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TELEMED                                                                               ClarUs User Guide, REV 4.0 2013.12.04 

33 

9.

 

TRANSPORTATION, STORAGE AND UTILIZATION 

9.1. 

Transportation and storage 

 

The  ultrasound  scanner  should  be  stored  and  moved  according  to  the 

package technical documentation and the standard procedures. 
 

9.2. 

Utilization 

 

Utilization/recycling  of  this  equipment  should  be  carried  out  by  a  specialized 

company and be performed in accordance with local laws and legislation. 
 

Содержание ClarUs

Страница 1: ...TELEMED ClarUs User Guide REV 4 0 2013 12 04 1 ClarUs ClarUs EXT 1M Ultrasound Diagnostic System USER GUIDE ...

Страница 2: ...MED UAB Dariaus ir Gireno str 42 Vilnius LT 02189 Lithuania Telephones 370 5 2106272 370 5 2106273 Fax 370 5 2306733 Internet http www telemed lt E Mail info telemed lt NOTE Non TELEMED product names may be trademarks or registered trademarks of their respective owners ...

Страница 3: ...Unit 18 4 2 3 ClarUs 19 4 2 4 ClarUs EXT 1M 19 4 3 Connection and Indication ClarUs 20 4 4 Peripherals Compatibility 22 5 INSTALLATION WARNINGS 23 5 1 Getting started with ClarUs 24 5 2 Status Indicator 24 5 3 Ultrasound Scanner Monitor utillity 24 5 4 Windows configuring 26 6 TROUBLESHOOTING 27 6 1 FAQ 27 6 2 Fuses locations ClarUs 27 6 3 Contact with technical support service 28 7 WARRANTY AND S...

Страница 4: ...Disinfection of Transducers Used in Endocavity Procedures 32 8 4 System accuracy performance verification 32 9 TRANSPORTATION STORAGE AND UTILIZATION 33 9 1 Transportation and storage 33 9 2 Utilization 33 10 DECLARATION OF CONFORMITY 34 APPENDIX 1 Guidelines for the safe use of diagnostic ultrasound 2 Vigilance system 3 Returned product form ...

Страница 5: ...ast cardiac peripheral vascular musculo skeletal conventional and needle guidance It is possible to provide diagnostic information outside of an imaging lab including at the bedside systems for navigated medical applications and in operating rooms critical care units ClarUs ultrasound systems provide many different scanning technologies B B B 4B B M M CFM PDI DPDI PWD B PWD Duplex B CFM PDI DPDI P...

Страница 6: ...TELEMED ClarUs User Guide REV 4 0 2013 12 04 6 Common view of ClarUs shown below Figure 1 Common view of ClarUs EXT 1M shown below Figure 2 ...

Страница 7: ...ontains Echo Wave II software to control its operation TELEMED provides the latest Echo Wave II software version and drivers package together with your system In the software the unique technologies making the intellectual property of TELEMED company are used Latest software versions can be downloaded directly on the Internet from http www telemed lt 1 4 Technical Specification Table 1 contains te...

Страница 8: ...l 50 dB angle steering for linear probes 10 real time spatial filter 3 values CFM palette 10 maps B Color priority control color threshold control CFM baseline control Doppler frequency selection 2 frequencies each probe color frame averaging 8 values PULSED WAVE DOPPLER PRF variable 0 3 10 kHz wall filter settings 16 steps 2 5 20 PRF gain control 50 dB angle steering for linear probes 10 single c...

Страница 9: ...is A B Ratio Human Measurements and Calculations Packages General calculations package Obstetrics Gynecology OB GYN calculations package Gynecology GYN Abdominal exam measurements and calculations Urology Endocrinology Vascular exam measurements and calculations Cardiology Veterinary Calculations Packages Obstetrics Canine Feline Ovine Bovine Equine Llama Goat Animal Cardiology User Interface The ...

Страница 10: ...lt in 60 watt hour lithium polymer battery battery life 60 min depending on scan mode battery charging time up to 2 hours POWER ClarUs EXT 1M 12 VDC 2 5 A External AC medical grade power supply 100 240 VAC 50 60 Hz SAFETY Electromechanical safety IEC601 1 2 Medical electrical equipment part 1 General requirements for safety Class I Type BF applied part EMC EMI standards European Norm EN 55011 1998...

Страница 11: ...s User Guide REV 4 0 2013 12 04 11 ultrasound equipment 1992 OPERATIONAL ENVIRONMENT Nominal operational environment Environment temperature 10 40 C Relative humidity not to exceed 85 Atmospheric pressure 70 106 kPa ...

Страница 12: ...irements The best solution is a fully IEC 601 1 certified PC or a battery operated portable PC and wireless peripheral devices All systems including monitors and other connected parts must be configured to comply with IEC 601 1 1 If in any doubt please contact the technical service department of your local representative Note that regardless of the above stipulations all personal computers used sh...

Страница 13: ... To avoid the risk of electrical shock do not open the cover of device blocks There are no parts that you can repair yourself In case of dificulties please contact the TELEMED service department or your nearest local authorized distributor 2 2 Equipment protection To protect your ultrasound system transducer and accessories please follow these precautions excessive bending or twisting of electrica...

Страница 14: ...utput level is factory calibrated and is based on device settings that yield an optimum image for the type of patient examination and do not exceed the following FDA recommended limits This default level is set when the system is first turned on when the probe is first turned on It is highly recommended to set the default level when changing from one exam category to another when changing from one...

Страница 15: ...ders should assure an adequate degree of protection from threats such as viruses and worms to avoid the risk of any unauthorized access to the network or the medical device database 2 6 Accuracy Measures CAUTION Gas ultrasound contrast agents are used during echocardiography to enhance a cardiac image but may cause side effects cardiac rhythm disturbances during perfusion studies Because of this s...

Страница 16: ...cy of any ultrasound system o Velocity of sound is constant 1540 m s o Velocity of sound uncertainty 5 o Caliper placement accuracy is one pixel operator dependent o Measurement accuracy is based on the root mean square combination of all independent sources of error o RMS errors are due to velocity of sound uncertainty pixel error and typical transducer geometry The chapter 4 7 Measurement accura...

Страница 17: ...bel Type BF Equipment man symbol IEC 878 02 03 indicates BF type equipment which provides a particular degree of protection against electric shocks particularly regarding allowable LEAKAGE CURRENT and reliability of the PROTECTIVE EARTH CONNECTION if present External probe outlet The symbol for CAUTION highlights the fact that there are specific warnings or precautions associated with the device R...

Страница 18: ...ion of the ultrasound attenuation due to travel depth re ordering the receiving signal sequence and focusing by applying the appropriate time delays shifting the center frequency of BPF band pass filter to follow the frequency shift that occurs according to the travel depth the ultrasound signal compression by means of Log Amplifier detection of the echo signal envelope 4 2 2 Probe Unit The probe ...

Страница 19: ...ansrectal Transvaginal Vascular Veterinary Biopsy Adaptor MC10 5R10N 5 0 8 0 10 156 MCV9 5R10N 5 0 8 0 10 156 MC4 2R20N 2 0 4 0 20 104 C7 3R50N 3 0 7 0 50 70 C5 2R60N 2 0 5 0 65 59 L12 5L40N 5 0 12 0 39 4 2 3 ClarUs ClarUs is an all in one modification combined beamformer and notebook 4 2 4 ClarUs EXT 1M ClarUs EXT 1M is the beamformer to be connected to a PC through USB 2 0 ...

Страница 20: ...TELEMED ClarUs User Guide REV 4 0 2013 12 04 20 4 3 Connection and Indication ClarUs Front view Rear view ...

Страница 21: ...erface of the ClarUs must be certified to IEC standards e g IEC 60950 and configured to comply with IEC 60601 1 1 All individuals who connect computer equipment to this interface are configuring a medical system and they are therefore responsible for ensuring that the system complies with IEC 60601 1 1 If in any doubt please contact the technical service department of your local representative ...

Страница 22: ...2 4 4 Peripherals Compatibility ClarUs family scanners can work operate with standard PC features USB mouse USB keyboard SVGA monitor Laser printer 600 dpi preferred HP printers optional Optional accessories Additional Probes Probes Carrying Сases ...

Страница 23: ...When moving the scanner from a cold to a warm place please wait for 0 5 to 1 hour before switching on the device This is necessary because of water condensation which may form on electronic parts Do not use the scanner close to any moisture source or in place with high humidity Do not use compressed air or vacuum cleaners when cleaning the device Do not drop hit or shake the device Take care when ...

Страница 24: ... probe connector into the socket found on the right side and turn the lock up Press the notebook power button and wait until Windows is ready Double click on the ECHO WAVE II icon displayed on the desktop The ultrasound software now starts Note See the battery status charging battery volume etc in the tray If the system is battery powered a warning will be displayed on the screen when only 15 is r...

Страница 25: ... is connected to the USB port and the system is ready to start Using the left mouse button double click on the GREEN highlighted Ultrasound Scanner Monitor icon and this message will appear Using the left mouse button double click on the RED highlighted Ultrasound Scanner Monitor icon and this message will appear By double clicking on the right mouse button on the Ultrasound Scanner Monitor icon a...

Страница 26: ...plug the power cable once this has been done 5 4 Windows configuring Configure the e mail program for example Outlook Express It is necessary for normal operation of the direct e mail sending feature of the ultrasound software Note There is no need to configure the e mail software if you are not planning to use it or if your computer is not currently connected to the Internet ...

Страница 27: ...se and interference is observed on ultrasound images as shown at Error Reference source not found What do I need to do in order to reduce the noise levels A The reason for this appearance may be electronic equipment and devices which emit this type of electromagnetic noises 6 2 Fuses locations ClarUs 2 fuses 250V 4A are under cover nearby power switch ClarUs rear panel ...

Страница 28: ...t send technical support service the following information Scanner type for example ClarUs EXT 1M Serial number of the scanner for example 2351 090428 9686 Probe type for example C7 3R50N Serial number of the probe for example 3241 090504 9701 TELEMED Drivers Package version for example TELEMED Drivers Package 1 0 1 Echo Wave II software version for example Echo Wave II 2 93 Attached Log file gene...

Страница 29: ...al consequential or any other damages 7 2 Warranty Shipments and Returns A warranty claim must be made without delay and must be received during the applicable warranty guarantee period by TELEMED If it is necessary to return a product for repair and or adjustment prior authorization from TELEMED must be obtained first Instructions as to how and where these products should be shipped will be provi...

Страница 30: ...d secure and that the labeling is legible Check the cables especially power cable If there is any peeling or cracking of the outside insulation carefully disconnect the cable and replace it with a new one 8 3 Probe maintenance and disinfection All transducers are supplied as non sterile Transducers in Endocavity Procedures should normally be used with a sterile sheath Transvaginal probes may be us...

Страница 31: ...uctions regarding concentration contact durations and storage and disposal Do not use alcohol or alcohol based solutions Thoroughly rinse all residues from the probe using sterile distilled water after removal from the germ killer Do not wipe the strain relief housing joint the strain relief or the cable with isopropyl alcohol Isopropyl alcohol can cause damage to these parts of the transducer Thi...

Страница 32: ...transducer for extended periods of time such as overnight to avoid rinsing or immersing near the strain relief 4 Removing the transducer from the disinfectant and thoroughly rinsing with sterile water 5 Checking the transducer for any residual organic material If any materials are present the disinfection of the transducer should be done again 8 4 System accuracy performance verification System ac...

Страница 33: ...on and storage The ultrasound scanner should be stored and moved according to the package technical documentation and the standard procedures 9 2 Utilization Utilization recycling of this equipment should be carried out by a specialized company and be performed in accordance with local laws and legislation ...

Страница 34: ...formance 2 Collateral standard Electromagnetic compatibility Requirements and tests IEC 60601 2 37 2007 08 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing 2003 ISO 10993 5 Biological Evaluation of Medical Devices Part 5 Tests for in vit...

Страница 35: ... be used for any of the following o obtaining pictures of the fetus solely for non medical reasons o learning the sex of the fetus solely for non medical reasons o for commercial purposes such as trade shows or producing pictures or videos of the fetus Thermal Effects The M mode is a valuable clinical tool and despite any potential risks is not contraindicated Operators however should be careful t...

Страница 36: ...egional organizations of ultrasound professionals B Conclusions General Although there are many exposure conditions for which the risk of injury during a diagnostic ultrasound examination is negligible this is not the case for every possible exposure condition using currently available equipment Therefore the persons responsible for the ultrasonic exposure must ensure that the exposure is justifie...

Страница 37: ...ecause of the potential for transducer self heating and heating of the transducer may add significantly to any ultrasonic heating which may occur Generally more caution may be warranted for transvaginal transesophegeal and transrectal examinations because heating of the transducer may potentially produce additional heat to adjacent tissue This conclusion and the following one provide guidance to t...

Страница 38: ...nded output limits are not exceeded mechanical effects are far less likely to be important in obstetrical ultrasound because of the absence of gas bodies Biological Effects The clinical effect of exposure depends on the nature and degree of tissue injury This can be assessed from biological effects studies Several extensive reviews have been published regarding the adverse biological effects of ul...

Страница 39: ... AIUM Bioeffects and safety of diagnostic ultrasound Laurel MD AIUM Publications 1993 American Institute of Ultrasound in Medicine National Electrical Manufacturers Association AIUM NEMA Standard for real time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment Revision 1 Laurel MD AIUM Publications 1998a American Institute of Ultrasound in Medicine Nationa...

Страница 40: ...ce of contrast agents on hemorrhage produced by lithotripter fields Ultrasound in Med and Biol 23 1435 1439 1997 Doody C Porter H Duck F A and Humphrey V F In vitro heating of human fetal vertebra by pulsed diagnostic ultrasound Ultrasound in Med and Biol 25 1289 1294 1999 Duck F A Starritt H C ter Haar G R and Lunt M J Surface heating of diagnostic ultrasound transducers Br J Radiology 67 1005 10...

Страница 41: ...nd Bond A D Assessment of the likely thermal index values for pulsed Doppler ultrasonic equipment Stage I calculation based on manufacturers data NPL Report CIRA EXT 018 1997 Shaw A Pay N M and Preston R C Assessment of the likely thermal index values for pulsed Doppler ultrasonic equipment Stages II and III experimental assessment of scanner transducer combinations NPL Report CMAM 12 1998 Siddiqi...

Страница 42: ...ondition in which the ultrasound beam passes through bone near the beam entrance into the body derated a derated quantity is one which has been measured in water using standard methods and then multiplied by a derating factor This accounts for attenuation of the ultrasound field by the tissue between the transducer and a particular location in the body along the beam axis The derating factor is 0 ...

Страница 43: ...ity is reduced by 3 dB a factor of 2 for a 5 MHz beam 2 cm into the body along the beam axis Mechanical Index MI a quantity related to the potential for mechanical effects during a diagnostic ultrasound examination It is given by the ratio of the largest value in the ultrasound beam of any derated rarefactional pressure to the square root of the transducer frequency The pressure is in Megapascals ...

Страница 44: ...this form in some other manner and do not use this device All data relating to the system can be found on its identification label In this way we will be able to take all adequate opportune and effective actions Post Marketing Vigilance Form To Quality Assurance Department UAB TELEMED Dariaus ir Gireno str 42 Vilnius LT 02189 Lithuania Phone1 370 5 2106272 Phone2 370 5 2106273 Fax 370 5 2306733 Sy...

Страница 45: ...NED PRODUCT _______ 200 _ ____ ____ COMPANY ADDRESS PRODUCT TELEMED OTHER SERIAL NUMBER REASON FOR RETURN INSTRUCTIONS REGISTERED BY NC REPORT PROPERTY OF TELEMED CUSTOMER WARRANTY WARRANTY YES NO Rows to be filled by sender COMPANY ADDRESS PRODUCT SERIAL NUMBER REASON OF RETURN ...

Страница 46: ...3 12 04 46 REVISION HISTORY Revision History REVISION REVISION COMMENTS ISSUE DATE 4 0 Added fuses and labels 2013 12 04 3 0 Corrections 2012 03 28 2 0 ClarUs EXT 1M added 2011 03 29 1 0 Initial release of the ClarUs User Guide 2009 11 09 ...

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