Dynatron Dynatronics ibox Operator's Manual

Iontophoresis system

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Dynatron® ibox™ Operator's Manual

Rev. 2

5/14/2019

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Summary of Contents for Dynatron Dynatronics ibox

Page 1 < < > >> table of contents prev topic next next topic symbols & labels limited warranty Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 2 & labels limited warranty OPERATOR’S MANUAL The Dynatron ibox , Iontophoresis System, is a non-invasive drug ® ™ delivery system designed as an alternative to hypodermic injections. Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 3 & labels limited warranty CAUTION IMPORTANT: Before treating a patient with the Dynatron Federal law restricts the Dynatron® ibox™ for sale by or on the order of a ® ibox ™ physician, chiropractor, physical therapist, or dentist licensed by the law of the read the entire Operator’s Manual paying specific attention to...
Page 4 Dynatron® ibox™ Operating Instructions . . . . . . . . . . . . . . . . . .
Page 5 . Warranty regis- tration must include the device serial numbers . The Dynatron ibox has the ability to set polarity, dosage, and intensity level while providing two delivery options: Single Phase (one drug) and...
Page 6 Case 1. POWER ON/OFF: The Dynatron ibox power is controlled by a key located at the bottom-left of the keypad and is shown by the international ON/OFF Selector Arrow Keys power symbol.
Page 7 40 mA-min. The (+) indicates that this treatment has a positive polarity. The Dynatron ibox power may be turned OFF before, during, or after Time: The remaining time for a treatment is displayed in standard a treatment.
Page 8 6. BATTERIES: Two 1.5 Volt AA Alkaline batteries are used to power the Dynatron ibox. They must be inserted into the battery compartment as shown with the correct orientation. Care Battery Compartment Cover...
Page 9 After depressing of this key, the parameter just modified will be captured and the next 9. CASE: The Dynatron ibox is enclosed in a plastic case. This case treatment parameter to be defined will be displayed. After all should not be opened by the user at any time. Clean the outer parameters have been entered, pressing the “Up Arrow”...
Page 10 11. ELECTRODE CABLE PLUG: The “plug-end” of the electrode cable The RETURN “clip-end” of the electrode cable is dark gray in color. is inserted into an Dynatron ibox channel jack connecting the device The clip attaches to the return electrode on the patient and may be output to the patient electrodes.
Page 11 Solutions: 1) Check that the electrode cable plugs are firmly inserted is less than 50 KOhms, the HIGH Z message will be displayed until the into the Dynatron ibox output jacks. resistance/impedance is lowered into the normal range. 2) Inspect the electrode cable wires for breaks or cracks.
Page 12 Following these beeps, and the outputs turned-off). the Dynatron ibox will no longer be operational (i.e. you may not setup a treatment or if a treatment is in progress, it will be discontinued).
Page 13 2) If a recurrent error, do not use the device for treatments. Contact Dynatronics for servicing of the device - (800) 874-6251. The Dynatron® ibox™ Iontophoresis Device Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 14 Carefully position the “active electrode” over the intended treatment site and firmly press it onto the site. Make sure that the edges of the electrode are firmly attached to the site. Dynatron® ibox™ Operating Instructions Dynatron® ibox™ Operator’s Manual Rev. 2...
Page 15 (current) of 0.5 until the display mA. The display to the right will be seen Default Treatment illuminates. The “Dynatron” logo will be by the user. displayed followed by the software version number as shown in the two illustrations.
Page 16 Dual Phase Pre-Launch Positive Polarity Negative Polarity Polarity In treatment pre-launch, the device awaits for the user to press either the up arrow key to start current delivery to the Dynatron® ibox™ Operating Instructions Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 17 40 Typical Dual comfortable maximum in order to shorten the total treatment time. mA-min has been delivered so far at the Phase Treatment Dynatron® ibox™ Operating Instructions Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 18 Treatment intensity (current) levels are not stored as part of default treatment parameters. Dynatron® ibox™ Operating Instructions Dynatron® ibox™ Operator’s Manual Rev. 2...
Page 19 Quick Reference: Single Phase Treatment Instructions Select Polarity Select Dose Pre-Launch During Treatment Completed Treatment (UP ARROW KEY) (UP/DOWN ARROW KEYS) (UP ARROW KEY (ENTER) (ENTER) OR ENTER) Dynatron® ibox™ Operating Instructions Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 20 Quick Reference: Dual Phase Treatment Instructions Select Polarity Select Dose Pre-Launch During Treatment Completed Treatment (UP ARROW KEY) (UP/DOWN ARROW KEYS) (UP ARROW KEY (ENTER) (ENTER) OR ENTER) Dynatron® ibox™ Operating Instructions Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 21 Iontophoresis is contraindicated for patients with Epilepsy. Previous Reactions to Electrotherapy The use of Iontophoresis is contraindicated for patients who have had previous reactions to any type of electrotherapy. Contraindications, Precautions, and Warnings Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 22 5. Use extreme caution when administering a treatment where sensory nerve damage is present or in any case where there is a loss of normal skin sensation; this includes areas desensitized by medication. Contraindications,Precautions, and Warnings Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 23 If electrode cables are damaged, they should be replaced immediately. Adverse Effects Skin irritation and burns beneath the electrodes have been reported with the use of iontophoresis. Contraindications,Precautions, and Warnings Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 24 Minimum Treatment Time: 15 sec. Maximum Treatment Time: 100 minutes If it is necessary to store the Dynatron ibox for an extended period Timing Accuracy: +/- 1 second (one month or more), remove the batteries and store the device in a cool, dry location.
Page 25 Electromagnetic Emissions and Immunity Tables 1 through 4 below list the Dynatron ibox’s declarations of electromagnetic emissions and immunity and give a user guidance on the use of the device in an electromagnetic environment per IEC 60601-1-2 guidelines.
Page 26 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Dynatron ibox is intended for use in the electromagnetic environment specified below. The customer or the user of the Dynatron ibox should assure that it is used in such an environment. Emissions test...
Page 27 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Dynatron ibox is used exceeds the applicable RF compliance level above, the Dynatron ibox should be observed to verify normal operation.
Page 28 Portable and Mobile RF Communications Equipment and the Dynatron ibox The Dynatron ibox is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Dynatron ibox can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Dynatron ibox as recommended below, according to the maximum power of the communications equipment.
Page 29 Long Period Non-Use of Batteries If the Dynatron ibox will not be used for a long period of time (more than one month), it is recommended that the batteries be removed from the battery compartment and stored for future use.
Page 30 Dynatronics’ removal of the battery compartment cover. There are no user Customer Service to obtain a return Service Order Number: serviceable parts inside the Dynatron ibox. The device should be returned to Dynatronics for repair. 1. User name and address 2.
Page 31 Cleaning Cleaning the Dynatron ibox Clean the outer surface of the Dynatron ibox with a slightly damp or lightly moistened cloth. Mild household cleaners work well on the frame, but do not use cleaners on the display window. Do not spray solutions directly on the device.
Page 32 Definitions accompany each symbol. Keep Dry Non-ionizing Electromagnetic Radiation Temperature Model Number Start/Continue Dynatronics Manufacturing Date Serial Number Type BF (patient-applied part) Serial Number Label Electrical Ratings Label Definition of Symbols and Labeling Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 33 Limited Warranty REGISTRATION REQUIRED . In order for this warranty to be valid, the DYNATRONICS CORPORATION warrants the Dynatron ibox (excluding other accessories that are purchased with the device) to be free from warranty registration page (included with the product) must be filled...
Page 34 TIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU . THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSO HAVE OTHER RIGHTS WHICH VARY FROM STATE TO STATE . Dynatron® ibox™Limited Warranty Dynatron® ibox™ Operator’s Manual Rev. 2 5/14/2019...
Page 35 Device Serial No. ____________ Device Model Number ________________ IMPORTANT: If there is anything about the operation or use of your Dynatron device that Practitioner/Contact Name __________________________________________ you do not understand, contact your dealer or Dynatronics for instruction. As a trained medical practitioner, you are solely responsible for determining appropriate application of this device for your patients.