Data Critical AVTS1010 AVTS1010 User Manual UserGuide

Data Critical Corporation AVTS1010 UserGuide

User Guide

EXHIBIT U – User Manual FCC ID# NMEAVTS1010
DATA CRITICAL CORP.AlarmView™Users Guide Document
Precautionary InformationCautionInstructions - For continued safe use of this equipment, it is necessarythat the listed instructions be followed. However, instructions listed inthis manual in no way supersede established medical proceduresconcerning patient care.Intended Use - The system is intended to monitor various patient-monitoring devices for alarm conditions, and responds by transmittingmessage data that includes text information from the patient.Confirmation - When the system sends out a page, there is NOconfirmation back that the intended pager has successfully received thepage.Maintenance - Failure on the part of the hospital or institution tomaintain the equipment as outlined in this manual may cause pre-matureequipment failure.Installation - The AlarmView System has been installed by qualifiedtechnicians. Modification of this installation may cause undue equipmentfailure.Electromagnetic Interference - The AlarmView System may causeelectromagnetic interference with devices operated in close proximity tothe transmitter (refer to Appendix C).System Components - Do not spill liquids on any of the AlarmView™System components.
WarningsPatient Monitoring - The most reliable method of patient monitoringcombines close personal surveillance with correct operation ofmonitoring equipment. Patient alarm conditions and notifications areprimary functions of the patient monitoring system. It is imperative thatthe caregiver and/or monitoring floor technicians monitor patient alarmconditions. The AlarmView System is not intended for use as theprimary source for the patient alarm notification.Accidental Spills - In the event fluids are accidentally spilled in theequipment, take the equipment out of service and check for damage.Check operation after drying 24 hours later.Antenna Placement - The transmitter unit with a transmitter antennamay interfere with computer equipment with electronic switchboardslocated close to the antenna. If the transmitter unit must be locatedclose to these types of equipment, a remote antenna should be used.Change of Performance - If the system fails to page users reliably,contact the hospital staff responsible for electromagnetic environmentand Data Critical Corp. immediately. (Data Critical Corp. 24 hour supportat 1-877-322-7828)Electrical Shock - To reduce the risk of electrical shock, DO NOTremove cover (or back). Refer servicing to qualified personnel. !
Environment - Data Critical Corporation does not assume responsibilityfor damage to the equipment caused by improperly vented cabinets,improper or faulty power, or insufficient wall strength to supportequipment mounted on such walls.Explosion Hazard - Do not use this equipment in the presence offlammable anesthetics, skin cleaning agents, and disinfectants. Greatcare must be exercised when the device is used in an oxygen-enrichedatmosphere. The atmosphere is considered to be oxygen enriched whenthe room air contains more than 25% of oxygen or nitrous oxide.Home Use - AlarmView™ System is not intended for home use.Power - Convenience outlets and all others that may be used for thepatient must be on the hospital emergency circuit so that they areenergized at all times.Site Surveys - Each institution is responsible for surveying existingequipment and ensuring no conflict exists when considering theintroduction of additional radiating devices.Transmission Bands - Each institution is responsible for maintainingcontinued surveillance of transmission bands being used in the facility toprevent co-occupation of bands and cross-band interference.
Indications for UseThis device is intended for use in real-time monitoring of routine patientstatus and alarm events on medical devices. It serves as a parallel,redundant mechanism to inform the clinical staff of patient events. It isintended to be a secondary means of annunciating and displaying patientalarm information to mobile healthcare providers.AlarmView is limited to use by qualified medical professionals who havebeen trained on the use of the device. It is intended for use in hospitaland hospital type environments and is not for home use.AlarmView is intended to supplement and not to replace any part of thecurrent device monitoring procedures.AlarmView is not considered in and of itself to be diagnostic withoutskilled interpretation and does not replace physician’s care.AlarmView is currently validated for use with the N-x9y and the N-3000data protocols.Please note that we have demonstrated compatibility with the dataprotocols that Nellcor Puritan Bennett has defined, not the individualmonitors. However, for FDA reference, the chart below indicates allmodels using the protocol. Data Critical is compatible with all the listedmonitors.Protocol: All Current Models:N-x9yN-290, N-295N-3000 N-3000
For devices not listed in the above compatibility chart, a separationdistance of 5.5 feet between the AlarmView Transmitter and otheremitting devices should be observed.For the devices listed on the above compatibility chart, the AlarmViewTransmitter may be placed in either of the configurations describedbelow:• The AlarmView transmitter can be located remotely from thepatient device (e.g. place the AlarmView Transmitter on thewall instead of the patient monitoring equipment).• When placing the AlarmView Transmitter in close proximityto the patient monitoring equipment, place it as shown in thedrawing below, using the velcro attachment provided:
Alarm DataThe alarm data that the AlarmView system echoes are listed in thefollowing chart.Alarm Nx9y N3000SPO2 Upper Limit X XSPO2 Lower Limit X XPR Upper Limit X XPR Lower Limit X XNo Pulse Motion X XNo Pulse No Motion X XSensor Disconnect X XHR Upper Limit XHR Lower Limit XAsystole XECG Lead Off XECG Cable Off XECG Operations Error XECG Noise XRR Upper Limit XRR Lower Limit XApnea XRespiration Lead Off XRespiration Cable Off XRespiration Ops Error XRespiration Noise XLow Monitor Battery X
It should be emphasized that this alarm data is passed to AlarmView viasimple text strings. No interpretation of this information is made.Whatever the monitor passes AlarmView is what will be passed throughand transmitted to the nurse.Also, these alarm modes are determined by the protocols we areclaiming compatibility with: N-x9y and N-3000.Service and Technical SupportDirect all inquires to:Data Critical Corporation19820 North Creek ParkwaySuite 100Bothell, WA 98011For technical advice or information concerning any equipment in yourAlarmView™ System, contact Technical Support. Call, toll free at 1-877-DCC-STAT (1-877-322-7828).Copyright © 1998-1999 Data Critical Corp. All Rights Reserved.
Conventions of this ManualTwo items that may help you as you work through the AlarmView User’sGuide are the special notes and cautions that appear throughout thistext. Individual icons identify these notes and cautions, and they alertyou to special information. The Caution icon alerts you to possible problems thatyou may encounter as you work through theAlarmView™ System programs. The possibility oflosing data, for example, is information that could bementioned in a caution. NOTE The Note icon alerts you to tips or hints that may makeit easier for you to work within AlarmView Systemprograms. These might include data entry tips,additional information about a window or field, orrecommended procedures.NOTE: Due to continuing product innovation, specifications in thismanual are subject to change without notice.Trademarks:Nellcor Puritan Bennett™ are registered trademarks of Nellcor PuritanBennett, Inc.Windows™ CE is a registered trademark of Microsoft Corporation.AlarmView™ System is registered trademark of Data CriticalCorporation.
IntroductionAlarmView™ System Product DescriptionThe AlarmView System is a secondary alarm notification system thattransmits alarm data from Primary Patient Monitoring Equipment (PME)to pagers that are worn by caregivers.• The AlarmView Pager - The AlarmView Pager is an off theshelf pager that is worn by caregivers responsible forindividual patient care.• The AlarmView Programmer - The AlarmViewProgrammer is an off the shelf Personal Digital Assistant(PDA) with Windows CE operating system and equippedwith AlarmView programming software. The PDA needs tohave an infrared (IR) port to communicate with thetransmitter.§ The AlarmView Transmitter - The AlarmView Transmitteris connected to the Patient Monitoring Equipment (PME)(i.e., Nellcor Puritan Bennett Pulse Oximeter – NPB-290,NPB-295, NPB-3000) with an AlarmView cable that isconnected to the PME’s serial port.
AlarmView System Diagram
AlarmView™ SystemSystem ComponentsTransmitterThe transmitter is Data Critical Corporation’s proprietary RF transmitteroperating in the UHF band (450-466MHz). It has an a BNC connectorfor the antenna needed for the RF transmissions, an IR port used forsetup, a button for power on/off and certain user initiated transmissions,and an RJ-45 connector for connection with the Patient MonitoringEquipment.<Insert AlarmView Transmitter Device Unit image here>PagerThe pager is a 4 by 20 character text based, off the shelf pager operatingin the UHF band (450-466MHz), and able to receive POCSAG encodedpages.<Insert AlarmView Paging Device Unit image here>PDA (Personal Digital Assistant) ProgrammerThe PDA programmer is an off the shelf Personal Digital Assistant withWindows CE operating system and equipped with AlarmViewprogramming software. The PDA programmer includes an IR port forcommunications with the transmitter. At least one PDA running WindowsCE with AlarmView software is needed to be used for user programmingof the transmitters.<Insert PDA image here>
Monitoring Device TypesThe AlarmView software is currently configured to be compatible withNellcor Puritan Bennett Pulse Oximeters N-290, N-295, or N-3000.<Add photo of NPB? >Getting StartedBefore turning on the transmitter, ensure that the antenna is attached tothe transmitter. The antenna is attached to the transmitter via a BNCconnector found on the back of the transmitter (directly behind the LED).The power cable is attached on the back of the transmitter to the farright. The unit can now be turned on by pressing the button on the top ofthe transmitter.<Insert AlarmView Transmitter Device Unit image with arrow pointing tobutton here>Survey ModeThe Survey Mode is a mode in which frequent periodic pages are sentfrom the transmitter to the assigned pager(s). To begin the SurveyMode, turn on the transmitter, as described above. The transmittershould not be attached to any patient monitoring equipment as this point.The LED on the front of the transmitter will be ORANGE to indicate thatthe transmitter is attempting to establish communications with the patientmonitoring equipment. Press the button on the top of the transmitter,and hold the button down for approximately 5 seconds. A numbered“Survey Page” will be sent. Every 15 seconds, another “Survey Page”will be sent. This will continue until one hundred pages have been sent.To stop the survey mode before one hundred pages have been sent,press the button on the top of the transmitter, and hold the button downfor approximately 5 seconds.
Pages sent during the Survey Mode will have a line of data, which willindicate that the Survey Mode is in process.Pages sent during the Survey Mode will contain the following data:Bed NumberTransmission Number (in sequence)<Insert photo>Programming ModeThe Programming Mode is the mode in which the PDA is used to changeor view the current setup (i.e. the bed number and the pager cap codes)of the transmitter. To program the transmitter, the transmitter must betrying to establish communications with the patient monitoring equipment(the LED is ORANGE), or have established communications with thepatient monitoring equipment (the LED is GREEN).
The Editor ProgramTurn the PDA “ON”. The first screen of the PDA will appear and willresemble the screen below.Select the Windows Start menu button.From the Windows Start menu, select the “AV System Manager”program.
The AlarmView System Manager main screen will appear as shownbelow.
Tap the About button for information about the System Managersoftware.Tap the OK Button to return from this dialog box.
Now tap the Editor Button on the Main Screen. The following warningwill appear.Pressing the “No Button” will return the user to the AlarmView SystemManager main screen. Pressing the “Yes Button” will launch the“AlarmView Editor” program. This is the program used to setup whichbed number and cap codes are present in the system. It can bereconfigured when pagers are sent back to the factory, or new pagersare obtained.
To configure the bed numbers available in the system, tap the BedNumbers 1 - 24 tab or the Bed Numbers 24 – 48 tab. The first tab liststhe first 24 bed numbers available to the system. The second tab liststhe last 24 bed numbers available to the system. It is not necessary tofill in all 48 slots.Below is the Bed Numbers 1 – 24 screen.
Below is the Bed Numbers 24 – 48 screen. Note that the “active” tab isdisplayed in all caps.
Bed Numbers can be added and deleted from this list. Click on a bednumber to edit. Using the stylus, tap the backspace key on the keyboardto delete the bed number to be edited (or highlight the entire bed numberas shown below), and using the numbers and letters on the key board,type in the new bed number. Tap the “Save” button on completion, orthe “Exit” button to exit the Editor Program.
If the key board is not visible, tap the keyboard icon to display thekeyboard. If an additional bed number is desired, a bed number can beadded to any blank space on page one or two of the bed number listing.Simply tap the cursor in the blank space and begin typing the new bednumber.To edit the pager numbers, tap the “Pagers” tab on the upper right of thescreen. The “AlarmView Editor” Screen Pagers page will appear.
Pager Cap Codes can be added and deleted from this list. Click on acap code number to edit. Using the stylus, tap the backspace key on thekeyboard to delete the cap code number to be edited (or highlight theentire cap code number), and using the numbers and letters on the keyboard, type in the new cap code number. Tap the “Save” button oncompletion, or the “Exit” button to exit the Editor Program.If the key board is not visible, tap the keyboard icon to display thekeyboard. If an additional bed number is desired, a bed number can beadded to any blank space on page one or two of the bed number listing.Simply tap the cursor in the blank space and begin typing the new bednumber.Note that the global cap code value can not be changed by the user.To restore values to the state they were in before editing began, tap theRestore Button on any of the pages before pressing the Save Button.Once the Save Button has been pressed, however, the original valuesare not restored.
When the “Editor Program” is exited, the Main Screen is again displayed.
The Configuration ProgramIf the main PDA screen is displayed, tap Windows Start menu button.From the Windows Start menu, select the “AV System Managerprogram.
The AlarmView System Manager main screen will appear as shownbelow.
To launch the Configuration Program, tap the Programming button. The“Configuration Program” Main Screen will appear. This program is usedto change the transmitter’s setup of bed numbers, cap codes, alarmseverity, and reminder page interval. It also displays information that cannot be modified by the user. This information includes: monitor identifier(N3000, N295, N290), transmitter number, hardware version, softwareversion, protocol version, authorize identification, paging frequency, andpaging baud rate. This program can be used at shift change, orwhenever there is a need to change/view the current transmitterconfiguration.
To obtain the current configuration programmed into the transmitter, tapthe “Download Configuration Button”. When this button is tapped, thePDA attempts to establish communications with the transmitter. If the IRport could not be accessed, the following dialog box will be displayed.Tap the OK button to close this dialog box and return to theConfiguration Program main screen.If the IR port could be accessed, but communications could not beestablished between the PDA and the transmitter, the following errordialog box will be displayed:
When “OK” is tapped on this dialog box, the Configuration Program mainscreen will be displayed with a status message informing the user of a“Failed to Connect” status.
At this point, simply point the PDA at the transmitter, and tap the“Download Configuration Button” again. While the transmitter is beingqueried, the Configuration Program main screen will be displayed with astatus message informing the user of a “Loading Data” status. The PDAwill be in this state for less than 2 seconds.
When the transmitter has been successfully queried, the Configurationprogram main screen will be displayed with a status message informingthe user of a “Transmitter Data Loaded” status.
At this point, if the displayed data is correct, no changes need be made,and the user is done. Exit the Configuration Program by tapping the “X”in the upper right corner of the screen.If the data needs to be changed, the Patient Bed Number can beselected by tapping on the bed number drop down list, and highlightingthe desired bed number.A maximum of two pagers can be selected by clicking the radio buttonnext to the desired pager number.To change/view alarm severity selection or reminder page intervals, tapthe Advanced Setup Button on the upper left of the screen. If no datahas been previously downloaded, the PDA will attempt to establishcommunications with the transmitter. When the data is downloaded, thefollowing screen will appear.
Alarm Severity selections:Send All Alarms indicates that all alarms will be sent to the pagersregardless of the severity of the alarms.Only Critical Alarms indicates that only critical (high prioirty and mediumpriority) alarms will be sent to the pagers.Reminder interval indicates the time interval at which reminders will besent after the original alarm has not been silenced.Tap the OK button when all changes have been made.To view transmitter data that can not be modified by the user, tap theCurrent Configuration Button on the upper left of the screen. If no datahas been previously downloaded, the PDA will attempt to establishcommunications with the transmitter. When the data is downloaded, thefollowing screen will appear.Tap the “Program Transmitter” button to program the transmitter with thenewly selected values.
If no bed number was selected before the “Program” button was tapped,the following error dialog box will appear.If no cap code was selected before the “Program” button was tapped, thefollowing error dialog box will appear.Exit both of the above dialog boxes by tapping the OK Button. After theabove error conditions are rectified, tap the “Program Transmitter” buttonagain. When this button is tapped, the PDA attempts to establishcommunications with the transmitter.
If the IR port could not be accessed, the following dialog box will bedisplayed.Tap the OK button to close this dialog box and return to theConfiguration Program main screen.If the IR port could be accessed, but communications could not beestablished between the PDA and the transmitter, the following errordialog box will be displayed:
When “OK” is tapped on this dialog box, the Configuration Program mainscreen will be displayed with a status message informing the user of a“Failed to Connect” status.
At this point, simply point the PDA at the transmitter, and tap the“Program Transmitter Button” again. While the transmitter is beingqueried, the Configuration Program main screen will be displayed with astatus message informing the user of a “Programming” status. The PDAwill be in this state for less than 2 seconds.
When the transmitter is successfully programmed, the ConfigurationProgram main screen will be displayed with a status message informingthe user of a “Programming Successful” status.
A “Programming Successful” page will also be sent to the newly selectedpagers, displaying the newly selected bed number.<Insert photo and or screen shot here>Exit the “Configuration” program by tapping the “X” in the upper rightcorner of the screen.When the Configuration Program has been exited, the System ManagerProgram main screen will be displayed as shown:Exit this program by tapping the Exit Button in the upper left of thescreen.
Communicating With PatientMonitoring EquipmentTurn on the transmitter, as described above. Attach the serial cable tothe RJ-45 port. Attach the other end of the cable to the patientmonitoring equipment. The transmitter will automatically detect themonitor (assuming it is an N-3000, N-295, or N-290). Oncecommunications have been established with the patient monitoringequipment, a page will be sent to the pager indicating this, and the LEDwill turn GREEN.The communications established page will have the following data:Bed: xxxxxComms OK<Insert photo and or screen shot here>From that point, all alarms at the patient monitoring equipment will besent to the pager(s), as assigned by the PDA (as described above).
Turn on the transmitter, as described above, and establishcommunications with the patient monitoring equipment (the LED will betransmitter (but, do not hold it down). A “Test Page” will be sentindicating the current patient data (SPO2, and Pulse Rate). Note thatTest PageBed: xxxxxSPO2: xxx<Insert photo and or screen shot here>The transmitter can only be turned off if it is not communicating with thepatient monitoring equipment (i.e. the LED is RED). To turn off thegoes off.
Communications NotEstablishedTurn on the transmitter, as described above. The transmitter should notbe attached to any patient monitoring equipment as this point. The LEDon the front of the transmitter will be ORANGE to indicate that thetransmitter is attempting to establish communications with the patientmonitoring equipment. After 10 seconds of no communications, a pagewill be sent indicating that no communications have been established.Bed: xxxxComm FailRetrying<Insert photo and or screen shot here>Every 10 minutes after that, another page will be sent indicating thatcommunications have not been established. This will continue for onehour. At this point, a page will be sent indicating that the transmitter isturning off.Bed: xxxxComm FailTx Shut down<Insert photo and or screen shot here>Low Battery WarningsIf the battery becomes too low for proper transmitter functioning, analarm will be sent indicating the low battery situation, and the transmitterwill be shut down.
Bed: xxxxLow Tx BatteryTx Shut down<Insert photo and or screen shot here>
Appendix AElectromagnetic InterferenceIt is a known fact that electronic devices that emit radio frequencies mayinterfere with the operation of other electronic devices. This has becomeproliferation of intentional electronic radiators such as cellular phones,paging systems, walkie-talkies, and wireless network LANs. The criticalare of special concern and incidents have been observed with apneamonitors, wheel chairs, and ventilators.to address this complicated issue through their respective workinggroups. The ANSI C63.6 working group made up of industry and themeans to evaluate critical care medical devices for electromagneticinterference problems by the clinical and biomedical staff using an adEMI fundamentals. A possible outline for management of potential EMIsources and education of the hospital staff is as follows:environment of their hospital and take actions on:•managing (increasing) distance between sources of EMI andsusceptible devices managing use of frequencies close to StatView™ System• EMI•lower power from internal EMI sources under hospital control(paging systems) labeling devices susceptible to EMI
• educating staff (nurses and doctors) to be aware of, and torecognize, potential EMI related problems• conducting technical remedial action to eliminate EMI, suchas shielding• sharing relevant EMI/EMC information with others, especiallyin evaluation of new equipment purchases which may haveemissions• identifying critical areas where life-support devices are in useand restricting the use of personal communicators (cellularphones) in those critical care areasPurchase critical care devices that comply with IEC 601-1-2 EMCstandards:• the required level of EMI immunity is 3 volts per meter• the interference level that a medical device can radiate(emit) is 0.0014 volts per meter
The AlarmView™ System has a transmit power level of up to 1 watt peakat a pre selected RF frequency between 450 MHz to 466 MHzProtection Distance Estimateof Immunity of Medical Device2 V/meterx ft x ft x ft1 watt x m x m x m
Appendix BTerms GlossaryBNC Connector: A type of connector used with coaxial cables. Thebasic BNC connector is a male type mounted ateach end of a cable. This connector has a centerpin connected to the center cable conductor and ametal tube connected to the outer cable shield. Arotating ring outside the tube locks the cable toany female connector. This is the type ofconnector that the antenna uses to connect to thetransmitter.IR Port: Infrared port. An IR Port is used by the PDA tocommunicate with the transmitter.PDA: Personal Digital Assistant (Win CE Device)POCSAG: Post Office Code Standardization Advisory Group– the protocol used for pager communicationsRF Transmissions: Radio Frequency transmissionsRJ-45 Connector: Short for Registered Jack-45, an eight-wireconnector commonly used to connect computers.Looks similar to the connectors used forconnecting telephone equipment, but they aresomewhat wider.UHF Band: Ultra High Frequency BandwidthWindows CE: The operating system of the PDA

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