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1. Skin irritation and electrode burns are potential adverse reactions Users should discontinue use immediately if there is any dermal discomfort A Few Good Tips Self Adhesive Electrodes Ifyou find the electrodes will not stick due to oily skin cleanse the skin with soap and water then rinse and dry the area around the electrode site If this does not work try cleansing the skin with a swab impregnated with alcohol Clip away hair on skin using scissors don t use a razor to remove hairs The electrode s conductive material is water based If it becomes saturated e g from perspiration it will lose its adhesive qualities After use leave the electrodes face up overnight to dry out replace on plastic film in the morning At some point the electrodes will become dry Moisten the adhesive surface with a few drops of water and apply onto the plastic film overnight This procedure will give you a few more days of electrode life PRIMERA User s Manual Page 12 2013 STW Inc What is Pain When we feel pain it is the body s process of informing us that something is wrong To feel pain is important without this feeling abnormal conditions may go undetected creating damage or injury to critical parts of the body Although pain is essential in warning our body of trauma or malfunction nature may have gone too far in its design Continued long term chronic pain has no useful value apart from its importance in dia
2. high fever abnormal blood pressure skin sensory disorders or skin problems hernia abdominal or inguinal any serious illness prone to impulsive foolish or stupid decisions PRIMERA User s Manual Page 10 2013 STW Inc Electrode Guidelines Please note that the correct selection of the skin electrodes for a TENS device is a significant concern The electrodes for this TENS device are FDA cleared 2 inch skin electrodes from Chattanooga To ensure you obtain the proper type of skin electrode please re order from Chattanooga DJO Global or your PRIMERA authorized dealer Never Apply Electrodes to the head or any area of the face the neck the chest across the heart on both sides of the thorax simultaneously laterally or front and back Caution with Electrodes Always turn the power to the PRIMERA off when applying or moving electrodes Ensure the entire surface of the electrode is stuck to the skin Ifskin irritation occurs move the electrodes to a different position Do not apply solvents or cleaning agents to electrodes Electrodes are for single patient use only do not share electrodes with another person Users should discontinue use immediately if there is any dermal discomfort PRIMERA User s Manual Page 11 2013 STW Inc Adverse Reactions Please note that this equipment is capable of delivering current densities for any electrodes exceeding 2mA r m s cm
3. PRIMERA User s Manual Contents Important Notes Warnings Safety and Indications Contraindications and Precautions Electrode Guidelines What is Pain What is TENS What is NMES How to Use the PRIMERA General Quick Start Instructions Programs Description of Kit Components Suggested General Electrode Placement Commonly Asked Questions Care and Maintenance Specifications Issues and Solutions PRIMERA Warranty Symbols Appearing on the Back of the Device Special Notes and Reorder Back Cover Page 2 2013 STW Inc PRIMERA User s Manual Page 3 2013 STW Inc Important Notes The PRIMERA is equipped with a mA LOCKOUT Forty five seconds after the stimulator is turned ON the intensity setting will lock To make any adjustment to the level of intensity mA you must first press the negative first to increase the mA Please carefully read the Warnings Safety and Indications sections of this user s manual and be fully aware of the contents of this user s manual before using your PRIMERA The device should not be used for any indication other than the intended use Indications for use Programs 01 to 07 and HAN are to be used for TENS The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back upper extremities arms and lower extremities legs due to strain from and or normal non commercial household work activities
4. Programs 08 to 13 are for NMES and are intended to be used to stimulate healthy muscles in order to facilitate and improve muscle performance CAUTION FEDERAL LAW U S A RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL PRIMERA User s Manual Page 4 Warnings F gt amp 2013 STW Inc The PRIMERA is a Class II Medical device for use by adults only Keep out of reach of children Always use this device in accordance with the manual Do not insert lead wires into a mains power supply Do not immerse unit into water or any other substance Do not use the PRIMERA unit in the presence of a flammable anaesthesia gas mixture and air or with oxygen or nitrous oxide Never connect the PRIMERA unit directly to a battery charger or any other mains powered equipment Electrodes are for single patient use only do not share electrodes with another person Operation in close proximity e g one meter three feet two inches to a shortwave or microwave therapy equipment may produce instability in the stimulator output Simultaneous connection to a patient to high frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator No modification of this equipment is allowed Only use leads electrodes and accessories provided by the manufacturer Safety of electrical stimulation during pregnancy has not be
5. User s Manual Page 22 2013 STW Inc NMES Program 8 Muscle massage to relax muscles Multiple applications as needed per day Unless otherwise indicated by an appropriately licensed healthcare professional do not use on muscle spasms and never on undiagnosed muscle spasms Program 9 Brief intense physical workout of muscles Up to three applications per day Program 10 Muscle massage and mild warm up cool down of muscles Up to three applications per day Program 11 Stimulate healthy muscles in order to improve and facilitate muscle performance mild exercise program to increase muscle strength Up to three applications per day Program 12 Muscle massage and moderate warm up cool down of muscle Up to three applications per day Program 13 Stimulate healthy muscles in order to improve and facilitate muscle performance Moderate exercise program to increase muscle strength Up to three applications per day PRIMERA User s Manual Page 23 2013 STW Inc Description of Kit Components PRIMERA Unit Complete with Carrying and the Accessories Shown Lead Wires 0 0 Item 77619 200 Electrodes 0e Item 42182 chattanooga Battery PRIMERA Complete Kit User s Manual Item 200001 001 Item 77615 Item 77617 Electrode Positioner Belt for the Back Item 77620 PRIMERA User s Manual Page 24 2013 STW Inc PRIMERA TENS NMES Complete Unit Item 77615 Contains Manual Lead wires 2 Garment Belt
6. Battery and Electrodes in the Plastic Case Accessories You can obtain replacement accessories from your authorized PRIMERA dealer PRIMERA Unit Sliding Back Cover Item 77616 User s Manual Item 77617 Plastic Carrying Case Item 77618 Leadwire Set 2 each Item 77619 Electrode Positioner Belt for the Back Item 77620 Battery Energizer 9 volt Item 200001 001 Dura Stick 2 Round Reorder Electrodes Item 42182 Includes 10 packs of 4 electrodes in each pack PRIMERA User s Manual Page 25 2013 STW Inc Suggested General Electrode Placement Red Positive Lead Black Negative Lead In treating lower back pain electrode placement is unique to the user and location should be determined by user response using systematic trial and error Use of the garment belt included is highly recommended to aid in the placement of electrodes on the lower back PRIMERA User s Manual Page 26 2013 STW Inc Ch B Upper Mid Back Pain Relief Upper Mid Back Muscle Improvement Red Positive Lead Black Negative Lead PRIMERA User s Manual Page 27 2013 STW Inc fet CY N Deltoids Trapezius Red Positive Lead Black Negative Lead PRIMERA User s Manual Page 28 2013 STW Inc Ch A Triceps Red Positive Lead Black Negative Lead PRIMERA User s Manual Page 29 2013 STW Inc Ch B Wrist Forea
7. return Manufacturer s serial number of the unit Present it together with LOT number when you report a technical fault or claim a warranty return PRIMERA User s Manual Page 43 2013 STW Inc Model number Present it together with LOT and SN numbers when ordering supplies report a technical fault or claim a warranty return Patient s shock protection type BF Body Floated Equipment This equipment is not earthed but contains a battery within an insulated unit IP indication for protection against ingress of water and particulate matter IP20 means protected against solid foreign objects of 12 5mm dia and greater Not protected against water At the end of the product life cycle do not throw this product into the normal household garbage but bring it to a collection point for the recycling of electronic components Incorrect disposal can be harmful to the environment and to human health Please contact your local authorities if you need more information about collection points in your area Special Notes The PRIMERA is equipped with a mA LOCKOUT Forty five seconds after the unit is turned ON the intensity setting will lock To make any adjustment to the intensity setting you must first press the negative button to increase the mA For reorder of replacement electrodes replacement batteries and accessories please visit our website Web www DJOglobal com chattanooga Distrib
8. warning function Contraindications Never use your PRIMERA on atrophied muscles muscles with spasms muscles associated with an impaired joint or limb muscles with undiagnosed pain Never use the PRIMERA when pregnant or if you think you are pregnant Do not use your PRIMERA with demand type cardiac pacemakers defibrillators or other implanted metallic or electronic devices over the carotid sinus neck region over the neck or mouth over the carotid sinus nerves trans cerebrally over the head over the eyes over the heart or chest when there is a tendency to haemorrhage following acute trauma or fracture following surgical procedures when muscle contraction may disrupt the healing process over areas of skin which lack normal sensation PRIMERA User s Manual Page 8 2013 STW Inc over swollen infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc Do not use your PRIMERA if you have one or more of the following medical conditions epilepsy cancerous lesions abdominal or inguinal hernia critical ischemia of lower limbs blood flow deficiencies venous thrombosis heart problems condition Precautions Isolated cases of skin irritation may occur at the site of the electrode placement following long term application Consult your physician if skin irritation develops The effectiveness o
9. PRIMERA by pressing the ON button please note electrodes must be in position before activation Using the PRG button select the program Slowly adjust left and right mA current output with the positive button This starts the program and you will begin to feel the stimulation Increase this to tolerance The PRIMERA is equipped with a mA LOCKOUT Forty five seconds after the stimulator is turned ON the intensity settling will lock To make any adjustment to the level of intensity you must first press the negative first to increase the mA You may notice some muscle contraction and this is normal You can track treatment time in the upper right hand corner of the PRIMERA screen At the end of the program duration remove the electrodes and replace the electrode covers You can treat every day but no more than as advised and never to a point of fatigue or pain PRIMERA User s Manual Page 20 Programs Prog No Description Rate Hz Pulse width uS Work time s Rest time s Prog time POI CON 80 200 n a n a hour P02 CON 150 175 n a n a 20 min P03 CON 2 175 n a n a 20 min 5 P04 BST 150 200 n a n a hour P05 BST 150 175 n a n a hour P06 MOD 100 65 200 100 n a n a hour P07 MOD 65 100 200 100 hour HAN HAN 2 70 250 150 30 min P08 NMES 12 200 5 5 5 min P09 NMES 35 250 8 8 5 min a P10 NMES 12 200 5 10 5 min 2 pi NMES 35 200 6 12 5 m
10. cted The unit turns ON Poor connection between but does not carry out electrode and skin commands e g mA intensity increases but then drops to OmA and readjustment to higher than 10mA level is not possible Open circuit detected Broken lead wires Turn unit OFF unplug lead wires at all connection points and then reinsert all points then turn unit ON Turn unit OFF Replace lead wires or electrode unit then turn unit ON Open circuit detected Lead wire connections are not secure Worn broken lead wires not always visible are the most common problem Never tamper with the electrode or lead wires Discard if any indication of damage to either the electrode or wires Consult your licensed health care professional if the solutions above do not address the issue continued to next page PRIMERA User s Manual Page 40 2013 STW Inc Turn unit OFF Remove the electrode lubricate it see electrode care reapply the Dry spots or other factors electrode then turn unit ON that could increase Increasing intensity resistance Use new electrodes or use causes unpleasant a different brand or style of sensation electrode gel Be less aggressive in mA Local muscle fatigue intensity or frequency of use PRIMERA User s Manual Page 41 2013 STW Inc PRIMERA Warranty DJO LLC a DJO Global Company provides a warranty to the original purcha
11. e or machinery When using the PRIMERA to improve muscle performance it is recommended that you only stimulate the muscle groups for sessions of 30 minutes three times per week Appropriate Treatment Mode There are five treatment modes available on the PRIMERA 1 Continuous TENS or Normal This is the most frequently used mode for pain relief For general TENS use the most common selection is program 01 2 Burst Mode This mode is comparable to the low rate TENS technique except that each low rate pulse is substituted by a short BURST of 9 pulses 200 uS at 150 Hz It is a combination of conventional and low rate TENS Use program 06 or 07 PRIMERA User s Manual Page 15 2013 STW Inc 3 Modulation TENS This mode was designed to help prevent nerve accommodation that some patients experience It is achieved by continuously cycling the pulse width and rate Use program 04 or 05 4 NMES Neuro Muscular Electrical Stimulation This mode enables the users to train their muscles NMES is generally used at higher milliamp levels Choose the program most suited to your requirements Choose the mode program most suited to your requirements For pain relief alternate between the programs 01 to 07 and HAN until you find the most effective program There is no clinical basis for selecting one mode over the other for temporary pain relief There is no output mode or waveform that can be detrimental to one s self Take care to u
12. en established Think about what you are doing and use common sense PRIMERA User s Manual Page 5 2013 STW Inc NEVER DO the following with the PRIMERA Never use it in ways other than those recommended by the user s manual Never operate without full understanding of the user s manual Never use it while driving or operating machinery Never use it in a humid wet atmosphere e g sauna bathroom bath shower or swimming pool Never use on people with diminished abilities Never use the unit if it is not functioning properly or you feel discomfort Stop using the unit if you feel nausea or dizziness Warnings Always place electrodes in accordance with this user s manual Do not place electrodes across the chest or heart as doing so may create rhythmic disturbances to the heart The PRIMERA is not effective in treating pain of central origin including headache The PRIMERA provides symptomatic relief only and has no curative value The PRIMERA in TENS mode provides symptomatic treatment and as such suppresses the sensation of pain which would otherwise serve as a protective mechanism The user must keep the PRIMERA away from children Electronic monitoring equipment such as ECG monitors and ECG alarms may not operate properly when PRIMERA stimulation is in use PRIMERA User s Manual Page 6 2013 STW Inc The long term effects of ch
13. f PRIMERA in TENS mode is highly dependent upon program selection and electrode placement determined by user response If in doubt consult a person qualified in pain management Caution should be used for patients with suspected or diagnosed heart problems Caution should be used for patients with suspected or diagnosed epilepsy Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium The irritation can usually be reduced by using an alternate conductive medium or an alternate electrode placement PRIMERA User s Manual Page 9 2013 STW Inc Electrode placement and stimulation settings should be in accord with the instructions in this manual or based on the advice of an experienced licensed health care professional Powered muscle stimulators should be kept out of the reach of children Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer Powered muscle stimulators should not be used while driving operating machinery or during any activity in which involuntary muscle contractions may put the user at undue risk of injury Do not immerse the unit in water or any other liquid Before using the PRIMERA please consult your physician if you are experiencing or have any of the following conditions an acute disease malignant tumor infectious disease heart disease
14. face once a week with a damp cloth or antiseptic wipes Do not use cleaning sprays or alcohol based cleaning solutions Expected service life is five years Battery Check periodically for any visable changes to the battery Immediately remove and replace the battery if there is any discharge Remove battery completely from unit if not in use for any extended period of time typically if placed in storage one month or longer Low battery indicator of 6 9 Volts shown on LCD display when flashing change battery for a new one Preferably use a Energizer 9 volt battery reorder instructions are on the back cover Expected average battery life of a standard 800 mAh alkaline battery is 24 hours Lead Wires The lead wires should be handled carefully and never stretched as this can cause the stimulation to function below normal standards or not at all Examine lead wires before each treatment for loose connections or damage Avoid stretching and twisting the lead wires Store the lead wires carefully after each use Expected service life is six months PRIMERA User s Manual Page 35 Seli Adhesive Electrodes Be sure the short pin connectors are securely completely attached to the electrode Replace electrodes onto plastic film after each use session If the electrodes drop onto the floor debris will adhere to conductive gel rendering the electrodes ineffective Expected service life is a ten day period
15. gnosis Pain only begins when a coded signal travels to the brain where it is decoded and analysed The pain message travels from the injured area of the body along small diameter nerves leading to the spinal cord At this point the message is switched to a different kind of nerve that travels up the spinal cord to the brain area The brain then analyses the pain message refers it back and the pain is felt What is TENS Transcutaneous Electrical Nerve Stimulation TENS uses a small battery operated unit to provide a noninvasive method of controlling acute and principally long term intractable pain It can also be used as an adjunctive treatment in the management of post surgical traumatic pain problems In TENS mild electrical impulses are transmuted through the skin via surface electrodes to modify the body s pain perception TENS does not cure problematic physiological conditions it only helps to control the pain perception TENS will not work for every user However physical therapists and PRIMERA User s Manual Page 13 2013 STW Inc physicians throughout the world prescribe TENS extensively and it is generally seen to work for the majority of users There are millions of small nerve fibers throughout the body and it only requires a few impulses to produce chronic pain In addition to small fibers which allow the sensation of pain to be felt the body is also made up of larger diameter nerve fibers These larger nerve fibers transm
16. ime duration of programs 15 minutes Physical and Environmental 1 Physical dimensions 108 x 62 x 26 mm without clip 32 mm with clip 2 Weight 0 09 kg without battery 0 1 kg with battery 3 Environmental conditions for storage and transport 10 to 50 degrees Celsius 14 to 122 degrees Fahrenheit 0 90 Humidity 4 Environmental conditions for use 5 to 40 degrees Celsius 41 to 104 degrees Fahrenheit 15 93 Humidity PRIMERA User s Manual Page 38 2013 STW Inc Issues and Solutions Battery symbol on LED flashing The voltage is low Replace the batteries Batteries discharged Replace batteries The display does not Batteries were incorrectly Remove batteries and replace come on and there is no positioned correctly Signal tromithe iiit Use a tool to push contacts in Battery contacts bent case forward Never tamper with the battery Discard the battery if any indication of damage Low Battery Indicator If the battery s Voltage goes below 6 9 0 2 Volts the battery symbol will flash on off once every second If the battery voltage is below 6 6 0 2 Volts the unit will not turn ON Dispose of batteries responsibly and in full compliance with all laws continued to next page PRIMERA User s Manual Page 39 2013 STW Inc Turn unit OFF Remove the electrode lubricate it see electrode care reapply the electrode then turn unit ON Open circuit dete
17. in P12 NMES 12 250 5 15 5 min P13 NMES 35 200 6 18 5 min Key to Program Description for above CON CONtinuous TENS BST BurST TENS MOD MODulation TENS HAN HAN Mode TENS NMES Neuro Muscular ElectroStimulation PRIMERA User s Manual Page 21 2013 STW Inc Program Notes TENS Program 1 Temporary relief of dull constant pain in the back and lower extremities Multiple applications as needed per day Program 2 Temporary relief of dull constant pain in the back and lower extremities Multiple applications as needed per day Program 3 Temporary relief of acute or sub acute pain due to strain from exercise or normal household activities To be used as needed Program 4 Temporary relief of pain associated with sore and aching muscles in the lower extremities Multiple applications as needed per day Program 5 Temporary relief of pain associated with sore and aching muscles in the lower extremities Multiple applications as needed per day Program 6 Temporary relief of pain combined with a muscle massage effect for pain associated with sore and aching muscles in upper extremities Multiple applications as needed per day Program 7 Temporary relief of pain combined with a muscle massage effect for pain associated with sore and aching muscles in upper extremities Multiple applications as needed per day Program HAN A combined frequency custom electrotherapy TENS program for the temporary relief of pain PRIMERA
18. it less unpleasant sensations such as touch or warmth assisting us to form an impression of our environment Stimulating the larger nerve fibers using TENS may have the effect of inhibiting the transmission of pain along the smaller nerve fibers to the spinal cord known as the Pain Gate Theory What is NMES Neuro Muscular Electrical Stimulation has been used for many years to stimulate muscle to treat a number of muscle and nerve related conditions The PRIMERA is a dual channel device combining several treatment programs into one unit Neuromuscular Stimulation is increasingly understood by therapists and physicians There is a better understanding of the mechanisms that exist between nerves and muscles that makes it possible to stimulate the neuromuscular system with precise electrical signals The PRIMERA offers precision giving full controls of Pulse Widths Rates Ramp up Times Work Rest cycles as well as alternating or synchronous application if two channels are used PRIMERA User s Manual Page 14 2013 STW Inc How to Use the PRIMERA In order to use the PRIMERA effectively you must consider the following points Planning of stimulation sessions Choice of appropriate treatment mode Stimulation intensity level Electrode placement Planning The PRIMERA is a portable device so no special planning is required for use of temporary pain relief The unit should not be used while operating a vehicl
19. nd to be less than indicated due to electrode impedance at 1 000 Ohms load Electrodes in poor condition the maximum will be limited to 70 mA at 1500 Ohms load the maximum will be limited to 65 mA Selectable pulse width 175 200 200 100 250 100 or 250 150uS 2 accuracy Program pulse rate selection in the continuous mode 2 80 or 150Hz 2 accuracy Modes Continuous Burst Modulated and HAN Burst Mode Bursts of 9 pulses 150112 at 200uS repeating twice every second Modulation Mode 6 second cycle of concurrent width modulation and pulse repetition rate modulation Width starting at 200uS and decreasing exponentially to PRIMERA User s Manual Page 37 2013 STW Inc 100US in three seconds and then returning back to 200uS in the next three seconds Hertz start at 65 or 100Hz and increasing or decreasing exponentially to 100 or 65Hz in three seconds and then returning back to 65 or 100Hz 7 HAN 2 Hz 250 uS 3 Sec then 70 Hz 150 uS 3 Sec Repeat 8 Time duration of programs 1 hour or less per session NMES 1 Amplitude 0 80 mA into 500 Ohms load indication only Actual mA will tend to be less than indicated due to electrode impedance at 1 000 Ohms load Electrodes in poor condition the maximum will be limited to 70 mA at 1500 Ohms load the maximum will be limited to 65 mA 2 Program selectable pulse width 15 200 or 250uS 2 accuracy 3 Program pulse rate selection 12 or 35Hz 2 accuracy 4 T
20. rm Red Positive Lead Black Negative Lead PRIMERA User s Manual Page 30 2013 STW Inc Abdominal two methods Red Positive Lead Black Negative Lead PRIMERA User s Manual Page 31 2013 STW Inc Ch A Hamstring Quadriceps Red Positive Lead Black Negative Lead PRIMERA User s Manual Page 32 2013 STW Inc Ch A Femoral Biceps Red Positive Lead Black Negative Lead PRIMERA User 5 Manual Page 33 2013 STW Inc Commonly Asked Questions The device should not be used for any indication other than the intended use Q How can I have a better chance of success A Seeking professional advice from your physical therapist or physician on how to best apply TENS is the best answer we can give to this question Q Are there circumstances in which TENS NMES should not be used A Yes For undiagnosed pain when using a cardiac pacemaker during pregnancy and other instances as fully detailed in this manual on pages 3 to 9 Q Can there be any permanent side effects A There are no known permanent side effects caused by using a TENS stimulator Q If I have any medical or product queries how can I get help A Any clinical advice on the PRIMERA be provided by your physical therapist or licensed health care provider PRIMERA User s Manual Page 34 2013 STW Inc Care and Maintenance Control Unit Wipe the sur
21. ronic electrical stimulation are unknown Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias Stimulation should not be applied over swollen infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc The effects of stimulation on the brain are unknown Therefore do not apply stimulation to or across the head Stimulation should not be applied to the neck Spasm of the laryngeal and pharyngeal muscles may occur and cause contractions which may close the airway Stimulation applied to the neck may have adverse effects on heart rhythm and blood flow Do not remove electrodes while the unit is being used Do not use on people with diminished capacity or capabilities Do not use while sleeping Do not use the unit for any purpose except what it is intended for Do not place electrodes over the abdominal region during menstruation periods Do not let electrodes come into contact with metal of any type during the session Do not use the unit for extended periods of time in case muscles become exhausted or painful If in doubt about the use of the PRIMERA unit contact your distributor or ask an experienced licensed health care professional for advice PRIMERA User s Manual Page 7 2013 STW Inc Contraindications and Precautions Remember pain is a signal your body creates as a very important
22. se the unit only at a comfortable level for the recommended program time limit Stimulation Intensity Level mA Patients respond differently to the level of intensity due to differences in individual skin resistance enervation and the type and condition of electrode being used Never use high intensity levels for pain relief only a slight sensation should be felt for optimal pain relief Lower and comfortable intensity levels should be used for temporary pain relief If using the PRIMERA for improving muscle performance select the highest comfortable PRIMERA User s Manual Page 16 2013 STW Inc stimulation level and gradually increase the intensity from session to session to achieve the best results How Long Do I Use TENS and NMES This depends on the individual patient s condition accuracy of electrode placement stimulation and the characteristics selected but typically the onset of pain relief starts after 20 30 minutes Generally TENS is used for longer periods normally 1 hour 30 minutes per session With some patients it can be much longer Before electing longer sessions consult an experienced licensed health care professional Electrode Placement CAUTION MUST BE EXERCISED AT ALL TIMES TO ENSURE SAFE AND PROPER ELECTRODE PAD PLACEMENT See warning section for areas on the body where not to apply electrodes The placement of electrodes is one of the most important parameters in achieving effective pain relief
23. ser that this product will be free from defects in the material components and workmanship for a period of two 2 years from the date of purchase invoice date If DJO LLC is satisfied that the product s is are defective the purchaser may return the unit s to DJO LLC or the appointed distributor for repair or replacement with a new unit All returns must first be authorized by DJO LLC The liability of DJO LLC under this limited product warranty does not extend to any misuse or abuse such as heating cooling freezing tampering with or dismantling the PRIMERA commercial use or normal wear and tear Any evidence of abuse or tampering with the PRIMERA will nullify this warranty This warranty does not cover consumable items including batteries lead wires garment belt and electrodes PRIMERA User s Manual Page 42 2013 STW Inc Symbols Appearing on the Back of the Device Caution electrical output Follow operating instructions Failure to do so could place the patient or operator at risk Neuromuscular Stimulation NMES STIM should not be used by patients fitted with demand style cardiac pacemakers Please seek advice from your health supervisor This product should be kept dry The unit is not protected from ingress of water droplets from a water shower if used outside the carrying case Manufacturer s LOT Batch number Present it together with SN number when you report a technical fault or claim a warranty
24. using TENS It is always wise to ask your physical therapist or physician to advise as to which location is most appropriate It is likely that various positions need to be experimented with before the user finds the most effective positioning An effective method to help with temporary pain relief associated with aching or sore PRIMERA User s Manual Page 17 2013 STW Inc muscles is to place electrode pads symmetrically over the pain site opposite of each other in a straight line going through the muscle Garment Belt If using the unit for temporary pain relief of back muscles we recommend using the garment belt to allow correct placement of electrodes Attach the electrodes to the garment belt and remove the plastic backing Insert the lead wire on the belt into Channel Aor B of the unit Attach the belt to your body with the electrodes placed on the lower back and secure comfortably around your front see page 25 Turn on the unit and increase the current intensity until you feel the desired sensation PRIMERA User s Manual Page 18 2013 STW Inc PRIMERA User s Manual Page 19 2013 STW Inc General Quick Start Instructions Check the polarity of the electrodes Be sure the lead wires are securely connected then position and apply the electrodes Insert lead wires into Channel A and or Channel B of the PRIMERA Insert a 9 Volt alkaline battery into the battery compartment and turn on the
25. uted by DJO LLC A DJO Global Company 1430 Decision Street Vista CA 92081 8553 U S A Revised Issue Date 7 1 2013 Document Number AM831 OM EN00 User s Manual Item Number 77617
26. within two years of the manufacture date Expiration date is clearly marked on each electrode package Garment Belt Keep the belt clean because use of the garment belt is recommended to aid in the proper placement of electrodes on the lower back and as such may make dermal contact Follow the cleaning instructions delineated in the sewn on care tag Expected service life is approximately one year User s Manual Keep the user s manual clean dry and away from any open flame or heat source Caution Static electricity may damage this product Note Do not perform unauthorized repairs under any circumstances Should the unit require service warranty or repair please contact the selling dealer or your local DJO customer service PRIMERA User s Manual Page 36 2013 STW Inc Specifications General 1 2 3 4 nu Dual channel individually isolated circuits Type Constant Current 500 to 1 500 Ohms Waveform Asymmetrical rectangular bi phasic with zero DC current Low Battery Indicator If the battery goes below 6 9 volts 0 2 Volts the battery symbol will flash on off once every second If the battery voltage is below 6 6 0 2 Volts the unit will not turn on Open Electrode Detect If an open circuit is detected at the output of channel A or B the output current will be reset at zero TENS 1 e Amplitude 0 80 mA into 500 Ohms load indication only Actual mA will te
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