FIOR & GENTZ e-Cast User manual

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EN
Digital Casting Aid
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2
EN
Content Page
1. Information 3
2. Safety Instructions 3
2.1 Classification of the Safety Instructions 3
2.2 All Instructions for a Safe Handling of the e-Cast 3
3. Intended Use 5
4. Functioning of the e-Cast 5
5. Scope of Delivery 5
6. Putting the e-Cast Operator Device into Operation 6
7. e-Cast Sensors 7
7.1 Sensor Types 7
7.2 Activating the Sensors 7
7.3 Storing Sensors During Transport 7
7.4 Attaching the Sensors 8
7.5 Replacing the Batteries 8
8. Main Menu of the e-Cast Operator Device 9
8.1 New Measurement 9
8.2 Saved Measurements 10
8.3 Delete Measurements 10
8.4 Settings 11
8.4.1 Display Options 11
8.4.2 Sound Options 11
8.4.3 Display Brightness 11
8.4.4 Language 12
8.4.5 Device Info 12
8.4.6 Update Sensors 12
8.4.7 Calibrate Sensors 12
9. Indication of Rechargeable Battery’s/Battery’s State of Charge 13
9.1 Rechargeable Battery’s State of Charge of the Operator Device 13
9.2 Battery's State of Charge of the Sensors 13
10. Charging the e-Cast Operator Device 13
11. Updating the e-Cast Operator Device 13
12. Dirt Removal from the e-Cast Operator Device 14
13. Dirt Removal from the e-Cast Sensors 14
14. Advice on Production Techniques 14
15. Short Guide for a New Measurement 15
16. Signs and Symbols 15
17. Legal Information 15

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1. Information
These instructions for use are addressed to orthotists or qualified/trained experts and do not contain any notes
about dangers which are obvious to them. To achieve maximum safety, please instruct the patient and/or care
team in the use and maintenance of the product.
2. Safety Instructions
2.1 Classification of the Safety Instructions
DANGER Important information about a possible dangerous situation which, if not avoided,
leads to death or irreversible injuries.
WARNING Important information about a possible dangerous situation which, if not avoided,
leads to reversible injuries that need medical treatment.
CAUTION Important information about a possible dangerous situation which, if not avoided,
leads to light injuries that do not need medical treatment.
NOTICE Important information about a possible situation which, if not avoided, leads to
damage of the product.
2.2 All Instructions for a Safe Handling of the e-Cast
WARNING
Risk of Injury Due to Improper Handling of the Operator Device
Use the operator device as described in these instructions for use. The operator device is a sensitive
electronic device with an integrated lithium-ion battery. Pay particular attention to:
- avoiding contact with strong heat or fire,
- not charging the operator device under direct sunlight, and
- not opening the operator device.
NOTICE
Failure of Function Due to Improper Handling
Do not expose the operator device to high humidity and do not immerse it in water.
NOTICE
Failure of Function Due to Improper Replacing of the Batteries
Replace the batteries of the sensors properly and as described in these instructions for use and use the
battery type specified in these instructions for use.

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NOTICE
Failure of Function Due to Missing O-Ring
Reinsert the O-ring before closing the sensor as described in these instructions for use, as otherwise water
may enter the sensor.
NOTICE
Failure of Function Due to Improper Shock Loads
Handle the sensors with care and do not expose them to great shocks, e.g. by falling down or hammer
blows.
NOTICE
Unsuitable Negative Cast Due to Improper Handling
Only trained personnel is allowed to use the operator device.
NOTICE
Unsuitable Negative Cast Due to Loosely Attached Sensors
Make sure that the sensors are attached firmly the whole time while making the negative cast.
NOTICE
Unsuitable Negative Cast Due to Continuing of the Measurement Without Sensors
Always start a new measurement once the sensors have been removed from the negative cast.
NOTICE
Unsuitable Negative Cast Due to Incorrect Calibration
Calibrate the sensors as described in these instructions for use and contact Technical Support if needed.
Note the following for the calibration:
- Calibrate the sensors once a year and after each battery replacement.
- Use a stable, plain surface (e.g. a suitable table) to calibrate the sensors.
- Remove casting residues and clean the sensors with a damp cloth to avoid uneven surfaces.
- Hold the sensor at its edges during calibration so that the sensor surface is not pushed in too much.
NOTICE
Damages to Operator Device, Sensors and Batteries Due to Improper Handling
Use the operator device and the sensors as described in these instructions for use. Pay particular attention
to only expose them to:
- operating temperatures between +5 and +45°C and
- storage temperatures between -20 and +45°C.

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3. Intended Use
The e-Cast is used for checking the joint angles. With an operator device you can control the leg position
while making the negative cast, which makes it possible to cast professionally and correct the position easily
with the patient lying or standing. The e-Cast must be handled by a professionally trained user.
4. Functioning of the e-Cast
The e-Cast was developed so that the joint angles can be checked and corrected while making the negative
cast. The estands for electronic. Depending on the orthosis type, you need two or three sensors for each
measurement, which have to be attached to the patient’s foot, lower leg and thigh. The e-Cast operator device
saves the ideal position for the negative cast, thus helping to control the patient's leg position while making
the cast.
5. Scope of Delivery
The e-Cast is delivered in a case. The case includes the following parts (fig. 1):
Item Article Number Description
1 ET3400-T operator device
2 ET3410-WE sensor for the thigh
3 ET3420-WE sensor for the lower leg
4 ET3430-WE sensor for the foot
5 WZ2067-T08 screwdriver, hexalobular socket, T8 x 60mm
6 ET0710 cable
7 ET0780 adapter
8 ET0830-2450 3 x batteries for e-Cast sensors
w/o fig. KL4200 glue dots for the fixation of the sensors, 48 pieces
w/o fig. KL4601 washers for marking the mechanical pivot points, self-adhesive, 28 pieces
1
5
6
7
8
4
3
2
fig. 1

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6. Putting the e-Cast Operator Device into Operation
1 The operator device is delivered with a rechargeable battery. If the battery is low, first charge the operator
device by using the delivered cable. Afterwards, it can immediately be put into operation.
2 Briefly press the Menu button to switch on the device. On the display you now see the four menu items
New measurement, Saved measurements, Delete measurements and Settings.
3 If you do not use the operator device or the connected sensors for more than 20 minutes, the operator
device switches off automatically. You can also switch off the device by pressing the Menu/Off button for
two seconds.
New measurementNew measurement
Saved measurementsSaved measurements
Delete measurementsDelete measurements
SettingsSettings
MenuMenu
Menu and O
button
Arrow button
to go down
Arrow button
to go up
Confirmation
button for
choosing
fig. 2

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7. e-Cast Sensors
7.1 Sensor Types
A sensor set consists of three sensors which are marked with dierent colours (after the trac light principle)
and are attached to a certain spot on the leg. The red sensor has to be attached to the thigh, the yellow one to
the lower leg and the green one to the foot (fig. 3).
7.2 Activating the Sensors
The sensors can be activated by slightly shaking them. You can see from the blinking that they are activated. If
they are not connected to the switched on operator device, they switch o automatically within one minute.
If they are connected to the switched on operator device, they stay activated as long as the operator device is
switched on.
7.3 Storing Sensors During Transport
When transporting the sensors (e.g. in a car), it is possible that they get activated by the shocks. To save bat-
tery power, you should put the sensors in sleep mode during transport. There are two ways to put the sensors
in sleep mode:
- Place the case in such a way that the sensors in it are upside down.
- Lay down the case in such a way that the sensors in it are face down, meaning the printed side is facing
down.
You can also find information on storing sensors on the sticker in your e-Cast case.
sensor for the
thigh, red
sensor for
the lower leg,
yellow
sensor for the
foot, green
fig. 3

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7.4 Attaching the Sensors
Stick one of the delivered glue dots to each of the three sensors. Attach
the sensors to the corresponding spot on the leg which is wrapped
in compression film (fig. 4). Make sure that the sensors are attached
firmly and that they are not upside down. If you have several sensor
sets, pay attention to always use a red, a yellow and a green sensor for
each measurement and not several with the same colour. If you want
to produce an AFO, you only need the sensor for the lower leg (yellow)
and the sensor for the foot (green). If you want to produce a KO, you
only need the sensor for the thigh (red) and the sensor for the lower leg
(yellow). For more information about the production technique for making a cast see our online tutorials at
www.fior-gentz.com.
7.5 Replacing the Batteries
1 You can replace the batteries of the sensors yourself when they are empty. To do so, first clean the sensor
with a damp cloth or under running water. Dry it afterwards.
2 Unscrew the four countersunk flat head screws on the front of the sensor with the delivered T8 hexalobular
screwdriver.
3 Open the sensor, e.g. by inserting a screwdriver into the gap under the sensor and levering the cover up.
4 Carefully take out the printed circuit board and turn it around. The battery is on the other side of the
printed circuit board and can be pushed out gently with a narrow object.
5 Insert a new battery of the type CR2450.
6 Carefully remove the plaster which has accumulated between cover, housing and O-ring with a dry cloth.
7 When closing the sensor, make sure that the O-ring is properly placed before putting the cover back on and
screwing it onto the sensor.
The battery replacement was successful if the sensor blinks after shaking it slightly.
fig. 4

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8. Main Menu of the e-Cast Operator Device
In the main menu of the operator device you can start a new measurement, view a saved measurement, delete
measurements or access the settings. To go to the main menu, press the Menu button.
You now see the following menu items on the display (fig. 5):
- New measurement
- Saved measurements
- Delete measurements
- Settings
To exit a menu item, press the Menu button. It then functions as
Back button.
8.1 New Measurement
Here, you can start a new measurement. To do so, you need the operator device and a sensor set. After having
attached the sensors required for the orthosis type to the patient's leg (see paragraph 7.4), you can start with
the measurement. Follow the steps listed below:
1 Select the menu item New measurement.
2 Now, you are in the area Select patient data (fig. 6) and have two
options:
- Create new patient data: Select <New> and decide which orthosis
type you would like to produce. You can choose between KAFO,
AFO and KO as well as between the left and right leg. Then, enter
the patient’s initials (two letters) and confirm by pressing Save.
- Use previously created patient data: If you choose from previously
created patient data, you can decide whether you would like to
Use connected sensors or Search for new sensors. Then, enter the
patient’s initials (two letters) and confirm by pressing Save.
3 The operator device searches for the sensors. If you have several
sensor sets, make sure that only one of the sensor sets is activat-
ed. Sensors which are not needed switch themselves off after one
minute at the latest when they are not moved. The operator device
then connects itself to the active sensors and you can start the
measurement.
4 Bring the patient's leg in a horizontal position with the toes point-
ing upwards. The foot should be in the desired external rotation
needed for the later orthosis (fig. 7). This position has to be kept for some seconds until you can see Press
OK on the display. Press OK.
If your patient suffers from a tremor, the operator device is going to recognise it. It then calculates an
average value and displays Recognised tremor. Confirm with OK.
New measurementNew measurement
Saved measurementsSaved measurements
Delete measurementsDelete measurements
SettingsSettings
MenuMenu
fig. 5
AA-AA-
<New><New>
KAFOKAFO
LEFTLEFT
Select patient dataSelect patient data
fig. 6
fig. 7

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5 Have the patient stand in their individual normal posture (fig. 8). Make sure that the
position is the correct one because this is the one saved by the operator device and
therefore it is decisive for the negative cast. The patient has to stay in this position for
some seconds without moving until Press OK appears again. If there is a tremor, the
operator device is going to recognise it here, too.
6 The position is now set. If you want to change this position, press Back. If you want to
keep this position, press Continue. The patient can sit or lay down again. First, you will
see the position of the ankle. With the arrows you can switch between the display of the
ankle and the knee position (fig. 9–10). A dot on the bar indicates in which direction you
have to move ankle or knee to reach the correct position. When the
dot is in the middle, you have reached the correct position (fig.10).
For setting options for the display of the correct position also see
paragraph 8.4.1 and 8.4.2.
This is how you proceed at every measurement. If you want to save
several measurements at the same time in the operator device, you
need a correspondent number of sensor sets.
8.2 Saved Measurements
Once you have performed a measurement, the last measurement is
shown when you switch on the operator device the next time. In the
menu item Saved measurements, you can also see the last measure-
ment or choose the desired one from various measurements, if existing
(fig. 11). However, to continue a measurement, the sensors have to
remain firmly attached and must not be removed in the meantime.
8.3 Delete Measurements
With this menu item, you have the possibility to delete old measure-
ments (fig. 12). To do so, select the measurement you want to delete
and confirm by pressing Yes.
ANKLEANKLE
DD -- PP
AAAA
fig. 9
KNEEKNEE
fig. 10
AA-AA-
KAFOKAFO
LEFTLEFT
Saved measurementsSaved measurements
fig. 11
fig. 8
New measurementNew measurement
Saved measurementsSaved measurements
Delete measurementsDelete measurements
SettingsSettings
MenuMenu
fig. 12

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8.4 Settings
8.4.1 Display Options
When displaying the correct position, you can always see the dorsiflex-
ion and plantar flexion of the ankle and the flexion and extension of
the knee. In the menu item Display options (fig. 13), you can choose
whether you would also like to see the pronation-supination of the
ankle and the genu varum/genu valgum of the knee. To do so, place or
remove the ticks according to your preference and press Save.
At delivery status, the display options Ankle Pron.-Sup. and Knee
Varus-Valgus are deactivated to facilitate the initial handling. Decisive
for the later functionality of the orthosis are the dorsiflexion and plan-
tar flexion of the ankle and the extension and flexion of the knee.
8.4.2 Sound Options
In this menu item, you can select whether there should be a beep when the dot on the bar gets closer to the
saved position. If the actual position diers too much from the saved one, no beep is emitted. If the dot is in
the middle right from the beginning, meaning you have found the correct position right away, there is also no
beep.
You have four possibilities for the sound setting:
- A beep is always emitted when you get closer to the correct
position.
- A beep is only emitted when you get closer to the correct
flexion-extension and dorsiflexion-plantar flexion.
- A beep is only emitted when you get closer to the correct
pronation-supination and genu varum-genu valgum.
- There is never any beep emitted.
To do so, place or remove the ticks according to your preference and
press Save (fig. 14).
8.4.3 Display Brightness
You can set the display brightness by choosing between values from 0
to 5 with the Arrow buttons (fig. 15). At 0, the display light is switched
o, whereas 5 is the maximum brightness level. Press OK to save. The
lower you set the display brightness, the longer is the rechargeable
battery’s life.
Display optionsDisplay options
Ankle Pron.-Sup.Ankle Pron.-Sup.
Knee Varus-ValgusKnee Varus-Valgus
SaveSave
fig. 13
Sound optionsSound options
Beep F-E & DPBeep F-E & DP
Beep P-S & V-VBeep P-S & V-V
SaveSave
fig. 14
Display brightnessDisplay brightness
55
fig. 15

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8.4.4 Language
You can set the language of the operator device in the menu item
Language (fig. 16). You can select between German and English. At
delivery, the German language is preset. Choose the desired language
with the arrow and confirm by pressing OK.
8.4.5 Device Info
Here, you can see the device version of the operator device in order to
check if your operator device is up to date. To do so, go to “Software
Updates” (see QR code, fig. 24) in the download section at
www.fior-gentz.com and compare your device version with the latest
one.
The versions of the last three sensors that were connected to the
operator device are also shown in this menu item (fig. 17).
8.4.6 Update Sensors
When updating the operator device (see paragraph 11), the sensor up-
date is downloaded simultaneously, if there is an update. In the menu
item Update sensors, you can then see if there is an update. Here, you
can update each active sensor separately. If you have activated several
sensors, the operator device can show up to eight sensors. If there is an
update available, you can select an item, e.g. Update yellow sensor. If
there is no update, this menu item cannot be selected (fig. 18). Always
update all three sensors of a sensor set if there is an update available.
8.4.7 Calibrate Sensors
In order to ensure that your measurements with the e-Cast are as exact
as possible and to minimise any deviations of these measurements, you
should calibrate all sensors once a year and after each battery replace-
ment. To do so, choose Settings in the menu of the operator device and
subsequently the menu item Calibrate sensors (fig. 19). Here, you can
calibrate each active sensor separately. If you have activated several
sensors, the operator device can show up to eight sensors.
Additionally, the display shows when the active sensors were last cali-
brated (e.g. 3 month(s) ago) or if a sensor’s calibration is recommended
(fig. 20). The display also shows a message if the sensor needs to be
updated first before it can be calibrated.
Follow the steps of the operator device to calibrate a sensor.
After you have finished calibration, you can repeat it with the other
sensors by activating (shaking) and choosing the required sensor in the
menu item Calibrate sensors.
LanguageLanguage
DeutschDeutsch
EnglishEnglish
fig. 16
Device infoDevice info
Device version 1.00.00Device version 1.00.00
Red: version 1.00.07Red: version 1.00.07
Yellow: version 1.00.07Yellow: version 1.00.07
Green: version 1.00.07Green: version 1.00.07
fig. 17
SettingsSettings
Sound optionsSound options
Display brightnessDisplay brightness
LanguageLanguage
Device infoDevice info
Update sensorsUpdate sensors
fig. 18
fig. 19
Display brightness
Language
Device info
Update sensors
Calibrate sensors
SettingsSettings
Green: calibration rec.
Yellow: calibration rec.
Red: 1 month(s) ago
Search again
!!
!!
Calibrate sensorsCalibrate sensors
fig. 20

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9. Indication of Rechargeable Battery’s/Bat-
tery’s State of Charge
9.1 Rechargeable Battery’s State of Charge of the
Operator Device
At the operator device you can see the rechargeable battery's state
of charge at the top right when displaying the correct ankle and knee
position (fig. 21). It indicates the state of the rechargeable battery of
the operator device. The rechargeable battery lasts about 15 hours at
maximum display brightness. To extend the rechargeable battery‘s life,
you can lower the display brightness.
9.2 Battery's State of Charge of the Sensors
At the operator device you can see the battery's state of charge at the
top left when displaying the correct ankle and knee position. It indi-
cates the state of the batteries of the three connected sensors (fig.22).
You can only see the battery's state of charge when the sensors are
connected and activated. If the sensors are not connected or not
activated, there are three crosses displayed (fig. 23). If the batteries are
almost empty, they blink on the display. The lifespan of the batteries is
about 150 hours.
To prevent the sensors from activating during transport, you can put
them in sleep mode. To do so, store the sensors in the case in such a
way that they are either upside down or face down (see also para-
graph7.3).
10. Charging the e-Cast Operator Device
The operator device has a rechargeable battery. To charge the operator device, connect it to the delivered cable
and adapter.
11. Updating the e-Cast Operator Device
When a new update is available, the operator device can be updated with the delivered
cable via “Software Updates” (see QR code, fig. 24) in the download section at
www.fior-gentz.com (for the sensors update see paragraph 8.4.6). We recommend to
check if your operator device is still up to date at regular intervals and to update it if
necessary. In the menu item Device info, you can see which version is on your operator
device. To update the operator device, proceed as follows:
1 Download the update and open the file.
2 Connect the operator device to your computer using the cable.
3 You must neither turn off the device nor remove the cable during the updating process.
4 Turn on the operator device.
5 If an update is available, you can see the message "Currently connected to ET3400-T version XXX. Device
can be updated to version XXX.". If your device is up to date, it says "Currently connected to ET3400-T
version XXX. Device is up to date.".
ANKLEANKLE
DD -- PP
AAAA
fig. 21
ANKLEANKLE
DD -- PP
fig. 22
ANKLEANKLE
DD -- PP
fig. 23
fig. 24

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12. Dirt Removal from the e-Cast Operator Device
To clean the operator device, use a damp cloth. Do not hold the device under running water. We recommend
wrapping the operator device in cling film while making the cast to keep it dry and clean.
13. Dirt Removal from the e-Cast Sensors
The sensors can be cleaned with a damp cloth or under running water. However, do not immerse them in a
water bath. It is also possible to disinfect the sensors.
14. Advice on Production Techniques
For information on how to proceed when using the e-Cast also see the fold-out poster
(see QR code, fig. 25) included in the e-Cast case.
You will find information on the general production technique for making a negative
cast (see QR code, fig. 26) on our website www.fior-gentz.com in the section “Online
Tutorials”. fig. 25
fig. 26

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15. Short Guide for a New Measurement
1 Go to the menu item New measurement and choose between new or previously created patient data. In
the first case, decide which orthosis type (KAFO, AFO or KO) you would like to produce for which leg (left or
right). In the latter case, decide if you want to Use connected sensors or Search for new sensors.
2 Save the patient’s initials and wait until the operator device is connected with the sensors.
3 Bring the patient's leg in a horizontal position with the toes pointing upwards and the foot being in the
desired external rotation. Press OK.
4 Have the patient stand in their individual normal posture and press OK.
5 Confirm again by pressing Continue to start with the casting. You will then see the position of the ankle
and the knee. With the Arrow buttons you can switch between the ankle and the knee display. When the
dot is in the middle, you have reached the correct position.
16. Signs and Symbols
Do not dispose of electronic devices with household waste. Dispose of the device
and accessories at ocial delivery points for electronic devices.
temperature limit values for storage/for transportation
17. Legal Information
With the purchase of this product, our General Terms and Conditions of Business Transactions, Sales, Delivery
and Payment will apply. The warranty only applies if the product is used under the described conditions and for
the intended purpose.
Since we are not able to check the compliance of handling and dealing with batteries, we cannot assume any
liability for any damages or costs caused by batteries.
The information in these instructions for use is valid at the date of printing. The contained product information
serves as guidelines. Subject to technical modifications.
All copy rights, particularly the distribution, copy and translation of these instructions for use or any part
of them, must be authorised by FIOR&GENTZ Gesellschaft für Entwicklung und Vertrieb von orthopädie-
technischen Systemen mbH. Reprints, copies and any other electronic reproductions, even partial, are not
permitted to be distributed without being authorised in writing by FIOR &GENTZ Gesellschaft für Entwicklung
und Vertrieb von orthopädietechnischen Systemen mbH.

PB3400-DE/GB-2023-01
Gesellschaft für Entwicklung und Vertrieb
von orthopädietechnischen Systemen mbH
Dorette-von-Stern-Straße 5
21337 Lüneburg (Germany)
info@fior-gentz.de
www.fior-gentz.com
[phone]
[phone]