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Magner is user guide

Magneris en 05-11-2010 Link

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Page 1: Magneris en 05-11-2010 Link

Magnerisuser guide

Page 2: Magneris en 05-11-2010 Link

Dear Customer,

We would like to thank you for choosing Astar’s device.

We believe the proper work on it will bring you satisfaction and your

patients a quick recovery.

All our products are made from high quality materials using the modern

technology according to all safety rules.

We recommend to read this manual, especially the maintenace part

for perfect satisfation of our device.

Astar.physiotechnology

Astar’s devices

and their dedicated physiotherapy

Electrotherapy

Laser therapy

Ultrasound

Magnetotherapy

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Plu

s

So

na

ris

Ma

gn

er

Plu

s

Ma

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Basic function

Additional function

Page 3: Magneris en 05-11-2010 Link

Magneris user guide

ISSUE DATE 05.11.2010

Page 4: Magneris en 05-11-2010 Link

page 4 MAGNERIS – USER GUIDE

0 INTRODUCTION AND DECLARATION OF CONFORMITY 6

1 INTENDED USE 8

2 WARRANTY AND MANUFACTURER’S RESPONSIBILITY 9

3 OPERATIONAL SAFETY 10

3.1 MAINS SUPPLY AND MODE OF OPERATION 10

3.2 STORAGE, OPERATION AND TRANSPORT CONDITIONS 10

3.3 WARNINGS AND SAFETY NOTICES 10

3.4 EXPLOSION PROOF ENVIRONMENT 11

3.5 PROTECTION AGAINST IMPACT OF ELECTROMAGNETIC FIELD 11

3.6 TECHNICAL SUPERVISION 12

3.7 DISPOSAL 12

4 UNIT DESCRIPTION 13

4.1 GENERAL CHARACTERISTICS 13

4.2 KEYBOARD 15

4.2.1 START key 15

4.2.2 STOP key 15

4.2.3 Confi rmation key 15

4.2.4 Escape key 15

4.2.5 Information key 16

4.2.6 Operation mode change key 16

4.2.7 Save key 16

4.2.8 Edit keys 16

4.3 REAR AND SIDE PANELS 16

4.4 NAME PLATE 16

4.5 TREATMENT PARAMETERS 17

4.6 MAGNETIC FIELD APPLICATORS 19

5 DEVICE INSTALLATION AND START-UP 20

5.1 UNIT INSTALLATION 20

5.1.1 Attaching the device to the shelf of the stand 20

5.1.2 Connecting applicators 20

5.1.3 Stand height adjustment 21

5.1.4 Plate applicator position adjustment 21

5.1.5 First start-up 22

5.2 SETUP MODE 23

5.2.1 Sounds 23

5.2.2 Contrast 24

5.2.3 Dose unit 24

5.2.4 Removal of user programs 24

5.2.5 Language 24

5.2.6 Start-up menu 24

Content

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6 UNIT OPERATION 25

6.1 OPERATION WITH PRESET TREATMENT PROGRAMS 25

6.2 OPERATION IN THE MANUAL MODE 28

6.3 USER DEFINED PROGRAMS 28

7 INDICATIONS AND CONTRAINDICATIONS 30

7.1 INDICATIONS 30

7.2 CONTRAINDICATIONS 30

8 MAINTENANCE, CLEANING, DISINFECTION 31

8.1 CLEANING, DISINFECTION 31

8.2 FUSE REPLACEMENT 31

9 SPECIFICATION AND ACCESSORIES 32

9.1 TECHNICAL SPECIFICATION 32

9.2 EMC PARAMETERS 34

9.3 ACCESSORIES 38

APPENDIX

APPENDIX A

LIST OF PRESET TREATMENT PROGRAMS 39

APPENDIX B

DESCRIPTION OF THE SYMBOLS, WHICH ARE PLACED ON THE UNIT CASING 42

NOTES 43

This manual includes 44 pages.

Page 6: Magneris en 05-11-2010 Link

page 6 MAGNERIS – USER GUIDE

0 INTRODUCTION AND DECLARATION OF CONFORMITY

0 Introduction and Declaration of Conformity

Read this Guide carefully before starting the operation of Magneris!

Follow the recommendations presented in this Guide!

The Magneris unit may only be operated by qualifi ed personnel

or under supervision of such personnel!

Descriptions of symbols used in this manual:

Read appropriate passage of this user guide, warnings or important information.

Failure to observe warnings can lead to injuries.

Important notices and information.

Following texts marked with this symbol facilitates device operation.

REMARK

The outlook of screens shown in this manual may slightly diff er from their

actual outlook during device operation. These diff erences may concern size

and type of fonts and size of symbols. There are no diff erences in the content

of shown information.

No modifi cation of this equipment is allowed!

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0 INTRODUCTION AND DECLARATION OF CONFORMITY

Version 1.1 date of issue 03.12.2010

DECLARATION OF CONFORMITY no 01/10/EN

Manufacturer: ASTAR ABR A.J DRZEJOWSKI, R.DZIENDZIEL S.J.

Address: Ul. STRA ACKA 81, 43-382, BIELSKO-BIAŁA, POLAND

Product name:

LOW FREQUENCY MAGNETIC FIELD THERAPY UNIT

Magneris Classification:

• class IIa rule 9 – for low frequency magnetic field therapy function

Declaration: Manufacturer declares under his own responsibility that the product described above complies with the requirements of Council Directive 93/42/EEC for medical devices.

Conformity assessment procedure: Annex II article 3 of EC Directive 93/42/EEC

Documentation of releasing a product to sell: „Final tests card” form MM-KBK, version 1.0, updated on 20.05.2010, as a part of the Technical File of the device, considered together with this Declaration of Conformity.

EC certificate: HD 60027842 0001 QMS certificate: SX 60027845 0001

Bielsko-Biała, Poland, 03.12.2010 signature:

(Robert Dziendziel)

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page 8 MAGNERIS – USER GUIDE

1 Intended use

Magneris, the low-frequency magnetic fi eld treatment unit, is designed to carry out

treatments using magnetic fi eld generated by dedicated applicators. The unit can

be connected to a coupled CP-type plate applicator or to a CSL60-type solenoid

applicator with a diameter of 60 cm. (The latter was used previously in Magner LT

and Magner Plus units.) The medical product comprises the Magneris device,

applicator stand and CP-type applicator.

The Magneris unit can be used to treat the following disorders:

• orthopaedic:

fractures

dislocations, sprains, bruises

ligament and sinew injuries

traumas, arthroses

complex regional pain syndromes

• neurological:

neuralgias

neuromas

phantom pains

• circulatory system:

peripheral arterial bloodstream disorders

• dermatological:

ulcerations

The unit has a built-in database of pre-programmed treatment procedures, but it also

allows the user to program custom procedures.

The Magneris magnetotherapy unit is a fully mobile device that has the following

features:

• the ability to move the stand owing to the installed wheels

• the ability to adjust the height of the plate applicator by means of the servo

arm with tilt regulation

• the ability to adjust the angle of the plate applicator

• the ability to adjust the relative position of the plate applicator coils – from

parallel to perpendicular

The treatments can be conducted anywhere in the consulting room or the hospital

room. No dedicated workplace is necessary.

The treatments using the Magneris unit are conducted locally. The magnetic fi eld

aff ects only the part of the body that is to undergo the therapy. Unlike in the clas-

sical method of magnetic fi eld application that employs solenoid applicators,

plate applicators allow to reduce the eff ect of magnetic fi eld on other parts

of the patient’s body as well as on the device’s environment, including the operating

personnel.

1 INTENDED USE

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2 WARRANTY AND MANUFACTURER’S RESPONSIBILITY

2 Warranty and manufacturer’s responsibility

The manufacturer warrants the device, stand and applicators to be free of faults

for two years and ensures after warranty service during 10 years from date of device

introduction in the market. The warranty includes all material and workmanship

faults.

The manufacturer undertakes to observe the warranty agreement, if the following

conditions are met:

• all repairs, changes, extensions and calibrations of equipment are performed

by manufacturer or authorized service personnel

• the mains supply system in the treatment room meets requirements of stan-

dards in force

• the unit is operated by qualifi ed personnel, in compliance with instructions

presented in this manual

• the unit is operated in compliance with its intended use

The warranty does not include consumables, such as connection cables, mains

cables, holders and fuses.

The manufacturer is not liable in case of transmission of infection by equipment

components.

The expected “life time” of the device is 10 years.

After elapse of 10 years from date of introduction of device and accessories

in the market the manufacturer is not liable for device and accessories’ faults or its

consequences.

The manufacturer bears no responsibility for results of faulty installation, wrong

diagnosis, wrong use of the device and equipment, failure to observe user’s

manual and performance of repairs by unauthorised persons.

Inside the device there are no user serviceable components, except for fuses.

On demand, the producer makes available technical diagrams, parts lists, descrip-

tions, instructions for calibration or other helpful information to appropriately

qualifi ed user’s technical staff to repair these parts of unit, which are described

by the producer as a reparable.

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page 10 MAGNERIS – USER GUIDE

3 Operational safety

3.1 Mains supply and mode of operationThe Magneris unit belongs to mobile devices. It is designed for supply from AC

mains with rating 230 V ±10 %, 50 Hz. It is a medical device under safety class I,

type BF. The unit features very high value insulation resistance and very small

leakage currents. The unit may be used only in rooms, where the electric system

is executed in compliance with standards in force.

3.2 Storage, operation and transport conditionsThe Magneris unit must be stored in closed rooms, where the atmosphere is free

from vapours and caustic substances and:

• the temperature is maintained between + 5°C and +45°C

• relative humidity does not exceed 75 %

• atmospheric pressure value is between 700 – 1060 hPa

The unit is intended for operation under the following conditions:

• ambient temperature between +10°C and +30°C

• relative humidity between 30 % and 75 %

• atmospheric pressure between 700 and 1060 hPa

In case further transport is necessary use the original package, in which the device

was delivered to the customer. The transport must be performed with covered

transport means.

Recommended transport conditions:

• ambient temperature between -10°C and +45°C

• humidity between 20 and 95 %

• atmospheric pressure between 700 and 1060 hPa

3.3 Warnings and safety notices• The Magneris unit may only be operated by qualifi ed personnel in compli-

ance with instructions presented further in this manual.

• To avoid the risk of electric shock, this equipment must only be connected

to supply mains with protective earth.

• No modifi cation of this equipment is allowed.

• The treatment station (bed, couch) shall be located away from other electric

devices and water supply/sewerage installation/central heating system,

so that it is impossible for the patient to touch any of them during treatment

procedure.

• Do not remove warning signs and labels put by the manufacturer on unit

casing and casings of magnetic fi eld applicators.

• Patient must wear protective glasses during treatment in a head area.

• Avoid exposing the unit and applicators to impact of high temperatures

and atmospheric conditions.

• Treatment of persons with implanted electronic devices (e.g. cardiac pace-

maker) shall be consulted with patient’s physician.

3 OPERATIONAL SAFETY

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• The unit is intended for continuous operation. It is not necessary to switch it off

from the mains between particular treatment procedures.

• The unit and CP applicator are equipped with fans ensuring appropriate air

circulation. It is inadmissible to cover ventilation holes in any way whatsoever.

• Only one CSL60 type applicator may be placed on the single rehabilitation

table.

• Only personnel may change position of the CSL60 type applicator placed

on the rehabilitation table.

• Damaged cables must be replaced immediately.

• The unit must be operated exclusively together with accessories, spare

parts, consumables, which are known to be safe and appropriate inspection

authorities did not make any reservations about them.

• It is recommended to use original accessories, spare parts and equipment

of Astar ABR Company. Use of accessories other than recommended

by the manufacturer may result in reduction of resilience and raise in unit

emissions in regard with electromagnetic interference.

• Avoid penetrating of any liquid inside the unit and applicators. In case of liquid

penetrating inside unit switch the unit off immediately, separate from

the mains and contact the service for inspection.

• It is recommended to keep minimal distance 1 m between two optional

applicators.

• During magnetotherapy treatment session personnel and bystanders shall

not be closer than 1 m to the magnetic fi eld applicator.

• A long-lasting exposure of personnel and bystanders on magnetic fi eld

could cause irritation, headache and insomnia.

• It is necessary to be careful during carrying the applicators due to their

weight.

3.4 Explosion proof environmentMagneris is not adapted to operation in rooms, where combustible gases

or their vapours occur. It is recommended to avoid anaesthetic or oxygen

derivate gases, such as nitrous oxide (N2O) and oxygen. Some materials (e.g.

cotton, wool) may after saturation with oxygen become combustible at high

temperatures generated with normal operation of equipment. It is recom-

mended that solutions of adhesive and combustible solvents be vaporised before

equipment is operated. It is also recommended to pay attention to the danger

of ignition of endogenous gases. The unit must be separated from the mains

before approaching the disinfection of the room, where it is installed.

3.5 Protection against impact of electromagnetic fi eldSimultaneous operation of the device and equipment generating strong elec-

tromagnetic fi eld, such as short wave and micro wave diathermies, may disturb

unit operation. For that reason keep appropriately big distance between them

or switching off the generator of strong fi elds during therapy with Magneris unit.

Mobile communication equipment operated with radio frequencies RF may infl u-

ence operation of Magneris unit.

3 OPERATIONAL SAFETY

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page 12 MAGNERIS – USER GUIDE

The unit meets requirements of standards in regard with electromagnetic inter-

ference and resistivity against such interference and shall not pose threat for correct

operation of other devices.

Sockets of magnetic fi eld applicators, marked with symbol shown to the left, are sen-

sitive to electrostatic discharges. Attention must be paid not to touch with fi ngers

sockets of the unit, especially in rooms with low air humidity. At the moment, when

applicators are being connected, the unit must be separated from the mains, and

the user must remove electrostatic charges from his fi ngers by touching earthed

metal component (e.g. earthed pin in mains socket or metal casing of earthed device).

Magnetic fi eld applicators are marked with non-ionizing radiation symbol.

3.6 Technical supervisionThe User of Magneris unit must perform technical inspection of the unit at year’s

intervals. The inspection must be performed by a unit authorized by manufac-

turer. The inspection is performed at the user’s expense.

The inspection should include:

• evaluation of keyboard function and operation

• control of correctness of the performed auto-test

• safety test

• cable test

• magnetic fi eld applicators operation test

The inspection must also include checking the quality of applied accessories

and treatment materials. The inspection results must be recorded with periodical

inspection register delivered with the unit.

3.7 DisposalIn case, when the liquidation of the unit will become necessary (e.g. after elapse

of its life time), please contact the manufacturer or manufacturer representative,

which must react in an appropriate way, i.e. collecting the unit from the user.

The user may also contact companies busy in the business of disposal of electrical

devices or computer equipment.

3 OPERATIONAL SAFETY

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4 Unit description

4.1 General characteristicsGeneral view of the unit, stand and plate applicator is presented in fi gure 4.1.

Figure 4.1 General view

Figure 4.1. View of rear side panel.

Construction of the stand allow to height adjustment (application of industrial

gas spring – further called servo) of the plate applicator, angle of rotation and

defl ection adjustment also.

4 UNIT DESCRIPTION

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page 14 MAGNERIS – USER GUIDE

Available methods of adjustments are presented in fi gure 4.3.

Figure 4.3. Adjustments of the plate applicator.

The stand has four wheels with brakes. Wheel with brake and servo are presented

in fi gures 4.4 and 4.5.

Figure 4.4 Wheel with brake.

Figure 4.5 Servo.

4 UNIT DESCRIPTION

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4 UNIT DESCRIPTION

4.2 Keyboard Arrangement of keyboard components is shown in fi gure 4.6.

Figure 4.6 Arrangement of keyboard components.

4.2.1 START keyPressing START button after:

• selection of treatment program or user-defi ned program in program mode

• edition of parameters in manual mode

causes the start of the treatment procedure.

Pressing START button after interruption of a treatment procedure (pause) makes

it possible to continue the procedure.

4.2.2 STOP keyPressing STOP button while performing treatment procedure causes the interrup-

tion of procedure. The unit enters the waiting state (pause). The timer will stop

then.

4.2.3 Confi rmation keyIt is used to confi rm:

• selection of function in program mode

• saving of user-defi ned program

• changes in the unit settings

4.2.4 Escape keyIts pressing causes abolition of action and going over on an early menu level.

Pressing the key during treatment procedure results in immediate interruption

of the procedure.

LCD

Indicator of selectedapplicator

Edit keys

Save key

Information key

Escape key

Confirmation key

Operation modechange key

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4 UNIT DESCRIPTION

4.2.5 Information keyPressing of this key causes displaying of more information with full name

and parameters of:

• treatment program

• user defi ned program

Escape from information menu follows after pressing of or key.

4.2.6 Operation mode change key Pressing of this key results in change from program operation mode to manual

mode (and vice versa).

4.2.7 Save key Pressing of this key enables saving of parameters of treatment procedure edited

in manual mode in the shape of user defi ned program.

4.2.8 Edit keysMenu item change keys:

Pressing of them results in change of menu item or change of arrow position with

introduction of access codes and name during edition of user defi ned programs.

Parameter change keys:

Pressing of them results in change of value of edited parameter and selection

of sign with introduction of access codes and name during edition of user defi ned

programs.

4.3 Rear and side panelsOn the right side wall of the unit the name plate is located.

On rear side wall are located:

• mains socket

• fuse socket

• mains on/off button

4.4 Name plateThe name plate is located on the rear wall of unit casing. On the name plate are

shown data as follows:

• unit version

• serial number

• rated voltage and operation frequency

• max. power consumption

• protection degree provided by casing

• appropriate graphic symbols

• types of applied fuses

• manufacturer’s data (address, phone and fax numbers)

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REMARKS:

• Magneris features two modes of generating magnetic fi eld: continuous and

interrupted. In the continuous mode magnetic fi eld is generated with

constant amplitude during the whole treatment procedure period. This mode

is selected by setting the pause time to cont. In the interrupted mode the mag-

netic fi eld is generated for 1 second, which is followed by a pause. The pause

length can be set between 0,5 s and 8 s. The drawing beneath shows operation

principle in interrupted mode.

Figure 4.7. Field shape in interrupted mode.

• Magnetic fi eld induction – is measured in militeslas (mT) or gausses (Gs).

The maximum value that can be set is 2.5 mT (25 Gs). This value is set in relation

to the geometric centre of the CSL60 applicator or the coils of the CP applicator

4 UNIT DESCRIPTION

4.5 Treatment parametersParameters description:

Rectangular

Triangular

Sinusoidal

Half-rectangular

Half-triangular

Półsinusoidalny

Symbol Defi nition

Applicator type

Magnetic fi eld shape

Frequency of magnetic fi eld

Pause time in operation mode with modulation

Magnetic fi eld induction

Timer

Available settings

2 – 60 Hz

cont – continuous operation 0,5 – 8 s

0 – 2,5 mT0 – 25 Gs

1 – 30 minutes, step 1 minute

CP type – plate applicator

CSL60 type – sollenoid applicator

pulse

1 s

break

0,5–8 s

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page 18 MAGNERIS – USER GUIDE

turned towards each other. At the edges of the applicator, the magnetic induction

can even be four times as high as the original value. The distribution of the magnetic

-fi eld induction of the CP applicator, depending on the relative position of the coils,

is shown below.

Figure 4.8. The distribution of the magnetic-fi eld induction and the relative position of CP applicator coils.

4 UNIT DESCRIPTION

9mT 9m

T6mT 6m

T4mT 4m

T3mT 3m

T

2,5mT

2,5mT

2mT

1,5mT

1mT

2mT

1,5mT

1mT

0 5 10 1551015 [cm]

0

5

10

5

10

[cm]

9mT

6mT

4mT

3mT

2,5mT9mT6mT4mT3mT

2mT

1,5mT

1mT

0 5 10 15 20510

0

5

10

5

10

1520[cm]

[cm]

1mT

1,5mT

2mT

2 mT,5

3mT

4mT

6mT

8mT

3mT

4mT

6mT

8mT

0

5

5

10

15

[cm]

0 5 10 15 20 25510152025[cm]

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4 UNIT DESCRIPTION

4.6 Magnetic fi eld applicatorsTwo types of magnetic fi eld applicators can be used with the Magneris unit:

• CSL60 – used previously in the Magner Plus and Magner LT units, solenoid

-type, can be attached to a treatment couch, diameter of 60 cm, maximum

induction of 2.5 mT

• CP – coupled plate applicator comprising two elements (labelled CP-ID1

and CP-ID2), mounted on a stand, allows for height and angle adjustment,

treatment fi eld illumination by means of LEDs, which also indicate the presence

of the magnetic fi eld (glow in continuous operation, pulse in intermittent

operation)

While adjusting the position of the CP applicator elements, care should be

taken not to excessively twist the connection cables.

The CSL and CP applicators feature cooling systems that prevent overheating

of the applicators’ surfaces:

• CSL60 – a passive system installed between the coil and the outer casing

• CP – active system consisting of fans (one in each applicator coil)

Under no circumstances should the vents in CP applicator element casings

be covered!

Figure 4.9. View of the CP applicator.

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5 DEVICE INSTALLATION AND START-UP

5 Device installation and start-up

5.1 Unit installationFirst installation of the unit should be done by qualifi ed distributor employee.

The instructions for the stand assembly are provided in a separate manual.

After removing the unit from carton, check if the complete unit has been deliv-

ered. In case of any inconsistencies contact the seller or manufacturer.

After removing the unit from transportation packaging wait approximately

two hours before proceeding to next installation steps. This is aimed at adap-

tation of the unit to conditions in operation room.

5.1.1 Attaching the device to the shelf of the standPlace the device on the shelf of the stand and secure it by means of the two screws

underneath the shelf, as shown in the fi gure 5.1.

Figure 5.1. Attaching the device to the shelf of the stand.

5.1.2 Connecting applicatorsOn the back of the unit, there are two dedicated applicator sockets. Plug

the applicator connector into the socket and turn clockwise 1/8 of a turn.

In order to disconnect the applicator, slide the metal latch on the connector

backwards, then turn the connector counterclockwise 1/8 of a turn. The sockets

are shown in the fi gure 5.2. The socket for the CSL60 applicator is labelled

as , while the socket for the CP applicator as . The meaning

of the ESD symbol is explained in section 3.5.

Figure 5.2. Applicator sockets.

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5.1.3 Stand height adjustmentIn order to adjust the height of the stand, use one hand to unlock the servo arm

actuator by means of its lever, and the other hand to move the arm up or down.

Figure 5.3. Actuator release lever.

5.1.4 Plate applicator position adjustmenta) in order to adjust the tilt of the applicator, perform the following:

• approach the applicator from the push-button side (see fi gure 5.4)

• with your right hand, move the lever (forwards or backwards, depending

on the spring’s torsion) and hold it in its place

• with your left hand, push the button labelled PUSH and hold it – changing

the applicator position will be much easier

• adjust the applicator position accordingly

• release the push-button

Figure 5.4. Plate applicator position adjustment.

5 DEVICE INSTALLATION AND START-UP

Push-button

Lever

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NOTE 1

If the push-button is loose, perform the following:

• pry the rubber cap labelled PUSH and take it off

• adjust the push-button in such a way that the gap between the stand arm

and the push-button is 1.5 – 2 mm wide

• using Allen wrench (supplied), tighten the setscrew in the centre of the push

-button

• install the rubber cap labelled PUSH

b) in order to adjust the angle of the applicator, rotate the bar that supports

the two applicator coils

c) in order to adjust the relative position of the applicator coils, rotate them

accordingly.

NOTE 2

If the thumbscrews fi xing the applicator coils to the bar or the bar to the arm

are too loose, tighten them.

NOTE 3

If the said thumbscrews are tightened too much, move the applicator coils

or the bar several times in order to loosen them.

While adjusting the position of the CP applicator elements, care should be

taken not to excessively twist the connection cables.

5.1.5 First start-upConnect the unit to the 230 V mains power supply using the supplied cable. After

switching the unit on, all functional blocks are tested. When the tests are fi nished,

a list of detected applicators is displayed. Screen examples are shown below:

If after the self-test procedure the screen displays an error message with an error

code, switch the unit off and contact technical support.z serwisem.

5 DEVICE INSTALLATION AND START-UP

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5 DEVICE INSTALLATION AND START-UP

If after the self-test procedure the screen displays information regarding incor-

rectly connected applicators, replace the connectors in the correct sockets

and start the unit again.

5.2 Setup modeTo enter setup mode, press the key marked with symbol during self-test.

The following information will be shown on the display:

The following functions are available:

• Sounds

• Contrast

• Dose unit

• Removal of user programs

• Language

• Start-up menu

The function is selected with keys . To enter the selected option press

the key. To exit the setup mode, switch off unit supply or in setup mode press

the (then the unit restarts, and the suitable information is shown on the display).

5.2.1 SoundsWith the Magneris unit the user may confi gure settings of acoustic signals, which

occur during unit operation. Description of available confi guration options:

• Keys sounds – sound signal is generated whenever a key is pressed

• Sounds during treatment – while performing treatment procedure sound

signals are generated at 1-second interval

• End of treatment sound – the end of a treatment procedure is signalled

by sequence of short sound signals

To select arrow position use the keys, switching on and off particular

option takes place with keys . That a particular option is on is confi rmed

by the „tick” symbol visible in the fi eld just opposite the option name. If the fi eld

is empty, this particular option has not been selected.

Approval of selection is performed by pressing the key. Escape without

approval (settings from before modifi cation remain) is performed by pressing

the key.

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5.2.2 ContrastIn the Magneris unit it is possible to adjust display contrast. With the key

the level of contrast is increased and with the key decreased. Approval of settings

is performed by pressing the key. Escape without approval (settings from

before modifi cation remain) is performed by pressing the key.

5.2.3 Dose unitIn the Magneris unit it is possible to choose units indication:

• mT – militesla

• Gs – Gauss

To select arrow position use the keys, switching on and off particular

option takes place with keys . That a particular option is on is confi rmed by

the „tick” symbol visible in the fi eld just opposite the option name. If the fi eld

is empty, this particular option has not been selected. Approval of selection is per-

formed by pressing the key. Escape without approval (settings from before

modifi cation remain) is performed by pressing the key.

5.2.4 Removal of user programsSelection of this option enables overall deletion of programs saved by the user.

In order to delete all user-defi ned programs, follow the instructions shown on

the display.

While editing settings, it is unnecessary to repeat deletion of user-defi ned

programs several times.

5.2.5 LanguageWith the Magneris unit information in the display may be presented in diff erent

languages. The user is free to select language option.

To change of language version use the keys, switching on particular

option takes place with the key. That a particular option is on is confi rmed

by the “tick” symbol visible in the fi eld just opposite the option name. Approval

of selection is performed by pressing the key. Escape without approval (settings

from before modifi cation remain) is performed by pressing the key.

5.2.6 Start-up menuThis option enables selection of mode, in which after switching on the mains supply

the Magneris unit will be started. Two options are available:

• Program mode

• Recently selected program

In the fi rst case, after switching on main supply, general menu will appear, when

one of the following options may be selected:

• Preset programs

• User programs

In the second case after switching on mains supply the list of preset programs will be

displayed at the program, which was recently selected in the last treatment cycle

or in manual mode.

5 DEVICE INSTALLATION AND START-UP

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6 UNIT OPERATION

6 Unit operation

The unit can be operated in one of the two modes:

• program mode

• manual mode

In the program mode you can take advantage of preset procedures:

• treatment programs

• user defi ned programs

In the program mode you cannot edit the introduced parameters. Such option

is available in the manual operation mode.

Transition between program operation mode and manual mode (and vice versa)

follows after pressing the key.

Under no circumstances should the applicators be connected or disconnected

during the treatment. This procedure should be performed when the unit is not

generating the magnetic fi eld!

Figure 6.1 shows an example treatment procedure.

Figure 6.1. Example of treatment procedure.

6.1 Operation with preset treatment programsThe simplest method to use the unit is to use its preset programs or treatment

sequences. The unit includes a base of several dozens of most frequently met

disorders together with suggested treatment types and parameters. The list of all

diseases with parameters is included in Appendix A at the end of the manual.

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6 UNIT OPERATION

Parameter values of treatment programs are selected on the basis of available

literature data and determined as average values. Sole responsibility for applica-

tion of preset programs rests with the user.

In order to perform the treatment procedure by means of a preset treatment

program:

1. Switch on the unit. Depending on the Menu function confi guration, after

powering on (see section 5.2.6) the unit starts up either in the PROGRAM

GROUPS menu mode or in a set treatment program (or user program) that was

used during the previous treatment procedure. In the latter case, in order

to select a diff erent program from the PROGRAM GROUPS menu, press the

key. When no program change is necessary, proceed to step 5.

The PROGRAM GROUPS menu screen:

2. Press the keys to choose the Preset programs option, and press the

key to confi rm.

3. Press the keys to choose the treatment program.

Press the key to display an information screen containing parameters

of the relevant treatment program (example shown below):

Defi nitions of symbols are provided in section 4.5.

In order to close the information window (showing the name or parameters),

press the or key.

4. Prepare the patient for treatment. Set up the applicator that will be used

during the treatment procedure.

5. To start the treatment procedure, press the START key.

6. Press the keys to adjust the magnetic-fi eld induction, if required.

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6 UNIT OPERATION

NOTE

If two magnetic fi eld applicators are connected, the applicator selection window

displays when the START key is pressed. The applicator selection window is shown

below:

Press the buttons to select an applicator. When the applicator type is selected,

press the START key again. The unit starts generating magnetic fi eld. An indicator

denoting the selected applicator lights up on the keyboard.

An example screen during the treatment procedure is shown below:

If during the treatment procedure the induction value is reduced to 0 [mT]/0 [Gs],

the following message displays on the screen:

In order to continue the treatment procedure, press the key. If you wish

to return to the Preset programs menu, press the key.

When the treatment procedure is fi nished, a message displays on the screen

and an audible signal is emitted (provided this feature is enabled; see section

5.2.1).

In order to pause the treatment procedure, press the STOP key. The time counter

will stop. In order to continue the treatment procedure, press the START key. If you

wish to return to the Preset programs menu, press the key.

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6 UNIT OPERATION

6.2 Operation in the manual modeIn the manual mode the user can set up custom treatment parameters. Perform

the following procedure:

1. Switch on the unit. Press the key in order to enter the manual mode.

2. Press the keys to choose a parameter or applicator selection fi eld.

The selected fi eld is highlighted. An example screen is shown below:

Defi nitions of symbols are provided in section 4.5

3. Press the keys to change the parameter values or the applicator type.

4. Prepare the patient for treatment. Set up the applicator that will be used

during the treatment procedure.

5. To start the treatment procedure, press the START key.

6. Press the keys to adjust the magnetic-fi eld induction, if required.

If when starting or during the treatment procedure the induction value is reduced

to 0 [mT]/0 [Gs], the following message displays on the screen:

In order to continue the treatment procedure, press the key. If you wish

to return to the treatment parameters screen, press the key.

When the treatment procedure is fi nished, a message displays on the screen

and an audible signal is emitted (provided this feature is enabled; see section

5.2.1).

In order to pause the treatment procedure, press the STOP key. The time counter

will stop. In order to continue the treatment procedure, press the START key. If you

wish to return to the treatment parameters screen, press the key.

6.3 User defi ned programsThe user may save up to twenty own treatment programs. Each program may be

given a name consisting of letters (19 signs max.).

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To edit and save a user defi ned program:

1. Start the unit in manual mode in compliance with rules given in section 6.2.

2. Set up treatment procedure parameters, as in section 6.2.

3. Press the key marked with symbol

4. With keys select the number, under which the edited program will be

saved. Confi rm your choice with key.

5. Enter program name – with keys select the sign, with keys

move the arrow. Below an example of screen after entering program name

is shown:

6. Press the key. On the screen the following information is displayed:

7. Pressing of key results in saving user defi ned program and return to

parameter edition menu.

At the fi rst attempt to save user program all memory locations are free. Saving

of consecutive user defi ned programs may follow to free locations or already

saved by their overwriting. In the second case, when attempting to save,

on the screen the following message will be displayed:

Pressing of key results in change to program name entry mode, method

of entering program name – see stage 5.

At every stage of user defi ned program edition you may return to an earlier

level by pressing the key.

In order to perform a treatment procedure based on user defi ned program,

follow the instruction of using preset treatment programs (see 6.1.1). Choose

User programs option in the PROGRAM GROUPS menu.

6 UNIT OPERATION

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7 INDICATIONS AND CONTRAINDICATIONS

7 Indications and contraindications

7.1 Indications• delayed union of fractured bone

• pseudoarthrosis

• osteoporosis

• degenerative joint disease

• rheumatoid arthritis

• ulcerations and trophic shank changes

• bacterial infection of skin and soft tissues

• keloids

• condition after cerebral stroke

• hemicrania and vasomotor headaches

• functional disorders of cranial and peripheral nerves

• multiple sclerosis

• cornea infection diseases

• optic atrophy

• arterial hypertension

• ischaemic heart disease

• heart arrhythmia

• hypersensitive large intestine

• chronic pancreatitis

7.2 Contraindications• pregnancy

• neoplastic disease

• active tuberculosis

• juvenile diabetes

• thyrotoxicosis

• bleeding from alimentary system

• severe infections

• presence of electronic implants (e.g. cardiac pacemaker)

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8 Maintenance, cleaning, disinfection

8.1 Cleaning, disinfectionCAUTION!

Before approaching the below operations separate the unit from the mains!

Cleaning of the unit shall be performed with lightly humid sponge or soft cloth

with delicate soap solution or soft detergent.

Do not use solvents! Do not also use excessively wet sponges, which could

bring about penetration of water inside the unit.

Cleaning of the applicators shall be performed with lightly humid sponge or soft

cloth with delicate soap solution or soft detergent, then dry the cleaned accessories

with dry cloth and leave for complete drying.

Do not use humid or wet cables!

Do not disinfect or sterilise unit casing.

Disinfection of accessories, which are not intended for contact with patient’s body

(for example cables), shall be carried out with liquid or spray agents dedicated

to that purpose at least once a week.

Applicator casing may contact with patient’s body during treatment procedure.

Perform disinfection after each such treatment procedure, it is recommended

to use 70 % alcohol solution. After disinfection, accessories must be washed

with clean, tepid water to avoid allergic reaction.

8.2 Fuse replacementWARNING

Before approaching the operations below separate the unit from the mains!

In case of burnt fuses replace them. The parameters are listed in section 9. and

in the name plate.

To replace fuses:

1. Isolate the device from the mains.

2. Disconnect the mains cable from the mains socket.

3. With fl at screwdriver lever the fuse socket until the moment of its slipping

from the socket.

4. Remove the socket with your fi ngers, replace the fuses, install them in the socket

again and press fi rmly.

5. Connect the mains cable – fi rst to the socket placed in the back panel

of the controller and then to the mains.

6. Check the device operation.

8 MAINTENANCE, CLEANING, DISINFECTION

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9 SPECIFICATION AND ACCESSORIES

9 Specifi cation and accessories

9.1 Technical specifi cation

Operation mode

Unit is intended for continuous operation.

Treatment parameters

shapes of magnetic fi eld rectangular, sinusoidal, triangular,

half-rectangular, half-sinusoidal, half-triangular

frequency 2 – 60 Hz, step variable

accuracy of frequency ±20 % preset value

pulse time in interrupted mode 1 s

accuracy of pulse time in interrupted mode ±20 %

pause time in interrupted mode 0,5; 1,0; 1,5; 2,0; 3,0; 4,0; 6,0; 8,0 s

accuracy of pause time ±20 % preset value

maximum induction 2,5 mT

maximum induction spread 5 mT

accuracy of preset induction ±20 % maximum value

for given applicator in his geometrical centre

available to preset induction values

• applicator CP 0,0; 0,5; 1,0; 1,5; 2,0; 2,5 mT

• applicator CSL60 0,0; 0,5; 1,0; 1,5; 2,0; 2,5 mT

Treatment programs

preset 50 programs

user-defi ned 10

Treatment timer

treatment time setting range 1 – 30 minutes

treatment time setting step 1 minutes

accuracy ±10 %

General

mains supply 230 V ±10 %, 50 Hz

power consumption 200 W, 250 VA

safety class I, typ BF

degree of protection provided by enclosure IP20

mains fuses time lag T 2 A, 250 V

unit dimensions (width x depth x height) 30x30x13 cm

unit weight max 6 kg

CP weight max 5,5 kg

CSL60 weight max 14 kg

stand with CP weight max 17,5 kg

total weight max 29 kg

dimensions of the stand area 65x75 cm

height adjustment range 40 – 110 cm

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9 SPECIFICATION AND ACCESSORIES

CP – angle of rotation 150°

wheels 4 wheels with brakes

Storage conditions

temperature range +5 – +45°C

relative humidity 30 – 75 %

pressure range 700 – 1060 hPa

Operation conditions

temperature range +15 – +30°C

relative humidity 30 – 75 %

pressure range 700 – 1060 hPa

Transport conditions

temperature range -10 – +45°C

relative humidity 20 – 95 %

pressure range 700 – 1060 hPa

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9 SPECIFICATION AND ACCESSORIES

9.2 EMC parameters In compliance with EN60601-1-2 standard

Compliance

Group 1

Class B

Class A

Complies

Electromagnetic environment – guidance

The LFMF unit Magneris uses RF energy only for its internal functions. Therefore, its RF emissions are very low and it is not probable, that they will cause any disturbances in the opera-tion of electronic equipment located nearby.

The Magneris unit is suitable for use in all establishments includ-ing domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Emissions test

RF emissions CISPR 11

RF emissions CISPR 11

Harmonic emissionsIEC 61000-3-2

Voltage fl uctuations/Flicker emissionsIEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic emissions

The LFMF unit Magneris is intended for use in the electromagnetic environment specifi ed below. The customeror user should assure that the LFMF unit Magneris is used in such an environment.

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9 SPECIFICATION AND ACCESSORIES

Immunity test

Electrostatic discharge (ESD)IEC 61000-4-2

Electrical fast transient/burstIEC 61000-4-4

SurgeIEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11

Power frequency (50/60 Hz) Magnetic fi eldIEC 61000-4-8

IEC60601test level

±6 kV contact±8 kV air

±2 kV for power supply lines±1 kV for input/output lines

±1 kV diff erential mode±2 kV common mode

<5 % UT

(>95 % dip in UT)

for 0,5 cycle40 % U

T

(60 % dip in UT)

for 5 cycles70 % U

T

(30 % dip in UT)

for 25 cycles<5 % U

T

(>95 % dip in UT)

for 5 sec

3 A/m

Compliance level

±6 kV contact±8 kV air

±2 kV for power supply lines±1 kV for input/output lines

±1 kV diff erential mode±2 kV common mode

<5 % UT

(>95 % dip in UT)

for 0,5 cycle40 % U

T

(60 % dip in UT)

for 5 cycles70 % U

T

(30 % dip in UT)

for 25 cycles<5 % U

T

(>95 % dip in UT)

for 5 sec

3 A/m

Electromagnetic environment – guidance

Floors should be wood, concrete or ceramic tile. If fl oors are covered with synthetic material, the relative humidity should be at least 30 %

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Magneris requires continued operation during power mains interrup-tions, it is recommended that Magneris be powered from an interruptible power supply or a battery.

Power frequency magnetic fi elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Indications and declaration of manufacturer – electromagnetic immunity

The LFMF unit Magneris is intended for use in the electromagnetic environment specifi ed below. The customeror user should assure that the LFMF unit Magneris is used in such an environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

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9 SPECIFICATION AND ACCESSORIES

Immunity test

Conducted RFIEC 61000-4-6

Radiated RFIEC 61000-4-3

IEC60601test level

3 Vrms

150 kHz to 80 MHz

3 V/m

26 MHz to 2,5 GHz

Compliance level

3 Vrms

3 V/m

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Magneris, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distanced = 1,2√Pd = 1,2√P 26 MHz to 800 MHzd = 2,3√P 800 MHz to 2,5 GHzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fi xed RF transmitters, as determined by an electromagnetic site surveya, should be less than compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol.

Indications and manufacturer’s declaration – electromagnetic immunity

The LFMF unit Magneris is intended for use in the electromagnetic environment specifi ed below. The customer or user should assure that the LFMF unit Magneris is used in such an environment.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fi xed transmitters, such a base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagneticenvironment due to fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which the Magneris is used exceeds the applicable RF compliance level above, the unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the unit.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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9 SPECIFICATION AND ACCESSORIES

Radiated maximum outputpower of transmitter W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHzd = 1,2√P

0,12

0,38

1,20

3,80

12,00

0,01

0,10

1,00

10,00

100,00

80 MHz to 800 MHzd = 1,2√P

0,12

0,38

1,20

3,80

12,00

800 MHz to 2,5 GHzd = 2,3√P

0,23

0,73

2,30

7,30

23,00

Recommended separation distances between portable and mobile RF communications equipment and LFMF unit Magneris

The Magneris unit is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the unit can help prevent electromagnetic interference by main-taining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Magneris as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can beestimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitterin watts (W) according to the transmitter manufacturer.NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aff ected by absorption and refl ection from structures, objects and people.

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9 SPECIFICATION AND ACCESSORIES

9.3 Accessories• controller Magneris

• stand dedicated to CP type applicator

• CP type applicator

• CSL60 type applicator – optional

• protective glasses for the patient

• mains cable

• User guide

• Warranty certifi cate

• Post inspection report

• Electrical safety test – inspection report

• spare fuses – time lag T 2 A/250 V type

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APPENDIX A LIST OF PRESET TREATMENT PROGEAMS

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APPENDIX A LIST OF PRESET TREATMENT PROGEAMS

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er

reco

nst

ruct

ion

of

liga

me

nts

acu

te c

on

dit

ion

Sta

tus

aft

er

reco

nst

ruct

ion

of

liga

me

nts

ch

ron

ic c

on

dit

ion

Po

st t

rau

ma

tic

inju

rie

s o

f p

eri

art

icu

lar

soft

ti

ssu

es

– a

cute

co

nd

itio

n

Po

st t

rau

ma

tic

inju

rie

s o

f p

eri

art

icu

lar

soft

ti

ssu

es

– c

hro

nic

co

nd

itio

n

Po

st t

rau

ma

tic

wo

un

ds

– in

fl a

mm

ato

ry s

tag

e

Po

st t

rau

ma

tic

wo

un

ds

– g

ran

ula

tio

n

an

d r

eco

nst

ruct

ion

sta

ge

Ba

ck p

ain

s in

an

kyl

osi

ng

sp

on

dyl

itis

Hyp

ert

on

ia –

La

xato

r

Po

st s

urg

ica

l wo

un

ds

– a

cute

sta

ge

Po

st s

urg

ica

l wo

un

ds

– c

hro

nic

sta

ge

Ove

rlo

ad

ch

an

ge

s o

f m

usc

le a

tta

chm

en

ts

MS

– M

ult

iple

scl

ero

sis

– L

axa

tor

Be

dso

res

Bra

in s

tro

ke

Sto

ma

ch u

lce

rati

on

Torn

lig

am

en

ts –

acu

te c

on

dit

ion

Torn

lig

am

en

ts –

ch

ron

ic c

on

dit

ion

Bro

nch

ial a

sth

ma

Bra

chia

l ne

ura

lgia

– a

cute

co

nd

itio

n

Bra

chia

l ne

ura

lgia

– c

hro

nic

co

nd

itio

n

Acu

te c

ata

rrh

al b

ron

chit

is

12

10

10

15

12

15

10

15

10

15

15

15

10

15

10

15

15

12

10

10

15

10

10

15

10

Page 41: Magneris en 05-11-2010 Link

ISSUE DATE 05.11.2010 page 41

APPENDIX A LIST OF PRESET TREATMENT PROGEAMS4

8

49

50

1,0

1,5

2,5

6 8

40

10

10

15

Sin

uso

ida

l

Sin

uso

ida

l

Re

cta

ng

ula

r

Acu

te c

olla

tera

l sin

usi

tis

an

d t

on

silli

tis

Sci

ati

ca –

acu

te c

on

dit

ion

Sci

ati

ca –

ch

ron

ic c

on

dit

ion

Page 42: Magneris en 05-11-2010 Link

page 42 MAGNERIS – USER GUIDE

APPENDIX B DESCRIPTION OF THE SYMBOLS, WHICH ARE PLACED ON THE UNIT CASING

Appendix B Description of the symbols, which are placed on the unit

casing

Explanation

Caution, see the ASSOCIATE DOCUMENTS

Application components of BF type

Date of manufacture : year

Protection level provided for by casing

Susceptibility to electrostatic discharges

Fuse

Unit version

Serial number

Disposal of worn-out device together with other waste is prohibited

Follow operating instructions

Background colour: blueSymbol/text: white

Stepping prohibited

Background colour: whiteCicular band and slash: red Symbol/text: black

Sitting prohibited

Background colour: whiteCicular band and slash: red Symbol/text: black

Symbol

IP20

VER

SN

or

or

or

Page 43: Magneris en 05-11-2010 Link

ISSUE DATE 05.11.2010 page 43

Notes

Page 44: Magneris en 05-11-2010 Link