Controller - Instructions For Use
READ THE HYBRESIS PATCH AND CHARGING STATION
INSTRUCTIONS FOR USE FOR ADDITIONAL IMPORTANT
INFORMATION.
REF: 199587
Page 1: ...Controller Instructions For Use READ THE HYBRESIS PATCH AND CHARGING STATION INSTRUCTIONS FOR USE FOR ADDITIONAL IMPORTANT INFORMATION REF 199587...
Page 2: ...g and causing skin burns in the area of the patch Refer to Instruction Manual Booklet Council Directive 2002 96 EC concerning Waste Electrical and Electronic Equipment WEEE Indicates a requirement not...
Page 3: ...composition of the Patch and numerous other factors DESCRIPTION The Hybresis System delivers charged water soluble drugs and other ionic substances across intact skin and consists of three components...
Page 4: ...tion CONTRAINDICATIONS Cardiac pacemakers Do not use on patients with pacemakers or other implanted devices Drug sensitivity Do not use on patients with known sensitivity to the drug to be administere...
Page 5: ...mation irritation or burns These skin reactions may be the result of individual sensitivity to the ionic solution used the condition of the skin at the onset of treatment reaction to the materials in...
Page 6: ...of skin irritation A transient erythematous reaction characterized by a uniform red pattern can sometimes occur directly under one or both electrodes The redness usually disappears within 12 hours of...
Page 7: ...Charging Station Doing so may cause a malfunction or patient injury Button Functions There are three buttons on top of the Controller The buttons have the following functions ON OFF Turns the power on...
Page 8: ...the Controller that indicate the following Hybresis Treatment One Green Light Hybresis Treatment selected Standard Mode One of Three Green Lights Standard Treatment of 2 3 or 4 mA selected Interpretat...
Page 9: ...poor contact between the Patch and the skin Press PAUSE to pause the treatment Check for loose connections properly hy drated drug pads and good contact between the Patch and the skin After correctin...
Page 10: ...circuitry It can deliver both negatively and positively charged water soluble drugs The Patch Only Treatment can be used with and without the Controller The Controller is used with the Patch to delive...
Page 11: ...vise the patient that iontophoresis causes mild tingling prickling and or a warm sensation This is normal and should be anticipated by the patient 2 Advise the patient to report immediately any pain d...
Page 12: ...ropriate polarity pad active pad On the other pad return pad apply 1 5 mL of supplied saline ampule Use negatively charged water soluble drugs on the negative drug pad and positively charged water sol...
Page 13: ...ve release liner from the hydrated Patch 7 Apply the hydrated Patch so that the drug pad is over the treatment site and secure it by pressing the adhesive border Avoid pressing directly over the pads...
Page 14: ...ton and wait a few moments for the Controller to turn off 1 Examine the Controller before use to assure that the two prongs that insert into the Patch are free of grime and debris Dirty contacts could...
Page 15: ...d discard the Patch after a minimum of one to two hours for a 40 to 80 mA minute dose respectively 10 Discard the Patch after treatment has been completed The Patch cannot be reused STANDARD MODE TREA...
Page 16: ...reatment The Green mA Light will blink more rapidly then glow steadily 6 To change the iontophoresis current setting while the Controller is administering a treatment press the Standard Mode button to...
Page 17: ...ter Flammablility Do not use around flammable gasses liquids or materials Treatment Hybresis and Standard Dimensions 5 5 cm H x 4 5 cm W x 1 5 cm L Weight 23 g Disposal Dispose according to local stat...
Page 18: ...rent Ramp Down Interrupt Alarm Buttons ON OFF START PAUSE and STANDARD Treatment Lights Green Flashing Hybresis 2 3 or 4 mA ramping up or ramping down Green Continuous Hybresis 2 3 or 4 mA steady stat...
Page 19: ...R 11 Group 1 The Hybresis Controller uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interfer ence in nearby electronic equipment...
Page 20: ...2kV common mode 1kV differential mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on powe...
Page 21: ...ransmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the follow...
Page 22: ...tter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 3 5 P V1 80 MHz to 800 MHz d 3 5 P E1 800 MHz to 2 5 GHz d 7 P E1 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1...
Page 23: ...er before long term storage Lithium ion batteries unlike Ni Cad batteries do not suffer from Memory Effect the lithium ion battery does not require a periodic full discharge and recharge to refresh th...
Page 24: ...e number and a description of the problem Return to Empi Attn Repair Department 47492 SD Hwy 22 Clear Lake SD 57226 Repair and Maintenance There are no user serviceable parts inside the Controller If...
Page 25: ...d from the Warranty and sold AS IS because their structure is such that they may be easily damaged before or during use III Limitation of Liabilities and Disclaimer of Warranties A Empi s sole obligat...
Page 26: ...paid as soon as reasonably possible following receipt of the Product by Empi If Empi determines in its sole reasonable discretion that the Product does not contain defective workmanship or materials E...
Page 27: ...above limitation may not apply to the Purchaser D EMPI SHALL NOT BE LIABLE TO ANY PERSON FOR ANY DIRECT INDIRECT SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES LOST PROFITS OR MEDICAL EXPENSES CAUSED BY...
Page 28: ...Empi Inc 205 Hwy 22 East Clear Lake SD 57226 USA 651 415 9000 800 328 2536 360353 Rev E 2007 2015 Empi Inc a company DJOglobal com...
