Ampa One — Frequently Asked Questions

Executive Summary

Ampa One is a transcranial magnetic stimulation (TMS) system cleared by the FDA for the treatment of Major Depressive Disorder in adult patients. This page answers the operational questions clinic staff ask most often when running the system day to day.

• Section 1 covers the FDA clearance and intended use, and Section 2 lists absolute contraindications and precautions before you screen a patient.
• Sections 3 through 6 walk through system components, hardware setup, cap fitting, and motor threshold mapping.
• Sections 7 through 12 address prescription libraries, treatment delivery, the Magic Arm, user roles, data export, and routine safety checks.
• Section 13 points you to third-party TMS education and insurance guidance.

Each summary bullet points to a section below. Full operational detail lives in the numbered sections, not here.

1. Regulatory Status & Intended Use

What is Ampa One cleared for?

Ampa One is cleared by the FDA for the treatment of Major Depressive Disorder in adult patients. The clearance covers treatment of MDD in patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Ampa One delivers repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex as its therapeutic target.

Which patients qualify for treatment?

The indication applies to adults aged 18 and older who carry a diagnosis of MDD and meet the treatment-resistance criteria in the labeling. Ampa One is not cleared for pediatric use, and it is not cleared for conditions outside MDD. A qualified physician makes the treatment decision for each patient based on that diagnosis and the patient's medication history.

Where do I find the full indication language?

Consult the Instructions for Use (IFU) and device labeling shipped with your Ampa One system for the complete, controlling indication statement. The IFU governs any clinical or regulatory question about intended use, and it takes precedence over any summary on this page. Prescribing physicians should review the full labeling before screening or treating a patient, since the exact diagnostic and treatment-history criteria matter for both clinical eligibility and reimbursement.

2. Safety & Contraindications

Screen every patient against the contraindications below before scheduling any session. Ampa One delivers repetitive magnetic pulses to the prefrontal cortex, and the same magnetic field that stimulates neural tissue can heat or displace ferromagnetic material near the coil. The device must not be used when a patient carries conductive, magnetic, or electronic implants in or near the head.

Which conditions rule a patient out entirely?

Do not treat a patient with any of the following absolute contraindications.

• Conductive, ferromagnetic, or magnetic-sensitive implants within 30 cm of the treatment coil, including aneurysm clips, stents, cochlear implants, and implanted stimulators or electrodes.
• Cardiac pacemakers, implantable cardioverter-defibrillators, or other active implanted devices whose function the pulse could disrupt.
• Metallic fragments or objects in the head or eyes.
• A history of seizure or a diagnosed seizure disorder, since rTMS can lower the seizure threshold.

Which patients need extra caution rather than exclusion?

Several conditions raise risk without being absolute bars, and each requires physician review before treatment.

• Medications or substances that lower the seizure threshold, such as certain antidepressants, stimulants, or recent alcohol withdrawal.
• A history of head injury, stroke, or neurosurgery.
• Pregnancy, where the treating physician weighs benefit against limited safety data.
• Sleep deprivation or acute intoxication on the day of treatment.

Document the physician's decision for any patient who falls into the precaution list, and confirm current medication status at each visit rather than at intake alone.

What adverse events should staff expect and watch for?

Seizure is the most serious adverse event, and it is rare. It typically occurs during stimulation, so a trained operator must remain present for the full session and know how to stop treatment and manage a convulsive event. Report any seizure through your clinic's adverse-event procedure and the device's reporting channel.

Syncope occurs more often than seizure and is usually a vasovagal response to the setting rather than the stimulation itself. Seat patients securely and monitor for lightheadedness, especially during the first few sessions.

Scalp discomfort and headache at or near the treatment site are the most common complaints. Most patients report that discomfort eases over the first week as they adjust. Persistent or worsening pain warrants a check of coil position and stimulation intensity, and a physician review if it continues.

Consult the Instructions for Use for the complete contraindication and warning language before screening.

3. System Components

A new technician should be able to identify five core parts of Ampa One before touching a patient. Each part has a distinct role in delivering and controlling a treatment session.

• Treatment coil. Delivers the magnetic pulses to the targeted cortical region. Held in position over the patient's head during stimulation.
• Control unit. Houses the pulse generator and the operator interface. You set intensity, select the prescription, and start or stop treatment from here.
• Neuronavigation cap. Fits over the patient's head and provides the reference points that keep coil placement consistent across sessions. Correct sizing determines targeting accuracy.
• Magic Arm. Mechanical support arm that holds the coil steady once positioned, so the technician does not maintain manual pressure through a full session.
• Chair and positioning hardware. Seats and stabilizes the patient at a fixed height and angle, keeping the head in a repeatable position relative to the coil.

Familiarize yourself with how the coil connects to the control unit and how the Magic Arm mounts to the chair, since those two connections are checked before every session. The neuronavigation cap and its sizing are covered in Section 5, and the Magic Arm adjustment and lock procedure appears in Section 9.

4. Hardware Setup & Troubleshooting

What should I expect during first-time setup?

Ampa One powers on through the control unit, runs a self-test, and confirms the coil, cap, and Magic Arm connections before it will allow treatment. The self-test takes about a minute. During that window, the system checks coil temperature, capacitor charge, and cable integrity. Do not begin motor threshold mapping until the status indicator confirms a ready state. If any connection is loose, the system holds in a fault state and identifies the affected component on screen.

What do the LED and status indicators mean?

The status LED on the control unit reports the system's operating condition through color and pattern. Match the indicator to the table below and take the listed action before proceeding.

What are the most common setup failures and how do I fix them?

Most setup problems trace to one of three causes, and each has a direct fix.

• Coil not detected (blinking amber). Reseat the coil cable at the control unit. A partially inserted connector is the usual cause.
• Overheat hold (solid amber). The coil exceeded its temperature limit during a prior session. Wait for the indicator to return to green rather than restarting the system.
• Cap or navigation not recognized (blinking amber). Confirm the cap cable is connected and the correct cap size is selected in software.

If a solid or blinking red indicator persists after a restart, stop using the device and contact Ampa support.

5. Neuronavigation Cap & Positioning

The neuronavigation cap holds the coil in a fixed relationship to the patient's scalp, so a poorly fitted cap moves the target and degrades every treatment that follows. Ampa One ships in multiple sizes, and you select the size from the patient's head circumference measured at the widest point above the brow and ears.

How do I choose the correct cap size?

Measure the head circumference with a soft tape, then match the measurement to the sizing table below. When a measurement falls on a boundary, fit both adjacent sizes and keep the one that sits flush without gaps or pressure points.

How do I confirm the cap is seated correctly?

Center the cap so the front reference marker sits at the nasion and the midline runs straight over the vertex. Check that the ear anchor points align symmetrically on both sides, since a cap rotated even slightly shifts the mapped target off the intended cortical site. Tighten the straps until the cap resists gentle side-to-side movement, then confirm no fabric bunches under the coil path.

How is positioning verified before treatment begins?

Ampa One registers the cap's reference markers to the patient's head model, and the system displays the coil position relative to the treatment target on screen. Do not start a session until the on-screen position indicator reports the coil within the accepted tolerance for the prescribed target. If the patient shifts in the chair, re-verify the registration before resuming, because a moved head invalidates the earlier alignment. Record the cap size in the patient record so subsequent sessions start from the same fit.

6. Motor Threshold Mapping

How does Ampa One determine the resting motor threshold?

Ampa One establishes the resting motor threshold (MT) by delivering single pulses over the primary motor cortex and recording the response that moves the patient's thumb or hand. You position the coil over the motor hotspot, deliver test pulses at increasing intensity, and identify the lowest stimulator output that produces a visible muscle twitch on the majority of trials. The system records that percentage as the patient's MT baseline.

What does the mapping workflow look like step by step?

The software guides the technician through a fixed sequence:

• Fit and verify the neuronavigation cap so targeting stays accurate during mapping.
• Position the coil over the estimated motor hotspot on the contralateral side to the target treatment area.
• Deliver single pulses and adjust coil position until you find the site that produces the strongest, most consistent thumb or finger movement.
• Step the intensity down until the twitch appears on roughly half of the pulses, and confirm that value.
• Save the recorded MT to the patient's record before building any prescription.

Why does MT need to be re-checked?

The MT reflects each patient's individual cortical excitability, which changes over time and with coil placement, so a stale value produces incorrect dosing. Re-map the MT in three situations: for every new patient before their first treatment; after a significant gap in the treatment course, because excitability and medication status shift; and whenever the coil position or cap fit changes materially between sessions.

How does MT affect subsequent dosing?

Ampa One calculates treatment intensity as a percentage of the recorded MT, so the MT sets the reference point for every pulse the patient receives. A prescription written at 120 percent of MT delivers a different absolute stimulator output for each patient because their thresholds differ. An inaccurate MT therefore under-doses or over-doses the patient across the entire course, which is why the recorded value must reflect the current session's mapping.

7. Prescription Management and Libraries

How are treatment protocols created and stored on Ampa One?

Ampa One stores treatment protocols in a shared protocol library on the control unit. A protocol defines the stimulation parameters for a course of treatment, including frequency, pulse train duration, inter-train interval, and total pulses per session. Once a physician builds and saves a protocol, it becomes available for reuse across any patient in the system, so your clinic does not rebuild the same depression protocol for each new case.

Who can create a protocol versus apply it to a patient?

The system separates protocol authorship from protocol application by user role.

• Physicians create, edit, and delete protocols in the library, and they write the individual prescription that links a protocol to a specific patient.
• Technicians apply an existing prescription and deliver the assigned protocol, but they cannot alter stimulation parameters or author new protocols.

That separation keeps clinical dosing decisions with the prescribing physician while allowing trained technicians to run daily sessions.

What prevents the wrong protocol from being applied to a patient?

Ampa One ties each prescription to a single patient record, and the system loads only that patient's prescribed protocol when their session begins. Before stimulation starts, the interface displays the patient identifier, the assigned protocol name, and the intensity derived from the patient's motor threshold for confirmation. If the motor threshold on file is missing or expired, the system blocks treatment until a physician resolves it. These checks stop a technician from delivering another patient's parameters or an unverified dose.

8. Treatment Delivery

How do I start a treatment session?

Confirm the patient's identity and the prescription assigned to them before you begin. Ampa One displays the selected protocol, the motor threshold value, and the treatment intensity on the session screen. Verify the coil is locked in position over the target and that the patient is seated comfortably, then start delivery from the control screen. The system will not begin until it confirms coil contact and a valid prescription.

Pausing and resuming a session

Use the pause control on the session screen to hold delivery at any point, and Ampa One retains the pulse count so the session resumes at the correct place. Pause the session whenever the patient needs to adjust position, take a break, or report discomfort. Resume only after you have reconfirmed coil placement.

What should I watch during a session?

Monitor the patient for signs of syncope, unusual facial or hand twitching, and any report of escalating scalp pain or headache. Watch the session screen for the running pulse count, elapsed time, and any error or contact-loss indicator. Stay within reach of the emergency stop for the full session.

A patient reports an adverse event mid-treatment. What do I do?

Stop delivery immediately using the stop control or emergency stop, then attend to the patient. Do not resume until a physician has assessed the event and cleared continuation. Document the event in the patient's record and follow your clinic's adverse event reporting procedure. If the patient shows signs of a seizure, follow your emergency protocol and do not restart treatment.

How is session data logged?

Ampa One records each session as it proceeds, capturing the protocol delivered, pulse count, intensity, and start and stop times. Completed and interrupted sessions are both logged, so a paused or aborted session appears in the record with its actual delivered dose.

9. Magic Arm

The Magic Arm holds the treatment coil in a fixed position against the patient's head throughout a session. It replaces manual coil holding, so the coil stays on the mapped target without operator drift.

How do I adjust and lock it?

The Magic Arm uses a single central tension lever that loosens every joint at once. Loosen the lever, position the coil against the target site on the cap, then tighten the lever fully until all joints hold firm.

Confirm the lock before every session. Apply light pressure to the coil head after tightening. If any joint shifts, the arm is not locked. Retighten the central lever and re-check until the coil holds position under pressure.

What should I inspect on the Magic Arm?

Check the arm for loosening between patients. A joint that will not hold firm under a fully tightened lever indicates a worn tension mechanism, and you should remove the arm from service and request maintenance. Section 12 covers the full inspection schedule.

10. User Roles, Access & Accounts

Ampa One assigns permissions by role, so each staff member can perform only the actions their clinical function requires. A practice administrator who understands these boundaries can set up new users correctly and avoid access errors that interrupt care.

Which roles does Ampa One support, and what can each one do?

The system defines three primary roles.

• Administrator. Creates and deactivates user accounts, assigns roles, manages system-level settings, and oversees data export. An administrator does not prescribe treatment protocols.
• Physician. Creates and approves patient prescriptions, sets motor threshold and dosing parameters, and reviews treatment records. A physician can also perform any technician action.
• Technician. Fits the cap, runs motor threshold mapping, and delivers treatment sessions under a physician-approved prescription. A technician cannot create or modify a prescription.

One person may hold more than one role where local licensure and clinic policy permit, though the physician role should stay restricted to credentialed prescribers.

How are accounts created and deactivated?

Only an administrator creates accounts. Each new user receives an individual login tied to a single named person, since shared credentials break the audit trail that links every action to an identifiable operator. Assign the narrowest role that lets the person do their job.

Deactivate an account immediately when a staff member leaves or changes function. Ampa One disables the login while preserving the historical record of that user's prior actions, so past sessions and prescriptions remain traceable. Do not delete an account to remove access. Deactivation keeps the record intact.

11. Data Export

How do we get treatment and session data out of Ampa One for our records or EHR?

Ampa One exports patient and treatment session data through the system's reporting interface. You can generate per-patient treatment summaries and session-level records that document motor threshold, prescription applied, intensity, pulse counts, and completion status for each visit.

Supported formats cover PDF for printed or filed clinical records and structured data files (CSV) for import into a practice management system or EHR. Confirm your EHR's intake format before your first export, since direct integration depends on the receiving system rather than on Ampa One alone.

Export permissions follow user roles. Administrators and physicians can export full patient and treatment data. Technicians can generate session summaries for the patients they treat but do not have unrestricted export of the full patient record. Verify each user's assigned role in Section 10 before granting export access.

Every export leaves an audit-trail entry recording who exported which data and when. Retain exported records according to your clinic's medical-record retention policy and applicable regulation, since the exported file becomes part of the patient's clinical documentation once it leaves the device. Do not treat an export as a substitute for the data retained on the system itself.

12. Maintenance & Safety Checks

What routine checks keep Ampa One safe and within spec?

Run a short set of checks before the first treatment each day, and repeat any check after moving or reconnecting the system. Daily verification confirms the device is safe to operate and that targeting will stay accurate through the session.

Before the first patient each day, confirm the following:

• The control unit powers on and shows a normal status LED. Compare any abnormal color or pattern against the LED indicator table in Section 4.
• The coil cable and connectors seat fully with no visible wear, kinks, or exposed conductor.
• The Magic Arm locks firmly at each joint and holds coil position without drift.
• The neuronavigation cap and any tracking markers are clean, intact, and correctly seated.
• The patient chair and positioning hardware move and lock as expected.

Periodic checks extend this list. Inspect the coil surface for cracks or heat damage on a schedule set in your device labeling, and record coil pulse counts so you can track service intervals. Clean the cap and contact surfaces between patients per the cleaning instructions in the IFU.

Fix simple issues yourself. A loose connector, an unlocked arm joint, or a status LED that clears after a reseat are user-correctable. Reconnect, relock, and reverify, then continue.

Contact Ampa service when a fault persists. Book a service call for a coil that shows physical damage, an error LED that does not clear after a restart, repeated failed self-tests, or any behavior that does not match the LED indicator table. Do not treat patients on a system showing an unresolved fault.

13. Educational Resources & Insurance Questions

Where should patients and clinics go for broader TMS background?

This page covers Ampa One operations, not general TMS science or treatment planning. For broader clinical background, point patients and referring providers to professional societies such as the Clinical TMS Society and the American Psychiatric Association, along with patient education material from established mental health organizations. These bodies publish vetted overviews of how TMS works, what a treatment course involves, and typical outcomes for Major Depressive Disorder.

Direct patients seeking device-specific instructions back to the numbered sections above or to the official Ampa One labeling and instructions for use.

Where do insurance and coverage questions go?

Handle insurance and coverage questions through your clinic's own billing and coverage guidance, not through this page. Coverage rules for TMS vary by payer, plan, and region, and only your billing staff can confirm what applies to a given patient. Ampa One documentation does not determine reimbursement. Big Leap Health is a useful resource for navigating insurance questions specific to TMS.

Have front-desk and billing staff maintain current payer requirements, prior-authorization steps, and appeal procedures, and route patient coverage questions to that team rather than to clinical operators.