The Magnesphere™ system is a device that generates a precise very low-strength uniform 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™ system has a modular design comprised of two 7' diameter coils, an ergonomically designed chair, a computer and controlling electronics. The patient sits in the chair and is immersed in the uniform EMF generated by the coils. The operator controls the system from the computer, which is located outside of the EMF.
Turn on the computer and click the Operator icon to log in. Enter "operator" for the password. The computer will then display the Magnesphere™ Web Application's Login screen. [https://www.mymagneceutical.com ] (Operator login username and password are provided by Magneceutical Health.)
Prior to entering Login and Password, the operator should review the Terms of Service and End User License Agreement and indicate his/her agreement by checking the "I accept these Terms of Service" box. Note: the Terms of Service and End User License Agreement are incorporated by reference in the Sales and License Agreement that was executed with the purchase of the Magnesphere™ system.
After logging in, you will be prompted to start a Magnesphere™ self-test.
Press OK to begin the test. This will cause the Magnesphere™ to perform a series of diagnostic tests to verify that it is operating properly. If you press Cancel, the self test will not run and the system will not allow you to run relaxation sessions. However, you will be allowed to perform all other software functions such as patient registration, report generation, etc.
Upon completion of the self-test, a pop-up will inform you that the test passed. In the unlikely event that the self-test failed, a pop-up will inform you of the reason for the failure and instruct you to try the test again and call customer service if the failure persists. If this happens, the system will not allow you to run relaxation sessions. However, you will be allowed to perform all other software functions such as patient registration, report generation, etc.
After the self-test, the home page will display your Login Name and how many minutes (and 1hr sessions) remain for your location. If the number of minutes/sessions falls below a pre-set amount then this area will flash red, and an administrator for your site will be notified via email that more minutes need to be purchased (for more information refer to the section "Admin Area" below.)
After logging in, click the Register New Patient image in the Home screen.
Enter the required Patient information.
If the Patient has a referring physician relationship that is important to capture then you may note this in the "Consult" field. You can select an existing physician from the given list, or enter a new one by clicking the "Enter new physician data" link next to the list.
After entering patient information, the patient should be given a chance to read, review, make inquiries, and electronically execute the two documents that are identified below the New Patient information section: Notice of Privacy Practices and Informed Consent and Waiver of Liability. (You may print these out and provide them to the patient for convenience). To accept these two documents, the patient must first check the box that indicates he or she agrees to the Federal Electronic Disclosure and Consent document, and then indicate his or her acceptance of the privacy and consent and waiver documents by putting their first and last initials in the box provided (note the System is case sensitive so the initials should match exactly those used in creating the patient information section), then press the Save button to continue:
After saving the New Patient information, you will be given the option to run a relaxation session for this patient immediately. If you cancel this option, you will be returned to the home screen. If you do choose to run a session immediately, the patient's treatment history will be displayed next. Skip to section D, below, to learn how to choose the relaxation session protocol.
After logging in, click the Run Session image in the Home screen.
Next, you'll see a list of patients you can treat. Click the Run link for your current patient.
The patient's session page will be displayed next. Proceed to section D, below, to learn how to choose the relaxation session protocol.
The patient's session view shows the Protocol Decision Tree, followed by the patient's session history -- a list of past relaxation sessions, including details on when the sessions were given, which protocols were used, etc. You can scroll to the bottom of the page, past the Decision Tree, to see the session history, or hide the decision tree by clicking the "Show/hide" link above it. Note that there are 0 sessions in a new patient's history. From here there are two ways to choose a protocol for the next session.
Either way the protocol was chosen, the next page is the Protocol Run view, which is explained in the next section.
Having selected a patient and relaxation protocol to run, you now see the Protocol Run view. It is initially obscured by a form for entering the patient's current condition. The first time you treat a patient, it is important to take 30 seconds and document the patient's current condition so that you may monitor and track the effectiveness of the sessions. Please enter this information and press the Submit button when ready.
On subsequent treatments for any patient, you will see that the condition and medication fields of this form are filled with your previous entries. Now, if you'd like to skip entering stiffness, pain, and quality-of-sleep ratings until later, perhaps to streamline operations on a busy day, you can click the Cancel button on this form. See section F, below, for details on how to enter treatment responses at a later time.
Whether you submit or cancel the form, it disappears and the protocol-run view behind it is revealed. You will see the patient's identification and the name of the protocol chosen above the protocol itself.
For one-hour protocols you will also see a time-scaling pull-down next to the protocol name. In the image below, the current selection is "60 Mins", which is the normal duration of the protocol. You can scale the protocol down to 45 minutes or up to 90 minutes. For half-our protocols your scaling options will be 20, 15, and 10 minutes.
Press the Start Protocol button to begin the session. 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 elapsed time. If the protocol has multiple steps, a bell sound is played between steps.
After a brief display of the above page, it will be replaced with a larger Session Timer graphic that allows the patient to see quickly how much time remains in the session and what step they are in. Also note that this window can be closed by clicking the close button on the timer and re-opened by clicking the show popup button indicated above.
Session Pause
Once the Pause button is pressed, a Resume button appears and the protocol can be resumed from the time it was paused.
If the protocol is paused for more than 20 minutes it will stop and resumption will not be allowed. The protocol can only be paused and resumed four times. Pressing the pause button a fifth time will cause the protocol to stop and resumption will not be allowed.
End of Session
When the protocol ends, a double-bell sound is played and a confirmation box appears. Press OK to confirm.
Stop Session
When the Stop button is pressed, a double-bell sound is played and a message box appears.
The treatment will be terminated and cannot be resumed. A confirmation message will appear informing the operator that the treatment was not completed:
If you submitted the initial session form, an end-of-session follow-up form is displayed when the protocol stops. This will happen whether the protocol ended naturally or was stopped with the Stop button. The follow-up form asks for the patient's stiffness and pain levels immediately after the relaxation session. Please take 30 seconds to gather and enter this information to help you in monitoring and tracking your patient's response to the relaxation sessions.
If you are not presented with this form because you cancelled the initial form, or if you want to submit this form now without entering numbers that you're sure about, you can enter or edit the information for this form later. See section F, below.
If you did not fill out the treatment response forms during treatment, or if you'd like to change the information you did enter, you can do so at any time for the last treatment only for any patient. To do this, follow the instructions in section C, above, to select an existing patient. You will now see that patient's session view. At the top of the page is the Protocol Decision Tree. Hide it or scroll down to the bottom to see the patients session history. You will notice that the top line of the history, which is the most recent treatment, is editable. Enter your information in the appropriate fields and click or tab out of any field for the changes to be saved.
Operators have very limited privileges in this area of the website. The following discussion pertains to Admin-level personnel.
From the Menu Bar at the top click the Admin button.
Click the Set Up Users button to create new, edit or delete other users for your location.
Other Admin functions include Set Up Device, which provides an On-Demand Self Test that exercises and confirms the attenuator printed circuit board and connections are operating properly. This is the same self test as that which is performed automatically when you log into the system.
Click the Start Self Test button to confirm that the system is operating correctly. After it is clicked, wait up to 70 seconds for a result. (You may notice a faint clicking sound coming from the attenuator.) You may also log out and log back in again to start the self test.
Other functions in this area include editing information associated with your Location.
From this area, Admin level personnel may edit most of the fields visible on the above page. Key areas include: location name (this is the name used in the Privacy Notice and Consent and Waiver of Liability documents that Patients will execute), the email contact (this is the person notified when the low minutes threshold is met), and the Threshold minutes (this determines when the "Low Minutes Remaining" warning is sent to Admin personnel, so that more minutes may be purchased so as to not interrupt Relaxation Treatment Sessions) .
An Admin-level user can also generate usage reports for his or her clinic.
After clicking the Reports button, you will see two calendars for selecting the start- and end-dates of the report. Clicking the Report button here will show you a usage report for the selected range of dates.
Purchasing Minutes for running Relaxation sessions is the final function associated with the Admin Area.
Our system provides a front end to Paypal so the information associated with credit cards is NOT retained by our web application and is secured through Paypal. This means that it will require Admin level personnel to input the specific information associated with the Credit Card each time minutes are purchased, but this process provides optimal security for your financial information.
Lastly, the Customer Hub button in the Admin page provides a link to a password-protected website for Magneceutical Health customers.
This website contains a number of resources that are primarily related to education, training, sales, and marketing. Customer Hub is constantly changing, so please visit us. Items typical of some of the areas we address:
Two kinds of errors might occur while you use the system. You may experience a connection failure between your PC and the Magnesphere™, or you may encounter an internal error in the web application server. In either case, we are automatically immediately notified about the problem.
If the operator PC fails to communicate with the Magnesphere™ at any time during testing or treatment, an alert is displayed and treatment is paused. If this happens:
1. Confirm that the PC is still connected to the internet and the signal is strong
2. Power down the attenuator and PC, and restart. Run the self test described in section 4 above or by logging out and logging back in again.
3. If this doesn't resolve your issues contact Magneceutical Health Customer Service.
If the web application encounters an internal processing error, an error page is displayed. The error page has a 'Home' button for you to click to resume operations by returning to your home screen. As we are notified about these errors immediately, be assured that we will find out the reason for the error and fix it in a reasonable time. Try to remember and write down what you were doing when you encountered the error. It might help us figure out what happened if our internal analysis raises questions.
The area in immediate proximity (5' or 1.5m) of the Magnesphere™ Coils must be kept clear of ferrous materials such as steel cabinets, etc., and EM sources such as computers, televisions, etc
| Facility Needs | Minimum Requirement | Recommended |
|---|---|---|
| Room Specification | 10' x 8' x 7' ceiling |
12' x 10' x 8x ceiling Door that can close Window Acoustical ceiling Carpet |
| Room Temperature |
65-75°F (18-24°C) |
72°F (22°C) Room temp control |
| AC Power |
1 outlet: 110V, 15A, 60Hz (230V, 15A, 50Hz) |
Power for optional TV, Stereo, etc. |
| Storage | None required in room | Small desk |
| Desk Space | None required in room | Small desk for computer/work area |
| Room Lighting | Adequate for patient to get in/out of chair | Dimmable to allow sleep/rest |
| Network Connections | Wireless connection | Wireless/Ethernet |
| Magnesphere™ Physical Specifications | |
|---|---|
| System Weight (without chair) | 150 lbs (68kg) |
| Chair Weight | 50 lbs (23kg) |
| Chair Maximum Capacity | 300 lbs (136kg) |
| System Dimensions |
7'2" (2.2m) x 4'1" (1.2m) x 6'4" (1.2m) High |
| Magnesphere™ Features and Performance Specifications | |
|---|---|
| Relaxation Protocol Power Level Range |
0.001µG to 500.0µG 0.01Hz to 300.0Hz |
| Coil Type | Modified Helmholtz coil |
| Relaxation Session Quality features | Automated Self Test |
| Relaxation Session Protocols | Proprietary Algorithms |
| Patient Comfort Features | Reclining, Orthopedic Chair |
| User Controls |
15" Color Laptop Computer Graphical User Interface |
| Data Security | Encrypted, Redundant, Secure Data Center |
| Room Requirements | See Section 6 Above |
| Regulatory Compliance |
ISO 13485:2003 (Design) ISO 9001:2008 (Manufacture) Certified by British Standards Institute (BSI) FDA 21 CFR 820 Canada Health (CSA) Standards |
| Safety Certifications | IEC 60601-1 |
The Magnesphere™ should be cleaned periodically with a mild non-abrasive detergent or cleaner and a soft cloth or paper towel. As necessary, the Magnesphere™ may be cleaned with isopropyl alcohol or a standard 0.25% Sodium Hypochlorite (bleach) solution.
To stay in compliance with the Manufacturer's Warranty obligations, the Orthopedic Recliner chair should be cleaned following the directions of the Manufacturer, as described in the materials delivered with the Chair.
Magnesphere™ periodic maintenance and calibration may be performed by, or at the direction of Magneceutical Health personnel.
[email protected]
611 Druid Rd. East, Suite 714
Clearwater, FL 33756
727.474.3722
Fax: 727.474.3738
www.magneceutical.com