Swiss Bionic Solutions Omnium1 iMRS one 2.0 User manual
intelligent Lifestyle
Operating Manual
2.0
2
Important Notes for Getting Started
We congratulate you on your purchase of the iMRS one magnetic reso-
nance stimulation system.
In combination with the Omnium1 control device, the iMRS one repre-
sents the latest development and application standard in the eld of ma-
gnetic 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 con-
dition. This condition shall not apply for software that has been licensed
under the General Public License (GPL) or other free open source licens-
ing 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 notication.
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. Identication & Technical Data .......................................................... 23
15.1 Identication ..................................................................................... 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-Reso-
nance-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 appli-
ances and well under the recommended threshold of 400 μT for harm-
lessness 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 reso-
nances) 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 emis-
sions 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 Inter-
ference 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 Electromagnec 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 residenal, and similar areas that
are directly connected to the PUBLIC
POWER GRID that also supplies buil-
dings used for residenal 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 61000-
4-2
± 6 kV contact
discharge
± 8 kV air dis-
charge
± 6 kV contact
discharge
± 8 kV air dis-
charge
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 con-
ductor-outer
conductor
± 2 kV voltage
outer conductor
- ground
± 1 KV voltage
outer conduc-
tor-outer conduc-
tor
Not applicable
The quality of the supply
voltage should correspond
to that in typical business
or hospital surroundings.
Voltage dips,
short inter-
ruptions and
uctuations 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 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 cor-
respond 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
Com-
pliance
Level
Electromagnetic Environment - Guidelines
Conducted RF
interference
acc. to IEC
610004-4-6
Radiated RF
interference
acc. to IEC
610004-4-3
3 V effec-
tive 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 trans-
mission 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 transmit-
ter 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 compli-
ance 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 reection 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 Tele-
communication 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 maxi-
mum 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 reection 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 pre-
viously 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 clarication.
10
2. Intended Use
With the iMRS one magnetic resonance stimulation system, weak, pulsating elec-
tromagnetic elds are used to activate various physiological processes in the
body. This occurs through the magnetic eld pulses and the strength of these
magnetic elds is no stronger than the average magnetic ux density of the
Earth’s own magnetic eld.
Use other than as described in this manual may lead to damage to the device and
unintended health consequence and should therefore be avoided.
3. Possible Applications
The iMRS one magnetic resonance stimulation system can be used:
• For wellness purposes and to generally increase vitality and well-being.
• For palliative purposes, such as the temporary relief of minor muscular
aches and pains.
• For a temporarily increase of local blood circulation.
• To relax muscles locally.
Important notice:
The iMRS one is regulated by the FDA as a therapeutic massager (21 CFR
890.5660). However, the iMRS one is not intended to diagnose, treat, cure or
prevent any disease.
Those seeking treatment for a specic disease should consult a qualied integra-
tive physician prior to using our products.
11
4. Scope of Delivery
If one part should be damaged or missing, please contact your consul-
tant at Swiss Bionic Solutions.
iMRS one Android software
(Pre-installed on the Omnium1)
OmniMat OmniPad OmniSpot
Not included with the iMRS one
basic set
D/A Converter 20-pin Cable Operating Manual
12
4.1 Control Unit
The iMRS one will only function in connection with the Omnium1 control
unit. The Omnium1 control device is included in the scope of delivery for
all iMRS one sets available. You will nd the operating instructions for
the Omnium1 in the special manual that accompanies the control device.
Omnium1 Tablet
Charging unit Earphones
20 Pin Cable Quick Start Guide
13
5. Installation
1. Take the individual parts out of the packaging. Place the full-body ap-
plicator on a stable, even surface, such as on the oor, on a couch or
under the mattress (but not box-spring mattresses) of your bed (pay
attention to the intensity adjustment, please). Heavily shaped and soft
furniture, such as a sofa, chair, very soft surfaces should be avoided,
since the pressure load on uneven supports may lead to damage to
the built-in copper coils.
2. Aside from this, make sure that your environment is as free of elec-
tro-smog as possible. There should not be any devices like: TVs, micro-
wave ovens, radio-based telephones and so forth in the immediate
vicinity (approx. 1-2m) during an application.
3. Connect one of the supplied applicators to the Omnium1 control de-
vice as follows:
• Connect the supplied D/A converter with the 20-pin ribbon cable
• Connect the second plug attached to the 20-pin ribbon cable with
the corresponding connection on the Omnium1
(see the Omnium1
operating manual)
.
• Connect the desired applicator with the D/A Converter.
4. Make sure that battery for your Omnium1 has been suciently char-
ged. The application will not be possible if the battery charge state
drops below 5%. In that case, connect the power supply with the Om-
nium1
(see the Omnium1 operating manual)
.
5. Check the system time selected (upper right) and set it to the current
time, if necessary
(see the Omnium1 operating manual)
. The built-in
organ clock will adjust automatically to this system clock during an
application.
5.1 Installing / removing the battery
To install the battery, open the rear battery cover, connect the plug to the
connector on the tablet, place the battery in the compartment and close
the cover.
To remove the battery, open the rear battery cover, pull out the battery,
disconnect the cable and close the cover.
14
6. Activation
After you have completely installed the system and checked the battery
charge state, activate the iMRS one app by tapping the program icon (1)
on the Omnium1 desktop (2).
Afterwards, the iMRS one initial screen will display the legally indicated
contraindications. As soon as it has been acknowledged (by pressing EN-
TER), you will see the user interface for the iMRS one application.
2
1
15
7. 7.Saving and Loading Pre-set
Parameters
The iMRS one application provides you with the ability to save various
users in advance. You can save all organ clocks with all time and intensity
levels for each applicator in advance and load them as needed.
7.1 Saving
In order to create a new user, tap on the “ Settings” button on the
user interface and then tap “Users”.
Tap the “Name” entry (4) and overwrite the placeholder. Then, tap on
Next and the virtual keyboard will disappear
You can now start making settings for the rst applicator with the rst
organ clock setting. To do so, tap the circle next to Timer (3) and set the
desired application duration from 1 to 60 minutes. It can be set in steps
of 1 minute.
Afterwards, tap the circle next to Intensity (5) and set the desired inten-
sity of the magnetic eld (ux density). This setting has been divided into
the levels: Sensitive, 10, 25, 50, 100, 150, 200 and 400.
Tap on “Next” (6) to set the next organ clock. If you have set all four organ
clocks (morning, afternoon, evening and night), you will automatically be
taken to the next applicator.
2
3
4
5
6
1
16
If you have set all of the applicators, tap on “Save” (6) to save your entries
permanently on the Omnium1.
If you want to create another user, tap the “+” icon (2) above the list of
users and repeat the process (in principle, any number of users desired
can be created).
If you created all of the users desired, you can tap “Back” (1) to return to
the main screen for the iMRS one application.
7.2 Loading
Choose the user, once the system has successfully been started. To do
that, tap on the User icon (2). A list of all of the created users (1) will
appear. Tap on the desired user and start the application by tap the
“Start/Stop” button (3). The iMRS one application will always detect auto-
matically the connected applicator and use the pre-set user parameters
from internal memory.
2
1
3
17
8. Starting an Application
Connect the D/A converter and the desired applicator (see Chapter 5,
Installation) and start the iMRS one application (see Chapter 6, Activa-
tion). After the system has been successfully started, chose the desired
application duration.
To do so, tap the circle next to Timer (1) and set the desired application
duration from 1 to 60 minutes. It can be set in steps of 1 minute.
Afterwards, tap the circle next to Intensity (4) and set the desired inten-
sity of the magnetic eld (ux density). This setting has been divided into
the levels: Sensitive, 10, 25, 50, 100, 150, 200 and 400.
The integrated organ clock will automatically adjust to the time set on
your Omnium1. You can see the organ clock setting on the display in the
upper right corner (3). However, if you want to change it manually, tap
on the organ clock icon (2) and choose the desired organ clock setting
(morning, afternoon, evening or night).
The magnetic eld application can be started by tapping the Start/Stop
button (5).
2
1
5
4
3
18
9. 9.Quick Start Programs
In addition to the parameters that can be manually set, the iMRS one
application provides ve pre-set quick start programs (exclusive with the
full body applicator). Tapping one button will suce to activate the fol-
lowing programs:
• Relaxation
• Performance
• Activation
• Sleep
• Regeneration
The magnetic eld application will start immediately after you have
touched one of the ve quick start buttons. All of the necessary parame-
ters have already been dened.
10. Settings
Tapping on the “ Settings” button will open a sub-menu with various
menu items. Tap the desired button to open a sub-menu item.
10.1 About
From this sub-menu item, you can see the version of the rmware &
hardware, the serial number for the D/A converter (if it is connected), the
version of the iMRS one software app as well as the serial number of the
Omnium1 unit.
19
10.2 Factory Settings
By tapping the “Reset Factory Settings” button, you can restore the iMRS
one app to its delivery state.
Note: all of the stored users will be deleted.
10.3 Users
See Chapter 7, Saving and Loading Pre-set Parameters.
11. Updating
Whenever your Omnium1 is connected to the internet (via WIFI), your
iMRS one App automatically veries, whether a new software version is
available. In this case a notication appears on your screen. Please klick
on „YES“ followed by clicking on „Install“. The System will automatically
update the App to the newest version.
12. Applicators
Three applicators are available for selection for the iMRS one app.
12.1 OmniMat
The OmniMat full body applicator, which is being used as a general full
body treatment. Three solid copper coil pairs with a different number
of windings (intensity) have been built into the full body applicator. The
copper coil pair at the head (cable connected to the applicator box) has
the lowest number of windings and thereby generates the lowest ux
density. The middle pair of copper coils has an already higher number of
windings and the bottom pair of coils (at the foot) has the highest num-
ber of windings with the high ux density.
The full body applicator is divided by seams. It can be folded into three
parts on the seams, however should not be bent or rolled in order to
protect the copper coils.
The full body applicator has been covered with certied articial leather.
The magnetic eld not only works directly above the full body applicator,
but also spreads itself out in all directions. The eld strength amounts
to less than or equal to 45 μT (micro-teslas) at the highest intensity set-
ting on the full body applicator. The recommended threshold for harm-
lessness in low-frequency magnetic elds is 400 μT in accordance with
20
the standard that preceded DIN 0848. Horizontally, the expansion of the
magnetic eld from the applicators will have largely abated at a distance
of about 1.5 meters.
This application can only be performed with the original full body appli-
cator. If an applicator is not connected or the applicator is defective, an
error message will appear on the Omnium1’s display. In both cases, the
application will not allow itself to be started.
12.2 OmniPad
The OmniPad pillow applicator can be used for local applications, for
example: a knee, a foot, a hand, a shoulder, the back and so forth. It
has been covered with certied articial leather. The material is easy to
maintain, can be cleaned and can be rinsed with mild disinfecting agents.
One pair of solid copper coils has been built into the OmniPad. It can be
folded in the middle and has an extensible attachment belt.
Please note that the pillow applicator should not be completely covered
by a blanket or plastic lm. Circulation of air must be ensured as a pro-
tective measure against the formation of moisture.
The magnetic eld not only works directly above the pillow applicator,
but also spreads itself out in all directions. The ux density of the pil-
low applicator is less than or equal to 70 μT at its highest intensity. The
recommended threshold for harmlessness in low-frequency electromag-
netic elds is 400 μT in accordance with the standard that preceded DIN
0848. Horizontally, the expansion of the magnetic eld from the applica-
tors will have largely abated at a distance of about 1.5 meters.
This application can only be performed with the original pillow applica-
tor. If an applicator is not connected or the applicator is defective, an
error message will appear on the Omnium1’s display. In both cases, the
application will not allow itself to be started
12.3 OmniSpot
(Not included with the iMRS one basic set)
The OmniSpot applicator can be used for isolated applications, for exam-
ple: a knee, a foot, a hand and so forth. It has been covered with certied
articial leather. The material is easy to maintain, can be cleaned and can
be rinsed with mild disinfecting agents.
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