Swiss Bionic Solutions IMRS Manual

Table of contents Page
1. Preliminary comments......................................................4
2. Safety instrucons – what you should take note of ..............................4
2.1. Contraindicaons ........................................................ 11
2.2 . Side eects ............................................................. 11
3. Correct use ............................................................. 12
3.1. Essenal performance characterisc of iMRS ................................. 12
4. Possible applicaons ..................................................... 12
5. Unpacking/keeping the packaging .......................................... 12
6. Scope of Delivery ........................................................ 13
7. Installaon and descripon of the equipment ................................ 15
8. Installaon ............................................................. 18
9. Starng up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
9.1. Basic Sengs ........................................................... 19
9.1.1. Clock .................................................................. 20
9.1.2. Volume ................................................................ 20
9.1.3. Language............................................................... 21
9.1.4. Contraindicaons ........................................................ 21
9.1.5. iMRS Opons ........................................................... 21
9.1.6. Factory Sengs ......................................................... 21
9.2. Save and recall of preprogrammed sengs................................... 22
9.2.1. Saving a preselected program .............................................. 22
9.2.2. Recall the storage........................................................ 23
9.3. Starng an applicaon .................................................... 23
10. Applicator mat .......................................................... 24
11. Applicator cushion ....................................................... 25
12. Applicator probe (iMRS complete, iMRS professional) .......................... 26
13. Applicaon ............................................................. 27
13.1. Mat applicaon ......................................................... 27
13.2. Local applicaon using the applicator cushion ................................ 28
13.3. Local applicaon using the applicator probe .................................. 29
14. Cleaning and caring for the system.......................................... 30
15. Maintenance/check ...................................................... 31
16. Idencaon, technical data............................................... 32
16.1. Idencaon............................................................ 32
16.2. Technical data iMRS ...................................................... 33
17. Guarantee .............................................................. 35

Page 4 / Operator‘s Guide / iMRS
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
1. Preliminary comments
Congratulaons on purchasing the Magnec Resonance Smulaon-System iMRS.
The iMRS-System is designed for inhome use.
The manufacturing of this product complies with the following direcves 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 therapeuc 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.
Reprinng, translang and copying in any form, in whole or in part, is prohibited without prior
wrien permission from the publisher.
The contents of this manual are subject to periodic revision and update.
The most current version please contact Swiss Bionic Soluons Schweiz GmbH at
inf[email protected].
2. Safety instructions – what you should take note of
In case of dizziness: get up very carefully!
There are no negave reports on the applicaon of Magnec-Resonance-Smulaon anywhere
in the world. However, for reasons of safety, we recommend that people with orthostac prob-
lems (dizziness when geng up) get up very slowly and carefully aer applicaon.
Avoid humidity:
This device may not be posioned in a damp or wet room!

Operator‘s Guide / iMRS / Page 5
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
Low pulsang electromagnec elds (LPEMF) do not create electrosmog!
Even at the highest intensity sengs, the average peak eld strength of the Magnec-Reso-
nance-Smulaon System is less than or equal to 300 µT (microTesla). This is less than the eld
strengths produced by common domesc 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 electromagnec elds within the Earth’s ionosphere.
Instrucons on electromagnec compability (EMC)
Medical, electric devices are subject to special precauons in terms of EMC and must be ins-
talled and brought into operaon in accordance with the EMC instrucons in the accompanying
documents. Electromedical devices can be parcularly aected by portable and mobile RF com-
municaons 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 electromagnec 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
Soluons Schweiz GmbH.
The device may not be operated in combinaon 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 observaon to check its operaon for the use intended when in such an
arrangement.
The propagaon of the magnec 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 applicaon.
We are legally obliged, in accordance with the EMC regulaons for medical products, to
provide you with the following informaon:
Guidelines and manufacturer‘s declaraon - electromagnec interference emissions
The iMRS is intended for operaon 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 Soluons Schweiz GmbH / 8834 Schindellegi / 2016
Interference emission mea-
surements
Compliance Electromagnec 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-
aons / icker according to
IEC 61000-3-3
Complies
Guidelines and manufacturer‘s declaraon - electromagnec interference emissions
The iMRS is intended for operaon 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 Electromagnec Environ-
ment - Guidelines
Discharge of stac
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 synthec mate-
rial, the relave air humidity
must be at least 30 %.

Operator‘s Guide / iMRS / Page 7
© Swiss Bionic Soluons 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
interrupons
and uctuaons 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 funconing,
even when interrupons
in the power supply occur,
it is recommended to feed
the iMRS from an uninter-
ruptable power supply or a
baery.
Magnec eld at a
supply frequency
(50/60 Hz) acc. to
IEC 61000-4-8
3 A/m 3 A/m Magnec 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 applicaon of the test level.

Page 8 / Operator‘s Guide / iMRS
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
Guidelines and manufacturer‘s declaraon - electromagnec immunity
The iMRS is intended for operaon 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
Electromagnec Environment - Guidelines
Conducted RF
interference
acc. to IEC
61000-4-6
Radiated RF
interference
acc. to IEC
61000-4-3
3 V eecve
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 equaon
for the transmied 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 transmier
in was (W) according to the informaon from
the transmier manufacturer and „d“ as the
recommended safe distance in metres (m). The
eld strength of staonary radio transmiers
should be invesgated 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 propagaon of electromagnec
waves is aected by absorpon and reecon 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 Soluons Schweiz GmbH / 8834 Schindellegi / 2016
The eld strength of staonary transmiers, such as the base staons of cordless telepho-
nes and land mobile radio systems, amateur radio staons, AM/FM and television transmit-
ters, cannot be determined theorecally in advance with precision. To establish the nature
of the ELECTROMAGNETIC SURROUNDINGS in terms of staonary transmiers, a study of
electromagnec phenomena should be considered for the locaon. If the eld strength
measured at the locaon where the iMRS is being is used exceeds the COMPLIANCE LEVEL
menoned above, the iMRS should be kept under observaon in order to verify the FUNC-
TION for the intended use. If unusual performance characteriscs are observed, addional
measures could be necessary, e.g. a change in the orientaon or a dierent locaon for the
iMRS.
The eld strength should be less than 3V/m over the frequency range 150 kHz to 80 MHz.
6) Naonal footnote: User here is meant in the sense of „RESPONSIBLE ORGANISATION“.
a
b

Page 10 / Operator‘s Guide / iMRS
© Swiss Bionic Soluons Schweiz GmbH / 8834 Schindellegi / 2016
Recommended safe distances between portable / mobile RF telecommunicaon
devices and the iMRS
The iMRS is intended for operaon 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-
magnec interference by keeping to the minimum distance between portable/mobile RF tele-
communicaon devices (transmiers) and the iMRS – dependent on the output power of the
communicaon device as given below
Nominal rang of the
transmier W
Safe distance (m) dependent on transmier 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 transmiers 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 equaon associated
with the parcular column, where «P» is the maximum nominal output of the transmier in
was (W) according to informaon 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 propagaon of electromagnec quan-
es is aected by absorpon and reecon from buildings, objects and people.
d = 1,2√Pd = 1,2√Pd = 2,3√P