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Classic
SwallowStim
User Manual
PRESCRIPTION INFORMATION:
Please read the following prescription
carefully before using your NMES unit.
If you have any questions regarding
this information, consult your health
care professional before using.
Part#20752 October 2019 Rev. A
CAUTION: Federal Law restricts this device
to sale by, or on the order of, a practitioner
licensed by the state in which he or she
practices to use or order the use of the device.
™
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Table of Contents
Related Manuals for Spectramed Classic SwallowStim
Summary of Contents for Spectramed Classic SwallowStim
- Page 1 Classic ™ SwallowStim User Manual PRESCRIPTION INFORMATION: Please read the following prescription carefully before using your NMES unit. If you have any questions regarding this information, consult your health care professional before using. Part#20752 October 2019 Rev. A CAUTION: Federal Law restricts this device to sale by, or on the order of, a practitioner licensed by the state in which he or she practices to use or order the use of the device.
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Page 2: Table Of Contents
Read carefully and understand fully before using the Classic SwallowStim device Device Legend ......12 Display Legend . -
Page 3: Warnings
• Where sensory nerve damage is present eruptions, e.g., phlebitis, thrombophlebi cerebrally by a loss of normal skin sensation 14. Do not use the Classic SwallowStim tis, varicose veins, etc. Neuromuscular Electrical Stimulation 2. Some patients may experience skin 10. Stimulation should be stopped if... -
Page 4: Adverse Reactions
General Information Guide Indicated for use: Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Adverse Reactions *IMPORTANT ADVISORY* » Skin irritation and burns beneath the stimulation CAUTION: Federal law restricts this device to sale by, or on the order of a licensed physician. This device should only be used under electrodes have been reported with the use of powered medical supervision for adjunctive therapy and for the treatment of medical diseases and conditions. -
Page 5: General Information
General Information Guide The Classic is manufactured in the USA The Classic SwallowStim Instructions For Use (also called IFU) is comprised of instruction guides ™ on varied topics, Device features such as getting started, maintaining the device in good working order, or if the need arises, troubleshooting and receiving warranty service. -
Page 6: Getting Started
Getting Started General Information Guide * SAFETY AND ADVISORY NOTICES * Read all instructions, warnings Protect this device from direct NMES and precautions (including these exposure to the sun. 021 015 notices) before using this device in a therapy. REMAIN STOP —... -
Page 7: Device Legend
Getting Started Classic SwallowStim — Device Legend Classic SwallowStim — Display Legend The LCD is backlight illuminated for user convenience. The backlight only stays illuminated for a few seconds to conserve battery power. During a therapy the backlight can be turned on by... - Page 8 Getting Started Simple Steps to Starting Your First Therapy Step 1 Step 2 Step 3 Step 4 Insert Batteries Connect Lead Wires to Device Connect Lead Wires to Electrodes Determine Electrode Placement Remove the battery door and insert (4) AA Connect each patient lead wire to the output Connect the patient lead wires to the electrodes Refer to Electrode Placement Section for...
- Page 9 Getting Started Simple Steps to Starting Your First Therapy Step 5 Step 6 Step 7 Step 8 Applying the Electrodes Power On the Device Attach Increase Therapy Output Prior to applying the electrodes, properly Power on the device by pressing the Power Attach lead wire clip to patient.
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Page 10: Specification
Technical Information Guide Classic SwallowStim Device — Specifications Classic SwallowStim Device — Batteries Battery Size and Voltage Battery Disposal SPECIFICATIONS The battery size is AA (also known internationally Alkaline batteries are safe to dispose of along as LR6). The voltage varies depending on the with household trash. -
Page 11: Miscellaneous
Electromagnetic Immunity The Device Service Life is unlimited. The This is the aggregate term for characteristics The Classic SwallowStim has been tested in the Device Service Life is not the same as the of an electrical device that determine its USA by a National Laboratory while in normal device Warranty. -
Page 12: Device Ownership Guide
Device Ownership Guide Care and Handling of Your Device, COMPLAINT POTENTIAL CAUSE / POTENTIAL SOLUTION Troubleshooting and Device Warranty Device does not power on Remove and reinsert batteries carefully observing battery polarity Insert fresh batteries Cleaning Your Device Customer Service »... -
Page 13: Warranty
Service Processor. of the programs when I turn it on The resolution of any Warranty Claim will be at the sole discretion of Spectramed, and is limited to repair or replacement of the Device. Spectramed, assumes no responsibility for incidental, direct, consequential or compensatory loss or damage related to an accepted Warranty Claim. -
Page 14: Notes
Notes Draft Part# 20752 Rev. Print Date xx/xx/xxxx Draft Part# 20752 Rev. Print Date xx/xx/xxxx... - Page 15 Notes Draft Part# 20752 Rev. Print Date xx/xx/xxxx Draft Part# 20752 Rev. Print Date xx/xx/xxxx...
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Page 16: Part Numbers For Reorder
Classic SwallowStim Device — Part numbers for re-order PART DESCRIPTION PART DESCRIPTION PART DESCRIPTION PART DESCRIPTION NUMBER NUMBER NUMBER NUMBER 05A150-10 10 pks .6875” mini-snap electrodes w/butterfly 05A156-10 10 pks 1.0” wired electrodes Hydroblue 05A163-30 30 pks .875 wired electrodes *TH1183BC-10 10 pks .875”... -
Page 17: Declarations Of Conformity
The Classic SwallowStim electrotherapy system is intended for use in the electromagnetic environment specified below. The customer or the user of the Classic SwallowStim system should assure that it is used in such an below. The customer or the user of the Classic SwallowStim system should assure that it is used in such an environment. - Page 18 FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Classic SwallowStim electrotherapy system is used exceeds the applicable RF compliance level above, the Classic SwallowStim should be observed to verify normal operation.
- Page 19 1601 Eastgate Pkwy Columbus, Ohio 43230 1-800-643-1917 www.spectramedonline.com...
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