Otto Bock ActiGait User manual

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2 3
4 5 6
7 8
1: ActiGait® Heel Switch
2: ActiGait® Belt Loop
3: ActiGait® Body Clip
4: ActiGait® Belt Clip
5: ActiGait® Control Unit
6: ActiGait® Antenna
7: ActiGait® Heel Sock
8: ActiGait® Antenna Fixture
9: ActiGait® Charger (model FW7711/0.7) incl. plugs
10: ActiGait® Charger Cable
9a 9b 9c 9d
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ActiGait® Implantable Drop Foot Stimulator
User Manual

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1. Introduction ...................................... 3
2. Intended Use .................................... 3
2.1 Medical Purpose .................................... 3
2.2 Application............................................. 3
2.3 Qualification of Clinician.......................... 3
2.4 Follow up Schedule ................................ 3
3. Indications/Contraindications .... 4
3.1 Indications ............................................ 4
3.2 Contraindications ................................... 4
4. Warnings and Precautions........... 5
4.1 Safety precautions ................................. 5
4.2 Warnings............................................... 5
4.3 General cautions ................................... 7
4.4 Potential Risks/Side effects ..................... 9
5. Service Information...................... 11
5.1 Scope of Delivery ................................. 11
5.2 Service................................................ 11
6. Description of the ActiGait®....... 12
6.1 The ActiGait®Implant ........................... 13
6.2 The ActiGait®....................................... 14
7. How ActiGait®works ................... 15
7.1 The Control Unit ................................... 16
7.1.1 The On/Off Button ............................. 17
7.1.2 The Stimulation Intensity Buttons ......... 18
7.1.3 The Mute Button ................................ 19
7.1.4 The Pairing Button ............................. 21
7.1.5 The Control Unit Battery Indicator ........ 22
7.1.6 The Heel Switch Battery Indicator ........ 23
7.1.7 Training Mode Indicator ...................... 25
7.1.8 Mute Indicator ................................... 27
7.1.9 Stimulation Intensity Indicators ............ 27
7.2 Putting On the Control Unit.................... 27
7.2.1 The Belt Clip ..................................... 28
7.2.2 The Belt Loop .................................... 28
7.2.3 The Body Clip ................................... 29
7.3 Putting On the Antenna Fixture............... 30
7.4 Putting On the Antenna ......................... 33
7.5 The Heel Switch ................................... 35
7.5.1 The Heel Sock................................... 36
7.5.2 Heel Switch Feedback........................ 37
7.6 The Charger ........................................ 38
7.6.1 Charging the Control Unit................... 39
7.6.2 Travel Kit for Charger ......................... 41
7.7 Audio Signals and Warnings .................. 42
7.7.1 Warnings .......................................... 42
7.7.2 Audio Signals .................................... 43
8. Lights and Audio Signals............ 43
8.1 How to Interpret the Light Indicators ....... 44
8.2 How to Interpret the Audio Signals ......... 46
9. Troubleshooting for ActiGait® ... 49
10. Warranty......................................... 51
11. Expected lifetime ....................... 52
12. Cleaning, Storage and
Disposal........................................... 52
12.1 Cleaning............................................ 52
12.2 Storage............................................. 53
12.3 Disposal ............................................ 53
13. Available Articles ....................... 53
14. Technical Data.............................. 55
14.1 ActiGait® Control Unit.......................... 55
14.2 ActiGait® Belt Clip .............................. 56
14.3 ActiGait® Belt Loop ............................. 56
14.4 ActiGait® Body Clip............................ 57
14.5 ActiGait® Antenna .............................. 57
14.6 ActiGait® Antenna Fixture..................... 58
14.7 ActiGait® Heel Switch.......................... 58
14.8 ActiGait® Heel Sock ............................ 59
14.9 19.9 ActiGait® Charger Cable .............. 59
14.10 ActiGait® Charger ............................. 60
14.11 ActiGait® Implant .............................. 61
14.11.1 X-Ray Identication......................... 62
15.Classication................................ 62
16. List of symbols............................. 63
16.1 Ingress Protection............................... 65
17. Declaration of Conformity ....... 65

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1. Introduction
This manual describes the use of the ActiGait® and is directed towards individuals
with an ActiGait® Implant. The manual is to be used as an information resource and
an instruction manual. The term “User” denes individuals who have an ActiGait®
Implant and thereby are users of the ActiGait®.
For clinicians the Clinician Manual (647G805=GB) is available
2. Intended Use
2.1 Medical Purpose
The ActiGait® is solely to be used as treatment in patients having a drop foot follow-
ing an upper motor neuron lesion.
2.2 Application
The ActiGait® system is a partially implantable medical device for treatment of drop
foot which activates the muscles of the lower leg during walking. The system is
intended for use by persons suering from paralysis of the ankle dorsiexor muscles
caused by damage to the central nervous system. The largest group of potential users
are persons with hemiplegia as a consequence of stroke. The system will not function
for people with drop foot caused by peripheral nerve damage.
2.3 QualicationofClinician
The selection of users for ActiGait®, setup and adjustment are done by clinicians such
as medical doctors, physiotherapists or equivalent. To be able to program and adjust
the ActiGait®, the clinician must have obtained a certicate on usage of the Clinical
Station software following training by Otto Bock
2.4 Follow up Schedule
It is recommended that the ActiGait® is activated 1-3 weeks after implantation, as the
wound healing must be nished rst. The user should thereafter be followed closely
with 2-3 follow-ups during the rst 6 months for ne-tuning of the settings and gen-
eral guidance. Subsequently, the user should be seen in the clinic on request.

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3. Indications/Contraindications
Potential candidates for the ActiGait® are stroke patients with drop foot. The pa-
tients who may benet from use of the ActiGait® are characterized by lacking the
ability to obtain normal heel contact during gait. It must be possible to correct the
heel contact by electrical stimulation of the peroneal nerve.
3.1 Indications
The individuals must:
• have a one-sided hemiparesis persisting for at least 6 months due to a cerebro-
vascular accident (CVA)
• be fully grown-up
• be able to walk 20 m in less than 2 minutes with or without a walking aid but
without the help of another person
• have a reduced speed of walking
• be able to stand upright with both heels touching the oor while hip and knee
are in neutral position
• have a passive range of movement of the aected ankle joint of at least 30 de-
grees
• have a positive response to surface electrical stimulation of the peroneal nerve –
i.e. muscle contraction results in ankle dorsiexion and improved gait
3.2 Contraindications
Individuals with:
• peripheral nerve damage in the aected leg
• severe or uncontrolled diabetes mellitus with peripheral nerve involvement
• poor skin condition on the aected leg
• a thickness of subcutaneous adipose layer on the thigh exceeding 40 mm.1
• inability to walk 100 m without stopping prior to CVA (with or without a walking
aid, but without the help of another person)
• poorly controlled epilepsy
• need for Ankle Foot Orthosis (AFO) to maintain ankle stability
• concomitant medical and psychological conditions, which would limit the suc-
cess of the ActiGait®, such as: active degenerative diseases of the back and legs,
neglect or drug abuse
1 Individuals who by visual inspection seem to have an adipose layer of about 40 mm at the
site where the stimulator should be placed must undergo a more precise examination to
measure the exact thickness of the adipose layer (e.g. using ultrasonic measurement
methods.)

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• concomitant medical and psychological conditions, which would compromise
the safety of the patient in connection with the implantation and use of the Ac-
tiGait®, such as: severe cardiac disease, uncontrolled hypertension or history of
malignancy within the preceding ve years
• other active implanted devices, such as demand pacemakers or implanted de-
brillators, as mutual electromagnetic interference may distort the ecacy of both
devices and expose the patient to dangerous situations
4. Warnings and Precautions
4.1 Safety precautions
Neurodan A/S is solely responsible for the safety, reliability, and function of the
apparatus on the condition that repairs, adjustments, and alterations, incl. replace-
ment of batteries, have been carried out by an individual appointed by Neurodan
A/S and when the apparatus is used in accordance with the manual.
The ActiGait® and the ActiGait® Accessories contain radio circuits approved by the
relevant authorities. Changes or modications to any part of the ActiGait® or the
ActiGait® Accessories could void your authority to operate the equipment.
Maintenance may only be carried out by trained personnel. It is the responsibility of
the physician to inform the patient about all potential risks, warnings and precau-
tions.
It is the responsibility of the clinician to instruct the patient in the correct use of the
ActiGait® and to inform the patient to contact the clinician about any discomfort
while using the ActiGait®.
4.2 Warnings
• The ActiGait® is a device for treatment of drop foot, and must be considered and
used accordingly. Stimulation of other nerves besides the peroneal nerve with the
ActiGait® involves a risk of potentially hazardous side eects. It is not meant as a
device that eliminates or cures any condition.
• Implanting the ActiGait® Implant requires experience in peripheral nerve opera-
tions and handling of active implantable medical devices. Training is performed
by self-study of the Surgeon Manual and the following steps:

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• Attending product training by OB personnel
• Observing or assisting in the implantation of an ActiGait® Implant by an
experienced surgeon
• Performing the rst surgery under supervision of a surgeon experienced in
the procedure
• The clinicians, who select the patients and set up the ActiGait® stimulation,
must be properly trained by someone experienced in patient selection and
programming of the ActiGait®. The trainer must be authorized by Otto Bock. Im-
proper selection of patients and programming of the ActiGait® may result in lack
of eect of stimulation or lack of improvement of gait. Improper selection and
programming may expose the patient to dangerous situations, discomfort or pain
and the risk of falling during walking.
• ActiGait® patients should not engage in any activity which leaves them in a dan-
gerous situation if the ActiGait® fails.
• The ActiGait® should not be exposed to therapeutic levels of ultrasound energy,
as the device may inadvertently concentrate the ultrasound eld and cause harm.
• Shortwave or microwave diathermy should not be used. Both the heating and
non-heating modes of operation pose a risk of tissue destruction. If given any
medical treatment in which an electrical current is passed through the body from
an external source, care should be taken to monitor the functioning of the Acti-
Gait® Implant during the initial stages of treatment.
• The electronic components of the ActiGait® Implant may be damaged by thera-
peutic ionizing radiation. This kind of damage may not be immediately detect-
able.
• Application of magnetic resonance imaging (MRI) or spectroscopy techniques to
a patient with the ActiGait® Implant involves a risk of potentially hazardous side
eects. Patients with an ActiGait® Implant should seek medical guidance before
entering environments with strong magnetic or electromagnetic elds, such as
magnetic resonance (MR) scanners or strong radio-transmitters or radars, includ-
ing areas protected by a warning notice preventing entry by patients tted with
a pacemaker, as strong electromagnetic elds may heat the device excessively or
result in uncontrolled pulses.
• Use of electrical stimulation in pregnancy involves a risk of potentially hazard-
ous side eects. For use during pregnancy qualied medical guidance should be
obtained.
• Extended periods of time with the legs in a xed position, e.g. during travelling,
should be avoided as this may cause uid retention in the leg.

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• The ActiGait® may not be used at an ambient temperature of more than 40° C
due to risk of skin burn2. If the ambient temperature is above 40°C, the surface
temperature of the ANT can exceed the intended maximum temperature of
42.5°C (the intended maximum temperature will not cause any harm to the skin).
However, if any problems occur, please contact your local ActiGait® representa-
tive or your clinician.
• The ActiGait® may be interfered with by other equipment, even if that other
equipment complies with CISPR emission requirements.
4.3 General cautions
• The ActiGait® should not be exposed to extreme pressure as this will damage the
device.
• The external parts of the ActiGait® (e.g. the Control Unit, Antenna and Heel
Switch) should not be immersed in water as this will damage the device. Proper
maintenance instructions must be followed and the external parts should be
shielded e.g. when walking in rain.
• The ActiGait® should not be used in areas where explosives are used or stored
due to radio interference.
• This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to part 15 and part 18 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 instruc-
tions, may cause harmful interference to radio communications. However, there
is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television recep-
tion, which can be determined by turning the equipment o 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 dierent from that to
which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help
2 In warm weather you must be extra aware of skin irritation where the ActiGait® is in contact
with your skin. In case of skin irritation you should remove the ActiGait®.

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• The ActiGait® is radio controlled and may be disturbed by interfering devices;
consequently, the eectiveness of the ActiGait® can be disturbed. In this situa-
tion you should move away from the source of the disturbance or turn o your
ActiGait®.
• The external parts of the ActiGait® must be turned o on airplanes during a
ight, as the radio transmission may interfere with other devices. Because the
Heel Switch cannot be turned o it should be taken o and removed from the
body during the ight to avoid activation of the switch.
• The ActiGait® may only be used at an atmospheric pressure between 700 hPa to
1060 hPa.
• Magnetic cards, such as bank or credit cards, should not be kept near the Control
Unit, the Antenna plug, the Charger Cable, the Clinical Interface, the Body Clip,
Belt Clip and Belt Loop at any time, as these devices contain magnets that may
demagnetize a magnetic card.
• Magnetic cards, such as bank or credit cards, should not be kept near the Anten-
na while the ActiGait® is in use, as the card may become demagnetized.
• Wireless communication equipment such as wireless home network devices, mo-
bile phones, DECT telephones and their base stations, Bluetooth devices etc. may
disturb the ActiGait® during its use. These devices should be kept at a distance
from the ActiGait® according to the table below.
• The Control Unit should be removed from the patient’s body while charging the
Control Unit or when the Control Unit is connected to a PC with the Clinical Inter-
face to eliminate the risk of the patient being exposed to electrical shock.
• The ActiGait® should never be connected to other cables, e.g. extension cables,
than the ones supplied with the ActiGait®. If another cable is used and this cable
is defect there will be a risk of electrical shock or overheating of the equipment.
• Only the ActiGait® Charger and ActiGait® Charger Cable should be used for charg-
ing the ActiGait®. Further, the ActiGait® Charger and ActiGait® Charger Cable
should not be used for charging other equipment than the ActiGait®. In such a
case, the manufacturer will not be liable for any damages.
Device type Distance
Mobile phone 0.33 m
DECT telephones (incl. base stations) 0.12 m
Wlan 0.23 m
Bluetooth devices 0.075 m

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• The internal batteries in the Control Unit and Heel Switch are not replaceable. If
you open the Control Unit or Heel Switch, the seals will be broken and you will
compromise the ingress protection. The Control Unit battery has a life time of
5 years. When the capacity of the Control Unit battery is no longer sucient to
last for 1 day of use, the Control Unit should be discarded and replaced with a
new one. When the Heel Switch battery runs out of power, the whole Heel Switch
must be discarded and replaced with a new one.
• The ActiGait® should not be used while operating dangerous machines, which
require foot or leg operation with the aected leg, such as motor vehicles, air-
planes, industrial machinery etc., as failure of the ActiGait® may leave the patient
in a dangerous situation.
• The ActiGait® fullls all technical and legal requirements for use in the European
Community. The ActiGait® has not yet been formally investigated for use outside
this area. ActiGait® uses a wireless communication technology. Restrictions of
its use may exist in some countries outside the area mentioned above. Please
contact your local ActiGait® representative if in doubt whether the ActiGait® may
be used in a specic area outside the European Community.
• There is a risk of rupture of the skin if the sutures are removed earlier than 14
days post surgery.
• Preoperative use of antibiotics is recommended to reduce the risk of infection.
Infection is a potential hazard at any kind of surgery and the principle of preop-
erative use of antibiotics is therefore generally accepted.
• If the leg is not bandaged with elastic bandage or antithrombotic stocking up to
the groin after surgery, uid collections, such as oedema, may occur around the
Implant.
4.4 Potential Risks/Side effects
As with all surgical procedures, the implantation of a stimulation system involves
some risks. In addition to those normally associated with surgery, the implantation
and use of the ActiGait® carries the following risks:
• Infection
• Accidental damage of the nerve during surgery
• Subjects undergoing anticoagulation therapies may be at greater risk for post
operative complications such as hematomas
• Reoperation due to malfunction of the Implant

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• Nerve damage in the case of the cu electrode constricting the nerve
• Skin reactions to the material of the external components of the ActiGait® (Heel
Switch and Antenna Fixture) in permanent contact with the body
• Device extrusion/migration
• In the presence of strong, environmental electromagnetic elds the device may
heat excessively or send out uncontrolled pulses to the nerve
• If the ActiGait® malfunctions and the device does not stimulate, the patient may
stumble
• Intolerable sensory stimulation during use (pain or paresthesia)
• Muscle pain may result from too high stimulation intensity or continuous stimu-
lation
• Pain in the ankle joint or other joints of the aected and non-aected lower limbs
may result from a change in movement pattern or improper programming of the
ActiGait®
• The distance between the Implant and the Antenna of the external device may
exceed 40 mm due to swelling around the Implant after operation, general
oedema, or increase in the subcutaneous adipose layer
• Damage to the external parts of the ActiGait® due to improper cleaning methods
• Inability to produce an acceptable dorsiexion movement due to 1) excessive
spasticity, 2) improper programming of the ActiGait® or 3) movement or incorrect
installation of the cu-electrode
The safety of the ActiGait® has been documented by evaluating reports on Device
Related Adverse Events and measurements of conduction velocity of the common
peroneal nerve (branches for extensor digital muscles, anterior tibial muscle and
peroneal muscles) before and three months after implantation.

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5. Service Information
5.1 Scope of Delivery
The term “ActiGait®” is dened as the parts of the system that you have in or on your
body. Besides this you will be given various “ActiGait® accessories” that you need for
maintaining your ActiGait®. To be able to use the ActiGait® system you will need the
following items:
Item Part Number
ActiGait®
1 ActiGait® Control Unit 9002=11
One of the following xtures
1 ActiGait® Belt Clip 9002M=11A
1 ActiGait® Body Clip 9002M=11B
1 ActiGait® Belt Loop 9002M=11C
1 ActiGait® Antenna 9002=13
1 package of ActiGait®
Antenna Fixtures of 15 pieces
9002=M03
1 ActiGait® Heel Switch 9002=12
1 ActiGait® Heel Sock 9002M=123
ActiGait® Accessories
1 ActiGait® User Manual 647G808=country code
1 ActiGait® Charger 9002=14
1 ActiGait® Charger Cable 9002=15
1 ActiGait® User Suitcase 9002=17
5.2 Service
The ActiGait®must be set up and put into service in accordance with the information
provided in this manual. Check ActiGait® for any visible damage before every use. In
case of damage, malfunction or unexpected operation or events, contact your clini-
cian or local ActiGait®representative.3
3 The Heel Socks have the following number format: 9002M=12[Size-Color code]. Sizes:
XS=Extra Small, S=Small, M=Medium, L=Large, XL=Extra Large, XXL= Extra Extra Large.
Color code: 0=Beige, 6=White, 7=Black

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Contact your local ActiGait®representative for assistance, if needed, in setting up,
using or maintaining the ActiGait®.
Modication of the equipment is not allowed. If the equipment is modied by an
unauthorized person or organization, the responsibility and liability for the equip-
ment is transferred to the person/organization modifying it.
6. Description of the ActiGait®
The ActiGait® Implant and other main parts of the ActiGait® are illustrated in Fig-
ure 1.
Figure 1: The Implant and other main parts of the ActiGait® and their locations during use.
Control Unit
Heel Switch
Cu Electrode
Stimulator body
Antenna
The purpose of the ActiGait®is to lift your foot during the swing phase of walking.
When you walk, the Heel Switch detects your heel strike and heel lift and transmits
signals wirelessly to the Control Unit. If you have the Heel Switch on the aected
foot, the Control Unit sends power and control signals to the Antenna on your thigh
when it receives a heel lift signal. The Antenna then transmits power to the im-

13
planted stimulator through the skin via an inductive link and the Implant activates
the muscles which produce a foot lift while you bring the aected leg forward in the
swing phase. When you put your heel down again, the Control Unit receives a heel
strike signal from the Heel Switch. The stimulation will continue shortly so that your
foot will be set down in a well balanced way.
If you have the Heel Switch on the unaected foot, the muscles on the aected leg
will be activated by a heel strike instead of heel lift to produce the foot lift at the cor-
rect time. You can choose which foot you want to carry the Heel Switch on according
to your preference and your clinician’s advice. However, you can only switch from
one foot to the other when you are at the clinic because your clinician must set up
the stimulation timing accordingly.
Your clinician can connect the Control Unit to a PC and adjust the stimulation inten-
sity and the timing with a dedicated ActiGait® software program so that it matches
your gait pattern and walking speed. The clinician will set a range within which you
can adjust the stimulation intensity with the Control Unit. Only trained clinicians
can adjust the ActiGait®.
6.1 The ActiGait®Implant
The Implant consists of a stimulator body (1), a cu electrode (2) and a cable (3).
The Implant does not have an internal power source (such as a battery) and is ac-
tivated through magnetic induction from an external power source. The Implant is
as such passive, and it is necessary to have an ActiGait® Control Unit and ActiGait®
Antenna to activate it.
Figure 2: The Implant
1
2
3

14
The stimulator body (1) contains the receiver coil and electronics. The coil converts
the signal from the external Antenna into an electrical current, which both powers
and controls the Implant.
The cable (3) consists of eight individual metal wires, coiled in two bundles of
four. The wires are individually coated with ETFE (Teon), and the two bundles
are inserted into a dual-lumen silicone tube. This design allows the cable to stretch
slightly and makes it resistant to exion and extension.
The cu electrode (2) is a silicone cu, 23 mm long with 12 platinum/iridium con-
tact discs located on the inside. These discs form the electrical contact to the nerve.
The electrode contacts are organized as four sets of three, each triplet making up
one channel. The four channels are distributed evenly around the nerve, in order to
allow selective stimulation of dierent fascicles inside the nerve.
6.2 The ActiGait®
The ActiGait® consists of the Heel Switch (1), the Belt Loop (2), the Body Clip (3),
the Belt Clip (4), the Control Unit (5), the Antenna (6), the Heel Sock (7) and the
Antenna Fixture (8) (see Figure 3).
1
7
3
8
54
2
Figure 3: The ActiGait®. 1: Heel Switch, 2: Belt Loop, 3: Body Clip, 4: Belt Clip, 5: Control Unit, 6: An-
tenna, 7: Heel Sock, 8: Antenna Fixture
6

15
Furthermore, you will be supplied with the accessories shown in Figure 4, i.e. the
Travel Kit for the Charger consisting of 4 dierent plugs (9), the Charger (10) and the
Charger Cable (11).
7. How ActiGait®works
When you receive your ActiGait®, the package will contain the items shown in
Figure 3 and Figure 4. This chapter explains everything about the ActiGait®and its
accessories.
9a 9d9b 9c 10
11
Figure 4: ActiGait® accessories. 9: Travel kit for Charger, 10: Charger, 11: Charger Cable

16
7.1 The Control Unit
The Control Unit (Figure 5) controls the implanted stimulator via the Antenna,
which must be located on the skin on top of the implanted stimulator. The Control
Unit receives signals from the Heel Switch (see section 7.5 on page 35) about
when to stimulate.
The various buttons are described in the following sections. The Control Unit should
be carried at the waist but additional positions are also possible. On the back of the
Control Unit there is a magnet that keeps the Control Unit xed to the various x-
tures used for carrying the Control Unit (see section 7.2 on page 27 about Control
Unit xation).
The Control Unit has a number of light indicators that show the status of the Control
Unit (see Figure 6)
Figure 5: The control Unit
Light indicators
On/o button
Intensity up button Intensity down button
Pairing button
Mute button

17
Figure 6: The light indicators on the Control Unit
Control Unit
battery indicator
Training mode
indicator
Mute indicator
Stimulation
intensity
indicators
Heel Switch battery
indicator/Heel Switch
Feedback indicator
The light indicators are described in the following sections:
• Control Unit battery indicator: Section 7.1.5 on page 22.
• Heel Switch battery indicator/Heel Switch Feedback indicator: Section 7.1.6 on
page 23, and section 7.5.2 on page 37
• Training mode indicator: Section 7.1.7 on page 25
• Stimulation intensity indicators: Section 7.1.2 on page 18
• Mute indicator: Section 7.1.8 on page 27, page 36
7.1.1 The On/Off Button
The on/o button is used for switching the ActiGait® Control Unit on and o. You
must press the on/o button for at least 1.5 seconds to activate it.
Press the on/o button for at least 1.5 seconds
to switch the Control Unit on or o.

18
Every time the Control Unit is switched on it performs an indicator check. This
means that all light indicators will ash once and a short beep is heard. This can be
used for diagnostics because it shows if any of the light indicators or the buzzer is
defect. If a light indicator is defect the function will most likely still be intact. When
you switch o the Control Unit a long beep is heard. If the mute indicator (see sec-
tion 7.1.8 on page 27) is red the beeps are not heard.
During use, the lights on the Control Unit will power down to save power. This
means that the lights are turned o 30 seconds after the latest activation of a button
but stimulation will continue as normal. When the lights of the Control Unit are
powered down, a press on any button will switch the lights back on. The rst press
of a button when the lights of the Control Unit are powered down will therefore not
activate this button’s usual function.
7.1.2 The Stimulation Intensity Buttons
When you walk you might experience that you sometimes need more stimulation
than other times to get an adequate foot lift. This can depend on the kind of surface
that you are walking on, your shoes, if you are tired or experience spasticity. You
can turn the stimulation intensity up and down at any time with the intensity up (+)
and intensity down buttons (–) on the Control Unit.
Turning the stimulation intensity up =
increasing the foot lift…
…and down = decreasing the foot lift

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The row of light indicators on top of the Control Unit shows the current intensity
level of the stimulation. There are 7 light indicators so the stimulation intensity can
be adjusted in 7 steps. Your clinician will set the range within which you can adjust
the stimulation intensity with the Control Unit.
If you press the intensity up button when the stimulation intensity is already at the
highest level, you will hear a long beep to let you know that the stimulation inten-
sity cannot be increased further. Likewise, if you press the intensity down button
when the stimulation intensity is already at the lowest level, you will hear a short
beep. If the mute indicator is red (see section 7.1.8 on page 27) these beeps are
not heard.
7.1.3 The Mute Button
The mute button is used for switching o the sounds from the Control Unit. The
mute button is hidden under the Antenna plug, so you must disconnect the Antenna
from the Control Unit to access it. The mute button is a pencil button, meaning that
you must use a pencil or another pointy tool to press it. The mute button is marked
with the same icon as the mute light indicator.
Press the mute button with a pencil or similar.
The current mute setting is shown by the mute
light indicator.