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 10

Site~Rite* 6

 Ultrasound System

Warnings (continued) 

Warning:

   Maximum shelf load on the VAD bedside roll stand is 22 lbs. Exceeding this weight may  

 

damage the roll stand.

Warning:

   Do not overtighten screws when attaching the scanner to the roll stand mount. Doing so  

 

may damage the scanner.

Warning:

   Use only screws provided in the packaging. Ensure the unit is secure against the roll  

 

stand mount. Failure to do so may cause the scanner to disconnect from the roll stand. 

Warning

:   Do not use the probe with high frequency surgical equipment. Doing so may damage the  

 

equipment.

Warning

:   Do not pull on the probe cable or overload the roll stand. Doing so may cause the system to  

 

tip. 

Warning

:   The keyboard tray and arm are designed to support the keyboard weight only. Additional  

 

weight may cause the stand to tip.

 

Precautions

Caution:  

The adverse biological effects of ultrasound on tissue appear to be threshold effects. When  

 

tissue is repeatedly exposed to ultrasound, with intervals in between, there will likely be  

 

no cumulative biological effect. If, however, a certain threshold has been passed,  

 

biological effects may occur. While the Site~Rite* 6 Ultrasound System acoustic output  

 

parameters fall well below all FDA thresholds for adverse biological effects, any given  

 

ultrasound procedure should be performed using the principle of ALARA (As Low As  

 

Reasonably Achievable). The licensed medical practitioner should limit the time of patient  

 

exposure to ultrasonic radiation using the principle of ALARA.

 

Caution:  

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Caution:  

Do not pull the cable to disconnect the probe connector from the scanner. Pulling the  

 

cable may damage the cable, cable connection or scanner. 

Caution:  

Do not twist or bend the probe cable in excess of that required during normal use of the  

 

probe. Excessive twisting or bending of the cable may cause failure, intermittent or  

 

unpredictable operation. 

Caution:  

When disinfecting the probe with a liquid disinfectant, do not soak the probe cable,  

 

cable bend relief, probe connector or probe buttons. Doing so may damage the probe.

Caution:  

Inspect the keyboard prior to each use. If damage is noted, do not use the keyboard.

Содержание Site-Rite 6

Страница 1: ...ACCESS SYSTEMS INSTRUCTIONS FOR USE REF 9770000...

Страница 2: ......

Страница 3: ...INSTRUCTIONS FOR USE...

Страница 4: ...on the order of a physician Rx Only Dangerous Voltage Attention see instructions for use Medical Electrical Equipment Classified by ETL with respect to Electric Shock Fire and Mechanical Hazards only...

Страница 5: ...o C 38o C Storage Temperature Parameters Fragile 15o C 38o C Operating Temperature Parameters Ultrasound Probe Do not dispose with ordinary municipal waste Keep Dry Direct Current Federal Communicatio...

Страница 6: ...attery 2 4 Connecting and Disconnecting Site Rite 6 Ultrasound System Probe 2 5 Powering on the Site Rite 6 Ultrasound System 2 6 Resetting the Site Rite 6 Ultrasound System 3 Site Rite 6 Ultrasound S...

Страница 7: ...Troubleshooting Error Screens 8 Upgrading Software 9 Calibrating the Rechargeable Batteries 10 Warranty 11 Service and Repair 12 Technical Specifications 12 1 Operating and Storage Conditions 12 2 Sc...

Страница 8: ...6 Site Rite 6 Ultrasound System...

Страница 9: ...ans and structures of the body may also be performed 1 2 Site Rite 6 Ultrasound System and Components The Site Rite 6 Ultrasound System is an easy to use and portable ultrasound scanner Site Rite 6 Ul...

Страница 10: ...d System A C adapter to charge the Site Rite 6 Ultrasound System Use of any other device to charge the Site Rite 6 Ultrasound System may damage the battery packs may cause intermittent or unpredictabl...

Страница 11: ...d service personnel Removal of system labels by anyone other than Bard Access Systems authorized service personnel Opening or servicing the base power unit or the A C adapter by anyone other than Bard...

Страница 12: ...ly be no cumulative biological effect If however a certain threshold has been passed biological effects may occur While the Site Rite 6 Ultrasound System acoustic output parameters fall well below all...

Страница 13: ...Latex Containing Medical Devices issued March 29 1991 Bard Access Systems distributes sterile probe covers and needle guide kits that do not contain latex Caution Do not force the probe connector Dam...

Страница 14: ...noted do not use the probe Damage to the system may occur Caution Hot water in excess of 113o F or 45o C may damage the probe Caution Use only Bard Access Systems cleaning and disinfection procedures...

Страница 15: ...d System and verify the contents against the packing slip Inspect all parts for damage If any damage is found please contact Bard Access Systems at 800 443 3385 2 1 Assembling the Roll Stand Refer to...

Страница 16: ...amage the system may result in injury and will void your warranty Warning Always properly dispose of dead battery packs in accordance with local regula tions Improper disposal may present an environme...

Страница 17: ...ate 4 To power off the Site Rite 6 Ultrasound System depress and release the power button again The system is powered off when the display screen darkens Warning Use only Bard Access Systems probes wi...

Страница 18: ...eld Depth Markers Toggles between depth mark ers gridlines and off Hold for more than 5 seconds to toggle between the low and high contrast image Print Sends the current image to the printer if conne...

Страница 19: ...17 Instructions For Use 3 2 Probe Controls Depth Decrease Gain Freeze Image Hold for more than 5 seconds to print or save the image on the screen On Off Reset Increase Gain...

Страница 20: ...riate catheter size for the vessel being imaged F9 toggles Catheter Size icons on and off Image Depth Markers When enabled the depth markers are shown as green dots superimposed on the image at 1 0 cm...

Страница 21: ...mage Freeze Mode blinking Run Mode A C Power Indicator Connected to A C Wall Power Not Connected to A C Wall Power Printer Indicator Printer Connected No Printer Connected Printing in Progress Printer...

Страница 22: ...d in each PID field including A Z a z 0 9 and space 3 To toggle between the PID 1 and PID 2 fields press the tab key 4 To close the Patient Information window press the enter key Note The information...

Страница 23: ...the left side of the probe This bump corresponds to the probe orientation mark located on the Site Rite 6 Ultrasound System display screen When using the Site Rite 6 Ultra sound System probe hold the...

Страница 24: ...ile probe covers and needle guide kits that do not contain latex To purchase sterile plastic probe covers contact Bard Access Systems Customer Service at Customer Service 800 545 0890 www bardaccess c...

Страница 25: ...tered on the target vessel slowly advance the needle while looking at the screen of the Site Rite 6 Ultrasound System scanner When the needle approaches the target vessel you should see the anterior w...

Страница 26: ...n buttons to change the selected date or time values 5 After setting the date and time press the Depth button cm to enter the image size field The current image size will be highlighted 6 Press the Ga...

Страница 27: ...uctures at different depths Adjusting the depth also adjusts the focus of the ultrasound Adjusting the depth to place the structure of interest at the appropriate focus will improve the ultrasound ima...

Страница 28: ...ide level of activity Warning Do not allow liquid to enter the scanner A C adapter base power unit probe connector or probe port Damage to the equipment may occur Warning Do not attempt to sterilize t...

Страница 29: ...lfunction is not resolved by resetting the system discontinue use and return to authorized repair facility Cause Battery empty Solution Connect system to A C outlet for operation and battery recharge...

Страница 30: ...the configuration screen appears 5 When the configuration screen appears simultaneously press and hold the Depth button cm and Depth Marker button until the software installation process begins Note T...

Страница 31: ...C power 2 Power on the Site Rite 6 Ultrasound System scanner and operate on battery power until the system powers off 3 Connect the Site Rite 6 Ultrasound System to A C power to recharge the batterie...

Страница 32: ...r than Bard Access Systems authorized service personnel Opening or servicing the base power unit or the A C adapter by anyone other than Bard Access Systems authorized service personnel Connecting the...

Страница 33: ...y anyone other than Bard Access Systems authorized service personnel will void the warranty and may result in injury or equipment damage 12 Technical Specifications 12 1 Operating and Storage Conditio...

Страница 34: ...rvals in between there will likely be no cumulative biological effect If however a certain threshold has been passed biological effects may occur While the Site Rite 6 Ultrasound System acoustic outpu...

Страница 35: ...h 1 9 cm Lateral Foci 12 5 Power Supply Specifications Note For 240 V applications use only center tapped 240 VAC single phase power as shown below A C Adapter Specifications Input Voltage 100 240 VAC...

Страница 36: ...al Equipment Part 1 General Requirements for Safety IEC 60601 1 1 2000 Medical Electrical Equipment Part 1 1 General Requirements for Safety Collateral Standard Safety Requirements for Medical Electri...

Страница 37: ...w The customer or user of the Site Rite 6 Ultrasound System should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Gr...

Страница 38: ...of a typical commercial or hospital environment Surge EN IEC 61000 4 5 1kV Differential 2kV Common 1kV Differential 2kV Common Mains power quality should be that of a typical commercial or hospital e...

Страница 39: ...4 6 Radiated RF EN IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 3 V m Portable and mobile communications equipment should be separated from the Site Rite 6 Ultrasound System...

Страница 40: ...Ultrasound System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the Site Rite 6 Ultrasound System as recom...

Страница 41: ...e expressed written consent of C R Bard Inc Site Rite 6 Ultrasound System Manufactured by Bard Access Systems Inc 605 North 5600 West Salt Lake City UT 84116 U S A 801 522 5000 Customer Service 800 54...

Страница 42: ......

Страница 43: ......

Страница 44: ...009 Bard Site Rite and Sherlock are trademarks and or registered trademarks of C R Bard Inc or an affiliate All other trademarks are the property of their owners Copyright 2009 C R Bard Inc All Rights...

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