TO USE .............................................................................................................. 12
HELP................................................................................................................................................................ 13
PREVENTIVE CARE AND MAINTENANCE................................................................................................................... 15
TECHNICAL SPECIFICATIONS AND SERVICE INFORMATION ........................................................................................... 16
CONTACT AND ORDERING INFORMATION ................................................................................................................ 19
APPENDIX ...................................................................................................................................................... 20
Page 4
INTRODUCTION
In the clinic, Peritron™ is used for objective assessment of the strength and endurance of
pelvic floor muscle contractions and for teaching pelvic floor exercises.
In operation, air displaced from the detachable Vaginal or Anal Sensor travels to a pressure
sensor in the Display Unit via a connecting tube. The signal from the sensor is interpreted by a
microprocessor and displayed either numerically in centimeters water pressure or as a multirange bar graph for biofeedback. Audio feedback can also be used.
Peak, average, gradient readings for a contraction and its duration may be recalled. The
Peritron also calculates “area under the curve”.
Two buttons control all functions on the device.
An optional vaginal sensor collar ensures repeatable depth of insertion.
Operating Instructions are summarized in the Quick Start guide.
Detailed Operating Instructions start on page 9.
RELIABILITY
Recent studies confirm that the Peritron is a reliable tool when used correctly. See Reliability
of Pelvic Floor Muscle Strength Assessment using Different Test Position and Tools by Frawley
et al. in the journal of Neurourology and Urodynamics (2006) 25(3):236-42; and also A
comparison of Perineometer to Brink Score for Assessment of pelvic floor muscle strength by
Hundley et al. in the American Journal of Obstetrics and Gynecology (2005) 192(5): 1583-91.
CAUTION AND WARNINGS
Caution
UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER
OF A LICENSED PHYSICIAN.
Warnings
Only trained technicians should operate this device. The operator must read the owner’s
manual entirely and refer to any additional training materials before using the device.
DO NOT ATTEMPT TO OPEN OR REPAIR the system by yourself or by an unauthorized party.
ONLY LABORIE trained technicians may service the unit.
LABORIE equipment is licensed by Governments and approved by Safety Agencies to work with
LABORIE accessories ONLY.
LABORIE accessories are licensed by Governments and approved by Safety Agencies to work
with LABORIE equipment ONLY.
LABORIE equipment is warranted to work with LABORIE accessories ONLY.
LABORIE accessories are warranted to work with LABORIE equipment ONLY.
LABORIE IS NOT RESPONSIBLE FOR LOSS OF PATIENT FILES OR TEST DATA. WE RECOMMEND
THAT YOU BACK UP PATIENT DATA ON A REGULAR BASIS.
ANY ADDITIONAL EQUIPMENT CONNECTED TO MEDICAL ELECTRICAL EQUIPMENT MUST
COMPLY WITH THE RESPECTIVE IEC OR ISO STANDARD (E.G. IEC 60950 FOR DATA PROCESSING
EQUIPMENT). ANY AND ALL CONFIGURATIONS SHALL COMPLY WITH THE REQUIREMENTS FOR
MEDICAL ELECTRICAL SYSTEMS. ANYONE CONNECTING SUPPLEMENTARY EQUIPMENT TO
MEDICAL ELECTRICAL EQUIPMENT CONFIGURES A MEDICAL SYSTEM AND IS THEREFORE
RESPONSIBLE THAT THE SYSTEM COMPLIES WITH THE REQUIREMENTS FOR MEDICAL
Peritron Owner’s Manual
1
Page 5
ELECTRICAL SYSTEMS. ATTENTION IS DRAWN TO THE FACT THAT LOCAL LAWS TAKE PRORITY
OVER THE AFOREMENTIONED REQUIREMENTS. IF IN DOUBT, CONSULT YOUR LOCAL LABORIE
REPRESENTATIVE OR THE TECHNICAL SERVICE DEPARTMENT.
Use water-based lubricant if necessary. Be sure to wash it off afterwards with soap and water
as long-term exposure may cause the silicone rubber sheath to lose tension.
INTENDED USE
Peritron is used in assessing the strength of pelvic floor muscles, teaching pelvic floor muscle
exercises, and for providing feedback during pelvic floor muscle exercises.
PERITRON EQUIPMENT CHECKLIST
Connecting tubes
Inflation
valve
vaginal
sensor
anal sensor
display unit
Model 9300V
(vaginal sensor only)
Model9300A
(anal sensor only)
Model 9300AV
(with anal and vaginal sensor)
Peritron Perineometer with
two standard AA 1.5 volt
alkaline batteries
Anal sensor
120cm Connecting Tube
Quick Start Guide
User Manual CD
Carrying case
Peritron Perineometer with
two standard AA 1.5 volt
alkaline batteries
Vaginal Sensor
80cm Connecting Tube
Quick Start Guide
User Manual CD
Carrying case
Peritron Perineometer with
two standard AA 1.5 volt
alkaline batteries
Vaginal Sensor
Anal Sensor
80cm Connecting Tube
120cm Connecting Tube
Quick Start Guide
User Manual CD
Carrying case
Optional Accessory:
Vaginal Sensor Collar (controls depth of insertion)
Peritron Owner’s Manual
2
Page 6
CONTROLS AND OPERATING QUICK START GUIDE
Peritron Owner’s Manual
3
Page 7
AUDIO
BLUETOOTH
DISPLAY
(APPLICABLE TO
BLUETOOTH MODEL ONLY)
POWER
ON/OFF/ZERO
Front panel controls
Side panel controls and inputs
Button
Zero Button
Toggle Button
(3WTS) - In
Toggle Button
(3WTS) - Up
Option
Audio
Device
Target
3WTS
LUER INPUT
Function
On – press and hold for 1 second
Off – press and hold for 3 seconds
Zero – press briefly (also resets statistics)
Press briefly to open the options menu
Press briefly to accept a changed option value (item flashes to show change has
been accepted
Hold in to cancel a changed value and return to the previous menu option
Hold in to return from the option menu to normal operation
Access Statistics (when in normal operation) – hold up to toggle through Peak,
Duration, Average, Gradient, Area under Curve. Release when a statistic name is
showing to view the statistic. Display returns to normal 3 seconds afterwards
Toggle up through menu options
Toggle up through option values
Description
This option enables the user to turn on and off Audio feedback (a continuous musically
pitched tone). The Audio feedback level is dependent upon the user’s level of activity
and the difficulty ‘LEVEL’ setting. The Audio volume is available in three levels, either
High or Low or Off.
This option is not available on all models. This option allows a user to alter the device’s
core functionality between:
1. Peritron™ device (A perineometer for measurement of Pelvic Floor activity)
2. Target device (A pressure based device for assessment of various muscular activities)
When set to Target mode, the user aims to achieve a preset target pressure
(contraction strength). Bar chart and audio feedback is given to indicate whether the
user is below, on or above target. Set the numerical value to the desired target level.
See the table on page 21 for more information on the relationship between target
values and level values.
Peritron Owner’s Manual
4
Page 8
Option
Level
Display
Description
This option determines the level of difficulty in the exercises feedback. It is used by the
Bar Chart display and Audio feedback levels to ensure that the range of input activity
can be tailored to a particular individual’s strengths. It can be thought of as a level of
sensitivity in the feedback.
The level value ranges from 1 to 99 with 1 being the easiest (i.e. most sensitive) and 99
being the most difficult. In more complicated terms, each increment in the level refers
to a step increase of approximately 5 cmH20; therefore a level setting of 1 refers to a
full scale deflection when the user achieves 5cm H20. If the level is set to 10 (default), a
full scale deflection needs the user to go from 0 to 50 cmH20. Refer to the Tolerance
chart on page 20 for more information. Being able to alter the level of difficulty enables
the feedback (Bar Chart or Audio) to be more relevant and attainable for each user).
Use the Up/Down toggle buttons to select the ‘Level’ value.
This option enables the user to toggle between a Bar Chart display and a numerical
(digital) display. To turn the Bar Chart on, select the ‘LIN’ or ‘LOG’ value. LIN represents
a linear chart where each bar represents the same step size in pressure, LOG is a
logarithmic chart where step size increases (becomes more difficult) as the pressure
increases.
Peritron Owner’s Manual
5
Page 9
ABOUT THE SENSORS
Both the vaginal and the anal sensor consist of an air-tight seamless silicone rubber sheath
over a skeleton that allows the central section to be pressed in radially in response to a
muscular contraction.
Silicone rubber was chosen for its high biocompatibility (i.e. none of the allergic responses
associated with latex), excellent flexibility, and high durability.
The wall thickness of the sheath has been kept to a minimum to ensure it transmits pressure
with high sensitivity unaffected by temperature over the physiological range.
There are no joints or crevices in the contact surfaces to trap contaminants.
Sensors should be washed in warm soapy water with tubes connected prior to initial use.
Single-user sensors are recommended. For such a personal item, users usually prefer their
own sensor. Single-user sensors eliminate the risk of cross-contamination and the practitioner
is relieved of the responsibility for the compliance of staff and the effectiveness of necessarily
rigorous and time-consuming disinfection procedures.
VAGINAL SENSOR PRB113
Connecting tube with end fittings
Tube PRB02041 is 80cm long and has a one-way valve for optional air inflation.
Depth of insertion
Normally the sensor is inserted until 1cm of the sheath remains outside. Optional sensor collar
BRA02011 ensures repeatable depth of insertion and simplifies patient training. It is especially
useful for ensuring repeatability during clinical trials.
Lubricant
When necessary, use a water-based lubricant. It is important to wash it off immediately
afterwards with soap and water otherwise it will soak into the sheath and cause it to lose
tension.
For care and cleaning information see page 15.
Peritron Owner’s Manual
6
Page 10
Technical note: The sensor requires 3-4 cmH2O to cause it to start to deform. After the initial
deformation the resistance to further deformation is 1-2 cmH2O. Therefore, once zeroed, the
reading on Peritron will lag the true pressure in the sensor by 1-2 cm/H2O.
Optional inflation of the vaginal sensor
For every patient, the initial Peritron reading after insertion will depend on the geometry of
the vagina, her estrogen status, time since intercourse, and stage of her menstrual cycle. It
may be possible to compensate for some of the variability of this initial reading by inflating the
sensor to a preset pressure after insertion. Also, an inflated sensor provides a larger and firmer
surface to ‘squeeze’ against.
100 cm reading on Peritron is suggested as a suitable pressure to inflate the sensor after
insertion.
Inflation technique
1. Insert the sensor.
2. Increase Peritron reading to 100 by syringe inflation with air via the ‘T’ in the
connecting tube.
3. Zero Peritron by pressing the button once, then ‘squeeze-and-lift’.
4. Take reading(s).
Tip: A 50 ml syringe is the most convenient. After reaching the inflation pressure, pull back the plunger of
the syringe to seat the one-way valve in the inflation ‘T’. Detach the syringe.
Technical note: Laboratory testing indicates that inflation tends to ‘stiffen’ the sensor and reduce its
sensitivity of response. Inflating to 100 cm reduces response by about 20%. However, in the clinic this
may be more than compensated for by the greater effect achieved by contracting against a firmer, larger
surface.
ANAL SENSOR PRB108
It is customary to use the anal sensor at atmospheric pressure (without inflation).
Connecting tubes
Supplied with 120cm tube PRB03040 with a male Luer connector for the anal sensor PRB108.
Lubricant
A water-based lubricant may be used if necessary. Some practitioners use disposable mini
latex sensor covers as sensor covers.
For care and cleaning information see page 15.
Technical note: The stiffness of the sheath of the sensor tends to reduce the actual pressure reaching the
Peritron display unit. In laboratory trials, the Peritron reading was ≈75% of the actual applied pressure.
The effect is linear over the normal operating range. Therefore, if the true pressure is required it may be
determined by dividing the Peritron reading by 0.75. E.g. when Peritron reading is 38cm, actual applied
pressure is 50cm.
Peritron Owner’s Manual
7
Page 11
BATTERY INSTALLATION
Access to the battery compartment is through the cover on the rear of the monitor. Use two
standard AA 1.5 volt alkaline batteries.
1. Gently press down and slide out the battery
cover. Place the cover aside.
2. Insert the batteries.
3. Slide the cover back onto the device until a
“click” is heard. The “click” sound signals that the
cover is securely in place.
Peritron Owner’s Manual
8
Page 12
HOW TO USE THE PERITRON
NOTE: Make sure batteries are installed before turning on the device. To see how to install the
batteries, see page 8.
1. Use the connecting tube to join the display unit to the sensor.
Use a slight twisting action when making the connection.
DISPLAY
During assembly, handle the sensor by the rigid part of the neck to ensure
the sheath remains fully round.
To eliminate the possibility of cross contamination, one sensor per user is
recommended.
2. Activate the Peritron by pressing and releasing (‘clicking’) the
power button.
It will usually display a figure of 1.0 to 2.5 when turned on. Zero the
display by clicking the power button again. Even after zeroing the display,
it may show a positive or negative number such as - 0.1. Remember this
unit is extremely sensitive.
If the Display is blank or shows LOBAT, place new batteries in rear
compartment.
3. Select the operating mode by using the 3-way toggle switch
(3WTS). This switch is used by pressing it up, down, or in. The
modes and options are outlined in the chart on page 3.
ONE CLICK ‘ON’
ANOTHER CLICK
TO ‘O’
LEVEL
Press the 3WTS in once to access the main mode menu. Then, press the
3WTS up or down to see the various modes. The words AUDIO, DISPLAY,
LEVEL, DEVICE, or TARGET will scroll along the screen. Press the 3WTS in
to select one of the modes. Then, press the 3WTS up or down to see the
settings for that mode. For example: if you select the AUDIO mode you
will then see the OFF, LO, and HIGH selections as you move the 3WTS.
Press the 3WTS in briefly while a setting is displayed to select that option.
When it has been selected the name of the setting will flash on the
screen and a three-tone beep will be emitted (if AUDIO is on). Pressing in
the 3WTS and holding for 3 seconds will return you to the main display.
AUDIO MODE. Choose either OFF, LO, or HIGH (volume). This will give
audio biofeedback.
DISPLAY MODE. Choose either NO for a NUMERICAL display or LIN for a
BAR display. (Bar display is a row of vertical bars – more bars = higher
pressure, linear progression). Choose LOG for a bar display with
logarithmic progression. The LEVEL setting affects the Bar display. When
set to Level 10, 8 bars will equal 50cm/H2O in either Log or Linear mode.
If set to Level 20, 8 bars will equal 100cm/H2O, and so on. Refer to the
table on page 20 for more information.
If necessary, in numerical or bar mode, re-zero the DISPLAY at any time
by clicking the power button once.
HIGH
AUDIO
NUMERICAL
BAR
NOTE: The readout in NUMERICAL mode can register negative values such as –
1.3. The display cannot register negative values when in FEEDBACK mode.
Peritron Owner’s Manual
9
Page 13
LEVEL MODE. Select from 1 to 99. The higher the number the harder the
patient will have to work to get some Audio or Visual biofeedback. Level
10 is the default setting.
DEVICE MODE. Select PERI (Perineometer) or Target. For doing pelvic
floor assessment and training you need to select PERI (this is the default
setting).
Vaginal Sensor
In use, handle the sensor by the tail of the connector of the connecting
tube.
Sensor Insertion
With user supine, a pillow or two under the head for comfort, knees at
90°, 45° angle between thighs and the mattress, knees and feet 30 cm (12
inches) apart, insert the sensor until 1.0 cm of the blue sheath is still
visible.
Some users will find a crook laying position (lateral laying knees drawn up
to about 45 degrees) more effective.
When repeatable depth of insertion is essential, use of the sensor
collar is recommended.
If the patient is tense she may bear down on the sensor and create
artificially high readings. It may help her to relax if she is asked to attempt
to minimize the reading after insertion.
Optional Inflation (see page 7)
After insertion, the sensor may be inflated to provide a standard base line
for the contraction reading and to provide a firmer and larger surface to
contract against.
AFTER OPTIONAL INFLATION
Suggested Inflation Protocol
With Peritron in Numerical display mode, insert the sensor. Use a syringe
in the ‘T’ of the connecting tube to introduce air until the reading reaches
100 cm. Pull back on the plunger to seat the valve in the ‘T’ and
disconnect the syringe.
4. Anal Sensor
(it is not general practice to inflate the anal sensor)
Insert sensor with patient in left lateral position and knees drawn up at
about 45°.
Tip: For highest accuracy and repeatability the user must be in the same
position during each session and the sensor must be inserted the same
amount.
TYPICAL READING AFTER
INSERTION 30-70
5. Zero the Display by pressing and releasing the button once.
Anal Sensor. If this step is omitted, during relaxation feedback, the
readings will decrease. For example, if reading on insertion is 50.0,
readings on relaxation will be 49.2, 48.4, and 47.8 etc...
If Peritron is zeroed after insertion, readings on relaxation will be
progressively negative e.g. 0.0, -1.3, -2.6, and 3.1 etc…
THIS FIGURE MAY
VARY QUITE
QUICKLY TO 0.2 OR
MORE OR LESS
Peritron Owner’s Manual
10
Page 14
6. Contraction
A. Measure the contraction
0.6 SECONDS
Vaginal Sensor: Ask the patient to ‘squeeze-and lift’ strongly and ‘hold’ as
long as possible.
Anal Sensor: Ask the patient to squeeze or relax as required.
1.2 SECONDS
There will be a new reading every 0.6 seconds when in the numerical
mode and ten times per second when in feedback mode.
Tip: To discourage users from bearing down on the sensor it may be
helpful to have them read out aloud the changing values.
1.8 SECONDS
B. Evaluate the contraction
Peak and Average readings. After the contraction you can ‘recall’ the
peak, duration, average, gradient, and area under curve readings by
holding the 3WTS up and releasing it when the name of the figure you
want is on the screen. For example, if you want the average reading, hold
the 3WTS up until AVE appears on screen and then release it. The figure
will be briefly displayed. The reading will cycle between these values for
the most recent contraction; that is since Peritron was last ‘zeroed’, or
switched off and on again (power cycle).
PRESS FOR
2 SECONDS
NEXT
For automated collection of statistics and detailed data analysis and
multimedia biofeedback you need PhysioLog Pro software.
Duration (in seconds - from when pressure goes above 5cmH20 to when
it drops below again)
NEXT
Average (area under curve / duration)
Peak (max value in cmH20)
NEXT
Gradient (in cmH20/second. This is the peak value divided by the time
taken to achieve the peak - it is a measure of onset speed (better
muscles, faster onset)
Area under curve (duration x average in cm/sec) Sampled ten times per
second. Divide this figure by ten to compare it with the figure obtained
manually at one reading per second.
NEXT
THE READING WILL BECOME
7. Withdraw the sensor.
Switch off by clicking and holding down the power button or wait for
auto-off after four minutes.
NEGATIVE, i.e. MINUS THE ‘REST’
PRESSURE OF STEP FOUR
Cleaning the Sensor. After use, the sensor should be washed with soap
and warm water and dried.
Disconnect. It is good practice to separate the sensor/tube/monitor after
use as to leave them coupled together for long periods could lead to
deterioration of the seals.
Peritron Owner’s Manual
11
Page 15
HOW TO KNOW WHICH MUSCLES TO USE
About 40% of women are unable to perform a voluntary ‘squeeze-and-lift’ pelvic floor
contraction. They require instruction. Peritron is invaluable in this situation as its supersensitive feedback will respond to the first ‘flickers’, thereby motivating them to keep trying.
ABDOMINALS VERSUS PELVIC FLOOR
The transversus abdominus and the pelvic floor muscles tend to work together. That is, a
pelvic floor contraction usually is accompanied by a contraction of the abdominals. Patients
should be taught to not involve rectus abdominus or the gluteal muscles at all, if accurate
measurements are needed.
As Peritron is measuring total pressure, it has no sure way of telling you whether it is
responding to a downwards push of the abdominals or a sideways and upwards ‘squeeze’ of
the pelvic floor. A digital examination will enable you to determine which group of muscles is
making a greater contribution to the Peritron reading.
Palpating the abdominals and gluteals will indicate if they are overactive. Attempting to push
out the sensor is a sure sign that the abdominals are overwhelming the contribution made by
the pelvic floor.
If the pelvic floor exercise is being done correctly you may notice a slight anterior tilt of the
sensor (towards the anus).
Your aim is to see your client’s pelvic floor making an ever increasing contribution to the
readings on the Peritron.
Peritron Owner’s Manual
12
Page 16
HELP
Q. Can I use the sensors on more than one patient?
A. Multi-patient use of sensors is not recommended. We recommend each patient has their
own personal sensor to eliminate any risk of cross-contamination. Being such a personal item,
ALL users prefer their own sensor which is available at a modest cost. Cleaning becomes the
responsibility of the user.
Q. My patients tend to push out the vaginal sensor…..
A. During a contraction both the abdominal muscles and the muscles of the pelvic floor act on
the sensor. The pelvic floor muscles push on the side of the sensor. The abdominals push
down, and in doing so, attempt to push it out. When the pelvic floor is weak it is not unusual
for the push created by the abdominals to be dominant. The tendency to push out the sensor
will lessen when the patient has learned to reduce the action of her abdominals and increase
the action of her pelvic floor.
Your aim is to see your patient’s pelvic floor making an ever increasing contribution to the
readings on the Peritron.
Q. What is a normal reading for vaginal measurements?
A. As readings are influenced by the geometry of the vagina, estrogen status, time since
intercourse, and stage of the menstrual cycle there is no such thing as a ‘normal’ reading. For
these reasons, session to session readings will also vary. However, by way of a guide, the
reading after insertion is usually 20-40. A satisfactory zero-based contraction will register 2030. A really strong one is 60. It is the session-to-session improvements that matter.
Q. What is a Normal reading for anal measurements?
A. A resting pressure of about 50 and a contraction of 100-150 is normal. A really strong
contraction will be about 250.
Q. The sensor has gone flat – There seems to be an air leak.
A. Click the sensor/tube/monitor together USING A SLIGHT TWIST. Twisting helps make a good
air-tight seal. If the sensor still goes flat then check that the short length of soft rubber tube on
the male connectors and the mating surface of the female connectors are free of particles.
Wipe them with a soft cloth/cotton swab.
The short length of soft tube makes an air-tight seal against the:
1 socket inside the vaginal sensor
2 female connector of the connecting tube of the vaginal sensor
Connector on connecting tube of vaginal sensor
Q. Sometimes the reading changes when it is not being used
A. Peritron is adjusting to a new or changing room temperature. Click the button to reset the
display to zero.
Q. What do I do when LOBAT appears in the Display?
A. Every time the ZERO button is pressed, for example when turning the Peritron on or when
zeroing the unit, the Battery Power is tested. If the Battery is low, the LOW BATTERY indicator
Peritron Owner’s Manual
13
Page 17
message “LOBAT” appears briefly – this is a warning that the batteries are low and should be
changed soon. At this point the device is still accurate - the message is just a warning. When
the batteries become critically low, and the accuracy of the device may be jeopardized, the
LOW BATTERY message will appear during normal usage, and may remain on during use.
For best practice, replace the batteries as soon as the LOW BATTERY indicator first appears.
Access to the battery compartment is via the battery cover on the rear of the monitor.
Replace it with two standard AA 1.5 volt alkaline batteries.
Q. How can I check the accuracy of the reading?
A. With the tube connecting the vaginal sensor to the Monitor, immerse the sensor in water,
zero the DISPLAY and then immerse it an additional known depth, say 30 cm. The reading on
the display should be 28 or 29.
Technical note: The sensor requires 3-4 cm water pressure to cause it to start to deform. After the initial
deformation the resistance to further deformation is 1.0-2.0 cm water pressure. Thus, once zeroed, the
reading on the Peritron will lag the true pressure in the sensor by 12 cm water.
TARGET DEVICE
The Target Device is used to provide audio and visual feedback to a maintained level of target
pressure. When using the Target device an additional menu option becomes available called
Target. Within this option, a specified Target pressure level can be indicated, for example 54
cm H2O. The user’s role is to achieve this target pressure and maintain it. Audio and visual bar
chart displays are used to indicate to the user if they are above or below the target level. See
page 21 for more information on the relationship between target and level values. When using
the Target Device, the bar chart display varies from the standard format, as illustrated below.
The bar chart is a series of lines that indicate proximity to the target activity. If the current
activity level is the same as the target, the display changes to a series of hyphens:
-----At this point audio feedback will also beep intermittently with a second long tone to indicate
the user is achieving the correct level. As the pressure level drops below the target level,
vertical lines appear to the left of the display – the lower the drop, the more lines appear. As
pressure goes above the target, vertical lines appear to the right of the display, for example:
Far below target
Medium below target
On target
Medium above target
Very far above target
|||| - -
|| -
----
- -||
-- | | | |
If preferred, you can use the numerical display in Target mode.
When the user pressure level is within 10% of the Level Range, the audio tone starts to beep
with 1 second intermittent tones. When the pressure level is outside of this 10% target zone,
the audio feedback is a continuous pitched tone. Using the audio tones alone, users can learn
to adjust their feedback levels of pressure – this allows the user to assume a more natural
position without needing to see the visual display.
Peritron Owner’s Manual
14
Page 18
PREVENTIVE CARE AND MAINTENANCE
DO NOT IMMERSE IN WATER TO CLEAN AS THE PERITRON IS NOT WATER RESISTANT.
NEVER IMMERSE ANY PART OF THE PERITRON AND NEVER ALLOW WATER TO ENTER THE
CONNECTING TUBE as it will damage the electronics in the device. The Peritron display unit
can be wiped clean with a damp cloth with a mild detergent if necessary.
Caution: Any lubricant allowed to remain on the sheath will soak into the microporous
surface causing it to lose tension and require replacement.
Tip: To prevent deterioration of the seals during storage always separate the connecting tube
from the Peritron and the sensor.
CARE OF THE VAGINAL SENSOR
After each use:
1. Disconnect the monitor from the tube. With the sensor still attached to the other end of
the connecting tube, wash the contact surfaces of both, using hand soap and warm water.
2. Rinse the sensor and tube connector in water, separate them, shake out any water that
may have entered accidentally, and allow both parts to air dry.
3. Return the sensor and tube to the case.
CARE OF THE ANAL SENSOR
After each use:
1. Disconnect the monitor from the tube. Disconnect the tube and sensor and wash the
sensor immediately in a pH neutral anti-bactericide or protealitic enzyme cleaner. Wash
the tube with hand soap and warm water.
2. Rinse the sensor and tube connector in water, shake out any water that may have entered
accidentally, and allow both parts to air dry.
3. Return the sensor and tube to the case.
CHECK FOR LEAKS
Water immersion leak test:
Join together the sensor, tube
and monitor using a slight
twisting action and immerse
the sensor and part of the tube
under water. Squeeze the
sensor firmly and look for
bubbles escaping. If there is a
hole in the sensor it should be
replaced.
If no bubbles escape and the
sensor is still flat then there
must be an air leak in the
monitor unit. Return it to your
distributor for repair. NEVER IMMERSE ANY PART OF THE MONITOR UNIT NOR ALLOW
WATER TO ENTER THE TUBE as it will damage the electronics in the monitor.
Peritron Owner’s Manual
15
Page 19
TECHNICAL SPECIFICATIONS AND SERVICE INFORMATION
Peritron is a microprocessor-based perineometer that measures the strength of pelvic floor
muscle contractions by sensing the pressure of air in a vaginal or anal sensor. The pressure is
displayed either numerically in centimeters water pressure or as a multi range analogue bar
graph.
Peritron requires no user adjustments or calibration.
Operating Range: 0-300 cm water pressure.
Environmental conditions Humidity: <80%RH
for operation: Temperature: 10 to 30 Degrees Celsius
Pressure (on sensor) < 75KPa
Transportation/storage Humidity: <80%RH (No dew condensation)
limitations Temperature: -20 to 70 Degrees Celsius
Display Resolution: 0.1 cm water.
Accuracy : Max Error < 0.7 cm H20 full scale (within operating temperature
range)
Monitor: Numerical: Liquid Crystal 4 digits 18 mm high with indicator for
battery power low. Reading updated every 0.6 seconds.
Analogue: Bar graph display of 8 elements. Reading updated 10 times/second.
Tolerance: +/- 3%
Peak, Average, Duration, Gradient, Recall, Area Under Curve When 3WTS is pressed upwards
the Display shows sequentially the readings of the most recent contraction.
Vaginal Sensor 26-28 mm dia. 55 mm long active surface, 108 mm overall with thin wall,
precision molded medical grade silicone rubber sheath suitable for inflation up to 100cm water
pressure.
Anal Sensor 15-19 mm dia. 30 mm long active area, 30 mm dia. flange, 80 mm overall with
medical grade silicone rubber sheath
Sensor Connecting Tube 80 cm PVC tube with connectors. Vaginal sensor has inflation ‘T’ and
one way valve .
Auto-off function operates after 3 minutes of no activity.
Battery 2 x 1.5V AA alkaline; accessible to user.
Carry case 27.3 x 24 x 5.6 cm, molded with insert.
Warranty warranted to be free of defects for 12 months.
Peritron is a totally lead free product, and voluntarily complies with RoHS (Restriction of
Substances Hazardous to Health) standards.
Peritron Owner’s Manual
16
Page 20
SYMBOLS
LABORIE logo
ATTENTION, See Accompanying Documents
CE Mark - European Compliance Symbol
Read Operator’s Manual
Type BF Applied Part
Consult instructions for use
SAFETY, CLASSIFICATIONS, AND SERVICE
Safety
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Perineometer is intended for use in the electromagnetic environment specified below. The customer or the user of the
Perineometer should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment guidance
RF emissions CISPR 11
Group 1
The Perineometer Model 9300 uses RF energy only for its
internal function. Therefore, its RF emissions are very low and
not likely to cause interference in nearby equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Not applicable
Voltage fluctuation / flicker emissions
|IEC 61000-3-3
Not applicable
The Perineometer Model 9300 is suitable for use in all
establishments, including domestic establishments and those
directly connected to the public low-voltage power supply
network that supplied buildings used for domestic purposes.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment
and the Perineometer
The Perineometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the Perineometer can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Perineometer as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output power of Separation distance according to frequency of transmitter (m)
transmitter (W)
150 kHz to 800 MHz 800 MHz to 2,5 GHz d = 1.2√P d = 2.3√P
0.01
0.12 0.23
0.1
0.38 0.73
1
1.2 2.3
10
3.8 7.3
100
12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Perineometer is intended for use in the electromagnetic environment specified below. The customer or the user of the
Perineometer should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment -guidance
Peritron Owner’s Manual
17
Page 21
Electrostatic discharge
(ESD) IEC 61000-4-2
± 6 kV contact ± 8 kV air
± 6 kV contact ± 8
kV air
Immunity test
IEC 60601 test level
Compliance level
± 2 kV for power supply
lines ± 1 kV for
input/output lines
Not applicable
± 1 kV line(s) to line(s) ± 2
kV line(s) to earth
< 5% UT (>95% dip in UT)
for 0.5 cycle 40% UT (60%
dip in UT) for 5 cycles
70% UT (30% dip in UT)
for 25 cycles < 5% UT
(>95% dip in UT) for 5 s
Not applicable
3/Am
Not applicable
Electrical
transient/burst
fast
Surge IEC 61000-4-5
Voltage dips, short
interruptions
and
voltage variations on
power supply input
lines IEC 61000-4-11
Power
frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30%
Electromagnetic environment -guidance
Not applicable
Note: UT is the a.c. mains voltage prior to the application of the test level.
Conducted RF IEC
61000-4-6
Radiated RF IEC 610004-3
3 Vrms 150 kHz to 80
MHz
3 V/m 80 MHz to 2,5 GHz
Not applicable
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the
Perineometer Model 9300, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to
2,5 GHz where P is the maximum output power
rating of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range. b Interference may occur in the
vicinity of equipment marked with a symbol.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from s tructures,
objects and people.
A. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Perineometer used
exceeds the applicable RF compliance level above, the Perineometer should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the contour 380.
B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
CLASSIFICATIONS
IEC60601-1 (Clause 5) Classification:
The Peritron is an INTERNALLY POWERED DEVICE with Type BF Applied Part for SHORT-TIME
OPERATION. The Peritron is NOT WATER RESISTANT. There is no protection against ingress of water
(IPX0).
SERVICE
Calibration is not required for the Peritron device. Being a sealed unit, a sensor cannot be
repaired or dismantled. If a sensor fails or if the sheath loses its tension it should be replaced.
See page 19 for ordering information.
Peritron Owner’s Manual
18
Page 22
CONTACT AND ORDERING INFORMATION
Ordering: onlineorders@laborie.com
LABORIE Personal Health Division
6415 Northwest Drive, Unit 10
Mississauga, Ontario
Canada L4V 1X1
Tel: 289-997-0994
www.pelvicfloorexerciser.com
Item Number
PRN09300
PRN09301
PRN09302
Item
Peritron Perineometer with Anal Sensor [Standalone Peritron
Device(PRN09000), Anal Sensor(PRB108), 120cm Connecting
Tube(PRB03040), Quick Start Guide, User Manual CD]
Peritron Perineometer with Vaginal Sensor [Standalone Peritron
Device(PRN09000), Vaginal Sensor(PRB113), 80cm Connecting
Tube(PRB02041), Quick Start Guide, User Manual CD]
Peritron Perineometer with Anal and Vaginal Sensor [Standalone Peritron
Device(PRN09000), Vaginal Sensor (PRB113), Anal Sensor(PRB108), 80cm
Connecting Tube(PRB03040), 120cm Connecting Tube(PRB03040), Quick Start
Guide, User Manual CD]
Additional and optional items
PRB108
Anal Sensor Manometry Probe
PRB113
Vaginal Sensor Manometry Probe
PRB03040
120cm tube with male Luer for anal sensor
PRB02041
80cm tube with inflation port for vaginal sensor
BRA02011
Vaginal Sensor Collar to control depth of insertion
BAT0100
AA Battery (pack of 2)
Peritron Owner’s Manual
19
Page 23
APPENDIX
TOLERANCE* CHART
Pressures Equivalent to each bar (I to IIIIIIII) in cmH2O at various levels.
Level Bar #
I
II
III
IIII
10**
IIIII
IIIIII
IIIIIII
IIIIIIII
I
II
III
IIII
20
IIIII
IIIIII
IIIIIII
IIIIIIII
I
II
III
IIII
30
IIIII
IIIIII
IIIIIII
IIIIIIII
I
II
III
IIII
40
IIIII
IIIIII
IIIIIII
IIIIIIII
I
II
III
IIII
50
IIIII
IIIIII
IIIIIII
IIIIIIII
Min
9.2
13.6
22.8
27.2
36.4
40.7
50.0
18.4
27.2
45.6
54.3
72.8
81.5
99.9
27.6
40.7
68.4
81.5
109.1
122.2
149.9
36.9
54.3
91.2
108.6
145.5
163.0
199.8
46.1
67.9
114.0
135.8
181.9
203.7
249.8
Nom
Set Zero
9.5
14.0
23.5
28.0
37.5
42.0
51.5
Set Zero
19.0
28.0
47.0
56.0
75.0
84.0
103.0
Set Zero
28.5
42.0
70.5
84.0
112.5
126.0
154.5
Set Zero
38.0
56.0
94.0
112.0
150.0
168.0
206.0
Set Zero
47.5
70.0
117.5
140.0
187.5
210.0
257.5
Max
9.8
14.4
24.2
28.8
38.6
43.3
53.0
19.6
28.8
48.4
57.7
77.3
86.5
106.1
29.4
43.3
72.6
86.5
115.9
129.8
159.1
39.1
57.7
96.8
115.4
154.5
173.0
212.2
48.9
72.1
121.0
144.2
193.1
216.3
265.2
Level
60
70
80
90
99
Bar #
I
II
III
IIII
IIIII
IIIIII
IIIIIII
IIIIIIII
I
II
III
IIII
IIIII
IIIIII
IIIIIII
IIIIIIII
I
II
III
IIII
IIIII
IIIIII
IIIIIII
IIIIIIII
I
II
III
IIII
IIIII
IIIIII
IIIIIII
IIIIIIII
I
II
III
IIII
IIIII
IIIIII
IIIIIII
IIIIIIII
Min
55.3
81.5
136.8
163.0
218.3
244.4
299.7
64.5
95.1
159.6
190.1
254.6
285.2
349.7
73.7
108.6
182.4
217.3
291.0
325.9
399.6
82.9
122.2
205.2
244.4
327.4
366.7
449.6
91.2
134.4
225.7
268.9
360.1
403.3
494.6
Nom
Set Zero
57.0
84.0
141.0
168.0
225.0
252.0
309.0
Set Zero
66.5
98.0
164.5
196.0
262.5
294.0
360.5
Set Zero
76.0
112.0
188.0
224.0
300.0
336.0
412.0
Set Zero
85.5
126.0
211.5
252.0
337.5
378.0
463.5
Set Zero
94.1
138.6
232.7
277.2
371.3
415.8
509.9
Max
58.7
86.5
145.2
173.0
231.8
259.6
318.3
68.5
100.9
169.4
201.9
270.4
302.8
371.3
78.3
115.4
193.6
230.7
309.0
346.1
424.4
88.1
129.8
217.8
259.6
347.6
389.3
477.4
96.9
142.8
239.6
285.5
382.4
428.3
525.1
The tolerance is +/-3% of the Nominal Value. The Nominal value is calculated for each bar in steps of 0.95L and 0.45L
alternatively.
L- represents the set level value.
** Default level value in a new unit.
Peritron Owner’s Manual
20
Page 24
TARGET AND LEVEL VALUE RELATIONSHIP
Table represents relationship between Target value and Level value when the device is set to Target
mode.
Below Target
III
II
I
Formula
T-2L
-20
-15
-10
-5
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
T-1.5L
-15
-10
-5
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
T-L
-10
-5
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
T-0.5L
T+0.5L
-5
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
105
95
100
105
110
115
120
125
130
140
150
160
170
180
190
200
210
220
230
240
250
260
270
280
100
105
110
115
120
125
130
135
145
155
165
175
185
195
205
215
225
235
245
255
265
275
285
105
110
115
120
125
130
135
140
150
160
170
180
190
200
210
220
230
240
250
260
270
280
290
110
115
120
125
130
135
140
145
155
165
175
185
195
205
215
225
235
245
255
265
275
285
295
Less than
III bar
value on
the right
Target
Value
Above Target
On Target
IIII
I
II
III
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
105
110
115
T+L
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
105
110
115
120
T+1.5L
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
105
110
115
120
125
T+2L
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
105
110
115
120
125
130
120
125
130
135
140
145
150
155
165
175
185
195
205
215
225
235
245
255
265
275
285
295
305
125
130
135
140
145
150
155
160
170
180
190
200
210
220
230
240
250
260
270
280
290
300
310
130
135
140
145
150
155
160
165
175
185
195
205
215
225
235
245
255
265
275
285
295
305
315
135
140
145
150
155
160
165
170
180
190
200
210
220
230
240
250
260
270
280
290
300
310
320
IIII
Greater
than III
bar
value on
the left
Peritron Owner’s Manual
21
Level
Value
T
L
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
105
110
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
115
120
125
130
135
140
145
150
160
170
180
190
200
210
220
230
240
250
260
270
280
290
300
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
Page 25
Peritron Owner’s Manual
22