Swiss Bionic iMRS One Operating Manual
intelligent Lifestyle
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 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:
• 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.
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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
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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. However, if such an arrangement is necessary, the operation of the device must be
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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 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 residenal, and similar areas that are directly 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 uctuaons 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 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 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 correspond
to values typical for a business or hospital environment.
Comment: Ut is the AC power voltage before the application of the test level.
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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 6100044-6
Radiated RF
interference acc.
to IEC 6100044-3
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
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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 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 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
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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 maintaining 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 electromagnetic
quantities will be affected by absorption and reection from buildings, objects and
people.
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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 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, consultation with a doctor or therapist with experience in the application of magnetic reso-
nance stimulation is recommended for purposes of safe clarication.
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