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Health Navigator Instruction Manual
Health Navigator Instruction Manual- English, Version 1, 24/05/2010
Page 1 of 23
Manufactured by iie GmbH & Co. KG
Health Navigator Instruction Manual
Contents
Health Navigator Instruction Manual ...................................................................................................... 1
Health Navigator Instruction Manual ..................................................................................................... 2
Health Navigator (HN) Intended Purpose ................................................................................................ 3
Health Navigator Instruction Manual ...................................................................................................... 3
HN Intended Applications ....................................................................................................................... 3
Important Safety Information ................................................................................................................. 3
Contraindications and Precautions ......................................................................................................... 4
Warnings ................................................................................................................................................. 4
Electrical Therapy .................................................................................................................................... 5
Health Navigator Instruction Manual – Electrical Therapy ...................................................................... 5
Indications for Electrical Therapy ............................................................................................................. 5
Frequency ................................................................................................................................................ 5
High Frequency TENS (10-150Hz) .................................................................................................... 5
Low Frequency TENS (2-10Hz) ......................................................................................................... 5
Pulse Duration and Shape ........................................................................................................................ 5
Continuous TENS .............................................................................................................................. 5
Burst (single application) .................................................................................................................. 5
Voltage and Current ................................................................................................................................. 5
Period of Use ........................................................................................................................................... 5
Specific Contraindications and Precautions ............................................................................................. 6
Magnetic Therapy ................................................................................................................................... 7
Indications for Magnetic Therapy ............................................................................................................ 7
Frequency ................................................................................................................................................ 7
Magnetic Field Strength ........................................................................................................................... 7
Period of Use ........................................................................................................................................... 8
Health Navigator Instruction Manual – Magnetic Therapy ..................................................................... 7
Specific Contraindications and Precautions ............................................................................................. 8
Light Therapy ........................................................................................................................................... 9
Health Navigator Instruction Manual – Light Therapy ............................................................................. 9
Indications for Light Therapy ................................................................................................................... 9
Health Navigator Instruction Manual
Frequency ................................................................................................................................................ 9
Luminous Intensity ................................................................................................................................... 9
Period of Use ........................................................................................................................................... 9
Specific Contraindications and Precautions ............................................................................................. 9
Using the HN ......................................................................................................................................... 11
Health Navigator Instruction Manual – Using the HN ........................................................................... 11
Initial Steps ............................................................................................................................................ 11
Operating Elements ............................................................................................................................... 11
Calibration of the HN ............................................................................................................................. 12
Turning off the HN .................................................................................................................................. 12
Additional Information for Users .......................................................................................................... 13
Additional Information for Users ........................................................................................................... 13
Maintenance and Storage/Usage Requirements ................................................................................... 13
Maintenance .................................................................................................................................. 13
Storage/Usage Requirements ....................................................................................................... 13
Description of HN Icons ......................................................................................................................... 14
Labelling ................................................................................................................................................. 14
Equipment .............................................................................................................................................. 16
Specifications ......................................................................................................................................... 16
EMC Manufacturer Information ............................................................................................................. 17
Health Navigator Instruction Manual – ................................................................................................. 13
Manufacturer ........................................................................................................................................ 19
Health Navigator Instruction Manual – Contacts ................................................................................... 19
Distributor .............................................................................................................................................. 19
Health Navigator Instruction Manual
Health Navigator (HN) Intended Purpose
The HN is intended for Transcutaneous Electrical Nerve Stimulation (TENS) therapy with light and
magnetic fields. The signals for each type of therapy are generated by an external frequency source.
By using a speaker connected to the device's monitoring connection the output of frequencies can
be controlled.
The HN should not be used for purposes other than those described above.
HN Intended Applications
The HN is intended for use in pain therapy, wound healing, and the treatment of depression.
The HN is intended for use by complementary medicine professionals only.
Important Safety Information
Please read the entire instruction manual prior to using the HN.
For the safe use of the HN:
1. Use only original equipment for the HN (e.g. See the equipment chapter for further
information)
Before using the HN external signal source (e.g. MP3-player, hi-fi, signal generator) the first time,
check that the signal source is conforming to the applicable IEC- or ISO- safety standards.
Note: If you are unsure your signal source is appropriate for use with the HN please feel free to ask
your distributor or the manufacturer of the Health Navigator.
2. Do not expose the HN to liquids
3. Do not use the HN in the same room with devices which have this sign
4. Be aware of the protection distances shown on page 18 of this manual between portable and
mobile radiofrequency telecommunication devices and the HN.
5. The HN should not be used after being dropped
6. Do not expose the HN to extreme temperatures or high air humidity. Use and store the HN
only at room temperature (<35°C) and maximum air humidity between 30%- 50%. Refer to
the storage/usage requirements provided in this instruction manual.
7. Never use the HN on a patient when it is broken or is malfunctioning
8. Store the HN in the supplied packaging when not in use
Health Navigator Instruction Manual
9. Do not use the HN outdoors
10. Do not use a multiple socket outlet for the HN
11. Use only the normal power supply network for the HN (100V - 240V)
12. Arrange the HN only on a solid surface. Do not set the HN up on the floor for use. The surface
for use shall wooden, concrete, or furnished with ceramic tiles.
13. Do not stand or sit on the HN
14. Set both intensities to zero on the HN before changing applicators
15. Refer to the EMC manufacturers information provided in this instruction manual
16. TENS therapy should not be completed on patients with electric implants (e.g. pacemaker)
without consulting a doctor before.
17. Use the HN on one patient at a time
18. Do not use the HN on inflamed skin, e.g. eczema or a wound in the area of the electrodes.
19. Do not use the HN if you are pregnant, or have a seizure disorder, and/or long-lasting pains
with unclear reason.
20. Use the LED-Array only on the upper part of the body or on the extremities. Don´t fix the
LED-Array to a patient’s throat or nose.
21. TENS electrodes should never be placed:
On or near the eyes
On the front of the neck
Directly on genitalia
On areas of numb skin/decreased sensation
On broken skin areas or wounds
On the throat, mouth or nose
Contraindications and Precautions
Refer to the contraindications and precautions given within this instruction manual under each
therapy type.
Health Navigator Instruction Manual
Warnings
Don´t use the HN and RF equipment (e.g. radio frequency surgery equipment) at the same time
because this can cause burns under the electrodes.
Health Navigator Instruction Manual – Electrical Therapy
Electrical Therapy
Indications for Electrical Therapy
The HN is used for TENS therapy. TENS is intended to reduce pain in patients.
Applicators: Adhesive electrodes and area electrodes on the surface of the box
Colour coding: Light blue
Intensity setting: the scale unit is Volt.
Note: Refer to the package insert of the adhesive electrodes. Use the adhesive electrodes only on
intact skin and only on the upper part of the body and on the extremities. Do not use the HN on
genitals, head or face. Use electrodes once only. Area electrodes on the surface of the device must be
disinfected after use.
Frequency
High Frequency TENS (10-150Hz)
Using high frequency pulses nerve endings can be stimulated, resulting in a reduction of pain or
complete pain relief.
Low Frequency TENS (2-10Hz)
Low frequency pulses cause the muscle being worked on to contract very fast. This reduces localised
pain and increases perfusion.
Pulse Duration and Shape
Continuous TENS
Square pulse with 10-300 μs.
Burst (single application)
Bursts with 80-100Hz, to be applied using 2-10Hz.
Voltage and Current
Voltage: 1-14 Volt
Current: 1-20mA
Period of Use
Each application can take a few minutes to a few hours. The HN should be used several times a week
or daily over a period of weeks, months, or years dependant on the individual.
Specific Contraindications and Precautions
1. TENS therapy should not be completed on patients with electric implants (e.g. pacemaker)
without consulting a doctor before.
Health Navigator Instruction Manual – Electrical Therapy
2. Use the HN on one patient at a time
3. Do not use the HN on inflamed skin, e.g. eczema or a wound in the area of the electrodes.
4. Do not use the HN if you are pregnant, or have a seizure disorder, and/or long-lasting pains
with unclear reason.
5. Use the LED-Array only on the upper part of the body or on the extremities. Don´t fix the
LED-Array to a patient’s throat or nose.
6. TENS electrodes should never be placed:
On or near the eyes
On the front of the neck
Directly on genitalia
On areas of numb skin/decreased sensation
On broken skin areas or wounds
On the throat, mouth or nose
Health Navigator Instruction Manual – Magnetic Therapy
Magnetic Therapy
Indications for Magnetic Therapy
The HN is used for magnetic therapy which is intended to improve wound healing
Applicator: Magnetic Field Applicator (see table below)
Note: clean the magnetic applicators with a damp cloth only. Keep away from water.
Colour coding: Orange
Intensity setting: Units are specified as Tesslar (see table of magnetic field intensity).
Magnetic Field Intensity Table
Applications Maximum Magnetic Field
magnetic field- full body mat 5 mT
magnetic field- spatial pulse applicator 4mT
magnetic field- orthopaedic applicator 20mT
magnetic field- shoulder applicator 20mT
magnetic field- local disc applicator 36mT
magnetic field- full body applicator 4mT
magnetic field- paddy applicator 16mT
Frequency
A frequency of 0-10Hz shall be used when using the HN for magnetic therapy.
Magnetic Field Strength
Maximum field intensity of 36 mT. Refer to the table of magnetic field intensity above.
Period of Use
Each application can take a few minutes to a few hours. The HN should be used several times a week
or daily over a period of weeks, months, or years dependant on the individual.
Specific Contraindications and Precautions
1. Magnetic therapy should not be completed in patients with electric implants (e.g.
pacemakers etc.) without consulting a doctor.
2. When using magnetic therapy a prickle and localised feeling of heat at the site of treatment
can be felt by the patient.
Health Navigator Instruction Manual – Magnetic Therapy
3. While using and after using magnetic therapy agitated melancholia, palpitations, perspiration
and anxiety can appear.
4. Use the HN on one patient at a time
5. Do not use the HN if you are pregnant, or have a seizure disorder, and/or long-lasting pains
with unclear reason.
Health Navigator Instruction Manual – Light Therapy
Light Therapy
Indications for Light Therapy
The HN light therapy for the treatment of symptoms of depression.
Applicator: LED-Array
Colour coding: Yellow
Note: The LED-Array should not contact the skin directly, ensure a transparent wound pad is used the
LED-Array. Refer to the package insert. The LED-Array can be fixed on the body by using a Velcro
strip. The LED-Array has 16 infrared (invisible light) and 16 red LEDs.
Clean the LED-Array with a damp cloth only. Keep away from water.
Frequency
A frequency of 0-1kHz shall be used when using the HN for light therapy.
Luminous Intensity
630 nm wavelength (red): Maximum is dependent on frequency 640 mcd
945 nm wavelength (infrared): Maximum is dependent on frequency 35mW
Period of Use
Each application can take a few minutes to a few hours. The HN should be used several times a week
or daily over a period of weeks, months, or years dependant on the individual.
Specific Contraindications and Precautions
1. Before plugging in the LED-Array to the HN fix it to the patient
2. Do not use light therapy on patients who have any of the following
An allergy to sunlight or a lack of pigmentation,
Many moles,
A hyperactive thyroid,
An infectious disease, or
A weak cardiovascular system.
3. Light therapy shall not be used in combination with plant compounds or drugs which
increase responsiveness to light
4. Use the HN on one patient at a time
Health Navigator Instruction Manual – Light Therapy
5. Do not use the HN on inflamed skin, e.g. eczema or a wound in the area of the electrodes.
6. Do not use the HN if you are pregnant, or have a seizure disorder, and/or long-lasting pains
with unclear reason.
7. Use the LED-Array only on the upper part of the body or on the extremities. Don´t fix the
LED-Array to a patient’s throat or nose.
8. TENS electrodes should never be placed:
On or near the eyes
On the front of the neck
Directly on genitalia
On areas of numb skin/decreased sensation
On broken skin areas or wounds
On the throat, mouth or nose
Health Navigator Instruction Manual – Using the HN
Using the HN
Initial Steps
1. Plug in the mains power supply to the HN (on the back of the HN)
2. Set the on/off switch (on the back of the HN) to on
3. Turn the frequency source on
4. Plug the external frequency source in “Source In” on the back of the HN. The voltage level of
the source must be between 0.3 and 2 volts.
5. Turn the rotary dials (Channel 1 and Channel 2) to intensity 0
6. Activate the HN by pressing the on switch located on the front of the HN. The output LED
should now be activated. If this does not occur, restart the steps from 1.
7. Refer to the calibration of the HN section of this instruction manual for further operating
information
Operating Elements
2 rotary dials – rotary switch for setting intensity
Small button – on switch
On/off switch
Mains power switch
Source in
Calibration of the HN
1. Change the intensity of the external frequency source until the INPUT OK LEDs illuminate.
2. Plug in the applicators and choose the desired intensity
3. Use only one set of applicators at any time. Ensure the colours match the plug and socket
selected.
4. Refer to the information supplied under each form of therapy (electrical, light and magnetic)
for information regarding specific operation based on therapy type.
Health Navigator Instruction Manual – Using the HN
Turning off the HN
1. Set both rotary dials to zero
2. Unplug the applicators
3. Set the on/off switch on the back of the HN to the off position
Health Navigator Instruction Manual – Additional Information for Users
Additional Information for Users
Maintenance and Storage/Usage Requirements
Maintenance
The manufacturer is responsible for any changes and repairs which were completed by an authorized
staff member of iie, and if the HN is used in compliance with this instruction manual.
A specific cleaning liquid is not required to clean the HN. It is recommended that a soft, lint-free
cloth is used.
Users must ensure that the HN is stored away from humidity.
When used within the specified intended purpose, the HN should not require servicing. The
distributor of the purchased product shall be contacted in the event of HN malfunction.
The HN does not include any dangerous substances and can be disposed of by the distributor.
Storage/Usage Requirements
Ambient conditions are required for the HN’s operation and storage. These are defined within the
table below:
Storage Temperature 5 °C - 50 °C
Operating Environment Temperature 10 °C - 40 °C
Relative Humidity Storage 10 % - 90 %
Relative Humidity Operating Environment 30 % - 50 %
Atmospheric Pressure Storage 500 hPa - 1060 hPa
Atmospheric Pressure Operating Environment 795 hPa - 1060 h
Health Navigator Instruction Manual – Additional Information for Users
Description of HN Icons
Refer to the instruction manual
Manufactured by
Serial number
Order Number
The HN grants protection against electric shock in the area of the permitted leakage current
No protective conductor
Labelling
LABELLING EXPLANATION
MONITOR CONNECTION CH1/CH2 stereo speaker connection possible on both connectors
ELECTRIC THERAPY Connectors for TENS
- CH1 Pin configuration: CH1 to blue, CH2 to red
- CH2 Pin configuration: CH1 to blue, CH2 to red
- INFORMATIONAL ELECTRODE
CH1/ REF
Choice of intensity over Channel 1
MAGNETIC THERAPY Connectors for magnetic therapy
- CH1 Choice of intensity over Channel 1
- CH 2 Choice of intensity over Channel 2
LIGHT THERAPY Connectors for LED-Array
- CH1/CH2 Channel 2/ choice of intensity for 16 LEDs over Channel 1 and
16 LEDs over Channel 2
- CH1/CH2 Choice of intensity for 16 LEDs over Channel 1 and 16 LEDs over
Channel 2
Health Navigator Instruction Manual – Additional Information for Users
LABELLING EXPLANATION
SOURCE IN Input of frequency shape
POWER IN Input for power supply FW7405M/05
ON Pushbutton for activation of HN
INPUT OK Signal for correct calibration of CHANNEL 1 and CHANNEL2
OUTPUT POWER Signal for power output
Equipment
The table below specifies HN items that are supplied by the manufacturer.
TERM ORDER NUMBER
Adhesive electrodes Stimex eco 281021
Mains adapter FW7405M/05 1890649
AC power line Australia 1812277
Eectrode connection cable 504001
LED Light-Array applicator 508300
Speaker LSPK-1050
Magnetic field- full body mat MMAT-1029
Magnetic field- spatial pulse applicator MPUL-1032
Magnetic field- orthopaedic applicator MORTH-1031
Magnetic field- shoulder applicator MSHLD-1034
Magnetic field- local disc applicator MDISC-1030
Magnetic field- full body applicator MBOD-1033
Health Navigator Instruction Manual – Additional Information for Users
Magnetic field- paddy applicator MPAD-1035
Specifications
No Protective Conductor Electrical
Therapy
Magnetic
Therapy
Light
Therapy
Input
max. current output (at 1kΩ real) 15mA 5mA 5mA ---
frequency range 0-20kHz 0-10Hz 0-1kHz 0-20kHz
max. voltage 15V 5V 5V 0,3 - 2V
connection of mains adapter FW7405M/05 Voltage Range: 100 - 240VAC
Frequency Range: 50 - 60 Hz
power supply Health Navigator "Power In" 5V/5A/DC
current consumption AC current (Typ.) 0.6/115VAC, 0.4/230VAC
EMC Manufacturer Information
Guideline and manufacturer declaration- electromagnetic emission
The HN is designed for using it in the following environment. The user of the HN must ensure that it is used in
the described environment.
measurement of emissions accordance electromagnetic environment- guideline
Radiated disturbance
according to CISPR22
Class B The HN uses high frequency energy exclusively
for its own internal function. Therefore its high
frequency energy is quite low and it is unlikely
that it disturbs nearby electronic devices.
Conducted disturbance
according to CISPR 22
Class B The HN will be connected to a public power
supply.
Harmonic current emissions
according to IEC 61000-3-2
Class A
Voltage fluctuations and flicker
in low-voltage supply systems
according to IEC 61000-3-3
NA
Health Navigator Instruction Manual – Additional Information for Users
Guideline and manufacturer declaration- electromagnetic emission
The HN is designed for using it in the following environment. The user of the HN must ensure that it is used in
the described environment
Immunity testing IEC 60601-testing level agreed testing levelElectromagnetic environment-
guideline
Electrostatic discharge
immunity according to
IEC 61000-4-2
± 6 kV contact
discharge
± 8 kV air discharge
± 6 kV contact discharge
± 8 kV air discharge
The floor should consist of wood,
concrete or furnished with
ceramic tiles. The humidity
should not be lower than 30
percent.
Fast transient electrical
disturbances bursts
according to IEC 61000-
4-4
± 2 kV for ac-power
line
± 1 kV for input- and
output-lines
± 2 kV for ac-power line
± 1 kV for input- and
output-lines
The HN will be connected to a
public power supply.
The length should be above 3 m.
Surge immunity test
according to IEC 61000-
4-5
± 1 kV push-pull
voltage
± 2 kV common mode
voltage
± 1 kV push-pull voltage
± 2 kV common mode
voltage
The HN will be connected to a
public power supply.
Voltage dips, short
interruptions and
voltage variations
immunity tests
according to IEC 61000-
4-11
< 5 % UT
(> 95 % break-in of UT
)
for 0,5 periods
40 % UT
(60 % break-in of UT
)
for 5 periods
70 % UT
(30 % break-in of UT
)
for 25 periods
< 5 % UT
(> 95 % break-in of UT
)
for 5 seconds
< 5 % UT
(> 95 % break-in of UT
)
for 0,5 periods
40 % UT
(60 % break-in of UT
)
for 5 periods
70 % UT
(30 % break-in of UT
)
for 25 periods
< 5 % UT
(> 95 % break-in of UT
)
for 5 seconds
The HN will be connected to a
public power supply.
Health Navigator Instruction Manual – Additional Information for Users
Power frequency
magnetic field
immunity test at supply
frequency of 50/60 Hz
according to IEC 61000-
4-8
3 A/m 3 A/m The HN consist of no components
which are sensitive to magnetic
fields.
ANNOTATION UT
is the alternating voltage before appliance of the testing level
Guideline and manufacturer declaration- electromagnetic emission
The HN is designed for using it in the following environment. The user of the HN must ensure that it is used in
such an environment.
Immunity testingIEC 60601-testing
levelAgreed testing level Electromagnetic environment - guideline
3 Veff
150 kHz bis 80 MHz
3 Veff
150 kHz bis 80 MHzd = 1,17 1/V * √P
3 V/m
80 MHz bis 2,5 GHz
3 Veff
150 kHz to 80 MHz
3 V/m
80 MHz bis 2,5 GHz
3 Veff
150 kHz to 80 MHz
d = 1,17 m/V * √P für 80 MHz bis 800 MHz
d = 2,33 m/V * √P für 800 MHz bis 2,5 GHz
Immunity to
conducted
disturbances,
induced by radio-
frequency fields
according to IEC
61000-4-6
Radiated, radio
frequency,
immunity test
according to IEC
61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m
80 MHz to 2,5 GHzPortable and mobile radio equipment
(including the lines) should not used at any
distances closer than the protection
distance. The protection distance is
calculated by an equation for the applicable
transmission frequency.
Recommended protection distance:
d = 1,17 1/V * √P
d = 1,17 m/V * √P for 80 MHz to 800 MHz
d = 2,33 m/V * √P for 800 MHz to 2,5 GHz
“P” is the rated power of the emitter in watts
(W) according to the specification of the
Health Navigator Instruction Manual – Additional Information for Users
manufacturer of the emitter. “d” is the
recommended protection distance in meter
(m).
The field strength of stationary radio
transmitters should be less than the agreed
testing level b
at all frequencies. Therefore
studies about the field strength should be
made locally a
.
Interferences are possible near devices
labeled with this sign.
ANNOTATION 1 At 80 MHz and 800 MHz the higher frequency range is essential.
ANNOTATION 2 This guideline will be not applicable in all cases. The propagation of electromagnetic values is
affected by absorption and reflection of buildings, items and humans.
a The field strength of stationary emitters, e.g. base stations of mobile telephones and land mobile radio
devices, amateur radio stations, AM- and FM-broadcast and television transmitters cannot be predestined
accurately. Surveys about the location should be considered to check the electromagnetic environment
regarding to stationary emitters. If the measured field strength at this location is above the agreed testing
level (see above) the HN must be observed for verifying its intended function. If unwanted behaviors are
observed, additional precautions need to be taken, e.g. move the HN to another position.
b Above the frequency range of 150 kHz to 80 MHz the field strange should be less than 3 V/m.
Recommended protection distances between portable and mobile HF-telecommunication devices and the HN.
The HN is designed for the operation in one of the electromagnetic environments as seen below. In these cases
the hf-disturbance is controlled. The user of the device HN can help to avoid electromagnetic disturbances by
keeping the minimum distance between portable and mobile hf-communication devices and the HN(depending
on the output power of the communication device).
Rated power of the
emitter W
Guard distance depending to the emission frequency
[m]
150 kHz bis 80 MHz
d = 1,17 1/V * √P
150 kHz to 80 MHz
d = 1,17 1/V * √P
80 MHz bis 800 MHz
d = 1,17 m/V * √P
80 MHz to 800 MHz
d = 1,17 m/V * √P
800 MHz bis 2,5 GHz
d = 2,33 m/V * √P
800 MHz to 2,5 GHz
d = 2,33 m/V * √P
0,01 0,12 0,12 0,23
Health Navigator Instruction Manual – Additional Information for Users
0,1 0,37 0,37 0,74
1 1,17 1,17 2,33
10 3,7 3,7 7,37
100 11,7 11,7 23,3
For emitter whose maximum rated power is not mentioned in the table above, the recommended protection
distance “d” in meter [m] can be calculated with the respective equation in the column above. “P” is the rated
power of the emitter in watt (W) according to the specification of the manufacturer of the emitter.
ANNOTATION 1 At 80 MHz and 800 MHz the higher frequency range is essential.
ANNOTATION 2 This guideline will be not applicable in all cases. The propagation of electromagnetic
values is affected by absorption and reflection of buildings, items and humans
Health Navigator Instruction Manual – Contacts
Manufacturer
iie GmbH & Co.KG
Dorfstr.20
83564 Soyen
+49 (0)8071-1034-26
Contact person: Korbinian Kreß
Distributor
Health Navigator, LLC
World-Wide Distributors
Voice Mail/Fax: 001 530 410 6311
General Email: [email protected]
www. energy-medicine.info