Home

currentsolutions

1. and any infectious disease On persons who are unable to effectively express themselves such as infants small children mentally disabled individuals individuals under the influence of alcoholic beverage or during extreme fatigue Product should not be applied on the following areas any wounds the mouth neuralgia sharp painful spots surgical areas sunburned skin sensitive skin and over skin implants made of metal plastic or silicone materials Do not use with other electronic equipment 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 use the device on persons with bleeding issues disorders 7 DO NOT use on areas under anesthesia A WARNING The device complies completely with all parts of 21 CFR 1050 10 under the performance standard for sonic infrasonic and ultrasonic radiation emitting products Use of controls or adjustments to performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy PARTS OF THE DEVICE 1 TIME INDICATOR LIGHT 2 TIME BUTTON 3 POWER INDICATOR LIGHT 3 4 INTENSITY INDICA
2. 3 JP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using 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 propagation is affected by absorption and reflection from structures objects and people LIMITED WARRANTY We warranty each new US Pro 2000 2 Edition 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 This warranty does not cover abuse accident or damage resulting from failure to follow operating instructions The warranty is voided if the unit has any alterations 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 abo
3. conditions such as pain relief muscle spasms and joint contractures but not recommended for the treatment of malignancies This is an FDA regulated product available by prescription only Keep out of reach of children EXPLANATION OF ULTRASONIC STIMULATOR EFFECT The US PRO 2000 2 Edition is an ultrasonic therapeutic device that generates pulsed high frequency sound waves 1MHz that are transferred to a specific body area via a sound head probe The pulsed sound waves travel deep into the tissue to generate vasodilation which helps increase blood flow to the treated area Therapeutic ultrasound is found to help relieve pain and reduce muscle spasms 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 CONTRAINDICATIONS 1 Do not use over or near bone growth centers until bone growth is complete 2 Do not use over a healing fracture 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 This 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
4. 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 tissue necrosis tissue death 9 Do not use over the carotid sinus nerves or arteries laryngeal or pharyngeal muscles PRECAUTIONS 1 Do not use on patients with hemorrhagic diatheses excessive bleeding disorders 2 Do not use over an area of the spinal cord following a laminectomy i e when major covering tissues have been removed 3 Do not use over areas that are under anesthesia 4 Avoid bony prominences 5 When using ultrasound keep the sound head moving while maintaining contact with the skin 6 If treatment becomes uncomfortable stop treatment and contact your physician 7 Do not immerse the portable ultrasound in water or other solvent 8 Do not use over metallic implants especially prostheses with a cement matrix 9 Only use the UL certified AC adapter that is included in the product case O N CAUTIONS 1 Always use this device under the directions of a physician 2 Patients with the following diseases symptoms or conditions should not use the device e During pregnancy or menstrual cycle Acute disease heart disease tubercle disease facial neuralgia sharp facial pain pernicious tumor hemophilia high fever abnormal blood pressure or under any unhealthy conditions On patients with sensitive physical conditions ringworm dermatitis
5. minimize this interference by not using other equipment in conjunction with it e The performance of the device was determined to be essential performance This device has been thoroughly tested according to tested and inspected to assure proper performance and operation TABLE 1 Guidance and manufacturer s declaration electromagnetic emissions The DU3035 device is intended for use in the electromagnetic environment specified below The customer or the user of the DU3035 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The DU3035 device uses RF energy only for its RF emissions internal function Therefore its RF emissions are CISPR11 roupi very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 eB Harmonic The DU3035 device is suitable for use in all emissions Class A establishments other than domestic and those IEC 61000 3 2 directly connected to the public low voltage power supply network that supplies buildings Voltage used for domestic purposes fluctuations Applicable flicker emissions IEC 61000 3 3 TABLE 2 Guidance and manufacturer s declaration electromagnetic immunity The DU3035 device is intended for use in the electromagnetic environment specified below The customer or the user of the DU3035 should assure that it is used in such environment
6. objects and people aField strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 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 Separation distance according to frequency of transmitter m song ae 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz d 1 2 P d 1 2 VP d 2
7. FORWARD INTENDED USE EXPLANATION OF ULTRASONIC STIMULATOR EFFECT CONTRAINDICATIONS PRECAUTIONS CAUTIONS PARTS OF THE DEVICE SPECIAL FEATURES STEPS TO CONNECT THE ADAPTOR 10 INSTRUCTIONS FOR USE 11 LOAD DETECTION SYSTEM CAUTION 11 MAINTENANCE 12 STORAGE CONDITIONS 13 TROUBLESHOOTING 14 UNIT SPECIFICATIONS 15 PRESCRIPTION STATEMENT 16 GLOSSARY OF SYMBOLS 17 IMPORTANT INFORMATION REGARDING EMC 18 LIMITED WARRANTY Oo OO N OAU A W N O OA N SN OV GO ua A A A N ey O Q WN N gt FORWARD This manual contains general information on the operation precautionary practices and maintenance information of the DU3035 US Pro 2000 2nd Edition In order to maximize the use efficiency and life of the device please read the manual thoroughly and become familiar with it before operating the device In particular pay attention to 1 Keep yourself informed of the contraindications 2 The device may not be used in close proximity i e less than 2 meters to shortwave equipment 3 The device may not be used in so called wet rooms hydrotherapy rooms The manufacturer cannot be held responsible for the results of using this apparatus for any purposes other than those described in these operating instructions INTENDED USE The US PRO 2000 2 Edition is a portable ultrasound device that generates deep ultrasonic waves within body tissues for the treatment of selected medical
8. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions input lines IEC 61000 4 11 2 kV for power supply lines 1 kV line s to line s lt 5 U_ gt 957 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 seconds 2 kV for power supply lines 1 kV line s to line s lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 seconds Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commerical or hospital environment If the user of the device requires continued operation during power mains interruptions it is needed that hte device be powered from an uninterruptible power supply TABLE 3 Guidance and manufacturer s declarati
9. Portable Ultrasound US PRO 2000 2 Edition INSTRUCTION MANUAL Model DU3035 PY ES ka m gt o e a CAUTION Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner This manual is valid for the DU3035 US PRO 2000 2 Edition Portable Ultrasound Unit This user manual is published by Roscoe Medical Inc Roscoe Medical does not guarantee its contents and 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 US Pro 2000 2nd Edition Rev V1 3 2014 Declaration of conformity Roscoe Medical Inc declares that the US Pro 2000 2nd Edition complies with the following normative documents IEC60601 1 IEC60601 1 2 IEC60601 2 5 IEC61689 ISO 7010 ISO14971 ISO10993 1 1S010993 5 ISO10993 10 IEC 60601 1 11 Complies with MDD 93 42 EEC and Amended by directive 2007 47 EC requirements because they are intended to keep you safe prevent injury and avoid a situation that It is important that you read all the warning and precautions included in this manual could result in damage to the device or on the order of a physician or licensed practitioner by the law of 0 CAUTION United States Federal Law restricts this device to sale by the State in which he she practices according to 21 CFR 801 109 TABLE OF CONTENTS
10. TOR LIGHT 5 MODE BUTTON 6 POWER SWITCH 7 7 ULTRASOUND HEAD SPECIAL FEATURES 1 All the ultrasound parts are assembled and tested under strict process controls 2 To ensure quality the device has been designed with a single chip microprocessor 3 Precious alloy round headed probe creates a smooth surface on the skin 4 The device has an attractive exterior and was ergonomically designed so that it fits to the human hand and is easy to hold and convenient to use 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 STEPS TO CONNECT THE ADAPTOR US Pro 2000 2 Edition requires the following steps for proper setup 1 Ultrasound transmission gel is required when treating a patient with the US Pro 2000 2nd Edition portable ultrasound device 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 the ultrasound unit Be sure you have a secure fit Then plug the AC DC adapter into a wall outlet to power the unit The DU3035 US Pro 2000 2 d Edition is now ready for treatment 4 Follow the INSTRUCTIONS FOR USE section of this manual tiene AC DC utlet Adap
11. Water IPX7 Only for Treatment Head Power Input Voltage AC 100 240V Frequency 50Hz 60Hz Adapter output Output voltage DC 15V Max Currency 1 2A Time Choose working time 5m 10m 15m Om stop covets Mode Choose modulation duty cycle 5 50 100 Indication Time Indication Lights 5 10 15 minutes Lights Duty Cycle Indication Lights Low L Medium M High H oo MODULATION OUTPUT POWER PROGRAM DUTY FACTOR WAVE CHARACTER L 5 Low 0 42 M 50 Medium 2 H 100 High 20 Operating Conditions 5 C 40 C 30 75 RH 800 1060hPa PRESCRIPTION STATEMENT CAUTION United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner by the law of the State in which he she practices according to 21 CFR 801 109 GLOSSARY OF SYMBOLS Type BF Applied Part Caution Type of protection against electric shock Class Il Equipment Electrical devices are recyclable material and should not be disposed of with household waste after their useful life Help us to protect the environment and save resources by taking this device to the appropriate collection points Please contact the organization which is responsible for waste disposal in area if you have any questions Ix P gt Refer to instruction manual Only for treatment head Protected against the effects of ae temporary immersion in water SN Serial number LOT Ba
12. ds 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 and tested by a Service Technician certified by an Authorized Service Center Cleaning of the applicator The applicator should be regularly inspected for damage e g hairline cracks which could allow the penetration of liquids Clean the contact surface immediately after each treatment Make sure that no ultrasound gel remains on the applicator We further recommend cleaning the head cable and adapter daily using a soft cloth damped with lukewarm water The applicator can be disinfected using a cloth moistened with an antimicrobial cleaner 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 CONDITIONS 14 F 122 F 20 93 RH TROUBLESHOOTING The device is manufactured through complete quality assurance system If your device does not seem to be operating correctly refer to the chart below to determine what may be wrong Should none of these measures correct the problem the device should be serviced Problem Possible Cause Solution The plug of the adaptor is lt gt Insert the plug of the not inserted into the adaptor into the socket socket pr
13. ll automatically exit the head warming feature if any load is detected in the preheating process Therefore do not apply the ultrasound head to the patient during the warming period To restart the warming feature you will have to power off the device and turn it back on again 2 Apply transmission gel Wash the area to be treated so that it is free of oil and dirt Apply a generous layer of ultrasound transmission gel on the treatment area The gel acts as a coupling substance and ensures effectiveness The area treated should be two times the diameter of the sound head 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 treatment time 5 10 and 15 minutes as shown by the TIME indicators When the time is chosen the system will start working During working time the user can press the TIME button to adjust the treatment time 5 Place sound head on treatment area and begin aS treatment Move the sound head in a slow flat circular motion S amp over the skin surface of the treatment area Apply the sound head evenly in time over the treatment area see page 11 for Load Detection System Caution 6 Turn off the device After completing the treatment se
14. on electromagnetic emissions The DU3035 device is intended for use in the electromagnetic environment specified below The customer or the user of the Du3035 should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic test level level environment guidance Conducted RF 3 Vrms Jy Portable and mobile RF communications rms IEC 61000 4 6 150kHz to 80 MHz equipment should be used no closer to any part 3V of the DU3035 device including cables than the m Radiated RF recommended seperation distance calculated 80 MHzto 3V m IEC 61000 4 3 gt Gli from the equation applicable to the frequency of z the transmitter Recommended seperation distance d 1 2 jP d 1 2VP 80MHz to 800MHz d 2 3VP 800MHz to 2 5GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked e with the following symbol NOTE I At 80 MHz ends 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
15. operly again POWER LED i The DC plug of the lt Connect the adaptor light up adaptor is not inserted with the device again into the DC receptacle on correctly the device correctly Did not press the ON OFF lt Press the ON OFF button button again POWER LED is performing normally Output intensity button lt gt Please make sure and but no output setting is incorrect set it again function occurs UNIT SPECIFICATIONS 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 Effective Radiating Area 4 0cm 20 Ultrasound waveform Pulsed Probe BNR Max 5 0 Max Effective Intensity 1 6Wcm 20 Modulation duty scycle at 100 Effective Intensity L 0 08W cm 20 M 0 80Wcm H 1 60Wcm 20 Working Time Adjustable at 5 minutes 10 minutes 15 minutes Preheat Temperature Max 35 5 degree centigrade NOTE Actual preheat temperature will be influenced by the environmental temperature and preheat time Preheat Time Max 3 minutes Dimension 202 mm L x 49 mm W x 70 mm H Weight 193g without adapter Material of Applicator Aluminum Alloy Beam Type Collimated Degree of Protection against
16. ssion the device will automatically shut off and all indicator lights will be off Power off the device physically by sliding the power switch downwards towards OFF Unplug the unit from its power source 7 Clean the device after every use With device turned off clean the ultrasound head probe with a wet towel or soft tissue Do not immerse the device in water Always store device in its protective case at room temperature in a dry location A 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 2 The device has a temperature protection function When the temperature of the treating head exceeds 107 F 42 C the treatment will automatically stop and the time indicator light will flash two times The device will not continue the treatment program until the temperature is below 104 F 40 C MAINTENANCE Switch off the device and disconnect it from the power supply The device can be cleaned with a damp cloth Use lukewarm water and a non abrasive liquid household cleaner no abrasive no alcohol content solution Ifa more sterile cleaning is needed use a cloth moistened with an antimicrobial cleaner CAUTION Do not submerse the device in liqui
17. tch code 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 Medical devices should also not interfere with other devices In order to regulate the requirements for EMC Electro Magnetic Compatibility with the aim to prevent unsafe product situations the IEC60601 1 2 standard has been implemented This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices Medical devices manufactured by Roscoe Medical Inc conform to this IEC60601 1 2 2007 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 Special precautions need to be observed e The use of accessories and cables other than those specified by Roscoe Medical may result in increased emission or decreased immunity of the device e Care must be taken when operating this device adjacent to or stacked with other equipment Potential electromagnetic or other interference could occur to this or other equipment Try to
18. ter a 2 Ultrasound u a Unit rn A 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 assembly instructions stated above INSTRUCTIONS FOR USE Please read this instruction manual carefully before using the US Pro 2000 2 Edition Portable Ultrasound Unit 1 Turning on the device and head warming feature Turn the device on by sliding the power switch upwards 4s towards ON The power indicator light will illuminate The device will automatically enter the preheat mode The six indicator lights will flash alternately during this period When the preset temperature is reached or the maximum preheat time has ended 3 minutes all of the indicators lights will flash five times Once complete the device enters standby mode This head warming feature takes approximately three minutes from a cold room temperature start to finish If the warming feature is not needed press both 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 AN WARNING During the head warming period the following items should be noted The device wi
19. ve limitations may not apply to you This warranty gives you specific legal rights and you may also have other rights that vary from state to state Product _US Pro 2000 2nd Edition Model DU3035 gt gt Serial Number Date of Purchase Distributor L q RO SCOEvszs ca Manufactured for Roscoe Medical Inc 21973 Commerce Parkway Strongsville Ohio 44149 Ph 800 871 7858 www roscoemedical com

currentsolutions

Contents

Download Pdf Manuals

Related Search

Related Contents