background image

16

Guidance and manufacturer’s declaration - electromagnetic emissions

Emissions test

Compliance

Electromagnetic environment - guidance

The DU3035 device uses RF energy only for its 
internal function. Therefore, its RF emissions are 
very low and are not likely to cause any 
interference in nearby electronic equipment.

The DU3035 device is suitable for use in all 
establishments other than 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 
fluctuations / 
flicker emissions 
lEC 61000-3-3

Group 1

Class B

Class A

Applicable

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.

TABLE 1

Summary of Contents for US PRO 2000 2nd Edition DU3035

Page 1: ...CAUTION FederalLawrestrictsthisdevicetosalebyoronthe orderofaphysicianorlicensedpractitioner Portable Ultrasound US PRO 2000 2nd Edition INSTRUCTION MANUAL Model DU3035...

Page 2: ...he 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 ISO10993 5 ISO10993 10 IEC 60601 1 11 Complies wit...

Page 3: ...FEATURES 9 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 STATEMEN...

Page 4: ...ce 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 warm...

Page 5: ...ow 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 CONTRAINDICATIONS 1 Do not use...

Page 6: ...rgical 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 con...

Page 7: ...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...

Page 8: ...und 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 2nd Edition is now ready for treatment 4 Follow the INSTRUCTIONS FOR USE...

Page 9: ...eded 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 indi...

Page 10: ...tion 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...

Page 11: ...non abrasive liquid 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 devi...

Page 12: ...aptor is not 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...

Page 13: ...0MHz 10 6 4W 20 Modulation duty cycle at100 L 0 32W 20 M 3 20W 20 H 6 40W 20 100Hz 10 L 5 M 50 H 100 4 0cm 20 Pulsed 5 0 1 6Wcm 20 Modulation duty scycle at 100 L 0 08W cm 20 M 0 80Wcm H 1 60Wcm 20 Ad...

Page 14: ...st electric shock Class II 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 r...

Page 15: ...sions 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 man...

Page 16: ...evice is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF em...

Page 17: ...burst IEC 61000 4 4 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s...

Page 18: ...situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular co...

Page 19: ...quency 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 th...

Page 20: ...n 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...

Reviews: