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Bard 9770000 Скачать руководство пользователя страница 4

2

Site~Rite* 6

Ultrasound System

Do not operate in the presence
of flammable anesthetics

BF Type Equipment

Federal (U.S.A.) law restricts
this device to sale by or 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 in
accordance with UL60601-1
and CAN/CSA C22.2 No. 601.1

Storage Humidity Parameters
(packaged)

Operating Humidity Parameters
Storage Humidity Parameters
(unpackaged)

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Содержание 9770000

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 in accordance with UL60601 1 and CAN CSA C22 2 No 601 1 Storage Humidity Parameters packaged Operating Humidity Parameters Storage Humidity Parameters unpackaged ...

Страница 5: ...0o 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 Communications Commission Manufacturer ...

Страница 6: ...Battery 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 System Information 3 1 Front Panel Controls 3 2 Probe Controls 3 3 Display Screen Information 3 4 Back Panel 3 5 Entering Patient Information 4 Using the Site Rite 6 Ultrasound System Probe 4 1 Probe ...

Страница 7: ...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 Scanner Specifications 12 3 Probe Acoustic Output Specifications 12 4 Probe Specifications 12 5 Power Supply Specifications 13 Standards Information 14 Disposal Information 15 EMC Tables Section ...

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

Страница 9: ...gans 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 Ultrasound System and Authorized Accessories include Site Rite 6 Ultrasound System scanner Site Rite 6 Ultrasound System vascular access probe Site Rite 6 Ultrasound System roll stand Site Rite 6 Ultra...

Страница 10: ...nd 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 unpredictable operation may damage the system may result in injury and will void your warranty Warning If a probe is damaged in any way discontinue use immediately Damage to the scanner may occur Warning Avoid s...

Страница 11: ...ed 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 Access Systems authorized service personnel Connecting the Site Rite 6 Ultrasound System scanner to any power source other than the Site Rite 6 Ultrasound System A C adapter and or base power unit C...

Страница 12: ...ely 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...

Страница 13: ...o 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 Damage to the connector and system could result Caution Always snap the needle guides on to the probe hook Do not slide the needle guide on to the needle guide hook as the sterile sheath may tear Cautio...

Страница 14: ...s 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 Failure to do so may damage the device Notes Note When cleaning the system and components it is important to remove all particles or other matter from all surfaces and crevices Note For 240 V applic...

Страница 15: ...nd 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 roll stand assembly instructions 2 2 Adjusting the Scanner on the Roll Stand Tilt and Swivel Adjustment ...

Страница 16: ...damage 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 environmental hazard Warning Inspect power cords for damage If any of the prongs are damaged use battery power until a replacement cord is obtained Caution Attach power source in such a way as to prevent dama...

Страница 17: ...nate 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 with this system Use of unapproved probes may result in patient injury or equipment damage Caution Do not pull the cable to disconnect the probe connector from the scanner Pulling the cable may damage ...

Страница 18: ...xt ﬁeld 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 connected If a USB storage device is connected to the system this button will also save the current screen image to the storage device 2 6 Resetting the Site Rite 6 Ultrasound System Should the scanner ...

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: ...priate 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 pitch with smaller dash marks at 0 5 cm Software Version Number Patient ID 1 Display Smooth Sharp Image F5 on the keyboard toggles between smooth and sharp imaging ﬁlters Enter Patient Information F...

Страница 21: ...Image 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 Error Battery Requires Calibration There are 5 charge levels on each battery indica tor When the unit is recharging the indicator is green for all 5 levels When the unit is operating on battery powe...

Страница 22: ...ed 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 in the PID 1 field will be displayed in the title bar above the image 5 To clear PID information press the F12 key Note The patient information will be lost when the system is powered off To avoid in...

Страница 23: ...n 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 probe so that the side with the needle guide hook points away from the heart Warning If the probe is damaged in any way discontinue use immediately Damage to the scanner may occur ...

Страница 24: ...rile 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 com To drape the probe for sterile use 1 Place the probe in the side arm probe holder on the roll stand 2 Apply a layer of non sterile ultrasonic coupling gel on the acoustic window of the probe head ...

Страница 25: ...ntered 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 wall indenting Once puncture occurs the vessel returns to normal shape 8 Hold the needle then gently rock the probe away from the needle for a smooth separation The needle guide channel opens and the ...

Страница 26: ...in 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 Gain buttons to select the desired image size 7 Press the Freeze button to store the updated settings and resume normal operation 5 2 Image Parameters The Site Rite 6 Ultrasound System image may be cha...

Страница 27: ...ructures 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 image Image Depth Setting Focal Depth 1 5 cm 0 6 cm 3 0 cm 1 5 cm 4 5 cm 3 0 cm 6 0 cm 5 0 cm Press the Depth button cm to select the image depth with the focal depth closest to that of the target struc...

Страница 28: ...cide 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 the Site Rite 6 Ultrasound System scanner or probe with ethylene oxide or heat sterilization methods Damage to the equipment may occur Caution When disinfecting the probe with a liquid disinfectant do...

Страница 29: ...alfunction 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 Cause Battery malfunction Solution Send system to authorized repair facility for battery replacement Cause Storage device error Solution Replace storage device Cause Printer error Solution Check pape...

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 The Site Rite 6 Ultrasound System will automatically upload the software from the attached USB drive Note The screen may appear blank and or inactive during part of the software installation process 6...

Страница 31: ...A 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 batteries Note At least five hours of charge time is recommended to fully charge the Site Rite 6 Ultrasound System batteries 4 Disconnect the Site Rite 6 Ultrasound System from A C power 5 Power on the Site ...

Страница 32: ...er 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 Site Rite 6 Ultrasound System scanner to any power source other than the Site Rite 6 Ultrasound System A C adapter and or base power unit Connecting the Site Rite 6 Ultrasound System to any unauthor...

Страница 33: ...by 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 Conditions Operating Temperature 59 F to 100 F 15 C to 38 C Storage Temperature 50 F to 100 F 10 C to 38 C Operating Humidity 5 to 85 Relative Humidity non condensing Storage Humidity packaged 5 to 95 Relati...

Страница 34: ...ervals 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 lice...

Страница 35: ...th 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 50 60 Hz Input Current Max 2 Amps Output Voltage 15 VDC Output Current Max 6 Amps Image Depth Focal Depth 1 5 cm 0 6 cm 3 0 cm 1 5 cm 4 5 cm 3 0 cm 6 0 cm 5 0 cm ...

Страница 36: ...cal 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 Electrical Systems IEC 60601 1 2 2001 Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601 2 37 2004 Medic...

Страница 37: ...ow 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 Group 1 The Site Rite 6 Ultrasound System 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 equipme...

Страница 38: ...t 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 environment Voltage Dips Dropout EN IEC 61000 4 11 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles 95 Dip for 5 Seconds 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles 95 D...

Страница 39: ...0 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 by no less than the distances calculated listed below D 1 2 P D 1 2 P 80 to 800 MHz D 2 3 P 800 MHz to 2 5 GHz where P is the max power in watts and D is the recommended separation dis tance in meter...

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 recommended below according to the maximum output power of the communications equipment Max Output Power Watts Separation m 150 kHz to 80 MHz D 1 2 P Separation m 80 kHz to 800 MHz D 1 2 P Separation m 80...

Страница 41: ...he 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 800 545 0890 Technical Clinical Support 800 443 3385 www bardaccess com Site Rite Needle Guides Distributed by Bard Access Systems Inc 605 North 5600 West Salt Lake City UT 84116 U S A 801 522 5000 Custome...

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Страница 44: ...2009 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 Reserved 0717804 0907R 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 800 545 0890 Technical Cl...

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