Nexan NX-300 Nexi-Clip User Manual User guide

Nexan Limited Nexi-Clip User guide

User guide

© 2000 NEXAN® Ltd.This document should be used for the intended use only and anyother distribution, copying, use or disclosure is strictly prohibited.NEXAN, NEXI, NEXOFT are registered trademarks of Nexan® Ltd.NEXAN® LtdInstructions for UseNEXAN® SYSTEM Nx-300
300-USM-103 US Issue 1.0Page 2 of 51 IndexManual purpose and intended usersThese instructions are intended for the Health Care Professional, as a guide to theuse of the Nx-300 System including the Nexan Software -Nexoft (found in theTelemonitoring Station computer).It is assumed that the user of the Telemonitoring Station and Nexoft is aRegistered Medical Practitioner who has experience of using Windows Softwareon a PC.The Patient is the user of the Nexi, Nexi-Clip, PDA, Base Station and AuxiliarySensors.A set of instructions, called ‘Patient Guide’ is intended to be left with the patient (toassist him/her with day-to-day-use)A set of instructions called ‘READ ME FIRST’ is provided with each Nexi forpatient application of Nexi and Nexi-Clip.User assistance informationTo obtain service contact Nexan Customer Support on 770-360-9090.Availability of Clinical Study DataClinical Study data, obtained using the Nx-300, is available on request fromNexan Ltd.Nexan Ltd, cautions the reader of this manual:•This manual, wholly or partially, is subject to change without notice. Somefeatures described in this manual may not be available with this Nexan system.•All rights are reserved: No one is permitted to reproduce or duplicate, in anyform, the whole or part of this manual without the permission of Nexan Ltd.•Nexan assumes no responsibility for usage not in accordance with this manualresulting in illegal or improper use of the Nexan system.
300-USM-103 US Issue 1.0Page 3 of 51IndexContentsSECTION 1Important informationGeneral warnings & precautions .................................................................................. 5Glossary of symbols & terms ........................................................................................ 7Environment ................................................................................................................. 7Symbols on Nx-300 system labelling ........................................................................... 8Intended use............................................................................................................... 10Contra-indications: ................................................................................................ 10SECTION 2Overview of Nx-300 systemSystem description ..................................................................................................... 11Description of parts: ................................................................................................... 12Parts supplied ............................................................................................................. 13System setup and operation....................................................................................... 14SECTION 3Setting up the PDA and Base StationConfiguring the PDA ................................................................................................... 15Accessing the HCP menu ..................................................................................... 15Clearing the memory ............................................................................................ 16Configuring the PDA for a new Nexi-clip............................................................... 17Other Configure PDA options ............................................................................... 17Viewing signals and data to check Nexi operation ............................................... 18Setting the PDA Clock and Calendar .................................................................... 20Viewing stored schedule information .................................................................... 20Configuring the Base Station...................................................................................... 21Accessing the HCP Menus ................................................................................... 21Setting the PDA (PDL) ID code............................................................................. 23Setting the Patient ID code ................................................................................... 24Setting or editing the measurements schedule..................................................... 25
300-USM-103 US Issue 1.0Page 4 of 51SECTION 4Setting up and using the TeleMonitoring StationTeleMonitoring Station (TMS) overview...................................................................... 26Setting up the TMS computer..................................................................................... 27Connecting the TMS ............................................................................................. 27Switching on the TMS ........................................................................................... 27Using Nexoft ............................................................................................................... 28Logging on ............................................................................................................ 28Patient Records .................................................................................................... 30Using the Calendar function to set a download schedule ..................................... 33Initiating an immediate download ......................................................................... 36Viewing Downloaded Data.................................................................................... 37Printing Information............................................................................................... 39On-line help .......................................................................................................... 41Shutting down the TMS .............................................................................................. 42SECTION 5General InformationTechnical Description ................................................................................................. 43Technical Specifications ............................................................................................. 44Power requirements ................................................................................................... 45Transport and Storage conditions .............................................................................. 46Operating Conditions .................................................................................................. 46Cleaning, Maintenance, Storage and Calibration ....................................................... 47Replacing the Base Station fuses .............................................................................. 48Regulatory Markings .................................................................................................. 49Federal Communications Commission (FCC) Compliance and Advisory Notice ....... 49Warranty ..................................................................................................................... 50Troubleshooting guide ................................................................................................ 51
300-USM-103 US Issue 1.0Page 5 of 51Section 1 - Important informationSECTION 1Important informationGeneral warnings & precautionsAll users should read these Safety Instructions carefully and thoroughly beforeusing the system. To ensure patient safety, all parts of the system must be used inaccordance with the Instructions for Use as indicated by the warning triangle onthe product labels. Particular attention should be made to WARNINGS, CAUTIONSand Notes identified within this document.•WARNING statements identify occurrences that could result in personal injury.•CAUTION statements identify conditions or practices that could result in damageto the equipment.•Note statements disclose pertinent information.Warnings•THE BASE STATION MUST BE CONNECTED TO AN EARTHED (GROUNDED)POWER SUPPLY.•THE NEXI® MUST NOT BE APPLIED TO BROKEN, DAMAGED OR IRRITATEDSKIN.•MONITORING OF PATIENTS WITH PHYSICAL OR MENTAL OR SENSORYIMPAIRMENT SHOULD ONLY BE UNDERTAKEN IF THE MEDICALPRACTITIONER/PHYSICIAN CONSIDERS THEY CAN USE THE Nx-300SYSTEM CORRECTLY AND THAT IT WILL NOT CAUSE UNDUE STRESS ORANXIETY.•THERE IS A POSSIBILITY OF DEGRADATION OF THE RESPIRATION SIGNALIN PATIENTS WITH HIGH BODY MASS INDEX.•REPLACE FUSES WITH CORRECT TYPE AND RATING; FOR PROTECTIONAGAINST FIRE AND OTHER HAZARDS.•IF USED IN HOSPITAL, THE BASE STATION UNIT MUST BE CONNECTED TOA HOSPITAL GRADE OUTLET.•THE Nx-300 IS NOT FOR USE AS A CRITICAL CARE MONITORING SYSTEM.•THE Nx-300 IS NOT AN APNOEA MONITOR.
300-USM-103 US Issue 1.0Page 6 of 51 Section 1 - Important informationPrecautions•Substitution of a component different from that supplied may result inmeasurement error.•Only use the Nexan Supplied Charger or Base Station Unit (BSU) to re-chargethe Personal Data Assistant (PDA).•Do not use two systems close together since corruption of data may occur. TheNx-300 system should be used under the supervision of Registered MedicalPractitioner.•Patients must be advised to contact their Registered Medical Practitioner if theyfeel any deterioration in their condition whilst using the Nx-300 system.•The Base Station, Auxiliary sensors and Telemonitoring Station (TMS) should beplaced in locations where the cables are safely positioned and the units cannotharm anyone if the units fall.•No part of the Nx-300 system should be allowed to come into contact with wateror other fluids, substances which could cause combustion, flammable/explosivegases.•Do not place any part of the system close to a source of heat (radiator etc.)•The performance of the Nx-300 system cannot be guaranteed if tampered within any way.•Inspect the Base Station power cord periodically for fraying or other damage. Donot operate the equipment from mains power with a damaged power cord orplug.•Ensure that air can circulate freely around the Base Station and thatcontaminates, e.g. talcum powder, are not allowed to ingress.
300-USM-103 US Issue 1.0Page 7 of 51Section 1 - Important informationGlossary of symbols & termsAs used in instructions and on product labels:Auxiliary sensorsAn Nx-300 facility to use additional sensors directlyconnected to the Base Station.DownloadData that is transferred from one location to another.EventSpecific occasion(s) of patient response.Monitoring scheduleA period of time during which patient monitoring iscarried out.Trend DataData from all the auxiliary sensor sessions which is viewedover an extended period of time.EnvironmentEnvironmental conditions that affect use:The Nx-300 system uses a radio frequency signal in the low power, unlicensedBands of 869.7- 870MHz in Europe and 916-917MHz in the United States ofAmerica (Part of the 902-928 Band) to transfer system information from the Nexi-Clip to the PDA. It is possible that interference may occur between the Nx-300 andother radio equipment operating on the same frequencies. Due to the low power ofthe transmissions, the potential for interference is only likely if the two are close toeach other.Before installing the Nx-300,it is recommended that the installation environment bechecked for other radio devices that may be affected.Examples of these environments are as follows:•Domestic•Social alarms•Radio-controlled car security devices•Hearing aids•CB radios•Panic alarms•Television receivers•Cordless telephones•FM receiversIt is recommended that if any such equipment is identified, then it should bechecked for correct operation while the Nx-300 is operating as close as possible tothe equipment. Should any problems be observed we recommend the Nx-300 isswitched off and Nexan Customer Support is contacted (see page 2 for contactdetails).
300-USM-103 US Issue 1.0Page 8 of 51 Section 1 - Important informationSymbols on Nx-300 system labellingSYMBOL TEXT DESCRIPTIONATTENTION, Consult Accompanying DocumentsType BF Equipment. Type B equipmment with an F-typeapplied part (patient isolation from electric shock)Used on Nexi.Type B Equipment. (patient isolation from electricshock). Used on Base StationSERIAL NUMBER of deviceDirect CurrentFuse 2x T2AH 250V (used on Base Station)Not for Re-use (Single Use Only) applies to Nexi(ISO7000/1051, BSEN980:1996)Use- by (Year-month) applies to NexiSN-
300-USM-103 US Issue 1.0Page 9 of 51Section 1 - Important informationSymbols on Nx-300 system labelling (continued)SYMBOL TEXT DESCRIPTIONInput - used on Base Station. Intended only for connectionto patients’ phone.Output- used on Base Station. Intended only forconnection to patients’ phone line.Used on Base Station to connect any auxiliary sensorAECG Type 1 equipments (all)Base Station Power ONBase Station Power OFFPDA Power ON/Confirm action button (green)R&TTE equipment Class 2 (Member States restrictions)May apply to Nexi-Clip and Portable Data Assistant (PDA)A BAECG 1IO
300-USM-103 US Issue 1.0Page 10 of 51 Section 1 - Important informationIntended use‘The Nx-300 system is an ambulatory patient monitoring system intended for use inthe home or alternate care settings. The device stores and transmits ECG data,respiration data, systolic and diastolic blood pressure (non-invasive), and PEF andFEV1’Contra-indications:•THE Nx-300 MUST NOT BE USED ON CHILDREN UNDER 9 YEARS OLD.•THE Nx-300 IS NOT CONSIDERED SUITABLE FOR USE ON PATIENTS WITHIMPLANTED DEFIBRILLATORS/PACEMAKERS.•THE Nx-300 MUST NOT BE USED ON PATIENTS WITH KNOWN SENSITIVITYTO MEDICAL ADHESIVES.•THE Nx-300 IS NOT FOR USE AS A CRITICAL CARE MONITORING SYSTEM.
300-USM-103 US Issue 1.0Page 11 of 51Section 2 - Overview of Nx-300 systemFigure 1. Nexan Nx-300 SystemNexiNexi-Clip PDA BSU TMSBody-worn itemsPSTNRadioInterface DirectlocalinterfaceDirect localinterface, or remotevia PSTNDirect Interfaces to3rd party analyserSpO2sensorSECTION 2Overview of Nx-300 systemSystem descriptionData from physiological measurements, taken by sensors on the chest andunderarm (Nexi) is converted into radio signals and transmitted via a radiotransmitter (Nexi-Clip attached to the Nexi) to a radio receiver in a Personal DataAssistant (PDA). The PDA also stores the data for the monitoring period andnormally sits (docked) in a Base Station Unit (BSU) located in the patients’s home.Whilst docked, the PDA transfers the data to the BSU. A TeleMonitoring Station(TMS) computer, located within a remote monitoring centre, interrogates anddownloads the data from the Base Station via the patient’s phone line. The TMScomputer software is then used by the Registered Medical Practitioner to displayand interpret the patient data.The diagram below shows the complete Nx-300 system in operation.(AuxiliarySensors
300-USM-103 US Issue 1.0Page 12 of 51 Section 2 - Overview of Nx-300 systemDescription of parts:Nexi: A disposable, multi-parameter adhesive sensor patchworn on the upper chest and underarm. Contains twobatteries used to power both the Nexi and the Nexi-Clipwhen connected.Nexi-Clip A Radio Transmitter which Clips to the Nexi and containsa transmitter.PDA: A Receiver and storage Unit for data storage of datarecieved by radio communications transferring that data tothe Base Station when docked.Base Station: A Base Unit, located in the patient’s home, for datastorage,analysis and transfer of data to a Telemonitoringcentre on request. Also permits connection of Auxiliarysensors such as Blood pressure and Spirometry devicesfor point-in-time measurements. The Unit also contains acall discriminator unit, which allows normal use of thepatient’s phone. The discriminator identifies the differencebetween incoming voice or data calls and routes the callappropriately.TeleMonitoring A dedicated PC, located in the Telemonitoring Centre,Station (TMS): running a Nexan software package.Nexan Software: A software package in the TMS for data interpretation andpresentation of the data received from the Patient’s BaseStation. Nexan software is only for use by HealthcareProfessional.Auxiliary Sensors: Auxiliary sensors connected to the Base Station for therecording of blood pressure,weight (option) andspirometry measurements.
300-USM-103 US Issue 1.0Page 13 of 51Section 2 - Overview of Nx-300 systemNOTE: Not all parts may besupplied to all HCPs12Parts suppliedParts supplied to patient1 TMS Personal Computer (containing installed Nexan Software)2 PrinterCAUTION: Do not store in a damp area. Dampness may affect the device andcause rust.Parts supplied to Health Care Professional (HCP)351 Nexi (One for each period of 24hrs required use)2 Nexi-Clip3 PDA4 PDA charger unit (as required)5 Base Station (BSU) + cablesAuxiliary sensors (as required) 12NOTE: Not all parts may be supplied to all patients4
300-USM-103 US Issue 1.0Page 14 of 51 Section 2 - Overview of Nx-300 systemSystem setup and operationSuccessful operation of the Nx-300 system depends on thorough patientinstruction. Nexan recommends that you walk through the following steps witheach patient, using the PATIENT GUIDE as a reference:-•Explain the equipment and procedures to the patient.•Connecting and powering up the Base Station and PDA.•Check the patient’s telephone still works (incoming & outgoing calls).•Applying the Nexi and Nexi-Clip using the READ ME FIRST guide supplied witheach Nexi.•Verifying operation of the equipment (check out).•Explain the basic operation of the system and on line help screens.•Patient tasks (e.g. take blood pressure) and display messages.•What to do if the telephone line is busy?•Discuss wearing the Nexi and Nexi-Clip day-to-day.•Discuss the use of the PDA day-to-day.•Taking auxiliary sensor measurements - if supplied.•Explain where and how to call for help/assistance.•Troubleshooting patient equipment.
300-USM-103 US Issue 1.0Page 15 of 51Section 3 - Setting up the PDA and Base StationSECTION 3Setting up the PDA andBase StationConfiguring the PDATo switch on the PDA, press and hold thegreen button. The screen will brieflydisplay an information view showing theunique PDA identification number, plus itssoftware and hardware revisions ðPersonalDataAssistantID 7800123456Software 12.34Hardware 56.78& Nexan Ltd.2000_____________________ABCDEFGHjkkl****HCP MenusPlease enterHCP PIN:to selectto confirmeach digitcdefab_________Accessing the HCP menuWhen preparing the PDA for a new patient, a number of actions should be carriedout, all of which require access to the HCP menus that are hidden from thepatient. A pre-set PIN code is required togain access to the HCP menus.To access the HCP menus:1 Press and hold the key to showthis display ð2 Press the key to begin enteringthe PIN. The first will be replacedwith ‘ ’.3 Use the or keys to select therequired PIN digit and press toconfirm when the number is correct.4 Repeat step 3 until all four digits areentered.
300-USM-103 US Issue 1.0Page 16 of 51 Section 3 - Setting up the PDA and Base StationAccessing the HCP menu (cont.)When the correct PIN has been entered, theHCP Main Menu is displayed ðNote: If the PIN is not known, then there isa second, fixed PIN, that will provideaccess. If required you can get this PIN bycontacting Nexan.jkklHCP Main MenuView signalsView summaryView scheduleView statusConfigureSet clockReset menucdefabto selectto confirmExit___ ____ ____jkklReset PDAErase all dataNoReset configNocdefabto selectto exitExit_____ ___Clearing the memoryWhen you are preparing the PDA for a new patient, the first action must always beto ensure that the memory is completely free of residual data.To clear the memory:1 Enter the HCP Menu.2 Press the key until ishighlighted. Press the key to displaythe Reset PDA screen ð3 Press the key until is highlighted and then press the key. Press the or keys until theoption states and then press .4 Press the key until is highlightedand press the key to execute the erasefunction and return to the HCP Main Menu.
300-USM-103 US Issue 1.0Page 17 of 51Section 3 - Setting up the PDA and Base StationConfiguring the PDA for a new Nexi-clipWhen setting up a new installation, you mustensure that the PDA is configured to recievedata from the specific Nexi-clip being used.To register a new Nexi-clip with the PDA:1 Enter the HCP menu.2 Press the key until ishighlighted. Press the key to display theConfigure PDA screen ð3 Press the key until ishighlighted and press the key tohighlight the first number of the Nexi-clipcode.On the rear of the Nexi-clip to be used,locate the printed label. On the label notethe three figure ID code - this is the codethat must be entered into the PDA.4 Press or to set the first digit of the Nexi-clip ID code and then press to store this value and move to the next digit. Repeat this procedure with theremaining two ID digits.5 When the last digit has been set, press the key until is highlightedand then press . The configured options are implemented as the screen isexited.Other Configure PDA optionsjkklConfigure PDANexi clip 123Sig. alarm onPIN ****Patient ID12345678Calendar onECG 3 offSpO2 oncdefabto selectto exitExit_________ ___jkklConfigure PDANexi clip 123Sig. alarm onPIN ****Patient ID12345678Calendar onECG 3 offSpO2 oncdefabto selectto exitExit_________ ___When ON, sounds analarm when the signal fromthe Nexi-clip becomesweak.When ON, displays thedate on the standbyscreen.When ON, enables storagefor optional ECG data froman external ‘flying lead’attached to the Nexi.Allows you to set a newPIN to gain access to theHCP menus (set to 0000 todisable the PIN)An eight figurerepresentation of thecurrent Patient ID.
300-USM-103 US Issue 1.0Page 18 of 51 Section 3 - Setting up the PDA and Base StationViewing signals and data to check Nexi operationThe PDA allows you to view the ECG and/or respiratory waveforms beingmonitored by the Nexi patch and sent to the PDA by the Nexi-clip. This function isuseful when checking that the patch has been correctly applied and that the Nexi-clip and PDA are communicating correctly.To view raw data signals:1 Apply the Nexi to the patient and attach theNexi-clip in the usual manner.2 Enter the HCP Menu.3 Press the key until ishighlighted. Press the key to display theSignals Menu ð4 Press the or keys until the requiredECG or Resp. signal is highlighted. Pressthe key to display the chosen raw datadisplay òjkklSignals MenuECG lead 1ECG lead 2ECG lead 3Resp. signalcdefabto selectto confirmExit_______ ____ECG1 HR 75 RR15 SpO2 95The screen changes to a‘landscape’ display and shows thecurrent waveform, plus along thetop: the current Heart Rate andRespiration Rate.If no waveform or HR/RR values aredisplayed then there may be acommunication problem or fault withthe Nexi/Nexi-clip combination.Note: If you do not see a good signal, refer tothe Troubleshooting section at the rear of this guide.5 Press the key to return to the Signals Menu.Additionally you can also view the incoming data simply as numeric values. Thismethod is discussed next.
300-USM-103 US Issue 1.0Page 19 of 51Section 3 - Setting up the PDA and Base Station751598jkklSummaryHR bpm:RR /min:SpO2 %:to exitab_______jkklPDA StatusId: 8700123456Nexi clip: 123Nexi clip OKMem free %: 85Signal mV:1234On at:10:15 Oct 12Session: 12310:25 Oct 12to exitab___ ______Indicates the ID number forthe current Nexi-clip.Indicates how much datastorage memory is freewithin the PDA.Indicates when the PDAwas last switched onIndicates the strength ofthe signal from theNexi-clip. 1000 or lessindicates a weak signalthat could result in dataloss. 2000 or moreindicates a strong signal.The patient ID number.Indicates that signals arebeing received from thedesignated Nexi-clip.Indicates the currentpatient session and when itcommenced.To view numeric signal values:1 Apply the Nexi to the patient and attach theNexi-clip in the usual manner.2 Enter the HCP Menu.3 Press the key until ishighlighted. Press the key to display theSummary screen ðThis screen shows incoming values for theHeart Rate and Respiration Rate.If the values remain at ### then there maybe a communication problem or fault withthe Nexi patch/Nexi-clip combination.To view the PDA Status screen:1 Enter the HCP Menu.2 Press the key until is highlighted. Press the key todisplay the PDA Status screen ò
300-USM-103 US Issue 1.0Page 20 of 51 Section 3 - Setting up the PDA and Base StationSetting the PDA Clock and CalendarThe PDA has an internal clock and calendar against which the incoming data ismonitored. It is important that the clock is set correctly when installing the system.To set the clock and calendar:1 Enter the HCP Menu.2 Press the key until ishighlighted. Press the key to display theSet PDA Clock screen ð3 Press or to highlight the requiredsetting and then press begin alteringthat setting.4 Press or to change the currentsetting and then press when it iscorrect.5 Repeat steps 3 and 4 until all time anddate settings are correct and then press or until Exit is highlighted. Press toquit the screen and apply the changes made.Viewing stored schedule informationIf the Base Station and PDA have anyscheduled extra measurements (bloodpressure, spirometry or weight) programmed,then it is possible to view a summary of theseon the PDA.To view scheduled measurements:1 Enter the HCP Menu.2 Press the key until is highlighted. Press the key to displaythe Schedule screen ðNote: This screen shows only the timesand dates for the scheduledmeasurements. It does not differentiatebetween the different measurements, nordoes it allow any editing of the entries.jkklSchedule# Time Date1 10:15 Oct 122 14:00 Oct 123 9:15 Oct 134 18:00 Oct 135678to exitab________jkklSet PDA ClockYear 2000Month 6Day 23Hour 15Minute 47Second 00Format 24hrcdefabto selectto exitExit___ ___ _____
300-USM-103 US Issue 1.0Page 21 of 51Section 3 - Setting up the PDA and Base StationConfiguring the Base StationAccessing the HCP MenusWhen the Base Station is switched on, it displays the patient home page. To configurethe Base Station for a new patient it is necessary to access the HCP menus.To access the HCP menus:1 Press the ‘smiley face’ logo (in top right corner) until the following is displayed:2 Press the HCP button to display:
300-USM-103 US Issue 1.0Page 22 of 51 Section 3 - Setting up the PDA and Base Station3 Enter your four digit PIN code to display:4 Press the Configure button to display:5 Select the required action that you wish to perform.HCP optionsHCP configuration options
300-USM-103 US Issue 1.0Page 23 of 51Section 3 - Setting up the PDA and Base StationSetting the PDA (PDL) ID codeEach PDA carries a unique identification (PDA ID) code to ensure that recordeddata can be traced back to a specific patient and their PDA. It is important that theBase Station is programmed with the correct ID number for the PDA in use.To set the PDA ID code:1 Enter the HCP/Nurse menu, choose Configure and then select the PDL IDoption. The following screen will be displayed:The unique 10-digit PDA ID code can be located in three ways:•It is printed on the label located on the base of the PDA,•It is displayed during the start-up screen of the PDA, and•It is displayed in the PDA Status screen that is mentioned earlier in thissection.2 Locate the 10-digit PDA ID code and enter it into the Base Station using theon-screen keypad.3 Press the Save button.
300-USM-103 US Issue 1.0Page 24 of 51 Section 3 - Setting up the PDA and Base StationSetting the Patient ID codeIn order to maintain a traceable link between recorded data and a particularpatient, it is important that Base Station is programmed with the correct Patient IDcode.To set the Patient ID code:1 Enter the HCP/Nurse menu, choose Configure and then select the PatientIDoption. The following screen will be displayed:2 Use the on-screen Up and Down buttons to increment/decrement each of thefour digits until the Patient ID code matches the number that has beendesignated for that patient.3 Press the Save button to store the entered code and exit to the optionsscreen.
300-USM-103 US Issue 1.0Page 25 of 51Section 3 - Setting up the PDA and Base StationSetting or editing the measurements scheduleSchedules for taking extra measurements (such as blood pressure, spirometry orweight) are generally set using the Nexoft software from the remoteTeleMonitoring Station (or TMS). However, it is sometimes necessary, or moreconvenient, to set or edit these settings whilst on-site with the Base Station.To increase or reduce the number of measurements:1 Enter the HCP/Nurse menu, choose Configure and then select the Scheduleoption. The following screen will be displayed:2 Use the on-screen Up and Down buttons to increment/decrement the quantityof Blood Pressure or Spirometry readings that are required.3 Press the Save button to store the new scheduled measurements and exit tothe options screen.Note: The scheduled measurements that are set on the Base Station will takepriority over any similar settings made at the remote TeleMonitoring Station.The next time that the TMS connects with the Base Station, the new settingswill be uploaded and used to alter the TMS schedules.
300-USM-103 US Issue 1.0Page 26 of 51 Section 4 - Setting up and using the TMSSECTION 4Setting up and using theTeleMonitoring StationTeleMonitoring Station (TMS) overviewData from the Base Station is transferred, via patient’s telephone line, to aTelemonitoring Centre. Here the Registered Medical Practitioner has access to theNexan software, called Nexoft, installed on a Nexan TMS computer.Note: It is recommended that archiving of patient data is carried out both as a pre-use check between patient use of the Nx-300 system and periodically.The Registered Medical Practitioner can control the use of the Nx-300 using theNexoft program that enables the following features:•Dial-up to a patient’s home for downloading the monitoring schedule to thepatient’s Base Station.•Dial-up to a patient’s home to retrieve and view recorded and /or analysed datafrom the patient’s Base Station.•Scheduling the download times.•Setting up or changing the schedule for blood pressure and/or, spirometrymeasurements; collectively known as auxiliary measurements.•Management of a database of recorded data.
300-USM-103 US Issue 1.0Page 27 of 51Section 4 - Setting up and using the TMSSetting up the TMS computerConnecting the TMS1 Unpack your TMS Computer following the instructions on the packaging.2 Connect the monitor, keyboard and mouse using the colour-coded plugs thenconnect the mains power cables to the monitor and computer.3 Next, using the modem cable provided, connect one end into the modemsocket of the computer and the other end into your telephone line socket.4 If required connect the computer to the supplied printer by following the printermanufacturer’s instructions.Switching on the TMSPRECAUTIONSIt is recommended that you do not install non-Nexan software onto your TMSmachine. Third-party applications may degrade the performance of the Nexansoftware or otherwise interfere with its operation.In particular:1 Do not use software that might use the modem(s) (e.g. browsing the Web).2 Do not run software that may occupy the processor for extended periods (e.g.long scientific computations).3 Be aware that the machine has a finite amount of disk space and any spaceused will not be available for storing patient data.4 Be aware that running multiple applications will reduce the availability of mainmemory, and degrade performance.Refer to the manufacturer’s instructions; connect power and switch on your TMSComputer and monitor. After approximately one minute the Nexan software logonscreen should appear.
300-USM-103 US Issue 1.0Page 28 of 51 Section 4 - Setting up and using the TMSUsing NexoftLogging onTo use the Nexoft Software, you must first log on. Wait a few seconds after thescreen in Figure 2 first appears then enter a username and a password. Click onthe ‘Log On’ button.Figure 2: Logon ScreenNOTE 1: The screens displayed throughout this section assume that the systemdefault configuration is being used.NOTE 2: If your password has expired you will be prompted to enter and confirm anew one. Do not use ‘common’ passwords.The splash screen providesfeedback while theapplication is loaded (sincethere can be 10-15 seconddelay loading all thescreens).Figure 3: Splash Screen
300-USM-103 US Issue 1.0Page 29 of 51Section 4 - Setting up and using the TMSThe main application window appears with the Search Patients panel (note the toolbar and menus).Figure 4: Nexoft main application windowYou can ‘undock’ (move around) the Search Patients dialog box, the toolbar andthe menu bar so that you can rearrange the screen to suit. Simply click and hold onthe item to be moved and drag it to a new position.The items within the toolbar and menu bar can also be customized using theConfiguration option within the Tools menu (or click the Config button on thetoolbar).Menu barToolbarSearch Patients dialog box
300-USM-103 US Issue 1.0Page 30 of 51 Section 4 - Setting up and using the TMSPatient RecordsNexoft allows you to add new patients or view the records of existing patients.To add a new patient:•Click the New Patient button on the toolbar, or•Select the File menu and then click the New Patient option.The Patient information dialog will be displayed:Figure 5: Entering new information using the Patient Information dialogThe Patient Information dialog is divided into four main areas:•Patient Identification - including the patient’s name, number and study code,•Nexystem Identification - including the ID (must be 4 characters) of the patient’sNx-300 system and the phone number on which the patient can be contacted,•Study/HCP Details - including the name of the patient’s physician or Health CareProfessional, the hospital/health care center name and the start date,•Additional Patient Details - including the date of birth and the gender of thepatient.When all necessary information has been entered, click the Save New Patientbutton.The new data is then displayed in the Patient Information screen shown overleaf.
300-USM-103 US Issue 1.0Page 31 of 51Section 4 - Setting up and using the TMSWhen new patient information has been entered (as discussed on the previouspage) the new data is presented for review in the following screen.Figure 6: Patient Information screen showing the entered informationThis screen allows further data to be added to the patient information in thefollowing areas:•Additional Patient Details - Patient Height and Weight. From this information aBody Mass Index (BMI) is automatically calculated (A warning will be displayedif the calculated BMI figure is greater than 45).•Additional Details - Study Description, Comments, Medications and Diagnoses.When changes are made to this screen, remember to click the Save Changesbutton in order to update the patient record.
300-USM-103 US Issue 1.0Page 32 of 51 Section 4 - Setting up and using the TMSTo locate existing patient records:1 If the Search Patients dialog is not already displayed:•Click the Find Patient button on the toolbar, or•Select the File menu and then click the Find Patient option.The Search Patients dialog allows you to Show All Patients or to search thedatabase using various criteria:•Patient Name•Patient Initials•Patient Study Code•Patient Number•HCP/Physician•All Patient Notes (search on any patient details)2 Click on the Search by: drop down list to select the required search criteria.Figure 7: Search Patient dialog showing the database search criteria3 Now enter additional search information into the text box labelled 2. Enter whatyou’re looking for:4 Click the Search button to interrogatethe database.The patient details that match yoursearch criteria will be displayed in theResults section.5To view a summary for a patient: Clickon the patient entry in the list - thesummary is displayed in the yellow boxbelow.To view a complete patient record:Double-click on the patient entry in thelist - the complete patient record isdisplayed in a new window. Figure 8: Search results
300-USM-103 US Issue 1.0Page 33 of 51Section 4 - Setting up and using the TMSUsing the Calendar function to set a download scheduleOnce a new patient has been added, or an existing patient located, the next stepis to organise a download schedule. This defines the dates and times when theTeleMonitoring Station (TMS) will dial the Base Station (installed at the patient’spremises) in order to download the recorded data.To set a download schedule:1 Display the record page for the required patient (see ‘To locate existing patientrecords’).2 Click the Calendar button on the toolbar. A calendar screen will be displayed:Figure 9: One month calendar view3 Optionally, use the Show:drop down list to select analternative calendar view.To change the current day:Click the smaller arrow buttonsabove the hourly view.To change the current month:Click the larger arrow buttonsabove the day by day view.
300-USM-103 US Issue 1.0Page 34 of 51 Section 4 - Setting up and using the TMS4 Right-click on the first required datacollection day and then left-click onthe Add Scheduled Data Collectionoption to display the Add ScheduledDownload dialog.5 Enter therequired StartTime and Date.Next, selectthe requiredDownloadType from thefollowingoptions:•Summary Report Only,•Summary Report and Waveforms, or•Summary Report and All Raw Data6 If only a single download is required, click the OK button.If a series of data downloads are required, click the Recurrence... button todisplay the Download Recurrence dialog:7 Set the requiredRecurrencepattern byselecting a Daily,Weekly, Monthlyor Yearly baseinterval asappropriate.8 In the Range ofrecurrencesection, set eitherthe End after: orthe End by:options asrequired.9 When all detailsof the downloadschedule havebeen entered, click the OK button. The Add Scheduled Download dialog willnow be visible again, click its OK button to apply the changes.The download schedule will be summarised in the previously selected calendarview as shown on the next page.
300-USM-103 US Issue 1.0Page 35 of 51Section 4 - Setting up and using the TMSFigure 10: Calendar view showing summary of scheduled downloadsTo edit or delete a download schedule:1 Display the record page for the required patient (see ‘To locate existing patientrecords’).2 Click the Calendar button on the toolbar. A calendar screen will be displayed.3 Right-click on the appropriate data collection dayand then left-click on either:•Edit scheduled download... option to displayan editable summary of the selecteddownload settings,•Remove scheduled download... option todisplay the Confirm Delete dialog:Select either the Delete all occurrences orthe Delete this one option as appropriateand click the OK button.
300-USM-103 US Issue 1.0Page 36 of 51 Section 4 - Setting up and using the TMSInitiating an immediate downloadThe system provides an option to make an immediate connection to the BaseStation in order to download data (in addition to, or instead of any programmeddownload schedule)To initiate an immediate download:1 Display the record page for the required patient(see ‘To locate existing patient records’).2 Click the Fetch button on the toolbar. TheDownload Data dialog will be displayed:3 Click the Connect button to open a connectionbetween the TMS and the selected Base Station.Once connected, the Download Data dialogprovides a number of options:•The Fetch the latest available summaryreports option allows you to select which ofthe reports (that are stored in the Base Unit)should be downloaded and in what form:•The Fetch raw data between option allowsyou to download stored data from monitoringsessions defined by date and time limits:•The View Live Data option allows you to view real time data as it iscollected by the Base Unit.4 When all required options have been set,click the Fetch Data button to begin thedownload. A dialog provides an indicationof progress. Once complete, you will beprompted to refresh the patient - click Yes.Note: Click Stop Download ifyou need to quit the download.
300-USM-103 US Issue 1.0Page 37 of 51Section 4 - Setting up and using the TMSViewing Downloaded DataOnce data has been downloaded for a particular user you can view variousaspects of the information in a graphical form.To view raw data on screen:1 Display the record page for the required patient (see ‘To locate existing patientrecords’).2 Click the Raw Data button on the toolbar. A Raw Data View dialog will bedisplayed with one or more channels enabled:Figure 11: Raw data view with two channels enabled
300-USM-103 US Issue 1.0Page 38 of 51 Section 4 - Setting up and using the TMSTo alter the viewed data:ChannelsThe channels to be displayed are controlled by the toolbar buttons shown on theleft hand edge of the screen. The channels are as follows:•II - ECG waveform from position modified lead 2 (II) of the Nexi.•V5 - ECG waveform from position modified lead V5 of the Nexi.•FL - Optional ‘floating’ sensor connected independently to the Nexi-Clip.•RESP - Respiration signal from the Nexi respiration impedance sensor.•Filter ON/OFF - When enabled, this baseline filter compensates for changesin the overall voltage levels measured by the ECG and flying lead sensors.To switch a channel on or off: Click the button representing that channel.The raw data view window and the channel toolbar can both be ‘undocked’ andrearranged to suit:Figure 12: Raw data view and channel toolbar undocked
300-USM-103 US Issue 1.0Page 39 of 51Section 4 - Setting up and using the TMSPrinting InformationThe system allows you to print various types of information, such as patient details,raw data graphs, etc.To print patient information:1 Display the record page for the required patient (see ‘To locate existing patientrecords’).2 Click the Print button on the toolbar. A print preview screen will be displayed:Figure 13: Print preview showing patient information3 Ensure that the printer is switched on and ready to receive, then click the Printbutton on the preview toolbar.
300-USM-103 US Issue 1.0Page 40 of 51 Section 4 - Setting up and using the TMSTo print raw data channels:1 Display the required raw data view (see ‘To view raw data on screen’).2 Click the Print button on the toolbar. A print preview screen will be displayed:Figure 14: Print preview showing raw data3 Ensure that the printer is switched on and ready to receive, then click the Printbutton on the preview toolbar.
300-USM-103 US Issue 1.0Page 41 of 51Section 4 - Setting up and using the TMSOn-line helpThe Nexoft system incorporates an extensive on-line help system.To access on-line help:1 Select the Help menu (or press F1) and then click either:•Contents - to display the help system table of contents,•Index - to view the index listing,or•Search - if you wish to enter a keyword and have the help system locaterelated topics.The help screen will be displayed with either the Contents, Index or Search tabselected on the left-hand side depending on which option was selected.2 Choose the required item from the Contents/Index list or enter your keyword toperform a search.Figure 15: Help screen showing the Contents listing on the left-hand sideNote: The help system is web-enabled so that you can transfer directly to theNexan website for futher details. Click the Nexan Website button on the helptoolbar.
300-USM-103 US Issue 1.0Page 42 of 51 Section 4 - Setting up and using the TMSShutting down the TMSCAUTION: If you exit Nexoft or shut down the computer, scheduled downloads willnot occur.1 In the main Nexoft window, click the Exit button. The Nexoft window will close,leaving the standard Windows desktop.2 Click the Windows Start button.3 Choose the Shut Down option and, in the dialog that appears, check that theShut down the computer? option is selected.4 Click the Yes button. After a short while the sceen will display the message It isnow safe to turn off your computer.4 On the front panel of the TMS Computer, press the button marked to set thecomputer to standby. If required, switch off the computer at the mains supply.
300-USM-103 US Issue 1.0Page 43 of 51Section 5 - General InformationSECTION 5General InformationTechnical DescriptionSystem comprising:a) The on-body equipment, comprising the Nexi and the Nexi-Clip processingelectronics. The Nexi is a disposable element, containing ECG electrodes,bioelectric impedance electrodes for respiration measurement, and aconnector for an additional ECG electrode. It is a disposable item, designed tobe worn for up to 24 hours. The Nexi-Clip takes measurements via theelectrodes, and transmits them to the Portable Data Assistant (PDA.) The Nexi-Clip is non-disposable, and is detachable from the Nexi.b) The PDA which stores up to 24 hours worth of data received from the on-bodyequipment.c) The Base Station Unit (BSU) which stores up to 14 days worth of data receivedfrom the PDA.d) The Tele-Monitoring Station (TMS) which is used to interrogate the BSU, andto interpret and display the data.Nexan Ltd will make available on request circuit diagrams, component parts lists,descriptions, calibration instructions or other information which will assist theuser’s appropriately qualified technical personnel to repair those parts ofequipment which are designated by the manufacturer as repairable.
300-USM-103 US Issue 1.0Page 44 of 51 Section 5 - General InformationTechnical SpecificationsGeneralNexi Two lead ECG sensors providing a modified Lead II view andmodified CM5. Respiration impedance waveform. Optional3rd flying lead with ECG electrode.Nexi-Clip Contains: PCBEurope- Radio TX UHF 868 MHzUS- Radio TX UHF 916.5 MHzPDA: Contains: PCB, Storage device (memory card)EU- Radio RX operating in unlicensed Band of 869.7-870MHzUS- Radio RX operating in UHF Band 916-917MHz* Displayed respiration by impedance:Range: 1 - 72* Breaths Per Minute Accuracy: ±2 Breaths Per Minute* Displayed two lead ECG sensors* Heart rate range: 30-250 Beats Per Minute* Heart rate accuracy: ± 3 Beats Per Minute* The values displayed are only for ‘Hook-up’ signal checks by the HCP.BaseStation Computer Mother Board with Pentium Processsor and HardDisk storage device, Call discriminator,LCD Touchscreen.PDA Desktopcharger unit Contains: PCBTMS Computer 700MHz Pentium III Computer with DVD Drive, backup tapedrive, modem.Printer HP Deskjet 840C. See manufacturer’s instructions for details.
300-USM-103 US Issue 1.0Page 45 of 51Section 5 - General InformationPower requirementsNexi-Clip and Nexi: Shared 3V requires 2 x 1.5V alkaline AAA cells. (fittedduring manufacture to the Nexi -Not user replaceable)PDA: 3.6V 1600mAh Re-chargeable Lithium Ion Cell. (No UserAccess) Recharge using only the following Nexansupplied charger units:a. Nx-300 Base Station Unit (PDA docking slot)b. Nx-300 PDA Desktop Charger UnitPDA Desktop charger Requires 7.5VDC 1A . Use only (Model No.JOD-48-09)supplied by Nexan for use with the with the Nx-300system.Base Station Requires 100-240V 50-60Hz~ Power consumption 2A-1A.Two UL approved fuses rated T2AH (250V).Omron ® IC BloodPressure monitor: 6V requires 4 x AA LR6 1.5V Alkaline batteries.Micro Plus Spirometer 9V requires 1 x PP3 9V dry cell battery.TMS Computer UK requires 220-240V 50/60Hz~US Requires 110-120V 60Hz~TMS Printer (Option) UK requires 220-240V 50/60Hz~US Requires 110-120V 60Hz~
300-USM-103 US Issue 1.0Page 46 of 51 Section 5 - General InformationTransport and Storage conditionsCAUTION: These devices may not meet their performance criteria if stored outsidethe ranges stated below.Nexi and Nexi-ClipTemperature* -20 to + 65°CHumidity* 5 to 90% non-condensingAmbient pressure* 700 to 1060 mbarBase Station UnitTemperature* -20 to +65°CHumidity* 5 to 90% non-condensingAmbient pressure* 700 to 1060 mbar*Set by EC38 as per ‘Stationary Equipment’.PDA and PDA Desktop ChargerTemperature* -20 to +65°CHumidity* 5 to 90% non-condensingAmbient pressure* 700 to 1060 mbar*Set by EC38 as per ‘Stationary Equipment’.Operating ConditionsCAUTION: These devices may not meet their performance criteria if stored outsidethe ranges stated below.Base Station Unit, PDA and PDA Desktop ChargerTemperature +10 to +40°CHumidity 30 to 75% non-condensingAmbient pressure 700 to 1060 mbarNexiTemperature +10 to +40°CHumidity 30 to 75% non-condensingAmbient pressure 700 to 1060 mbarNexi-ClipTemperature +10 to +40°CHumidity 30 to 75% non-condensingAmbient pressure 700 to 1060 mbar
300-USM-103 US Issue 1.0Page 47 of 51Section 5 - General InformationCleaning, Maintenance, Storageand CalibrationIt is intended that maintenance is carried out between patient use by a suitablytrained person. It is not intended that the patient will carry out any maintenance orrepair (including Base Station fuse replacement) and there are no patientreplaceable parts. If a fault occurs when using the system, first read the Troubleshooting guide. If the fault is still present then contact Customer Support asdetailed in Page 2. If Customer Support request the return of a part of the system,it should be returned in its original packaging.Maintenance of Base Station, PDA and Nexi-ClipWARNING: REMOVE MAINS POWER FROM THE BASE STATION BEFORECLEANING.WARNING: DO NOT ALLOW THE CLEANING SOLUTION OR WATER TO RUNINTO CREVICES OR OPENINGS.The Base Station, PDA and Nexi-Clip can be wiped with a nearly-dry clothcontaining warm water and detergent. Thoroughly wipe off any excess residualcleaning solution from the Nx-300 system and allow to dry.While cleaning the Base Station, PDA and Nexi-Clip, they should be checked forunusual wear or possible damage from an accident.Re calibration of the Base Station, PDA and Nexi-Clip are not required.Power CablesWARNING: DO NOT OPERATE THE EQUIPMENT FROM MAINS POWER WITH ADAMAGED POWER CORD OR PLUG.The Base Station mains power supply cable supplied is intended to be used onlywith the Nextation and should not be used for any other electrical equipment.Disconnect the power cable from mains power before inspecting the power cordperiodically for fraying or other damage, and replace as needed.
300-USM-103 US Issue 1.0Page 48 of 51 Section 5 - General InformationReplacing the Base Station fusesThe Base Station contains two fuses that can easily be replaced by servicepersonnel if necessary.CAUTION: Replace each fuse only with the specified type - as indicated on theBase Station label adjacent to the fuse holder.Note: Both fuses should be replaced at the same time, even if only one fuse isfound to be unserviceable due to an over current situation. The other fuse mayhave become stressed and could become unreliable.To replace the Base Station fuses:1 Unplug the power cord from the ac mains supply outlet then unplug theremovable cord from the ac mains inlet of the Base Station.2 Locate the fuse holder, which protrudes from below the mains inlet socket ofthe Base Station.3 Using a flat bladed screwdriver, depress the centre tab, then carefully withdrawthe fuse holder.4 Replace both fuses with the specified type.5 Refit the fuse holder.
Regulatory MarkingsFederal Communications Commission(FCC) Compliance and Advisory NoticeThis equipment has been tested and found to comply with the limits for a Class Bdigital device, pursuant to Part 15 of the FCC Rules. These limits are designed toprovide reasonable protection against harmful interference in a residential installa-tion. This equipment generates, uses and can radiate radio frequency energy and,if not installed and used in accordance with the instructions for use, may causeharmful interference to radio communications.However, there is no guarantee that interference will not occur in a particularinstallation. If this equipment does cause harmful interference to radio or televisionreception which can be determined by turning the equipment off and on, the user isencouraged to try to correct the interference by one or more of the followingmeasures:· Reorient or relocate the receiving antenna.· Increase the separation between the equipment and the receiver.· Connect the equipment into an outlet on a circuit different from that to whichthe receiver is connected.· Consult the dealer or an experienced radio/television technician for help.This device complies with Part 15 of the FCC Rules. Operation is subject to thefollowing two conditions: (1) this device may not cause harmfulinterference, and (2) these devices must accept any interference received,including interference that may cause undesired operation.FCC ID: PCPNX-300Section 5- General Information Page 49 of 51300-USM-103 US Issue 1.0CAUTION: Changes or modifications not expressly approved in writing by Nexan Ltdmay void the user’s authority to operate this equipment..
300-USM-103 US Issue 1.0Page 50 of 51 Section 5 - General InformationWarrantyNexan Ltd. warrants to the original purchaser that the Nx-300 (Product), providedin the sales packaging, is free from defects in material and workmanship, undernormal installation and use, according to the following terms and conditions:1 The warranty for the ‘Product’ extends for ninety (90) days from the date ofpurchase by the customer.2 The warranty for the installed/supplied software extends for ninety (90) daysfrom the date of purchase by the customer.3 Nexan Ltd shall be under no liability in respect of any defect arising from fairwear and tear, wilful damage, negligence, abnormal working conditions, failureto follow Nexan Ltd’s Instructions (whether conveyed orally or in writing),misuse, improper installation or alteration or repair of the Products withoutNexan Ltd’s approval.4 The above warranty does not extend to parts, materials or equipment notmanufactured by Nexan Ltd, in respect of which the Customer shall only beentitled to the benefit of any such warranty or guarantee as is given by themanufacturer to Nexan Ltd.5 Subject as expressly provided here, all warranties, conditions or other itemsimplied by statute or common law are excluded to the fullest extent permittedby law.6 Any claim by the Customer which is based on any defect in material orworkmanship of the products shall be notified to Nexan Ltd immediately afterdiscovery of the defect. If the Customer does not notify Nexan Ltd accordingly,the Customer shall not be entitled to reject the products and Nexan Ltd shallhave no liability to the Customer.7 Where any valid claim in respect of any of the Products which is based on anydefect in the materials or workmanship of the Products is notified to Nexan Ltd,Nexan Ltd shall be entitiled to replace with new or refurbished replacementitems or repair (at Nexan Ltd’s sole discretion, either at the customerspremises or at Nexan Ltd’s premises in the UK) the Products (or part inquestion) but Nexan Ltd shall have no further liability to the Customer.Repaired, refurbished or replacement ‘Product’ is warranted for the balance ofthe warranty period.8 Nexan Ltd shall not be liable to the Customer by reason of any representation,or implied warranty, condition or other term, or any duty at common law, or forany consequential loss or damage (whether for loss of profit or otherwise),costs, expenses or other claims for consequential compensation whatsoeverarising out of or in connection with any act or omission of Nexan Ltd relating tothe manufacture or supply of the Products or use by the Customer.
300-USM-103 US Issue 1.0Page 51 of 51Section 5 - General InformationTroubleshooting guideBase Station green lamp not lit when Base Station power switch is set to On.Base Station may not be plugged into wall socket. Ensure that the power lead isplugged into wall socket and it is switched on.PDA ECG trace shows poor signals.If no trace is seen:•check the Nexi-Clip is transmitting satisfactorily - see Signal mV option onPDA Status screen. If no radio signal is present, check the Nexi-Clip iscorrectly clipped together.•check the Nexi-Clip Id is correctly configured.•if no trace is seen on ECG3, check ECG3 is enabled.•if still no trace, check for Nexi battery failure by trying another clip.If a noisy trace is seen:•check Nexi is properly attached to patient. Pay special attention to skinpreparation before application.If there are gaps in the trace:•this indicates poor radio reception, possibly due to local radio interference.Try to identify and remove the source of interference.•move PDA closer to patient.If a flat-line is seen:•if seen on ECG3, the flying lead may not be properly connected to the Nexi;•may indicate a faulty connection within the Nexi-Clip - try another.

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