MSM ProMedico GmbH

SPHINCTOMETER Manual Jülicher Str. 338 a

52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

SPHINCTOMETER
- System -

- Measurement device for analtonometrie and perineometrie

- Trainings device for incontinence therapy and

Therapy of pelvic floor insufficiency

Version 1.51

Please see all accompanying documents before first use!

 MSM ProMedico GmbH

Jülicher Str. 338 a
52070 Aachen
Germany

Telefon: 0049-(0)241-96 82 -10 • Fax: 0049-(0)241-96 82-122

1
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

Inhalt
1 INTRODUCTION............................................................................................................................................... 4
1.1 MEASURED VALUES WITH THE SPHINCTOMETER ...................................................................................... 4
1.2 INTENDED USE .............................................................................................................................................. 5
2 MEDIZINPRODUKTEGESETZ ...................................................................................................................... 5

3 SYSTEM OVERVIEW SPHINCTOMETER/ SPHINCTOMETER-TRAINER ......................................... 6

3.1 OVERVIEW .................................................................................................................................................... 6
4 .................................................................................................................................................................................... 6

5 DESCRIPTION OF THE SYSTEM SPHINCTOMETER ............................................................................. 7

6 HANDLING OF THE SPHINCTOMETERS (DIAGNOSTIC DEVICE)..................................................... 9

6.1 PREPARATION OF THE MEASUREMENT (DIAGNOSTIC DEVICE ONLY)......................................................... 9
6.1.1 Check on water level of the Sensor .................................................................................................... 9
6.1.2 Correct the water fill level .................................................................................................................. 9
6.1.3 How to control the effective range ................................................................................................... 10
6.2 PERFORMING MEASUREMENTS .................................................................................................................. 10
6.2.1 Applying the single use protection ................................................................................................... 10
6.2.2 Handling sequence for measurements ............................................................................................. 10
6.2.3 Other buttons and functions............................................................................................................. 13
6.2.4 10 second mean value measurement ................................................................................................ 14
6.3 CHARGE LEVEL AND RECHARGING OF THE BATTERY ............................................................................... 14
6.3.1 Charge level display .......................................................................................................................... 14
6.3.2 Automatic switch off at discharged battery .................................................................................... 15
6.3.3 Recharging the battery ..................................................................................................................... 15
6.4 UNIT OF MEASUREMENT............................................................................................................................. 16
6.5 CHECKING THE MEASURE FUNCTION ........................................................................................................ 16
7 SPECIFICS OF THE SPHINCTOMETER-TRAINER ................................................................................ 17
7.1 TRAININGS DEVICE ..................................................................................................................................... 17
7.2 SIGNALISIERUNG ZUR UNTERSTÜTZUNG DES TRAININGS ........................................................................ 17
7.3 ENTER THE TRAINING PARAMETER ........................................................................................................... 17
7.4 TRAINING PROCEDURE ............................................................................................................................... 18
7.5 DATA TRANSFER TO THE PC ...................................................................................................................... 18
7.6 BRIEF INSTRUCTION FOR PATIENTS ........................................................................................................... 18
7.7 ENTERING TRAINING PARAMETER MANUALLY IN PROGRAMMING MODE ................................................ 19
8 HANDLING OF THE SPHINCTOMETER-TRAINERS DURING A TRAINING SESSION................. 21
8.1 PREPARATION ............................................................................................................................................. 21
8.2 SWITCHING ON THE TRAINER AN CONNECTING THE SENSOR ................................................................... 21
8.3 DISPLAYS DURING A TRAINING SESSION .................................................................................................... 22
9 USING THE SPHINCTOMETER/SPHINCTOMETER-TRAINER WITH A PC.................................... 23
9.1 INTRODUCTION ........................................................................................................................................... 23
9.2 HARD- AND SOFTWARE REQUIREMENTS ................................................................................................... 23
9.3 CONNECTION TO THE PC ........................................................................................................................... 23
9.4 MENU AND SYMBOL BARS IN “SPHINCTODAT” ......................................................................................... 24
9.5 ENTERING PATIENT DATA / MEASUREMENTS WITH THE SPHINCTOMETER ............................................. 25
9.5.1 Eintragungen am PC......................................................................................................................... 25
9.5.2 Measurements with the Sphinctometer ........................................................................................... 26
9.5.3 Measure data transfer (rest tonus and maximum contraction) .................................................... 26
9.5.4 Tranfering measure data (Online-Visualisation und Kurvenverlauf)......................................... 28

2
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

9.5.5 Editing measurements....................................................................................................................... 29

9.5.6 Analysis and graphical display of the course of pressure .............................................................. 30
9.6 THE SPHINCTOMETER-TRAINER CONNECTED TO THE PC ....................................................................... 31
9.6.1 Data of the Sphinctometer-Trainers on the PC .............................................................................. 31
9.6.2 Sending training parameter to the Sphinctometer-Trainer .......................................................... 31
9.6.3 Transferring the training results to the PC .................................................................................... 32
9.6.4 Analysing the training results on the PC......................................................................................... 32
9.7 PRINTING THE RESULTS FOR DOCUMENTATION ........................................................................................ 33
10 IMPORTANT NOTIFICATIONS............................................................................................................... 35
10.1 PERMISSIBLE DEVICE COMBINATIONS ....................................................................................................... 35
10.2 SINGLE USE PROTECTION AND LUBRICANT ............................................................................................... 35
10.3 OPERATING CONDITIONS ........................................................................................................................... 35
10.4 HOW TO HANDLE DAMAGED DEVICES........................................................................................................ 35
10.5 STEADY NON REPRODUCABLE CONTROLMEASUREMENTS ........................................................................ 35
10.6 BATTERY CARE AND EXCHANGE ................................................................................................................ 35
10.7 PROTECTION OFF HEAT SOURCES AND ELECTROMAGNETICALLY SENSITIVE DEVICEC. ......................... 35
10.8 CONTRA INDICATORS ................................................................................................................................. 36
10.9 SIDE EFFECTS AND RISKS............................................................................................................................ 36
10.10 CLEAN AND CARE ....................................................................................................................................... 36
10.11 CONTROL MEASUREMENTS ........................................................................................................................ 36
10.12 CHECK BY MANUFACTURER ....................................................................................................................... 36
10.13 GENERAL SAFETY GUIDELINES .................................................................................................................. 36
10.14 DISPOSE GUIDELINES.................................................................................................................................. 36
11 WARRANTY/CERTIFICATES.................................................................................................................. 37
11.1 WARRANTY AND LIABILITY ....................................................................................................................... 37
11.2 CE-SIGN ..................................................................................................................................................... 37
12 TECHNICAL INFORMATION.................................................................................................................. 37
12.1 FUNCTION AND STRUCTURE ....................................................................................................................... 37
12.2 TECHNICAL DATA ....................................................................................................................................... 38
13 MANUFACTURER/RESELLER................................................................................................................ 38
13.1 MANUFACTURER ........................................................................................................................................ 38
13.2 RESELLING / MAINTENANCE/ SENDING BACK ............................................................................................ 38
13.2.1 Sphinctometer (doctor’s device)....................................................................................................... 38
13.2.2 Sphinctometer-Trainer ..................................................................................................................... 38
13.2.3 Appurtenance .................................................................................................................................... 39
13.2.4 Rent devices ....................................................................................................................................... 39
13.2.5 Returning used or defect devices ..................................................................................................... 39
13.3 SERVICELINE .............................................................................................................................................. 39
14 ENCLOSURES.....................................................................FEHLER! TEXTMARKE NICHT DEFINIERT.
14.1 DECLARATION OF CONFORMITY BY MANUFACTURER .............................................................................. 39
14.2 CERTIFICATE (EG-CHECK) BY RWTÜV.................................................................................................. 39
14.3 BRIEF INSTRUCTIONS ON THE SPHINCTOMETER (DOCTOR’S DEVICE)..................................................... 39
14.4 BRIEF INSTRUCTIONS „REFILLING THE SENSOR WITH WATER“ ............................................................... 39
14.5 BRIEF INSTRUCTIONS ON THE SPHINCTOMETER-TRAINER (ENCLOSED IF APPLICABLE) ........................ 39
14.6 MANUAL SPHINCTOMETER-TRAINER (ENCLOSED IF APPLICABLE) ......................................................... 39
14.7 VALUE TABLE (SEPARATE PAPER).............................................................................................................. 39

3
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

1 Introduction

1.1 Measured values with the Sphinctometer

The Spinctometer allows the evaluation of the pelvic floor muscles through vaginal and of the sphinctermuscles
through anal tension measurements.

The measured values can be read off the device after inducting the specific sensor in the anus (sensor A)/ the vagina
(sensor B).

The following table shows norm values of healthy persons of different age.

Pressure ca. Females Males Elucidations of device display

Tension / mmHg 40 - 60 60 ARD: relaxed anal pressure
Contractionpressure / mmHg 100 150 AMD: maximum anal pressure

Normalw ertverteilung bei kontinenten Frauen Normalw ertverteilung bei kontinenten Männern
Meßmethode Sphinctometer Meßmethode Sphinctometer
MSM Promedico MSM Promedico

250
250

200 200
[mmHg]

150
[mmHg]

150

100 100

50 50

0 0
Alter
10 - 20

20 - 30

30 - 40

40 - 50

50 - 60

60 - 70

70 - 80

80 - 90

10 - 20

20 - 30

30 - 40

40 - 50

50 - 60

60 - 70

70 - 80

80 - 90

Alter

Basistonus Basistonus
Willkürkontraktionskraft Willkürkontraktionskraft
Anzahl Patienten Anzahl Patienten

The Spinctometer effective range is between 0 and 300 mmHg.

Please use the Sphinctometer-Trainer for patient training. The effective range of this device is up to 250 mmHg.
Please see also chapter XXX of this instruction manual for detailed information on the Sphinctometer-Trainer.

4
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

1.2 Intended use

The system Sphinctometer is meant to be used in doctor’s surgerys, clinics and sanatoriums. The handler has to
know the instruction manual, and has to be introduced to the device. In case the device is used together with a
computer and the program SphinctoDat the patient has to be alluded that his data can be saved. Handicaped persons
may need further support during the examination. Please keep the Sphinctometer away from children.

2 Medizinproduktegesetz
Das System Sphinctometer unterliegt als Medizinprodukt der Richtlinie 93/42/EWG über Medizinprodukte und dem
Medizinproduktegesetz.
Durch die Klassifizierung gilt folgende Einordnung:
Der Meßsensor (Anwendungsteil) des Sphinctometers ist Klasse IIa (Regel 5) zuzuordnen.
Der Meßsensor wird mit dem Grundgerät betrieben, das der Klasse I zuzuordnen ist (Regel 12).
Unsere Geräte werden nach der Richtlinie 93/42/EWG in Einzelprüfung einer EG-Prüfung unterzogen, die von der
Benannten Stelle RWTüV Essen durchgeführt wird und uns zum Anbringen des CE-Zeichens berechtigt.

Damit stellen wir Ihnen optimal vorbereitete Geräte zur Verfügung.

5
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

3 System overview Sphinctometer/ Sphinctometer-Trainer

Sphinctometer/-Trainer
Handgehäuse
PC

Sensor bereit LED Trainingsanzeige

(nur Sphinctometer-Trainer)
Start drücken
V

3 4

1 2
Ein/On

5
PC-Anschlußkabel
serielle Schnittstelle

LED Ladekontrolle

Meß –
Sensor

Buchse Meß- Buchse PC-

Sensor Schnittstelle
Tastaturlegende: 1 Ein/On
2 Betätigung/Enter
3 Senden/Send (PC)
4 Aus/Off
5 Ton/ Sound (nur aktiv beim Sphinctometer-Trainer)
[Funktionen nur, wenn Tasten aktiv]

3.1 Overview
The image shows the Sphinctometer hand device, the sensor and a serial connection to a computer. The sensor is
connected to the left connector. The data cable is connected to the right connector. Both connections are designed to
fit only in the right way. The Sphinctometer is delivered with a desk stand with an integrated power supply unit. The
battery is charged automatically when the hand device is in the desk stand. All this is applicable on the
Sphinctometer-Trainer, too.

3.2 Dogging Station

Sphinctometer
(Handcase)

Dogging Station

6
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

4 Description of the system Sphinctometer

The Sphinctometer is composed of the hand device with the sensor. The associated desk stand is concipated a
storage place where the battery is recharged.

Types:
The Sphinctometers is offered in two versions:

1. Sphinctometer (doctor’s diagnosis device)

2. Sphinctometer-Trainer (Therapy device)

To 1.: The Sphinctometer as a diagnosis device allows quick and precise measurements. The measured values can
be transferred to a PC. This allows easy documentation and data storage. To use this function the software
„SphinctoDat“ by MSM is needed. Of course the Sphinctometer can be used without the software.

To 2.: The Sphinctometer-Trainer in concipated as a training device. It can be used ambulant, at home, in
rehabilitation centres, etc. The device is based on a Biofeedback-base. It has a light signal and an optional audio
signal asking the patient to squeeze. It does also have a PC interface, which allows the user to enter training data
into the Trainer, and to transfer the training results from th trainer to the PC.

Sphinctometer and Sphinctometer-Trainer are struckturally identical but differ in function.

Hand device:
The Sphinctometers/ Sphinctometer-Trainers is handled with the five-button-keyboard. The integrated display
shows enter requests as well as measured data.

The device has the following interfaces:

• LCD – Display
• Button ON (lower middle)
• Button ENTER (upper middle)
• Button SEND PC (upper left)
• Button OFF (upper right)
• Button SOUND (lower right, active only at the Trainer)

To switch on the device please press the “ON” button. All active buttons are marked with a “V”. Please follow the
screen notifications. The display leads automatically through the measure or training programme. You handle the
sensor and meanwhile press the particular buttons as indicated by the screen.

Working with the Sphinctometer always follows the same course:

• Connect the sensor
• Sensor ready (the sensor is calibrated now – please make sure no pressure is applied to it)
• Insert sensor
• Start measurement
• Measure rest tonus and maximum contraction force
• Read off measured values
• If applicable: Send data to the PC
• Start new measurement or switch off device

The button marked with a speaker symbol turns the sound on or off.
It is not possible to cancel the procedure once started. This makes sure no data is lost accidentially.

Note: When the screen shows the notification “Sensor Not Ready” the pressure inside the sensor is too high. . ‚In
this case please see the brief instructions “refilling the sensor with water”.

7
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

Sensor A for analtonometrie:

The sensor A is the component used for analtonometrie and training.
It is made of a plastic handle and a silicon tube. This sensor with a cone head is inserted ito the patient’s anus after a
one way protection has been applied to it.
The protections avoids a pollution of the sensor. It has to be renewed with every new patient. The sensor is
connectet with a flexible cable to the hand device.

Sensor V for perineometrie:

The sensor V is another component of the Sphinctometers/-Trainers used for Perineometrie and training of the
pelvic floor muscles.
The only difference to sensor A is its form. It is used in the same way.

Controle measurements with the measure clips:

To perform a control measurement to check the full function of the Sphinctometer (doctor’s device) please use the
enclosed measure clips. For further information please see paragraph 6.5 of this manual.

Power supply:
Sphinctometer and Sphinctometer-Trainer are run by the integrated battery. Both devices have an automatic switch-
off-function to save power. Completely charged the device is operable for at least two hours. To make sure the
Sphinctometer is always operable please put it back to the desk stand where it is recharged when your measurement
is done. The desk stand has the necessary qualification according to DIN EN 60601.

Datatransfer from/to the PC:

The Sphinctometer/ -Trainer is designed for a use with the PC (although it can as well be used without one).
For further information please see paragraph 9 – 9.7

Desk stand
Sphinctometer and Sphinctometer-Trainer werden are delivered with a desk stand. This desk stand has a power
connector (230V) and functions as charging device. Please put the Sphinctometer/ -Tainer back on th desk stand
when you finished using it.

8
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

5 Handling of the Sphinctometers (diagnostic device)

In the following paragraph you will find some instructions on the handling of the Sphinctometer and the
Sphinctometer-Trainer.
For information on the measure procedure please see paragraph 5.2

5.1 Preparation of the measurement (diagnostic device only)

Please connect the sensor cable to the left connector of the hand device. Now please check if the battery of the hand
device is charged sufficiently. The green light in the lower right corner indicates the state of charge. New or long
time unused devices have to be charged for at least 4 hours before use. Please make sure the desk stand is connected
to a socket (230 V).

5.1.1 Check on water level of the Sensor

Before measuring is has to be checked if the sensor is filled with water sufficiently. In order to do so please open the
screw top located at the handle of the sensor. Please use a syringe to fill in tap water (better distilled water) as
bubble free as possible. It should be at room temperature. It may help to squeeze the tube in order to get the last
bubbles out. Please close the screw top slowly, so the superfluous water can pour out. Please check if the gasket is in
the right position. While closing the sensor make sure to hold it at the white handle, only. Now you can switch on
the Sphinctometer (Button EIN/ON). If the pressure in the tube is small enough the display shows that the sensor is
ready.

Sensor Ready

Push Start
V

5.1.2 Correct the water fill level

If the pressure in the tube is too high it may occur that the Sphinctometer is not able to ‘find’ the sensor. In this case
the following notification will be displayed:

Please Connect

Sensor

Please loose the screw top at the handle of the sensor, so that the tube can release the superfluous pressure. Now
hold the sensor so, that no pressure is in the tube, and that no water can pour out. Now the sensor can be ‘found’ by
the Sphinctometer. Please press the Enter button twice (please ignore the notifications “Sensor ready“ and “Induct
Sensor“. Now you can see the measured values on the display.

9
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
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mmHg
150 – 15 mmHg
100 –
50 –
0 –----------------------
done

The current pressure is now 0 mmHg. Now please slowly fasten the screw top again. The pressure may rise to
maximum 25 mmHg. Should the pressure be too high please consider to loosen the screw a little or to slightly
squeeze the tube before closing it. These measures help to adjust the sensor to a value of 10-15 mmHg when lying
horizontal on the desk. Now please switch of the device by ending the measurement, then select “no“ and finaly
press the off button.

5.1.3 How to control the effective range

To assure that the whole pressure range is measureable please check the maximum pressure that can be measured.
To do so perform a measurement as described in paragraph 6.2 “Performing measurements”. At the same time
please check the tightness of the system. Use your fingers to squeeze the tube. Please try to cover a similar area the
sphinctermuscle would cover. A pressure of about 300 mmHg should be displayed to cover the full range. No water
must pour out of the whole system. If the pressure is to low please repeat the filling ob the sensor as air bubbles may
be the reason for low pressure. Another potential source of error is that the pressure after fastening the screw top is
higher that 25 mmHg (sensor lying horizontally). After long time use the silicontube may also change its elasticity.
In this case the sensor has to be renewed. Please send the whole device back to the manufacturer.

5.2 Performing measurements

5.2.1 Applying the single use protection

To perform a measurement please apply a sinlge use protection on the sensor. Please make sure the whole sensor is
covered, to avoid a contamination. As protection latex hulls for ultrasonic sensors can be used (e.g. by the company
MAPA, Zeven, Art.-Nr. 11.150.023). You can find further hints in paragraph 9.2

5.2.2 Handling sequence for measurements

Connect the sensor to the hand device and press the “on” button.

The display shows:

Sphinctometer

If the sensor is not connected yet you are now asked to do so. In case the device still show “connect sensor” please
proceed as described in paragraph 5.1.2

10
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
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Please Connect

Sensor

When the sensor is connected properly the display shows:

Sensor Ready

Push Start

To proceed press the enter button. It is marked by the “V”.

IMPORTANT: The sensor must not undergo any external pressure as in this phase the sensor is calibrated.
Please put the sensor into a horizontal position, or to a similar position in which the measurement will later
be performed.
By doing so you avoid a value falsification through the own weight of the water.

Please wait until the display shows a new notification.

Measurement

Insert sensor

done

Now stick the latex tube part of the sensor which is covered by the single use protection up to the handle into the
anus.
Hold the sensor now, and keep it in a neutral position so the values are not falsificated by the own weight of
the sensor.
Start the measurement whent the sensor is in the right position.

To do so press the enter button (the middle one) over which the display shows “proceed”.

Now the values are measured continuosly. You can now read the current values off the display. The unit is mmHg.
The values of the last 15 seconds are displayed as a curve for orientation purposes. Please ask your patient to
squeeze in order to create pressure..

11
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
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mmHg
150 – 54 mmHg
100 –
50 –
0 –----------------------
done

When the patient has applied his maximum pressure let him relax again to see the course of pressure on the display.
Is the minimum tone reached end the measurement by pressing the enter button.

Note: The minimum and maximum values are being saved. In practice it turned out to be useful to first measure and
document (either by hand or PC) the relaxed and maximum pressure, and then in a second measurement all other
functions (e.g. pressure during coughing, pressure over a certain period of time etc.)

IMPORTANT:
During the whole measurement process the position of the sensor must not be changed! When the
measurement i finished press the enter button BEFORE you begin to remove the sensor. Otherwise the data
can be falsified.

Now you have the option to do a mean value measurement. By pressing “yes” the pressures applied in the next 10
seconds are averaged.
Please see also paragraph 5.2.4 “10 second mean value measurement”

Mean Value

Averaging 10 sec

yes no

If you do not wish a mean value measurement simply press the “no“ button. On the display you can now see the
minimum pressure (ARD) and the maximum pressure (AMD) of the current measurement:

ARD: ...... mmHg

AMD: ...... mmHg
Mean: ...... mmHg
Send New off
V V V

This is the result of your measurement.

To check the result a second measurement can be conductive. Simply press the “new” button.
Please make sure the sensor is in the right position.

12
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
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5.2.3 Other buttons and functions

To send the measured data to a PC you have to connect the data cable to the Sphinctometer (you can do it after the
measurement or before). If you do not use a PC for data storing please note the values and proceed to the next
measurement or switch off the device.

The buttons you can see in the display have the following meaning:

Send PC (Button SENDEN/SEND PC):

Curent measured data can be saved on a PC. To do so please use the data cable an the
Software “SphinctoDat”.
Please see paragraph 8 for more information.

new (Button ENTER):

You get back to the start display and can start a new measurement after pressing the enter
button.

Measurement

Insert Sensor

done

off (Taste AUS/OFF):

Pressing this button switches the Sphinctometer off. Please put it back to the desk stand.

If no other measurements are necessary please remove the sensor and the protection hull. For cleaning and
disinfecting please see the clean and care paragraph of this manual (10.10)

Important information:

The measurement has to be started and ended while the sensor is in the anus. Otherwise the measured data
can be falsified.

Furthermore we recommend to do several measurements to obtain reproducible results. Doing so please check the
correct fit of the sensor, again.
You will be familiar with the procedure within short time

13
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
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5.2.4 10 second mean value measurement

Subsequent to the normal measurement is is possible to do a 10 second mean value measurement. If you wish to
perform such a measurement simply press the “yes” button when the disply shows “Mean value 10 sec”

Mean Value

Averaging 10 sec

yes no

All values measured within the next ten seconds are now being averaged. The result is presented in th third line
under “Average.

ARD: ...... mmHg

AMD: ...... mmHg
Mean: ...... mmHg
Send New off
V V V

Information on the 10 second mean value measurement:

Unusualy low values for the rest tonus can have th following cause:
When the patient is asked to relax in order to measure his rest tone he may reflectively detente his sphincter muscles
an due to this let the values sink. As the Sphinctometer always takes the lowest value as rest tone it may be useful to
do a 10 second mean value measurement in order to get an objective rest tone value

5.3 Charge level and recharging of the battery

5.3.1 Charge level display

You can see the chargelevel of the battery in the upper right corner.

T T T

blinking

Battery charged Battery at 50% Battery discharged

Is the battery discharged the Sphinctometer is no more operable. The device has to be put back on the desk stand and
be recharged. It is advisable to keep the device charged. Otherwise it may not be operable for long time use.

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5.3.2 Automatic switch off at discharged battery

When the akkumulator is discharged too much the disply will show a notification that charging is necessary and
following the device will switch off automatically.

Please Recharge
Battery
o

The device is operable again when the battery is recharged.

5.3.3 Recharging the battery

Put the Sphinctometer (or the Sphinctometer- Trainer) on the desk stand when the measurement is finished and the
device is switched off. To recharge the device please check if the desk stand is connected to the electric circuit
(230V).
Please disconnect the desk stand from the power supply when the Sphinctometer is charged and you are not going to
use it in short time. When long time unused the Sphinctometer has to be recharged before reuse.

When the charge control LED (green light) in the lower right corner of the desk stand is on, the Sphinctometer is
currently being charged.

Charge control LED

After putting the Sphincotmeter on the desk stand the green light in the lower right corner of the desk stand indicates
the state of charge.

1. LED blinking: Normal-charge: Battery is charged normally.

If the light does not stop blinking within 5 hours and still is discharged the
battery is defect.

2. LED shines steadily: Quick-charge: Battery is charged quickly.

3. LED blinking: Battery is charged: Battery is charged completely.

If the battery is not discharged completely it will recharge in quick charge mode.

Important:
If the light should stay blinking without shining steady for more than 5 hours the device has to be returned to the
manufacturer. You can recognize the state of complete dischargement at the almost invisible output on the display.

Possible sources of error when LED does not shine:

• The desk stand is not connected to a 230V electric circuit.

• The Sphinctometer has not been put on the desk stand correctly.

IMPORTANT: Opening the Sphinctometer or the desk stand must only be done by the manufacturer or
authorized personel. Batteries must not be taken out or changed by the user.

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5.4 Unit of measurement

The Sphinctometer measures the pressure in mmHg. The following table shows some conversion factors.

Pa (Pascal) = 1 N/m²

mmHg 10 50 100 150 200 250 300

hPa 13,33 66,66 133,32 199,98 266,64 333,31 399,97
Pa 1333 6666 13332 19998 26664 33331 39997
= N/m²

5.5 Checking the measure function

The Sphinctometer is delivered justified and calibrated. The measure precision is ± 4 mmHg. The high quality
mechanical components guarantee properly used a high durability and precision. Nevertheless it is usefull to check
the correct function of the Sphinctometer from time to time. To do so please use the enclosed measureclips and
compare the measured values with those given in the table (13.7). Is there a high deviation of the values there Is not
enough fluid in the sensor. Please refill the sensor as described in paragraph 13.4 “refilling the sensor with water“.

Note: The Sphinctometer-Trainer does not has to be checked, as it is filled with air.

Sketch of the check with the measure clip:

Clip

Sensor

The clip is positioned in the middle of the tube!

Course of control measurement:

1. Check the sensor on air bubbles. Refill water if necessary.

2. The sensor must lie freely, or be in the desk stand.
3. Now switch on the Sphinctometer. Please do not touch the sensor in this phase.
4. Start a measurement with the Sphinctometer.
5. Apply the clip in the middle of the tube during a measurement.
6. Please note down the measured value and compare it to the values given in table 13.7

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The measured value must equal the reference value range within the scope of measure precision given by the
manufacturer. See table (13.7).
Should there be higher deviations that can not be corrected by refilling the sensor it has to be send back to the
manufacturer to be checked. In case of asymmetric sensor tubes there can occur deviations due to sensor position.
The values apply for water and oil filled systems.
The control measurement is meant to debare a malfunction of the Shinctometer and is an optional additional
security.

6 Specifics of the Sphinctometer-Trainer

6.1 Trainings device

The Sphinctometer-Trainer is concepted as trainings device for the patient. It allows the patient to do an effective
training programme with an included performance check. Easy handling and patient specific programmability
through the doctor excel this device.

6.2 Signalisierung zur Unterstützung des Trainings

The trainings device has a yellow light right under the display and a vibration feature. These acoustic and visual
signals indicate when the patient has to squeeze and when he can relax. Additionally the display shows a bar which
enlarges proportionally to the contraction power. After some training sessions the patient should not concentrate on
the bar but on the training process itself. The acoustic and optic signals are ment to indicate the durance of sqeezing.
The achieved squeeze power remains visible on the display. This sort of training helps to sensitize the patient for his
pelvic floor and sphincter muscles.

6.3 Enter the training parameter

The doctor can enter patient specific training parameter.

To do so press the left and the right upper button at the same time, and hold them for about 3 seconds. If you now
choose “enter training parameter“ and subsequently “manual“ you can enter the specific training data.
Another way to enter the training data is by PC. This happens with the help of the software “SphinctoDat“ and will
be explained in paragraph 8.

Training data that is entered is:

• Squeeze durance / Sec.

• Rest durance / Sec.
• Training pressure / mmHg
• Number of squeeze cycles

To enter the training pressure please note:

You have to enter the desired pressure between rest tone and target pressure (100%). Please note that the effective
increase of pressure is between rest tone and target pressure.

Example:
- Rest tone: 20 mmHg
- max. contraction power: 70 mmHg
- Trainingszieldruck: 35 mmHg
- Training pressure: 15 mmHg This value has to be entered for 100%!

To let the patient train with 50% of his maximum contraction power, what is in this example 35 mmHg as training
pressure 15 is entered. This is the difference between rest tone and the desired training pressure.

17
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except Trainer) Fax: 0049-(0)241-96 82-122
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6.4 Training procedure

The training procedure follows this course:

• Connect the sensor to the hand device. (left connector)

• Switch on the device
• Follow the menu
• Stick the sensor in.
• Squeeze and relax according to the given cycle an target value

The device switches off automatically when the training is finished. The instructions given to the patient must be to
try to push the bar (which fills almost the complete display when the target pressure is reached) up to the last third.
The sketch shows the bar. Pressures a little higher than the target pressure are displayed, too.

Rest tone Target pressure Over target pressure

Rest tone - Target pressure

110% (Rest tone – Target pressure )

The performed squeeze power remains visible throughout the training procedure for orientating purposes.

6.5 Data transfer to the PC

The training parameter can be transferred directly from the patients file to the Sphinctometer-trainer with the help of
“SphinctoDat”.

Furthermore it is possible to transfer the training log files from the Sphinctometer-trainer to the PC. This allows the
doctor to check the training and evaluate the success of the training procedure. Statistics and graphs contribute to
cleanliness and allow a good evaluation.

6.6 Brief instruction for patients

Enclosed you will find a brief instruction that shows the most important steps in the course of the training procedure.
Apart from that all points you find in the Sphinctometer manual account for the Spinctometer-trainer. One important
feature is that the trainer’s sensor is not filled with water, but with air.
The patient has to be introduced to the device by the doctor or an assistant. All relevant points of the manual have to
be motioned to guarantee a successful and safe treatment. Especially safety guidelines have to be explained. The
patient can get a full length manual if he desires to have one, which does not contain e.g. the programming
guidelines.

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6.7 Entering training parameter manually in programming mode

After switching on the device you can enter the programming mode. To do so please press the upper left and right
button at the same time and hold it for about 3 seconds.
In the programming mode you see the following displays. (The values are for explanation purposes only)

First you see the number of training session the patient performed. In the second column you see how many sessions
have been successful.

Number: 14
positive: 12
done
V

Number: 14 14 training sessions have been performed by the patient.

positive: 12 At 12 of 14 sessions he achieved more than 50% of the target pressure (Training target
(100%) – rest tone).

With the ”done“ button you come to the next screen.

Send Training
Results ?

yes no

By pressing “Yes“ the saved data is send to the PC. For more information please see the following paragraph. If no
PC is connected please press “no”.

“Yes” the saved data is send to the PC

“No” proceeds to the next screen

Enter training data:

receive manual
V V

Now you can choose between:

”receive“ If the PC is connected the training parameter can be transferred from the patient’s file to
the training device.
”manual“ If you choose manual input you see the following screen:

Squeeze durance: 6 s

- done +
V V V

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By pressing “+” or “-“ the squeeze durance is changed in steps of one second. When the desired squeeze durance is
reached please press “done” to proceed.

The other parameters are entered in the same way:

Relax durance:

Relax: 3 s

- done +
V V V

Training pressure:
(Target pressure (100%) – rest tone)

Tr. pressure: 50 mmHg

- done +
V V V

Please note that the training pressure is the difference between rest tone and target pressure (100%).

Squeeze cycles:

Squeeze cycles: 20

- done +
V V V

Finally you can delete the training results that are saved in the trainer:

Delete training results?

yes no
V V

When you are done the device switches off automatically.

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7 Handling of the Sphinctometer-trainers during a training session

7.1 Preparation
Important information for the preparation of a training can be found in the “brief guidelines for the Sphinctometer
trainer”, which you find enclosed. It is meant to be given to the patient. After the patient has come to his exercise
position an the trainer and sensor is prepared the training can start.

7.2 Switching on the trainer an connecting the sensor

Single use protection and optional attachment clips have to be applied to the sensor. The trainer with the connected
sensor is taken off the desk stand. The sensor has to lie freely without any pressure being applied to it. Now the
device is switched on with the green “On” button.
Now the start screen appears.

Sphinctotrainer

Now it is checket if the sensor is connected properly.

Please connect
Sensor

When the device is ready this screen appears:

Insert Sensor

Push Button
V

Now please insert the sensor. To start press the middle upper button.

Note:
In case the sensor is not found please check if the correct sensor has been connected. To do so please compare the
serial number which you find in the packaging note. Furthermore you can try to open the screw top of the sensor for
a short time and then close it carefully. If the sensor is still not found please phone our service line.

Note:
After two minutes the device swtches off automatically, thus the training should start within those two minutes.
After an automatic switch-off the sensor has to be removed again.
To restart the trainer please put the sensor on a plain surface.

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7.3 Displays during a training session

The training session follows the trainings data entered by the doctor. The number of training cycles is displayed and
counted down in the course of the training session. Each cycle comprimese of one relax- and one catraction phase.
The patient can recognize the contraction phase by the yellow light an the sound. The sound can be turned off as
well. To switch it off or on press the speaker button right to the “on“ button.

This is how the last three cycles of a training session look like:

Relax Squeeze

Cycle: 3 Cycle: 3

Relax Squeeze

Cycle: 2 Cycle: 2

Relax Squeeze

Cycle: 1 Cycle: 1

During the relax phase a bar signalises the reached compression. The bar length during the squeeze phase should be
more than 50% of the full length. Each cycle fulfilling this criteria is marked a “passed”.

If more than 50% of the trainings cycles were “passed” the display shows a praise before it switches off
automatically:

Well done ! ! !

Important:
If a second training session shall be performed at once the sensor first has to be removed from the body as the
sensor is calibrated before each session. Again it has to lie on a plain surface.

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8 Using the Sphinctometer/Sphinctometer-Trainer with a PC

8.1 Introduction
The Sphinctometer allows to perform measurements without using a PC. For further diagnostics and to build up a
patient database we recommend to use the Sphincotmeter with a PC. The Sphintcotometer-trainer can also be
connected to a PC. Here you can send the training parameter from the patien’s master file to the trainer, and in the
other direction get the training data of the training sessions the patient performed into your PC database. The trainer
can save 200 training session with up to 250 cycles that can be transported to the PC at the doctor’s. The
documentation duty can be dealt with by simply printing the result protocol.
You can perform measurements while the Sphinctometer is not connected to a PC and thus move around freely.
Simply connect the cable when you want to transport the measured data to the PC. In normal surroundings the cable
length should be enough to use the Sphinctometer stationary.

8.2 Hard- and Software requirements

To use the software you need at least:

• Windows 95/98 compatible PC,

• Windows 95/98 or WIN NT- operating system,
• Software „SphinctoDat“ by MSM,
• Sphinctometer and a data cable for a serial PC connection,
• Optionally: A printer to print the results.

The Sphinctometer is delivered with the data cable for the serial COM-interface of the PC if the software
“SphinctoDat” has been ordered.

8.3 Connection to the PC

The structure and installation of the necessary components is very easy.

• First install the Software ”SphinctoDat“ which is located on the floppy-disk.

• Connect the enclosed Cable to the Sphinctometer an the serial COM-interface of your PC
• Connect the sensor to the Sphinctometer.

Start the installation by opening the file “setup.exe” located on the floppy-disk. Now following files are copied to
your computer:
- SphinctoDat.exe (Programme file)
- Pat-db.scd (Patient database)
The installation program runs self-reliant. Please follow the notifications and enter the needed data into the window.

Please connect the datacable to the Sphinctometer (right connector) and the Computer (serial COM port).

Please start the program by opening “SphinctoDat.exe“ either directly from the desktop or the explorer.
After starting the software you have to fill in which com port you use. To do so please click on => EDIT =>
SETTINGS and fill in e.g. “COM1” or “COM2”.

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8.4 Menu and symbol bars in “SphinctoDat”

In the menu bar you adjust all necessary settings and execute the different program functions.

You can execute the following actions among others:

Command in the menu bar Description

File -Database -New Create new patien database.
-Open Choose and open patient database
(patient database contains data of many patients.)
-Save Save current database under a current name.
-Save as ... Save database under a different (new or old) name.
-Print Print database on the connected printer.
-Seitenansicht Preview of the printable pages with adjustoptions.
-Install printer Installation of a printer

Edit -Settings Please enter here which COM port you use (COM1 or COM2)
-neuen Eintrag Creates a new patient file in the current patient data base.
anlegen
-akt. Eintrag Deletes the current patient file.
löschen Attention: All measurements are deleted!
-erster Patient Here you can choose a patient from you patient list. The
-Eintrag zurück commands “first patient”, “next entry” “previous entry” and
-Eintrag vor “last patient” can also be activated with the four arrow keys.
-letzter Patient

View -Symbolleiste Show/hide symbol bar

-Statusleiste Show/hide status bar (comment at the window bottom)
-Patientenliste Show/hode additional window with the patient list.

Some commands can be activatet with the help of buttons placed under the menu bar. Following functions can be
activated this way:

Save

New patient file

Delete patient file (ATTENTION: All measurements are deleted!)

Arrow keys to choose patient from the patient list

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Show/hide patient list

Search patient by name

Print patient data (including measurements)

8.5 Entering patient data / Measurements with the Sphinctometer

In general sending measured data from the Sphinctometer to the PC looks like this:

8.5.1 Eintragungen am PC
In the patient database “pat-db.scd“ you first have to create a patient file. To do so please click on this button:

Please enter all needed data into this file. If you created the specific patient file before you can of course open this
one. Please use the arrow keys in the symbol bar or the search function.

After clicking “NEW MEASUREMENT” a window called “Measurement” opens. Now you can carry out your
measurement with the Sphinctometer.

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8.5.2 Measurements with the Sphinctometer

Now you perform a measurement on the patient. When all data is measured please connect the datacable to PC and
Sphinctometer if this did not already happen.
Please click on the “READIN” button. Now the PC waits for about 30 seconds for data coming from the
Sphinctometer. You should also see a counter next to the button “READIN” counting down from 60. If you could
not transfer any data until this counter reached zero please click „READIN“ again.
On your Sphinctometer you have to press the “SEND” button after the measurement.

AMD: .....mmHg
ARP: ......mmHg
Mean: .......mmHg
send new off
V V V

8.5.3 Measure data transfer (rest tonus and maximum contraction)

The data transfer is carried out automatically Both PC and Sphinctometer show a notification when the data has
been transferred successfully.

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READIN

Activate Online-Visualisation

If the current measured data is not useful simply perform a second measurement to overwrite the measured data.
Are the measured values ok you can finish the value entry by clicking the “OK” button.

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8.5.4 Tranfering measure data (Online-Visualisation und Kurvenverlauf)

During a measurement you can visualise the values on the PC. To do so please make sure that you activatet “Online-
Visualisation” before clinking on “reading”. Please click “reading” next. After starting the measurement on the
Sphinctometer you have to can now see the graph of the measured values on the screen. The bar and the number in
the upper right corner show the current pressure.

Measure bar
Measured pressure in mmHg

Course of measurement (different

visualisations availlable)

Status information

To finish a measurement please press the “Stop Measuring” button on the Sphinctometer.

MmHg
150 – 54 mmHg
100 –
50 –
0 –----------------------
Stop Measuring

While the PC ist waiting for the final results you can choose to do a mean value measurement on the Sphinctometer.

Mean Value

Averaging 10 sec

yes no

ARD: ...... mmHg

AMD: ...... mmHg
Mean: ...... mmHg
Send new off
V V V

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When you finished measureing please press “send“ on the Sphinctometer. The PC monitor will show a notification
that the data has been transferred successfully. You can finish the data transfer by clicking “Ok” If you want to
perform further measurements please press “new” on your Sphinctometer. The procedure is now the same.

8.5.5 Editing measurements

Click on a measurement in the lower subwindow.

For better orientation the data base entry are marked by:

- Running numbers
- Date of measuring rsp. date of data transfer
- Rest tonus and maximum Contraction force
- Availlability of training results (yes/no)

To edit a measurement simply double click it, oder click “Edit Measurement”.

Above: Patient file

The button “Delete Measurement” allows you to delete the selected, or the active measurement.

Attention: Please do not mix up this delete function with the command “delete current patient” which deletes the
current patient file including all measurements!

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8.5.6 Analysis and graphical display of the course of pressure

You can open an analyse any saved measurement at any time. If the values have been recorded in the online
visualisation mode you will also see the course of the measurement. To open a certain measurement please select it
in the patients file and click on “Edit Measurement”.
To get a better impression of the measurement course please click on “Extended View”. You can now read off any
value with the help of the mouse. If you move the mouse to a specific point in the graph you will find the current
values displayed under the x-axis named “Measurements”. The pressure value in mmHg can be read off the y-axis.
Another feature are the red bars which help you reading of th exact values. Please double-click on the desired
position a little below the x-axis and a red bar will appear. You can grab it with the left mouse button and move it to
any position you want. If you should need a second bar please proceed as before.
To zoom in grab one corner of the window an stretch it until it serves you needs. To move the window grab it at the
bar at the top (next to “Measurement-Course”).

The next paragraph will inform you about the possibilities the Sphinctometer-Trainer offers to you.

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8.6 The Sphinctometer-Trainer connected to the PC

8.6.1 Data of the Sphinctometer-Trainers on the PC

If you select and edit a measurement you will see the data recorded in the specific measurement. The lower part of
the window is used for the Sphinctometer-Trainer entries. On the left side the doctor can enter the training
parameter, while the right side displays the training results.

The training device Sphinctometer-Trainer is connected to the PC in the same way as the Sphinctometer. The data
connection allows you to transfer the training parameter from the PC to the device, and on the other way the training
results from the Device to the PC.

8.6.2 Sending training parameter to the Sphinctometer-Trainer

The patient specific training parameter can be transferred with the PC-Software „SphictoDAT“ from the PC to the
„Sphinctometer-Trainer“. The following data is transferred:

- Squeeze durance /s
- Relax durance /s
- Training goal /mmHg (= Zieldruck – Ruhetonus, zur Einstellung s. Abschnitt 6.4)
- Number of training cycles per training session

The picture above shows the window where the data is entered (lower left part).
To carry out the data transfer please select “receive ” when you are asked to enter the training data in the
programmers mode in the Sphinctometer trainer.

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Enter training
data:
Receive manual
V V

Note: To get into the programmers mode please press the upper left and the uper right button at
the same time shortly after you turned the device on.

When the Sphinctometer trainer is ready to receive the training data please click the send button. There will be a
notification on the PC that the data transfer ws successful if everything was done correctly:

8.6.3 Transferring the training results to the PC

The data transfer from the Sphinctometer-trainer to the PC is quite similar.

You will find a screen showing “send training results“ in the programmers mode of the Sphinctometer-Trainer. By
pressing yes the data transfer to the PC is startet.

Send training results ?

yes no

Now please press the “readin” button on the PC. Shortly after this there should appear a notification that the data
transfer was successful.
Please make sure that you associate the training results to the right measurement by selecting the correct one before
transferring the training results.

8.6.4 Analysing the training results on the PC

The results are visualised in a graph. The results are subdivided in three classes. The citeria is the achieved pressure
during the squeeze procedure.:

Classes: Good: T > 75 % x TP

Moderate: T > 40 % x TP
Bad: T <= 40 % x TP

0 mmHg ------------------------------------- R----------------------------------T-----------------TG(100%)—TG(110%)

Training pressure TP

T = Achieved training pressure (Difference to the rest tonus)

R = Rest tonus
TG(100%) = Training goal (100%-Value of the bar in the display)
TP = Training pressure (entered parameter = effective measured pressure = TG(100%)– rest tonus R)

32
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

Remember: TP = entered training goal parameter for the Sphinctometer-Trainer.

The parameter TP is the difference between the measured Value TG(100%) and the rest tonus R

The result of this evaluation is displayed on the PC monitor.

If you click on “extended view” a new window will open where you can differenciate the training result more
exactly.

Picture: Graph showing the training results. Differenciation according to the three classes (good, moderate and bad)

The extended view shows how successful the different training sessions were. You can also choose which classes
are displayed.

The value training days is calculated automatically. It shows the time difference between the doctor’s measurement
and the incoming data from the Sphinctometer-Trainer.
This function gives a survey over the preriod of time the training results have been achieved.

8.7 Printing the results for documentation

To document the measured values you can print the patient files. Please press the print button in the symbol bar or
use the extended view function in the menu. Now you can change several setting e.g. high or horizontal format,
choose pages etc.

On your print-out you will find the measurements you performed as well as the training results. Also the course of
measurement will be printed if the measurement has bee carried out and saved in online mode.

33
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

The documentation print out contains:

• Patient data (Name, insurance number, ...)

• Diagnosis
• Measured data (including date of measurement)
• Graphic of the course of measurement
• Training data
• Course of last measurement (left graph)
• Last training results (right graph)
• Space for signature

34
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

9 Important notifications
9.1 Permissible device combinations
The device Sphinctometer/-Trainer and the sensor are delivered as a unit and must only be used in this combination,
as the device is calibrated for this specific sensor. Using other sensors than the one delivered with the device will
lead to false measure data.
Both device and sensor have a serial number which must correspond. The two serial numbers are the same except
the two letters at the end.
Example: Device STM-0001-G is run with the sensor STM-0001-A or STM-0001-V.
Enclosed you find a table (13.7) which is designed specially for your device.
Important note: Water filled sensors must not be filled with oil or vice versa.

9.2 Single use protection and lubricant

As protection latex hulls for ultrasonic sensors can be used (e.g. by the company MAPA, Zeven, Art.-Nr.
11.150.023) or other fitting protection hulls used for analtonometrie. In case of latex allergy silicon hulls can be
used as well (Acquireable at the company Medesign GmbH, Partnachplatz 7, 81373 Münschen).
At proctological (analtonometrie) use we recommend Recto-Lyss as lubricant. Used vaginally we recommend Gyn-
Lyss empfohlen (both by Medesign).
In case of skin irritation or a rejection by the patient vaseline or water can be used as well.

9.3 Operating conditions

The Sphinctometer and all associated components are designed for indoor-use only. Please keep the device away
from highly flammable substances. The sensor may be cleaned with hot water and cleaning substancesthat are hand
neutral. Antiseptics for endosonographical devices may be used as well. Please make sure to keep the connector dry
during the cleaning process. Please use easy approachable sockets only.

9.4 How to handle damaged devices

In case of damage, corrosion, or wearout of housing, cable or other parts of the Sphinctometer the device must not
be used any longer to avoid disfunction and potential dangers. Especialy if connectors or cables are damaged
practise is not safe anymore. Please make sure to disconnect the power supply of the desk stand in such cases. A
damaged device has to be returned to the manufacturer.

9.5 Steady non reproducable controlmeasurements

In case of a negative control measurement, or obvious mismesurements that do not result from wrong use please
contact manufacturer. Please dicribe the state, the storing conditions and other remarkabilities.

9.6 Battery care and exchange

To keep the battery intact it has to be recharged from time to time if the Sphinctometer is not used for a longer
period. The battery must only be changed by the manufacturer. Opening the house leads to expiration of the
warranty.
Please keep the battery away from children. At annual inspections the battery is checked and changed if necessary.

9.7 Protection off heat sources and electromagnetically sensitive devicec.

Storing the Sphinctometer/Sphinctometer-Trainer above heat sources (e.g. heater) should be avoided for reasons of
wearout and disfunction. Please do not store the device in the direct sunlight. Cleaning the housing with hot wet
cloth is possible in case the interior electronic components do not get warmer than 50°C. The device must in no
case be immersed in water!

Important:
The sensor element is located in the handle of the sensor. It is encapsulated from the environment so that hot water
may be used for a short time to clean the outer sensor.
Inside the sensor the measuring unit is hardly proteced, so refilling must only be carried out with room
temperatured water.

35
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

The device is manufactured with a permanent magnet. Please make sure that no electromagnetically sesitive devices
are around (e.g.: floppy discs, electric devices, check cards...). Please keep all deviced away from children.

9.8 Contra indicators

Performing measurements is interdicted in following cases:
- Rotundity or injury of the anus or vagina area.
- Danger of irritation of polys, tumors or Gefahr der Reizung oder Verletzung von Polypen, Tumoren, ggf. offene
innere/äußere hemorrhoids,
- Incompability to the patient (e.g. in size)
In any case the doctor has to evaluate if the Sphinctometer is applicable.

9.9 Side effects and risks

For the exception of the cases listed under contra indicators (10.8) using the Sphinctometer/-Trainer is not
dangerous for the patient. Side effects are not known. In case of harmful interactions th manufacturer has to be
informed.
If there are loose parts especially at the sensor the Sphinctometer must not be used. In general the components are
not dangerous.

9.10 Clean and care

The Sphinctometer/-Trainer can be cleaned with a wet cloth and detegents. Please dry the device before reuse.
The device must not be hold under running water. High air humidity can damage the device. Please do not use
aggressive antiseptics.
The sensor may be cleaned with hot water and cleaning substancesthat are hand neutral. Antiseptics for
endosonographical devices may be used as well.
Antiseptics must be proper for plastics.
Usable desinfectants are e.g.:
- Desonite by Merz&Co. Hygieneartikel, 60318 Frankfurt,
or the following two substances by Dr. Schumacher GmbH, 34201 Melsungen:
- DESCOSEPT,
- Perfektan Endo

Warning:
The electric connectors kmust be kept dry. Corrosion can lead to disfunction and malmeasurements.
Furthermore heat can cause severe damage (see paragraph 10.7)

9.11 Control measurements

Please perform controle measurements regularly (e.g. once per month). Please see paragraph 5.5 for further
information.

9.12 Check by manufacturer

Sphinctometer/-Trainer are affected by natureal wearout effects. To keep the device in good condition please send it
in for a general check once per year. Worn out components are exchanged at this opportunity. Please use the original
cartonage and please fill in the delivery note including the disinfection confirmation. Please inform about the current
fees.

9.13 General safety guidelines

If there is a suspicion about damage or disfunction of the device please send it back to the manufacturer before using
it again.

9.14 Dispose guidelines

To dispose the device please pay attention to the local rules for electronic waste. Sending the device back to the
manufacturer is possible as well.

36
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

Batterys must not be disposed in the trash, but be given back to the reseller or manufacturer. This applies for both
Sphinctometer and Trainer.

10 Warranty/Certificates
10.1 Warranty and liability
The manufacturer gives a warranty of 24 months in case of proper use. Damage caused by leaking batteries or use
of an external power supply as well as intervention on the device by non authorized personel cause an expiration of
warranty.
A liability for any damage caused by faulty software or its application is debared. Non proper use debares any kind
of liability and warranty. Liabilities of deliverers remain unaltered.
As area of jurisdiction it is herewith agreed on Aachen

10.2 CE-Sign

Sphinctometer/ –Trainer have undergone an EG-check according to 93/42/EWG for medical products (appendix.
IV). The check of the device has been performed by: RWTüV Essen.
You will find the certificate enclosed.

11 Technical information
11.1 Function and structure
Battey mode: Sphinctometer and Sphinctometer-Trainer operate in battery mode. The battery is
recharged in the desk stand.

Power save function: existent

Display: fluid crystal-grafic-Display

Sensorunit: Piezo-pressure sensor element

Measure sensor with water/oil filling (Doctor’s device)
Measure sensor with air filling (Training device)

Housing material: Sphinctometer: ABS

Sensor: Silicon-tube
Stainless steel
POM (Polyacetal)
Interior silicon sealing agent
Interior rubber gasket

Appurtenance: PC data cable (serial)

Software „SphinctoDat“ for patient specific data storing

37
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

11.2 Technical data

Measure precision: Doctor’s device: ± 4 mmHg

Trainer: ± 6 mmHg (± 10 mmHg if values are < 30 mmHg)
Bar display (Trainer): ± 10 mmHg
Range of bar display: Difference: (110% Training goal – rest tonus)
Measure range: 0 to 300 mmHg (Doctor’s device)
0 to 250 mmHg (Trainer)
Nominal voltage: 230 V∼/ 12 V DC (Power supply unit)
Power supply: Integrated NiMH-Akku (9,6 V)
Power supply unit (12 V DC) (desk stand)
Protection class: III, II with power supply unit
Kind of protection: masked
Sensor: Typ BF

Store temperature: 5 – 40 °C
Working environment temperature: 20 – 40 °C
Air humidity: 35-80 %, Sensor: 100%

12 Manufacturer/Reseller

12.1 Manufacturer

If nothing else is given the device has been manufactured and sold by:

MSM ProMedico GmbH

Jülicher Str. 338 a
52070 Aachen

0044
12.2 Reselling / maintenance/ sending back

12.2.1 Sphinctometer (doctor’s device)

The Sphinctometer is delivered to surgeries, clinics etc as a diagnostic device. For maintenance the device has to be
returned to the manufacturer where it will be checked, and if necessary repaired or exchanged.

12.2.2 Sphinctometer-Trainer

The Trainer is send to the doctors’ when prescribed, where it is handed over to the patien for the period of rent.
When the period is over the device and all appurtenance has to be returned to the manufacturer where it will be
checked. The ensures a proper disposal of the components

38
 MSM ProMedico GmbH
SPHINCTOMETER Manual Jülicher Str. 338 a
52070 Aachen
(waterfilled sensor, Tel.: 0049-(0)241-96 82-10
except Trainer) Fax: 0049-(0)241-96 82-122
e-mail: [email protected]
Sphinctometer Instruction Manual New.doc
Manual

12.2.3 Appurtenance

The Sphinctometer/ -Trainer is delivered with:

- Sensor A or sensor V
- Desk stand with power supply
- Starter pack protection hulls
- Lubricant (Tainer)
- Controle kit
- Manual incl. Brief instructions

Optional availlable:

- PC-Software „SphincoDat“
- PC data cable

12.2.4 Rent devices

Rented devices have to be handled proper and with care. The remain in posession of the manufacturer and have to
be returned after the stipulated period. Sensors remain in possesion of the patient

12.2.5 Returning used or defect devices

If a device is defect or not used anymore it has to be returned to the manufacturer. In case a new device is ordered th
desk stand can remain at the doctors’.
Should a new sensor be needed the device and the sensor have to be returned.
The patient will receive a new device that will be send to the doctor who has to check on the training data, promptly.

Note: Please use the original cartonage for return and fill in delivery note and disinfection confirmation

12.3 Serviceline

If you have any questions that can not be answered by this manual feel free to phone us: +49-241-96 82-10

12.4 Declaration of conformity by manufacturer

12.5 Certificate (EG-check) by RWTüV

12.6 Brief instructions on the Sphinctometer (Doctor’s device)

12.7 Brief instructions „refilling the sensor with water“

12.8 Brief instructions on the Sphinctometer-Trainer (enclosed if applicable)

12.9 Manual Sphinctometer-Trainer (enclosed if applicable)

12.10 Value table (separate paper)

39