Safety Warning and Cautions
Contents
1. Easily fragile product Keep the product in the dry place Be away from water and rain Product package should be recycled i 5 B He Stacked up 4 cartons at most Temperature range 0 C to 48 C Humidity 10 to 85 Atmospheric pressure 400hpa to 1060pha The electrode pads coming with the device are disposable and should be replaced when their adhesiveness becomes worse Contact Prospera for replacements Do not let the sticky side of the pad touch anything including the greasy finger tips Clean the pads if necessary with a soft damp cloth Part R eplacement Contact Prospera to order replacement parts Be sure to use only Prospera s Electronic Pulse Massager Check the Prospera website at www prosperacorp com for additional Product information Electronic Pulse Massager Part PLOO9 Electrode Pads Part PL009 P Electric Wire Part PLOO9 W Conformity to Standards 1 The PLOO9 Electronic Pulse Massager is compliance with e 1 C60601 1 Medical electrical equipment Part 1 General requirements for safety e 1EC60601 1 2 Medical electrical equipment Part 1 2 General requirements for safety Collateral Standard Electromagnetic compatibility Requirements and tests e EC 60601 2 10 Medical electrical equipment Part 2 Particular requirements for the safety of nerve and muscle stimulators 2 The electrode pad is compliance with e EN ISO 10993 5 Biological Evaluation of Medical Devices Part 5 Tests2. Rotate the switch knobs on both sides to make the power ON There are two identical power knobs located on the device s upper left and upper right sides respectively To start use the device rotate the switch knobs to tum the power ON Afterwards a letter P will be showed on the LCD display You may use the two channels simultaneously or separately If you decide to Switch Button use one channel only you may just turn one knob to OFF Important Do not rotate the switch knob too fast This knob is also for the Intensity control 5 Step Select one of automatic stimulation programs LCD display shows P Five automatic stimulation programs for waist shoulder joint hand foot sole plus a repeat to stimulate the same area again The LCD display will show a timer of 15 minutes when you choose one of them oes 5 automatic stimulation programs repeat 6 Step Gradually increase the massage intensity to a comfortable level The beginning intensity level should start from 1 Adjust the power intensity to a comfortable level during the treatment by tuning the power knobs The lowest level is 1 and the strongest level is 10 Intensity adjustment 7 Step Select one of massage modes and adjust electronic pulse speed The manual programs for MASSAGE BEAT and KNEAD can be selected by pressing the corresponding button Speed program is available for them Find suitable speed by tun
3. electrical stimulation can put you at risk of injury Do not use the device on children Consult with your physician before using this device because the device may cause lethal rhythm disturbances to the heart in susceptible individuals and Apply stimulation only to normal intact clean healthy skin Do not use this device in high humidity areas such as a bathroom Do not attempt to move the electrode heads while the device is operating and Keep the device away from wet high temperature and direct sunshine Shady and dry place is good for device stock CAUTION AN This device is not effective for pain of central origin including headache This device is not a substitute for pain medications and other pain management therapies This device has no curative value This device is a symptomatic treatment and as such suppresses the sensation of pain that would otherwise serve as a protective mechanism The long term effects of electrical stimulation are unknown Since the effects of stimulation of the brain are unknown stimulation should not be applied across your head and electrodes should not be placed on opposite sides of your head 1 The safety of electrical stimulation during pregnancy has not been established 8 You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium gel 9 If you have suspected or diagnosed heart disease you should follow precautions r
4. 3 uC 500 1 4mA cm 500 18mA 500 0 23W cm 500 25 0 2 1 sec 5 25 1 sec 1 sec The test result of each step should meet the following pass criteria Otherwise it is considered failed and you should contact Prospera Corporation for a repair or replacement K ey function test When the functional keys are pressed step by step the outputs of the device should be identical to the following description 1 When the left or right ON OFF knob at the off condition is turned on the device is turned on but no output at the moment 2 When the function keys such as knead and massage are pressed the corresponding output will be generated on the turned on side 3 When the left or right intensity adjust knob is gradually turned the intensity of the output on the corresponding side will be adjusted to the level showed on the knob 4 When the increase decrease speed keys are pressed the speed of the outputs on both left and right sides will be adjusted to the level displayed on the LCD screen LCD check The information displayed on the LCD screen should be identical to the following description 1 When the ON OFF knob is turned on to start the device the LCD screen displays a letter P 2 When a button of Massage Beat or Knead is selected the LCD screen displays an icon corresponding to the selected button 3 When a button of Waist Shoulder Joint Hand Foot or Sole is sele
5. Safety Warning and Cautions AYN 10 11 I 13 14 15 16 17 18 oo ae Nn WARNING S Do not use this device if you have a cardiac pacemaker implanted defibrillator or other implanted metallic or electronic device Such use could cause electric shock burns electrical interference or death If you are in the care of a physician consult with your physician before using this device Do not apply stimulation on your heart head mouth pudendum or blemished skin areas Do not apply stimulation across your chest because the introduction of electrical current into the chest may cause rhythm disturbances to your heart which could be lethal Do not apply during pregnancy Do not apply stimulation over painful areas If you have painful areas you should consult with your physician before using this device Do not apply stimulation over open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins Do not apply stimulation over or in proximity to cancerous lesions Do not apply stimulation in the presence of electronic monitoring equipment e g cardiac monitors ECG alarms which may not operate properly when the electrical stimulation device is in use Do not apply stimulation when in the bath or shower Do not apply stimulation while sleeping Do not apply stimulation while driving operating machinery or during any activity in which
6. arm and lower extremities leg due to strain from exercise or normal household work activities Introduction of PL 009 Electronic Pulse M assager Overview Py IN N i j ka af n The Device s Parts Lao way outumert Bolg Rightway cutout holy bii au Ba Display screen i _ Lattewaylintensity Rightway intensity Switch knot switch kaol wW Eloslreacia piisi How the device works The operational principle of the device is to generate small pulses of electrical current and deliver the pulses to an ordinary user s skin through electrode adhesive pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved D uick Operation Guid The following steps are used to guide the device operation iS Step Turn both knobs to OFF then insert4pc AAA batteries into the device ee Step Connect the electrode pads to the wire and then connect the wire to the device are Step Put the electrode pads on massage needed body area 4th Step Rotate the switch knobs on both sides to turn the power ON 5th Step Select one of automatic stimulation programs oth Step Gradually adjust the massage intensity qh Step Select one of massage modes and adjust the electronic pulse speed gt Step Start massaging gth Step Rotate the switch knobs on both sides to turn off the device For the details of operation p
7. cted the LCD screen displays a dot on a position in a human figure icon corresponding to the selected button 4 When the speed adjustment key is pressed the LCD screen displays a speed bar comprising of squares which are moving faster 5 When the speed adjustment key is pressed the LCD screen displays a speed bar comprising of squares which are moving slower Program stability test The program should work consistently and identically as designed during multiple tests Use damp cloth or water to clean the device Do not let the sticky side of the pad touch anything including the greasy finger tips Clean the pads if necessary with a soft damp cloth Maintaining the Electronic Pulse M 1 The device uses 4pc AAA batteries To replace the battery make sure both switch knobs are turned OFF Slide the compartment cover open Remove the old batteries Insert 4pc AAA batteries according to the diagram And finally close the cover 2 Be sure the electrode pads are suitable sticky Replace the pads if the following situations occur a cannot sense the stimulation b the stimulation is weaker c cannot stick the pads on the skin d electrode pads are oily wet or their covers having breaking or worn out Recommend to use Prospera s electrode pads 3 Change a new wire if it is too old or broken Recommend to use Prospera s wire How to store the Electronic Pulse Massager Environmental condition for transport and storage
8. ecommended by your physician 10 If you have suspected or diagnosed epilepsy you should follow precautions recommended by your physician 11 Use caution if you have a tendency to bleed internally such as following an injury or fracture 12 Consult with your physician prior to using the device after a recent surgical procedure because stimulation may disrupt the healing process 13 Use caution if stimulation is applied over the menstruating uterus 14 Use caution if stimulation is applied over areas of skin that lack normal sensation 15 Keep this device out of the reach of children 16 Turn off the stimulator if the stimulation feels unpleasant or does not provide pain relief 17 Use this device only with the leads electrodes and accessories recommended by the manufacturer Adverse Reactions e You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin e You may experience headache and other painful sensations during or following the application of electrical stimulation near your eyes and to your head and face and e You should stop using the device and should consult with your physician if you experience adverse reactions from the device Safety symbols A Type B applied part A Indications for U se Attention see operating manual for use To be used for temporary relief of pain associated with sore and aching muscles in the shoulder waist back neck upper extremities
9. for In Vitro Cytotoxicity e EN ISO 10993 10 Biological evaluation of medical devices Part 10 Tests for irritation and delayed type hypersensitivity Trouble Shooting If the device is not operating properly please check it for the following problems or conditions If the recommended action does not solve the problem please return it to the authorized dealer for the replacement repair of the device MALFUNCTION CAUSE SOLUTION Stimulation is weak or not Are the electrode heads in Remove clean and place existent close contact with the skin back on the skin Do the electrode heads If so then separate touch each other Are the wires connected to Disconnect clean and the electrode heads and the reconnect all the parts main device properly Are the batteries dead Replace the dead batteries Skin turns red Is treatment time too long Treat another area Skin feels numb Are electrode heads dirty Clean with damp cloth Do the electrode heads Remove and place again on touch the skin closely the skin Device does not turn on Batteries installed Remove and install correctly batteries Are batteries dead Replace the dead batteries Pads are not sticky Pads get deteriorative Contact Prospera for replacements 10 C onsumer W arranty Prospera offers a 90 day standard warranty to the massage products Labor and parts are included during warranty period Consumers are required to provide model number and dated
10. ing Speed or Speed Massage modes and Speed 8 Step Start massaging After the setting of device it is working The pads can be covered with clothing Turn off the device if necessary or whenever you don t feel comfortable 9 Step Rotate the switch knobs on both sides to turn off the device The best treatment time is 15 minutes each session Disconnect the wires and electrode pads after the massaging Take the batteries out if not used frequently Put the device in a dry and shady place Important Please make sure every part of device and accessories in good conditions before the use of the device Ask for replacement in case of any breaking cracking and scratching Power Source Number of Output Modes Number of Alternating Output Channels Timer Range minutes Weight Dimensions in W x H x D Waveform Shape Maximum Output Voltage Maximum Output Current Duration of primary depolarizing phase Pulse Duration Frequency Net Charge Maximum Phase Charge Maximum Current Density Maximum Average Current Maximum Average Power Density Burst Mode Pulses per burst Bursts per second Burst duration Duty Cycle ON Time OFF Time 6V Battery 3 2 15 min 8 21 oz battery and wire included 2 24 x 7 80 x 0 91 Monophasic Rectangular 12 8 V 500 51V 2k 368V 10 k 15mA 500 3 2mMA 2 k 0 6mA 10k 40 msec 100 680 usec 1 100Hz 18000uUC 500 2
11. lease see the following operating instructions insert the 4pc AAA batteries into the Make sure both the power knobs on both sides are turned OFF To insert the battery slide the compartment cover downward until the cover pops off Insert 4pc AAA batteries according to the diagram in the battery compartment and then close the cover IMPORTANT Match the flat end of the battery to the negative mark and match the other end to the positive mark 2 Step Connect the electrode pads to the wire and then connect the wire to the device The device has two identical ports for connecting the two identical lead wires Each lead wire is coupled to a pair of identical electrode pads Connect the first Electric wire insertion pair of electrode pads to the two terminals of the first lead wire and insert the first lead wire s other end into the first port Connect the second pair of electrode pads to the two terminals of the second lead wire and insert the second lead wire s other end into the second port Electric wire connection to the TIP One channel is suggested for the first electrode pads time use 3 Step Put the electrode pads on massage needed body area 2 pads from one channel are placed on the body area such as shoulder at the same time Make sure the pads stick on the skin Do not place or move the pads when the device is on Note Keep the skin clean before placing the pads 4 Step
12. proof of purchase sales receipt when contacting Prospera for the warranty service Non warranty service is provided on a per incident basis The consumer will verify that the product has failed and provide information for servicing the unit All applicable repairs parts shipping handling local tax and per incident fees will be charged for non warranty repairs and support calls 11 Positions Hand or Foot W arranty Card te O50 nr CSP co prospera Warranty Registration F orm Product Name Product Model Purchase Price Date of Purchase Retailer First Name Last Name Address City State Zip Phone Email Signature and date Please mail to Prospera Corporation 405 Boulder Ct Ste 500 Pleasanton CA 94566 Telephone 925 225 0888 Fax 925 225 0660 Email sales prosperacorp com 13 M anufacturer s Contact Information Prospera Corporation U S 405 Boulder Court Suite 500 Pleasanton CA 94566 Tel 925 225 0888 Fax 925 225 0660 Email jane prosperacorp com
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