Model: GM320TE (COMBO)
Page 1: ...Model GM320TE COMBO ...
Page 2: ...r to an appropriate collection point for the recy cling of electrical and electronic equipment For more detailed information about the recycling of this product please contact your local city office household waste disposal service or the retail store where you purchased this product Authorised representative in the European Community Manufacturer SYMBOLS CE mark and notified body registration num...
Page 3: ...NINGS AND PRECAUTIONS 5 DANGER 8 ABOUT THE DEVICE 9 THE DEVICE CONTROLS 10 ATTACHING THE LEAD WIRES 12 ELECTRODE SELECTION AND CARE 12 TIPS FOR SKIN CARE 13 CONNECTING THE DEVICE 14 BATTERY INFORMATION 15 CHANGING THE BATTERY 16 CLEANING FOR YOUR DEVICE 16 TROUBLESHOOTING 17 TECHNICAL SPECIFICATIONS 18 ...
Page 4: ...is equipped with a Liquid Crystal Display indicating operation modes and output as well as an 8 bit micro computer for controlling the system The electronics of the unit create electric impulses the intensity duration frequency per second and modulation of these impulses can be adjusted through the button or knob GENERAL DESCRIPTION SYSTEM COMPONENTS Your device may include the following component...
Page 5: ...res carrying case damage resulting from failure to follow the operating instructions accidents abuse alterations or disassembly by unauthor ized individuals Read the operation manual before using the device Federal law USA restricts this device to sale by or on the order of a physician Observe your phy sician s precise instructions and let him show you where to apply the electrodes For a successfu...
Page 6: ...cement that applies current to the carotid sinus neck region Patients with implanted electronic devices for example a pacemaker or metallic implants should not undertake Any electrode placement that causes current to flow transcerebrally through the head The use of unit whenever pain symptoms are undiagnosed unit etiology is determined The use of TENS whenever pain syndromes are undiagnosed until ...
Page 7: ...ntion or retardation of disuse atrophy Increasing local blood circulation Muscle re education Immediate post surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion Contraindications Powered muscle stimulators should not be used on patients with cardiac demand pacemakers ...
Page 8: ...electrodes over the carotid nerve The device is not effective for pain of central origin headaches The device may interfere with electronic monitoring equipment such as ECG monitors and ECG alarms Electrodes should not be placed over the eyes in the mouth or internally These devices have no curative value TENS devices should be used only under the continued supervision of a physician TENS is a sym...
Page 9: ...ontinued until reevaluation by a physician clinician Always turn the device off before applying or removing electrodes Skin irritation and electrode burns are potential adverse reactions The following statements are available for EMS operation function Warnings The long term of chronic electrical stimulation are unknown Stimulation should not be applied over the carotid sinus nerves particularly i...
Page 10: ...ncy has not been established Caution should be used for patients with suspected or diagnosed heart problems Caution should be used for patients with suspected or diagnosed epilepsy Caution should be used in the presence of the following a When there is a tendency to hemorrhage following acute trauma of fracture b Following recent surgical procedures when muscle contraction may disrupt the healing ...
Page 11: ...operating machinery or during any activity in which involuntary muscle contractions may put the user at undue risk of injury Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators DANGER The device does not have AP APG protection Explosion hazard is possible if used in the presence of explosives flammable materials or flammable anesthetics Ca...
Page 12: ...llable output channels This device creates electrical impulses whose amplitude duration and modulation can be altered with the controls or buttons The device controls are very easy to use the cap and slide cover protect accidental changes in settings ...
Page 13: ...de key is used to select set the type of treatment utilized The seven modes are Burst B Continuous C Modulation M Strength Duration and Rate modulation SDR Strength Duration and Width modulation SDW Synchronous S Alternation A TIME Treatment Time of device can be pre select set with Time key There are three programs fixed dura tion of 15 30 and 60 minutes and one program of continuous output Press...
Page 14: ...nt setting WIDTH The pulse Width key regulates the pulse width for both channels RATE The pulse Rate key regulates the number of pulse per second for both channels SET ENT The SET ENT keys are used to select the type of treatment utilized The type of treatment utilized includes cycle On time On Ramp time and cycle Off time The selected parameter will flash during adjust The keys regulate the numbe...
Page 15: ...ad wire instead of its insulated connector may cause wire breakage Caution Never insert the plug of the lead wire into an AC power supply socket ATTACHING THE LEAD WIRES ELECTRODE SELECTION AND CARE Your physician practitioner should decide which type of electrode is best for your condition Follow application procedures outlined in electrode packaging to maintain stimulation and prevent skin irrit...
Page 16: ...on that is recommended by your physician Apply let dry and apply electrode as directed This will both reduce the chance of skin irritation and extend the life of your electrodes Avoid excessive stretching of the skin when applying electrodes this is best accomplished by ap plying the electrode and smoothly pressing it in place from the center outward When removing electrodes always remove by pulli...
Page 17: ...odes before applying the electrodes to the skin Note Be sure both intensity controls for Channel 1 and 2 are turned to the OFF position 3 Place Electrodes on Skin Place the electrodes on the skin as recommended by your clinician 4 Insert Lead Wire Connector to device Plug end of lead wire into the channel output receptacle to be used pushing plug in as far as it will go 5 Select Treatment Settings...
Page 18: ...ocess for Channel 2 if appropriate Close the cap after intensity setting ok If the stimulation levels are uncomfortable or become uncomfortable reduce the stimulation amplitude to a comfortable level Cease stimulation and contact your physician practitioner if problems persist BATTERY INFORMATION A 9 volt disposable battery is provided with your unit When the low battery indicator appears the batt...
Page 19: ...compartment Note the proper polarity alignment indicated on both the battery and the compartment CLEANING FOR YOUR DEVICE CHANGING THE BATTERY Your device may be cleaned by wiping gently with a damp cloth moistened with mild soap and water Never immerse the device in water or other liquids Wipe lead wires with a damp cloth as above if they become soiled To properly store the device for an extended...
Page 20: ... the electrodes are in place If the unit appears to be functioning and no stimulation occur the lead wires or electrodes may need to be replaced 3 If the battery appears to be charged and the unit is not functioning turn both intensity Control Knobs to the OFF position counter clockwise for about 7 sec Then gradually turn the intensity Control Knob clockwise until stimulation is felt If device sti...
Page 21: ... By changing mode the output will reset to zero then ramp up to its original setting intensity It will protect users from a sudden surge Patient Compliance counter Shows the treatment times in hours Patient Lock System Prevents the user from changing any fixed parameters set by the physician or li censed practitioner Timer 15 30 60 minute and continuous mode selectable LCD TENS Show modes pulse ra...
Page 22: ...d vice versa The stimulation intensity decreases 20 from the intensity control setting and returns to the setting value the pulse rate increase 45 from the modulated rate to the setting value and return to the modulated rate Total cycle time is 6 seconds Rate Width and Intensity are full adjustable SDW Strength Duration and Width modulation SDW consists of Alternating modulated intensity amplitude...
Page 23: ...hasic square pulse Max charge per pulse 21 micro coulombs maximum Voltage 0 110 Volt Open Circuit Power Source 9 Volt Battery Dimensions 108mm H 61 5mm W 25mm T Weight 140grams battery included Operation Temperature 10 C to 35 C Humidity 20 to 90 non condensing Storage Shipping Temperature 0 C to 70 C Humidity 20 to 90 non condensing All electrical specifications are 10 500Ω load ...
Page 24: ...lectromagnetic interence by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ME equipment as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 ...
Page 25: ...no closer to any part of the EQUIPMENT or SYSTEM including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Interference may occur in the vicinity of equipment marked with the following symbol Declaration electromagnetic immunity The ME system is intended for use in the electromagnetic environment specified below The custom...
Page 26: ...cal 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 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power ...
Page 27: ...to perform its intended function Nearby electronic equipment may be affected Harmonic emissions IEC 61000 3 2 Passed The ME system must be used only in a shielded location with a minimum RF shielding effectiveness and for each cable that exits the shielded location a minimum RF filter attenuation of 80 dB from 10 MHz to 20 MHz 100 dB from 20 MHz to 80 MHz and 80 dB from 80 MHz to 100 MHz The minim...
Page 28: ... you can see the hr symbol show on the LCD the rate is 0 Hz you are in the doctor mode Some model with min symbol 2 See Compliance meter value After you enter the doctor mode the compliance meter value is showing on the LCD with hr symbol Some models with min symbol 3 Reset the compliance meter value When the doctor want to reset the compliance meter s value for a new treatment cycle you can do as...
Page 29: ...nly adjust the amplitude knobs for his comfortable intensity lock key Width for TENS Combo SET for EMS Rate for IF HV 5 Unlock the parameter When the doctor want to change the prescription parameters which had been locked you must to unlock it first The follow steps are to unlock the parameters Enter the doctor mode Press the MODE key first then press the unlock key Thus the lock symbol will disap...
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Page 32: ...AP 320TE COMBO A04 APEX MEDICAL CORP No 9 Min Sheng St Tu Cheng New Taipei City 23679 Taiwan www apexbrand com Print 2013 All rights reserved APEX MEDICAL S L Elcano 9 6a planta 48008 Bilbao Vizcaya Spain ...
