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1 | Users manual | Users Manual | 1.85 MiB |
HOLINOW SAdNIVeAdWAL LAdLNO ANIYN GALVWOLNYN Soup) .Ouve WL RATOR'S MANUA MODEL: BK ection 1 - Indications for Use, Contraindications, Warnings and Cautions Indications for Use Contraindications... Warnings Cautions FCC Declaration of Conformity Section 2 - Quick Start Guide ................cscsssssscsccnssessenssessesarenseseoesserscssssssesseresens B Section 3 - Product Description ...............::scsscsesssssesrscrssssstesstsssesssesessnstessenaeeees G System Overview... Uros Monitor Description User Hardware Barp Uros Monitor Temperature Monitoring Barp Uros Monitor RS232 Connection Connecting the Sensing Cable to Probe Adapter... Barp SureSter Foley Tray System Barp Uros Precision Urine Output Meter Attaching the URos Meter Section 4 Installation, Setup, and Operation ..............s:ssssessessssssssassesesseeees 15 Unpacking... System Battery Installing or Replacing Battery Mount Stand Bracket to Monitor Hardware / Software Operation General Overview... Screen Backlight Alarming Uros Monitor User Interface Icons System Units of Measure Uros Monitor User Interface .... Boot Display Screen Calibration Instructions Startup Display Primary / Secondary Display Display Information Starting a New Patient Case Switching Primary Display Accessing Patient History Ending Patient Case Urine Output Threshold Alarms Default Urine Output Threshold Alarm Settings Example Flow Rate Alarm Customizing Urine Output Threshold Alarm Core Bladder Temperature Measurement Temperature Alarm Example Customizing Temperature Threshold Alarms.. System Alarms Customizing Temperature Threshold Alarms System Settings General System Alarms Table: ...........0.cccccscscscsssesscsecssecsesereseseseseaes 35 Section 5 - Troubleshooting eeareene 38 Section 6 - Specifications .............sssssssecsssssssesscssssessessessessersessessenstssnsncsssesesses OT Environmental Requirements Uros Battery Module... Section 7 - Care and Maintenance ............sscsssscsssssseserersstsscessesevesesssrsseatsasens OB Cleaning and Maintenance Device Inspection Section 8 - Shipping. ......sescssscessessesecvesrsscrscsssesssssccesessesssausnesenssnesenscecessessszeners OO Section 9 - Baro Uros Monitor Replacement / Spare Parts ..........c.00000.40 Section 10 - Baro Uros Monitor Warranty / Service............:scsssssssssesresres 41 Section 11 - Appendix ............s:ccsssccsessesssesssessccsssesnenenans Classification System Error Codes .. Data Stream Output Definition Section 12 - Symbols ... ection 1 - Indications for Use, Contraindications, Warnings and Cautions Indications for Use The Uros Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature. Contraindications There are no known contraindications for the use of the Uros Automated Urine Output and Temperature Monitor. Warnings The Uros Automated Urine Output and Temperature Monitor requires special precautions regarding EMC and needs to be installed and put into service accordingly. Portable and mobile RF communications equipment may affect the operations of URos Automated Urine Output and Temperature Monitor. The Uros Automated Urine Output and Temperature Monitor should not be used adjacent to or stacked with other equipment. If it is absolutely necessary to use the Uros Automated Urine Output and Temperature Monitor in close proximity with other equipment, the Uros Automated Urine Output and Temperature Monitor should be observed to verify normal operation in the configuration in which it will be used. Do not immerse or submerge the Uros Automated Urine Output and Temperature Monitor or turn it upside down when cleaning. During long-term storage, remove primary batteries to prevent battery leakage. When shipping the Uros Automated Urine Output and Temperature Monitor for service or repair:
o Remove battery pack from device to prevent battery leakage. o Package battery pack separately in a non-conductive bag. o Place warning label on the outside of the shipping package (See Section 8, Shipping Lithium Batteries). To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth. User shall not place the UrRos Automated Urine Output and Temperature Monitor within the sterile field. Cautions Federal Law (USA) restricts this device to sale by or on the order of a physician. Use only a URos Automated Urine Output and Temperature Monitor compatible battery. Do not incinerate batteries. Recycle or dispose of them properly. Contact Baro for disposal information. State and Federal regulations govern the packaging necessary for return of medical product which may have been contaminated. Refer to local, state and Federal regulations when packaging the URos Automated Urine Output and Temperature Monitor for return. There are no user serviceable components inside the Uros Automated Urine Output and Temperature Monitor. The user should not attempt to repair the URos Automated Urine Output and Temperature Monitor. To do so may void the warranty and could result in erroneous monitor readings. For Service and/or Repair, call Baro Customer Service at: 1-800-526-4455, U.S. only. Use of cables or sensors and other accessories other than those specified for use with the Uros Automated Urine Output and Temperature Monitor, except those sold by Barp for use as a replacement part or repair components, may result in increased emissions or decreased immunity (more susceptible to equipment interference) of the URos Automated Urine Output and Temperature Monitor to electromagnetic interference. The Uros Automated Urine Output and Temperature Monitor should be recycled properly per European Union directive 2012/19/EU on Waste Electronic and Electrical Equipment, July 4, 2012. Do not dispose with ordinary municipal waste. Regulations and laws pertaining to the recycling and disposal of lithium ion batteries and battery packs vary widely from country to country, as well as by state and local governments which may have additional requirements. Please dispose of in accordance with state and local procedures. 5 Battery Module o Do not open, crush, or heat the battery pack above 50C or incinerate. o Risk of fire and burns. o Store pack at -20C to 50C. Avoid kicking or knocking over the monitor with Foley bag attached. Avoid placing the Uros Automated Urine Output and Temperature Monitor on the bed. Always pause the Uros Automated Urine Output and Temperature Monitor utilizing the user interface when transporting the patient or replacing the bag. The Uros Automated Urine Output and Temperature Monitor shall be used with the provided mounting options. The mounting options shall only be used with the URos Automated Urine Output and Temperature Monitor. It is recommended that the URos Automated Urine Output and Temperature Monitor receive a maintenance inspection annually or more frequently as dictated by hospital protocol. The inspection must be performed at an authorized Barv Service Facility. To arrange for service from Barb, call 1-800-526-4455. Always perform a functional checkout of the URos Automated Urine Output and Temperature Monitor prior to putting the monitor into service after repair. The Uros Automated Urine Output and Temperature Monitor is designed for use with only Baro products
(SureSTerp Foley Tray Systems and the Uros Precision Urine Output Meter). The Uros Automated Urine Output and Temperature Monitor is designed for use only with the provided external power supply (See Section 9: Replacement / Spare Parts). Medical electrical equipment needs special precautions to minimize electromagnetic interference. The following are manufacturers guidance:
o The use of accessories or cables other than those specified or sold by Barp is not recommended. o Use of unapproved accessories or cables may result in increased emissions or in decreased immunity of the Uros Automated Urine Output and Temperature Monitor to electromagnetic interference. If the URos Automated Urine Output and Temperature Monitor is used directly adjacent to other equipment, the user should periodically observe the URos Automated Urine Output and Temperature Monitor to verify it operates normally in that environment. o Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The Uros Automated Urine Output and Temperature Monitor contains a Class 3R laser. Class 3R lasers are considered safe when handled carefully. o AClass 3R laser is low powered. o There is only a small hazard potential for accidental exposure. o It normally would not harm eyes during a momentary exposure of less than % second. This is within the aversion response, where a person turns away and/or blinks to avoid bright light. o Do not deliberately look or stare into the laser beam. o Laser protective eyewear is normally not necessary. ederal Communications Commission Declaration of Conformity This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy. If not installed and used in accordance with the instruction manual it may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference, which can be determined by turning the medical device off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
o Reorient or relocate the medical device. Increase the separation between the medical device and receiver. o Connect the medical device into an outlet on a circuit different from that to which the receiver is connected, if operating on mains power. o Consult an authorized dealer or service representative for help. Barp is not responsible for any equipment interference caused by using other than specified or recommended cables and connectors, or by unauthorized changes or modifications to this medical device. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This manual is intended for use by qualified personnel who are familiar with electromechanical medical devices. The manual can also be used as a learning tool for those persons who will be using the Baro Uros Automated Urine Output and Temperature Monitor (hereinafter referred to as URos Monitor). Preparing Monitor | Start Monitoring 5. Attach Uros Meter/Bag assembly to monitor
(2) Hang bag hook on monitor
@) Swing and press Uros Meter into monitor awniee [Qe 7. Begin Patient Case Foley catheters are intended for use in drainage and/or collection and/or measurement ef urine. Temperature sensing Feley catheters provide a measure of core bladder temperature and are intended for use with compatible 480-series temperature sensing monitors. Please consult product label and insert for any indications, centraindicatiens, hazards, warnings, cautiens and directions for use. The Foley catheters included in the Bardex |.C. and Lubri-Sil |.C. System centain Bacti-Guard silver alley coating licensed from Bactiguard A.B. Bacti-Guard is a registered trademark of Bactiquard A.B. Sntlkghh for-2 12 hours ORi andthe for for X24 hours?
ORy 30.nWhs for 24hy Note: Only Compatible SureSter Foley Tray Systems will work with the URos Monitor and URos Meter. 1. Unpack monitor E 4. Power system O 3. DeraultA PRAYED ection 3 - Product Description System Overview The Barp Uros System is composed of three primary components. (1) The Uros Monitor measures urine output and core bladder temperature. (2) The SureStep Uros Foley Tray System includes all necessary components for the placement of an indwelling temperature-sensing Foley catheter. The tray also incorporates connections for the Uros Precision Urine Output Meter. (3) The Uros Precision Urine Output Meter, when attached to the SureStep Uros compatible Foley Tray system, will enable precision electronic urine output monitoring. Uros Monitor Description The Uros Monitor enables electronic urine output monitoring for patients requiring accurate urine output and temperature monitoring. The URos Monitor is capable of communicating real-time data by connecting to electronic medical record systems. Both thresholds and alarms are user definable allowing users to customize the system to thei specific requirements. Uros Monitor User Hardware Uros Monitor - Front Vie Ambient Light Sensor Bag Hanger Slot Touch Sensitive Interactive Display Iluminated le Alarm Indicator Communication Port Power Switch Speaker for audible alarms Battery Module Attachment Screws Monitor - Rear Vie artridge Mount Optical Laser Detector:
Communications Port Battery Compartment Bag Hanger Slot Vionitor - Top View Ambient Light Sensor Bag Hanger Slot Bubble Level Touch Sensitive Interactive Display Illuminated Visible Alarm Indicator Uros Meter Release Button 5 a c 2 rs) c Cc fo) oO 2 a 2 3
8 a 5
-e Communication Port monitor core bladder temperature with Bard Temperature Sensing Foley Catheter, insert the Uros two pin adapter cable to the monitor. Barp Uros Monitor RS232 Connection Connecting the RS232 Serial Communication Cable to the Uros Monitor To monitor core bladder temperature with Bard Temperature Sensing Foley Catheter, insert the Uros two pin adapter cable to the monitor. Uros Monitor Temperature Monitoring Connecting the Patient Temperature Probe Adapter Cable to the Uros MONITOR Barpb SureStep Foley Tray System The Barp SureSter Foley Tray System provides closed system trays that are available in a wide variety of configurations to meet critical needs of patients. Please call 1-800-526-4455 or contact your local sales manager fo he most current list of available configurations. Baro SureSter Foley Tray System are Uros Compatible onnecting the Foley Temperature Sensing Cable to the Patient Temperature Probe Adapter Cable Molex Style Termination 1/8 inch Mono Plug Termination SURESTEP FOLEY TRAY SYSTEM REE TSN rat a roam DoesThs t ntMeet he D dn Indwe ling Ureth a theter CP Paty thas acu te CIN ed 1 O se(rst ted OT a stnh O)Pat treque pr O mprove F onnect the catheter side of the adapter cable to the temperature lead on the third port of the catheter. Depending on the catheter temperature lead, either a Molex or a 1/8 inch style adapter cable will be required Ros compatible trays can be identified by the blue URos markings identified above NOTE: ONLY Uros Compatible trays will work with the Uros Monitor. s Temperatura-Sens ab lization De ice lerobiat Conrmo-F Ou let Device Bacte wsta 1c O sinag Tube Bactertastatic Collection Bag (2000 mi}
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Ben are k Soap Tt fe as Hong zi ote Bed Save YO Syed of Ste Ware timiontie Feentcaten Bape Towa | Siren tanger Sect Cae Spar wren tne ath e@ for acc rate ur Uo ee sug Oo ss) 1 ealing ten irs To! como e wo connected = Band = > ey +60 194 T monrature Monitors. is intended st Grainage and/or ocalecuon and/or messi Lot Laine end In scryunetion with att tt tonic monitor of nesnutenngol cor bod temprawe degrees Fanrenne:t 4 iu i Paie t C CGul efi es for ' rica Use?
haryr tet) orbladderoul to tru ine outpu measurements ricalpr e te oalopensacr o rineal wounds olonged m obh at n ttfor ndof fe re other s00 roe D0 not use W atergic ta lodine cretepieal vie andy. Werte Gn cothates, do na use elntmonts os hierkc ames heveng 4 petretabwen Rove. Thay wit demnoge cone
"Couve hetboun ta beret. Een CONTRO FOLE LOYCOAT 3 Catheter Precision Output Meter When precision electronic monitoring of urine output and temperature is required, a URos Meter can be inserted into the connection ports on the SuRESTer Foley Tray System. The Uros Meter has been specifically designed to easily attach to SuRESTerp Foley Tray System while maintaining a closed system. The meter is designed for single patient use. Once attached, the meter cannot be removed. If monitoring is no longer required, the meter does not interfere with non-electronically monitored urine output. Uros Meter The Uros Meter allows the addition of metering capabilities for electronic monitoring of urine output. Uros Meter Top Port cD Uros Meter Top Port RFID Tag Bottom Port Uros Meter Back Side The UrRos Meter has a unique identifier which authenticates the meter to the Uros Monitor. The identifier can be used to create the Positive Patient Identification within Electronic Medical Record systems. SurestTer Foley Tray System is configured in a URos compatible configuration, which provides a monitoring enabled closed Foley system. compatible Foley tray systems incorporate URos Meter connection ports. Otherwise, they are identical to standara SureStep Foley trays in design. ene:
2000
Beggs Meter Connection Port Compatible Logo ection 4 Installation, Setup, Operation Unpacking Contents in package:
* Uros Monitor Uros Battery Module External AC/DC Power Supply Temperature Probe Adapter Cable Operators Manual System Battery Charging The Uros Monitor uses a high capacity lithium ion battery designed to allow continuous operation for approximately 12 days of typical usage between charging. An on-screen indicator of battery life remaining is located on the display and is visible at all times. The system will alarm the user in the event the battery power is at or below 3% of full charge capacity. The system battery is designed to be charged with the battery in place. To charge, simply plug in the power supply. During the charging process, the small battery icon seen at the top of the screen will increment from empty to full indicating the battery is currently charging. A new battery will take approximately 12 hours to become fully charged fro a completely discharged state. The battery is designed to charge-cycle approximately 250 cycles while retaining 50%
capacity before requiring replacement. If the system battery does not maintain a charge, cannot be charged fully or has a significantly reduced run time, a replacement battery may be necessary. Replacement batteries can be purchased by calling 1-800-526-4455 or contact your local sales manager for replacement. Attaching the Uros Meter The Uros Meter allows the addition of metering capabilities for electronic monitoring of urine output. Bottom Port To attach the URos Meter to the Uros compatible urinary drainage system, simply attach the bottom port, followed by the top port and the assembly is ready for use in the URos Monitor. Please refer to the Uros Precision Urine Output Meter Instructions for Use for further information.
Sa Upon unpacking and prior to use, the battery module must be installed and charged To install battery module, slide into place as illustrated above. Tighten two bolts (pre-attached to battery) Mount to monitor stand (please refer to stand instructions for use for mounting) Charge with supplied external power supply until fully charged Your system is ready to use Align mounting holes of Stand Bracket to the back of the monitor as pictured above Fasten Stand Bracket by using the included 4 sets of washers and screws Sracket to Monitor Directions for mounting Stand Bracket to Monito Directions for installing or replacing system batte Hardware and Software Operation General Overview The Uros Monitor is designed to be intuitive and easy to use. The interface has been designed to maximize the use of icons to simplify user interaction. Screen Backlight The Uros Monitor has a backlit display providing visibility in low light conditions. The backlight is optimized to maximize battery usage. The system will automatically adjust brightness levels depending on ambient light conditions. The backlight will automatically activate in low ambient light conditions. In low ambient light conditions, the backlight will automatically turn off after 30 seconds of inactivity. Reactivating the backlight can be accomplished by touching anywhere on the display. The initial touch will only reactivate the backlight regardless of where touched. To select a new function a second touch on that function will be required. Alarming Only system critical alarms will produce audible alarms in addition to a white blinking visible alarm. Urine output and temperature related alarms are silent, but visible and color coded to indicate patient status. They have been designed to easily observe patient status from a distance without disturbing the patient. These alarms also include on-screen icons that work in conjunction with the color coded visible alarms. Uros Monitor User Interface Icons Many system icons will be found in the graphical display. Below is a list of icons with their description and function. Most active icons will have a black background to indicate it has been selected unless otherwise noted. Primary Functions Buttons and Icons Home screen button. Select to return to Data history (black is the home screen and primary display selected.) Start Case Icon Alarm icons indicating which stage alarm the patient is Select to view, change current patient currently experiencing. information. The system alarm thresholds can be modified to user preference. Select to view, change current patient Flow Rate threshold button. information. White button is selected. Patient Case Stop confirmation button. Kilogram selection button. Select to confirm end of patient case. Black is selected. Device Configuration. Select to configure system options. Black is selected. Clock Icon appears on the time date settings screen. Flow Ratelcon appears in the secondary field of the main display. Monitoring Duration of patient. Appears in the Case Info screen. Cancel button. Appears in confirmation screen and allows user to cancel previous input. Timed Interval Volume. 12 hour interval is available. Patient Temperature button found on Data History screen. Select to retrieve temperature history. Pound Selection button. Black is selected. Weight Field. Enter patient weight. Factory Reset to factory default values. Found in Device Configuration settings. Factory Reset icon. Confirmation/Accept button. Select to confirm entry. Timed Interval Volume icon. Graphing View buiton. Select to display urine output and temperature graphing. Yjju Information Status Buttons and Icons Flow Rate Found on Primary and in Units and Alarm Setting screen. Flow Rate History button Found on Graphing screen and Data History screen. Data Output Icon Found in Device Configuration screen. Turns data I/O on or off. Data Connected Found on main screen if Data Output has been enabled. Data Not Connected - Found on main screen if Data Output has been enabled. Found on Device Configuration screen. Enabled Mode. Found on Device Configuration screen. Disabled Mode. ml/kg/h Toggle between Flow Rate displayed as mi/kg/h and weight normalized flow rate displayed as ml/h. Toggle between m iter/kg selection button. C and F selection button. Toggles between options. Time entry button. Used to set Flow Rate Alarm duration. White is selected. Alarm Threshold settings. Select each of 5 levels to customize. Directional button selections. Additional information will be displayed when selected. Alarm Buttons and Icons Alarm Code Icon Status. Found on relevant alarm screens with relevant alarm code number. Battery Alarm. Found on primary screen. If present, the system is notifying user the battery has less than 3%
power remaining. Battery Alarm icon. Battery Icon found on primary screen. As battery power is depleted, the battery indicator will show a depleting charge. When battery has less than 3% charge, an empty battery will be displayed and the battery alarm will activate. Flow Rate Alarm. Found on primary screen. If present, the system is notifying user of a Flow Rate alarm. Flow Rate Icon Patient Temperature Alarm Button Found on primary screen. If present, the system is notifying user of a temperature alarm Tilt Alarm. If present, the monitor is tilted off-level by more than 10%. Return monitor to level to disable the alarm. Alarm Icon Patient Temperature lower limit setting. White is selected. Found in the Patient Temperature Alarm Settings screen. Patient Temperature upper limit setting. White is selected. Found in the Patient Temperature Alarm Settings screen. Alarm button. Select to confirm acknowledgment of changes for alarm settings. Found on Patient Temperature. Allows toggling temperature alarm ON. Alarm button. Select to confirm acknowledgment of changes for alarm settings. Found on Patient Temperature. Allows toggling temperature alarm OFF. tem Units of Measure lb = pounds kg = kilogram F = degrees Fahrenheit er per kilogram per hour C = degrees Celsius Upon boot up, the splash screen will be displayed for a short time. Below the Bard logo, the current software version and system serial number will be displayed. (The top number on the splash screen indicates the software version. The lower number indicate:
the monitor serial number.) vionitor User Interface Boot Display 1 234567890ABCDE Power on the Uros Monitor and wait for the splash screen to appear as shown below. LBANIIRID 1.0.0 1234567890ABCDEF As soon as the Splash screen appears press and hold the monitor screen for approx. 3 seconds until the corner image appears on the upper left hand corner of the screen as shown in the below image. Press the Image in the upper left corner and as it moves to the remaining 3 corners of the screen and continue pressing the image until the calibration process is completed and the Main screen appears as shown in the image below. ollowing display of the Boot Screen, the system will display the Startup Screen. Initial data values will be reported as dashes unti the system is set up to monitor a patient. tartup Displa econdary Display The Uros Monitor user interface is flexible and customizable to prominently display whichever parameter is preferred in the primary display. Secondary parameters are found in the secondary display area across the bottom and are presented in a smaller ont size. The primary display is considered the active parameter. Touching the primary display area will allow for additional settings to be made for the active parameter. 0 enable a secondary parameter to become active in the primary display area, simply select any of the secondary isplay parameters and it will be swapped into the primary display area. System Settings Additional functions are displayed on either side of the primary display area. Some functions will remain constant in all screens, while other functions are context sensitive and will change depending on the current screen or settings selected. Status indicators across the top of the primary display such as the battery and connectivity status will remain present at all times in the primary display mode. Primary Secondary Display Primary Display
R C onnectivity Statu _ YC) Battery Status Qe Flow Rate Patient Information Display Informatio tarting a New Patient Case es Li Select to start case
, a 3. Select Home to begin 3 A | 1. Enter Weight t) Uros Meter ID 9 123458789ABCDEF 2. Select to Accept J Case Information Screen Case Information i fo; CG ae 3 100 Cumulative Time on Monitor To start a case. (e.g. Add Patient), Select Add Patient icon. Next, enter weight using toggle buttons and accept entry to begin case. The Uros Meter ID will be displayed at the bottom of the screen. This ID is unique to the Uros Meter and will never be duplicated. The Uros Meter ID will be transmitted in the data stream and can be used to establish Positive Patient Identification (PPID) within Electronic Medical Record (EMR). 4. The Uros Meter ID can be retrieved by accessing the ongoing case via selecting the Case Information Screen. 5. The Cumulative Time on Monitor will be displayed. NOTE: If the active case is terminated or the patient is switched between monitors, the Cumulative Time on Monitor w reset to zero. If system is connected to an Electronic Medical Record system, depending on the integration, the data may be retained and re-associated with the Uros Meter ID Since the Uros Meter ID does not change unless the Foley catheter is discontinued and a new Uros Meter is used. NOTE: Flow Rate can be reported in mi/kg/hr (default) or mi/hr. Entry of the patient's weight will determine the global setting and calculations. Once set, the system will adjust all reported values to correspond to the users selection. NOTE: The Uros Monitor begins monitoring as soon as the URos Meter is plugged in. Any urine collecting in the Uros Meter that has not been lost in the overflow will be accounted for while user is starting the case. NOTE: Repeatedly press the down arrow until --- is displayed to disable the weight normalized calculations. NOTE: Uros Meter RFID Operation Each Meter will display a unique identifier, which is contained in the RFID tag located on the back of the meter. This unique identification number can be accessed via the patient settings screen. 24 witching Primary Display Interval Volume Screen Flow Rate Graph Select to switch primary display to ml/kg/h 10:00 43:00 Select to toggle between Temperature and Flow Rate graph Patient Temperature Graph Select to switch primary display to temperature 07:00 10:00 13:00 16:00 Select to switch primary display to graphing Three parameters are displayed on the screen at all times:
1. Interval Volume provides immediate view of accumulated volume during the 12 hour timed interval 2. Flow Rate provides current flow rate (normalized by patient weight if selected) 3. Temperature provides current patient temperature (either C or F) Trended graphing of either Flow Rate or Temperature can also be displayed in the primary screen, but is not actively displayed or updated until selected as the primary screen. Select any Secondary Display area to switch it to the Primary Display. electing the graph will display either trended Flow Rate or Temperature. Selecting the button on the bottom left of the graph display will toggle between the Flow Rate and Temperature graph. Accessing Patient History Timed Interval Temperature Flow Rate Q e7 tle =f Select Display a) rm mi/kg/h 2015-03-19 2015-03-19 Data History Data History Data History Data History 2015-02-19 a eI Fy Timed Interval, Temperature for | or Flow rate Icon prey Hourly Data Data History Scroll Backward . ~y Scroll Forward istory can be accessed through Timed Interval, Temperature or Flow Rate screens. Once these screens are selected, a Data History button will appear Selecting Data History button will open the Patient Data History An icon at the top of the screen will identify which data set (Timed Interval, Temperature or Flow Rate) is displayed Scroll backward or forward to access hourly Patient History data Go back to the previous settings page by selecting the Left Arrow button Go to the Home Screen by selecting the home button NOTE: Pressing the i icon will toggle between Timed Interval, Temperature, and Flow Rate. NOTE: Once a patient case has ended, all data in history will be lost. nding Patient Case Primary Active Patient Screen 0.0 Uros Meter ID Cumulative Time on Monitor End Case Confirm End Case o end a case or access the active Case Information Screen from the Home Screen:
Select the Active Patient button from the Home Screen The Uros Meter ID will be displayed The Cumulative Time on the Uros Monitor will be displayed 2. To end active case, select the End Case button 3. Either Confirm or Cancel Confirmation and the system will return to the Home Screen NOTE: If the active case is terminated or the patient is switched between monitors, the Cumulative Time on Monitor w reset to zero. If system is connected to an Electronic Medical Record system, depending on the integration, the data may be retained and re-associated with the URos Meter ID Since the URos Meter ID does not change unless the Foley catheter is discontinued and a new Uros Meter is used. Output (Flow Rate) Threshold Alarm settings are:
Default Threshold
<0.5 mi/kg/h for 6 hours OR 50 mi/h for 6h
<0.5 mi/kg/h for 2 12 hours OR 50 mi/h for 6h
<0.3 mi/kg/h for X24 hours OR 30 ml/h for 24h Anuria for 2 12 hours
>15 mli/kg/h at any time OR 1500 ml/h at any time Audible Alarm Visible Alarm Color Blink Rate Blinks 1 X every 5 seconds (illumination period ~0.1 sec) Blinks 2x in rapid succession every 5 seconds. Blinks 3x in rapid succession every 5 seconds. Blinks 4x in rapid succession every 5 seconds. Blinks 5x in rapid succession every 5 seconds. Output Threshold Alarms The Uros Monitor has been designed to monitor patient urine output and core temperature. Urine output will be displayed in several user selectable values: Volume, Shift Volume and Flow Rate. Timed Interval Volume The total volume output by patient during the timed interval. The length of the Timed Interval Volume calculation is fixed at 12 hours. Upon starting a new case, a new Timed Interval Volume will begin. The initial volume will accumulate until either 0700 or 1900 hours is reached, whichever time point is reached first. From this point forward, the Timed Interval Volume will reset to zero volume at both 0700 and 1900 hours until the case is ended. Flow Rate Is a calculated value that is based on volume output over time.
* The Flow Rate can be displayed as ml/h or mi/kg/h depending on whether the weight has been entered and normalization by weight has been activated. Urine volume is continuously monitored at 10 second intervals and posted via communication protocols every 5 minutes. (The Uros Monitor must be integrated into an Electronic Medical Record (EMR) system before informatio can be visualized off monitor.) Flow Rate Alarm Flow Rate Gage G3 15:07 neem Threshold BD 1 Alarm the patient flow rate drops to the defined alarm threshold, a Flow Rate alarm will activate. The Flow Rate alarm butto will appear on the right side of the primary display. 1. Selecting the Flow Rate alarm button will open the alarm specific display. Specific alarm information can be found on this display. 2. Select the Home button to return to the Primary Display. The Alarm Icon on the Primary Display in addition to the visible blinking alarm will continue to alert while the patient meets the alarm threshold requirements. ij f t i;
i;
Ployselyj ouiiy Jamoyieddn yas sployseuuy Wweye |e Jo jeaday etting tne urine output thresholds begins on the primary display. A total of 5 alarms are available to customize Select the Settings icon Select the units of measure (ml/hr or mi/kg/h) (if weight is entered) Select a threshold alarm number 1-5 Select upper or lower volume/rate threshold limit 1. 2 3 4. Select a logic identifier (<, =, >) 5 3) Select a length of time the threshold must be in violation before alarm will notify user Vv ore Bladder Temperature Measurement The Uros Monitor has been designed to monitor bladder core temperature when used in conjunction with a Barv 400-Series bladder temperature sensing catheter. Core bladder temperature display shows the bladder temperature in F or C, as determined by the user. If the temperature cannot be determined or is out of range, --- will be displayed. Defauit temperature threshold alarm settings are:
| __ Alarm _| Default Threshold | Audible Alarm | Visible Alarm Color Blink Rate
. Blinks 1 X every 3 seconds High Temperature >38.3C | None Magenta (illumination period ~0.1 sec) Blinks 1 X every 3 seconds Low Temperature | orc |e] ae (illumination period ~0.1 sec) Page Icon Temperature Temperature Alarm System Time Alarm Code the patient temperature is above or below the defined alarm threshold, a Temperature Alarm will activate. The Temperature Alarm button will appear on the right side of the Primary Display. 1. Selecting the Temperature Alarm button will open the alarm specific display. Specific alarm information can be found on this dispiay. Select the Home button to return to the Primary Display. he alarm icon on the primary display in addition to the visible blinking alarm will continue to alert while the patient meets the alarm threshold requirements. emperature Alarm Example eee w eee m= =Q
0 Select anywhere on the primary display to access 98 . 6) Temperature settings ott . wee ee | eee ee eee eee Toggle between C and F Retum to Main Display Toggle between Alarm On/Off Temperature for both upper and lower alarm thresholds is user definable. To adjust:
Select Temperature so it is displayed in the Primary Display Select Temperature anywhere on the Primary Display Toggle between C and F Select the Right button to display the Threshold Settings screen Select the Upper or Lower alarm button Adjust Temperature Threshold Alarm using toggle buttons (Set to ---.- to disable alarm) Confirm Entry to return to Home Page Upper Temperature Threshold Temperature Threshold Select to switch primary display to temperature ustomizing Temperature Threshold Alarms melee jj wuely 910u9 Uuely WLLL
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9 st
3 Tne UrRos Monitor has several audible alarms. All audible alarms will have a highly visible white blinking indicator light below the display. here are three types of audible alarms. When active, the display will also identify which type of alarm is active with a specific button along the right side of the display. When selected, additional alarm information will be presented. NOTE: The Tilt Alarm can easily be resolved by leveling the monitor using the bubble level indicator. NOTE: The Low Battery Alarm can easily be resolved by charging the unit with the supplied external AC Power Supply. NOTE: If your system has an active General Alarm, please refer to the alarm code reference in this manual for further information. Most general alarms can be reset by simply rebooting the system. If the alarm persists, please contact BarRp Customer Service at: 1-800-526-4455. generic fault alarm is alerting, reference the General Systems Alarm table on page 35, for resetting instructions. Battery Alarm will activate when charge is at or belo 3% and device is not charging. Charge battery to reset alarm. ystem Alarms Customizing Temperature Threshold Alarm iit Alarm ts alerting, leve system to reset alarm. System Time Data Communication Factory Reset OVO Ove C3 5 bn YYYY - MM - DD
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2015-09-30 | 13.56 ~ 13.56 | DXT - Part 15 Low Power Transceiver, Rx Verified | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2015-09-30
|
||||
1 | Applicant's complete, legal business name |
Medivance, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0020747788
|
||||
1 | Physical Address |
321 S. Taylor Avenue
|
||||
1 |
Louisville, Colorado 80027
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
v******@intertek.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
ZFK
|
||||
1 | Equipment Product Code |
URNBK
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
B******** R****** S****
|
||||
1 | Title |
Sr. Project Engineer
|
||||
1 | Telephone Number |
720 8********
|
||||
1 | Fax Number |
720 8********
|
||||
1 |
b******@medivance.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Medivance (dba C.R. Bard, Inc.
|
||||
1 | Name |
B******** R****** S********
|
||||
1 | Physical Address |
321 S. Taylor Avenue
|
||||
1 |
Louisville, 80027
|
|||||
1 |
United States
|
|||||
1 | Telephone Number |
(720)********
|
||||
1 | Fax Number |
(720)********
|
||||
1 |
b******@medivance.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Medivance (dba C.R. Bard, Inc.
|
||||
1 | Name |
B****** R****** S******
|
||||
1 | Physical Address |
321 S. Taylor Avenue
|
||||
1 |
Louisville, 80027
|
|||||
1 |
United States
|
|||||
1 | Telephone Number |
(720)********
|
||||
1 | Fax Number |
(720)********
|
||||
1 |
b******@medivance.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXT - Part 15 Low Power Transceiver, Rx Verified | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Bard Uros Automated Urine Output and Temperature Monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Mobile operation. Integral antenna. This radio must not be co-located with any other radio except according to multi-transmitter guidelines. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Intertek Testing Services NA Inc.
|
||||
1 | Name |
Y**** L******
|
||||
1 | Telephone Number |
978 6********
|
||||
1 |
y******@intertek.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC