Otto Bock ActiGait User Manual

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2 3

4 5 6

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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 follow­ing 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.

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• 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 Ac­tiGait®, 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. replace­ment 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 precau­tions.

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 opera­tions 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 dan­gerous 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 Acti­Gait® 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 hazard­ous 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® representa­tive 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 instruc­tions, 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 situa­tion 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 charg­ing 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=12

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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 clini­cian 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 equip­ment 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 Fig­ure 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-

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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 cor­rect 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 inten­sity 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

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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

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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 x­tures 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

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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 sec­tion 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

19

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 inten­sity 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.

20

The mute button has three settings:

As default, all sounds are activated and therefore the mute light indicator is green.
If you press the mute button once, the light indicator turns yellow and if you press
it once more, it turns red. The settings of the various audio signals are listed in
Table 1.

Warnings cannot be muted, only audio signals. See section 7.7.2 on page 43 for

explanation of the audio signals

All sounds are on.

All sounds are on, except for the Heel Switch feed­back.

All sounds are o, except for warnings.

Table 1: Mute settings

Stimulation

Intensity

maximum or

minimum

Heel Switch

feedback

Indicator

check

On On On

On O O

O O O

21

7.1.4 The Pairing Button

To avoid that another user’s Heel Switch can communicate with your Control Unit,

your Control Unit must be set up to only recognize your Heel Switch. This is called

pairing. The pairing button is a pencil button hidden under the Antenna plug below
the mute button. The pairing button is marked with the same icon as the heel switch
light indicator.

Each Control Unit can be paired with up to 4 Heel Switches at the same time. If you

pair a fth Heel Switch, the rst one will be erased from the Control Unit’s memory.

When you start using a new Heel Switch or Control Unit always remember to pair
them.

Press the pairing button with a pencil or similar…

…all indicators will light up…

…press the Heel Switch once. Your Control Unit
and Heel Switch are now paired and the lights

of the Control Unit are turned o.

22

Note that if the Control Unit is powered down you must press the pairing button

twice; rst to activate the Control Unit and second to pair the Control Unit and Heel

Switch.

Be aware that you will get a warning when you press the Heel Switch to indicate that
the Antenna is not connected to the Control Unit. This is only the case if you usually

wear the Heel Switch on the non-aected leg.

7.1.5 The Control Unit Battery Indicator

The Control Unit is powered by an internal rechargeable battery. You must charge
the Control Unit with the ActiGait® Charger and it is recommended that you make a
habit of charging the Control Unit regularly, e.g. every night (see section 7.6 on page
38 about the Charger and how to charge the Control Unit). The Control Unit bat-

tery is not exchangeable.

The Control Unit battery indicator.

The color of the Control Unit battery indicator can be green, yellow or red reecting

how much power you have left on the Control Unit.

23

The battery level of the Control Unit is normal and
you have power for at least one day of walking.

The battery level of the Control Unit is medium and
you have power for less than one day.

Red and the Control Unit beeps once every 30 sec­onds: The battery level is low and you have power
for less than 2 hours. Charge the Control Unit as
soon as you can.

Red and ashing while other light indicators are
turned o and the Control Unit beeps for 8 seconds

with an interval of 30 seconds:
The Control Unit is out of power and stimulation

has stopped. Turn o the Control Unit until you can

charge it.

When the Control Unit battery is out of power, both this light indicator and the light

indicator for the Heel Switch battery will ash and the Control Unit will beep for 8
seconds, while all other light indicators are switched o. You can tell which of the

two batteries is low by checking which one of the two is red: the Control Unit battery
indicator or the Heel Switch battery indicator.
It is recommended that you charge the Control Unit every night to avoid running out
of power at an inconvenient time.

7.1.6 The Heel Switch Battery Indicator

The Heel Switch is powered by an internal battery. The Heel Switch battery cannot

be recharged or exchanged so when the battery is empty you must discard the whole

Heel Switch (see section 12.3 on page 53 about disposal). Remember to pair the
new Heel Switch with the Control Unit when you replace it (see section 7.1.4 on
page 21).

24

The battery indicator for the Heel Switch is shown by the top left light icon on the
Control Unit.

The Heel Switch battery indicator.

The Heel Switch battery indicator can be green, yellow or red reecting how much

power you have left on the Heel Switch.

The battery level of the Heel Switch is normal and
you have power for at least 3 months.

The battery level of the Heel Switch is medium and
you have power for at least 1 week.

Red and ashing while other light indicators are
turned o and the Control Unit beeps for 8 seconds

with an interval of 30 seconds:
The battery level of the Heel Switch is low and you
must discard the Heel Switch and replace it with a
new one.

When the Heel Switch battery level is low both this light indicator and the light

indicator for the Control Unit battery will ash for 8 seconds while all other light
indicators are switched o. You can tell which of the two batteries is low by check-

ing which one of the two is red: the Control Unit battery indicator or the Heel Switch
battery indicator.
The Heel Switch battery indicator also serves as an indicator for the Heel Switch

Feedback (see section 7.5.2 on page 37), i.e. the indicator ashes every time you

step on the Heel Switch.

25

7.1.7 Training Mode Indicator

The Training Mode indicator ashes when the Control Unit is in Training Mode.

The Training Mode is used to increase your muscle strength and endurance, and
to inhibit spasticity. In Training Mode the ActiGait® Implant is cyclically activated
without an input from the Heel Switch, e.g. during sitting or lying down. Training

Mode will automatically be turned o if the Heel Switch is activated during training

so Training Mode cannot be used for walking. The duration of each activation cycle
is set by your clinician. Consult your clinician for advice about when and how to use
training mode.

The Training Mode indicator.

You must be sitting or lying down during training. You must wear the Antenna and

Control Unit but you do not need the Heel Switch. Training Mode is switched o by
pressing the on/o button on the Control Unit for 1.5 seconds.

Switch o your Control Unit if it is on.

Sit or lie down in a comfortable position with
the Antenna mounted on your leg and connected
to the Control Unit. You do not need the Heel
Switch.

26

Press the on/o button and either of the

intensity buttons at the same time for at least

1.5 seconds.

The Training Mode light indicator ashes as long
as the Control Unit is in Training Mode.

Continue training for as long as recommended
by your clinician.

Press the on/o button on the Control Unit
for 1.5 seconds to stop Training Mode.

27

7.1.8 Mute Indicator

With the mute functionality you can switch the audio signals of the Control Unit

on and o according to your preference. There are 3 dierent settings and the mute

indicator shows the current setting.

All sounds are on.

All sounds are on, except for the Heel Switch feed­back.

All sounds are o, except for warnings.

See section 7.7 on page 42 for further information about the audio signals and
section 7.1.3 on page 19 about how to operate the mute button.

7.1.9 Stimulation Intensity Indicators

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. See section 7.1.2 on page 18
about how to adjust the stimulation intensity.

7.2 Putting On the Control Unit

You should wear the Control Unit on your waist so that you can easily access it

while walking and sitting. You can use the three dierent Control Unit Fixtures to

attach the Control Unit to your clothing, a belt or your skin or you can carry it in
your pocket. The Antenna is available in two cable lengths so that you can choose to

carry the Control Unit at the aected side or the non-aected side.

28

7.2.1 The Belt Clip

The Belt Clip is suitable if you want to attach the Control Unit to e.g. the waist line of
a pair of trousers or a skirt or at the lining of your pocket.

Attach the Belt Clip to your clothing, e.g.
your waistline or a pocket…

…orient the Control Unit as shown and slide

it against the Belt Clip to x the two together.

The Control Unit is held in place by magnets inside both the Control Unit and the
Belt Clip.

7.2.2 The Belt Loop

The Belt Loop is suitable if you want to carry the Control Unit on your waist and you
are wearing a belt.

Slide the Belt Loop onto your
belt as you are putting the belt on...

29

.
.put the belt on and slide the Belt Loop
to the right position...

...orient the Control Unit as shown and slide

it against the Belt Loop to x the two together

The Control Unit is held in place by magnets inside both the Control Unit and the
Belt Loop.

7.2.3 The Body Clip

The Body Clip is suitable if you want to carry the Control Unit discretely underneath
your clothing e.g. if you are wearing a dress. The Body Clip ts to the Antenna Fix­ture that is also used for attaching the Antenna to your thigh.

Put on an Antenna Fixture where you want the Control Unit to sit, e.g. on your stom­ach (see section 7.3 on page 30 about how to put on the Antenna Fixture).

The knob in the middle of the Body Clip

ts to the plastic part of the Antenna Fixture.

30

Insert the knob of the Body Clip into the

opening in the plastic part of the xture and

push the Body Clip downwards until you hear
a click.

Orient the Control Unit as shown and slide it

against the Body Clip to x the two together.

The Control Unit is held in place by magnets inside both the Control Unit and the
Body Clip.

7.3 Putting On the Antenna Fixture

In order for the Antenna Fixture to sit securely on the skin, the following guidelines

should be followed:

1. Wash and dry the skin thoroughly before positioning the Antenna Fixture.

2. Remove hair on the skin if the hair will prevent the Antenna Fixture from sitting

securely

3. The adhesive side of the Antenna Fixture should not be touched as this will redu-

ce its adhesiveness.

4. The use of moisturizer will reduce the adhesiveness of the Antenna Fixture.

Please note that the Antenna Fixture must not be placed on top of a wound.

The Antenna Fixture consists of 3 layers (Figure 7). On the backside, there is a
bearing liner which protects the adhesive qualities of the Antenna Fixture. In the

middle there is an adhesive patch with a round plastic disc onto which the Antenna

is secured. On the front, there is a sti applicator liner which makes it easier to place
the Antenna Fixture.

31

Place the Antenna Fixture on a table with the
bearing liner facing upwards. Peel o the rst

part of the bearing liner. Do not touch the
adhesive side as this will decrease its
adhesiveness.

Attach the Antenna Fixture on the skin on top

of the Implant by pressing the adhesive half of

the xture onto the bare skin. Orient the Antenna
Fixture so the large opening points upward.

Figure 7: The 3 layers of the Antenna Fixture

Bearing
Liner

Adhesive

Applicator
Liner

32

Peel o the remaining part of the bearing liner.

Press the entire Antenna Fixture rmly onto

the skin to warm it up and ensure the
adhesiveness of the xture. Keep the pressure
for 30 seconds.

Finally, remove the applicator liner on the front

of the Antenna Fixture. This is done by carefully
peeling o the two halves of the applicator liner.

The Antenna Fixture is now ready for use.

33

If you experience any skin irritation where the Antenna Fixture is placed, you
should stop using the xture and your ActiGait® for a while. If the problem contin-

ues, contact your clinician.

7.4 Putting On the Antenna

When you have attached the Antenna Fixture to your thigh above the Implant, you
can click the Antenna into the Fixture.

The knob in the middle of the Antenna ts into
the plastic part of the Antenna Fixture.

Insert the knob of the Antenna into the opening

in the plastic part of the xture and push the

Antenna downwards until you hear a click.

Connect the Antenna plug to the Control Unit.

34

You can turn the Antenna plug both ways so that the Antenna Cable comes out at
the top or at the bottom of the Control Unit.

Make sure you attach the Antenna plug properly to ensure the connection to the
Control Unit, otherwise you will get a warning when you start to walk, meaning

that the Control Unit will beep and the stimulation intensity indicators will ash

for 8 seconds.

WrongCorrect

The Antenna plug is held in place by magnets inside both the plug and the Control
Unit

You can disconnect the Antenna plug at any time, for example, when using a rest

room. Never pull the cable to disconnect the Antenna from the Control Unit but take
hold of the plug itself. Be careful not to make any sharp bends in the Antenna cable
as this might damage the cable.

35

7.5 The Heel Switch

The ActiGait® Heel Switch (see Figure 8) is the device that sends information to the
Control Unit about whether the foot is on the ground or lifted. It needs to be mount­ed on the foot, so that the sensor is placed under the heel, and the Heel Switch
housing is placed along the ankle.

The sensor consists of a mechanical switch that activates when you put enough
weight on it, i.e. when you place your heel on the ground. The radio transmitter
transmits a radio code to the Control Unit for every heel lift and heel strike. The
Control Unit reacts by activating the stimulation which makes the muscles lift the
foot. The Control Unit and Heel Switch must be paired to communicate with each
other (see section 7.1.4 on page 21).

Figure 8: The Heel Switch

Housing with
battery and radio
transmitter

Sensor

It is essential that the Heel Switch is kept in place when you walk so that the switch
is activated and de-activated properly for every heel strike and heel lift, respectively.

The Heel Switch can be placed under either foot; however, it can only be switched
over in connection with reprogramming the Control Unit at the clinic. See section

7.5.1 on page 36 about how to place the Heel Switch and how to use the Heel

Sock.

The Heel Switch battery is not exchangeable. If you open the Heel Switch to ac­cess the battery, you will break the sealing and thereby compromise the ingress
protection against water and particles. When the battery of the Heel Switch is out
of power, the whole Heel Switch must be discarded (see section 12.3 on page 53
about disposal).

36

7.5.1 The Heel Sock

Your ActiGait® is delivered with a Heel Sock that keeps the Heel Switch in place. If
you choose not to use the supplied sock but just put the Heel Switch into a normal
sock, be aware that the Heel Switch could have a tendency to slide away from your
heel when you walk.

Pull the Heel Sock over your foot…

…pull it in position.

Put the round plate of the Heel Switch
into the pocket under your heel…

…and put the house of the Heel Switch into
the pocket at your ankle.

37

Be careful not to pull the pockets of the Heel Sock. The pockets are constructed only
for holding the Heel Switch in place and not for being pulled.

7.5.2 Heel Switch Feedback

The Control Unit gives a short beep and the Heel Switch light indicator ashes for

every signal from the Heel Switch; both at heel lift and heel strike. This is called Heel
Switch feedback. It can be used to check if the Heel Switch is activated properly during
walking. The Heel Switch feedback can be muted (see section 7.1.3 on page 19).

When you have put on the Heel Switch and before you start to walk, you should
check that the Heel Switch is activated when you put your weight on it.

The Heel Switch light indicator.

Make sure that the Control Unit is switched on. If the Control Unit is switched on but
no lights are on, the lights are powered down and you must press one of the buttons
to turn them back on.

Stand up with your weight on the foot
without the Heel Switch

38

…watch the Control Unit and press a button to
make sure that the lights are not powered down…

…while you shift your weight to the Heel Switch.

Check that the Heel Switch indicator ashes

when you put your weight on the Heel Switch.

If the Heel Switch indicator does not ash, it is probably because the Heel Switch

is not placed properly under your heel. Adjust the position of the Heel Switch and
check the connection again or go to section 9 on page 49 for troubleshooting.

If the mute indicator is green, you will hear a short beep for every time you step onto

the Heel Switch and every time you step o it again, i.e. two beeps for every step.

7.6 The Charger

The Control Unit is charged with the supplied ActiGait® Charger and ActiGait®
Charger Cable (see Figure 9). The Charger Cable has one light indicator that shows if
the Charger is correctly connected to the wall outlet. For safety reasons the Charger
Cable uses the same plug socket as the Antenna so you cannot use the ActiGait® for
stimulation while charging the Control Unit. Do not keep the Control Unit on your
body while charging.

39

The Control Unit battery is not replaceable. If you try to open the Control Unit to
change the battery, you will compromise the sealing of the Control Unit.

The Charger Cable is connected to the Charger with a USB plug. The Control Unit
should only be charged with the supplied Charger and Charger Cable. If the Charger
Cable is connected to some other equipment via the USB plug, e.g. a PC, the Control
Unit might be harmed.

7.6.1 Charging the Control Unit

It is recommended that you charge the Control Unit regularly instead of waiting until
the power level is low. Charging the battery will take a maximum of 5 hours depend­ing on how much power is left on the battery.

Connect the Charger Cable to the Charger …

…connect the Control Unit to the Charger
Cable.
Put the Charger into a wall outlet and the
Control Unit is charged.

Figure 9: The Charger and Charger Cable

USB
plug

Charger

Charger
Cable

40

When the Charger is connected correctly to the wall outlet, the light indicator on the
Charger Cable will switch on. This means that the Charger is powered. If the Control

Unit is switched o, the Charger will switch it on to show the charging status with

the Control Unit battery indicator.

When the Control Unit is connected to the Charger, you can see the status of the
power level on the light indicator for the Control Unit battery.

Control Unit battery indicator.

Charging status:

The power level is low.

You have enough power for a short walk.

You have power for at least one day of normal use.

Flashing:
Control Unit is fully charged.

The light indicator will show a constant green light when the Control Unit is ready
for one day of normal use. It is recommended that you charge the Control Unit bat-

tery fully, i.e. until the green light starts ashing, to ensure that you do not run out

of power at an inconvenient time. However, do not hesitate to interrupt the charging
if you want to use the Control Unit for walking, it will not shorten the lifetime of the
battery to only charge it partly.

41

Charging stops when you disconnect the Charger Cable from the Control Unit or

when the Control Unit is fully charged, i.e. the light indicator is green and ashing.

It does not harm the Control Unit or the battery to leave it connected to the Charger
Cable even though it is already fully charged.

The lifetime of the Control Unit battery is 5 years as a minimum. The capacity of a
rechargeable battery of this type becomes lower over time. When the battery is new,
it can hold power for some days of use but after 5 years it can only hold power for
one day

The Control Unit battery is not exchangeable. If you open the Control Unit to access

the battery, you will break the sealing and thereby compromise the ingress protec­tion against water and particles. When the battery of the Control Unit can no longer
hold enough power to last for one day of use, the whole Control Unit should be
discarded (see section 12.3 on page 53 about disposal).

7.6.2 Travel Kit for Charger

The Charger includes a travel kit with dierent wall plugs for dierent countries.

Slide the wall plug into the Charger
to connect them.

42

7.7 Audio Signals and Warnings

The Control Unit has a number of audio signals and a warning signal. A warning

consists of short beeps for 8 seconds while some or all of the light indicators ash

depending on the reason for the warning. An audio signal is a single beep that can
be either short or long.

7.7.1 Warnings

The Control Unit will always give a warning if it receives signals from the Heel
Switch without being able to send a signal to the Antenna. This will typically be if
the Antenna is disconnected but it can also be because there is not enough power on
the Control Unit battery to send signals to the Antenna.

Reasons for warnings:

• The Control Unit is out of power. The Control Unit battery indicator is red and
ashing and the Control Unit will beep for 8 seconds with an interval of 30 sec­onds until you charge it. The Heel Switch battery indicator is also ashing while
all other indicators are turned o.

• Response: Charge the Control Unit as soon as possible (see section 7.6.1 on

page 39 about charging of the Control Unit).

Figure 10: Wall plug Europe

Figure 11: Wall plug UK

Figure 12: Wall plug US and Japan

Figure 13: Wall plug Australia

43

• You start to walk while the Antenna is not properly connected to the Control Unit.
The Control Unit will beep for 8 seconds while the stimulation intensity indica-

tors ash.

• Response: Make sure that the Antenna plug is properly connected to the

Control Unit. (see section 7.4 on page 33 about the Antenna).

7.7.2 Audio Signals

The Control Unit has a number of audio signals to make it easier to adjust the set­tings. The audio signals mentioned in this section can all be muted but the warnings
described above cannot.

• Stimulation Intensity

• Long beep: You have pressed the intensity up button when you are already
at the maximum level

• Short beep: You have pressed the intensity down button when you are

already at the minimum level.

• Heel Switch feedback: The Control Unit gives a short beep for every signal from

the Heel Switch; both at heel lift and heel strike. This can be used to check if the
Heel Switch is activated properly during walking.

• Low battery level of the Control Unit: When the Control Unit battery indicator is

red the Control Unit will give a short beep for every 30 seconds until you charge
the battery.

• Indicator Check: Every time the Control Unit is switched on it performs an indi-
cator check. This means that all light indicators ash once and a short beep is

heard.

8. Lights and Audio Signals

The Control Unit has a number of light indicators and sounds that tell you dierent

things about the settings or status of the Control Unit and the Heel Switch. This chap-

ter contains a table of all the dierent light indicators and a table of the audio signals

and what they mean.

The tables are meant to give an overview and therefore the explanations are very

short. If you want more information please go to the chapters that are referred to in
the tables.

44

8.1 How to Interpret the Light Indicators

Battery status of the Control Unit

You have power for at least one day of walking.

You have power for less than one day.

Red and the Control Unit beeps once every 30 seconds: You have
power for less than two hours. Charge the Control Unit as soon as
you can.

Red and ashing and the Control Unit beeps for 8 seconds with an

interval of 30 seconds:
The Control Unit is out of power and stimulation has stopped. Turn

o the Control Unit until you can charge it.

See section 7.6.1 on page 39.

Training Mode

Flashing:
Training Mode is on.

See section 7.1.7 on page 25.

Stimulation intensity

The number of lights shows the cur­rent stimulation intensity.

See section 7.1.2 on page 18.

45

Mute

All audio signals are on.

All audio signals except the Heel Switch Feedback are on.

All audio signals are o but warnings can still be heard.

See section 7.1.3 on page 19.

Indicator check

All lights ash once when you switch

on the Control Unit:
This is the indicator check that is
performed every time you switch on
the Control Unit.

See section 7.1.1 on page 17.

WARNING

The intensity level indicators ash

and the Control Unit beeps for 8
seconds:
WARNING: The Control Unit cannot
send signals to the Implant. Check
that the Antenna is connected cor­rectly to the Control Unit.

See section 7.4 on page 33.

46

Pairing the Control Unit and Heel Switch

All lights are switched on when you
press the pairing button for the Heel
Switch. When you press the Heel

Switch they are switched o

See section 7.1.4 on page 21.

8.2 How to Interpret the Audio Signals

The Control Unit has audio signals and a warning signal. A warning means that the
Control Unit will beep for 8 seconds whereas audio signals are single beeps. Warn­ings can never be muted. A warning means that stimulation has stopped and you

must nd out what the warning is about and respond accordingly.

In this section you can see the dierent audio signals and warnings. The Control

Unit only has one type of sound that can be short or long, single or continuous.
Therefore, a short or long beep can mean dierent things depending on the situa­tion. Most often the audio signals are used in combination with light signals making
it possible to interpret what the audio signal tells you.

Short beep

+

A short beep when you press the intensity down button. Only one stimulation
intensity light indicator is on:
The stimulation intensity is already at the minimum level. See section 7.1.2 on
page 18.

47

Short beep

+

A short beep when you press the on/o button for 1.5 seconds. All lights ash

once: Indicator Check. The Control Unit is now on.
See section 7.1.1 on page 17.

Short beep

+ +

ashing

A short beep when you step onto the Heel Switch and when you step o it
again. The Heel Switch battery light indicator ashes when the beeps are heard.
The color of the light indicator can be green, yellow or red reecting the Heel

Switch Battery level: Heel Switch Feedback. See section 7.5.2 on page 37.

Short beep

+

One short beep every 30 seconds. The Control Unit battery indicator is red:
Charge the Control Unit, the power level is low.
See section 7.1.5 on page 22 for more information and section7.6.1 on page
39 for charging the Control Unit.

48

Short beeps
30 seconds
Short beeps

+ +

ashing

Short beeps for 8 seconds with a 30 seconds interval while the battery light

indicators ash. All other light indicators are turned o.

WARNING: The Control Unit is out of power and stimulation has stopped. Turn

o your Control Unit and charge it.

See section 7.1.5 on page 22 for more information and section 7.6.1 on page
39 for charging the Control Unit.

Short
beeps

+ +

Flashing

Short beeps for 8 seconds while the stimulation intensity indicators ash.

WARNING: The Control Unit cannot send signals to the Implant. Check that the
Antenna is connected correctly to the Control Unit.
See section 7.4 on page 33.

Long

beep

+

A long beep when you press the intensity up button. All stimulation intensity
light indicators are on:

The stimulation intensity is already at the maximum level.

See section 7.1.2 on page 18.

49

Long
beep

+

A long beep when you press the on/o button for 1.5 seconds.
The Control Unit is now turned o.

See section 7.1.1 on page 17.

9. Troubleshooting for ActiGait®

In this chapter you will nd solutions to the most common problems that you might
experience with your ActiGait®. If none of the described solutions works, or if you
experience a problem that is not described, please contact your clinician.

Check regularly if all of the equipment is intact and has no visible damage. You
should never pull the Antenna cable when you remove the Antenna from the

Antenna Fixture or the Control Unit as this can damage the cable. Take hold of the

Antenna or plug instead.

Problem Solution

You do not get a foot
lift when you are
walking
or
You do not get a foot
lift at every step

Make sure that the Control Unit is switched on (see
section 7.1.1 on page 17).

Make sure that the stimulation intensity is high
enough (see section 7.1.2 on page 18). If it is

already at the maximum, your need for stimulation

may have changed since your last visit at the clinic.
Contact your clinician for reprogramming of your

ActiGait®.

Make sure that the Antenna is placed correctly in the

Antenna Fixture above the Implant. Check that the

Antenna cable is intact and with no sharp bends.

50

Problem Solution

Check that the Heel Switch is placed correctly under
your heel inside the Heel Sock (see section 7.5 on
page 35).

Check the connection between the Heel Switch and
the Control Unit (see section 7.5.2 on page 37).

Check that the Heel Switch works properly by press-

ing the switch with your ngers. If you cannot get a

stable response when you are walking, contact your
clinician or order a new Heel Switch.

If the Control Unit does not respond with light sig­nals and/or audio signals when you activate the Heel
Switch:

1. Check the battery status of the Heel Switch (see sec­tion 7.1.6 on page 23) and the Control Unit (see
section 7.1.5 on page 22).

2. Repeat pairing of the Heel Switch and Control Unit
(see section 7.1.4 on page 21).

3. Replace the Heel Switch.

If the Control Unit responds with light signals and/
or audio signals when you activate the Heel Switch:
Check that the Antenna plug is properly connected
to the Control Unit.

You do not get a suf-

cient foot lift when

you are walking

Make sure that the stimulation intensity is high
enough (see section 7.1.2 on page 18). If it is

already at the maximum, your need for stimulation

may have changed since your last visit at the clinic.
Contact your clinician for reprogramming of your

ActiGait®.

Your foot is lifted too
much when you are
walking

Make sure that the stimulation intensity is low
enough (see section 7.1.2 on page 18). If it is
already at the minimum, your need for stimulation
may have changed since your last visit at the clinic.
Contact your clinician for reprogramming of your

ActiGait®.

51

Problem Solution

You get unwanted
stimulation when you
are not walking

Adjust the position of the Heel Switch so that it does
not activate unless you stand on it

Your muscles hurt
when you walk

You may be experiencing training induced muscle

soreness, especially if you have been walking more
than usual or if you have just started using your

ActiGait®. Make sure to get enough rest so that your
muscles have time to restitute

Make sure that the stimulation intensity is low
enough (see section 7.1.2 on page 18). If it is
already at the minimum, your need for stimulation
may have changed since your last visit at the clinic.
Contact your clinician for reprogramming of your

ActiGait®

Your muscles and/or
joints hurt, also when
you are not walking

Reduce the stimulation intensity (see section 7.1.2 on
page 18) and/or walk less until the pain is reduced.
Make sure to get enough rest so that your muscles
have time to restitute. If the pain continues, contact
your clinician.

10. Warranty

Safe and eective use of the ActiGait® requires that the product be transported,
stored and used as intended, without modications, following all the manufac-

turer’s recommendations. The product must have been used and prescribed in
accordance with the ActiGait® User Manual (647G808=GB), Clinician Manual
(647G805=GB) and Surgeon Manual (647G806=GB).

The following parts of the ActiGait® are consumables with reduced warranty:

• ActiGait® Antenna Fixture

• ActiGait® Heel Sock

• ActiGait® Heel Switch

52

In accordance with European law, the following parts are covered by a 2 year war­ranty:

• ActiGait® Control Unit

• ActiGait® Belt Clip

• ActiGait® Body Clip

• ActiGait® Belt Loop

• ActiGait® Antenna

• ActiGait® Charger Cable

• ActiGait® Charger

• ActiGait® Implant

11. Expected lifetime

• ActiGait® Antenna Fixture: 7-14 days

• ActiGait® Heel Sock: 50 washes

• ActiGait® Heel Switch: 1 year (depending of the intensity of use the lifetime of the

Heel Switch may vary)

• ActiGait® Control Unit: 5 years

• ActiGait® Control Unit Fixtures: 5 years

• ActiGait® Antenna: 2 years

• ActiGait® Charger Cable: 5 years

• ActiGait® Charger: 5 years

• ActiGait® Implant: 10 years

12. Cleaning, Storage and Disposal

12.1 Cleaning

The various parts of the ActiGait®should be cleaned when needed. To keep the Control
Unit, Heel Switch, Antenna, Charger, Body Clip, Belt Clip and Belt Loop clean, they
can be wiped down with a clean damp cloth. The electrical contacts in the Antenna
plug and the Control Unit should not be cleaned.

Cleaning detergents or excessive amounts of water shall be avoided. ActiGait® is de­signed to withstand splashes of water and moisture, but not to be submerged in water.
The Charger Cable should only be wiped with a clean, dry cloth.

53

12.2 Storage

When the equipment is not in use, the Antenna Fixtures should be stored at a tem­perature between +10˚C and +27˚C for up to 6 months. The rest of the equipment
can be stored in a dry place at a temperature between +10˚C and +40˚C for up to 2

years.

In order to maintain the Control Unit battery’s ability to become fully charged, the
Control Unit must be charged with regular intervals during storage. If the Control
Unit has been in use, it must be charged with 3 months intervals.

It is recommended that the equipment is stored in the original sales boxes or the

User Suitcase to avoid accidental damage.

12.3 Disposal

The Antenna Fixtures, Heel Socks, Body Clip, Belt Clip and Belt Loop can be dis­posed of as household waste. The Control Unit, Antenna, Heel Switch, Charger and
Charger Cable contain batteries or electronics and shall therefore be disposed of ac­cording to the national regulations for electronic and electrical waste. The parts can
be returned to the clinician or your local ActiGait®representative.

13. Available Articles

Please contact your local ActiGait®representative to purchase any of the articles
mentioned below.

Item Part Number

ActiGait®

ActiGait®Control Unit 9002=11

ActiGait®Belt Clip 9002M=11A

ActiGait®Body Clip 9002M=11B

ActiGait®Belt Loop 9002M=11C

ActiGait®Antenna 58 cm 9002=13A

ActiGait® Antenna 78 cm 9002=13B

ActiGait®Antenna Fixtures, package of 15 pieces 9002=M03

ActiGait®Heel Switch 9002=12

54

Item Part Number

ActiGait®Heel Sock, extra small, black 9002M=12XS-7

ActiGait® Heel Sock, small, black 9002M=12S-7

ActiGait® Heel Sock, medium, black 9002M=12M-7

ActiGait® Heel Sock, large, black 9002M=12L-7

ActiGait® Heel Sock, extra large, black 9002M=12XL-7
ActiGait® Heel Sock, extra extra large, black 9002M=12XXL-7
ActiGait® Heel Sock, extra small, whit 9002M=12XS-6

ActiGait® Heel Sock, small, white 9002M=12S-6

ActiGait® Heel Sock, medium, white 9002M=12M-6

ActiGait® Heel Sock, large, white 9002M=12L-6

ActiGait® Heel Sock, extra large, white 9002M=12XL-6
ActiGait® Heel Sock, extra extra large, white 9002M=12XXL-6
ActiGait® Heel Sock, extra small, beige 9002M=12XS-0

ActiGait® Heel Sock, small, beige 9002M=12S-0

ActiGait® Heel Sock, medium, beige 9002M=12M-0

ActiGait® Heel Sock, large, beige 9002M=12L-0

ActiGait® Heel Sock, extra large, beige 9002M=12XL-0
ActiGait® Heel Sock, extra extra large, beige 9002M=12XXL-0

ActiGait® Accessories

ActiGait® User Manual 647G808=country code

ActiGait® Charger 9002=14

ActiGait® Charger Cable 9002=15

ActiGait® User Suitcase 9002=17

55

14. Technical Data

14.1 ActiGait® Control Unit

Dimensions 9.5 cm x 4.8 cm x 1.8 cm

Mass 80 g (including battery)

Battery Li-ion 1100mAh

Operating time

Minimum 16h after full 5 hour charging. Charg­ing every night is recommended to ensure optimal
performance of the ActiGait®

Charging time 5 hours

Ingress IP 54

Operating temperature Between +10 °C and +40 °C

Storage temperature Between +10 °C and +40 °C

Humidity 30 – 75 % rel. H non-condensing

Short time storage and
transportation tempera­ture

Between -20 °C and +60 °C for max 2 months

Receiver frequency 2,401MHz

Transmitter

Frequency: 2,401 MHz

Output power: 0.5 dBm
Modulation: MSK

56

14.2 ActiGait® Belt Clip

Dimensions 5.3 cm x 4.6 cm x 1.3 cm

Mass 27 g

Operating temperature Between +10 °C and +40 °C

Storage temperature Between +10 °C and +40 °C

Humidity 30 – 75 % rel. H non-condensing

Short time storage and
transportation tempera­ture

Between -20 °C and +60 ° C for max 2 months

14.3 ActiGait® Belt Loop

Dimensions 5.3 cm x 4.6 cm x 1.3 cm

Mass 21 g

Operating temperature Between +10 °C and +40 °C

Storage temperature Between +10 °C and +40 °C

Humidity 30 – 75 % rel. H non-condensing

Short time storage and
transportation tempera­ture

Between -20 °C and +60° C for max 2 months

57

14.4 ActiGait® Body Clip

Dimensions 5.3 cm x 4.6 cm x 1 cm

Mass 20 g

Operating temperature Between +10 °C and +40 °C

Storage temperature Between +10 °C and +40 °C

Humidity 30 – 75 % rel. H non-condensing

Short time storage and
transportation tempera­ture

Between -20 °C and +60° C for max 2 months

14.5 ActiGait® Antenna

Dimensions Ø 5.7 cm x 0.7 cm

Mass 10 g

Ingress IP 54

Operating temperature Between +10 °C and +40 °C

Storage temperature Between +10 °C and +40 °C

Humidity 30 – 75 % rel. H non-condensing

Short time storage and
transportation tempera­ture

Between -20 °C and +60° C for max 2 months

Surface temperature Max. 42.5 °C

Transmitter

Frequency: 6,772 MHz

Modulation: CW
Output power: 12.3 dBuA/m at 3 m

58

14.6 ActiGait® Antenna Fixture

Dimensions Ø 6.2 cm x 0.4 cm

Mass 1.3 g

Storage temperature Between +10 °C and +27 °C for max 6 months

Short time storage and
transportation tempera­ture

Between -20 °C and +60 °C for max 2 months

14.7 ActiGait® Heel Switch

Dimensions 17 cm × 2.5 cm x 0.8 cm

Mass 15.5 g

Battery Lithium coin cell type CR2032

Operating time Minimum 1 year

Transmitting range Minimum 2 m

Ingress IP 54

Operating temperature Between +10 °C and +40 °C

Storage temperature Between +10 °C and +40 °C

Humidity 30 – 75 % rel. H non-condensing

Short time storage and
transportation tempera­ture

Between -20 °C and +60 °C for max 2 months

Transmitter

Frequency: 2,401 MHz

Modulation: MSK
Output power: 2 dBm

59

14.8 ActiGait® Heel Sock

Sizes XS, S, M, L, XL, XXL

Washing directions

1. Maximum 40 °C normal machine wash

2. Do not bleach

3. Do not iron

4. Do not dry-clean

5. Do not tumble-dry

14.9 ActiGait® Charger Cable

Dimensions 3.5 cm x 4.7 cm x 1.8 cm

Mass 33 g

Input voltage 5 VDC

Input current 500 mA

Frequency DC

Output voltage 5 VDC

Output current Max 500 mA

Ingress IP 4X

Operating temperature Between +10 °C and +40 ºC

Storage temperature Between +10 °C and +40 °C

Humidity 30 – 75 % rel. H non-condensing

Short time storage and
transportation tempera­ture

Between -20 °C and +60 °C for max 2 months

60

14.10 ActiGait® Charger

Mass 50 g

Input voltage 100-240 VAC (±10 %)

Output voltage 5 VDC

Input current 75 mA

Output current Max 500 mA

Frequency input 50-60 Hz

Eciency 70 % typ. at full load

EMC

Conforms to EN 55022 + A1, CISPR 16-1, CISPR
16-2, AS/NZS CISPR 22

Output voltage tolerance ± 5 %

Operating temperature Between 10 °C and +40 ºC

Storage temperature Between 10 °C and +40 °C

Humidity 5 % to 95 % non-condensing

Short time storage and
transportation tempera­ture

Between -20 °C and +60 °C for max 2 months

Standards

Fulls Class II SELV for the following applica­tions: EN 60950/IEC 60950, UL 60950, VDE, CE
label

Plug connector

AC input: FRIWO exchangeable mains plug sys­tem: EURO, UK, USA/Japan, Australia
DC output: USB socket type A

61

14.11 ActiGait® Implant

Implant length 365 mm

Implant weight 16 g

Stimulator body size Length: 60 mm Width: 30 mm Thickness: 6.2 mm

Cu length 23 mm

Cu sizes

4.5 mm, 5.4 mm, 6.4 mm and 7.6 mm (inner
diameter)

Pulse shape

Bipolar, charge-balanced. Active phase: Fixed

1.2 mA current, pulse width modulated 0-255 µs

in steps of 0.25 µs. Passive phase: Exponential

discharge (capacitive)

Number of channels 4 bipolar, interleaved

Current Amplitude of active phase = 1.2 mA

Repetition rate

5 Hz – 50 Hz, for each channel. Inter pulse inter­val 20-200 ms

Storage

Between +10 °C and +40 °C. Exposure to tem­peratures outside this range may result in Implant

malfunction. Do not expose to sunlight or other

heating sources. Store in a dry place, in original
packaging, with seal unbroken

Humidity Non-condensing

Short time storage and
transportation tempera­ture

Between -30 °C and +70 °C for max 2 months

Receiver frequency 6,772 MHz

62

14.11.1 X-RayIdentication

The Implant bears a tag that is identiable by X-ray (see Figure 14). The X-ray tag

makes it possible to identify the manufacturer and the year of manufacture as re­quired by regulations.

The format of the information on the tag is “NAS 000 Y”, where:

• NAS is the manufacturer identication, short for Neurodan A/S

• 000 is an internal reference that identies the Implant model. On Implants

manufactured later than February 2009 it says AG, short for ActiGait.

• Y is the year of manufacture represented by a letter.

• A is year 2001

• B is year 2002

• C is year 2003

• etc.

15. Classication

The ActiGait®is classied as internally powered ME equipment according to IEC/EN

60601-1.

Figure 14: The X-ray tag of the Implant

X-ray tag

63

16. List of symbols

Caution, see instruction

Follow operating instructions, see instruction

SN

Serial number

Lot number

PN

Part number

Keep Dry

Temperature limitation

Type BF applied part

Use by/expiry date

IP 54

Protection against ingress of water and particles

IP 4X

Protection against ingress of particles

Date of manufacture

64

Manufacturer

Product contains battery, limitations on disposal of battery

The device includes RF transmitter(s)

40°

Maximum 40 °C normal machine wash

Do not bleach

Do not iron

Do not dry clean

Do not tumble dry

Recycle

In compliance with the applicable European directives

FCC

FCC ID number

C-tick

IC

IC ID number

65

16.1 Ingress Protection

The IP (Ingress Protection) classication marked on the various parts of the Acti­Gait® denes the degree of protection against ingress of water and particles. The
rst number denes the protection against particles and the second number denes

the protection against water.

Classication Denition

IP 54

Particles:
5: Dust protected. Ingress of dust is not totally
prevented, but dust shall not penetrate in a quan­tity to interfere with satisfactory operation of the
apparatus or to impair safety.

Water:
4: Protected against splashing water. Water
splashed against the enclosure from any direction

shall have no harmful eects.

IP 4X

Particles:
4: Protected against solid foreign objects of 1.0
mm Ø and greater. The object probe of 1.0 mm Ø,
shall not penetrate at all.

Water:
X: Protection against ingress of water is not rel­evant.

17. Declaration of Conformity

This device complies with Part 15 of the FCC rules and RSS-210 IC rules. Operation
is subject to the following two conditions:

1. This device may not cause harmful interference.

2. This device must accept any interference received, including interference that
may cause undesired operation.

This ISM device complies with Canadian IES-001.

This device also complies with:

• 90/385/EEC for active implantable medical devices amended by 2007/47/EC

• 99/5/EC for R&TTE.

66

67

Manufacturer:

ActiGait® is a product made by the Danish manufacturer Neurodan A/S. Development and

production is carried out with the highest possible diligence and in compliance with existing

European directives and national medical devices laws and regulations. Warranties and other

claims will be covered by the manufacturer if not explicitly stated otherwise.

Neurodan A/S is a Member of the Otto Bock Group and committed to “Quality for Life”. The

Otto Bock Group logo will therefore be used in respective presentations.

Neurodan A/S

Soendalsvej 85 | DK-9200 Aalborg SV | Denmark

Phone [phone] | Fax [phone]

[email protected] | www.neurodan.com

Neurodan A/S has been certied by TÜV Rheinland LGA Products GmbH.

647G808=US Draft ver. 1.0 / 2012