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Richmar EMG Pro Instruction Manual

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EMG Pro
DQEMG
INSTRUCTION MANUAL

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  • Page 1 EMG Pro DQEMG INSTRUCTION MANUAL...
  • Page 2 EMG Pro This manual is valid for the EMG Pro. harmful interference in a residential installation. This equipment generates, uses This instruction manual is published by and can radiate radio frequency energy Compass Health Brands Corp. and, if not installed and used in accordance with the instructions, may cause harmful Compass Health Brands Corp.

  • Page 3: Table Of Contents

    EMG Pro TABLE OF CONTENTS Symbols ................................4 Introduction................................. 5 Intended Use ............................6 Contraindications ............................ 6 Safety Information ............................7 Warnings ..............................7 Precautions ............................... 10 Package Contents .............................12 About Device ..............................13 Operation Instructions .........................13 Lead Wire and Electrode Assembly .....................13 Electrode Placement .............................

  • Page 4: Symbols

    EMG Pro SYMBOLS GLOSSARY OF SYMBOLS Type BF applied part. Refer to instruction manual / booklet. Medical Device Electrical devices are recyclable material and should not be disposed of with household waste after their useful life. Help us Medical Device protect the environment and save resources and by taking this device to the appropriate collection point.

  • Page 5: Introduction

    EMG Pro INTRODUCTION The EMG Pro is a single channel, hand- NMES is the elicitation of muscle contraction using electrical impulses. The held, non-sterile, battery-powered, multi- patient device intended to be used by impulses are generated by the device adult patients under the supervision of a and delivered through the electrodes or trained clinical healthcare provider.

  • Page 6: Intended Use

    EMG Pro INTRODUCTION INTENDED USE NMES detrusor muscles through reflexive Relaxation of muscle spasms mechanisms and strengthening of • Prevention or retardation of disuse pelvic floor muscles • atrophy Incontinence treatment for • Increasing local blood circulation assessing EMG activity of the •...

  • Page 7: Safety Information

    EMG Pro SAFETY INFORMATION DO NOT drive a vehicle while the facial area unless you are under • device is stimulating and attached strict guidance from a qualified to your body. clinician. Skin irritation from the treatment • of NMS or EMG itself does not generally occur.
  • Page 8 EMG Pro SAFETY INFORMATION Simultaneous connection of a producing equipment that causes patient to a high frequency surgical electrical sparks etc. In the equipment may result in burns at EMG mode, the device may be the site of the stimulator electrodes...
  • Page 9 EMG Pro SAFETY INFORMATION Ensure NO residual skin lotions Electrode placement and • • or conductive gels are left on the stimulation settings should be skin prior to using the electrodes based on the guidance of the as this can result in burns due to prescribing practitioner.

  • Page 10: Precautions

    EMG Pro SAFETY INFORMATION People with extra-urethral People with complete peripheral • • incontinence (fistula, ectopic denervation of the pelvic floor ureter) MUST NOT be treated with MUST NOT be treated with probe. probe. DO NOT use probe for treatment •...

  • Page 11: Adverse Reactions

    EMG Pro SAFETY INFORMATION When patients have absence of DO NOT place electrodes over • • sensation due to denervation of the carotid sinus nerves, larynx pelvic floor. or trachea, inside mouth, on NOT for use in children. anaesthetized or desensitized skin.

  • Page 12: Package Contents

    EMG-RLW EMG Channel EMG-CLW Lead Wire EMG USB Cable EMG-USB EMG Device Stand EMG-STAND EMG Carrying Case EMGCC EMG PRO WITH PROBES PACKAGE CONTENTS Description SKU# EMG PRO DQEMG EMG Vaginal Probe EMG-VP EMG Rectal Probe EMG-RP 2” x 2” Multistim Electrodes (4/pk)

  • Page 13: About Device

    EMG Pro ABOUT THE DEVICE OPERATION INSTRUCTIONS ON/OFF press to power on or switch off the device press to finish the session (program) or the settings, or return to previous menu THRS [ ] THRS [ ] adjust the EMG threshold level...

  • Page 14: Electrode Placement

    EMG Pro ELECTRODE PLACEMENT ELECTRODE PADS 1.  Connect electrode pads to lead wires. Insert the lead wire connector into electrodes connector. Make sure no bare metal of the pins is exposed. Electrode connection 2. Make sure the device is turned off. Connect lead wires to the device.

  • Page 15: Vaginal Probe

    EMG Pro ELECTRODE PLACEMENT 3. Apply a suitable lubricant to the rectal probe and gently insert it into the anus, as Position shown on the right. of rectal probe VAGINAL PROBE 1. Connect vaginal probe to lead wire. Insert the lead wire connector into probe connector.

  • Page 16: Replacing Batteries

    EMG Pro BATTERY INFORMATION 2. Insert four AA batteries. Make sure the polarity of batteries correspond to the sign on battery box. 3. Reposition the battery cover back onto device. REPLACING BATTERIES 1.   When low battery alert displays on screen, it’s time to replace with new AA batteries.
  • Page 17 EMG Pro QUICK START GUIDE Surface Electrode and Probe Placement When using EMG or ETS mode, connect the EMG reference lead wire to an electrode pad and place it on the body site indicated by your physician, making sure the skin is free from grease and dirt. Repeat the above procedure with the other two electrode pads.

  • Page 18: Turning Off The Device

    EMG Pro QUICK START GUIDE Note: Place the device on its pedestal or hold the device in hand. • For EMG and ETS sessions, relax the muscle so that the microvolt reading is • as low as possible. Below 6µV is acceptable, while below 4µV is ideal.

  • Page 19: Home Menu

    EMG Pro HOME MENU The EMG Pro has a Patient Mode for general use and a Therapist Mode more practical for a clinician. Patient Mode has functions of the device locked and preset programs and parameters of custom programs cannot be selected.
  • Page 20 EMG Pro HOME MENU SETTING UP PATIENT MODE The default treatment mode is Therapist Mode. In Therapist Mode, all programs are available and the treatment mode icon appears. Follow the below steps to set up a program as a prescription for patients.

  • Page 21: Emg Treatment Functions

    EMG Pro EMG TREATMENT FUNCTIONS EMG WORK/REST and firmly as possible. During rest The W/R phase consists of Work and period the patient should relax as Rest periods and repeated trial times quickly as possible, below 4µV or (repetitions). During the work period, lower.
  • Page 22 EMG Pro EMG TREATMENT FUNCTIONS EMG PARAMETERS The range of EMG parameters are as follows: SETTINGS VALUE Time 99 minutes max Work Time 2-99 seconds Rest Time 2-99 seconds Trials 2-99 Thrs. 0-2000 µV A/M Thrs. Manual/Auto. Auto. Fill Disable/Enable...
  • Page 23 EMG Pro EMG TREATMENT FUNCTIONS AUTO AND MANUAL THRESHOLD didn’t trigger the stimulation during (A/M THRS.) the work period, the next threshold There are two ways to adjust EMG will be reduced by 5%. threshold - Auto and Manual. Manual Threshold:...
  • Page 24 EMG Pro EMG TREATMENT FUNCTIONS HEART FILTER on the lower abdominals, legs, lower If the patient measures EMG near the arms, lower back, buttock or pelvic heart, a Heart Filter should be used area. The filter makes sure the 60 to filter out the heartbeat.
  • Page 25 EMG Pro EMG TREATMENT FUNCTIONS EMG PROGRAM SELECTION CP1 = Custom Program 1 • W:5s = Work time of every trial is 5 • seconds R:5s = Rest time of every trial is 5 • seconds Press button to choose •...
  • Page 26 EMG Pro EMG TREATMENT FUNCTIONS EMG TREATMENT SYMBOL DESCRIPTION EMG threshold in µV Current trial cycle / total number of trial cycles Real time EMG voltage in µV Threshold Indicator Standby Status Indicator Work Status Indicator Biofeedback Voice Level Countdown timer Indicates the EMG value is above the threshold and holds for at least one second.
  • Page 27 EMG Pro EMG TREATMENT FUNCTIONS EMG TREATMENT – STANDBY Press [THRS] to adjust threshold. • Press to adjust the level • [▲] [▼] of biofeedback prompt voice. Press [OK] to start and pause a • session. Press [ESC] to go back to the prior •...
  • Page 28 EMG Pro EMG TREATMENT FUNCTIONS Muscle Strength Grading Scale Measured in EMG Microvolts µV Scale 1 Virtually no muscle contraction and very little microvolt readings Scale 2 Slight muscle contraction with little movement, increase microvolt reading and a short muscle contraction holding time...
  • Page 29 EMG Pro EMG TREATMENT FUNCTIONS EMG RESULTS Press [THRS] to save the EMG • treatment results. Press [OK] to go back to the • function menu and save the data Press [ESC] to go back to the • function menu but not save the data...
  • Page 30 EMG Pro EMG TREATMENT FUNCTIONS RESULT MEANING CALCULATION OnSet Time The average onset of The average time taken after each muscle contraction respective “work” prompt to reach measured in seconds; 75% of the average value of the readings below 1 previous work period.

  • Page 31: Ets Treatment Functions

    EMG Pro ETS TREATMENT FUNCTIONS ETS PARAMETERS ETS combines EMG and NMES. The EMG parameters are the same as EMG function. SETTINGS VALUE Time 99 minutes max Work Time 2-99 seconds Rest Time 2-99 seconds Trials 2-99 Thrs. µV 0-2000 A/M Thrs.
  • Page 32 EMG Pro ETS TREATMENT FUNCTIONS HOW TO SET EMG THRESHOLD Press [OK] – Biofeedback screen • FOR ETS SESSION will populate, and user can manually ETS treatment is useful for muscle set biofeedback using the [THRS] improvement. ETS begins with EMG buttons work/rest training.
  • Page 33 EMG Pro ETS TREATMENT FUNCTIONS ETS MODE SELECTION Four modes: Incontinence, Re-education, Custom, and App Program. Press button to choose • [▲] [▼] a mode. Press [OK] to go to the next user • interface. Press [ESC] to go back to the prior •...
  • Page 34 EMG Pro ETS TREATMENT FUNCTIONS ETS SETTINGS Press button to choose • [▲] [▼] a setting. Press [OK] to go to the next user • interface. Press [ESC] to go back to the prior • user interface. Press [THRS] to adjust parameters.
  • Page 35 EMG Pro ETS TREATMENT FUNCTIONS NMES Output Indicator When the real-time EMG value is above the threshold, this appears and holds one second at most. Meanwhile, the NMES output is activated immediately and continue until the NMES countdown timer is over.
  • Page 36 EMG Pro ETS TREATMENT FUNCTIONS ETS TREATMENT – CONTRACT Press [ESC] to finish a session. • Press [OK] to pause a session. • Note: To avoid the effects of electromagnetic interference, NEVER use the device in the EMG or ETS function within 3-4 meters of a mobile telephone or near any other powerful radio interference producing equipment that causes electrical sparks.
  • Page 37 EMG Pro ETS TREATMENT FUNCTIONS ETS TREATMENT – RELAX Press [ESC] to finish a session. • Press [OK] to pause a session. • ETS TREATMENT – PAUSE Press [ESC] to finish a session. • Press [OK] to continue a session.

  • Page 38: Tens Treatment Functions

    EMG Pro TENS TREATMENT FUNCTIONS TENS PARAMETERS Settings Value Time 1-99 minutes Frequency 2-120 pps Duration 50-450 µs TENS WAVEFORM F: Pulse Frequency D: Phase Duration...
  • Page 39 EMG Pro TENS TREATMENT FUNCTIONS TENS MODE SELECTION TENS offers three modes: Pain Relief, Custom and App program. Press button to choose • [▲] [▼] a mode. Press [OK] to go to the user next • interface. Press [ESC] to go back to the prior •...
  • Page 40 EMG Pro TENS TREATMENT FUNCTIONS TENS TREATMENT SYMBOL DESCRIPTION Waveform Frequency in pps Phase Duration in µ Output Intensity Standby Status Indicator Work Status Indicator Countdown Timer Stimulation Work Period Indicator Pause Indicator Press to go to check program settings [►]...
  • Page 41 EMG Pro TENS TREATMENT FUNCTIONS TENS TREATMENT – WORK Press [ESC] to finish a session. • Press [OK] to pause a session. • TENS TREATMENT – PAUSE Press [ESC] to finish a session. • Press [OK] to continue a session.

  • Page 42: Nmes Treatment Functions

    EMG Pro NMES TREATMENT FUNCTIONS NMES PARAMETERS Settings Value Phase Current Phase/Total Phase Time 1-99 minutes Work Time 2-99 seconds Rest Time 2-99 seconds Work Fre. 2-120 pps Rest Fre. 0-4 pps Duration 50-450 μs Ramp Up 0.1-9.9 seconds Ramp Down...
  • Page 43 EMG Pro NMES TREATMENT FUNCTIONS NMES WAVEFORM PHASE There may be up to five phases in a program. • 1/5 represents a total of 5 phases in a program, with the screen displaying the • parameters of phase 1. 1/1 represents only one phase in this program.
  • Page 44 EMG Pro NMES TREATMENT FUNCTIONS NMES MODE SELECTION NMES offers four modes: Incontinence, Re-education, Custom and App program. Press button to choose • [▲] [▼] a mode. Press [OK] to go to the user next • interface. Press [ESC] to go back to the prior •...
  • Page 45 EMG Pro NMES TREATMENT FUNCTIONS NMES TREATMENT SYMBOL DESCRIPTION Waveform Frequency Phase Duration Output Intensity Standby Status Indicator Work Status Indicator Countdown TImer Stimulation Work Period Indicator Stimulation Rest Period Indicator Pause Indicator Press to go to check program settings [►]...
  • Page 46 EMG Pro NMES TREATMENT FUNCTIONS NMES TREATMENT – STANDBY Press [ESC] to go back to prior user • interface. Press mA[+], and [mA-] to adjust • TENS output intensity. When the NMES output intensity is • greater than zero, the NMES session begins.

  • Page 47: Smart Operations

    EMG Pro NMES TREATMENT FUNCTIONS NMES RESULTS Press [ESC] or [OK] to go back to • Home Menu. Treatment results cannot be saved in • NMES mode. Time: Total time of treatment session • NMES Avg: Average stimulation level •...
  • Page 48 EMG Pro SMART OPERATIONS UPLOAD EMG HOME REPORT The device can store user’s EMG training data and upload it to the Computer App. This allows a healthcare professional to make a prescription for at home use. This device cannot distinguish training data between different patients. Only when the device is connected via the computer software, can the recorded data in the computer distinguish between patients.

  • Page 49: Tips

    EMG Pro TIPS The Tips interface provides useful information to patients, including the definition of Muscle Strength Grading Scale, Operation Steps, explanation of Abbreviations and how to use Auto. Fill function. Press button to choose • [▲] [▼] an item.

  • Page 50: Line View

    EMG Pro HISTORY LINE VIEW A single page will display seven sets of training data. Press button to choose a • [◄] [►] different set of data. Press [OK] to check detailed • information. TABLE VIEW A single page can display seven sets •...

  • Page 51: System Settings

    EMG Pro HISTORY DELETING ALL TREATMENT DATA To delete all treatment data, do the following: Press [OK] to delete. • Then, press [OK] again to confirm • action. Press [ESC] or [OK] to return after • the processing has finished.

  • Page 52: Date Settings

    EMG Pro SYSTEM SETTINGS DATE SETTINGS Press button to select an • [▲] [▼] item. Press THRS [︽], THRS [︾] to adjust • the value. Parameters will save automatically after adjustment. Press [ESC] to return to the previous • interface.
  • Page 53 EMG Pro SYSTEM SETTINGS TREATMENT MODE The default treatment mode is Therapist Mode. In Therapist mode, all programs are available. The treatment mode icon appears. THERAPIST MODE TO PATIENT MODE Follow the below steps to set up a program as a prescription for patients. The patient can then bring the device home for treatment.

  • Page 54: Sound Settings

    EMG Pro SYSTEM SETTINGS PATIENT MODE TO THERAPIST MODE go to Therapist mode and the screen will go to next user Press • [◄] [►] interface automatically. Enter the correct passwords to complete the settings and • [▲] [▼] [◄] [►] switch back to therapist mode.

  • Page 55: Language Settings

    EMG Pro SYSTEM SETTINGS LANGUAGE SETTINGS Press button to select an • [▲] [▼] item. Press THRS [︽], THRS [︾] to adjust • the value. Parameters will save automatically after adjustment. Press [ESC] to return to the previous • interface.

  • Page 56: Specifications

    EMG Pro SPECIFICATIONS MAIN DEVICE Service Life 3 Years Dimensions 5.47” x 2.68” x 1.26” / 139mm x 68mm x 32mm Weight 5.57oz (without batteries) / 158g BATTERY Type: DC 6V, 4×1.5V AA • Service Life for New Super Heavy Duty Batteries: Approximately 30 days •...
  • Page 57 EMG Pro SPECIFICATIONS STIM-TENS Single Channel Amplitude: 0-100 mA at 500 Ohm load (Actual mA will tend to be less than indicated due to Electrode impedance.) Type: Constant Current Waveform: Symmetrical Biphasic Pulse Width 50-450 μs Pulse Rate 2-100Hz Time...

  • Page 58: Electromagnetic Compatibility (Emc)

    EMG Pro SPECIFICATIONS Program Time: 1-99 minutes Threshold(μV): 0 - 2000μV Filter: Wide/Narrow Biofeedback: Above/Below/Continue/OFF Work/Rest Time(s): 2-99 seconds Number of Trials: 2-99 Threshold Setting: Auto/Manual Time(s): 2-99 seconds Frequency(Hz): 2-120Hz 50-450 μs Pulse width(μs): Ramp Times(s): 0.1-9.9 seconds ELECTROMAGNETIC COMPATIBILITY (EMC) This device should not be used adjacent to or stacked with other equipment •...

  • Page 59: Emc Tables

    RFID devices, etc.) emit radio frequencies that could interrupt EMG Pro operation if operated in a range too close to the EMG Pro. Practitioners should be aware of possible radio frequency interference if portable devices are operated in close proximity to the EMG Pro.
  • Page 60 EMG Pro EMC TABLES Table 2 DECLARATION - ELECTROMAGNETIC IMMUNITY The device is intended for use in the electromagnetic environment specified below. The customer or the user of device should assure that it is used in such an environment. Immunity test...
  • Page 61 EMG Pro EMC TABLES Table 3 DECLARATION - ELECTROMAGNETIC IMMUNITY The device is intended for use in the electromagnetic environment specified below. The customer or the user of device should assure that it is used in such an environment. Immunity test...
  • Page 62 EMG Pro EMC TABLES NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

  • Page 63: Cleaning And Maintenance

    EMG Pro CLEANING AND MAINTENANCE WARNING Only medically approved accessories should be used. MAIN DEVICE Turn the power off and disconnect lead wires from the device • Medical Device After each use, clean the device with a soft, slightly moistened cloth and •...

  • Page 64: Tips

    EMG Pro CLEANING AND MAINTENANCE TIPS Ensure NO residual skin lotions or conductive gels are left on the skin prior to • using the electrodes as this can result in burns due to inadequate adhesion. Remove hair on skin using scissors; DO NOT use razor to remove hair.

  • Page 65: Disinfection Instruction

    EMG Pro CLEANING AND MAINTENANCE Dry the probe with cloth/towel or air dry. • Visually inspect entire probe to make sure that it’s clean, no visible • soil remains, and there are no defects in the probe housing or cables, which could potentially cause harm to the patient.

  • Page 66: Troubleshooting

    EMG Pro TROUBLESHOOTING If you are experiencing trouble with the device, please follow the steps below: Check the lead wires for splits or breaks in the wire or at the end where the • connectors are attached to the wire.

  • Page 67: Limited Warranty

    EMG Pro LIMITED WARRANTY Compass Health Brands warrants that your exclusion or limitation of incidental or EMG Pro is free of defects in material and consequential damages, so the above workmanship. This warranty shall remain limitation or exclusion may not apply in effect for three (3) years* from the date to you.

  • Page 68: Custom Programs

    EMG Pro APPENDIX CUSTOM PROGRAMS Treatment Pulse Work Rest Ramp Ramp Frequency time width Time Time Down (Hz) (min) (us) 1~99min 2~100 50~450 2~99 2~99 0.1~9.9 0.1~9.9 1~99min 2~120 50~450 1~99min 2~120 50~450 2~99 2~99 0.1~9.9 0.1~9.9 1~99min 5~80 150~400...
  • Page 69 EMG Pro APPENDIX NMES PRESET PROGRAMS FOR INCONTINENCE Phase Work Rest Work Rest Ramp Ramp Phase Width Application Phase Time Fre. Fre. Time Time Down Type (us) (Hz) (Hz) Sensory Nerve Damage F/M Rectal Stimulation Pelvic Workout Max Pelvic Floor...
  • Page 70 EMG Pro APPENDIX NMES PRESET PROGRAMS FOR INCONTINENCE Phase Work Rest Work Rest Ramp Ramp Phase Width Application Phase Time Fre. Fre. Time Time Down Type (us) (Hz) (Hz) Weekly Maintenance New Mums Pain Relief...
  • Page 71 EMG Pro APPENDIX NMES PRESET PROGRAMS FOR RE-EDUCATION Phase Work Rest Work Rest Ramp Ramp Phase Width Application Phase Time Fre. Fre. Time Time Down Type (us) (Hz) (Hz) Muscle Re-Education 10/10 Muscle Re-Education 10/20 Muscle Re-Education 10/30 Strength Augmentation...
  • Page 72 EMG Pro APPENDIX NMES PROTOCOLS Application Indications Intensity (mA) Comments Increase intensity to desired level - Strength of submaximal - Neuromuscular control Appropriate for Muscle contraction. Should - Training with stronger stronger contractions Re-education produce a strong. submaximal contractions that require greater...
  • Page 73 EMG Pro APPENDIX TENS PRESET PROGRAMS FOR PAIN Phase Work Rest Work Phase Width Application Phase Time Fre. Fre. Time Type (us) (Hz) (Hz) Sensory TENS 1 Sensory TENS 2 Motor TENS 1 Motor TENS 2 Mixed Frequency TENS 100/2...
  • Page 74 EMG Pro APPENDIX Application Indication Intensity (mA) Comments Increase the intensity slowly. Mixed Frequency Chronic Pain The device will repeatedly TENS may be helpful in and for those cycle between Sensory TENS preventing habituation who are no and Motor TENS producing...
  • Page 75 EMG Pro NOTES _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________...
  • Page 76 Manufactured for: Compass Health Brands Corp. Toll Free 1.888.549.4945 6753 Engle Road Middleburg Heights, OH 44130 richmarweb.com DQEMG_UM_B_241210 ©2024 Compass Health Brands Corp. Made in China.

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