Swiss Bionic Solutions Omnium1 iMRS one 2.0 Operating Manual

intelligent Lifestyle

Operating Manual

2.0

2

Important Notes for Getting Started

We congratulate you on your purchase of the iMRS one magnetic reso­nance stimulation system.

In combination with the Omnium1 control device, the iMRS one repre­sents the latest development and application standard in the eld of ma­gnetic resonance stimulation systems for home use.

The iMRS one is a system for use at home. In medical use, it can also play
an accompanying and supportive role for a number of conditions.

The iMRS one complies with the following guidelines and standards:

• Medical Product Guidelines (MPG)

• IEC 60601-1 Electrical Safety

• IEC 60601-1-2 Tolerance of Electromagnetic Fields

This operating manual is a component of the scope of delivery.

It should be kept close at hand and remain with the system when sold.

Copyright

Copyright © 2019 Swiss Bionic Solutions Holding GmbH
All rights reserved.
No part of this manual, including the products and software described
herein, may be reproduced, transferred, transcribed, stored in a retrieval
system or translated into another language, without the implicit written
permission of Swiss Bionic Solutions Holding GmbH. Documentation
stored by the purchaser for backup purposes is excluded from this con­dition. This condition shall not apply for software that has been licensed
under the General Public License (GPL) or other free open source licens­ing systems.
Omnium1, the Omnium1 logo and the iMRS Logo are trademarks of Swiss
Bionic Solutions Holding GmbH. All other trademarks are the property of
their corresponding owners. The details of the content of this manual
may deviate from the product or the associated software. All information

in this document may be changed without prior notication.

3

Table of Contents

1. Safety Instructions: Where You should be Careful ................................ 4

1.1 Contra-indications ................................................................................. 9

1.2 Side Effects ............................................................................................ 9

2. Intended Use ......................................................................................... 10

3. Possible Applications ............................................................................ 10

4. Scope of Delivery ................................................................................... 11

4.1 Control Unit ......................................................................................... 12

5. Installation ............................................................................................. 13

5.1 Installing / removing the battery.........................................................13

6. Activation ............................................................................................... 14

7. Saving and Loading Pre-set Parameters .............................................. 15

7.1 Saving ................................................................................................... 15

7.2 Loading ................................................................................................ 16

8. Starting an Application.......................................................................... 17

9. Quick Start Programs ............................................................................ 18

10. Settings ................................................................................................ 18

10.1 About ................................................................................................. 18

10.2 Factory Settings ................................................................................. 19

10.3 Users .................................................................................................. 19

11. Updating .............................................................................................. 19

12. Applicators ........................................................................................... 19

12.1 OmniMat ............................................................................................ 19

12.2 OmniPad ............................................................................................ 20

12.3 OmniSpot ........................................................................................... 20

13. Cleaning and Maintenance ................................................................. 21

14. Maintenance & Error Message ........................................................... 22

15. Identication & Technical Data .......................................................... 23

15.1 Identication ..................................................................................... 23

15.2 Technical Data ................................................................................... 23

16. Warranty .............................................................................................. 25

4

1. Safety Instructions: Where You
should be Careful

If you feel dizzy, be careful when standing up!

There are no negative reports on the application of Magnetic-Reso­nance-Stimulation anywhere in the world. However, for reasons of
safety, we recommend that people with orthostatic problems (dizziness
when getting up) get up very slowly and carefully after application.

Avoid humidity:

This device may not be positioned in a damp or wet room!

The strength of the eld of magnetic resonance stimulation system also
corresponds to no more than 120 μT at its highest intensity setting.

Thereby, it is well under the values of popular electrical household appli­ances and well under the recommended threshold of 400 μT for harm­lessness according to DIN 0848.

The fact that these values are in the range of the Earth’s owns natural
magnetic elds and the frequencies in the ionosphere (Schumann reso­nances) exclude all possible danger.

Note about electromagnetic tolerance (EMC)

Medical, electric devices are subject to special precautions in terms
of EMC and must be installed and placed in operation in accordance
with the EMC instructions in the included documents. Electro-medical

devices are particular susceptible to the radio frequencies of portable
and mobile communications equipment, such as cell phone phones and

walkie-talkies.

The manufacturer only guarantees the compliance of the device

with the EMC requirement when used with the accessories listed

in 14.2. The use of other accessories may lead to increased emis­sions of electromagnetic interference or to reduced resistance
to such interference. The accessories listed may only be used
together with an Omnium1 control system from Swiss Bionic
Solutions Schweiz GmbH.
The device may not be operated in combination with other devices, nor
be placed in a stack of, or located in the proximity, to such other devices.

5

However, if such an arrangement is necessary, the operation of the
device must be checked to ensure that it will operate as intended when
stored in this manner.

The expansion of the magnetic eld from the applicators will have largely

abated at a distance of about 1.5 meters. People who are not receiving
treatment should remain outside the indicated range during the course
of an application.

We are legally obliged, in accordance with the EMC regulations for
medical products, to provide you with the following information.

Guidelines and Manufacturer‘s Declaration: Electromagnetic Inter­ference Emissions

The iMRS one is intended for operation in an ELECTROMAGNETIC ENVIRONMENT
as shown below. The customer or user of the iMRS one should ensure that it is
operated in such an environment.

Interference emission mea-

surements

Compliance Electromagnec Environment Gui-

deline

RF emissions acc. to CISPR 11 Group 1 The iMRS one only uses RF energy for

its internal OPERATION. Its RF emis-

sion is therefore very low and it is
unlikely to interfere with neighboring
electronic devices.

RF emissions acc. to CISPR 11 B The iMRS one is suitable for use in

all establishments including those
in residenal, and similar areas that

are directly connected to the PUBLIC

POWER GRID that also supplies buil­dings used for residenal purposes.

Emission of harmonic

frequencies according to IEC

61000-3-2

A

Emission of voltage uctua­ons or icker according to

IEC 61000-3-3

In compliance

6

Interference
Immunity Tests

IEC 60601 Test
Level

Compliance Level Electromagnetic Environ-

ment - Guidelines

Discharge of
static electricity
(ESD)
Acc. to IEC 61000­4-2

± 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 tiles. If

the oor is covered with

synthetic material, the
relative air humidity must
be at least 30 %.

Fast-transient
interference 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

- ground

± 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 inter­ruptions and

uctuations in the

supply voltage
acc. to IEC 61000­4-11

< 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 sec

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
sec

The quality of the supply

voltage should correspond
to that in typical business
or hospital surroundings. If

the iMRS one user requires

continuous operation,
even when interruptions
in the power supply occur,
supplying the iMRS one
from an uninterruptible
power supply or a battery
is recommended.

Magnetic eld

at a supply

frequency (50/60

Hz) acc. to IEC
61000-4-8

3 A/m 3 A/m Magnetic elds at power

grid frequency should cor­respond to values typical
for a business or hospital
environment.

Comment: Ut is the AC power voltage before the application of the test level.

7

Guidelines and Manufacturer’s Declaration:

Electromagnetic Stability Interference

The iMRS one is intended for operation in an ELECTROMAGNETIC ENVIRONMENT
as indicated below. The customer or iMRS user should ensure that it is operated
in such an environment.

Interference
Immunity Tests

IEC 60601
Test Level

Com­pliance
Level

Electromagnetic Environment - Guidelines

Conducted RF
interference
acc. to IEC
610004-4-6
Radiated RF
interference
acc. to IEC
610004-4-3

3 V effec­tive value
150 kHz up
to 80 MHz
3 V/m
80 MHz up
to 2.5 GHz

3V Portable and mobile radio devices, includ-

ing their cables, should not be used at
a distance closer to the iMRS one than
recommended, which has been calculated

according to relevant equation for the trans­mission frequency.

Recommended safe distance:

for 80 MHz up to 800 MHz
for 800 MHz up to 2.5 GHz

Where P is the rated power of the transmit­ter in watts (W) according to the information
from the transmitter manufacturer and d is
the recommended safe distance in meters

(m). The eld strength of stationary radio

transmitters should be investigated locally
for all frequencies lower than the compli­ance level

6

Interference is possible in proximity
to devices that bear the following
symbol.

NOTE 1 The higher frequency range applies at 80 MHz and 800 MHz.

NOTE 2 These guidelines may not apply in all cases. The expansion of electromagnetic

quantities will be affected by absorption and reection from buildings, objects and

people.

The eld strength of stationary transmitters, such as: the base stations of cordless

telephones and land mobile radio systems, amateur radio stations, AM/FM radio and
television transmitters; cannot be determined in advance with theoretic precision. A
study of the electromagnetic phenomena of the location should be considered in order
to determine the nature of the ELECTROMAGNETIC SURROUNDINGS in terms of sta-

tionary transmitters. If the eld strength measured at the location where the iMRS one

will be used exceeds the COMPLIANCE LEVEL mentioned above, the iMRS one should
be checked to verify its OPERATION in the manner intended. If unusual performance
characteristics are observed, additional measures may necessary, such as changing the
orientation or choosing a different location for the iMRS one.

The eld strength should be less than 3V/m over the frequency range 150 kHz to 80

MHz.

6)

National footnote: User here is meant in the sense of RESPONSIBLE ORGANISATION.

d = 1,2√P
d = 1,2√P
d = 2,3√P

8

Recommended Safe Distances between Portable or Mobile RF Tele­communication Devices and the iMRS one

The iMRS one is intended for operation in an ELECTROMAGNETIC ENVIRONMENT

in which radio frequency interference is controlled. The customer or the iMRS

one user can help with the avoidance of electromagnetic interference by main-

taining the minimum distance between portable and mobile radio frequency

telecommunication devices (transmitters) and the iMRS one, depending on the
output power of the communication device as indicated below.

Nominal rating of
the transmitter W

Safe distance (m) dependent on transmitter 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

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters whose maximum nominal output is not indicated in the table
above, the recommended safe distance of d in meters (m) should be determined
from the equation associated with the particular column, where P is the maxi­mum nominal output of the transmitter in watts (W) according to information
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 expansion of electro-

magnetic quantities will be affected by absorption and reection from buildings,

objects and people.

9

1. 1. Contraindications

Use of the iMRS one system is contraindicated for the following conditions:

• Pregnancy

• Epilepsy

• Electronic implants such as pace makers or insulin pumps
(with the exception of approval by the consulting physician)

The iMRS one system may only be used with the approval of a health care
practitioner and under medical supervision under the following conditions:

• Presence of tumors

• Serious cardiac arrhythmia

• Acute attacks of hyperthyroidism

• Extreme sensitivity to electromagnetic radiation

In principle:

Magnetic resonance stimulation does not replace medical therapy. Always

consult your doctor rst about any unfamiliar complaints.

1. 2. Side Effects

In therapeutic treatment of chronic cases, a so-called initial worsening (healing

reaction) arises in approximately 10% of the patients treated in the rst days or

weeks of application, such as through an increase in the symptoms. This should

be frequently expected after prolonged medication, which should be interpreted

as a side effect of the medicinally induced regulatory habit and of the transfer
process to the activation of self-regulation.

A light itching on the body or a warm feeling may be felt in the prophylactic use.
In exactly the same manner, bruises, cramps, strains, wounds and problems with
the bones, joints, teeth or jaw may make themselves known as light pain as a
consequence of the activation of the circulatory system. In all cases in which pre­viously unnoticed physical reactions become noticeable as an accompaniment
of the application, consultation with a doctor or therapist with experience in the
application of magnetic resonance stimulation is recommended for purposes of

safe clarication.