EDAN PA Series User manual

I
About this Manual
P/N: 01.54.459103
Version 1.1
MPN: 01.54.459103011
Release Date: Mar. 2022
© Copyright EDAN INSTRUMENTS, INC. 2022. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product
better. It is reminded that the product shall be used strictly complying with this manual.
User's operation failing to comply with this manual may result in malfunction or
accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be
held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN,
any materials contained in this manual shall not be photocopied, reproduced or
translated into other languages.
Materials protected by the copyright law, including but not limited to confidential
information such as technical information and patent information are contained in this
manual, the user shall not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or
implicitly, any right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and
performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried
out by persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Product Information
Product Name：Biofeedback and Stimulation System
Model：PA4, PA4 Plus, PA4 Pro, PA36, PA35, PA38, PA39, PA40
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
AWARNING label advises against certain actions or situations that could result in

II
personal injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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Table of Content
Chapter 1 Safety Guidance...................................................................................................... 3
1.1 Intended Use/Indications for Use ........................................................................................................3
1.2 Contraindications.................................................................................................................................3
1.3 Safety Precautions...............................................................................................................................3
1.4 Definitions and Symbols ................................................................................................................... 11
Chapter 2 Introduction .......................................................................................................... 14
2.1 Main Unit .........................................................................................................................................15
2.1.1 Indicators..............................................................................................................................16
2.2 Accessories........................................................................................................................................16
2.2.1 Sensor Cable.......................................................................................................................17
2.2.2 Vagina Sensor.....................................................................................................................17
2.2.3 Rectum Sensor....................................................................................................................18
2.2.4 Stress Probe........................................................................................................................18
2.3 Rechargeable lithium battery.........................................................................................................19
2.3.1 Replacing the Battery.........................................................................................................19
2.3.2 Battery Status on the Main Screen ..................................................................................19
2.3.3 Charging the Battery..............................................................................................................20
2.3.4 Maintaining the Battery.........................................................................................................20
2.3.5 Storing the Battery.................................................................................................................20
2.3.6 Checking Battery Performance..............................................................................................20
2.3.7 Recycling the Battery ............................................................................................................21
Chapter 3 Installation............................................................................................................. 22
3.1 Opening and Checking the Package..................................................................................................22
3.2 ConnectingAC Power.......................................................................................................................22
3.3 Switching on the System...................................................................................................................22
3.4 Switching off the System...................................................................................................................22
Chapter 4 Basic Functions and Operations.......................................................................... 23
4.1 Connecting to Patient ........................................................................................................................23
4.2 Adjusting Current ..............................................................................................................................23
4.3 Sensor/Probe/Electrodes Off .............................................................................................................24
Chapter 5 *Software Operation ............................................................................................ 25
5.1 Starting up the Software....................................................................................................................25
5.2 Main Interface ...................................................................................................................................25
5.3 Patient Information............................................................................................................................25
5.3.1 Patient Information Interface.................................................................................................25
5.3.2 Adding Patient .....................................................................................................................26
5.3.3 Searching Patient................................................................................................................27
5.3.4 Patient Record.....................................................................................................................27
5.4 Assessment ........................................................................................................................................27
5.4.1 Free Training........................................................................................................................28
5.4.2 Quick Screening..................................................................................................................29
5.4.3 EMG Screening...................................................................................................................30
5.4.4 EMG Assessment ...............................................................................................................30
5.4.5 Pressure Assessment.........................................................................................................30
5.4.6 Lumbago Assessment........................................................................................................31
5.4.7 Sexual Function Assessment............................................................................................31
5.4.8 Cough Reflex Assessment ................................................................................................32
5.4.9 Screening Assessment Report..........................................................................................32
5.5 Treatment...........................................................................................................................................32
5.5.1 Defined Protocol..................................................................................................................33
5.5.1.1 Intelligent Protocol.......................................................................................................33
5.5.1.2 Fixed Protocol...............................................................................................................34
5.5.1.3 MVC Detection.............................................................................................................35
5.5.1.4 Protocol Treatment .......................................................................................................36
5.5.2 Custom Treatment..............................................................................................................41
5.6 Postpartum Rehabilitation .................................................................................................................41

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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5.7 Database ............................................................................................................................................43
5.7.1 Patient Information..............................................................................................................44
5.7.2 Patient Record.....................................................................................................................44
5.8 Settings..............................................................................................................................................44
5.8.1 User Settings.......................................................................................................................44
5.8.1.1 Hospital Name............................................................................................................44
5.8.1.2 Application...................................................................................................................44
5.8.1.3 Adding User................................................................................................................44
5.8.1.4 Modifying User ...........................................................................................................45
5.8.1.5 Login Settings.............................................................................................................45
5.8.2 General Settings.................................................................................................................45
5.8.2.1 Interface Settings.......................................................................................................45
5.8.2.2 Channel Settings........................................................................................................46
5.8.2.3 Other Settings.............................................................................................................46
5.8.2.4 Restoring Factory Configurations............................................................................46
5.8.3 Printing Settings..................................................................................................................46
5.8.4 Protocol Management........................................................................................................47
5.8.5 Database.................................................................................................................................48
5.8.5.1 Backing Up Database................................................................................................48
5.8.5.2 Rebuilding Database.................................................................................................48
5.8.5.3 Updating System........................................................................................................48
5.8.6 Communication Settings........................................................................................................49
5.8.6.1 Wifi Settings................................................................................................................49
5.8.6.2 BT Settings .................................................................................................................49
5.8.6.3 NFC Settings..............................................................................................................49
Chapter 6 Maintenance and Cleaning .................................................................................. 50
6.1 Maintenance ......................................................................................................................................50
6.1.1 Inspection...............................................................................................................................50
6.1.2 Daily Maintenance.................................................................................................................50
6.2 Care and Cleaning .............................................................................................................................51
6.2.1 Safety Instructions.................................................................................................................51
6.2.2 General Points........................................................................................................................51
6.2.3 Cleaning.................................................................................................................................52
6.2.4 Disinfecting ...........................................................................................................................53
6.2.5After Reprocessing.................................................................................................................54
6.2.6 Storage and Transport............................................................................................................55
Chapter 7 Warranty and Service.......................................................................................... 56
7.1 Warranty ............................................................................................................................................56
7.2 Contact information...........................................................................................................................56
Appendix 1Product Specifications.......................................................................................... 57
A1.1 Environmental Specifications................................................................................................57
A1.2 Physical Specifications...........................................................................................................57
A1.3 Performance Specifications...................................................................................................58
A1.4 Rechargeable Lithium-ion Battery........................................................................................59
Appendix 2 Troubleshooting................................................................................................... 60
A2.1 Trouble with Starting Up................................................................................................................60
A2.2 Trouble with Identifying U Disk or Other USB Device.................................................................60
A2.4 Unstable EMG Signal.....................................................................................................................60
A2.5 Falling Off Issue.............................................................................................................................61
Appendix3 EMC Information................................................................................................. 63
A3.1 Electromagnetic Emissions.............................................................................................................63
A3.2 Electromagnetic Immunity .............................................................................................................64
A3.3 Electromagnetic Immunity .............................................................................................................65
A3.4 Recommended Separation Distances..............................................................................................68
Appendix 4 Ordering Information......................................................................................... 70

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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Chapter 1 Safety Guidance
CAUTION
Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
NOTE:
1 To ensure proper running of the device and safety of the operator and patient,
read through this chapter before using the device.
2 This user manual is written to cover the maximum configuration. Therefore,
your model may not have some of the parameters and functions described,
depending on what you have ordered.
1.1 Intended Use/Indications for Use
The Biofeedback and Stimulation System collects, analyzes patients’ surface
electromyography or stress signal and performs biofeedback, treating muscular
dysfunction, promoting blood circulation and providing analgesia and tissue metabolism
by electrical stimulation and EMG-electrical stimulation.
1.2 Contraindications
a) Gestation
b) Lochia not finished after delivery or menstrual period
c) Patients who wear cardiac pacemakers
d) Malignant tumor
e) Surgical scar rupture
f) Nervous system disease
g) Other diseases that doctor considers not applicable
1.3 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the device.
WARNING
1 The device is intended to be used only by trained and qualified personnel in
hospitals, clinics and private medical institutions.
2 This device is provided for the use of professionally trained and qualified
physicians, or under guidance of these personnel. Familiarize yourself with the
contents of this user manual before operation.
3 Do not use the device in the presence of flammable anesthetics due to
explosion risk.
WARNING

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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4 SHOCK HAZARD–Do not attempt to connect or disconnect a power cord with
wet hands. Make sure that your hands are clean and dry before touching a
power cord.
5 SHOCK HAZARD - The power receptacle must be a three-wire grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet. A hospital grade
outlet is required. If the outlet has only two slots, make sure that it is replaced
with a three-slot grounded outlet before attempting to operate the system.
6 Electromagnetic Interference –Ensure that the environment in which the
device is installed is not subject to any source of strong electromagnetic
emissions, such as CT, radio transmitters, mobile phone base stations, etc.
7 Electromagnetic Interference –Do not use mobile phones nearby the device,
otherwise it may interfere with device operation.
8 Do not touch the signal input or output connector and the patient
simultaneously.
9 Accessory equipment connected to the device must be certified according to
the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the system standard
IEC/EN 60601-1. If any question, please consult our technical service
department or your local distributor.
10 Connecting any accessory or equipment to the device makes a medical system.
In that case, additional safety measures should be taken during installation of
the system, and the system shall provide:
a) Within the patient environment, a level of safety comparable to that
provided by medical electrical equipment complying with IEC/EN 60601-1,
and
b) Outside the patient environment, the level of safety appropriate for
non-medical electrical equipment complying with other IEC or ISO safety
standards.
11 Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system. You can refer to the label or silk-screen
for the maximum permitted load.
12 SHOCK HAZARD –Do not connect non-medical electrical equipment, which
has been supplied as a part of the system, directly to the wall outlet when the
non-medical equipment is intended to be supplied via a multiple portable
socket-outlet with a separating transformer.
WARNING
13 SHOCK HAZARD –Do not connect electrical equipment, which has not been
supplied as a part of the system, to the multiple portable socket-outlet

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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supplying the system.
14 Multiple portable socket-outlets shall not be placed on the floor. An additional
multiple portable socket-outlet or extension cord shall not be connected to the
system.
15 Only accessories supplied by the manufacturer can be used.
16 Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1 approved to the device. The
operation or use of non-approved equipment or accessories with the device is
not tested or supported, and device operation and safety are not guaranteed.
17 Using accessories other than those specified by the manufacturer may result
in increased electromagnetic emissions or decreased electromagnetic
immunity of the device.
18 Make sure that all the components and accessories are connected correctly
and checked before powering on.
19 No part of the device is intended to be maintained by the user. Unauthorized
servicemen shall not open the enclosure. Otherwise, safety hazards may
happen.
20 The mains plug is used as isolation means from supply mains. Position the
device in a location where the operator can easily access the disconnection
device.
21 The device should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the device should be observed
to verify normal operation in the configuration in which it will be used.
22 The medical electrical equipment needs to be installed and put into service
according to the EMC Information provided in this user manual.
23 The device should be operated under certain circumstances, such as power
supply, humidity and altitude.
24 Portable and mobile RF communications equipment can affect medical
electrical equipment, refer to section A3.4 Recommended Separation
Distances.
25 Do not service or maintain the device or any accessory which is in use with a
patient.
WARNING
26 The assembly and modifications of the device during actual service life shall
be evaluated based on the requirements of IEC60601-1.
27 Only electrodes recommended by the manufacturer should be used in case of
skin reactions, burns or other hazards caused by excessive current densities.

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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28 Please do not plug a random USB flash disk into the device, please use a
specialized USB flash disk without virus.
29 Do not apply the device simultaneously with other PATIENT-connected
equipment, such as, a cardiac pacemaker or other electrical stimulators, on the
same patient.
30 Operation in close proximity (e.g.1m) to a shortwave or microwave may
produce instability in the stimulation output.
31 Simultaneous connection of a patient to a high frequency surgical equipment
may result in burns at the site of the stimulator electrodes and cause possible
damage to the stimulator.
32 Application of electrodes near the thorax/heart may increase the risk of cardiac
fibrillation.
33 A patient with an implanted electronic device (for example a cardiac pacemaker)
should not be subjected to stimulation.
34 A hazard could exist if excessive current densities are present.
35 This device is capable of generating current densities exceeding 2mA
r.m.s./cm²that may require special attention of the operator.
36 Use of any equipment in a biofeedback or stimulation context should be
immediately terminated upon any sign of treatment-related distress or
discomfort.
37 The electrodes should not be placed crossing over the heart.
38 The operator is responsible for ensuring the safety of any device controlled or
triggered by the device or software. The software must be configured or device
be connected in such a way to acquire reliable data. Processing or control
functions can trigger patient feedback, but the stimulus shouldn’t be too much.
39 Stimulations should not be applied across or through the head, directly on the
eyes, covering the mouth, on the front of the neck, (especially the carotid
sinus).
40 The device should not be applied around swollen, infected inflammation or
tetter, phlebophlogosis, thrombophlebitis.
41 The device should not be applied during pregnancy.
WARNING
42 Caution should be used for patients with suspected or diagnosed heart
problems.
43 Caution should be used for patients with suspected or diagnosed epilepsy.
44 Some patients may have skin allergy due to electrical stimulation, please
reduce the current intensity or change the location of electrodes.

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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45 Do not use with diminished mental capacity or physical competence limiting
the use of the device.
46 Please do not apply stimulation in below situations:
a. after bleeding or fracture;
b. muscle contraction during surgery;
c. during period or pregnancy;
d. Skin numbness.
47 Electrode placement and stimulation settings should be operated by qualified
personnel.
48 Avoid accidental contact between connected but unused applied parts and
other conductive parts including those connected to protective earth.
49 If damage is evident of the unit or accessories, discontinue use and contact
your supplier for further information on repair.
50 Please protect the sensitive information of patients.
51 Please destroy sensitive information in free or waste devices, for example,
delete the database in Android settings.
52 The current waveform outputted by the treatment system has no direct
component. The impulse frequency, impulse width and amplitude peak are not
influenced by load impedance.
53 The allowable maximum output of stimulation sensor is 40mA r.m.s., excessive
current may cause skin discomfort.
54 If any serious incident that has occurred in relation to the device, user and/or
patient should report to the manufacturer and the competent authority of the
Member State in which the user and/or patient is established.
For using the Battery:
55 Before using the rechargeable lithium-ion battery (hereinafter called lithium
battery), be sure to read the user manual and safety precautions thoroughly.
56 The lithium battery can only be used for this device.
57 The lithium battery can only be charged in this device.
58 Do not reverse the lithium battery polarity.
WARNING
59 Do not connect the positive (+) and negative (-) terminals with metal objects
such as lead wire, which can result in short circuits.
60 The cycle life of the lithium battery is 500 times. The service life of the lithium
battery may shorten if it is used inappropriately. It is recommended to replace
the lithium battery after 500 charge-discharge cycles, or it may cause safety
risks such as heat and liquid leakage, and risks such as failure or decline of
performance.

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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61 Do not heat or throw the lithium battery into a fire.
62 Do not immerse, throw or wet the lithium battery in water, beverages or other
liquids.
63 Do not use or leave lithium battery at high temperature (charging>45 ℃,
discharging>60 ℃, such as in direct sunlight or in a very hot car), otherwise it
may cause overheat, fire, malfunction to the lithium battery, shorten the service
life of the lithium battery, or damage the lithium battery.
64 Do not place the lithium battery near microwave equipment or other cooking
devices. If the lithium battery is heated or subjected to strong electromagnetic
radiation, liquid leakage, heat, smoke, fire, etc. may occur.
65 Do not hit it with a hammer, step on it or throw or drop it to cause strong shock.
66 Do not weld the lithium battery directly.
67 Do not use a lithium battery of other specifications.
68 Do not use a lithium battery with serious scratch or deformation.
69 Keep lithium batteries out of the reach of children.
70 Power off the device, remove and stop using the lithium battery if abnormal
heat, odor, discoloration, deformation or abnormal condition is detected during
use, charge, or storage, or it may cause safety accidents such as heat, smoke,
and fire.
71 Do not touch a leaking lithium battery. If the liquid leaked from the lithium
battery gets into eyes, do not rub the eyes. Wash them well with clean water
and see a doctor immediately.
72 When the device is running on lithium battery power, do not replace the lithium
battery during operation of the device.
73 High internal temperature may also cause the lithium battery unable to be
charged. Keep the device at room temperature and move it away from heat
sources or out of direct sunlight. The lithium battery will resume charging
when the temperature is within range again.
WARNING
74 Lithium batteries should be charged, used and stored in places far away from
static electricity.
75 Lithium batteries are hazardous waste. Do NOT dispose them together with
house-hold garbage. At the end of their life hand the batteries over to the
applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or lithium batteries, please
contact your local Civic Office, or the shop where you purchased the product.
CAUTION
1 The device is designed for continuous operation. Do not water the device.

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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2 Keep the environment clean. Make the device far from corrosive medicine, dust
area, high-temperature and humid environment. Avoid vibration. Do not move it
with the power cord connected.
3 Do not operate the device if it is damp or wet because of condensation or spills.
Avoid using the device immediately after moving it from a cold environment to
a warm, humid location.
4 Keep the workstation at least 5cm away from the wall for the sake of heat and
air dissipation.
5 Do not sterilize the device or any accessory with autoclave or gas.
6 This system is medical equipment. Unauthorized third party software is
forbidden to be installed on it.
7 Do not delete the system files. That's to avoid improper system running.
8 Do not change the time of the system unless necessary, otherwise the
appointment data may be lost.
9 The waste adhesive electrodes should be treated as medical waste.
10 The waste vagina sensor and rectum sensor should be treated as medical
waste.
11 The device and accessories are to be disposed of according to local
regulations after their useful lives. Alternatively, they can be returned to the
dealer or the manufacturer for recycling or proper disposal.
12 Please install protection software and update the virus database when internet
is connected.
13 When turning on Bluetooth and connecting to a Bluetooth audio device, please
do not connect to unfamiliar devices.
14 Please do not root the system.
15 Please enable the firewall and add the software installed in the device to the
whitelist.
16 Please do not install other software after the device leaves the factory.
17 For secure deployment, please use wired network in case of unstable
bandwidth and network led by Wi-Fi or unstable network device, and cause
data transmission problem.

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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FCC Statement
This device complies with Part 15 of the FCC rules. Operation is subject to the
following two conditions: 1) this device may not cause harmful interference, and 2)
this device must accept any interference received, including interference that may
cause undesired operation.
Note: This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential installation.
This equipment generates uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
--Reorient or relocate the receiving antenna.
--Increase the separation between the equipment and receiver.
--Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
--Consult the dealer or an experienced radio/TV technician for help.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
FCC Radiation Exposure Statement
This device complies with FCC RF radiation exposure limits set forth for an
uncontrolled environment. This transmitter must not be co-located or operating in
conjunction with any other antenna or transmitter.
This device must operate with a minimum distance of 20 cm between the radiator
and user body.

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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1.4 Definitions and Symbols
No.
Symbol
Description
1
Alternating Current
2
Battery check
3
Direct Current
5
On/Off switch
6
Caution
7
Consult instructions for use
8
Part Number
9
SERIAL NUMBER
10
General symbol for recovery/recyclable
11
Date of manufacture
12
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
13
MANUFACTURER
14
CE marking
15
Disposal method

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
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16
Refer to instruction manual/booklet
(Background: Blue; Symbol: White)
17
No pushing
(Background: White; Symbol: Black; Outline:
Red)
18
This way up
19
Fragile, handle with care
20
Keep away from rain
21
Stacking limit by number
23
Do not roll
24
Non-ionizing electromagnetic radiation
25
Adjust Intensity
26
Type BF applied part
27
CH1-CH4
Channel Interface
28
CH-P
Stress Probe Interface
29
Do not reuse
30
Medical device
31
Unique Device Identifier

PA Series Biofeedback and Stimulation System User Manual Safety Guidance
13
NOTE:
1 The user manual is printed in black and white.

PA Series Biofeedback and Stimulation System User Manual Introduction
14
Chapter 2 Introduction
NOTE:
The user manual introduces PA4 as an example. You may not have all of these
features, depending on the configuration purchased. The pictures and interfaces
provided in this manual are for reference only.
This device is used with an all-in-one computer and a trolley. For details of the trolley,
please refer to the PA trolley installation guide.
The overall appearance figure is as below:
Figure 2-1Appearance
1
Main Unit
2
Storage basket
3
Trolley
CAUTION
The maximum load is 2.5 kg for the storage basket. Do not put objects exceeding
the load limit on them.
1
2
3

PA Series Biofeedback and Stimulation System User Manual Introduction
15
2.1 Main Unit
Figure 2-2 Front View
Figure 2-1 Left Side
Figure 2-2 Right Side
5
1
3
4
2
6
78910 11 12

PA Series Biofeedback and Stimulation System User Manual Introduction
16
Figure 2-3 Bottom
1
Touchscreen
2
AC indicator and
charge indicator
3
Control knobs
4
Channel interface
5
Scanner
6
Power switch
7
Finger Unlocking
8
Power interface
9
Network
Interface
10
USB interface
11
Type-C interface
12
SD card slot
13
Supporting
bracket
14
Battery
compartment
2.1.1 Indicators
Charge Indicator
On
The battery is being charged
Off
No battery or the battery is fully charged
AC Indicator
On
The main unit is connected toAC power supply.
Off
The main unit is not connected toAC power supply.
2.2 Accessories
Accessory List
13
14

PA Series Biofeedback and Stimulation System User Manual Introduction
17
2.2.1 Sensor Cable
The sensor cable connects the sensor with the host to conduct signals.
2.2.2 Vagina Sensor
There are two types of vagina sensors, the reusable one and the disposable one.
The vagina sensor is used to conduct electrical signals between the pelvic floor muscles
and the host, including pelvic floor Surface Electromyography signal (SEMG) and
electrical stimulation signals.
Using methods:
1. Open the package and connect the vagina sensor to the host with the sensor
cable.
2. Insert the vagina sensor into the vagina till the end of the sensor. Select an
assessment protocol or treatment plan and start it.
3. After the assessment or treatment, disconnect the sensor from the cable. For
disposable vagina sensor, pull it out and dispose of it as medical waste. For
Name
Model
Specification
Area
Actual Area
Figure
Impedance
Pelvic
Floor
Intracavit
y Sensor
SV2
Intracavity
sensor,
which is
applied in
the vagina
and it is
reusable
no less
than
8cm2
12.34 cm2
length*width:57
mm*23.2 mm
Error ：±5%
Pelvic
Floor
Intracavit
y Sensor
SV1
Intracavity
sensor,
which is
applied in
the vagina
and it is
disposable.
no less
than
8cm2
12.34 cm2
Irregular
length*width ：
57mm*23.2 mm
Error ：±5%
Adhesive
Electrode
s
SK1
Adhesive
electrodes,
which are
applied on
the skin and
they are
disposable
no less
than
15cm2
19.625cm2
Diameter:5cm
Error：±5%
<500Ω
±5%
Vagina
Stress
Probe
PV
Intracavity
stress
probe, which
is applied in
the vagina
and it is
reusable.
/
/
/
/