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Dynatron® ibox™ Operator’s Manual

Rev. 2

5/14/2019

Contraindications, Precautions, and Warnings

Contraindications,

Precautions, and Warnings

Contraindications

Do not use Iontophoresis for patients with the following conditions:

Pacemakers / Electrically Sensitive Implanted Devices

This device is contraindicated for patients with pacemakers or electrically
sensitive implanted devices.

Cardiac Conditions

Patients with Dysrhythmia or where possible heart problems are suspected
should not receive iontophoresis treatments.

Malignancy

The use of Iontophoresis is contraindicated for patients with clinically
diagnosed cancer.

Epilepsy

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.

Previous Adverse Reactions Iontophoresis Drugs

The use of Iontophoresis is contraindicated for patients who have had
adverse reactions to selected drugs.

Pregnancy

Iontophoresis is contraindicated during pregnancy as the safety of
electrical stimulation during pregnancy has not been established.

Abnormal Skin Conditions / Skin Lesions

Iontophoresis is contraindicated over areas of abnormal skin conditions
including lesions, lacerations, or abrasions.

Содержание Dynatronics ibox

Страница 1: ...1 Dynatron ibox Operator s Manual Rev 2 5 14 2019 table of contents symbols labels limited warranty next prev topic next topic ...

Страница 2: ... 5 14 2019 table of contents symbols labels limited warranty prev next prev topic next topic OPERATOR S MANUAL The Dynatron ibox Iontophoresis System is a non invasive drug delivery system designed as an alternative to hypodermic injections ...

Страница 3: ...lectrical Shock Hazard Contact with other sources of electricity may pose a risk of electric shock Do not connect this deice to any source of electricity IMPORTANT Before treating a patient with the Dynatron ibox read the entire Operator s Manual paying specific attention to Contraindications Warnings and Precautions COMPLIANCE The contents of this Instructions For Use manual are exactly the same ...

Страница 4: ...s 16 Quick Reference Single Phase Treatment Instructions 19 Quick Reference Dual Phase Treatment Instructions 20 Contraindications Precautions and Warnings 21 Contraindications 21 Warnings 22 Precautions 23 Adverse Effects 23 Technical Information 24 Outputs 24 Treatment Timing 24 Dimensions 24 Environmental Conditions 24 Electromagnetic Emissions and Immunity 25 Batteries 29 Maintenance and Repai...

Страница 5: ...carrier and take any steps necessary to file a claim for the damage sustained If possible use the original shipping carton if the device must be shipped for any reason Improper packaging of the device during transport can result in damage and will invalidate the warranty Complete the warranty registration form and return it to Dynatronics within 30 days of purchase This is to insure that you are n...

Страница 6: ...om left of the keypad and is shown by the international ON OFF power symbol Power ON Press and hold the symbol until a beep is heard and the display illuminates When first powered on the Dynatron ibox logo will be displayed followed by the software version number The initial screen displayed after power on allows the user to choose between a default treatment or a custom treatment Power OFF Press ...

Страница 7: ... milliampere minutes mA min and is followed by a or sign to indicate the polarity of the treatment Below is an example of a dose ratio displayed during a treatment 6 40 This figure indicates that 6 mA min of dose has been delivered and that the total target dose for the treatment is 40 mA min The indicates that this treatment has a positive polarity Time The remaining time for a treatment is displ...

Страница 8: ...n of this manual for additional information on the Dynatron ibox batteries 5 OUTPUT JACK The output jack allows for connection of the electrode cable The jack only accepts an authorized Dynatron ibox electrode cable The electrode cable plug is keyed so that it must be orientated properly before insertion into the jack 6 BATTERIES Two 1 5 Volt AA Alkaline batteries are used to power the Dynatron ib...

Страница 9: ...user to be captured as part of a treatment setup After depressing of this key the parameter just modified will be captured and the next treatment parameter to be defined will be displayed After all parameters have been entered pressing the Up Arrow key starts the treatment An enter key is not used during a treatment However depression of an enter key when not delivering a treatment will cause the ...

Страница 10: ...ut to the patient electrodes 12 ACTIVE ELECTRODE CLIP The ACTIVE clip end of the electrode cable is light gray The clip attaches to the active electrode on the patient and may be squeezed in order to attach to the electrode more easily or it can be pushed onto the electrode without squeezing 13 RETURN ELECTRODE CLIP The RETURN clip end of the electrode cable is dark gray in color The clip attaches...

Страница 11: ...es anywhere along the path of the wires including the electrodes clips and plugs Solutions 1 Check that the electrodes are not touching each other on the patient 2 Check that the electrode clips are not touching each other 3 Carefully inspect the entire electrode cable for any shorted wires caused by breaks in the wire Replace the electrode cable if any break or damage is found The treatment conti...

Страница 12: ...during a treatment the battery voltage is less than 2 1 Volts During display of this message eight long beeps will be generated by the internal speaker Following these beeps 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 Solutions 1 If message occurs with power on replace both batteries and retry powering o...

Страница 13: ... not shut down due to the over current condition MSP430 ERROR This error message is displayed if the internal mi crocontroller circuit encounters difficulty controlling the device If this condition occurs any treatments in progress will be discontinued and the outputs turned off Although this is a rare condition if it is recurrent the user should not use the device for any further treatments and D...

Страница 14: ...annel output jack located at the top of the device The plug end of the cable is keyed and must be oriented appropriately before it can be inserted into the jack Do not force the plug into the jack 3 Prepare the electrode sites on the patient Use an alcohol preparation pad to gently remove any dirt and or oils at the site of the intended electrode placement on the patient Make sure that the area pr...

Страница 15: ...edefined treatment or a custom treatment Default Treatments Default Treatments are commonly used treatment setups that have been previously stored by the user from prior treatments or manufac turer s settings Default treatments allow for rapid treatment setups without having to enter treatment polarities modes and doses These treatments are stored inside the device s microcontroller and are not af...

Страница 16: ...pt this polarity mode 12 Enter a custom dose s For a single phase treatment use the up and down arrow keys to adjust the dose of the treatment to the desired amount The dose can be adjusted from 1 to 160 mA min Holding down an up or down arrow key accelerates the dose value up or down so that the user does not have to press a key for each increment of dose When the desired dose is finally chosen p...

Страница 17: ...fifteen seconds At the completion of a single phase treatment the intensity current will be automatically ramped down by the device to 0 mA over a period of about ten seconds At this time the device will generate four beeps followed by two beeps to signal the end of the treatment Dual Phase The display shown on the right is a typical display of a dual phase treatment currently occurring and shows ...

Страница 18: ...the memory of the device s microcontrol ler for use as Default Treatments in the future This allows the user to recall and start a commonly used treatment on a channel without having to enter the treatment parameters To store a channel s default treatment the user must wait for a treatment to complete The user then presses the up arrow key The display below will be seen by the user If the user pre...

Страница 19: ...ctions table of contents symbols labels limited warranty prev next prev topic next topic Quick Reference Single Phase Treatment Instructions Select Dose UP DOWN ARROW KEYS ENTER During Treatment Select Polarity UP ARROW KEY ENTER Pre Launch UP ARROW KEY OR ENTER Completed Treatment ...

Страница 20: ...uctions table of contents symbols labels limited warranty prev next prev topic next topic Quick Reference Dual Phase Treatment Instructions Select Dose UP DOWN ARROW KEYS ENTER During Treatment Select Polarity UP ARROW KEY ENTER Pre Launch UP ARROW KEY OR ENTER Completed Treatment ...

Страница 21: ...s treatments Malignancy The use of Iontophoresis is contraindicated for patients with clinically diagnosed cancer Epilepsy 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 Previous Adverse Reactions Iontophoresis Drugs The use of Ion...

Страница 22: ...reatment and consult the prescribing physician 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 WARNING A transient skin reaction can sometimes occur directly under an electrode This reaction is identified by a uniform red pattern and will usually d...

Страница 23: ...soap is recommended Do not immerse the device in water or use cleaning sprays Do not attempt to sterilize the device using any type of sterilization equipment including autoclaves 5 Damaged electrode cables Avoid stretching cables to full length bending cables sharply or wrapping cables tightly Undue stress on cables can damage connections If electrode cables are damaged they should be replaced im...

Страница 24: ...Treatment Deliverable Dose 1 160 mA min Number of 40 mA min Treatments 89 Minimum Treatment Time 15 sec Maximum Treatment Time 100 minutes Timing Accuracy 1 second Dimensions Length 4 5 Width 2 66 Height 1 25 Weight 3 6 oz without battery or electrode cable Display Organic Light Emitting Diodes OLED Environmental Conditions Transport and Storage a Ambient temperature range 10C 50C b Relative humid...

Страница 25: ...ent specified below The customer or the user of the Dynatron ibox should assure that it is used in such an environment Emissions test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 EN55011 Group 1 The Dynatron ibox RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF em...

Страница 26: ... power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Not Applicable Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 7...

Страница 27: ... RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Conducted RF IEC 61000 4 6 Radiated RF EN55011 Not Applicable 3 V m 80 MHz to 2 5 GHz Not Applicable 3 V m NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 Thes...

Страница 28: ... communications equipment Separation distance according to frequency of transmitter W Separation distance according to frequency of transmitter 150 kHz to 80 MHz d 1 17 x P 80 MHz to 800 MHz d 1 17 x P 800 MHz to 2 5 GHz d 2 33 x P 0 01 0 12 0 12 0 23 0 01 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters at a maximum output power listed above the recommended separation dis...

Страница 29: ...ccur with older batteries that drain quickly during a treatment 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 Replacing the Battery 1 Remove the battery compartment cover located on the back of the device by sliding the cover ...

Страница 30: ...w the device to be properly tracked through the repair process and returned to you as quickly as possible Returning a Device for Repair If it becomes necessary to return the device during the warranty period the following information must be supplied when calling Dynatronics Customer Service to obtain a return Service Order Number 1 User name and address 2 User phone number 3 Serial number of the ...

Страница 31: ... and then wipe the device off Solvents caustic solutions and harsh or abrasive cleaners must never be used Cleaning the Battery Contacts Battery contacts may be cleaned with a cotton swap lightly dampened with isopropyl alcohol Never use sandpaper or other abrasive material Cleaning the Electrode Cables Periodically clean the electrode cables with a damp cloth and mild soap Gently wipe the cable d...

Страница 32: ...of the following symbols are included in the labeling for this device Definitions accompany each symbol Warning Caution On Off power connection to the mains Read the Instructions Follow Instructions for Use Keep Dry Non ionizing Electromagnetic Radiation Temperature Model Number Start Continue Dynatronics Manufacturing Date Serial Number Type BF patient applied part REF Electrical Ratings Label Se...

Страница 33: ...ONSTITUTE THE SOLE AND EXCLUSIVE REMEDY IN THE EVENT OF A BREACH OF WARRANTY REGISTRATION REQUIRED In order for this warranty to be valid the warranty registration page included with the product must be filled out and returned to DYNATRONICS within 30 days of purchase by the original owner A copy of an invoice or receipt may be requested to verify purchase date REPAIRS All repairs must be performe...

Страница 34: ...covered by this limited warranty ANY IMPLIED WARRANTIES COVERING THIS PRODUCT INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ARE LIMITED IN DURATION TO ONE YEAR FROM THE DATE OF PURCHASE BY THE ORIGINAL OWNER DYNATRONICS SHALL NOT IN ANY CASE BE LIABLE FOR SPECIAL INCIDENTAL CONSEQUENTIAL INDIRECT OR OTHER SIMILAR DAMAGES ARISING FROM BREACH OF WARRA...

Страница 35: ...________________________________________________________ City_________________________ State_____________ Zip_________________ Dynatronics Dealer__________________________________________________ Salesperson________________________________________________________ I have read and understand the information contained in the operator s manual for this device I have received inservice training from my...

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