Swiss Bionic iMRS One User manual
intelligent Lifestyle
Operating Manual
Operating Manual
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 reso-
nance 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:
• DIN EN ISO 13485
• 93/42/EEC Annex VI - Section 3 Medical Product Guidelines (MPG)
• IEC 60601-1 Electrical Safety
• IEC 60601-1-3 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 © 2014 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 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
2.1 Essential Performance Characteristics of the iMRS one...........................10
3. Possible Applications ....................................................................................10
4. Scope of Delivery...........................................................................................11
4.1 Control Unit.................................................................................................12
5. Installation.....................................................................................................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-Resonance-Stim-
ulation 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 cor-
responds 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. How-
ever, if such an arrangement is necessary, the operation of the device must be
5
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 treat-
ment should remain outside the indicated range during the course of an appli-
cation.
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 Interfer-
ence 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 Guideline
RF emissions acc. to CISPR 11 Group 1 The iMRS one only uses RF energy for
its internal OPERATION. Its RF emission
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 resi-
denal, and similar areas that are direc-
tly connected to the PUBLIC POWER
GRID that also supplies buildings 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 Environment
- 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 mate-
rial, 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 conduc-
tor-outer conduc-
tor
± 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
interruptions 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 con-
tinuous operation, even when
interruptions in the power
supply occur, supplying the
iMRS one from an uninter-
ruptible 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 busi-
ness 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 effective
value
150 kHz up
to 80 MHz
3 V/m
80 MHz up
to 2.5 GHz
3V Portable and mobile radio devices, including
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 recom-
mended 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 quanti-
ties 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 trans-
mitters; cannot be determined in advance with theoretic precision. A study of the electro-
magnetic phenomena of the location should be considered in order to determine the nature
of the ELECTROMAGNETIC SURROUNDINGS in terms of stationary 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 man-
ner 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 Telecom-
munication 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 maintaining the
minimum distance between portable and mobile radio frequency telecommunication
devices (transmitters) and the iMRS one, depending on the output power of the com-
munication 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 out-
put 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 electromagnetic
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 practi-
tioner 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 reac-
tion) 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, consul-
tation with a doctor or therapist with experience in the application of magnetic reso-
nance stimulation is recommended for purposes of safe clarication.
10
2. Intended Use
With the iMRS one magnetic resonance stimulation system, weak, pulsating electro-
magnetic 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 unin-
tended health consequence and should therefore be avoided.
2.1. Essential Performance Characteristics of the
iMRS one
The essential performance characteristic of the iMRS one is the generation of specied
magnetic eld pulses and the reinforcement of the body›s own energy elds.
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 integrative
physician prior to using our products.
11
4. Scope of Delivery
If one part should be damaged or missing, please contact your consultant 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
Protective display lm Quick Start Guide
one sets available. You will nd the operating instructions for the Omnium1 in
the special manual that accompanies the control device.
Quick Start Guide
13
5. Installation
1. Take the individual parts out of the packaging. Place the full-body applica-
tor 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 electro-smog
as possible. There should not be any devices like: TVs, microwave ovens, ra-
dio-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 device 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 charged.
The application will not be possible if the battery charge state drops below
5%. In that case, connect the power supply with the Omnium1
(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.
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 Om-
nium1 desktop (2).
Afterwards, the iMRS one initial screen will display the legally indicated cont-
raindications. As soon as it has been acknowledged (by pressing ENTER), 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 intensity 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.
In order to create a new user, tap on the “ Settings” button on the user
2
3
4
5
6
1
16
If you have set all of the applicators, tap on “Save” (6) to save your entries per-
manently 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 cre-
ated).
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 automatically the connected appli-
cator 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, Installa-
tion) and start the iMRS one application (see Chapter 6, Activation). 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 dura-
tion 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 intensity 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 appli-
cation provides ve pre-set quick start programs (exclusive with the full body
applicator). Tapping one button will su ce to activate the following 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 parameters have
already been de ned.
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 & hard-
ware, 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.
Tapping on the “ Settings” button will open a sub-menu with various menu
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 number 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 setting on the full body
20
applicator. The recommended threshold for harmlessness in low-frequency
magnetic elds is 400 μT in accordance with 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 applicator. 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 protective mea-
sure 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 pillow applica-
tor is less than or equal to 70 μT at its highest intensity. The recommended
threshold for harmlessness in low-frequency electromagnetic elds is 400 μT
in accordance with 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 pillow applicator. 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 example:
a knee, a foot, a hand and so forth. It has been covered with certied articial
Table of contents
