Swiss Bionic Solutions IMRS Manuel
Table of contents Page
1. Preliminary comments......................................................4
2. Safety instrucons – what you should take note of ..............................4
2.1. Contraindicaons ........................................................ 11
2.2 . Side eects ............................................................. 11
3. Correct use ............................................................. 12
3.1. Essenal performance characterisc of iMRS ................................. 12
4. Possible applicaons ..................................................... 12
5. Unpacking/keeping the packaging .......................................... 12
6. Scope of Delivery ........................................................ 13
7. Installaon and descripon of the equipment ................................ 15
8. Installaon ............................................................. 18
9. Starng up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
9.1. Basic Sengs ........................................................... 19
9.1.1. Clock .................................................................. 20
9.1.2. Volume ................................................................ 20
9.1.3. Language............................................................... 21
9.1.4. Contraindicaons ........................................................ 21
9.1.5. iMRS Opons ........................................................... 21
9.1.6. Factory Sengs ......................................................... 21
9.2. Save and recall of preprogrammed sengs................................... 22
9.2.1. Saving a preselected program .............................................. 22
9.2.2. Recall the storage........................................................ 23
9.3. Starng an applicaon .................................................... 23
10. Applicator mat .......................................................... 24
11. Applicator cushion ....................................................... 25
12. Applicator probe (iMRS complete, iMRS professional) .......................... 26
13. Applicaon ............................................................. 27
13.1. Mat applicaon ......................................................... 27
13.2. Local applicaon using the applicator cushion ................................ 28
13.3. Local applicaon using the applicator probe .................................. 29
14. Cleaning and caring for the system.......................................... 30
15. Maintenance/check ...................................................... 31
16. Idencaon, technical data............................................... 32
16.1. Idencaon............................................................ 32
16.2. Technical data iMRS ...................................................... 33
17. Guarantee .............................................................. 35
Page 4 / Operator‘s Guide / iMRS
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
1. Preliminary comments
Congratulaons on purchasing the Magnec Resonance Smulaon-System iMRS.
The iMRS-System is designed for inhome use.
The manufacturing of this product complies with the following direcves and standards:
• 93/42/EWG
• IEC 60601-1:1988 + A1:1991 + A2:1995
• IEC 60601-1-2 (ed.2)
• FDA 21 CFR 890.5660, regulated as a therapeuc massager
This owners manual is part of the scope of delivery.
It must be kept within easy reach and must remain with the equipment, if the equipment is sold.
Reprinng, translang and copying in any form, in whole or in part, is prohibited without prior
wrien permission from the publisher.
The contents of this manual are subject to periodic revision and update.
The most current version please contact Swiss Bionic Soluons Schweiz GmbH at
2. Safety instructions – what you should take note of
In case of dizziness: get up very carefully!
There are no negave reports on the applicaon of Magnec-Resonance-Smulaon anywhere
in the world. However, for reasons of safety, we recommend that people with orthostac prob-
lems (dizziness when geng up) get up very slowly and carefully aer applicaon.
Avoid humidity:
This device may not be posioned in a damp or wet room!
Operator‘s Guide / iMRS / Page 5
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
Low pulsang electromagnec elds (LPEMF) do not create electrosmog!
Even at the highest intensity sengs, the average peak eld strength of the Magnec-Reso-
nance-Smulaon System is less than or equal to 300 µT (microTesla). This is less than the eld
strengths produced by common domesc appliances and well below the recommended limit of
400 µT (microTesla) for compliance with DIN 0848.
Safety is ensured by the fact that the frequencies and eld strengths employed are on the same
magnitude as naturally-occurring electromagnec elds within the Earth’s ionosphere.
Instrucons on electromagnec compability (EMC)
Medical, electric devices are subject to special precauons in terms of EMC and must be ins-
talled and brought into operaon in accordance with the EMC instrucons in the accompanying
documents. Electromedical devices can be parcularly aected by portable and mobile RF com-
municaons equipment, e.g. mobile phones or walkie-talkies.
The manufacturer only guarantees the compliance of the device with the EMC requirement
when used with the accessories listed in 16.2. The use of other accessories can lead to an incre-
ased emission of electromagnec interference or to a reduced resistance against such interfe-
rence. The accessories listed may only be used together with an iMRS system from Swiss Bionic
Soluons Schweiz GmbH.
The device may not be operated in combinaon with other devices, nor be stacked with or loca-
ted in the proximity of these. Should such an arrangement, however, be necessary, the device
must be kept under observaon to check its operaon for the use intended when in such an
arrangement.
The propagaon of the magnec eld from the whole-body / pad applicators has largely abated
at a distance of about 1.5 metres. Persons not receiving treatment should remain outside such a
range during the course of an applicaon.
We are legally obliged, in accordance with the EMC regulaons for medical products, to
provide you with the following informaon:
Guidelines and manufacturer‘s declaraon - electromagnec interference emissions
The iMRS is intended for operaon in an ELECTROMAGNETIC ENVIRONMENT as given below.
The customer or user of the iMRS should ensure that it is operated in such an environment.
Page 6 / Operator‘s Guide / iMRS
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
Interference emission mea-
surements
Compliance Electromagnec Environment Guideline
RF emissions acc. to CISPR 11 Group 1 iMRS only uses RF energy for its inter-
nal FUNCTIONING. Its RF emission is
therefore very low and it is unlikely that
neighbouring electronic devices will be
interfered with.
RF emissions acc. to CISPR 11 BiMRS is suitable for use in all establish-
ments including those in living areas
and such that are immediately connec-
ted to the PUBLIC MAINS SUPPLY that
also supplies buildings used for residen-
al purposes.
Emission of harmonic
frequencies according to IEC
61000-3-2
A
Emission of voltage uctu-
aons / icker according to
IEC 61000-3-3
Complies
Guidelines and manufacturer‘s declaraon - electromagnec interference emissions
The iMRS is intended for operaon in an ELECTROMAGNETIC ENVIRONMENT as given below.
The customer or user of the iMRS should ensure that it is operated in such an environment.
Interference
Immunity Tests
IEC 60601 Test
Level
Compliance Level Electromagnec Environ-
ment - Guidelines
Discharge of stac
electricity (ESD)
Acc. to IEC 61000-
4-2
± 6 kV contact
discharge
± 8 kV air
discharge
± 6 kV contact
discharge
± 8 kV air
discharge
Floors should be made of
wood or concrete or covered
in ceramic les. If the oor is
covered with synthec mate-
rial, the relave air humidity
must be at least 30 %.
Operator‘s Guide / iMRS / Page 7
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
Fast-transient
immunity test/
Bursts acc. to IEC
61000-4-4
± 2 kV for power
supply lines
± 1 kV for input
and output lines
± 1 kV for power
supply lines
Not applicable
The quality of the supply
voltage should correspond
to that in typical business or
hospital surroundings.
Surges
acc. to IEC 61000-
4-5
± 1 kV voltage
Outer conductor -
outer conductor
± 2 kV voltage
outer conductor
- earth
± 1 kV voltage
Outer conductor -
outer conductor
Not applicable
The quality of the supply
voltage should correspond
to that in typical business or
hospital surroundings.
Voltage dips, short
interrupons
and uctuaons in
the supply voltage
Acc. to IEC 61000-
4-11
< 5 % Ut
< (> 95 % dip in Ut
) for 1/2 period
40 % Ut (60 %
dip in Ut ) for 5
periods
70 % Ut (30 %
dip in Ut ) for 25
periods
< 5 % Ut (> 95 %
dip in Ut ) for 5 s
0 % Ut
< (> 95 % dip in Ut
) for 1/2 period
40 % Ut (60 %
dip in Ut ) for 5
periods
70 % Ut (30 %
dip in Ut ) for 25
periods
0 % Ut (> 95 % dip
in Ut ) for 5 s
The quality of the supply
voltage should correspond
to that in typical business or
hospital surroundings. If the
user of the iMRS requires
uninterrupted funconing,
even when interrupons
in the power supply occur,
it is recommended to feed
the iMRS from an uninter-
ruptable power supply or a
baery.
Magnec eld at a
supply frequency
(50/60 Hz) acc. to
IEC 61000-4-8
3 A/m 3 A/m Magnec elds at mains fre-
quency should correspond to
values typical of a business
or hospital environment.
Remark: Ut is the mains AC voltage before the applicaon of the test level.
Page 8 / Operator‘s Guide / iMRS
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
Guidelines and manufacturer‘s declaraon - electromagnec immunity
The iMRS is intended for operaon in an ELECTROMAGNETIC ENVIRONMENT as given below.
The customer or user of the iMRS should ensure that it is operated in such an environment.
Interference
Immunity Tests
IEC 60601
Test Level
Com-
pliance
Level
Electromagnec Environment - Guidelines
Conducted RF
interference
acc. to IEC
61000-4-6
Radiated RF
interference
acc. to IEC
61000-4-3
3 V eecve
value
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3V Portable and mobile radio devices should not
be used at a distance from the iMRS, including
the cables, less than the recommended safe
distance calculated by the relevant equaon
for the transmied frequency.
Recommended safe distance:
for 80 MHz to 800 MHz
for 800 MHz to 2.5 GHz
with „P“ as the rated power of the transmier
in was (W) according to the informaon from
the transmier manufacturer and „d“ as the
recommended safe distance in metres (m). The
eld strength of staonary radio transmiers
should be invesgated locally for all frequen-
cies a lower than the compliance level b
Interference is possible in the vicinity of
devices carrying the following symbol.
NOTE 1 The higher frequency range applies in the cases of 80 MHz and 800 MHz.
NOTE 2 These guidelines may not apply in all cases. The propagaon of electromagnec
waves is aected by absorpon and reecon from buildings, objects and people.
d = 1,2√P
d = 1,2√P
d = 2,3√P
3V/m
Operator‘s Guide / iMRS / Page 9
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
The eld strength of staonary transmiers, such as the base staons of cordless telepho-
nes and land mobile radio systems, amateur radio staons, AM/FM and television transmit-
ters, cannot be determined theorecally in advance with precision. To establish the nature
of the ELECTROMAGNETIC SURROUNDINGS in terms of staonary transmiers, a study of
electromagnec phenomena should be considered for the locaon. If the eld strength
measured at the locaon where the iMRS is being is used exceeds the COMPLIANCE LEVEL
menoned above, the iMRS should be kept under observaon in order to verify the FUNC-
TION for the intended use. If unusual performance characteriscs are observed, addional
measures could be necessary, e.g. a change in the orientaon or a dierent locaon for the
iMRS.
The eld strength should be less than 3V/m over the frequency range 150 kHz to 80 MHz.
6) Naonal footnote: User here is meant in the sense of „RESPONSIBLE ORGANISATION“.
a
b
Page 10 / Operator‘s Guide / iMRS
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
Recommended safe distances between portable / mobile RF telecommunicaon
devices and the iMRS
The iMRS is intended for operaon in an ELECTROMAGNETIC ENVIRONMENT in which RF inter-
ference is controlled. The customer or the user of the iMRS can help here in avoiding electro-
magnec interference by keeping to the minimum distance between portable/mobile RF tele-
communicaon devices (transmiers) and the iMRS – dependent on the output power of the
communicaon device as given below
Nominal rang of the
transmier W
Safe distance (m) dependent on transmier frequency
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
11,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmiers whose maximum nominal output is not given in the above table, the recom-
mended safe distance «d» in metres (m) should be determined from the equaon associated
with the parcular column, where «P» is the maximum nominal output of the transmier in
was (W) according to informaon from the manufacturer.
NOTE 1 The higher frequency range applies at 80 MHz and 800 MHz.
NOTE 2 These guidelines may not apply in all cases. The propagaon of electromagnec quan-
es is aected by absorpon and reecon from buildings, objects and people.
d = 1,2√Pd = 1,2√Pd = 2,3√P
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