Otto Bock ActiGait User Manual Download Page 66

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16.1 Ingress Protection

The IP (Ingress Protection) classification marked on the various parts of the Acti

Gait® defines the degree of protection against ingress of water and particles. The

first number defines the protection against particles and the second number defines

the protection against water.

Classification

Definition

IP 54

Particles:

5: Dust protected. Ingress of dust is not totally

prevented, but dust shall not penetrate in a quan-

tity 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 effects.

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 rel-

evant.

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.

Summary of Contents for ActiGait

Page 1: ... 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 9 10 ...

Page 2: ...ActiGait Implantable Drop Foot Stimulator User Manual ...

Page 3: ...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 Ligh...

Page 4: ... of the ankle dorsiflexor 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 Qualification of Clinician The selection of users for ActiGait setup and adjustment are done by clinicians such as medical doctors phy...

Page 5: ...se to surface electrical stimulation of the peroneal nerve i e muscle contraction results in ankle dorsiflexion and improved gait 3 2 Contraindications Individuals with peripheral nerve damage in the affected leg severe or uncontrolled diabetes mellitus with peripheral nerve involvement poor skin condition on the affected leg a thickness of subcutaneous adipose layer on the thigh exceeding 40 mm 1...

Page 6: ...es contain radio circuits approved by the relevant authorities Changes or modifications 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 ...

Page 7: ...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 immediatel...

Page 8: ...as 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...

Page 9: ... 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 Un...

Page 10: ...chnology 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 specific 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 ...

Page 11: ...nd non affected 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 Inabilit...

Page 12: ...enna 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 v...

Page 13: ...rts 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 Cuff 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 Contro...

Page 14: ...r 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...

Page 15: ... a silicone cuff 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 different fascicles inside the nerve 6 2 The ActiGait The Acti...

Page 16: ...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 9d 9b 9c 10 11 Figure 4 ActiGait accessories 9 Travel kit for Charger 10 Charger 11 Charger Cable ...

Page 17: ...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 fixed to the various fix tures used for carrying the Control Unit see section 7 2 on page 27 about Control Unit fixation The Control Unit has a number of light indicators that show the status of the Control Unit see Figure...

Page 18: ...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 off button is used for switching the ActiGait Control Unit on and off You must press the on off ...

Page 19: ...test 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 first 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 some...

Page 20: ...e 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 off the sounds from the Control Unit The mute button is hidden under the Antenna plug so you must disconnect the Antenna from ...

Page 21: ...rns 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 feed back All sounds are off except for warnings Table 1 Mute settings Stimulation Intensity maximum or minimum Heel Switch feedback Indicator check On On ...

Page 22: ...rked 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 fifth Heel Switch the first 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 ...

Page 23: ... non affected 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 exchan...

Page 24: ... of power both this light indicator and the light indicator for the Heel Switch battery will flash and the Control Unit will beep for 8 seconds while all other light indicators are switched off 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 U...

Page 25: ...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 flash for 8 seconds while all other light indicators are switched off You can tell which of the two batteri...

Page 26: ... 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 off by pressing the on off...

Page 27: ... same time for at least 1 5 seconds The Training Mode light indicator flashes as long as the Control Unit is in Training Mode Continue training for as long as recommended by your clinician Press the on off button on the Control Unit for 1 5 seconds to stop Training Mode ...

Page 28: ...trol 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...

Page 29: ...hing e g your waistline or a pocket orient the Control Unit as shown and slide it against the Belt Clip to fix 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 t...

Page 30: ...he 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 fits to the Antenna Fix ture 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 stom ach see section 7 3 on page 30 about how to put on the Antenna Fixture The knob in the ...

Page 31: ...ng 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 o...

Page 32: ...ouch 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 fixture 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 ...

Page 33: ...onto the skin to warm it up and ensure the adhesiveness of the fixture Keep the pressure for 30 seconds Finally remove the applicator liner on the front of the Antenna Fixture This is done by carefully peeling off the two halves of the applicator liner The Antenna Fixture is now ready for use ...

Page 34: ... 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 fits into the plastic part of the Antenna Fixture Insert the knob of the Antenna into the opening in the plastic part of the fixture and push the Antenna downwards until you hear a click Connect the Antenna plug to the Control U...

Page 35: ...ning that the Control Unit will beep and the stimulation intensity indicators will flash for 8 seconds Wrong Correct 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 ...

Page 36: ... 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 conn...

Page 37: ...d 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 ...

Page 38: ... 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 ...

Page 39: ... 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 off 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...

Page 40: ...e 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 depend ing on how much power is left on the battery Connect the Charger Cable to the Charger connect the Control Unit to the Charg...

Page 41: ...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 f...

Page 42: ...attery 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 protec tion against water and particles When the battery of the Control Unit can no longer hold enough power to last for one day of use ...

Page 43: ...ly 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 flashing and the Control Unit will beep for 8 seconds with an interval of 30 sec onds until you charge it The Heel Switch battery indicator is also fla...

Page 44: ...p 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 perform...

Page 45: ... Charge the Control Unit as soon as you can Red and flashing 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 off 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 cu...

Page 46: ... flash 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 flash and the Control Unit beeps for 8 seconds WARNING The Control Unit cannot send signals to the Implant Check that the Antenna is connected cor rectly to the Control Unit See section 7 4 on pag...

Page 47: ...as stopped and you must find out what the warning is about and respond accordingly In this section you can see the different 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 different things depending on the situa tion Most often the audio signals are used in combination with light signals ...

Page 48: ...ain The Heel Switch battery light indicator flashes when the beeps are heard The color of the light indicator can be green yellow or red reflecting 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 in...

Page 49: ...or 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 flash 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 stimula...

Page 50: ... 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 51: ...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 ficient foot lift when you are walking Make sure that the stimulation intensity is high enough see section 7 1 2 on pa...

Page 52: ...ct 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 effective use of the ActiGait requires th...

Page 53: ...tures 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 t...

Page 54: ... 3 Disposal The Antenna Fixtures Heel Socks Body Clip Belt Clip and Belt Loop can be dis posed of as household waste The Control Unit Antenna Heel Switch Charger and Charger Cable contain batteries or electronics and shall therefore be disposed of ac cording to the national regulations for electronic and electrical waste The parts can be returned to the clinician or your local ActiGait representat...

Page 55: ...ock 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 9002...

Page 56: ...ght 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 tempera ture Between 20 C and 60 C for max 2 months Receiver frequency 2 401MHz Transmitter Frequency 2 401 MHz Output power 0 5 dBm Modula...

Page 57: ...n condensing Short time storage and transportation tempera ture 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 tempera ture Between 20 C and 60 C for max 2 months ...

Page 58: ... ture 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 tempera ture Between 20 C and 60 C for max 2 months Surface temperature Max 42 5 C Transmitter Frequency 6 772 MHz Modul...

Page 59: ...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 tempera ture Between 20 C and 60 C for max 2 months Transmitter Frequency 2...

Page 60: ...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 tempera ture Between 20 C and 60 C for max 2 months ...

Page 61: ...utput 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 tempera ture Between 20 C and 60 C for max 2 months Standards Fulfils Class II SELV for the following applica tions EN 60950 IEC 60950 UL 60950 VDE CE label Plug connector AC input FRIWO exchangeable mains plug sys te...

Page 62: ...ntial 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 inter val 20 200 ms Storage Between 10 C and 40 C Exposure to tem peratures 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 un...

Page 63: ...Y where NAS is the manufacturer identification short for Neurodan A S 000 is an internal reference that identifies 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 Classification The ActiGait is classified as internally powered ME equipment accor...

Page 64: ...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 ...

Page 65: ... 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 ...

Page 66: ... Water splashed against the enclosure from any direction shall have no harmful effects 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 rel evant 17 Declaration of Conformity This device complies with Part 15 of the FCC rules and RSS 210 IC rules Operation is ...

Page 67: ...66 ...

Page 68: ...67 ...

Page 69: ... 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 Sofiendalsvej 85 DK 9200 Aalborg SV Denmark Phone 45 70 27 22 97 Fax 45 70 27 22 17 Neurodan neurodan com www neurodan com Neurodan A S has been...

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