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BLADDERSCAN BVI 3000 Скачать руководство пользователя страница 47

39

Operations & Maintenance Manual: Cleaning & Disinfecting

PROCEDURE 2. DISINFECT THE INSTRUMENT

Failure to heed the following may cause device damage not covered by the warranty:
• Do not immerse the instrument in the disinfectant solution.
• Do not subject any part of the instrument to steam, ethylene oxide, radiation, or similar methods of

sterilization or autoclaving.

• Do not use CidexPlus

®

to disinfect the instrument. CidexPlus will damage the plastic enclosure.

IMPORTANT

Disinfectants and cleaning methods listed are based on compatibility with product materials, not biological

effectiveness. Refer to the instructions from the manufacturer of the disinfectant for guidance on biological

effectiveness of the disinfectant.

The following liquid disinfectants and wipes are compatible with the materials used in the instrument:

• A‑456

®

II Disinfectant

• Accel

®

TB Wipes

• CaviCide

®

• CaviWipes

®

• Chloro‑Sol Spray

®

• Clorox

®

Germicidal Wipes

• Mikro Quat
• Sani‑Cloth

®

Bleach Wipes

• Sani‑Cloth

®

Germicidal Wipes

• Sani‑Cloth

®

Plus Germicidal Wipes

• Sporicidin

®

Disinfecting Towelettes

• T‑Spray II

®

The level of disinfection required for a device is based on the type of tissue it contacts during use. Based on the

intended use of the BladderScan BVI 3000 system, low‑level disinfection is the minimum level required.

1. Ensure the instrument has been properly cleaned according to the procedure

Clean the Instrument

2. Ensure the disinfectant has not expired.

3. If using a liquid disinfectant, prepare the disinfection solution according to the manufacturer’s label

instructions, ensuring that you are using the proper concentration.

4. Apply the solution to a soft cloth or wipe.

Note: Do not spray or apply liquid disinfectants directly to the surface of the device, and do not soak the

device in liquids.

5. Wipe the surfaces of the device and allow the surface to remain wet for the required contact duration. Follow

the manufacturer’s instructions for the appropriate disinfection level contact duration.

6. Do not re‑use cloths or wipes.

7. If rinsing or removal of the disinfectant solution from the device is required by the disinfectant manufacturer’s

instructions, wipe with a clean soft cloth dampened in sterile water. Verathon

®

recommends wiping the

device three separate times to remove all residual disinfectant.

8. Allow the device to air dry, or towel dry the device with a clean, dry cloth.

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Содержание BVI 3000

Страница 1: ...BLADDERSCAN BVI 3000 OPERATIONS MAINTENANCE MANUAL ...

Страница 2: ...0900 0383 15 60 ...

Страница 3: ...BLADDERSCAN BVI 3000 Operations Maintenance Manual Effective March 6 2015 Caution Federal United States law restricts this device to sale by or on the order of a physician ...

Страница 4: ...ax 31 0 20 210 30 92 verathon com 0123 Copyright 2014 2015 by Verathon Inc All rights reserved No part of this manual may be copied or transmitted by any method without the express written consent of Verathon Inc Verathon the Verathon torch symbol BladderScan and the BladderScan symbol are either trademarks or registered trademarks of Verathon Inc All other brand and product names are trademarks o...

Страница 5: ...ogical Safety 2 Contraindications 2 Precautions Warnings 2 INTRODUCTION 6 COMPONENTS FEATURES 6 Control Unit 7 Scanhead 8 Batteries Battery Charger 8 SYSTEM COMPONENTS ACCESSORIES 9 BUTTONS ICONS CONNECTIONS 9 Battery Icon 9 Buttons 9 SETTING UP 10 ASSEMBLING THE INSTRUMENT 10 Procedure 1 Charge the Batteries 10 Procedure 2 Insert or Remove a Battery 12 Procedure 3 Connect the Scanhead to the Cont...

Страница 6: ...firm the Scan Results 29 MANAGING SCAN RESULTS 31 Procedure 1 Add a Patient ID Number Optional 31 Procedure 2 Add Notes Optional 32 Procedure 3 Print the Scan Result Optional 34 Procedure 4 Print a Histogram of Cost Savings Optional 36 CLEANING DISINFECTING 38 Procedure 1 Clean the Instrument 38 Procedure 2 Disinfect the Instrument 39 MAINTENANCE TROUBLESHOOTING 40 ANNUAL CERTIFICATION OF CALIBRAT...

Страница 7: ...nt Accuracy 47 DEVICE DISPOSAL 47 WARRANTY 48 Disclaimer of Additional Warranties 48 PRODUCT SPECIFICATIONS 49 SAFETY PERFORMANCE SUMMARY 49 ACCURACY RANGE 49 COMPONENT SPECIFICATIONS 50 Control Unit Scanhead Specifications 50 Battery Charger Specifications 52 Battery Specifications 53 ELECTROMAGNETIC COMPATIBILITY 54 Electromagnetic Emissions 54 Electromagnetic Immunity 55 Recommended Separation ...

Страница 8: ......

Страница 9: ...ge of the bladder which is used to determine bladder volume noninvasively ESSENTIAL PERFORMANCE Essential performance is the system performance necessary to achieve freedom from unacceptable risk The essential performance of the BladderScan BVI 3000 system is to produce ultrasonic output energy and display numerical values for bladder volume The system has a passively temperature controlled transd...

Страница 10: ...nual pay attention to sections labeled Important as these contain reminders or summaries of the following cautions as they apply to a specific component or use situation To ensure safe and reliable operation for the user and patient please heed the following warnings and cautions PRECAUTIONS The BladderScan BVI 3000 and related devices may contain mineral oils batteries and other environmentally h...

Страница 11: ...likely to cause harmful interference with other devices in the vicinity There is no guarantee that interference will not occur in a particular installation Evidence of interference may include degradation of performance in this device or other devices when operated simultaneously If this occurs try to correct the interference by using the following measures Turn devices on and off in the vicinity ...

Страница 12: ...ble image WARNING Electric shock hazard Do not attempt to open the system components This may cause serious injury to the operator or damage to the instrument and will void the warranty Contact Verathon Customer Care for all servicing needs WARNING Risk of electric shock or burns Do not use the BladderScan instrument in conjunction with high frequency surgical equipment WARNING This product may on...

Страница 13: ...and these components WARNING Risk of explosion fire or serious injury The BladderScan BVI 3000 system is battery powered Failure to note the following when handling the battery may result in serious injury or damage Never short circuit the battery by bringing the battery terminals into contact with any other conductive object Never expose the battery to abnormal shock vibration or pressure Do not ...

Страница 14: ...u may purchase optional accessories and additional supplies such as ultrasound gel thermal paper for the printer a mobile cart or a carrying case For more information about available accessories see System Components Accessories on page 9 or contact Verathon This section describes the main components and their parts and features Figure 1 BladderScan BVI 3000 Control Unit and Scanhead ...

Страница 15: ...tons The measured bladder volume and a target shaped aiming icon are clearly displayed on the LCD screen helping the operator to achieve accurate measurement results Figure 2 Control Unit Components Battery eject button Battery Power button Function buttons 5 Light sensor Printhead release lever and manual paper feed wheel Scanhead cable port Paper well ...

Страница 16: ... Components Scan button Cable Cable connector Dome Patient orientation icon BATTERIES BATTERY CHARGER Two NiMH rechargeable batteries are included with the BladderScan BVI 3000 One battery can be recharged in the battery charger while the other is being used to power the BVI 3000 This ensures that there is no instrument downtime due to battery charge Figure 4 Battery Charger Battery charger Batter...

Страница 17: ...able 2 Battery Icons ICON STATUS PERCENT REMAINING DESCRIPTION 100 Afully darkened battery icon indicates that the battery is fully charged and ready for use 75 A battery icon that is almost full indicates a partially discharged battery 50 When the battery icon is half darkened the battery is partially discharged This is the most common display shown during the majority of the battery s charge lif...

Страница 18: ... original package until ready to use If the battery is leaking or its case is cracked put on protective gloves to handle it and discard it immediately Always dispose of used batteries in compliance with all applicable laws and regulations Put insulating tape such as cellophane tape on the electrodes during transportation in order to avoid a possible short circuit fire or electrical shock WARNING I...

Страница 19: ... the charger starts to top off the charge and the green light flashes quickly At this point you may use the battery in the BVI 3000 instrument Slowly Flashing Green If the green light flashes slowly upon inserting a battery then the battery level is too low for fast charge mode The charger slowly charges the battery until the power level is high enough to begin fast charge mode When the battery po...

Страница 20: ...ry 3 Align the charged battery with the battery well as shown in the following figure Battery contacts facing up 4 Slide the battery into the well and press until the battery clicks into place REMOVE A BATTERY 1 Next to the battery well press the battery eject button The battery is released from the control unit Battery eject button 2 Slide the battery out of the control unit 3 Recharge or store t...

Страница 21: ...le connector so that the arrow is facing up Arrow on scanhead cable connector 2 Press the connector directly into the port until you hear a click 3 If you want to disconnect the scanhead from the control unit grip the black plastic ring on the cable connector and then pull straight out Do not twist the cable or connector ...

Страница 22: ... paper roll cut off the first inch of the new paper 4 Ensure that the end of the paper roll is cut straight Do not fold the end of the paper roll cut it diagonally or cut it to a point 5 Turn the BVI 3000 on by pressing the power button 6 Insert the end of a new paper roll with the thermal side down into the paper input slot The BVI 3000 senses the presence of the paper and automatically feeds the...

Страница 23: ... Turn the BVI 3000 on by pressing the power button 2 On the Main Menu screen press the ALT button BVI 3000 SCAN ALT PRINT NOTES 13 27 05 22 14 3 If you are prompted enter your PIN code Note The default PIN code is 0000 For information about how to change the PIN code see the procedure Adjust User Preferences on page 21 4 On the Alternate Menu screen press the NAME button NAME TIME DATE Copyright 2...

Страница 24: ...any empty character and then press the SEL button When the right or down buttons are pressed and held the cursor moves one character per second ERASE VERATHON_ SEL DONE L Y M Z A N 0 B O 1 C P 2 D Q 3 E R 4 F S 5 G T 6 H U 7 I V 8 J W 9 K X 6 If you would like to delete a character press the ERASE button This deletes the last character entered ERASE VERATHON_ SEL DONE L Y M Z A N 0 B O 1 C P 2 D Q...

Страница 25: ...I 3000 on by pressing the power button 2 On the Main Menu screen press the ALT button BVI 3000 SCAN ALT VERATHON PRINT NOTES 13 27 05 22 14 3 If you are prompted enter your PIN code Note The default PIN code is 0000 For information about how to change the PIN code see the procedure Adjust User Preferences on page 21 4 On the Alternate Menu screen press the DATE button NAME TIME DATE Copyright 2013...

Страница 26: ...5 22 14 MM DD YY DONE 7 Press the button to toggle between increasing or decreasing the year and then press the YY button until the correct year is displayed 05 22 14 MM DD YY DONE 8 When you are finished entering the date press the DONE button 05 22 14 MM DD YY DONE The date you entered is now displayed on the Main Menu screen BVI 3000 SCAN ALT VERATHON PRINT NOTES 13 27 05 22 14 ...

Страница 27: ...ladderScan BVI 3000 on by pressing the power button 2 On the Main Menu screen press the ALT button BVI 3000 SCAN ALT VERATHON PRINT NOTES 13 27 05 22 14 3 If you are prompted enter your PIN code Note The default PIN code is 0000 For information about how to change the PIN code see the procedure Adjust User Preferences on page 21 4 On the Alternate Menu screen press the TIME button NAME TIME DATE C...

Страница 28: ...e MM button to increase the minute value 13 27 HH HH MM MM DONE 7 When you are finished entering the time press the DONE button 13 27 HH HH MM MM DONE The time you entered is now displayed on the Main Menu screen BVI 3000 SCAN ALT VERATHON PRINT NOTES 13 27 05 22 14 ...

Страница 29: ...e images without identifying the bladder walls WALLS_ONLY Bladder outline only 12_PLANES All 12 scan planes printed as in the ADD_WALLS mode Quick OFF default When you press the PRINT button the Print screen appears and you may select whether you would like to print the last scan result cost savings or a test print ON When you are on the Scan Results screen if you press the PRINT button the scan r...

Страница 30: ...ollable scan counter to zero Note There are two scan counters in the BVI 3000 One may be reset by users and the other may only be reset by an authorized Verathon representative Reset histogram Reset the histogram to being a new analysis of cost savings Change PIN code Change the PIN code The current PIN is displayed Enter the desired PIN and then press DONE If you change the PIN code ensure that y...

Страница 31: ...TO Beep volume 1 Language ENGLISH Date MM DD YY Printout WALLS ONLY SEL SEL DONE 6 When you have selected the parameter you wish to adjust change the parameter value by pressing the plus or minus buttons Backlight AUTO Beep volume 1 Language ENGLISH Date MM DD YY Printout WALLS ONLY SEL SEL DONE 7 Repeat Step 5 through Step 6 as needed to adjust desired preferences 8 When you are finished adjustin...

Страница 32: ...en scanning patients who have had abdominal surgery Catheterization A catheter in the patient s bladder may affect the accuracy of the bladder volume measurement however the volume measurement may still be clinically useful if it is large detecting a blocked catheter for example Obesity Obesity may affect bladder volume measurements Lift as much abdominal adipose tissue out of the way of the instr...

Страница 33: ...sufficiently charged If necessary recharge or replace the battery 3 Turn the BladderScan BVI 3000 on by pressing the power button 4 On the Main Menu screen press the SCAN button BVI 3000 SCAN ALT VERATHON PRINT NOTES 13 27 05 22 14 5 On the Scan screen press the Male Female button in order to select the patient s gender The LCD screen shows a male or a female icon to indicate the gender that is se...

Страница 34: ... s Right Side Scanhead Patient s feet Patient s head Bladder Field of vision Symphysis pubis Figure 7 View from Patient s Feet Scanhead Scan button Bladder Field of vision Patient s right side Patient s left side 11 On the scanhead press and release the scan button The scan initiates 12 Hold the scanhead steady throughout the scan The scanhead clicks once at each of the twelve scan planes When the...

Страница 35: ...re the bladder volume measurement To achieve an accurate measurement re aim the scanhead toward the bladder image and then repeat the scan Volume too high The bladder overlaps two sides of the Aiming icon This indicates that the bladder is too large to be fully contained within the scanhead s field of vision The instrument recognizes this condition and displays a greater than symbol before the bla...

Страница 36: ...r example if the bladder image is located on the right side of the icon aim the scanhead so the ultrasound will be projected further to the right Repeat Step 11 through Step 12 of the Measure Bladder Volume procedure Verify the accuracy of the scan according to the instructions in this procedure 4 When you have collected sufficient scans in order to confirm aiming accuracy press the DONE button DO...

Страница 37: ...plane results to the results in the following table Table 5 Scan Plane Result RESULT SCAN PLANE DESCRIPTION Accurate The light colored bladder images are completely contained within the dark triangular scan planes Inaccurate The light surface in either scan plane is overlapping the edge of the black area or appears to be cut off Part of the bladder was not contained in the scanhead s field of visi...

Страница 38: ... on page 32 PRINT NOTES SCAN 21 cm2 21 cm2 MAIN 132 ml If you want to print the scan results press the PRINT button and then complete the procedure Print the Scan Result Optional on page 34 Note If you have enabled the QUICK setting in user preferences when you press the PRINT button the instrument automatically prints the scan results without displaying the Print screen For more information see t...

Страница 39: ...is entered the instrument assumes a patient ID number was entered and 0000000000 will be included on the printout 1 Using the left and right buttons select the digit you want to change the selected digit is underlined DONE 00000000000 2 Using the plus or minus buttons increase or decrease the value in order to select the correct digit DONE 00000000001 3 Repeat Step 1 through Step 2 until you have ...

Страница 40: ...his exam type is selected by default if the measured bladder volume is between 100 ml and 400 ml CAPACITY The measurement was taken prior to patient voiding and the bladder was filled to maximum capacity This exam type is selected by default if the measured bladder volume is greater than 400 ml SEL DONE EXAM TYPE ALLOWED TO FILL POST VOID PATIENT CATHED PATIENT VOIDED NO ACTION TAKEN X 2 If you wa...

Страница 41: ...ed by pressing the plus and minus buttons Note By default the amount of voided or catheterized urine is equal to the volume measured during the scan SEL DONE EXAM TYPE ALLOWED TO FILL CAPACITY PATIENT CATHED 410 ml PATIENT VOIDED NO ACTION TAKEN X 4 When you are finished entering notes press the DONE button SEL DONE EXAM TYPE ALLOWED TO FILL POST VOID PATIENT CATHED PATIENT VOIDED NO ACTION TAKEN ...

Страница 42: ...he scan results without displaying the Print screen Figure 11 Print Screen PRINT SEL DONE TEST PRINT COST SAVING LAST IMAGE X Note If the facility name date and time have not been set those lines will not be included on the printout Figure 12 Printout of Scan Results BladderScan tm VERATHON MALE 132 ml 05 27 14 08 55 Patient name Patient ID Procedure code Signature Probe 21308 Box 00001965 VER 3 0...

Страница 43: ...RINTING IN PROGRESS 4 When printing is completed tear the paper from the instrument by pulling the printout towards the back of the instrument 5 If desired create a photocopy of the printout The BVI 3000 instrument prints on thermal paper Over time the printout will fade For maximum storage life Verathon recommends that you create a photocopy of the printout ...

Страница 44: ...dicate that a certain percentage of catheterizations lead to urinary tract infections UTIs By avoiding unnecessary catheterizations the resulting UTIs may be prevented The default setting for percent of catheterizations leading to UTIs is 3 Cost of UTIs avoided Literature suggests that the additional costs associated with treating UTI amount to 680 00 per patient infection The default setting is 6...

Страница 45: ...NGS 49107 00 3913 4 When printing is completed tear the paper from the instrument by pulling the printout towards the back of the instrument Histogram VERATHON 05 27 14 08 55 Volume CATHs AVOIDED 2089 UTIs AVOIDED 63 SAVINGS 49 107 scans 000 099 100 199 200 299 300 399 400 499 500 599 600 699 700 799 800 899 900 999 1000 870 1 219 589 488 252 176 154 87 69 5 4 5 If desired create a photocopy of th...

Страница 46: ...ur local representative For additional contact information visit verathon com contact us WARNING Ensure that you follow the manufacturer s instructions for handling and disposing of the cleaning and disinfection solutions provided in this manual WARNING Procedure 1 CLEAN THE INSTRUMENT Cleaning is critical to ensuring the component is ready for disinfection Failure to properly clean the device cou...

Страница 47: ...ection required for a device is based on the type of tissue it contacts during use Based on the intended use of the BladderScan BVI 3000 system low level disinfection is the minimum level required 1 Ensure the instrument has been properly cleaned according to the procedure Clean the Instrument on page 38 2 Ensure the disinfectant has not expired 3 If using a liquid disinfectant prepare the disinfe...

Страница 48: ...of the instrument Any apparent cracks or faults in the control unit scanhead or the cable that links the control unit and the scanhead must be referred to your authorized Verathon Service Center or your local distributor MONTHLY ACCURACY CHECK Each month or whenever accuracy assessment is desired you should test the accuracy of the instrument according to the instructions in the procedure Verify I...

Страница 49: ...RINT NOTES 13 27 05 22 14 3 If you are prompted enter your PIN code Note The default PIN code is 0000 4 On the Alternate Menu screen press the SELF TEST button The instrument begins the self test NAME TIME DATE Copyright 2013 by VERATHON Corporation VER 3 020 D949 Box ID 00001965 PREF SELF TEST As the test is completed the Self Test screen displays the status of the systems tested When the test is...

Страница 50: ...y s charge is too low to allow normal operation but not too low to permit operation of the internal circuitry the BVI 3000 displays the following message BATTERY CHARGE LEVEL IS TOO LOW FOR INSTRUMENT OPERATION RECHARGE BEFORE NEXT USE BATTERY CHARGE LEVEL IS TOO LOW FOR INSTRUMENT OPERATION RECHARGE BEFORE NEXT USE 1 Replace the battery or recharge the current battery For more information see Cha...

Страница 51: ... the printhead overheats TOO HOT 1 Turn off the BVI 3000 and then wait for the instrument to cool down 2 Ensure that this is not the result of a paper jam For more information see Clear a Paper Jam on page 44 3 If the printhead continues to overheat contact Verathon Customer Care or your local representative RESCAN INTERFERENCE The BVI 3000 displays the message RESCAN if it detects interference of...

Страница 52: ...ing the manual paper feed wheel counterclockwise gently pull the paper backward until the paper jam is cleared and the paper roll is free of the instrument 3 Turn the printhead release lever so that it is pointing to 10 o clock 4 Trim any damaged paper off of the paper roll 5 Ensure that the new end of the paper roll is cut straight Do not fold the end of the paper roll cut it diagonally or cut it...

Страница 53: ...into the instrument according to the instructions in the procedure Load The Thermal Paper Roll on page 14 2 On the Main Menu screen press the PRINT button BVI 3000 SCAN ALT VERATHON PRINT NOTES 13 27 05 22 14 3 On the Print screen press the SEL button until TEST PRINT is selected PRINT SEL DONE TEST PRINT COST SAVING LAST IMAGE X 4 Press the PRINT button The instrument begins printing Note Printin...

Страница 54: ... by pulling the printout towards the back of the instrument 7 Ensure that the instrument prints an array of alphanumeric characters and a simple grayscale test pattern 01234 56789 ABCDEFGHI JKLMNOPQRSTUVWXYZ _ʽabcdefghijklmnopqrs tuvwxyz üäåÄÅÉÆöõï 000 002 004 006 008 000 001 002 003 004 000 000 001 001 002 Probe 21308 Box 00001965 VER 3 020 D949 Probe Scan Count 865 Console Scan Count 1282 ...

Страница 55: ...ding to the instructions in the chapter Using the Instrument on page 24 measure the post void volume of the bladder This checks for any post void residual PVR 4 Subtract the post void measurement collected in Step 3 from the pre void measurement collected in Step 1 This is called the measured volume 5 Compare the voided volume collected in Step 2 to the measured volume from Step 4 If the voided vo...

Страница 56: ...used in conformance with Verathon product specifications as provided in the Product Specifications chapter Warranty conditions may differ in some countries Contact your local distributor for warranty terms DISCLAIMER OF ADDITIONAL WARRANTIES There are no understandings agreements representations of warranties expressed or implied including warranties of merchantability or fitness for a particular ...

Страница 57: ...and pelvic surgery patients Scar tissue surgical incisions sutures and staples can affect ultrasound transmission and reflection To conserve power the BladderScan BVI 3000 turns off automatically when not in use Verathon recommends that new operators first use the BVI 3000 on patients with moderately full bladders rather than initially attempting to locate a bladder with a low volume Warning There...

Страница 58: ...er Ingress protection against water IPX1 drip proof a higher than ordinary level of protection from drips leaks and spills Table 8 Operating Storage Conditions SPECIFICATION VALUE Operating Conditions Use Indoor Ambient temperature range 10 40ºC 50 104ºF Atmospheric pressure range 700 1060 hPa Relative humidity 30 75 non condensing Storage Conditions Storage Indoor Ambient temperature range 20 60º...

Страница 59: ...SPTA 3 mW cm2 ISPPA 3 W cm2 Global Maximum Value 0 218 0 0676 2 95 Associated Acoustic Parameter pr 3 MPa 0 317 Wo mW 0 0676 0 238 fc MHz 2 12 2 12 2 12 zsp cm 2 80 2 80 Beam dimensions x 6 cm 0 367 y 6 cm 0 377 PD µsec 1 17 1 17 PRF Hz 400 400 EDS Az cm 5 46 Ele cm 1 20 TIS TIB TIC range 0 0 1 0 Image Rate 5 55 Hz M Lines 72 Sector Angle 120 Sector Offset 2 035 cm Both MI and TI values are below ...

Страница 60: ...ZA units 0 25 A European LZE units 0 38 A Universal LZU units Output No load to full load at rated voltage Refer to unit label Input connection The power supply employs a direct plug in AC prongs for wall plug in units Insulation The power supply is Class I with basic insulation to each terminal Environmental Specifications Operating temperature 10 to 40 C 50 to 104 F Transient overvoltage Categor...

Страница 61: ... metal hydride NiMH Nominal voltage 7 2 V Battery service life 500 cycles IEC standard approximately 2 years at 5 cycles per week Charging time and conditions 160 mA for 16 hours at 20 C 68 F Rated capacity 1 6 Ah Charging voltage 9 32 V DC source Max weight 195 g 0 43 lbs Width 61 mm 2 4 in Length 59 mm 2 3 in Height 36 mm 1 4 in ...

Страница 62: ...ffected under the test conditions described in the following tables For more information about the essential performance of the BladderScan BVI 3000 system see Essential Performance on page 1 ELECTROMAGNETIC EMISSIONS Table 11 Guidance and Manufacturer s Declaration Electromagnetic Emissions The BladderScan BVI 3000 system is intended for use in the electromagnetic environment specified below The ...

Страница 63: ... should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles 5 Ut 95 dip in Ut for 5 s In compliance Mains power quality should be that of a typical commercial or hospital environment If the user of th...

Страница 64: ...owing symbol Note Ut is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all 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 cordless telephones and...

Страница 65: ... 3 8 3 8 7 3 100 12 12 23 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 At 80 MHz and 800 MHz the separation distance for the h...

Страница 66: ...ionizing electromagnetic radiation Product Use Specifications Refer to the operations maintenance manual Manufacturer Use by date Use in indoor dry location only Catalog part number Serial number Batch code Temperature limitation Humidity limitation Atmospheric pressure limitation Statement of prescription Orient scanhead so that icon aligns with the patient s head and feet ...

Страница 67: ...ccordance with the Medical Device Directive MDD CSA Canadian Standards Association mark of certification to applicable standards for electromedical equipment EC REP Authorized Representative in the European Community RoHS Meets standards for Restriction of Hazardous Substances RoHS UL Underwriters Laboratories certification mark for electrical shock fire and mechanical hazards only UL Underwriters...

Страница 68: ...formance The system performance necessary to achieve freedom from unacceptable risk F Fahrenheit g Gram GHz Gigahertz HIPAA Health Insurance Portability and Accountability Act hPa Hectopascal Hz Hertz IEC International Electrotechnical Commission in Inch IPA Isopropyl alcohol ISM Industrial scientific and medical kHz Kilohertz kV Kilovolt lbs Pounds m Meter mAh Milliampere hour MDD Medical Device ...

Страница 69: ...tive humidity RoHS Restriction of Hazardous Substances TI Thermal index TIB Thermal index for bone TIC Thermal index for the cranium TIS Thermal index for soft tissue UTI Urinary tract infection V Volt Vrms Voltage root mean squared W Watt WEEE Waste electrical and electronic equipment ...

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