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7.  PACKAGE CONTENTS 

1.  FORWARD
2.  INTENDED USE 
3.  EXPLANATION OF ULTRASONIC STIMULATOR EFFECT  
4.  CONTRAINDICATIONS
5.  PRECAUTIONS
6.  CAUTIONS

8.  PARTS OF THE DEVICE
9.  SPECIAL FEATURES
10.  STEPS TO CONNECT THE ADAPTOR
11.  INSTRUCTIONS FOR USE
12.  LOAD DETECTION SYSTEM CAUTION
13.  MAINTENANCE
14.  STORAGE CONDITIONS
15.  TROUBLESHOOTING
16.  UNIT SPECIFICATIONS
17.  GLOSSARY OF SYMBOLS
18.  DISPOSAL

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TABLE OF CONTENTS

19.  ELECTROMAGNETIC COMPATIBILITY (EMC)

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20.  LIMITED WARRANTY

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Summary of Contents for UT1032

Page 1: ...INSTRUCTION MANUAL UT1032 Portable Ultrasound Device www nutekmedical com ...

Page 2: ...ed 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 All Rights Reserved UT1032 Rev V2 2 2020 ...

Page 3: ...EVICE 9 SPECIAL FEATURES 10 STEPS TO CONNECT THE ADAPTOR 11 INSTRUCTIONS FOR USE 12 LOAD DETECTION SYSTEM CAUTION 13 MAINTENANCE 14 STORAGE CONDITIONS 15 TROUBLESHOOTING 16 UNIT SPECIFICATIONS 17 GLOSSARY OF SYMBOLS 18 DISPOSAL 4 4 4 5 5 6 8 8 9 10 12 12 13 13 14 15 15 TABLE OF CONTENTS 19 ELECTROMAGNETIC COMPATIBILITY EMC 16 7 20 LIMITED WARRANTY 21 ...

Page 4: ...ms and is one of the most frequently used therapies by physicians and physical therapists Most patients will feel nothing at all during treatment while some patients may feel slight warmth EXPLANATION OF ULTRASONIC STIMULATOR EFFECT This manual contains general information on the operation precautionary practices and maintenance information of the UT1032 read the manual thoroughly 1 Keep yourself ...

Page 5: ...is can also damage the system components 5 Do not use to treat malignancies nor in the region where malignant tumors are present 6 Do not use on patients with demand type cardiac pacemakers 7 Do not use on someone who is pregnant 8 Do not use over ischemic tissues in patients with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and may result in t...

Page 6: ... damaged device may cause injury improper results or serious danger 14 Do not store the device at an extremes temperature below 10 C or over 50 C or extremes humidity below 20 RH or over 93 RH Failing to do so may affect the performance of the device 15 Store the device in the dry clean place Keep the device away from pet and pests 16 Do not expose the product to any chemical solvent water lint du...

Page 7: ...ment such as ECG machine etc even if this device conforms to the EMC requirements 3 DO NOT use on the thoracic region if you have a pacemaker 4 DO NOT use on areas where malignant tumors are present 5 DO NOT use on the areas of blood inhibited tissue because there is not enough blood supplied to the area to meet the metabolic demand and this could result in tissue necrosis tissue death 6 DO NOT us...

Page 8: ...nomically designed so 5 Single button control microcomputer makes the device easy to use 6 Designed with three output intensities and three treatment time selections to meet a wide range of therapy requirements 7 The device has a head warming feature that pre heats the sound head applicator for increased patient comfort SPECIAL FEATURES PARTS OF THE DEVICE 1 TIME INDICATOR LIGHT 2 TIME BUTTON 3 PO...

Page 9: ...female connector of adapter into a wall outlet to power the unit The UT1032 is now ready for treatment 4 Follow the INSTRUCTIONS FOR USE section of this manual WARNING The device can only be used safely with the original adapter it came with DO NOT re assemble or change the specification of the adapter Doing so may cause damage to the unit and or personal injury Be sure to follow the specific asse...

Page 10: ...th the MODE button and the TIME button simultaneously The device will go back to standby mode When the device is in standby mode the modulation duty cycle is defaulted at 5 and the L indicator light will be illuminated WARNING During the head warming period the following items should be noted The device will automatically exit the head warming feature if any load is detected in the preheating proc...

Page 11: ...r soft tissue Do not immerse the device in water Always store device in its protective case at room temperature in a dry location 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 Set treatment time Press the TIME button to cycle through the treat...

Page 12: ...quid household cleaner no abrasive no alcohol content solution If a more sterile cleaning is needed use a cloth moistened with an antimicrobial cleaner CAUTION Do not submerse the device in liquids Should the unit accidentally become submersed contact the dealer or Authorized Service center immediately Do not attempt to use the device that has been submersed in any liquid substrate until inspected...

Page 13: ... inserted into the socket properly The DC plug of the adaptor is not inserted into the DC receptacle on the device correctly Did not press the ON OFF button Insert the plug of the adaptor into the socket again Connect the adaptor with the device again correctly Press the ON OFF button again Output intensity button setting is incorrect Please make sure and set it again When not in use store the dev...

Page 14: ... 0cm 20 Pulsed Continuous 5 0 1 6W cm2 20 Modulation duty scycle at 100 L 0 08W cm2 20 M 0 80W cm2 H 1 60W cm2 20 Adjustable at 5 minutes 10 minutes 15 minutes Max 35 5 degree centigrade NOTE Actual preheat temperature will be influenced by the environmental temperature and preheat time Max 3 minutes 202 mm L x 49 mm W x 70 mm H 193g without adapter Aluminum Alloy Collimated IPX7 Only for Treatmen...

Page 15: ...as warnings and precautions Keep dry Date of manufacture The name and the address of the manufacturer The name and the address of the Authorized EC representative in Europe The device contains materials that can be recycled and or are noxious to the environment When you dispose of the unit find out about local regulations concerning waste management Complies with the European Medical Device Direct...

Page 16: ...devices manufactured by Shenzhen Dongdixin Technology Co Ltd conform to this IEC60601 1 2 standard for both immunity and emissions Refer to EMC table guidance supplied in this manual regarding the EMC environment in which the device should be used The device needs to be installed and put into service in accordance with the information provided in the instruction Special precautions need to be obse...

Page 17: ...se any interference in nearby electronic equipment The UT1032 device is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions lEC 61000 3 2 Voltage lEC 61000 3 3 Group 1 Class B Class A Applicable theuserof...

Page 18: ...ent Surge IEC 61000 4 5 1kV for line s to line s 2kV for line s to earth 1kV for line s to line s 2kV for line s to earth 30 A m NOTE UT is the a c mains voltage prior to application of the test level 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Mains power quality should be that of a typical commeri...

Page 19: ...rs m determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE I At 80 MHz ends 800 MHz the higher frequency range applies a and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be the location in which the device is used ...

Page 20: ...ing the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE I At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic people Thedeviceisintendedforuseinanelectromagneticenviro...

Page 21: ...s or has been disassembled We shall not be liable for any direct or indirect consequential damages resulting from the use of this unit Some states do not allow limitations on how long an implied warranty lasts or the exclusion or limitation of incidental or consequential damages so the rights and you may also have other rights that vary from state to state If you have any problems with this device...

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Page 24: ...ng 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 Eiffestraße 80 20537 Hamburg Germany Tel 0049 40 2513175 Fax 0049 40 255726 ...

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