Halo 719-1000 User manual

DO NOT DISCARD – Please Retain this Manual

Model No. 719-1000

Home User Manual

THE HALO DEVICE IS INTENDED TO ENHANCE FEELINGS OF

RELAXATION, AND IS NOT INTENDED TO

DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE.

Magnesphere

TM

HALO Resonator System

User Manual

719-9010 rev. E Page 1 of 15

Contents

1. System Description and Intended Use

2

2. Contraindications

2

3. Warnings and Cautions

3

4. Getting Started

4

Unpacking the HALO

4

Assembling the HALO

4

Positioning the HALO

4

Cable Connections

5

Preparing your Computer

6

Chair Selection and Placement

6

5. System Operation

7

Starting the System

7

Running the Relaxation Protocol

9

Pausing a Session

11

Stopping a Session

11

End of Session

11

Turning the System Off

12

Assigning Nicknames to Protocols

12

6. Error Messages

13

7. Cleaning the HALO

14

8. System Maintenance and Calibration

14

9. Electrical Requirements

15

10. System Specifications

15

11. Customer Service Contact Information

15

US Patents 6,099,459 - 8,613,695 - 8,615,293 - 7,186,209 - D689,612 - D701,960 - 8,421,457 - D275,779

- D726,915 - 6,458,071 - 6,733,434

US Patents Pending 12/546,385 - 14/079,890 - 29/448,963 - 13/827,014

Canada Patents 2232869 - 2730089 Canada Patents Pending 2734992 - 2735422 - 152905 - 158862

China Patents HK 1039290 - ZL200980135319.2 China Patents Pending 20098014141 - 20133044161

EU Patents 1109598 - GE69930755.4 - UK1109598 - IT1109598 - FR 1109598 - GE231969 - FR231969 -

UK231969 – 002309237-0001 - 002309237-0002 - 002309237-0003 EU Patent Pending 097918510

India Patents 200697 - 242449 - 242450 - 242451 - 242452 - 242448

India Patents Pending 845KOLNP20 - 115KOLNP20 - 256527 - 256528 - 256529

Japan Patent 4214185

Israel Patent 141768

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TM

HALO Resonator System

User Manual

719-9010 rev. E Page 2 of 15

1. System Description and Intended Use

The Magnesphere

TM

HALO system generates a precise, homogeneous

(uniform) very low-strength electromagnetic field (EMF) intended to be

applied to the entire body, or to a specifically targeted portion of the body for

the purpose of enhancing feelings of relaxation. It is not intended to

diagnose, treat, cure, or prevent any disease.

The Magnesphere

TM

HALO system is intended to be used in the indoor home

environment by patients that have been undergoing Magnesphere

TM

procedures under a health-care provider’s care.

The Magnesphere

TM

HALO system consists of a Coil Assembly and an

electronic Control Box that is connected to a user-provided computer to

operate the system. The patient reclines in a chair placed in the center of the

Coil Assembly.

2. Contraindications

Magneceutical™ therapy relaxation sessions should not be administered to

Patients with the following Health Conditions:

 Implanted electrical stimulators in the Brain

 Chronic Atrial Fibrillation (poorly controlled)

 Epilepsy

 CHF (Congestive Heart Failure)

 High Blood Pressure (poorly controlled)

WARNING

Risk of Electrical Shock

Do Not Remove Control Box Cover

Double-Insulated Class II Equipment IP21 Ingress Protection

PLEASE READ THE FOLLOWING WARNINGS AND CAUTIONS

CAREFULLY and COMPLETELY

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TM

HALO Resonator System

User Manual

719-9010 rev. E Page 3 of 15

3. Warnings and Cautions

 Serious injury may result - The Magnesphere

TM

HALO system is not to be

used by anyone other than the person

o under the direction of a licensed health-care provider and,

o who has executed (signed) the Documentation associated with the

purchase/lease and license to use the Magnesphere

TM

HALO

system (including but not limited to a. Authorization to Use/Release

Health information (HIPPA), b. Informed Consent & Waiver of

Liability, and c. Sales (or Lease) & License Agreement)

 Relaxation Sessions are complementary to standard medical treatments

or therapies that your health-care provider has prescribed for you, so they

are to be used “in addition” to your standard medical prescriptions not

“instead of”. Relaxation Sessions do not replace the advice or

prescriptions of your health-care provider.

 You understand that there are no known or anticipated medical risks with

exposure to the low level EMF. You also understand that Magneceutical

Health does not know all of the consequences from its use. The FDA has

not decided that the Magnesphere

TM

or HALO

TM

devices or exposure to

them are safe. It is possible that you may suffer discomfort or pain, but it is

not likely. Severe Injury could occur, but it is extremely unlikely.

 You understand Magneceutical Health has not conducted any studies

involving children under 18, or pregnant women and therefore have no

information as to how the low level EMF may impact their health or

enhance their feelings of relaxation.

 While participating in Relaxation Sessions, should you experience any

serious adverse effects you should immediately stop your session and call

your HealthCare Practitioner, Doctor, or 911 if appropriate.

 Individuals with any of the listed contraindications should not be within 5’

(1.5m) of the HALO during a treatment.

 Warning – There is a potential risk of strangulation resulting from an infant

or child becoming entangled in the system cables.

 There are no user-serviceable parts in the HALO system – Do not

disassemble any part of the HALO.

 Warning – Risk of Electrical Shock - Do Not Remove the Control Box

Cover.

 The HALO structure is intended to be flexible – Do not hang items from or

lean items against the HALO.

 Do not place the HALO near open flames or heat sources such as radiant

heaters.

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HALO Resonator System

User Manual

719-9010 rev. E Page 4 of 15

4. Getting Started

Computer Selection

Unless you have purchased the Chromebook option, you will need to

provide your own computer to operate the HALO. An acceptable computer

or laptop should be located in the same room as the Magnesphere

HALO

TM

and have at a minimum:

 a connection (wired or wireless) to your Internet Service Provider

(i.e. access the Web)

 an available USB port (or Ethernet port)

 one of the following Operating System and Browser combinations:

Computer and Operating System

Browser

PC running Windows 7, 8, or 10

Latest Chrome, Safari, or

Firefox; or Internet Explorer 11+

Mac running OS 10.7 ("Lion") or later

Latest Chrome, Safari, or

Firefox

Chromebook purchased in 2013 or later

Latest Chrome

The accompanying Assembly Instructions will walk you through the simple

steps to configure your computer to work with the HALO.

Unpacking the HALO

See accompanying Assembly Instructions.

Assembling the HALO

See accompanying Assembly Instructions.

Positioning the HALO

The front of the system is open, and the chair will face the open end in the

same way as the Magnesphere

TM

in the clinic.

The area in immediate proximity (3' or 1m) of the Coils should be kept

clear of ferrous materials such as steel file cabinets, etc., and

electromagnetic (EM) sources such as computers, televisions, etc.

The Control Box can be placed anywhere between the Computer and the

Coil Assembly, but must be at least 3’ (1m) from the Coil Assembly.

Generally it is placed on or under the desk or table where the computer is

located.

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User Manual

719-9010 rev. E Page 5 of 15

Cable Connections

The system cable connections are shown below. Please reference the

Assembly Instructions for connection details.

NOTE: Ensure the Coil Cables are routed clear of any walkways so as not

to be a trip hazard.

NOTE: When connecting the Coil Cables, align the white marks on both

connector halves and gently push together until it snaps closed. Do Not

Force – Damage may Result.

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User Manual

719-9010 rev. E Page 6 of 15

Preparing Your Computer

The accompanying Assembly Instructions will walk you step by step

through the process to setup your computer to work with the HALO. This

includes configuring the Ethernet or USB port, and changing the sleep

mode/energy settings and screen saver settings.

Your computer will be otherwise unaffected and will still run other devices

through the USB ports.

Please go to the Assembly Instructions and perform the computer

configuration process before continuing.

Chair Selection and Placement

Chair Selection

Customer shall be solely responsible for insuring they have an acceptable

Chair to facilitate relaxation sessions with their MAGNESPHERE HALO

TM

.

The Chair should be no more than 36” wide, and be comfortable

(preferably recline), have minimal iron or ferrous metal structures

(aluminum is OK), and no electrical apparatus. Ideally the top of the seat

will be at least 18” from the floor.

Chair Placement

The chair should be centered between the coils and placed so the

patient’s hips are aligned with the centerline of the coils when viewed from

the side as shown:

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TM

HALO Resonator System

User Manual

719-9010 rev. E Page 7 of 15

5. System Operation

Starting the System

1. Turn on the power switch located on the front of the Control Box.

2. Turn on the computer and direct the browser to your bookmark for

https://www.MyLocationofRelaxation.com. The computer will then display

the HALO Login screen. The login username (in email format) and

password are provided by Magneceutical Health.

Note: If you can’t see this screen, or you get an error message once

you’ve input your correct email and password, then try the following:

a. Confirm that the computer is still connected to the internet and the

signal is strong by looking at the wireless icon in the lower right

corner of the desktop. If the wireless signal is weak or there is no

internet connection:

i. Locate your internet router and cycle the power by turning it off

and back on again.

ii. If the internet connection is through an Ethernet cable, ensure

the cable is properly inserted to the router and the computer.

iii. If using a laptop, ensure the wireless switch is in the on position.

b. Confirm the computer operating system meets the minimum

requirements listed on page 5 of this Manual.

c. Confirm the internet browser is compatible per page 5 of this

Manual.

d. Confirm the internet browser is up to date; update if necessary.

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TM

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User Manual

719-9010 rev. E Page 8 of 15

3. After Login, you will be prompted to run a Self-Test; press the “Start Self-

Test” button.

4. The Self-Test can last up to 70 seconds; you may hear some clicking

noises during the self-test; this is normal.

5. Once the Self-Test ends and you select “Close”, the home page will

display.

NOTE: Go to the Error Messages section of this Manual if a Self-Test Failure

alert is displayed.

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719-9010 rev. E Page 9 of 15

6. The Home page shows your Relaxation protocol selection(s), how many

minutes you’ve used of your daily allotment, and whether your account is

in good standing (e.g.: you are current with your payments). If you have

used your daily allotment of minutes you must wait until 12:01am to begin

your next Relaxation session. If your payments are not current you will be

notified and instructed via email on the payment process.

Running the Relaxation Session Protocol

NOTE: Remove metal items such as keys, coins and belt-buckles from your

person prior to treatment; most jewelry and underwire bra’s are not a

problem. DO NOT USE electronic devices (e.g. phones, computers,

electronic reader or tablet during the treatment.)

1. Press the Drop down arrow next to the list of Relaxation protocols

(example on screen is “A1-60”), and select your relaxation treatment

protocol.

2. Below the “Start” button is an area that allows you to change the duration

of your Relaxation Protocol (in the example above there is a default 60

minute protocol, using the drop down menu you can change that protocol

to a 30 or 90 minute protocol)

3. Press the “Start Protocol” button to begin the session. After you press

“Start Protocol” a 30-second timer will appear, as shown below, allowing

you 30 seconds to get seated in the chair before the treatment session

starts.

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4. Once started you may pause, resume, and stop the session. While the

protocol is running, the menu bars are hidden and session timers are

displayed. The page will display the current protocol step and the total

remaining protocol run time. If the protocol has multiple steps, a bell sound

is played between steps.

5. The Run page has a Session Timer graphic that allows the user to see

quickly how much time remains in the relaxation session and what step of

the protocol they are in. Also note that this Session Timer window can be

closed by clicking the “close” button on the timer and re-opened by

clicking the “show popup” button.

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TM

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User Manual

719-9010 rev. E Page 11 of 15

Session Pause

Once the “Pause” button is pressed, a “Resume” button appears and the

protocol can be resumed from the time it was paused. The session can

remain paused indefinitely, but the user will eventually be logged out after

prolonged inactivity.

Session Stop

When the “Stop” button is pressed, a double-bell sound is played and the

“Relaxation Session Complete” message box appears. The session will be

terminated, and a partially-completed relaxation session cannot be resumed.

Press the “Close” button to confirm. (Note: Only the number of minutes

actually used is deducted from your daily allotment of minutes. So if you start

a 60 minute protocol and stop the session 15 minutes into the Relaxation

session, only 15 minutes will be deducted from your daily allotment of

minutes)

End of Session

When the protocol ends, a double-bell sound is played and a confirmation

box appears. Press the “Close” button to confirm.

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TM

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User Manual

719-9010 rev. E Page 12 of 15

Turning the System Off

The system (both the Computer and the Control Box ie: Black Box) should

be powered down every day. To turn the HALO system off, log out, close the

browser and turn off the power switch on the front of the Control Box.

Assigning Protocol Nicknames

You can assign nicknames to your protocols for easy identification.

To give your protocols nicknames:

1. Click "Profile" in the menu.

2. Click into the "Protocol Nicknames" tab.

3. Enter nicknames for your protocols in the fields next to each protocol

name.

4. Click the "Submit" button.

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Now click "Home" in the menu and you'll see your protocols' nicknames when

you click the protocol selector:

6. Error Messages

If the system fails Self-Test, an alert is displayed:

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HALO Resonator System

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If the computer fails to communicate with the HALO during a test or a relaxation

session, an alert is displayed and the session is stopped:

If either of these alerts occurs:

1. Turn the power switch on the front of the Control Box off for a couple of

seconds, and then on again.

2. Restart the computer.

3. Log in, allow the self-test to run, and if the self-test is successful

execute the relaxation protocol.

4. If you have a second test failure, turn off Control Box again AND unplug

power cord from outlet for a few seconds. Then connect the power cord

to outlet and turn power switch back on the front of the Control Box.

Restart the computer again.

5. If the HALO continues to display an error message contact

Magneceutical Health Customer Service:

Email: [email protected]

Phone: 727.474.3722 ext. 2

7. Cleaning the HALO

The fabric HALO coil assembly should be cleaned periodically with a mild non-

abrasive detergent or cleaner and a soft cloth or paper towel. If necessary, the

HALO may be cleaned with isopropyl alcohol. Do not use an excessive amount

of fluid to clean the HALO components.

8. System Maintenance and Calibration

The HALO system requires no periodic maintenance or calibration. The self-

test at login confirms functionality and will notify you if any action is required.

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HALO Resonator System

User Manual

719-9010 rev. E Page 15 of 15

Electrical Requirements

AC Power (1 connection)

110/230VAC, 60/50Hz, 10W Class II

Internet Connection

 Wireless -or-

 Hard-Wire Ethernet connection

System Specifications

System Packaged Weight (2 boxes)

17 lbs (7.7 kg), 7 lbs (3.2 kg)

Assembled HALO Dimensions

88” (2.2m) x 43” (1.1m) x 75” (1.9m) High

EM Power Level Range

0.001µG to 500.0µG

EM Frequency Level Range

0.01Hz to 300.0Hz

Coil Type

Modified Helmholtz Coil

Relaxation Session Quality features

Automated Self-Test

Relaxation Session Protocols

Proprietary Algorithms

Data Security

Encryption; Redundant, Secure Data Center

Regulatory Compliance

ISO 13485:2003 (Design)

ISO 9001:2008 (Manufacture)

Certified by British Standards Institute (BSI)

FDA 21 CFR 820

Canada Medical Device Regulations

(SOR/98-282)

Medical Device Safety Certifications

IEC 60601-1 3

rd

ed./CSA C22.2 601.1

Ingress Degree of Protection Rating

IP21

Expected Service Life

7 years

Environmental Conditions Operating

(Normal)

Temperature: 5 to 40°C

Relative Humidity: 15-93% non-condensing

Altitude (Pressure): 700 to 1060 hPa

Environmental Conditions for Shipping

Temperature: -25 to +70°C

Relative Humidity: up to 93% non-condensing

Altitude: 700 to 1060 hPa

Environmental Conditions for Storage

Temperature: -25 to +70°C

Relative Humidity: up to 93% non-condensing

Altitude: 700 to 1060 hPa

Magneceutical Health

611 Druid Road East Suite 714

Clearwater, FL 33756

Phone: 727.474.3722

Fax: 727.474.3738

www.magneceutical.com

Customer Service and Support

Email: custservice@magneceutical.com

Phone: 727.474.3722 ext. 2

Halo 719-1000 User manual

Halo 719-1000 User manual

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