17B200 E-MAG Control - Ottobock US Healthcare | Homepage · 2 | Ottobock E-MAG Control 1...

17B200 E-MAG Control Mounting and Service Instructions �� 1

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E-MAG Control Ottobock | 1

Service Instructions for the E-MAG Control

Table of Contents Page

1 Introduction .......................................................................................................................21.1 Field of application ..................................................................................................21.2 Support ...................................................................................................................21.3 Symbol legend ........................................................................................................3

2 General Safety Precautions ..............................................................................................3

3 Delivery Information and Accessories ..............................................................................53.1 Parts .......................................................................................................................53.2 Remote Control .......................................................................................................53.3 Accessories .............................................................................................................8

4 Mounting Instructions .......................................................................................................94.1 Mounting the E-MAG Control into an orthosis .......................................................9Begin modeling the plaster positive as usual. ..............................................................94.2 Casing ................................................................................................................... 134.3 Final assembly ...................................................................................................... 19

5 Putting into Operation .....................................................................................................235.1 Charging the battery ............................................................................................ 235.2 Start sequence ..................................................................................................... 255.3 Energy-saving mode ............................................................................................. 26

6 Operation ........................................................................................................................266.1 Possible signal combinations................................................................................ 276.3 Opening the lock ...................................................................................................306.4 Closing the lock ...................................................................................................336.5 Switching between response profiles ...................................................................33

7 Maintenance ....................................................................................................................347.1 Proper functioning and premature wear ...............................................................357.2 Changing the bearing washer and bearing bushing ............................................36

8 Failures and Troubleshooting ..........................................................................................378.1 System does not start properly ............................................................................. 378.2 Failure of the electronics ...................................................................................... 378.3 Remote Control does not work ............................................................................. 378.4 Lock does not close .............................................................................................38

9 Warranty ..........................................................................................................................38

11 Declaration of Conformity .............................................................................................40

12 Technical Data...............................................................................................................40

E-MAG Control2 | Ottobock

1 Introduction

E-MAG Control is an electromagnetic lock joint with remote control for leg orthoses. The joint can be installed using different types of orthotic techniques. We recommend the lamination resin or the pre-preg technology.

The E-MAG Control 17B200=* knee joint system is delivered as a complete package. All parts required for functioning are included in delivery. This comprises the battery, remote control, electronic unit, knee joint and dummies. However, system joint bars are not included. The remote control and electronic control unit have already been adjusted to each other at factory.

These Service Instructions describe the function of the E-MAG Control and the steps required for mounting it into an orthosis. They do not explain the fabrication of an orthosis.

We strongly recommend you also read the user Instructions for Use. This will allow you to better inform patients about the functions of the E-MAG Control and its remote control.

1.1 Field of application

The E-MAG Control is designed exclusively for use with lower extremity orthoses with locked knee joint and the following indications:

• Posttraumatic conditions that resulted in paralysis or weakness of the knee extensors

• Condition following poliomyelitis

Not indicated are: fittings with knee joint contractures, as this prevents the release of the lock. The lock can only be opened if the user is able to extend the knee joint all the way to the com-plete extension.

The weight categories for the E-MAG Control are as follows:

• Patients up to 55 kg body weight with joint bar on one side only

• Patients up to 85 kg body weight and a maximum lower leg length of 52 cm with joint bars on both sides and medial support

1.2 Support

The Otto Bock Team of you country will be pleased to answer your technical questions. Contact addresses and telephone numbers are listed on the last page of this manual.


1.3 Symbol legend

CAUTION!Indicates a situation which, if not avoided, may result in personal injury.

WARNING!Indicates a situation which, if not avoided, may cause damage to the product.

TIPUseful tips for the technician

READRead the Instructions for Use first!

2 General Safety Precautions

CAUTION!Risk of InjuryPatients are not to use the E-MAG Control knee joint if technical problems occur.

CAUTION!Risk of InjuryDo not put the E-MAG Control into operation if the cable or casing is visibly damaged.

CAUTION!Risk of InjuryComponents and replacement parts that have not been authorized by the manufacturer may break. Use only original parts for installation and service.

CAUTION!Explosion HazardDo not expose the battery to fire or heat. Avoid direct sunlight.

CAUTION!Proximity to strong electromagnetic fields may disrupt functioning of the E -MAG Control knee joint. Avoid direct proximity to power transformers and radio transmitters.

WARNING!Errors made during installation and operation may damage the E-MAG Control. Please read carefully all instructions delivered with the product. Ensure that all patients obtain their Instructions for Use 647G312 included with delivery and familiarize them with the use of the electronics and remote control.


WARNING!Interference of signal transmission possible.Avoid temperatures below -10° C and above 55° C.

WARNING!Solid particles and fluid in the joint, lock or electronics of the 17B200 E-MAG Control may lead to malfunctioning. Do not expose parts to excessive smoke or dust or mechanical vibrations and shocks.

WARNING!The E-MAG Control emits electromagnetic energy when activated. This may affect electronic devices in its proximity.

WARNING!This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

WARNING!The E-MAG Control is not intended for re-use.

The E-MAG emits electromagnetic energy when activated and must therefore not be used in potentially explosive areas!


3 Delivery Information and Accessories

3.1 Parts

The following parts are included in the delivery of the 17B200 E-MAG Control:

1. Dummy for battery (317X20)2. Dummy for electronics (317X2=2)3. Dummy for battery receptacle (317X20=1)4. Dummy for electronics receptacle (317X2=1)5. Dummy for knee joint (317X200=*)6. Receptacle for battery (317Z20)7. Lock unit for battery (317R20) 8. Receptacle (317B12) for electronic control

unit with power cord (317E20)9. Battery (317B20)10. Electronic control unit (317B2)11. E-MAG knee joint (30G11=[right/left])12. AC Adapter for battery charger (757L16-1)13. Remote control (317B10)14. Battery charger (317L20)

Key for manual opening (30Y121) (not on picture)

3.2 Remote Control

The remote control for the E-MAG Control can be used manually or mounted into a crutch.

WARNING!The remote control may only be mounted into crutches of type 22K2/4. Installation into any other type of crutch may damage the remote control.

1

12

13

14

9

10

12

53

4

1186

7


The communication protocol between the remote control and the electronics is coded. Each remote control is fine-tuned exclusively to the electronic control unit with which it was delivered and cannot be used for any other E-MAG Control Systems.

3

1. Remote control activator2. Batteries, AAAA, 1.5V, alkaline3. Casing for manual operation4. Plastic tab

+-

2

2

3

1

4


In the event of having to reorder a remote control, always give the serial number of the entire E-MAG Control 17B200=R/L unit (Fig. 3).

The remote control can be operated from a conventional handheld device or from a crutch. Changing between these variations is easy and involves only a few turns of the hand.

Simply pull on the plastic tab to remove the remote control from the handheld or crutch recepta-cle. Then moisten the seal slightly and push the remote control completely into the crutch handle or into the casing of the handheld device. For use of the unit integrated into a crutch, a rubber ring is included in the delivery to fix the batteries in position.


Patients weighing over 55 kg will require the following accessories:

Additional System Bar (605P8=20) 5 mm (thickness) x 20 mm (width) x ca. 2 m (bar length) – light metal –for 17B205.

Medial Support (17B205=[left/ right])

6 7

4 5

UL System Bars (17LS1=2) 7 mm (thicknees) x 17.8 mm (width) x approx. 1 m (bar length)

Forearm Crutch, gray (22K2) / blue (22K4) – light metal –

3.3 Accessories

The following accessories are not included in the delivery of the E-MAG Control and can be ordered separately.


4 Mounting Instructions

This section describes the steps for mounting the E-MAG Control into an orthosis. It also in-cludes instructions for fabricating a casing which, attached to the transfemoral calf, protects the electronics, cables and battery unit from outer impacts.

WARNING!Electronics components are vulnerable to damage during the fabrication of the orthosis!Use the dummies included in delivery for all working steps until completion of the orthosis. Exchange the dummies with the electronics components directly before trial fitting or upon completing the fabrication.

TIPWe recommend fabricating a trial orthosis before proceeding with the final product. If fit and function are satisfactory, the trial orthosis can then be duplicated. This minimizes the risk of assembly-related deviations that could prevent the E-MAG Control from being fully extended or from being opened or closed.

4.1 Mounting the E-MAG Control into an orthosis

Begin modeling the plaster positive as usual.

Position dummy (A) (for knee joint (B)) (Fig. 8) directly onto the Nietert’s compromise pivot point with the help of the Joint Alignment Fixture 743R6 (Fig. 9). If need be, align the medial support dummy parallel to the E-MAG knee joint dummy.

98

AB


READRead the supplementary brochure for the Medial Support (647G336).

The dummy is constructed such that the E-MAG knee joint has a 6 mm posterior placement.

Now select the position of the electronics components.

The battery and electronics are to be placed only on the thigh. This allows for appropriate weight distribution in addition to protecting the cable that runs between the knee joint and the electronics.

Select soft tissue regions that adapt easily to the form of the dummies. The dummies must lie flat on the selected regions when forming the plaster positive. Otherwise, they may become curved through heat build-up during lamination. As a result, original parts of the final orthosis may then not fit into their respective recesses (Fig. 10).

When arranging the parts, take the length of the cables into consideration:

• Battery – electronics: 50 cm, variable length (Fig. 40)• Electronics – knee joint: 30 cm, fixed length

WARNING!The cable leading from the knee joint to the electronics will be damaged if cut, i.e. shortened or lengthened. If it is too long, wrap it and fasten it to the orthosis.

10


Now draw the final position of the dummies on the thigh region as follows:

• Dummy (C) for battery (D) with receptacle (E) - medially (Fig. 11)• Dummy (F) for electronics (G) with receptacle (H) - laterally (Fig. 12)

Mark the future path of the cable between: • Knee joint and electronics (Fig. 13)• Electronics and battery (Fig. 14)

15 16

13 14

11 12

CE

D

F

G

H


Then draw the contour of the casing (Fig. 15) and the position of the lamination plates (Fig. 16) for the future screw connection of the casing onto the transfemoral socket.

TIP The only function of the casing is to protect and fixate the battery, electronics and cable connections. In most cases, the casing surface only has to be large enough to enclose these parts. The casing surface should be larger if patients have requested padding on their transfemoral socket. In that case, the pad is glued directly onto the casing. (Otherwise, the padding would have to be stripped and again glued every time a technician needs to access components that lie beneath.)

CAUTION!A broken joint bar can lead to injury of the patient. Carefully sand down and smoothen fissures and ridges of the joint bars before laminating the orthosis.

WARNING!Danger of breaking joint bars. Do not set joint bars below a flexion radius of 15°.The joint bars must not be subjected to heat treatment.

Remove all dummies except the knee joint dummy and set up the system joint bars as usual (Fig. 17).

The drilled holes in the system box of the knee joint allow to temporarily screw and fasten the system bars during assembly of the orthosis. The corresponding hole (for 4 mm screws) in the system bar will be drilled by the technician.

Laminate the orthosis according to the requirements of the patient profile up until the second-to-last layer (Fig. 18).

17 18


Attach the lamination plates prior to the last stockinette layer and fasten them with small pieces of carbon (Fig. 19).

Then pour and process the lamination resin. Once the resin is distributed without air chambers, firmly press the dummies onto their designated surfaces of the sheet.

Wrap the dummies with Vulkolan® tape in order to maintain the pressure during hardening (Fig. 20). This will create an optimal support surface for the electronic parts.

Once the lamination has hardened, fabricate the casing on the transfemoral lamination.

4.2 Casing

This section describes how to fabricate a casing for the protection and fixation of cables and electronic components.

Cut the knee joint dummy free as illustrated in Fig. 21. Remove the knee joint dummy.

Carefully mill a cable groove in the bar guide guidance (Fig. 22 and Fig. 23).Reinsert the knee joint dummy.

19 20

21


Measure the length of the accompanying cable dummies:

• Dummy for cable connecting knee and electronics (7 mm wide, Fig. 24)

• Perlon cable for cable connecting electronics and battery (Fig. 25).

22 23

24 25


Take off the Vulkolan® tape and fasten the battery receptacle dummy and electronics receptacle dummy with double-sided adhesive tape.

Then fill the edges between dummy and socket with Plastilin® molding dough, making for a smooth transition (Fig. 28).

Pull a Nylon Sock 99B25 over the completed orthosis on the plaster model. In this way, the PVA base coat, that is subsequently added, will be evenly suctioned off (Fig. 29).

Fasten the cable dummies onto the designated recesses of the electronics and battery dummies as follows:

• from knee joint to electronics (Fig. 26)• from electronics to battery (Fig. 27)

26 27

28 29


Reinforce the casing as follows:

a) PVA base coat

b) 2 layers of perlon stockinette, fortified with carbon.

TIPThe carbon maintains the tension of the shell and secures the frames and screw connections.

c) 2 further layers of perlon stockinette

d) PVA top coat

Then laminate the casing with an appropriate amount of lamination resin.

Wait until the casing has hardened.

30 31

32 33


Drill through the screw connections on the lamination plates from the outside (Fig. 30) and tap a 4 mm threaded hole (Fig. 31). Then sink in the screws, stopping one rotation prior to the limit. Briefly heat up the surrounding lamination with the jet of a hot air blower (Fig. 32). As soon as bubbles begin building on the PVA coating, tighten the screws to their limit, thereby fully sinking in the screw heads.

Before taking off the casing and the orthosis, carefully and evenly sand down the material cover-ing the dummies until the edges are free (Fig. 33).

CAUTION!Overlapping sockets may cause the patient to suffer painful contusions when bending the knee.

The knee joint reaches a maximum flexion angle of 150°. When cutting the socket contours, ensure that the patient can freely bend his/her knee.

Cut the orthosis free as usual.

Unscrew the casing and take it off. Should the screws be too long, shorten them.

Remove all dummies and the Plastilin® molding dough from the casing and orthosis.

Sand down the edges of the orthosis and the casing.

Clamp the dummy for the electronics (A) (Fig. 34) into its corresponding receptacle (B) and place the latter from the outside into the casing (Fig. 35).

Fasten the unit from the outside with PVC adhesive tape. Seal off the unit as much as possible by pulling the tape tight.

TIPEnsure that the cable connection points in the right direction: Knee joint cable toward the electronics, electronics cable toward the battery!

A B

34 35


WARNING!Sealing resin inside the receptacle can damage the latter.Resin dissolves the material of the receptacle. Do not let resin leak into the receptacle.

Turn the casing such that you can see the inside on the receptacle. Mix a small amount of sealing resin with a sufficient amount of hardener. Do not add too much hardener as this could cause the resin to form bubbles during hardening, in turn causing the connection to become brittle.

Glue the receptacle to the casing by letting the sealing resin flow gently and slowly around the receptacle into the recess (Fig. 36).

Then glue in the battery receptacle. Follow the above-mentioned instructions for gluing the bat-tery receptacle. Put the casing aside for hardening.

Finalize the orthosis as usual :

Mount the knee and, if need be, the ankle joint and attach inner pads and closures.

36


Connect both cables to the electronics receptacle (see Fig. 37 to Fig. 40).

4.3 Final assembly

Remove the electronics and battery dummies from their receptacles.

WARNING!Risk of short circuit! Do not insert the battery until the entire system has been assembled.

1 2

3 4

1 2

3 4

1 2

3 4

1 2

3 4

37 38

39 40


Then connect the electronics with the battery. Place three to four small strips of double-sided adhesive tape (depending on cable length) into the cable ridge. Glue the cable into the casing (Fig. 41).

You may shorten the battery cable in the battery plug section. Leave approximately 5 cm ad-ditional cable length to allow mounting the lock unit (Fig. 42).

Ensure proper polarities (see Fig. 43): plus cable (red) to plus connection (+ symbol on battery), minus cable (gray) to minus (no symbol) (Fig. 44).

TIPE-MAG Control has an integrated polarity protection: If set to a wrong polarity, the electronics shuts off automatically, avoiding a short-circuit. Should the E -MAG Control fail to function despite proper cable connections (see Section 8, Failures and Troubleshooting), verify polarities.

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rot gekennzeichnet

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44

marked red

marked red marked red


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2 3

4 5

Join the lock units of the battery cable (Fig. 45 and Fig. 46).

WARNING!Shortening, lengthening and frequent bending may damage the electronics cable. If possible, do not bend or crease the cable until it is ready to be fastened into its final position.

Position the cable from the knee joint to the electronics. Place it, if need be, in flat loops until it lies against the socket without tension between the knee joint and electronics (Fig. 47). Press the loops onto each other and fasten the cable with adhesive tape into the casing.

Electric connections can oxidize. Protect contacts and cable transitions with Silicone Grease 633F11 as indicated in Fig. 48.

45 46

47 48


Insert the electronics into the receptacle (Fig. 49) and fasten it with enclosed screws (Fig. 50) using a maximum tightening torque of 1 Nm.

49 50

51 52

53 54


WARNING!Dust and moisture may damage the electronics. Always close the electronics before commencing with sanding or other work on the orthosis.

TIPThe casing and the electronics cable should be removed when working on the orthosis. To remove the unit, release the cable directly at the knee joint and proceed as illustrated in Fig. 51 to Fig. 54.

WARNING!The patient may fall and become injured if the bars loosen from the joint connec-tions. Therefore, before the final fitting of the orthosis, glue all system joint bars with the Adhesive 636W28. Roughen the joint bars and degrease them before glu-ing.

Screw the casing onto the transfemoral socket. Then insert the battery and verify all functions (see Section 5, Putting into Operation).With delivery of the finalized E-MAG Control, hand the user the Instructions for Use, explain the functions of the product and inform him/her about the recommended bi-annual maintenance intervals. After a complete charging and subsequent installation of the battery, the system is ready for operation.

5 Putting into Operation

This section will describe how the E-MAG Control can be activated and how it can be reacti-vated from the energy-saving mode. The section also explains how the electronic system starts and which signals the system emits during activation. The inside cover page of these Service Instructions features a color overview of these signals. A table of all possible signals and signal combinations and their meanings is listed in Section 6.1, Possible signal combinations.

5.1 Charging the battery

WARNING!The E-MAG Control is to be used only with the Ni-MH Battery 317B20. That battery was developed especially for the system. Both receptacle and lock unit are designed to fit with the form of this battery.


READBefore putting the E-MAG Control into operation, read the instructions for the Battery 647G309 and the Battery Charger 647G310. Follow the safety instructions!

Charge the Battery 317B20 fully using only the Battery Charger 317L20 before using it for the first time (Fig. 55). To do so, plug the battery charger into a power outlet and insert the battery into the charger. One full charging cycle takes between 8 to 10 hours.

In daily use, the charging time depends on the remaining capacity of the battery.

TIPThe charger can charge two batteries at the same time.

Place the charged battery into its receptacle; it should snap easily into the holder (Fig. 56).

Once the battery is connected to the system, the E-MAG Control is activated and the start se-quence launched. Please also read the following section 5.2, Start sequence.

55 56


5.2 Start sequence

CAUTION!Risk of Falling.Missing signals during the start sequence indicate a failure of the E-MAG Control. Be attentive to all signals listed here.

Every time the E-MAG Control is activated, the electronic control unit runs a short self-test that emits the following signals:

SignalStatus

Light Sound Vibration

System ready

Blue 1x deep / 1 x high (long)longRed

White

Signal table 1: Launched start sequence

After successful completion of the start sequence, the electronics will indicate the current status of the lock with a set of light, sound or vibration signals, or a combination of these signals.

The current lock status is indicated with either one of two available response profiles, i.e. sets of signals. Users can select their preferred profile (Blue or Purple) and switch back and forth between them.


READFor a detailed description of both response profiles, see Section 6.1, Possible signal combinations.

With every activation of the E-MAG Control, the signals of the “Blue Profile” indicate the status as follows:

SignalStatus


Lock closed Green3 x deep, short 3 x short

Lock open Red3 x high, long 3 x long

Signal table 2: Confirmation of the activation with status indication according to the “Blue Profile”

5.3 Energy-saving mode

With every opening of the lock, the E-MAG Control switches into the energy-saving mode. The electronics reactivates automatically when the lock again closes.

If neither the direct start button nor the remote control are not activated for more than two hours with a closed lock, the system shuts off automatically. In order to reactivate the E-MAG Control, press briefly on the direct start button of the electronic control unit. The start sequence begins shortly after letting go of the key. Once the start sequence has finished, the E-MAG Control is again ready for operation. The Blue Profile is active.

6 Operation

This section describes the possible signal combinations of the response system, how to open the lock, close the lock, and how to switch between response profiles.


6.1 Possible signal combinations

The E-MAG Control features a system which informs patients of a change of their lock status.

This section features both response profiles and the possible signal combinations they may communicate during use of an E-MAG Control.

The Blue Profile uses visual, acoustic and haptic status and warning signals. These signals are generally well perceivable in a normal environment even with elevated background noise.

SignalStatus


Lock closed Green 3 x deep, short 3 x short

Lock open Red 3 x high, long 3 x long

Knee under flexion load –Lock does not open–

Yellow, flashing

1 x deep, continuous tone long

Signal table 3: Possible signals of Blue Profile


The Purple Profile does not use acoustic signals and is recommended for settings in which additional sound is perceived as disruptive (e.g. conference, theatre).

SignalStatus


Lock closed – –3 x short

Lock open – –3 x long

Knee under flexion load – Lock does not open –

– –1 x long

Signal table 4: Possible signals of Purple Profile

6.2 Warning signals

The following situations trigger warning signals:

SignalStatus


Battery empty

Red/Yellow, flashing

Short, alternatingly high and deep Short

/

5 x short

Failure

Blue

Continuous lightor

Continuous tone–

Yellow

Red

Purple


Knee under flexion angle – lock does not open

Blue Profile

Yellow, flashing deep, continuous tone long vibration

Purple Profile – –

For safety reasons, the E-MAG Control can only be opened when the knee joint is fully extended. If the user tries to open the lock while bearing a flexion load, the electronics will respond with, at least, a long vibration to indicate a failure. The sound signal and yellow flashing are active only in the Blue Profile.

Battery status

WARNING!The electronics will turn off if the battery is completely empty.In that case, the user can still open the knee manually, though this is cumbersome.Please advise the orthosis wearer to check the battery status regularly.

This warning is repeated after each opening or closing until the battery has been changed.

After the first signal, the lock will open or close for approximately ten more times. The speed with which a battery becomes discharged depends on the ambient temperature: The colder the temperature, the faster the remaining capacity is used up.

Failure of the electronics

The E-MAG Control is not vulnerable to failure. However, should disruptions occur, the electron-ics recognizes the failure and sends a warning signal.


Continuous light: High, continuous tone

RedBlue

PurpleYellow

– –

In the case of a failure, the knee joint can only be opened manually.


6.3 Opening the lock

The E-MAG Control can be opened either with the remote control or with the direct start button at the electronic control unit. In both cases, the system will issue a response. Depending on which response profile is selected, the system will issue the following responses when opening the lock.

SignalStatus


E-MAG Controlopen Red

3 x high, long 3 x long

Signal table 5: Open lock, Profile Blue (normal environment)

SignalStatus


E-MAG Controlopen – –

3 x long

Signal table 6: Open lock, Profile Purple (quiet environment)


Remote control

On the remote control, push the activation key two times, one quickly after the other, into the direction as illustrated above (Fig. 57).

Direct start button

Press two times, one quickly after the other, onto key (A) of the electronics (Fig. 58).

TIPKey entries that are too fast are filtered out and disregarded. This prevents activating the lock by mistake.

58

57

A


Manual opening and closing

Manual opening is possible only with full extension of the E-MAG knee joint.

If the E-MAG Control cannot be opened electronically (e.g. battery empty), the user can activate the lock manually with the 30Y121 key. The key is pushed from underneath into the key opening at the E-MAG knee joint (Fig. 59-62).

61 62

59 60


6.4 Closing the lock

The electromagnetic lock automatically snaps into place as soon as the user has fully extended his or her knee joint.

Once the lock is closed, the system emits the following signals, depending on the selected profile:

SignalStatus


Lock closed Green3 x deep, short 3 x short

Signal table 7: Blue Profile (normal environment)

SignalStatus


Lock closed – –3 x short

Signal table 8: Purple Profile (quiet environment)

6.5 Switching between response profiles

Users can choose from two response profiles depending on their environment. The Blue Profile (normal environment) is the default profile activated with each putting into operation.

To change to the Purple Profile (quiet environment), press the direct start button on the electron-ics for approximately 2 seconds until you perceive the following signals:


SignalStatus


Purple Profile active Purple

Deep, continuous tone

Continuous vibration

Signal table 9: Changing profiles from Blue to Purple

Once you perceive these signals, you have successfully activated the Purple Profile. The signal transmission stops as soon as you release the direct start button.

In order to return to the Blue Profile, press the direct start button again for 2 seconds until you perceive these signals:

SignalStatus


Blue Profile active BlueHigh, continuous

tone Continuous vibration

Signal table 10: Changing profiles from Purple to Blue

The Blue Profile is now again active.

7 Maintenance

WARNING!Compressed air may damage the electronics.Carefully remove dust and dirt particles in the electronics with a small brush.

WARNING!Plastic parts are sensitive to scratches.Unscrew the knee joint screw from the inside, if possible, in order to protect the black plastic shell of the E-MAG Control.

WARNING!Scratches on the joint surfaces may cause premature wear of the bearing washer and bearing bushing. Avoid contact with sharp-edged objects.


Carry out a maintenance check of your E-MAG Control orthosis every six months.

TIPDocument maintenance works and intervals. The maintenance plan at the end of these Service Instructions serves as a reference guide. We recommend attaching a copy of the maintenance plan to each contract. Inform your client about the required maintenance intervals.

7.1 Proper functioning and premature wear

The bi-annual maintenance control verifies the proper functioning of the• lock and• the electronics.

Open the joint as indicated in Fig. 63. Check:• premature wear (play in the joint, fissure building or visible wear in the bushing material),• joint bushing A, • bearing bushing B, and• whether dust or dirt has settled inside the joint.

To open the lock, loosen the two screws at the right and left of the cap.

63

35 Nm

BA


Check whether dust or dirt has settled on spring (D) or lock (E) (Fig. 64 and Fig. 65). If need be, clean with a small brush.

Are the plug contacts (F) (Fig. 65) from joint to electronics clean?

Before reassembling the unit, reapply protective silicone grease to the plug contacts. A plastic syringe with a short, cut-off cannula facilitates controlling the dosage.

7.2 Changing the bearing washer and bearing bushing

64 65

D

E

Replace the bearing washers and bushings with the service set 17B200 as indicated with the 17BS200 Service Set (Fig. 66). Carefully pry out the bushing with a screwdriver. Take care not to scratch the inner surface of the joint.

F

66

35 Nm

BA


8 Failures and Troubleshooting

WARNING!Danger of short-circuit.Never open electronic parts. Should a part be defect, send the complete E-MAG Control to your service technician. You will be temporarily supplied with a Service Set 17B200=S.

If sending in your E-MAG Control for repair, make sure to include the following parts:

• Electronics• Battery• Battery charger• Remote control• Case with serial number

Section 4.2 Casing describes how to remove and reinstall these individual components.

8.1 System does not start properly

If the system does not start properly (see Section 5.2, Start sequence), remove the battery, wait 30 seconds and reinsert it. Should the system still fail to start, the electronics is defect. Exchange the E-MAG Control for a Service-Set.

8.2 Failure of the electronics

If a continuous light or tone indicates a failure (see Section 6.2, Warning signals), follow the steps as described in the above Section 8.1, System does not start properly.

Inform the orthosis wearer that the electronics must be exchanged immediately once a failure occurs.

8.3 Remote Control does not work

If the E-MAG Control does not open with the remote control, check the batteries in the remote control and, if need be, exchange them. If this does not resolve the failure, the E-MAG Control can still be operated with the direct start button.


If the direct start button also fails to open the lock, exchange the E-MAG Control for a Service-Set (see Section 8.2, Failure of the electronics).

8.4 Lock does not close

If the lock of the E-MAG Control does not close, check (in the following sequence):

1. the proper setup of the orthosis and if the orthosis wearer reaches the required extension,

2. the joint and bearing bushings for premature wear or dust particles inside the joint (see Sec-tion 7, Maintenance).

If these checks do not resolve the failure, exchange the E-MAG Control for a Service-Set (see 8.2, Failure of the electronics).

9 Warranty

Otto Bock HealthCare issues a two year warranty for the E-MAG Control.The E-MAG Control is only to be utilized under the prescribed conditions, for its intended purpose and with authorized parts. The warranty does not cover wearing parts such as bearing washers and bushings.The manufacturer recommends to respect the prescribed maintenance intervals of six months.

The manufacturer is not liable for damages caused by parts which Otto Bock has not authorized for the E-MAG Control.


10 Maintenance Plan

Item Area1

2

3

4

5

E-MAG ControlPatient:

Routine Mainenance Plan

Medial support:

yes no

First use on:

Check list

Left RightPatient weight: kg Body height: cm

Serial number:

Medial support (if patient has one)

yes no Measure

Remote control

Battery und battery charger

Notes:

The maintenance service was carried out by: on:

- Is there play when joint is closed?- Is there play when joint is open?- Do the unlocking and locking functions work properly?- Is the noise appropriate?- Proper cable connection for knee electronics?- Solid connection between bars and joints?

- Is there play when joint is open?- Is the noise appropriate?- Solid connection between bars and joints?

- Are the cable connections solid and undamaged?- Are the plug contacts clean and non-oxidized? - Are the settings for the electronic control unit correct?- Does the direct start button function properly?- Do the vibration, sound, light signals function properly?- Does the system function with remote control?

- Batteries OK?- Battery contacts clean and non-oxidized? - Does start key function?- Function with electronics OK?

- Battery OK and undamaged?- Battery contacts clean and non-oxidized? - Battery housing smooth and contacts clean?- Battery charger OK?

Do the settings correspondto the patient's requirements?


11 Declaration of Conformity

E-MAG Control bears the CE marking in accordance with the Medical Devices Directive 93/42/EEC.

12 Technical Data

Range of transmission: approx. 10 m inside buildings, approx. 30 m outside

Performance of transmitter: 5 dBm

Ambient temperature: -10°C to +55°C

Power supply for handheld device: 2 x AAAA batteries, 3 V nominal voltage (equalling 3V nominal voltage)

Power supply for joint: NiMh battery, 4.8V nominal voltage

FCC No. FCC ID TDMRF

IC No. IC: 5496C-RF

Kundenservice/Customer Service

EuropeOtto Bock HealthCare Deutschland GmbHMax-Näder-Str. 15 · 37115 Duderstadt · Germany T +49 5527 848-3433 · F +49 5527 848-1460 e-mail: [email protected] · www.ottobock.com

Otto Bock Healthcare Products GmbHKaiserstraße 39 · 1070 Wien · Austria T +43 1 5269548 · F +43 1 5267985 e-mail: [email protected] · www.ottobock.at

Otto Bock Adria Sarajevo D.O.O.Omladinskih radnih brigada 5 71000 Sarajevo · Bosnia-Herzegovina T +387 33 766200 · F +387 33 766201 e-mail: [email protected] · www.ottobockadria.com.ba

Otto Bock Bulgaria Ltd.41 Tzar Boris III‘ Blvd. · 1612 Sofia · BulgariaT +359 2 80 57 980 · F +359 2 80 57 982e-mail: [email protected] · www.ottobock.bg

Otto Bock Suisse AGPilatusstrasse 2 · CH–6036 Dierikon T +41 41 455 61 71 · F +41 41 455 61 70 e-mail: [email protected] · www.ottobock.ch

Otto Bock ČR s.r.o.Protetická 460 · 33008 Zruč-Senec · Czech Republic T +420 377825044 · F +420 377825036 e-mail: [email protected] · www.ottobock.cz

Otto Bock Iberica S.A.C/Majada, 1 · 28760 Tres Cantos (Madrid) · Spain T +34 91 8063000 · F +34 91 8060415 e-mail: [email protected] · www.ottobock.es

Otto Bock France SNC4 rue de la Réunion - CS 90011 91978 Courtaboeuf Cedex · France T +33 1 69188830 · F +33 1 69071802 e-mail: [email protected] · www.ottobock.fr

Otto Bock Healthcare plc 32, Parsonage Road · Englefield Green Egham, Surrey TW20 0LD · United Kingdom T +44 1784 744900 · F +44 1784 744901 e-mail: [email protected] · www.ottobock.co.uk

Otto Bock Hungária Kft.Tatai út 74. · 1135 Budapest · Hungary T +36 1 4 5110 20 · F +36 1 4 5110 21 e-mail: [email protected] · www.ottobock.hu

Otto Bock Adria d.o.o.Dr. Franje Tuđmana 14 ·10431 Sveta Nedelja · CroatiaT +385 1 3361 544 · F +385 1 3365 986e-mail: [email protected] · www.ottobock.hr

Otto Bock Italia Srl UsVia Filippo Turati 5/7 · 40054 Budrio (BO) · Italy T +39 051 692-4711 · F +39 051 692-4720 e-mail: [email protected] · www.ottobock.it

Otto Bock Benelux B.V.Ekkersrijt 1412 · 5692 AKSon en Breugel · The Netherlands T +31 499 474585 · F +31 499 4762 50 e-mail: [email protected] · www.ottobock.nl

Industria Ortopédica Otto Bock Unip. Lda.Av. Miguel Bombarda, 21 - 2º Esq. 1050-161 Lisboa · Portugal T +351 21 3535587 · F +351 21 3535590 e-mail: [email protected]

Otto Bock Polska Sp. z o. o.Ulica Koralowa 3 · 61-029 Poznań · Poland T +48 61 6538250 · F +48 61 6538031 e-mail: [email protected] · www.ottobock.pl

Otto Bock Romania srl Șos de Centura Chitila - Mogoșoia Nr. 3077405 Chitila, Jud. Ilfov · Romania T +40 21 4363110 · F +40 21 4363023 e-mail: [email protected] · www.ottobock.ro

OOO Otto Bock Servicep/o Pultikovo, Business Park „Greenwood“, Building 7, 69 km MKAD 143441 Moscow Region/Krasnogorskiy Rayon Russian Federation T +7 495 564 8360 · F +7 495 564 8363 e-mail: [email protected] · www.ottobock.ru

Otto Bock Scandinavia ABKoppargatan 3 · Box 623 · 60114 Norrköping · Sweden T +46 11 280600 · F +46 11 312005 e-mail: [email protected] · www.ottobock.se

Otto Bock Slovakia s.r.o.Röntgenova 26 · 851 01 Bratislava 5 · Slovak Republic T +421 2 32 78 20 70 · F +421 2 32 78 20 89 e-mail: [email protected] · www.ottobock.sk

Otto Bock Sava d.o.o.Maksima Gorkog bb · 18000 Niš · Republika SrbijaT +381 18 4285888 · F +381 18 4539191e-mail: [email protected] · www.ottobock.rs

Otto Bock Ortopedi ve Rehabilitasyon Tekniği Ltd. Şti.Ali Dursun Bey Caddesi · Lati Lokum Sokak Meriç Sitesi B Block No: 6/1 34387 Mecidiyeköy-İstanbul · Turkey T +90 212 3565040 · F +90 212 3566688 e-mail: [email protected] · www.ottobock.com.tr

AfricaOtto Bock Algérie E.U.R.L.32, rue Ahcène Outaleb - Coopérative les Mimosas Mackle-Ben Aknoun · Alger · DZ Algérie T +213 21 913863 · F +213 21 913863 e-mail: [email protected] · www.ottobock.fr

Otto Bock Egypt S.A.E.28 Soliman Abaza St. Mohandessein - Giza · Egypt T +202 330 24 390 · F +202 330 24 380 e-mail: [email protected] · www.ottobock.com.eg

Otto Bock South Africa (Pty) LtdBuilding 3 Thornhill Office Park · 94 Bekker Road Midrand · Johannesburg · South Africa T +27 11 312 1255 e-mail: [email protected]

AmericasOtto Bock Argentina S.A.Av. Cabildo 924 · CP 1426 Ciudad Autônoma de Buenos Aires · Argentina T +54 11 4706-2255 · F +54 11 4788-3006 e-mail: [email protected]

Otto Bock do Brasil Ltda.Rua Jovelino Aparecido Miguel, 32 13051-030 Campinas-São Paulo · Brasil T +55 19 3729 3500 · F +55 19 32 69 6061 e-mail: [email protected] www.ottobock.com.br

Otto Bock HealthCare Canada5470 Harvester RoadBurlington, Ontario, L7L 5N5, Canada T +1 289 288-4848 · F +1 289 288-4837 e-mail: [email protected] · www.ottobock.ca

Otto Bock HealthCare Andina Ltda.Clínica Universitária Teletón, Autopista Norte km 21 La Caro Chia, Cundinamarca · Bogotá · Colombia T +57 1 8619988 · F +57 1 8619977 e-mail: [email protected] · www.ottobock.com.co

Otto Bock de Mexico S.A. de C.V.Prolongación Calle 18 No. 178-ACol. San Pedro de los PinosC.P. 01180 México, D.F. · Mexico T +52 55 5575 0290 · F +52 55 5575 0234 e-mail: [email protected] · www.ottobock.com.mx

Otto Bock HealthCareTwo Carlson Parkway North, Suite 100 Minneapolis, MN 55447 · USA T +1 763 553 9464 · F +1 763 519 6153 e-mail: [email protected] www.ottobockus.com

Asia/PacificOtto Bock Australia Pty. Ltd.Suite 1.01, Century Corporate Centre · 62 Norwest Boulevarde Baulkham Hills NSW 2153 · Australia T +61 2 8818 2800 · F +61 2 8814 4500 e-mail: [email protected] · www.ottobock.com.au

Beijing Otto Bock Orthopaedic Industries Co., Ltd. B12E, Universal Business Park 10 Jiuxianqiao Road, Chao Yang District Beijing, 100015, P.R. China T +8610 8598 6880 · F +8610 8598 0040 e-mail: [email protected] www.ottobock.com.cn

Otto Bock Asia Pacific Ltd.Suite 3218, 32/F., Sun Hung Kai Centre 30 Harbour Road, Wanchai, Hong Kong · China T +852 2598 9772 · F +852 2598 7886 e-mail: [email protected]

Otto Bock HealthCare IndiaBehind FairLawn Housing Society St. Gregorios Lane, Sion Trombay Road Chembur, Mumbai, 400071 · India T +91 22 2520 1268 · F +91 22 2520 1267 e-mail: [email protected]

Otto Bock Japan K. K.Yokogawa Building 8F, 4-4-44 ShibauraMinato-ku, Tokyo, 108-0023 · JapanT +81 3 3798-2111 · F +81 3 3798-2112e-mail: [email protected] · www.ottobock.co.jp

Otto Bock Korea HealthCare Inc.4F Agaworld Building · 1357-74, Seocho-dongSeocho-ku, 137-070 Seoul · KoreaT +82 2 577-3831 · F +82 2 577-3828 e-mail: [email protected]

Otto Bock South East Asia Co., Ltd.1741 Phaholyothin Road, Kwaeng Chatuchark, Khet ChatucharkBangkok 10900 · Thailand T +66 2 930 3030 · F +66 2 930 3311 e-mail: [email protected] · www.ottobock.co.th

Other countriesOtto Bock HealthCare GmbHMax-Näder-Str. 15 · 37115 Duderstadt · Germany T +49 5527 848-1590 · F +49 5527 848-1676 e-mail: [email protected] · www.ottobock.com

Ottobock has a certified Quality Management System in accordance with ISO 13485.

Otto Bock HealthCare GmbHMax-Näder-Str. 15 · 37115 Duderstadt /GermanyT +49 5527 848-0 · F +49 5527 72330 [email protected] · www.ottobock.com

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