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Instruction Manual The Fischer R13 page 29 of 33

Appendix 1 – Electromagnetic compatibility

Electromagnetic emissions

The Fischer

device is designed for operation in the electromagnetic environment specified below. The

user should ensure that the device is used in such an environment.

interference emission

Compliance

Electromagnetic surrounding - Guidance

RF emission

according CISPR 11

Group 1

The Fischer

uses RF energy only for its

internal function. Therefore, its RF emissions

are very low and are not likely to cause any

interference in nearby electronic equipment.

RF emission
according CISPR 11

Class B

The Fischer

is suitable for use in all

establishments, including domestic

establishments and those directly connected

to the public low-voltage power supply

network that supplies buildings used for

domestic purposes.

Harmonic emission

according IEC 61000-3-2

Not applicable

Voltage fluctuations/flicker

emissions IEC 61000-3-3

Complies

Electromagnetic immunity

The Fischer

device is designed for operation in the electromagnetic environment specified below. The

user should ensure that the device is used in such an environment.

Immunity test

IEC 60601-

test level

Compliance level

Electromagnetic environment –

guidance

Electrostatic

discharge

(ESD);

IEC 61000-4-2

± 8 kV

contact

discharge

max. ± 15 kV

air discharge

± 8 kV

± 15 kV

Floors should be wood, concrete or ceramic

tile. If floors are covered with synthetic

material, the relative humidity should be at

least 30%.

Electrical

transients /

bursts;

IEC 61000-4-4

± 2 kV

for power

supplies

± 2 kV

Mains power quality should be that of a typical

commercial or hospital environment.

Surge;

IEC 61000-4-5

± 1 kV

for

line(s) to line(s)

± 1 kV

Mains power quality should be that of a typical

commercial or hospital environment.

Voltage dips,

short

interruptions

and voltage

variations on

power supply

input lines;

IEC 61000-4-11

0 %

for 0.5 cycle

0 %

for 1 cycle

70 %

for 25 cycles

0 %

for 250/300

cycles

0 %

for 0.5 cycle

0 %

for 1 cycle

70 %

for 25 cycles

0 %

for 250/300 cycles

Mains power quality should be that of a typical

commercial or hospital environment. If the

user of The Fischer® requires continued

operation during power mains interruptions, it

is recommended that The Fischer® is

powered from an uninterruptible power supply

or a battery.

Power

frequency

(50/60 Hz)

30 A/m

Power frequency magnetic fields should be at

levels characteristic of a typical location in a

typical commercial or hospital environment.

Содержание The Fischer

Страница 1: ......

Страница 2: ......

Страница 3: ...he Fischer has been designed to be more powerful and easier to use than conventional iontophoresis devices Setup and start treating in less than 5 minutes This user manual will guide you through setting up The Fischer familiarize you with its 3 button interface and functions and provide hyperhidrosis treatment recommendations Please read the following carefully ...

Страница 4: ...3 page 2 of 33 1 Scope of Delivery The Fischer Tap Water Iontophoresis Catalog No 07 80 000 10 Main control unit 2 water bath trays 2 silicone graphite electrodes 2 foam inserts 2 electrode cables power adapter user manual storage bag ...

Страница 5: ...words if you live in the U S you need a prescription to purchase The Fischer The Fischer may only be powered by the adapter provided which has been specially designed for this device The use of non original parts may be hazardous to the user and even lead to death Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could also resul...

Страница 6: ...ending on storage conditions the temperature adaptation may take up to 2 hours Prior to starting a treatment session please remove any metallic jewelry rings watches bangles etc as electric current concentrations in these regions might result in minor injuries local electrical burns current marks Any small skin lesions or breaks must be covered with petroleum jelly Vaseline to insulate them from t...

Страница 7: ... skin has to heal completely In case of an unexpectedly strong skin reaction a medical professional must be consulted before further treatments are administered You may not be treated by two devices simultaneously The device may not be modified Keep out of reach of children unless otherwise supervised Do not leave the device unattended Risk of strangulation and injuries Portable RF communications ...

Страница 8: ...lements inside The treatment system may only be serviced by RA Fischer Co Warning Potential systemic adverse effects may result from use of this device Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects Carefully read all labelling of the drug or solution used with this device to understand all potential adverse effects and to ensu...

Страница 9: ...e intended to treat hyperhidrosis pathological sweating affecting hands feet underarms or all three Any other use or usage beyond this scope is considered un intended use and may have dangerous consequences The Fischer is intended to be used in closed rooms Allow the device to reach room temperature before conducting a treatment The Fischer may only be used in a dry environment The required minimu...

Страница 10: ... a water bath or wet sponge facilitates this current flow which leads to a reduction of the sweat secretion of the treated skin regions To put it simpler imagine your skin is a sponge The Fischer uses an electric current to push the natural minerals found in tap water into the holes your sweat pores plugging them up to create a long lasting dryness barrier This therapeutic effect has been validate...

Страница 11: ...sent in the current path hands or feet Large skin defects wounds that cannot be covered with Vaseline Any area where sensation is absent or impaired e g polyneuropathy User s with palpitations cardiac arrhythmia User s with seizure disorders epilepsy User s with potentially malignant lesions acute localized infections skin eruptions or swollen broken or inflamed areas User s with severe local infl...

Страница 12: ...nt Pay attention to the references on the unit and in this user manual Switch the unit off after each treatment session 10 Treatment Setup 10 1 Setup for hands and or feet Set up your device as follows Place the water bath trays on a level and firm surface If you only treat your hands place both trays next to each other on a table If you only treat your feet place both trays next to each other on ...

Страница 13: ...ea being treated A good sign that you ve added the right amount of water the palms of your hands and or soles of your feet are completely wetted by water and the outsides of your fingers and or toes are partially covered Unless you suffer from sweating on the tops of your hands and or feet refrain from submerging your entire hand foot in water Tip Use lukewarm water to make the treatment more plea...

Страница 14: ...course of a treatment session If necessary simply pause treatment and soak the sponge pad again When ready insert the moistened sponge pad sleeves with the connector cables pointing to the front under your arms Keep them in place by applying slight pressure with your arms If possible avoid abrupt movements during the treatment since these can cause current fluctuations Should you experience irregu...

Страница 15: ...al polarity switch There is no start button Once the main control unit has been turned on and the current level has been set you re ready to begin treatment Place your hands feet into the water bath trays You should feel a mild tingly sensation On screen you ll notice the Active Treatment Display ATD generating a bar graph as the current level slowly ramps up Treatment Duration min sec The initial...

Страница 16: ...ecially at the onset of the therapy the user must determine for him herself which current strength is tolerable Within limits the individual tolerance can also fluctuate between the applications or change over the course of multiple treatments until a higher current level can be tolerated Sensitivity also depends on the extremities being treated notably your feet are the least sensitive while your...

Страница 17: ...down Put it this way what s the more effective way of driving down the highway Accelerating to 65 mph and keeping a steady speed until you reach your destination and then slowing to a stop direct current Or accelerating to 100 mph then decelerating down to 0 then re accelerating back up to 100 all the way down the highway puled current Sure you were technically going faster in our pulsed current m...

Страница 18: ...lectrode is placed on the left right or table floor for patients treating hands and feet at the same time knowing which electrode is positive can help you focus the treatment for faster results For example instead of taking 2 weeks to see drier results in both hands on AUTO you could see a reduction in sweat in your right hand in less than a week by treating it with the positive electrode on manua...

Страница 19: ...device switches to pause mode when you remove your hands feet from the tray and thus interrupt the current flow You ll notice the current symbol stops blinking on the ATD the treatment timer stops and the remaining time blinks Additionally the device beeps to indicate that the treatment has been paused Once your hands and or feet are placed in the water bath trays again the treatment session conti...

Страница 20: ...Instruction Manual The Fischer R13 page 18 of 33 Only after the treatment session is complete should you turn off The Fischer using the main on off switch ...

Страница 21: ...ablished at the end of therapy initiation Most patients treat at 10 15 mA for 15 minutes 3x a week during this phase However remember that everyone s bodily resistance is different so whatever settings and routine you ve established you want to stay consistent The third and final phase is your maintenance schedule You can begin to reduce the frequency of use settling into an as needed routine Most...

Страница 22: ...ed for 15 to 20 min each Direct DC pulsed PS current preferably DC PC if required preferably DC PC if required DC or PC Direction of current Auto Auto manual reversal Auto manual reversal Current It is impossible to provide reliable guide values for therapeutically effective and simultaneously tolerable current strengths since these can fluctuate very strongly from individual to individual Start y...

Страница 23: ...Instruction Manual The Fischer R13 page 21 of 33 Schematic Therapy Procedure Tip Use your Treatment Journal to record each session from milliamperes to side effects ...

Страница 24: ... if needed so as not to unnecessarily shorten its service life If The Fischer is being used by several patients the sponge pad sleeves and foam inserts may only be used to treat a single user The other components such as the water bath trays silicone graphite electrodes the cables and the control unit must be cleaned and disinfected before any patient change in order to prevent infections between ...

Страница 25: ...fy that the plugs on the electrode cables have been pushed all the way into the control unit and silicone graphite electrodes The current will only boot up to the selected current level if treatment time has been set to more than 1 minute and the settings have been confirmed by pushing the SET button once and the skin areas to be treated have closed the treatment circuit Rule out a device defect V...

Страница 26: ...tment Additionally you can use a very thin fleece or sponge cloth in place of the blue foam inserts over the silicone graphite electrodes This will reduce the water path and thus the resistance In case of a device failure or if the actions mentioned above are unsuccessful please contact RA Fischer Co by phone 800 525 3467 15 Product Life Cycle and Service Life The service life of The Fischer is de...

Страница 27: ... occur our manufacturer s warranty covers all defects caused by material deficiency or manufacturing error This manufacturer s warranty extends over 4 years Any intervention on The Fischer by buyer or third parties renders the warranty null and void Any defects which are or might have been caused by improper handling or disregard for the intended use listed in this user manual result in the immedi...

Страница 28: ...rrent Input max 130 mA Performance Input max 3 1 W Output Direct Current Treatment Voltage max 58 V Treatment Current max 30 mA Output Pulsed Current Treatment Voltage max 58 V Treatment Current max 30 mA Pulse Rate 10 kHz Rectangular Protected against solid foreign objects 12 5 mm and vertically falling water drops power supply excluded IP21 Power Supply unit ...

Страница 29: ...Output Rated Output Voltage 24 V Current Output max 300mA Max Output Rating 8 VA Overall System Requirements for Operation Transport and Storage Temperature Relative Humidity Atmospheric Pressure 10 C to 30 C 50 F to 86 F 30 to 70 700 hPa to 1060 hPa 20 C to 70 C 4 F to 158 F 90 non condensing 700 hPa to 1060 hPa ...

Страница 30: ...t information If necessary contact us for assistance regarding the use or maintenance of The Fischer device or to report unexpected operations or incidents Importer Distributor RA Fischer Company 25 W Easy St Suite 301 Simi Valley CA 93065 U S A Internet www rafischer com Mail info rafischer com Phone 800 525 3467 FAX 818 775 2941 Manufacturer Saalmann medical GmbH Co KG Suedbahnstrasse 34 D 32547...

Страница 31: ...vironment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact discharge max 15 kV air discharge 8 kV 15 kV Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical transients bursts IEC 61000 4 4 2 kV for power suppli...

Страница 32: ... MHz within ISM bands and amateur radio bands 3 V rms 6 V rms Radiated RF IEC 61000 4 3 10 V m 80 MHz to 2700 MHz 10 V m Radiated RF according IEC 61000 4 3 in close proximity to wireless communicati on devices according to IEC 60601 1 2 2014 Table 9 passed corresponds to a recommended safety distance of 0 3 m to the devices of the corresponding radio services Field strengths from fixed RF transmi...

Страница 33: ...Instruction Manual The Fischer R13 page 31 of 33 Appendix 2 Treatment Journal Name ________________________________________ Date Area Treated Settings mA DC PC Duration mins notes ...

Страница 34: ...Instruction Manual The Fischer R13 page 32 of 33 Date Area Treated Settings mA DC PC Duration mins notes ...

Страница 35: ...Instruction Manual The Fischer R13 page 33 of 33 Date Area Treated Settings mA DC PC Duration mins notes ...

Страница 36: ...Instruction Manual The Fischer R13 page 34 of 33 www rafischer com info rafischer com 800 525 3467 818 775 2941 ...

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