Nu-Tek UT1032 Instruction Manual

Nu-Tek UT1032 Instruction Manual

Portable ultrasound device

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INSTRUCTION MANUAL
UT1032
Portable Ultrasound Device
www.nutekmedical.com

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March 11, 2025

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Summary of Contents for Nu-Tek UT1032

  • Page 1 INSTRUCTION MANUAL UT1032 Portable Ultrasound Device www.nutekmedical.com...
  • Page 2 This manual is valid for the UT1032 This user manual is published by Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Dongdixin Technology Co., Ltd. reserves the right to improve and amend it at any time without prior notice. Amendments will however be published in a new edition of this manual.
  • Page 3: Table Of Contents

    TABLE OF CONTENTS 1. FORWARD 2. INTENDED USE 3. EXPLANATION OF ULTRASONIC STIMULATOR EFFECT 4. CONTRAINDICATIONS 5. PRECAUTIONS 6. CAUTIONS 7. PACKAGE CONTENTS 8. PARTS OF THE DEVICE 9. SPECIAL FEATURES 10. STEPS TO CONNECT THE ADAPTOR 11. INSTRUCTIONS FOR USE 12.
  • Page 4: Forward

    INTENDED USE The UT1032 is a portable ultrasound device that generates deep ultrasonic waves within body tissues for the treatment of selected medical conditions such as pain relief, muscle spasms, and joint contractures, but not recommended for the treatment of malignancies.
  • Page 5: Contraindications

    CONTRAINDICATIONS 1. Do not use over or near bone growth centers until bone growth is complete. 2. Do not use over a healing fracture. 3. Do not use over the eyes. 4. Do not use on patients with implanted neurostimulation systems because tissue damage can occur at the location of the implanted electrodes resulting in severe injury or death.
  • Page 6: Cautions

    9. The device should be used only with adapter recommended for use by the manufacturer. 10. Do not modify this equipment without authorization of the manufacturer. 11. Do not service and maintain the device while it is in use. 12. The device must only be served ,repaired and opened by individuals at authorized sales centers.
  • Page 7: Package Contents

    6. DO NOT use the device on persons with bleeding issues/disorders. 7. DO NOT use on areas under anesthesia. WARNING Use of controls or adjustments to performance of procedures other ● ultrasonic energy. PACKAGE CONTENTS Part Quantity UT1032 Adapter User manual Ultrasound gel...
  • Page 8: Parts Of The Device

    PARTS OF THE DEVICE (1) TIME INDICATOR LIGHT (2) TIME BUTTON (3) POWER INDICATOR LIGHT (4) INTENSITY INDICATOR LIGHT (5) MODE BUTTON (6) POWER SWITCH (7) ULTRASOUND HEAD SPECIAL FEATURES 1. All the ultrasound parts are assembled and tested under strict process controls.
  • Page 9: Steps To Connect The Adaptor

    2. The AC/DC adapter is required to power the device. No battery is used. 3. Join the male connector of the AC/DC adapter to the female connector of adapter into a wall outlet to power the unit. The UT1032 is now ready for treatment.
  • Page 10: Instructions For Use

    INSTRUCTIONS FOR USE Please read this instruction manual carefully before using the UT1032 Portable Ultrasound Unit. 1. Turning on the device and head warming feature: Turn the device on by sliding the power switch upwards (towards “ON”). The power indicator light will illuminate.
  • Page 11 3. Set ultrasound intensity: Press the “MODE” button to select the modulation duty cycle. The mode button has three levels, Low (L) - 5%, Medium (M) - 50% and High (H) - 100%, each level corresponds to a LED light indicator. 4.
  • Page 12: Load Detection System Caution

    LOAD DETECTION SYSTEM CAUTION: 1. The device has a load detection system for safety. When the treatment head does not have good contact with the skin, the device will stop treatment automatically, and the time indicator light will flash one time. The device will not continue the treatment program until good contact is made.
  • Page 13: Storage Conditions

    STORAGE CONDITIONS When not in use, store the device with the adapter in a dry room and protect it against extreme moisture, heat and direct sunlight. Never place any heavy objects on the storage case. Storage and transportation conditions:-20°C-55°C; ● 10%-93%;...
  • Page 14: Unit Specifications

    UNIT SPECIFICATIONS Item Description Ultrasound Modulation Frequency: 1.0MHz±10% Max. Output Power: 6.4W±20% (Modulation duty cycle at100%) Output Power: L: 0.32W±20% M: 3.20W±20% H: 6.40W±20% Pulse Repetition Rate: 100Hz±10% Modulation Duty Cycle: L (5%), M (50%), H (100%) 4.0cm²± 20% Waveform: Pulsed, Continuous (Max): Beam type:...
  • Page 15: Glossary Of Symbols

    GLOSSARY OF SYMBOLS Type BF Applied Part Class II equipment Disposal in accordance with Directive 2012/19/EU (WEEE) Refer to instruction manual IPX7 temporary immersion in water. Serial number Batch code Consult the instructions for use for important cautionary information such as warnings and precautions Keep dry Date of manufacture The name and the address of the manufacturer...
  • Page 16: Electromagnetic Compatibility (Emc)

    ELECTROMAGNETIC COMPATIBILITY (EMC) IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC) With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation.
  • Page 17 Guidance and manufacturer’s declaration - electromagnetic emissions UT1032 the user of the UT1032 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The UT1032 device uses RF energy only for its internal function. Therefore, its RF emissions are...
  • Page 18 TABLE 2 Guidance and manufacturer’s declaration - electromagnetic immunity customer or UT1032 the user of the UT1032 should assure that it is used in such environment. IEC 60601 Compliance Electromagnetic Immunity test test level level environment - guidance Floors should be wood, Electrostatic ±8 kV contact...
  • Page 19 TABLE 3 Guidance and manufacturer’s declaration - electromagnetic emissions UT1032 the user of the UT1032 should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic Immunity test test level level environment - guidance Portable and mobile RF communications...
  • Page 20 TABLE 4 Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and as recommended below, according to the maximum output power of the communications equipment.
  • Page 21: Limited Warranty

    LIMITED WARRANTY We warranty each new UT1032 (excluding gel, wires and adapter) for one year from defects in materials and workmanship from the original date of purchase. This warranty applies only to the original purchaser. The original invoice or receipt must accompany all returns.
  • Page 24 Name: Shenzhen Dongdixin Technology Co., Ltd. Add: Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang 518108 Nanshan District, Shenzhen P. R. China Tel: 0086-755-27652316 E-mail: www.nutekmedical.com Shanghai International Holding Corp. GmbH (Europe) Ei estraße 80, 20537 Hamburg Germany Tel: 0049-40-2513175 Fax: 0049-40-255726...

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