Moticon SENSORINSOLE2 User manual

1
Sensing
Foot
Dynamics
No Wires. No Limits.
Instruction Manual
Model: SENSORINSOLE2

1 Warning Symbols and Location of Labels
The following signs and symbols are used in these instuctions for use, the sensor insole labeling, and the
packaging labeling:
Safety critical warning
Safety critical warning, prohibited action
Safety critical warning, mandatory action
Indicates that the instuctions for use must be consulted
Caution sign
Do not dispose of in your houshold waste (EU WEEE Directive 2012/19/EU)
Identification of manufacturer and date of production (year/month)
Device serial number
Product is a Type BF Applied Part
International Protection (IP) Marking
Temperature range for operation/storage
Humidity range for operation/storage
Handle package with care
On the sensor insole, the labeling is located in the heel area of the lower surface, and on the battery lid. On
the packaging, handling instructions are given on the outer surface of the packaging.
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2 Product Description
Note: In the following, the term “sensor insole” refers to an individual left/right sensor insole, as well as to a
pair of sensor insoles.
Intended Use
Measurements may be incorrect when the product is used outside of the defined intended use.
The sensor insole is intended to be used inside a shoe for measuring the plantar pressure at the sole of foot,
and the acceleration of the foot in three axes.
The use of the product is not specific to certain diseases or symptoms. It is the responsibility of the user to
interpret the measurement data obtained from the product, and no diagnosis or treatment decision shall be
carried out solely on the basis of the data.
Contraindications
The following conditions are absolute contraindications for using the product:
–open wounds of the foot, irritated or otherwise unhealthy foot skin
–orthopedic or other reasons depending on the health status of the patient, which do not allow for wearing
the sensor insoles
–severe gait impairments where the sensor insole might increase the risk of fall
–inability of the patient to wear closed shoes for wearing the sensor insoles
When applying the sensor insole to a patient for more than one day, the user applying the product to the
patient must ensure that the patient will not encounter negative orthopedic long-term effects from wearing the
product, and must instruct the patient to report discomfort and pain due to wearing the device, and to stop
wearing the device in such cases.
Device User Group
The device user group applying the product to the patient are health professionals familiar with the provision of
insoles or foot orthotics, such as clinical doctors, physicians, orthopedic specialists, physiotherapists or nurses.
The user must be able to correctly apply sensor insoles to patients, including proper size selection/fitting and
identification of contraindications.
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Product Types
SCIENCE sensor insoles provide the standard functions. SCIENCE Pro+ sensor insoles provide further optional
functions, which are in the following indicated by “only SCIENCE Pro+”.
Product Functions
The sensor insole is controlled wirelessly via ANT from a PC or smartphone (“controlling device”), and supports
different operation modes.
Live: Wireless data streaming to the controlling device
Recording: Measurement function which stores the data directly on the sensor insole memory
Smart recording: Recording function with automatic start/pause function triggered by motion pattern detec-
tion and longterm time sync exchange between left and right insole (only SCIENCE Pro+)
Smart monitoring: Extended recording time through memory saving with total force and center of pres-
sure (COP) computation directly on the sensor insole (instead of storing individual sensor values) (only
SCIENCE Pro+)
In the operation modes live, recording and smart monitoring the sensor insole measures the plantar pressure
and the acceleration of the foot.
Further functions:
–Automatic shutdown for saving energy
–Zeroing of pressure sensors, initiated from controlling device
–Wireless ANT download of recorded measurement data
–USB download of recorded measurement data (only SCIENCE Pro+)
–Pairing mode for pairing the sensor insole with the controlling device
The pressure sensor layout is as follows (not to scale):
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3 Application Procedure
This section describes the general application procedure. See Sec. 4 for details about how to operate the sensor
insole.
Safety warnings for application:
The sensor insole is not an orthotic. In case an orthotic is used by the patient, the attending doctor
must be consulted about whether it can be replaced by the sensor insole.
The sensor insoles must be worn only pairwise (both left and right) in order to avoid asymmetric gait.
Only sensor insoles with appropriate size may be worn. Incorrect sizes (too small, too big, or improper
fit) are potentially dangerous, may be damaged during walking, and cause erroneous measurement
values. Check the proper fit of the sensor insole after insertion into the shoe.
The sensor insole may only be worn in closed footwear.
The battery compartment must face down towards the floor when inserting the sensor insole into a shoe.
Immediately stop wearing sensor insoles in case of pain or skin irritation.
The weight of the patient wearing the sensor insole may not exceed 120 kg.
Remove the battery from both insoles after finishing a measurement, or when the battery is not used
for some time. Store the sensor insole only without battery.
In case of an internal fault, surface temperatures of 41 ◦C to 43 ◦C may occur, constituting a possible
temperature hazard.
The sensor insole may not be worn with open wounds or ulcers.
The sensor insole must be worn with socks in order to avoid direct skin contact.
See the detailed product information and tutorial videos on www.moticon.com/support
Safety warnings against misuse:
Do not attempt to modify the size or shape of a sensor insole. Do not cut the sensor insoles!
This is dangerous and will damage the sensors.
Do not bend or twist the sensor insole, to prevent damage of electronics. The sensor insole is
designed to be used inside a shoe, atypical bending or torsion will destroy it.
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Do not sting or prick the sensor insoles. Sharp elements can cause dangers and severe damage. Remove
any sharp or spiky objects from the footwear when wearing sensor insoles. Do not use sensor insoles
when damaged.
Do not use sensor insoles for measurements outside of footwear.
Do not wear sensor insoles when driving a car or climbing a ladder.
Do not use the sensor insole in wet or humid conditions, e.g. rain or strong foot sweat.
Application steps:
1. Select an appropriate sensor insole size
2. Insert the batteries into the sensor insoles
→Refer to Sec. 4, Battery Handling
3. Insert the sensor insoles into the patient’s shoes
→Refer to Sec. 4, Sensor Insole Handling
4. Let the patient put on the shoes
5. Let the patient walk 20–30 steps
6. Check the walking comfort of the patient
7. Connect the sensor insoles using a controlling device/software
→Refer to Sec. 4, Sensor Insole Handling
8. Carry out the sensor zeroing
→Refer to Sec. 4, Sensor Insole Handling
9. Start the measurement
10. . . . Patient wears the sensor insole. . .
11. Stop the measurement
12. Remove the sensor insoles from the patient’s shoes
13. Remove the batteries from the sensor insoles
→Refer to Sec. 4, Battery Handling
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4 Using the Sensor Insoles
Battery Handling
Never use batteries other than batteries provided by Moticon for your sensor insoles. They are labelled
as follows: Route JD Inc Li-ion Rechargeable 3.7V
Do not use the sensor insole in case of a damaged, demolished or shifted battery contact.
Do not use the sensor insole with open battery compartment.
Do not remove the battery during a measurement. For longer measurements, instruct the patient to
not remove the battery and to not remove the battery lid.
Do not use sharp objects for removing the battery. Only use the tip of the finger.
Only insert fully charged batteries into sensor insoles, otherwise the battery level indicator in the software
of the controlling device will display wrong values.
How to insert the battery into the sensor insole:
1. Make sure that positive (+) pole of the coin cell battery points towards you. With this orientation, slide
the coin cell battery under the contact flap.
2. Sink the battery into the battery case by gently pushing it downwards.
3. Place the lid loosly on the top of the groove that runs around the battery case. The prominent flap on
one side of the battery lid must rest above the corresponding gap in the sensor insole.
4. Snap in the battery lid into the circular groove by pushing in the center of the lid. Only when you noticed
the snap, the lid rests in the groove correctly
How to remove the battery from the sensor insole:
1. Pull on the flap of the battery lid to remove the battery lid from the sensor insole
2. If the battery does not readily slide out of the battery case, use your fingertip to gently remove it
3. Warning: Never pull on the battery flap, and do not bend the battery flap away from the sensor insole.
For removing the battery, it is sufficient to only slightly elevate the battery flap.
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Sensor Insole Handling
Do not bend or twist the middle part of the sensor insole when putting it into or taking it out from a
shoe.
Wireless connections are potentially unstable. When starting a recording, check in the software of the
controlling device that the recording has started properly before letting the patient walk.
Do not disconnect the sensor insole from the USB download cable or the USB download cable from the
PC during data transfer. The data transfer will not resume after reconnecting the cable.
The sensor insole does not have any switch. In order to turn the sensor insole on, it is sufficient to moderately
shake the sensor insole. The sensor insole will enter a power-safe mode after 30 s time of inactivity, so it does
not have to be turned off. However, the battery must be removed before storing the sensor insole.
Before connecting the sensor insole with a controlling device, the sensor insole must be paired. To bring the
sensor insole into pairing mode, shake it to turn it on, put it upside down on a flat surface, and leave it in this
position while carrying out the pairing. Please refer to the software manual about how to carry out the pairing.
How to put the sensor insole into a shoe:
1. If the shoe has a removable inner sole or liner, remove it before inserting the sensor insole.
2. Place the sensor insole into the shoe, with the top layer pointing towards you, and the battery compartment
pointing towards the bottom of the shoe. Note: The lower sides of the sensor insoles are marked with
“left” and “right”, indicating the respective foot side.
3. When sliding the sensor insole all the way into the shoe, pay particular attention to not bend the sensor
insole in the mid foot area, since this will damage the sensor insole.
4. Gently push the heel area all the way into the shoe.
5. Check that the sensor insoles fits neatly into the shoe, otherwise use an appropriate sensor insole size.
How to remove the sensor insole from the shoe:
1. Slightly lift the sensor insole in the medial midfoot area.
2. Gently pull on the heel area of the sensor insole to pull it out of the shoe, while paying particular attention
to not bend the sensor insole in the mid foot area.
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Accessories
Only use USB download cables provided by Moticon.
Only use accessories supplied by Moticon. Using unauthorized is potentially dangerous and may damage
the product.
The USB download cable (optional) is used to download recorded data from the sensor insole. For using the
USB download cable:
1. Remove the battery lid from the sensor insole while leaving the battery in the sensor insole.
Caution: The data download via USB requires an inserted battery in the sensor insole.
2. Plug in one of the two sensor insole connectors of the USB download cable into the sensor insole. The
connector has the same shape as the battery lid. Please refer to the above explanation of how to insert
the battery lid.
3. Plug in the standard USB plug into a compatible connector of the controlling device (PC).
4. Refer to the software manual about how to start the data transmission via USB.
5 Reprocessing
The sensor insole is not a sterile product.
Do not spray the disinfection spray on skin or feet. Pay attention to the safety instructions provided by
the disinfection spray manufacturer.
Only use disinfection spray based on the active ingredients didecyldimethylammonium chloride and
ethanol.
If worn by different patients, the sensor insole must be reprocessed before it can be reused.
Cleaning and disinfection procedure:
1. Remove the battery, and properly insert the battery lid.
2. Clean the upper and lower side of the sensor insole with a damp soft wipe, then dry with a clean soft
wipe.
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3. Spray disinfection spray on the upper and lower side of the sensor insole. Only use disinfection spray
based on the active ingredients didecyldimethylammonium chloride and ethanol.
4. Let the disinfection spray work for 1 minute, then let dry.
If necessary, repeat the cleaning and disinfection procedure with the top layer being taken off. The top layer is
cloth which sticks to the top of the sensor insole. It can be removed and re-attached by hand. Do not attempt
to open the seam on the edge of the sensor insole!
The top layer can be replaced, as required. Please contact Moticon or your local distributor for replacement
top layers.
6 Technical Data
General information:
–Power supply: PD2032 3.7 V Li-ion rechargeable coin cell battery (supplied by Moticon)
–16 MB flash memory
–Recording duration (at different sampling rates): 48 h (5 Hz), 29 h (10 Hz), 11 h 36 m (25 Hz), 5 h 48 m
(50/100 Hz). With smart monitoring up to 58 h (5 Hz) (only SCIENCE Pro+).
–9 available size from 32/33 to 48/49 (EU)
–Selftest function: The sensor insole continuously carries out a monitoring self-test. In the case of a sensor
defect, the sensor insole will not allow any further measurements to be started.
Environment:
–Operation temperature range: 20 ◦C to 30 ◦C
–Storage temperature range: -10 ◦C to +50 ◦C
–Storage humidity range: 5% to 95%
–Air pressure range for storage and operation: 690 hPa to 1070 hPa (≡max. 3000 m altitude)
–The sensor insole operates in the 2.4 GHz ISM band. Disadvantageous radio performance may occur if
used in an environment with other devices operating at 2.4 GHz (e.g. WLAN, Bluetooth). In this case,
stop using the sensor insole in this environment.
–The sensor insole must not be used in environments where radio emissions at 2.4 GHz are potentially
harmful or forbidden by law.
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7 Specifications
The sensor insole outputs binary data, which is repre-
sented by the controlling device in the following output
format:
–Pressure in N/cm2
–Total force in N
–Acceleration in g
–Center of pressure (COP) in mm
Pressure sensors:
–13 capacitive pressure sensors per sensor insole
–Pressure range: 0. . . 40 N/cm2
–Pressure resolution 1.0 N/cm2
–Accuracy of pressure at 10 N/cm2:±25%
–Accuracy of peak total force in walking: ±25%
–Accuracy of COP in x/y direction: ±20 mm
Acceleration sensor:
–3D acceleration sensor (MEMS)
–Acceleration range per axis: ±8 g
–Resolution of acceleration: 0.0625 g
–Zero-g offset: ±0.1 g
Sampling rates and timing:
–Sampling rates: 5, 10, 25, 50, 100 Hz (8 sensors)
–Relative timing accuracy: 2/fS(fS= sensor
sampling frequency)
–Absolute timing accuracy: 0.01 ·TM(TM=
measurement duration)
Product Life Expectancy:
–Durability: 100 km walking distance
–250 reprocessing cyles
8 Waste of Electrical and Electronic Equipment (WEEE)
According to the WEEE Directive 2012/19/EC, electrical and electronic equipment (EEE) covered by this
directive should be disposed of and collected separately and use the best available treatment, recovery and
recycling techniques.
It is important to collect WEEE separately from other wastes, since it contains hazardous substances to the
human health and environment, and is also a valuable resource of raw materials.
Moticon products are subject to the Directive. We therefore urge you to not dispose the equipment as
normal household waste. Instead, please send all products back to Moticon. We will take care of proper
disposal of these products.
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9 Product Compliance
Standards compliance:
–IEC 60601-1
–IEC 60601-1-2 (for EMC)
Equipment classifications:
–Internally powered Medical Electrical Equipment
–Type BF Applied Part
–Medical device class Im
–Mode of operation: Continuous Operation
–IP classification: IPX1
Notified body:
T¨ UV S¨ UD Product Service GmbH
Ridlerstr. 65, 80339 M¨unchen, Germany
Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO
standards (e.g. IEC 60950 for data processing equipment). In addition, all configurations shall comply with the
requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1).
Anybody connecting additional equipment to medical electrical equipment configures a medical system, and is
therefore responsible that the system complies with the requirements for medical electrical systems. Note that
local laws take priority over the above mentioned requirements. If in doubt, consult your local distributor or
the Moticon support.
Imprint
Moticon GmbH
Machtlfinger Str. 21
81379 M¨unchen
Germany
Phone [phone]
suppo[email protected]
www.moticon.de
Instuctions for Use, version 1.2, 03.01.2017
The information in this document is subject to change without notice. All rights reserved.
c
2017 Moticon
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