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Health Navigator Instruction Manual

Health Navigator Instruction Manual- English, Version 1, 24/05/2010

of 23

Manufactured by iie GmbH & Co. KG


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


Light Therapy ........................................................................................................................................... 9

Health Navigator Instruction Manual – Light Therapy ............................................................................. 9

Indications for Light Therapy ................................................................................................................... 9


Frequency ................................................................................................................................................ 9

Luminous Intensity ................................................................................................................................... 9

Period of Use ........................................................................................................................................... 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 (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


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.


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








On or near the eyes






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




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.




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




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


Health Navigator Instruction Manual – Light Therapy







On or near the eyes






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


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


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


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




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


4-5

± 1 kV push-pull

voltage

± 2 kV common mode

voltage

± 1 kV push-pull voltage

± 2 kV common mode

voltage



Voltage dips, short

interruptions and

voltage variations

immunity tests


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


)

for 25 periods

< 5 % UT


)

for 5 seconds

< 5 % UT


)

for 0,5 periods

40 % UT


)

for 5 periods

70 % UT


)

for 25 periods

< 5 % UT


)

for 5 seconds




Power frequency

magnetic field

immunity test at supply

frequency of 50/60 Hz


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



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


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


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

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