Otto Bock 3B1-3 User manual

| © Ottobock
User Instructions
User instructions | Genium 3B1-3 | Academy | 1
General Information
02.11.2018
•The information given is essential for safe
usage
•Instructions for use (IFU) with patient
information and safety instructions
(646D1282*)
•Non-compliance with safety instructions
can lead to malfunctions of the knee joint
and possible risks to the end-user
•Changes or modifications to the system
components are not permitted

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User Instructions
User instructions | Genium 3B1-3 | Academy | 2
Feedback Signals
02.11.2018
•Important events (e.g. switching modes) are
indicated by feedback signals
•Feedback signals:
Vibration signals
Acoustic signals
•Do not ignore unexpected feedback signals
(check prosthetic function)
•Volume and tone (pitch) can be adjusted with X-Soft

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User Instructions
User instructions | Genium 3B1-3 | Academy | 3
Mode switching without Cockpit App
02.11.2018
•Switching into 1./2. MyMode via 3x/4x bouncing within 1 second
•After the weight is taken off the prosthesis one long beep signal occurs
•After that, a beep signal indicates correct switching (1, 2 or 3 beeps)
•Switching back into basic mode is always possible
40 % weight
Audio signals
indicate the
chosen mode
3x/4x in
1 sec
1x/2x/3x1x

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Charging
02.11.2018
•Connect the charger with the
Genium (magnetic connection)
•Check the charging status via the
color of the illuminated ring
•After removing the charger, the
knee joint performs a self-test (keep
the knee joint at rest –otherwise an
error could be detected)
•A single vibration and beep signal
indicates that the knee joint is ready
for operation (3x vibration usually
indicates an exceeded service
interval)
Only charge with the AXON
tube adapter connected
Charging is only possible at
temperatures between 10°C and
45°C (50°F –103°F). Do not charge
the knee joint next to a heater.

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LEDs and charging status
02.11.2018
•The LEDs on the side of the
charger show the charging
status of the knee joint
•Charging status:
5 LEDs = 90% and more
4 LEDs = 70-90%
3 LEDs = 50-70%
2 LEDs = 30-50%
1 LEDs = 10-30%
0 LEDs = 0-10%

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Query charging status
02.11.2018
•Turn the prosthesis upside down
•Keep knee joint at rest for 2 sec. and wait for feedback
signals (short beeps)
•Charging status:
5x = > 80%
4x = > 60%
3x = > 40%
2x = > 20%
1x = < 20%
•The charging status indication doesn’t work if:
•the charger is still attached
•the knee joint is not in Basic Mode (e.g. in a MyMode
plus)
•the volume is set to “0” in X-Soft
•the Mute mode is activated in Cockpit App
Charging feedback
doesn’t indicate a
system error!

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User Instructions
User instructions | Genium 3B1-3 | Academy | 702.11.2018
Status Status LED Charging status indicator
Charger is connected
to outlet and is not
charging
Continuous
green All five LEDs off
Charger is connected
to the knee joint, good
connection and
charging
Purple
pulsing Charging status indicator
Charger has been
disconnected Continuous green All five LEDs off

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User Instructions
User instructions | Genium 3B1-3 | Academy | 802.11.2018
Status Status LED Charging status indicator
Charger is connected
to the knee joint, poor
connection Weak purple Charging status indicator
a) Charger excess
temperature
b) Knee joint excess /
insufficient temperature
c) Poor connection
Continuous
yellow (= no
charging)
a) 2nd and 4th LED
illuminated
b) 1st, 3rd and 5th LED
illuminated
c) 3rd LED illuminated
Charger fault (error
may be rectified by
reconnecting the power
supply)
Flashing red Error code for service

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Charging status
02.11.2018
The charging status is also indicated via feedback signals and displayed
on the Cockpit app (and remote control).
Remaining
operating time Charging status Feedback signal
approx. 24 h 25 % 3x long vibration signal
approx. 6 h 10 % 5x long vibration signal
0 h 5 % 10 x long vibration and
beeping signal

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Lowering the power consumption
02.11.2018
•There are two possibilities to lower the power
consumption significantly:
The knee joint is in a sitting or lying position and is kept
at rest for longer than 2 seconds (the knee joint switches
into the energy saving mode whenever sitting is detected
whether or not the sitting function is activated in the knee
joint)
The extended knee joint is kept at rest and is not under
load (after 2 minutes the knee joint switches into the
energy saving mode).
•In both cases, certain sensors are deactivated
•If the knee joint leaves the sitting/power saving position,
all sensors are automatically reactivated

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Safety modes –General information
02.11.2018
•The Genium features various safety
modes
•As soon as an error is recognized
the joint activates one of the safety
modes
•Depending on the type and severity
of the error different levels of
residual functionality are offered
•The knee joint remains in the safety
state until the error is corrected
Residual functionality
Error
type

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Safety modes –General information
02.11.2018
•As soon as a warning signal is emitted stop all activities
involving the prosthesis immediately
•An error is displayed with at least 5 long beeps and 5
slow pulsing vibration signals
•Stairs and Obstacles function, Auto Stance function,
Sitting function and OPG are always deactivated!

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Safety modes –Reasons
02.11.2018
•Error from one or more of the sensors (AXON tube
adapter, IMU etc.)
OR
•Self-test error after disconnecting the charger
Connect and disconnect the charger to restart the
knee joint (possible to do this multiple times). If the
error remains, please contact the OB helpline
OR
•Empty battery

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Safety modes –Overview
02.11.2018
Moderate error
•Loss of the AXON tube adapter
Severe error
•Loss of one or more sensor(s)
Total failure
•Insufficient or no electrical functionality
Drained battery
Overheating mode
≤ 5%
0%
Andauernd
Every 5 seconds
1x

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Safety modes –Moderate error
02.11.2018
•Three co-operating sensor groups:
AXON tube adapter (strain gage sensors)
Knee moment senor
Knee sensors (IMU)
•If the tube adapter is lost, the two remaining groups take over
•This error is displayed with 5 long beep and vibration
signals (vibration signal repeats every 60 seconds)
•Triggering stance release is possible due to the other sensor
groups
•No PreFlex, no OPG, no possibility to switch into a MyMode
(walking comparable with C-Leg 3)

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Safety modes –Severe error
02.11.2018
•Loss of the knee angle sensor, knee moment sensor or IMU (also in
combination with AXON tube adapter):
•These errors are displayed with 30 long beep signals and
alternating short and long vibration signals
•Stance release is not possible
•Usage of the knee joint is not permitted anymore
•Depending on the error:
•In X-Soft adjusted safety mode flexion resistance OR
•Locked knee joint in flexion direction (error of valve sensor)
•The safety mode flexion resistance can be set individually by the
CPO in X-Soft and adjusts gradually in case of an error (within
max. 10 seconds)
•With a low resistance, the knee joint has to be actively secured at
heel strike
See your CPO
immediately!

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Safety modes –Total failure
02.11.2018
•Undetermined status
•These errors are displayed with a continuous
vibration signal
•Insufficient or no electrical functionality (e.g. in case
of a short circuit caused by water penetration)
•Use of the knee joint is not permitted anymore
•Potentially the joint has to be actively secured at
heel strike
•Stance release is not possible
See your CPO
immediately!

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Safety modes –Drained battery
02.11.2018
•This safety mode is displayed with 10 long beep and
vibration signals (Battery level < 5%)
•The knee joint adjusts to the safety mode flexion resistance
•The safety mode flexion resistance can be set individually
by the CPO in X-Soft and adjusts gradually in case of a
drained battery (within max. 10 seconds)
•With a low resistance, the joint has to be actively secured at
heel strike
•No stance release possible
In the case of a drained battery, the prosthesis switches
back to basic mode after the battery is charged!
< 5%

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User Instructions
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Overheating mode
02.11.2018
•Typically caused by heavy use of the knee joint (e.g. long
downhill walking, biking in basic mode)
•Overheating is indicated by long vibrations every 5 seconds
•Reaction of the knee joint depends on the temperature
increase:
Stance phase flexion resistance increases (with
increasing temperature)
Swing phase flexion resistance decreases (with
increasing temperature)
•Consequence → User has to walk slowly
•Reduce activity until the hydraulics have cooled down
•OPG, PreFlex, sitting and stance function are still
available