Related Manuals for eNeura sTMS mini
Summary of Contents for eNeura sTMS mini
- Page 1 Instructions for Use sTMS mini Patient Manual Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
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Page 2: Table Of Contents
Delivering the Treatment ..........................14 Renewing Your Prescription ........................15 Replacing the Micro SIM Rx card ......................... 15 Additional Information .............................. 16 Caring For Your sTMS mini............................17 Understanding System Display Messages ......................... 18 Troubleshooting ................................ 19 Service ................................. 20 Return Goods Policy ............................ -
Page 3: Before You Begin
Call Customer Care if you don’t understand something in this manual. eNeura and your doctor are committed to helping you manage your migraine pain. The sTMS mini is a new, safe, non-drug therapy to treat migraine at the first sign of pain. -
Page 4: Intended Use
Intended Use The sTMS mini (The System) is indicated for the acute and prophylactic treatment of migraine headache. The System is designed for self-treatment and delivers a non-invasive, brief, single pulse of magnetic energy to the back of the head. - Page 5 Risk of electrical shock. Do not allow the System or power cords to get wet. Quickly wipe up spills on or near the sTMS mini. Do not use the System in or near water. For example, do not use while in the bathtub or shower, in the rain, or while standing in water or on a wet surface.
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Page 6: Contraindications
WARNING: Failure to follow the restrictions listed below could result in serious injury or death. The sTMS mini creates a very strong single-pulse magnetic field. The System has been prescribed by your doctor for your use only. The System may not be used in patients who have metals, conductive materials, or metal-containing implants in their head, neck or upper body. - Page 7 Keep the sTMS mini device at least 2 feet (0.6 meter) from these devices when it is powered on and in use. Keep credit cards, audio/video tapes, computers, computer disks, flash memory sticks, cell phones, personal digital assistants (PDAs), MP3 players, headphones, digital cameras, portable glucose meters and other electronic devices or electronic storage media more than 2 feet (0.6 meter) away from the...
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Page 8: Clinical Trial And Adverse Reactions
Clinical Trial and Adverse Reactions eNeura completed a clinical study in Headache Centers in the United States designed to support safety and effectiveness for use of the Spring TMS device, an earlier design of the sTMS mini, for the acute treatment and prophylaxis of migraine headache. Baseline medication and symptoms were recorded for 28 days via patient diary. -
Page 9: Getting To Know Your Device
Located on left side on the top of the System. Confirms a valid Micro SIM Rx card is installed and shows the status of the prescription programmed on the Micro SIM Rx card. Contact eNeura Customer Care Action required. Temperature warning The device temperature is not in range for safe use. - Page 10 – Located on the back of the System beneath the Accessory Door. Insert the micro SIM RX card into this port. Precaution: Use only eNeura-supplied accessories with your System: Battery charger (reorder no. DWG-0505) and Micro SIM Rx card.
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Page 11: Using Your Device
Setting Up the Device Be prepared to treat your migraine when needed. Set up your sTMS mini as soon as it arrives and keep your device charged and ready to treat. NOTE: Use only as directed. The device should only be used per the instructions of your physician who prescribed the System. -
Page 12: Preparing For Treatment
Preparing for Treatment To treat the symptoms of a migraine headache, use the sTMS mini at the first sign of migraine pain with aura. Consult your doctor about your specific condition and the best timing of your sTMS treatment. Precaution: Keep the System away from other electronic devices that depend-on (receive) or radiate (transmit) radio frequency energy, when it is powered on. - Page 13 WARNING: Stay at least 2 feet (0.6 meter) from others when using the sTMS mini. This device could be harmful to anyone with an electronic implant such as a pacemaker. Remove any personal medical devices such as insulin pumps, other medicinal pumps, bone growth stimulators, Transcutaneous Electrical Nerve Stimulator (TENS) devices and hearing aids.
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Page 14: Positioning The Device
Positioning the Device With the sTMS mini in front of you: The treatment buttons should be facing up and the accessory door should be facing away from you. Place your hands on the sides of the device with your thumbs on the treatment buttons. -
Page 15: Renewing Your Prescription
NOTE: The System is intended for use under the care of a doctor. For more information on renewing your prescription, please contact eNeura Customer Care. An active prescription is required. NOTE: The System only delivers sTMS treatments if the Micro SIM Rx card has been properly inserted and has not expired. -
Page 16: Additional Information
Your sTMS mini has rechargeable batteries. The battery capacity indicator on your device shows how much charge is remaining in the battery. eNeura recommends that you keep your device’s battery charged so that it is always ready when you need it. Typically, a fully charged battery can deliver 18 treatments. Your battery pack life is roughly a minimum of 100 charge cycles. -
Page 17: Caring For Your Stms Mini
Inspect your device regularly Before using your sTMS mini always check to make sure your device is in good working order. If you notice damage to the exterior of the device or rattling when you shake the device DO NOT USE the device and contact your eNeura representative for a replacement. -
Page 18: Understanding System Display Messages
Micro SIM Rx card, install it in your device. If you need a new Micro SIM Rx card, contact eNeura or your local Representative for assistance. An active prescription is required. eNeura can contact your physician if a renewal prescription is required. -
Page 19: Troubleshooting
The battery may be completely discharged. Plug in the battery charger to charge the battery for at least 15 minutes. Be sure that only the eNeura battery charger (DWG-0505) is being used. When you plug in the battery charger, the display should light. Check that the battery icon on the display is lit to indicate that the battery is charging. -
Page 20: Service
Please have your device available when calling eNeura Customer Care. When the System is no longer usable, return it to eNeura or your local Representative. Do not dispose of the device. For questions, contact eNeura or your local Representative for assistance. -
Page 21: Operating Environment
Storage Environment The sTMS mini may be stored at -40°C to 60°C (-40°F to 140°F) with a relative humidity of up to 90% non-condensing and an atmospheric pressure range of 700 hPa to 1060 hPa and storage altitude of less than or equal to 3000m. -
Page 22: Reach And Warning Statement
(including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the sTMS mini, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. However, there is no guarantee that interference will not occur in a particular installation. -
Page 23: Emc Guidance
EMC Guidance In accordance with Clause 4.3 of IEC 60601-1, the Essential Performance of the sTMS Mini is to not deliver a pulse above 0.95T. EMC interference from other equipment may disrupt normal operation of the sTMS Mini and may impede the delivery of the 0.9T magnetic pulse to the patient’s head. - Page 24 EMC Guidance (continued) Guidance and Manufacturer’s Declaration – Immunity The DWG-0500 is intended for use in the electromagnetic environment specified below. The customer or user of the DWG-0500 should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Electromagnetic Environment –...
- Page 25 RF communications equipment and the sTMS Mini The sTMS Mini is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the sTMS Mini can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the sTMS Mini as recommended below, according to the maximum output power of the communications equipment.
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Page 26: Glossary Of Abbreviations
Warning in European Community EMC non-ionizing Temperature limitation radiation Humidity limitation Smart Card status Power button On/Off Contact eNeura Customer Care Preparing for Treatment Treatment not allowed Lock switch enabled Ready for Treatment Rechargeable Battery capacity level AC Adapter connected... -
Page 27: Medical Device Reporting
Warranty and Limitation of Liability eNeura Inc. warrants that the product when delivered is free from defect in materials and workmanship and conforms to the manufacturer’s product specifications. eNeura shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from the use of, or inability to use, its product. - Page 28 Inc. The device and the method of use that comprise the eNeura sTMS mini are protected by U.S. Patents 6,402,678, 7,294,101, 7,494,458 and 7,601,116; by European Patents 1 307 260 B1 and 1 977 787 B1; and by Canadian Patent 2423840.
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