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
Magnesphere
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
Magnesphere
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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TM
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.
Magnesphere
TM
HALO Resonator System
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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TM
HALO Resonator System
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:
Magnesphere
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.
Magnesphere
TM
HALO Resonator System
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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TM
HALO Resonator System
User Manual
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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TM
HALO Resonator System
User Manual
719-9010 rev. E Page 10 of 15
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.
Magnesphere
TM
HALO Resonator System
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.
Magnesphere
TM
HALO Resonator System
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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TM
HALO Resonator System
User Manual
719-9010 rev. E Page 13 of 15
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:
Magnesphere
TM
HALO Resonator System
User Manual
719-9010 rev. E Page 14 of 15
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.
Magnesphere
TM
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
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