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Hoggan Scientific microFET 2 User Manual

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USER GUIDE
IFU 01.EN Rev E
P a g e | 1

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  • Page 1 USER GUIDE IFU 01.EN Rev E P a g e | 1...
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  • Page 3: Table Of Contents

    Table of Contents Page What is Included Contraindications Warnings and Notifications Directions for Use Operating Features General Use Data Retrieval Mode Wireless Operation Threshold Settings Force Measurement Settings Battery Check Muscle Testing Low Battery Charging Battery Replacing Battery Storage and Transporting Service / Maintenance / Cleaning Calibration Warranty...

  • Page 4: What Is Included

    ® microFET 2 System CAUTION: Federal (USA) law restricts the sale of this device by or on the order of a physician. USER QUALIFICATION ® The microFET 2 must be used by a physician or by medical personnel under the supervision of a physician. The user must have received sufficient training in clinical procedures.

  • Page 5: Contraindications

    Available Muscle Testing Positions wall chart and Upper and Lower Body test record forms can be downloaded and printed from the website at https://hogganscientific.com/product/microfet2-muscle- tester-digital-handheld-dynamometer/. CONTRAINDICATIONS ® The microFET 2 is contraindicated under the following: On or near open wounds Patients having severe osteoporosis On or near burned tissue On or near the eye...
  • Page 6 Rechargeable lithium-ion battery is only serviceable part. Do not service the battery while in use with patient. Making any modifications or using any accessories not specifically approved by Hoggan Scientific, LLC may void the warranty as well as reduce immunity to electromagnetic interference, or increase electromagnetic emissions, and result in improper operation.

  • Page 7: Directions For Use

    The use of portable and mobile Bluetooth (RF) equipment: A. Can possibly affect medical electrical equipment normal operation. B. The RESPONSIBLE ORGANIZATION (Hospital, clinic, healthcare professional) should identify, analyze, evaluate and control related risks. C. RESPONSIBLE ORGANIZATION - Changes to IT- ®...

  • Page 8: General Use

    • Threshold Button – (See Figure 2) Controls the amount of ® force required before the microFET 2 begins recording test data. • LCD Windows – Display Test Results and Option Settings. Peak Force – Displays peak force of muscle test Duration –...

  • Page 9: Data Retrieval Mode

    DATA RETRIEVAL MODE (View Saved Tests) • With the device in the test mode (displaying zeroes in both display windows), hold down the threshold button and click the reset button, this puts the device in data retrieval mode. • The device will display the peak force (in the peak force window), test number (in the left hand side of the duration window), and duration of the test (in the right hand side of the duration window) (See Figure 3).

  • Page 10: Threshold Settings

    Figure 4. Wireless Mode Setting • The duration screen will display the current wireless power mode as “On” or “Off”. • Toggle the wireless power setting by pressing the threshold button to select wireless “On” or “Off”. • Press the reset button. ressing reset saves the setting in eprom memory, and returns the device to test mode.

  • Page 11: Force Measurement Settings

    Figure 5. LCD Display Windows /Threshold Setting and Sample Test Results • The threshold can be toggled between high and low by pressing the threshold button (see Figure 2) when the device is in test mode. During testing, live force and time readings will display in LCD windows when the force being applied goes above the threshold selected, and ends when force goes below the threshold.

  • Page 12: Battery Check

    BATTERY CHECK • With the device powered on in test mode, hold down the threshold button and click the reset button. • Continue to hold the threshold button for five seconds. The device will display “P” in the peak force window and a number from 1 to 100 in the duration window.
  • Page 13 position to exert force against the limb associated with the muscle. The test begins with the clinician gradually applying force and the patient trying to resist. The object of the test is for the clinician to overcome, or "break" the patient's resistance. Multiple published studies show that hand-held dynamometry provides consistent, reliable results, both across multiple tests by single tester, and across multiple testers.

  • Page 14: Low Battery

    The criteria used for interpretation of validity is as follows: Intrinsic Hand Muscles: VALID 0-15.0% EQUIVOCAL 15.1-20.0 % INVALID >20.0 % The criteria used for all other muscles is: VALID 0-10.0 % EQUIVOCAL 10.1-15.0 % INVALID > 15.0 % LOW BATTERY INDICATOR Blinking readouts in LCD displays or unlit segments of the LCD display ®...

  • Page 15: Replacing Battery

    REPLACING THE BATTERY When replacing rechargeable battery, use only rechargeable battery supplied by Hoggan Scientific, LLC: Model ICR14250 (1) 3.7V ½ AA LI-ion rechargeable battery, 280 mAH. Other batteries may cause damage to device and void warranty. These batteries can be purchased from Hoggan Scientific, LLC LLC.

  • Page 16: Storage And Transporting

    Figure 10. Battery Replacement STORAGE AND TRANSPORTING ® The microFET 2 is provided with a hard sided protective carry case. It is recommended to keep the device in the case when in transportation or when not in use. Store the device in a cool dry location. SERVICE, MAINTENANCE, AND CLEANING ®...

  • Page 17: Calibration

    2 fails to operate because of defect in materials or workmanship at any time within one (1) year of the ship date, it will be repaired free of charge by Hoggan Scientific LLC. (return shipping not included). Extended warranties are available for an additional fee.

  • Page 18: Warranty Exclusions And Limitations

    2 warranty does not cover damage by negligence, misuse, or accident. Damage or device failure caused by modifications or repairs other than those approved by Hoggan Scientific, LLC or its authorized repair agent, or damage to equipment resulting from improper installation or operation is not covered. Any warning or instructional labels or decals must remain on the device for the warranty to be valid.

  • Page 19: Specifications

    Contact Hoggan Scientific, LLC. Replacement parts (attachments) will be shipped directly from Hoggan Scientific, LLC. All repair services will be performed at Hoggan Scientific, LLC Manufacturing plant. Except for replacing battery, do not attempt to repair device. Attempted repairs will void all warranties.

  • Page 20: Device Classifications

    IEC 61000-4-3 (2006), A1:(2007), +A2:(2010) IEC 61000-4-8 (2009) CISPR 11 Emissions Class B (2009), +A1:2010 Radiated Emissions Conducted Emissions FCC Part 15B TECHNICAL ASSISTANCE: For further assistance, contact Hoggan Scientific, LLC at: Phone: 800-678-7888 / 801-572-6500 Email: sales@hogganscientific.com Website: www.hogganscientific.com IFU 01.EN Rev E...
  • Page 21 Electromagnetic Compatibility Guidance (in accordance with EN/IEC 60601- 1-2:2014) TABLE 1: Manufacturer’s Declaration – Electromagnetic Emissions ® The microFET is intended for use in the electromagnetic environment specified ® below. The customer or the user of the microFET should ensure that it is used in such an environment.
  • Page 22 TABLE 3: Manufacturer’s Declaration – Electromagnetic Immunity ® The microFET is intended for use in the electromagnetic environment specified ® below. The customer or the user of the microFET should assure that it is used in such an environment. IMMUNITY 60601 Compliance Electromagnetic Environment - Guidance...
  • Page 23 is observed, additional measures may be necessary, such as reorienting or relocating ® the microFET Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 TABLE 4: Recommended separation distanced between portable and mobile RF communications equipment and the microFET®2 ®...

  • Page 24: Graphic Symbols And Definitions

    GRAPHIC SYMBOLS AND DEFINITIONS Device will not work when connected to AC outlet Attention, See Instructions for Use Model number Serial Number Keep Dry For prescription use only IPX0 Do not wet the device Class II Electrical Equipment Type B applied part – External Body only contact FCC Compliant Device Direct Current Device is provided non-sterile...

  • Page 25: Manufacturer Information

    © 2023, Hoggan Scientific, LLC. All Rights reserved. Printed in the U.S.A. microFET is a registered trademark of Hoggan Scientific, LLC. Bluetooth is a registered trademark of the Bluetooth Special Interest Group (SIG). 2797 0086 Hoggan Scientific, LLC 3653 West 1987 South, Bldg. 7...

  • Page 26: Muscle Test Record Forms

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  • Page 32 3653 WEST 1987 SOUTH, BLDG. #7 SALT LAKE CITY, UT 84104 USA PH: 800-678-7888 / 801-572-6500 www.hogganscientific.com IFU 01.EN Rev E P a g e | 32...

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