INSTRUCTIONS FOR USE
Contents
1. gt PEL DUAL CHANNEL IONTOPHORESIS SYSTEM INSTRUCTIONS FOR USE SEmpi JO company 5329R Cover indd 1 6 1 10 6 16 2 Table of Contents Table of Contents 3 Theory Of Op ratiON 6 Indications and Contraindications 7 MELDE 8 PRECAUTIONS cei 10 Switches and Displays caca bn pite 12 Operating Instr cCtlons 15 Operational Considerations sss 20 Changing the Battery 23 Maintenance and 26 Cleaning Storage and Disposal 27 Technical Information s 29 Description of Device Markings 33 siad sip PI nd oU rade 34 Limited Warranty and Disclaimer 36 Federal USA law restricts this device to use by or on the order of a physician Introduction 3 Introduction The DUPEL Dual Channel lontophoresis System from Empi delivers ionic drug solutions directly to the body site being treated System components and accessories may include the following DUPEL lontophoresis Device User s Manual Empi lontophoresis Lead Wires Empi Buffered lontophoresis Electrodes Each set of electrodes contains one treatment electrode and one return electrode 9 Vol2. The LCD Window will now display the dosage to be delivered by Channel 1 and Channel 2 The DUPEL device is automatically set at a 40mA min dosage for Channel 1 Step 7 To adjust the dosage for Channel 1 press the up or down Dosage Control Button until the correct number is displayed in the LCD Window Step 8 To set the dosage for Channel 2 move the Treatment Control Switch to S2 and repeat Step 7 Step 9 Set the current for the channel s to the desired level To do this move the Treatment Control Switch to P Pause Current for the programmed channel s now appears in the LCD Window Tosetthe desired current for each channel rotate the appropriate Current Control Knob located on top of device Note Do not operate the DUPEL device while Operating Instructions 19 the flip cover is open Close the flip cover before initiating or resuming treatment Step 10 To start the treatment turn the Treatment Control Switch to R Run One or both if both channels are being used of the green LED indicators will light indicating that current is being output to the corresponding channel s Current will automatically ramp up to set levels over a period of 30 seconds During ramping current is displayed in the LCD Window and corresponding channel indicator CH 1 or CH 2 blinks Once current reaches set level the display in the LCD Window will switch to Dose and show dose delivered as it increments up to the
3. US hazards only in accordance with UL 60601 1 and TINI CAN CSA C22 2 No 601 1 M90 Do not wear electrode or controller during Magnetic Resonance Imaging MRI scans as this may result in metal overheating and causing skin burns in the area of the patch 34 Troubleshooting For repair of device call 1 800 862 2343 Mon Fri For supplies call 1 800 325 5663 For Clinical Application call 1 800 328 2536 ext 8506 For optimal use 1 Replace leadwires annually 2 Do not use rechargeable batteries with this device Empi recommends Energizer 9V batteries 3 Do not wrap bandage or weigh down electrodes This will cause uneven current distribution which can cause skin irritation 4 There should not be pressure put on the site receiving the treatment Note If the following measures fail to alleviate the problem please call the repair department at 1 800 862 2343 Problem Device is shutting down Electrodes 1 Fill volume 1 Insure electrode is appropriate for fill ratio 2 Poor electrode contact 2 Reapply and secure firmly Electrode should have complete contact with skin 3 Placement 3 Electrodes should be a minimum of four inches apart Leadwires 1 Old worn damaged 1 Replace 2 Connection not complete 2 Insure leadwires are properly seated in the device and properly connected to electrode Some devices have an adapter the leadwires fitinto Insure the adapter is properly seated inthe devi
4. A Empi warrants to the initial purchaser Purchaser and to no other person that the Product with the exclusion of accessories such as batteries electrodes lead wires and the component parts thereof distributed or manufactured by Empi shall be free from defects in workmanship and materials for three years after the date of purchase the Warranty Period B Accessories including but not limited to batteries electrodes and lead wires are excluded from the Warranty and are sold AS IS because their structure is such that they may be easily damaged before or during use Limitations of Liabilities and Disclaimer of Warranties A Empi s sole obligation in the case of any breach of its warranties set forth in Paragraph above shall be at Limited Warranty and Disclaimer 37 Empi s option to repair or replace the Product without charge to Purchaser or to refund the purchase price of the Product In order to recover under this Warranty Purchaser must send Empi written notice of the defect setting forth the problem in reasonable detail prior to expiration of the Warranty Period and within 30 days of discovery of the defect Upon Empi s written request and authorization Purchaser shall return the Product to Empi freight and insurance prepaid for inspection Notice and return shipment shall be sent to Empi at Clear Lake Industrial Park Clear Lake South Dakota 57226 USA Purchaser may request shi
5. 52 and then back to Pause or Run The microprocessor remembers the most recently set target dosage If the same dosage is used repeatedly this feature allows the user to bypass manual setting of dosage When the device power is shut off any previous programming is lost If you forget to turn the power off after a treatment whether in the R Run position or not the device will begin to sound a reminder Operational Considerations 23 beep after 20 minutes This beep will then sound every 30 seconds until the device power is turned off This feature will help preserve battery life The low battery indicator icon appears when the battery nears the end of its life If you elect to continue treatment the device goes into an automatic shutdown just before the battery fails At this time the low battery indicator icon blinks anda beep sounds repeatedly At this point review and record how much of the intended treatment was completed turn the device power off and replace the battery Make sure to record the dose already delivered because this information will be lost when the battery is replaced Changing the Battery The DUPEL device is powered by a single 9 volt alkaline battery For best results when replacing batteries Empi recommends the use of Eveready Energizer model 522 or Varta brand model 4022 Change the battery when the low battery indicator icon illuminates or begins to blink or if the device will n
6. of Operation The DUPEL lontophoresis System operates on the physical principle that electrically like charges repel each other A positively charged substance is forced away from a positively charged electrode A negatively charged substance is forced away from a negatively charged electrode When you attach the treatment electrode to the lead wires connected to the DUPEL device and start the current flowing the ionic solution is forced into the skin away from the like charged electrode Polarity is critical If a positively charged solution is to be administered attach the treatment electrode to the positive lead wire If a negatively charged solution is being driven attach the treatment electrode to the negative lead wire The dosage of ionic drug solution delivered depends on two factors the current applied to the treatment electrode and the length of time for which the current is applied The dosage calculation is as follows Dosage mA min current mA x time min Indications and Contraindications 7 Indications and Contraindications A Observe the following indications and contraindications for using the DUPEL lontophoresis System Indications lontophoresis can be used as an alternative to hypodermic injection for the administration of ionic solutions Contraindications The DUPEL lontophoresis System is contraindicated for use on patients with Known adverse reactions to the application of
7. target dosage Step 11 After treatment has been completed the current will ramp down to zero over a period of 30 seconds A continuous beep will sound for up to 10 seconds Wait until the current has ramped down and the green LED indicator goes off before removing lead wires and electrodes 20 Operational Considerations If both channels are being used the continuous beep signaling the end of treatment will sound for each channel If one treatment is done before the other the beep will sound and the LED indicator for that channel will go off indicating current output to that channel has stopped Operational Considerations DUPEL contains a microprocessor with a number of smart features that allow the user to monitor the set parameters and modify treatment without changing dosage These features are e You can view the set current level mA for either channel at any time during a treatment in the P Pause or R Run mode by selecting C Current with the DISPLAY Button You can view the time required to complete a treatment at any time during treatments except during current ramping in the P Pause or R Run mode by selecting T Time with the Operational Considerations 21 DISPLAY Button You can view the amount of dosage delivered in mA min at any time during a treatment except during current ramping in the P Pause or R Run mode by selecting D Dosage with the DISPLAY
8. Button You can pause the treatment without affecting the time by selecting P Pause Selecting R Run after P causes the treatment to resume with the timer countdown continuing at the point P was selected For safety and comfort reasons current will automatically ramp down when pause is selected and ramp up again to the set level when treatment is resumed You can change the current setting during a treatment without going into the Pause condition When current is changed the time remaining is automatically recalculated ensuring the desired target dosage remains constant If an electrode becomes disconnected or if a high impedance situation occurs the treatment is automatically paused the LED indicator for 22 Operational Considerations the channel having trouble blinks and a beep sounds Also the LCD pointer will indicate which channel requires correction To correct the situation you must select P Pause the beep will stop and re establish the electrical circuit When the fault has been corrected select R Run to resume the treatment Again for safety and comfort reasons current will ramp back up to the set level After a treatment has finished the current has ramped down to zero and the 10 second tone has sounded youcan start anew treatment using the same dosage as the previous treatment without resetting Simply turn the treatment control switch to either setup position 51 or
9. CCESSORIES ARE SOLD AS IS AND THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF THE PRODUCT IS WITH PURCHASER THE WARRANTY PROVIDED IN PARAGRAPH II A IS INTENDED SOLELY FOR THE BENEFIT OF THE INITIAL PURCHASER AND EMPI DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE PROVIDED HOWEVER THAT NOTWITHSTANDING THE FOREGOING SENTENCE IN THE EVENT AN IMPLIED WARRANTY IS DETERMINED TO EXIST THE PERIOD FOR PERFORMANCE BY EMPI THEREUNDER SHALL BE LIMITED TO THE LIFETIME OF THE INITIAL PURCHASER NO EMPLOYEE REPRESENTATIVE OR AGENT OF EMPI HAS ANY AUTHORITY TO BIND EMPI TO ANY AFFIRMATION REPRESENTATION OR WARRANTY EXCEPT Limited Warranty and Disclaimer 39 AS STATED IN THIS WRITTEN WARRANTY POLICY This Warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state Some states do not allow limitations of how long an implied warranty lasts so the above limitation may not apply to 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 ANY DEFECT FAILURE MALFUNCTION OR OTHERWISE OF THE PRODUCT REGARDLESS OF THE FORM IN WHICH ANY LEGAL OR EQUITABLE ACTION MAY BE BROUGHT AGAINST EMPI E G CONTRACT NEGLIGENCE OR OTHERWISE THE REME
10. Channel 1 and Channel 2 O e The pointers for CH 1 and CH 2 illuminate y during an electrode fault high impedance or open circuit situation and identify which channel requires correction e The low battery indicator icon illuminates during a low battery situation and begins to blink just prior to automatic low battery shutdown of the device Figure 3 illustrates the top of the device Outlet Jacks CURRENT Treatment Control Switch Current Indicator Lights Figure 3 Top of the Device 14 Switches and Displays The Treatment Control Switch has four settings 1 for setting the target dosage for Channel 1 S2 for setting the target dosage for Channel 2 to pause the device to pause current output R to run the device to initiate or resume current output The Current Control Knobs rotational used are to set the current in mA for each channel The lead wire for Channel 1 is connected to Outlet Jack 1 and for Channel 2 to Outlet Jack 2 The green LEDs beneath the channel Outlet Jacks light continuously when current is being output to the corresponding channel They flash when there is an interruption of current flow on the corresponding channel Figure 4 shows the controls and switches beneath the front cover of the device Figure 4 Controls and Switches Under Front Cover Operating Instructions 15 The POWER Switch turns the device on and off e The Dosa
11. DY PROVIDED IN PARAGRAPH HEREOF SHALL CONSTITUTE PURCHASER S SOLE REMEDY IN NO EVENT SHALL EMPI S LIABILITY UNDER ANY CAUSE OF ACTION RELATING TO THE PRODUCT EXCEED THE PURCHASE PRICE OF THE PRODUCT This warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation may not apply to you DUZPEL DUAL CHANNEL IONTOPHORESIS SYSTEM Your authorized representative EU REP MDSS Medical Device Safety Service GmbH Schiffgraben 41 30175 Hannover Germany Tele 49 511 62 62 86 30 4 Empi 205 Hwy 22 East S Empi Clear Lake SD 57226 USA CC 651 415 9000 1 800 328 2536 0473 360379 Rev 2010 Empi 3 10 Pat 5 254 081 5 431 625 D319 881
12. actions e Keep the DUPEL system out of the reach of children Safe use of this device requires proper instruction Do not use the DUPEL system on pregnant women The safety of electrical stimulation during pregnancy has not been established Do not apply electrodes across the temporal region as safety has not been established Do not use any other electrodes with this system The safety of using electrodes other than the Empi Buffered lontophoresis Electrodes with the Dupel lontophoresis Device has not been established Do not wear electrode or controller during Magnetic Resonance Imaging MRI scans as this may result in metal overheating and causing skin burns in the area of the patch 10 Precautions Precautions The following precautions apply to using the DUPEL lontophoresis System Before giving an iontophoresis treatment consult the directions for the drug being administered for indications contraindications and warnings concerning its use e The current setting should not exceed comfortable level for the patient Advise the patient to report any undue sensation of pain or burning during the iontophoresis treatment The maximum recommended dosage is 80mA min e lontophoresis can cause transient inflammation of the skin skin irritation or skin burns Advise the patient of this possibility before starting treatment If a skin reaction does occur discontinue the treatment and consult the p
13. ce and connection is secure 1 Try a new 9V Energizer battery Note Energizer batteries are recommended for use with this device Troubleshooting 35 Problem Device is shutting down Treatment site has high resistance Try any of the following measures Ex Plantar Fasciitis 1 Leave the intensity set to 5mA Turn treatment control switch to R Run Remain at this intensity for 30 60 seconds then increase intensity as patient tolerates 2 Soak treatment site in tepid water pool for 20 30 minutes prior to treatment 3 Insure skin is properly prepped as defined in the Instructions for Use 4 Treatment sites that are severely callused may need to be filed down Problem Device does power 1 Try a new 9V Energizer battery Note Energizer batteries are recommended for use with this device Battery Contact Check the following on the battery contacts 1 Both contacts are in place 2 Neither of the contacts are broken or damaged 3 Both contacts are not pushed in They should make contact with the battery when it is inserted 36 Limited Warranty and Disclaimer Limited Warranty and Disclaimer 1 Warning While in the opinion of Empi Empi the use of the DUPEL Dual Channel lontophoresis System the Product has been shown to deliver certain ionic drug solutions Empi makes no warranties to the purchaser as to the effectiveness of the Product Il Warranty
14. electrical current e Cardiac pacemakers or other electrically sensitive implanted devices e Known sensitivity to the drugs to be administered 8 Warnings Warnings N The following warnings apply to using the DUPEL lontophoresis System Do not plug lead wires into wall sockets or line cord receptacles under any circumstances Doing so could result in severe shock or burns whether the lead wires are attached to the device or not e The lead wires and electrodes should be removed before using industrial scientific or medical equipment Group 2 ISM that intentionally generates high frequency or high energy electromagnetic radiation Operation in close proximity e g 3m to this equipment may startle the user by producing changes in output or improper operation of the device Simultaneous connection to the user may result in burns and possible damage to the device Examples of Group 2 ISM Equipment are radio frequency rf induction heating cutting or welding equipment and short wave microwave therapy and diagnostic equipment such as diathermy or surgical electrocautery units Warnings 9 Avoid operation in close proximity e g lt Im to transmitting cellular wireless telephones ortwo way radios This equipment may produce sudden unexpected changes in the device output Do not apply electrodes over broken or compromised skin e g sunburn cuts acne due to increased risk of skin re
15. f it as two single channel devices If the channels are used at different sites the channels are entirely independent in the treatment applied by each In this case therefore set the treatment parameters as though you were using two single channel devices If the channels are used at the same site the dosages of the channels are additive That is the total dosage you want to apply should be split between the two channels Operating Instructions 17 Perform the following steps to operate the DUPEL lontophoresis System Step 1 Connect the lead wires to the electrodes with careful attention to the polarity required for the treatment electrode If a positively charged solution is used connect the positive lead wire to the treatment electrode and the other lead wire to the return electrode Use the negative lead wire for a negatively charged solution Step 2 Prepare and attach the electrodes to the body site to be treated Follow the instructions accompanying the electrodes for proper filling and preparation Step 3 After ensuring that the POWER Switch is OFF connect the lead wire to the Channel 1 Outlet Jack Step 4 If a second channel is to be used repeat steps 1 3 for this channel Step 5 To begin a treatment turn the POWER Switch under the front cover to ON 18 Operating Instructions Step 6 Turn the Treatment Control Switch on top of the device to the set up position for Channel 1 S1
16. g treatment 30 Technical Information R for running current output at the set parameters Display Controls A push button to select which display parameter appears in the LCD Window LED Annunciators Two green LEDs indicate status of channels current output or no current output as follows LEDs blink when open circuit or high impedance situation occurs LEDs on continuously when current output is within normal parameters LCD Annunciators Segments on the LCD indicate the following Channel 1 and Channel 2 numeric dose readout Low battery indicator icon Channel 1 and Channel 2 markers Electrode fault open channel icon Time min dose mA min and current mA units Technical Information 31 Beeper Annunciator Battery Information Supply Voltage Range Low Voltage Indicator Threshold Expected Battery Life Sounds when the following occurs Power on Treatment complete Electrode fault Twenty minutes inactivity e Low battery auto shutdown 5 6V dc minimum to 10V dc maximum 6 5V dc 3V dc One channel on 1700mA min dose Recommended Batteries Alkaline Use a 9 volt battery brand such as Eveready Energizer No 522 or Varta No 4022 IEC 6LR61 Type BF Applied Part Internally powered only Ordinary protec tion against entry of liquids Continuous operation Not suitable for use in the presence of a flammable anaesthetic mix
17. ge Control Buttons push up or down are used to set the target dosage in mA min for each channel The Treatment Control Switch must be in S1 or S2 to set dosage for Channel 1 or Channel 2 e The DISPLAY Button selects which data is shown the LCD Window T time D dosage C current Operating Instructions This section explains how to operate the DUPEL lontophoresis Device Decide if the treatment requires single or dual channel operation The instructions in this section cover both modes of operation If you are using the dual channel mode operate the device as though you were setting up two iontophoresis treatments You will need to set up two drug delivery electrodes and two return electrodes The dual channel mode of operation enables you to 16 Operating Instructions do the following Treat two different treatment sites simultaneously with one system e Reduce the treatment time or current without affecting the dosage at a single target site Because two channels are delivering the drug solution each can have a lower current and treatment time than a single channel delivering the same total dosage Treat a larger target site without reducing the dosage or increasing the time Because two channels rather than one are delivering the drug solution the dosage remains at the desired level over a larger body area The use of the DUPEL dual channel device is easy to understand if you think o
18. ot turn on See Battery Information in the 24 Operational Considerations Technical Information section of this manual for the typical life of your battery Actual battery life will depend upon the battery type skin impedance and device settings used To Insert the Battery Caution Turn the device off and disconnect the lead wires before inserting a fresh battery Figure 5 Battery Compartment 1 Unlatch the Front Panel Cover by pressing on the bottom edge of the device Pull the cover up Figure 5 Operational Considerations 25 If you pull up too far on the cover the cover will snap off the hinges Snap the cover back on by aligning the hinges and pressing down firmly 2 Remove the discharged battery from the unit by lifting the bottom of the battery 3 Place the new battery into the space provided Figure 5 Be sure the terminals are in proper alignment The of the battery should be at the terminal of the device and the of the battery should be at the terminal Do not force the battery If force is required you may be putting the battery in backwards Check the and markers Caution Inserting the battery incorrectly may cause it to rupture or generate intense heat if allowed to remain in the incorrect position This may cause irreversible damage to the battery If there are signs of this type of damage discard or recycle the battery and order a re
19. placement 26 Maintenance and Repair Maintenance and Repair Maintenance Check periodically for signs of wear or damage such as cracked insulation on lead wires and replace these items as they wear out Under normal conditions the device does not require periodic maintenance or calibration however if it becomes necessary to perform periodic safety checks all the necessary information is included in the Technical Information section of this manual These checks should be performed by a qualified technician Repair There are no user serviceable parts inside the device If the unit appears to be non functional call the Clear Lake Service Center at 1 800 862 2343 for instructions In the case of repairs or returns outside of North America notification and return shipment shall be sent to an Empi Authorized Service Center To locate the appropriate Service Center outside of North America contact your Authorized Empi Distributor or contact Empi directly at 1 651 415 9000 Cleaning Storage and Disposal 27 Cleaning Storage and Disposal Cleaning Cleaning the Device Use a cloth moistened with soap and water to clean the exterior of the device Use of other cleaning solutions may damage the case Never immerse the device in water or other liquids Cleaning the Battery Contacts Gently clean the battery contacts using a cotton tipped swab soaked in rubbing alcohol Do not use sandpaper or other ab
20. pment approval by calling Empi Warranty Repair Department on its toll free number 1 800 862 2343 In the case of repairs or returns outside of North America notification and return shipment shall be sent to an Empi Authorized Service Center To locate the appropriate Service Center outside of North America contact your Authorized Empi Distributor or contact Empi directly at 1 651 415 9000 Empi will not be responsible for damage due to improper packaging or shipment If Empi determines in its sole reasonable discretion that the Product contains defective workmanship or materials Empi will refund to the Purchaser the purchase price for the defective product or return the repaired Product or a replacement thereof to Purchaser freight and insurance prepaid 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 38 Limited Warranty and Disclaimer defective workmanship or materials Empi will return the Product to the Purchaser freight and insurance billed to the Purchaser B This Warranty is voided immediately as to any Product which has been repaired or modified by any person other than authorized employees or agents of Empi or which has been subjected to misuse abuse negligence damage in transit accident or neglect EXCEPT AS PROVIDED IN PARAGRAPH II A THE PRODUCT IS BEING SOLD ON AN AS IS BASIS ALL A
21. rasive material Cleaning the Lead Wires Periodically wipe the lead wires clean with a cloth dampened in a mild soap solution then gently wipe them dry Use of rubbing alcohol on the lead wires will damage the insulation and dramatically shorten their life Storage To properly store the device for an extended period of time i e 90 days or more remove the battery from the device and store the device in a dry location 28 Cleaning Storage and Disposal Disposal Ship the device postage prepaid to the Clear Lake Service Center for proper disposal or recycling Please enclose a note indicating that the item is being returned for disposal or recycling Technical Information 29 Technical Information Standard Measurement Conditions Output per channel Dosage Control Timer Treatment Controls 25 8 5V supply voltage Constant direct current 5 to 4mA 10 over 100 to 12kQ load Two push button knobs One knob increases and the other decreases the desired setting in 1mA min increments up to 160mA min Accuracy of delivered dose 2mA min Time is calculated automatically based on the target dosage and current level selected Treatment control switch with the following settings S1 to set target dosage to be delivered to Channel 1 S2 to set target dosage to be delivered to Channel 2 P for setting initial treatment parameters or for pausing current output durin
22. rescribing physician A transient erythematic reaction can sometimes occur directly under one or both ofthe electrodes as a result of treatment This reaction which has a uniform red pattern will usually disappear within 12 hours of the treatment Precautions 11 e Patients with known skin sensitivities or allergies should be treated with lower current settings and longer treatment times due to increased risk of skin reactions e Handle the system with care Do not immerse the system in fluids or allow it to be connected with other electrical devices Do not drop abuse or in any way exceed normal use During iontophoresis electrical discharges are possible These could ignite flammable material or gases skin reaction occurs the patient should be evaluated for possible drug sensitivity 12 Switches and Displays Switches and Displays This section describes the switches and displays on the DUPEL lontophoresis Device Figure 2 shows the LCD displays on the front of the device 8 TIME min Dose mAemin 05 fr A Li tlt CURRENT ma Figure 2 Front Panel Displays The numeric portion of the LCD Window displays either the time the dosage or the current for both channels The TIME DOSE and CURRENT indicators specify which of these is displayed by the numeric portion of the LCD Window Switches and Displays e CH 1 and CH 2 correspond to
23. t Alkaline Batteries This manual tells how to operate the DUPEL lontophoresis Device Instructions for using the Empi Buffered lontophoresis Electrodes are included in the electrode packaging Figure 1 shows the DUPEL lontophoresis Device 4 Introduction Figure 1 DUPEL lontophoresis Device The DUPEL Dual Channel lontophoresis System provides the capabilities of two single channel systems in a single device package The user sets the dosage and current levels for each channel independently The length of treatment time is dependenton the dosage and current selected by the user Introduction 5 The channels can deliver drugs with different ionic charges Channel 1 can deliver a negatively charged drug at the same time Channel 2 delivers a positively charged drug If desired like charged solutions can be usedin the treatment electrodes for both channels A dual channel system offers the following advantages over a single channel system Capability of delivering a single ionic solution or two different ionic solutions simultaneously to two different body sites with both sites receiving an accurate constant current dosage e Reduction of the treatment time by 50 without increasing the current e Reduction of the current by 50 without increasing the treatment time e Capability of delivering drug solutions simultaneously at different delivery rates 6 Theory of Operation Theory
24. ture with air or with oxygen or nitrous oxide 32 Technical Information Physical Dimensions Size H x W x D Approx Weight with battery Approx Weight without battery 9 4cm x 6 2cm x 2 2cm 3 7in x 2 4in x 0 9in 111g 3 902 70g 2 450z Environmental Conditions Transportation and Storage Operating 25 C to 80 10 to 40 MZ s 29 lt aN J Store cool dry place Description of Device Markings 33 Empi Clear Lake SD 57226 USA declares under its sole responsibility that the markings on your DUPEL device are your assurance of its conformity to the highest applicable standards of medical equipment safety and electromagnetic compatibility One or more of the following markings may appear on your device Council Directive 93 42 EEC Concerning Medical CC Devices Medical Device Directive m CSA C22 2 No 125 M1984 Electromedical equipment Canadian SP Electrical Code Part Il Safety Standards for Electrical Equipment CSA Risk Class 2 LR 64406 EN60601 1 2 1993 EMC Directive In accordance with Article 10 1 of Council C Directive 89 336 EEC Medical electrical equipment Part 1 General requirements for safety Part 2 Collateral standard Electromagnetic compatibility Requirements and tests T ASSIS Classified by Underwriters Laboratories SN with respect to electric shock fire and mechanical
Download Pdf Manuals
Related Search