User guide
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| Document ID | 128988 |
| Application ID | UybxX5uIHi8OjyxWC6YHhw== |
| Document Description | User guide |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 63.34kB (791749 bits) |
| Date Submitted | 2000-12-15 00:00:00 |
| Date Available | 2000-12-14 00:00:00 |
| Creation Date | 2000-11-09 15:29:35 |
| Producing Software | Acrobat Distiller 4.05 for Windows |
| Document Lastmod | 2000-11-23 08:57:14 |
| Document Title | User guide |
Instructions for Use NEXAN® SYSTEM Nx-300 © 2000 NEXAN® Ltd. This document should be used for the intended use only and any other distribution, copying, use or disclosure is strictly prohibited. NEXAN, NEXI, NEXOFT are registered trademarks of Nexan® Ltd. NEXAN® Ltd Manual purpose and intended users These instructions are intended for the Health Care Professional, as a guide to the use of the Nx-300 System including the Nexan Software -Nexoft (found in the Telemonitoring Station computer). It is assumed that the user of the Telemonitoring Station and Nexoft is a Registered Medical Practitioner who has experience of using Windows Software on a PC. The Patient is the user of the Nexi, Nexi-Clip, PDA, Base Station and Auxiliary Sensors. A set of instructions, called ‘Patient Guide’ is intended to be left with the patient (to assist him/her with day-to-day-use) A set of instructions called ‘READ ME FIRST’ is provided with each Nexi for patient application of Nexi and Nexi-Clip. User assistance information To obtain service contact Nexan Customer Support on 770-360-9090. Availability of Clinical Study Data Clinical Study data, obtained using the Nx-300, is available on request from Nexan Ltd. Nexan Ltd, cautions the reader of this manual: • This manual, wholly or partially, is subject to change without notice. Some features 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 any form, the whole or part of this manual without the permission of Nexan Ltd. 300-USM-103 US Issue 1.0 • Nexan assumes no responsibility for usage not in accordance with this manual resulting in illegal or improper use of the Nexan system. Page 2 of 51 Index Contents SECTION 1 Important information General warnings & precautions .................................................................................. 5 Glossary of symbols & terms ........................................................................................ 7 Environment ................................................................................................................. 7 Symbols on Nx-300 system labelling ........................................................................... 8 Intended use ............................................................................................................... 10 Contra-indications: ................................................................................................ 10 SECTION 2 Overview of Nx-300 system System description ..................................................................................................... 11 Description of parts: ................................................................................................... 12 Parts supplied ............................................................................................................. 13 System setup and operation ....................................................................................... 14 SECTION 3 Setting up the PDA and Base Station 300-USM-103 US Issue 1.0 Configuring the PDA ................................................................................................... 15 Accessing the HCP menu ..................................................................................... 15 Clearing the memory ............................................................................................ 16 Configuring the PDA for a new Nexi-clip ............................................................... 17 Other Configure PDA options ............................................................................... 17 Viewing signals and data to check Nexi operation ............................................... 18 Setting the PDA Clock and Calendar .................................................................... 20 Viewing stored schedule information .................................................................... 20 Configuring the Base Station ...................................................................................... 21 Accessing the HCP Menus ................................................................................... 21 Setting the PDA (PDL) ID code ............................................................................. 23 Setting the Patient ID code ................................................................................... 24 Setting or editing the measurements schedule ..................................................... 25 Index Page 3 of 51 SECTION 4 Setting up and using the TeleMonitoring Station TeleMonitoring Station (TMS) overview ...................................................................... 26 Setting up the TMS computer ..................................................................................... 27 Connecting the TMS ............................................................................................. 27 Switching on the TMS ........................................................................................... 27 Using Nexoft ............................................................................................................... 28 Logging on ............................................................................................................ 28 Patient Records .................................................................................................... 30 Using the Calendar function to set a download schedule ..................................... 33 Initiating an immediate download ......................................................................... 36 Viewing Downloaded Data .................................................................................... 37 Printing Information ............................................................................................... 39 On-line help .......................................................................................................... 41 Shutting down the TMS .............................................................................................. 42 SECTION 5 General Information 300-USM-103 US Issue 1.0 Technical Description ................................................................................................. 43 Technical Specifications ............................................................................................. 44 Power requirements ................................................................................................... 45 Transport and Storage conditions .............................................................................. 46 Operating Conditions .................................................................................................. 46 Cleaning, Maintenance, Storage and Calibration ....................................................... 47 Replacing the Base Station fuses .............................................................................. 48 Regulatory Markings .................................................................................................. 49 Federal Communications Commission (FCC) Compliance and Advisory Notice ....... 49 Warranty ..................................................................................................................... 50 Troubleshooting guide ................................................................................................ 51 Page 4 of 51 SECTION 1 Important information General warnings & precautions All users should read these Safety Instructions carefully and thoroughly before using the system. To ensure patient safety, all parts of the system must be used in accordance with the Instructions for Use as indicated by the warning triangle on the product labels. Particular attention should be made to WARNINGS, CAUTIONS and 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 damage to 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 IRRITATED SKIN. 300-USM-103 US Issue 1.0 • MONITORING OF PATIENTS WITH PHYSICAL OR MENTAL OR SENSORY IMPAIRMENT SHOULD ONLY BE UNDERTAKEN IF THE MEDICAL PRACTITIONER/PHYSICIAN CONSIDERS THEY CAN USE THE Nx-300 SYSTEM CORRECTLY AND THAT IT WILL NOT CAUSE UNDUE STRESS OR ANXIETY. • THERE IS A POSSIBILITY OF DEGRADATION OF THE RESPIRATION SIGNAL IN PATIENTS WITH HIGH BODY MASS INDEX. • REPLACE FUSES WITH CORRECT TYPE AND RATING; FOR PROTECTION AGAINST FIRE AND OTHER HAZARDS. • IF USED IN HOSPITAL, THE BASE STATION UNIT MUST BE CONNECTED TO A HOSPITAL GRADE OUTLET. • THE Nx-300 IS NOT FOR USE AS A CRITICAL CARE MONITORING SYSTEM. • THE Nx-300 IS NOT AN APNOEA MONITOR. Section 1 - Important information Page 5 of 51 Precautions • Substitution of a component different from that supplied may result in measurement error. • Only use the Nexan Supplied Charger or Base Station Unit (BSU) to re-charge the Personal Data Assistant (PDA). • Do not use two systems close together since corruption of data may occur. The Nx-300 system should be used under the supervision of Registered Medical Practitioner. • Patients must be advised to contact their Registered Medical Practitioner if they feel any deterioration in their condition whilst using the Nx-300 system. • The Base Station, Auxiliary sensors and Telemonitoring Station (TMS) should be placed in locations where the cables are safely positioned and the units cannot harm anyone if the units fall. • No part of the Nx-300 system should be allowed to come into contact with water or other fluids, substances which could cause combustion, flammable/explosive gases. • 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 with in any way. • Inspect the Base Station power cord periodically for fraying or other damage. Do not operate the equipment from mains power with a damaged power cord or plug. 300-USM-103 US Issue 1.0 • Ensure that air can circulate freely around the Base Station and that contaminates, e.g. talcum powder, are not allowed to ingress. Page 6 of 51 Section 1 - Important information Glossary of symbols & terms As used in instructions and on product labels: Auxiliary sensors An Nx-300 facility to use additional sensors directly connected to the Base Station. Download Data that is transferred from one location to another. Event Specific occasion(s) of patient response. Monitoring schedule A period of time during which patient monitoring is carried out. Trend Data Data from all the auxiliary sensor sessions which is viewed over an extended period of time. Environment Environmental conditions that affect use: The Nx-300 system uses a radio frequency signal in the low power, unlicensed Bands of 869.7- 870MHz in Europe and 916-917MHz in the United States of America (Part of the 902-928 Band) to transfer system information from the NexiClip to the PDA. It is possible that interference may occur between the Nx-300 and other radio equipment operating on the same frequencies. Due to the low power of the transmissions, the potential for interference is only likely if the two are close to each other. Before installing the Nx-300,it is recommended that the installation environment be checked for other radio devices that may be affected. Examples of these environments are as follows: • Domestic • Panic alarms • Social alarms • Television receivers • Radio-controlled car security devices • Cordless telephones • Hearing aids • FM receivers 300-USM-103 US Issue 1.0 • CB radios It is recommended that if any such equipment is identified, then it should be checked for correct operation while the Nx-300 is operating as close as possible to the equipment. Should any problems be observed we recommend the Nx-300 is switched off and Nexan Customer Support is contacted (see page 2 for contact details). Section 1 - Important information Page 7 of 51 Symbols on Nx-300 system labelling SYMBOL TEXT DESCRIPTION ATTENTION, Consult Accompanying Documents Type BF Equipment. Type B equipmment with an F-type applied part (patient isolation from electric shock) Used on Nexi. Type B Equipment. (patient isolation from electric shock). Used on Base Station SN- SERIAL NUMBER of device Direct Current Fuse 2x T2AH 250V (used on Base Station) Not for Re-use (Single Use Only) applies to Nexi (ISO7000/1051, BSEN980:1996) 300-USM-103 US Issue 1.0 Use- by (Year-month) applies to Nexi Page 8 of 51 Section 1 - Important information Symbols on Nx-300 system labelling (continued) SYMBOL TEXT DESCRIPTION Input - used on Base Station. Intended only for connection to patients’ phone. Output- used on Base Station. Intended only for connection to patients’ phone line. A B Used on Base Station to connect any auxiliary sensor AECG 1 AECG Type 1 equipments (all) Base Station Power ON Base Station Power OFF 300-USM-103 US Issue 1.0 PDA Power ON/Confirm action button (green) R&TTE equipment Class 2 (Member States restrictions) May apply to Nexi-Clip and Portable Data Assistant (PDA) Section 1 - Important information Page 9 of 51 Intended use ‘The Nx-300 system is an ambulatory patient monitoring system intended for use in the home or alternate care settings. The device stores and transmits ECG data, respiration data, systolic and diastolic blood pressure (non-invasive), and PEF and FEV1’ 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 WITH IMPLANTED DEFIBRILLATORS/PACEMAKERS. • THE Nx-300 MUST NOT BE USED ON PATIENTS WITH KNOWN SENSITIVITY TO MEDICAL ADHESIVES. 300-USM-103 US Issue 1.0 • THE Nx-300 IS NOT FOR USE AS A CRITICAL CARE MONITORING SYSTEM. Page 10 of 51 Section 1 - Important information SECTION 2 Overview of Nx-300 system System description Data from physiological measurements, taken by sensors on the chest and underarm (Nexi) is converted into radio signals and transmitted via a radio transmitter (Nexi-Clip attached to the Nexi) to a radio receiver in a Personal Data Assistant (PDA). The PDA also stores the data for the monitoring period and normally 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 and downloads the data from the Base Station via the patient’s phone line. The TMS computer software is then used by the Registered Medical Practitioner to display and interpret the patient data. The diagram below shows the complete Nx-300 system in operation. Nexi SpO2 sensor Nexi-Clip Direct Interfaces to 3rd party analyser PDA BSU 300-USM-103 US Issue 1.0 Body-worn items PSTN TMS Auxiliary Sensors Radio Interface Direct local interface Direct local interface, or remote via PSTN Figure 1. Nexan Nx-300 System Section 2 - Overview of Nx-300 system Page 11 of 51 Description of parts: A disposable, multi-parameter adhesive sensor patch worn on the upper chest and underarm. Contains two batteries used to power both the Nexi and the Nexi-Clip when connected. Nexi-Clip A Radio Transmitter which Clips to the Nexi and contains a transmitter. PDA: A Receiver and storage Unit for data storage of data recieved by radio communications transferring that data to the Base Station when docked. Base Station: A Base Unit, located in the patient’s home, for data storage,analysis and transfer of data to a Telemonitoring centre on request. Also permits connection of Auxiliary sensors such as Blood pressure and Spirometry devices for point-in-time measurements. The Unit also contains a call discriminator unit, which allows normal use of the patient’s phone. The discriminator identifies the difference between incoming voice or data calls and routes the call appropriately. TeleMonitoring Station (TMS): A dedicated PC, located in the Telemonitoring Centre, running a Nexan software package. Nexan Software: A software package in the TMS for data interpretation and presentation of the data received from the Patient’s Base Station. Nexan software is only for use by Healthcare Professional. Auxiliary Sensors: Auxiliary sensors connected to the Base Station for the recording of blood pressure,weight (option) and spirometry measurements. 300-USM-103 US Issue 1.0 Nexi: Page 12 of 51 Section 2 - Overview of Nx-300 system Parts supplied Parts supplied to patient Nexi (One for each period of 24hrs required use) Nexi-Clip PDA PDA charger unit (as required) Base Station (BSU) + cables Auxiliary sensors (as required) NOTE: Not all parts may be supplied to all patients Parts supplied to Health Care Professional (HCP) TMS Personal Computer (containing installed Nexan Software) Printer 300-USM-103 US Issue 1.0 NOTE: Not all parts may be supplied to all HCPs CAUTION: Do not store in a damp area. Dampness may affect the device and cause rust. Section 2 - Overview of Nx-300 system Page 13 of 51 System setup and operation Successful operation of the Nx-300 system depends on thorough patient instruction. Nexan recommends that you walk through the following steps with each 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 with each 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. 300-USM-103 US Issue 1.0 • Troubleshooting patient equipment. Page 14 of 51 Section 2 - Overview of Nx-300 system SECTION 3 Setting up the PDA and Base Station Configuring the PDA To switch on the PDA, press and hold the green button. The screen will briefly display an information view showing the unique PDA identification number, plus its software and hardware revisions ð ABCDEFGH Personal ________ Data ____ Assistant _________ ID 7800123456 Software 12.34 Hardware 56.78 & Nexan Ltd. 2000 Accessing the HCP menu 300-USM-103 US Issue 1.0 When preparing the PDA for a new patient, a number of actions should be carried out, all of which require access to the HCP menus that are hidden from the patient. A pre-set PIN code is required to gain access to the HCP menus. To access the HCP menus: 1 Press and hold the key to show this display ð key to begin entering Press the the PIN. The first * will be replaced with ‘0’. or keys to select the Use the required PIN digit and press to confirm when the number is correct. Repeat step 3 until all four digits are entered. HCP Menus _________ jkkl Please enter HCP PIN: **** cdef to select ab to confirm each digit Section 3 - Setting up the PDA and Base Station Page 15 of 51 Accessing the HCP menu (cont.) When the correct PIN has been entered, the HCP Main Menu is displayed ð Note: If the PIN is not known, then there is a second, fixed PIN, that will provide access. If required you can get this PIN by contacting Nexan. jkkl HCP ____ Main Menu ___ ____ Exit View signals View summary View schedule View status Configure Set clock Reset menu cdef to select ab to confirm Clearing the memory When you are preparing the PDA for a new patient, the first action must always be to ensure that the memory is completely free of residual data. key until Reset Menu is Press the highlighted. Press the key to display the Reset PDA screen ð key until Erase all Press the data is highlighted and then press the key. Press the or keys until the option states Yes and then press key until Exit is highlighted Press the key to execute the erase and press the function and return to the HCP Main Menu. Page 16 of 51 _____ Reset ___ PDA jkkl Exit Erase all data No Reset config No cdef to select ab to exit Section 3 - Setting up the PDA and Base Station 300-USM-103 US Issue 1.0 To clear the memory: 1 Enter the HCP Menu. Configuring the PDA for a new Nexi-clip When setting up a new installation, you must ensure that the PDA is configured to recieve data from the specific Nexi-clip being used. To register a new Nexi-clip with the PDA: 1 Enter the HCP menu. key until Configure is Press the key to display the highlighted. Press the Configure PDA screen ð key until Nexi clip is Press the highlighted and press the key to highlight the first number of the Nexi-clip code. On the rear of the Nexi-clip to be used, locate the printed label. On the label note the three figure ID code - this is the code that must be entered into the PDA. jkkl Configure ___ PDA _________ Exit Nexi clip 123 Sig. alarm on PIN **** Patient ID 12345678 Calendar on ECG 3 off SpO2 on cdef to select ab to exit 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 the remaining two ID digits. When the last digit has been set, press the key until Exit is highlighted and then press . The configured options are implemented as the screen is exited. 300-USM-103 US Issue 1.0 Other Configure PDA options Allows you to set a new PIN to gain access to the HCP menus (set to 0000 to disable the PIN) An eight figure representation of the current Patient ID. When ON, enables storage for optional ECG data from an external ‘flying lead’ attached to the Nexi. jkkl Configure ___ PDA _________ Exit Nexi clip 123 Sig. alarm on PIN **** Patient ID 12345678 Calendar on ECG 3 off SpO2 on cdef to select ab to exit Section 3 - Setting up the PDA and Base Station When ON, sounds an alarm when the signal from the Nexi-clip becomes weak. When ON, displays the date on the standby screen. Page 17 of 51 Viewing signals and data to check Nexi operation The PDA allows you to view the ECG and/or respiratory waveforms being monitored by the Nexi patch and sent to the PDA by the Nexi-clip. This function is useful when checking that the patch has been correctly applied and that the Nexiclip and PDA are communicating correctly. To view raw data signals: 1 Apply the Nexi to the patient and attach the Nexi-clip in the usual manner. Enter the HCP Menu. key until View signals is Press the highlighted. Press the key to display the Signals Menu ð or keys until the required Press the ECG or Resp. signal is highlighted. Press the key to display the chosen raw data display ò ECG1 HR 75 RR15 SpO2 95 jkkl _______ ____ Signals Menu Exit ECG lead 1 ECG lead 2 ECG lead 3 Resp. signal cdef to select ab to confirm The screen changes to a ‘landscape’ display and shows the current waveform, plus along the top: the current Heart Rate and Respiration Rate. If no waveform or HR/RR values are displayed then there may be a communication problem or fault with the Nexi/Nexi-clip combination. Note: If you do not see a good signal, refer to the Troubleshooting section at the rear of this guide. Press the key to return to the Signals Menu. Additionally you can also view the incoming data simply as numeric values. This method is discussed next. Page 18 of 51 Section 3 - Setting up the PDA and Base Station 300-USM-103 US Issue 1.0 To view numeric signal values: 1 Apply the Nexi to the patient and attach the Nexi-clip in the usual manner. Enter the HCP Menu. key until Press the highlighted. Press the Summary screen ð Summary _______ View summary is key to display the This screen shows incoming values for the Heart Rate and Respiration Rate. jkkl HR bpm: 75 RR /min: 15 SpO2 %: 98 If the values remain at ### then there may be a communication problem or fault with the Nexi patch/Nexi-clip combination. ab to exit To view the PDA Status screen: 1 Enter the HCP Menu. key until View status is highlighted. Press the Press the display the PDA Status screen ò key to jkkl PDA ___ Status ______ The patient ID number. 300-USM-103 US Issue 1.0 Indicates that signals are being received from the designated Nexi-clip. Indicates the strength of the signal from the Nexi-clip. 1000 or less indicates a weak signal that could result in data loss. 2000 or more indicates a strong signal. Id: 8700123456 Nexi clip: 123 Nexi clip OK Mem free %: 85 Signal mV:1234 On at: 10:15 Oct 12 Session: 123 10:25 Oct 12 ab to exit Section 3 - Setting up the PDA and Base Station Indicates the ID number for the current Nexi-clip. Indicates how much data storage memory is free within the PDA. Indicates when the PDA was last switched on Indicates the current patient session and when it commenced. Page 19 of 51 Setting the PDA Clock and Calendar The PDA has an internal clock and calendar against which the incoming data is monitored. It is important that the clock is set correctly when installing the system. To set the clock and calendar: 1 Enter the HCP Menu. key until Set clock is Press the highlighted. Press the key to display the Set PDA Clock screen ð or to highlight the required Press begin altering setting and then press that setting. Press or to change the current setting and then press when it is correct. Repeat steps 3 and 4 until all time and date settings are correct and then press or until Exit is highlighted. Press to quit the screen and apply the changes made. jkkl Set ___ PDA Clock ___ _____ Exit Year 2000 Month Day 23 Hour 15 Minute 47 Second 00 Format 24hr cdef to select ab to exit Viewing stored schedule information To view scheduled measurements: 1 Enter the HCP Menu. key until View schedule Press the is highlighted. Press the key to display the Schedule screen ð Note: This screen shows only the times and dates for the scheduled measurements. It does not differentiate between the different measurements, nor does it allow any editing of the entries. Page 20 of 51 Schedule ________ jkkl # Time Date 1 10:15 Oct 12 2 14:00 Oct 12 3 9:15 Oct 13 4 18:00 Oct 13 ab to exit Section 3 - Setting up the PDA and Base Station 300-USM-103 US Issue 1.0 If the Base Station and PDA have any scheduled extra measurements (blood pressure, spirometry or weight) programmed, then it is possible to view a summary of these on the PDA. Configuring the Base Station Accessing the HCP Menus When the Base Station is switched on, it displays the patient home page. To configure the 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: Press the HCP button to display: 300-USM-103 US Issue 1.0 Section 3 - Setting up the PDA and Base Station Page 21 of 51 3 Enter your four digit PIN code to display: HCP options Press the Configure button to display: Select the required action that you wish to perform. Page 22 of 51 Section 3 - Setting up the PDA and Base Station 300-USM-103 US Issue 1.0 HCP configuration options Setting the PDA (PDL) ID code Each PDA carries a unique identification (PDA ID) code to ensure that recorded data can be traced back to a specific patient and their PDA. It is important that the Base 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 ID option. 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 300-USM-103 US Issue 1.0 • It is displayed in the PDA Status screen that is mentioned earlier in this section. Locate the 10-digit PDA ID code and enter it into the Base Station using the on-screen keypad. Press the Save button. Section 3 - Setting up the PDA and Base Station Page 23 of 51 Setting the Patient ID code In order to maintain a traceable link between recorded data and a particular patient, it is important that Base Station is programmed with the correct Patient ID code. To set the Patient ID code: 1 Enter the HCP/Nurse menu, choose Configure and then select the PatientID option. The following screen will be displayed: Use the on-screen Up and Down buttons to increment/decrement each of the four digits until the Patient ID code matches the number that has been designated for that patient. Press the Save button to store the entered code and exit to the options screen. 300-USM-103 US Issue 1.0 Page 24 of 51 Section 3 - Setting up the PDA and Base Station Setting or editing the measurements schedule Schedules for taking extra measurements (such as blood pressure, spirometry or weight) are generally set using the Nexoft software from the remote TeleMonitoring Station (or TMS). However, it is sometimes necessary, or more convenient, to set or edit these settings whilst on-site with the Base Station. 300-USM-103 US Issue 1.0 To increase or reduce the number of measurements: 1 Enter the HCP/Nurse menu, choose Configure and then select the Schedule option. The following screen will be displayed: Use the on-screen Up and Down buttons to increment/decrement the quantity of Blood Pressure or Spirometry readings that are required. Press the Save button to store the new scheduled measurements and exit to the options screen. Note: The scheduled measurements that are set on the Base Station will take priority over any similar settings made at the remote TeleMonitoring Station. The next time that the TMS connects with the Base Station, the new settings will be uploaded and used to alter the TMS schedules. Section 3 - Setting up the PDA and Base Station Page 25 of 51 SECTION 4 Setting up and using the TeleMonitoring Station TeleMonitoring Station (TMS) overview Data from the Base Station is transferred, via patient’s telephone line, to a Telemonitoring Centre. Here the Registered Medical Practitioner has access to the Nexan software, called Nexoft, installed on a Nexan TMS computer. Note: It is recommended that archiving of patient data is carried out both as a preuse check between patient use of the Nx-300 system and periodically. The Registered Medical Practitioner can control the use of the Nx-300 using the Nexoft program that enables the following features: • Dial-up to a patient’s home for downloading the monitoring schedule to the patient’s Base Station. • Dial-up to a patient’s home to retrieve and view recorded and /or analysed data from the patient’s Base Station. • Scheduling the download times. • Setting up or changing the schedule for blood pressure and/or, spirometry measurements; collectively known as auxiliary measurements. 300-USM-103 US Issue 1.0 • Management of a database of recorded data. Page 26 of 51 Section 4 - Setting up and using the TMS Setting up the TMS computer Connecting the TMS Unpack your TMS Computer following the instructions on the packaging. Connect the monitor, keyboard and mouse using the colour-coded plugs then connect the mains power cables to the monitor and computer. Next, using the modem cable provided, connect one end into the modem socket of the computer and the other end into your telephone line socket. If required connect the computer to the supplied printer by following the printer manufacturer’s instructions. Switching on the TMS PRECAUTIONS It is recommended that you do not install non-Nexan software onto your TMS machine. Third-party applications may degrade the performance of the Nexan software 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 space used will not be available for storing patient data. 4 Be aware that running multiple applications will reduce the availability of main memory, and degrade performance. 300-USM-103 US Issue 1.0 Refer to the manufacturer’s instructions; connect power and switch on your TMS Computer and monitor. After approximately one minute the Nexan software logon screen should appear. Section 4 - Setting up and using the TMS Page 27 of 51 Using Nexoft Logging on To use the Nexoft Software, you must first log on. Wait a few seconds after the screen in Figure 2 first appears then enter a username and a password. Click on the ‘Log On’ button. Figure 2: Logon Screen NOTE 1: The screens displayed throughout this section assume that the system default configuration is being used. NOTE 2: If your password has expired you will be prompted to enter and confirm a new one. Do not use ‘common’ passwords. Figure 3: Splash Screen Page 28 of 51 Section 4 - Setting up and using the TMS 300-USM-103 US Issue 1.0 The splash screen provides feedback while the application is loaded (since there can be 10-15 second delay loading all the screens). The main application window appears with the Search Patients panel (note the tool bar and menus). Menu bar Toolbar Search Patients dialog box Figure 4: Nexoft main application window You can ‘undock’ (move around) the Search Patients dialog box, the toolbar and the menu bar so that you can rearrange the screen to suit. Simply click and hold on the item to be moved and drag it to a new position. 300-USM-103 US Issue 1.0 The items within the toolbar and menu bar can also be customized using the Configuration option within the Tools menu (or click the Config button on the toolbar). Section 4 - Setting up and using the TMS Page 29 of 51 Patient Records Nexoft 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 dialog The Patient Information dialog is divided into four main areas: • Patient Identification - including the patient’s name, number and study code, • Study/HCP Details - including the name of the patient’s physician or Health Care Professional, the hospital/health care center name and the start date, • Additional Patient Details - including the date of birth and the gender of the patient. When all necessary information has been entered, click the Save New Patient button. The new data is then displayed in the Patient Information screen shown overleaf. Page 30 of 51 Section 4 - Setting up and using the TMS 300-USM-103 US Issue 1.0 • Nexystem Identification - including the ID (must be 4 characters) of the patient’s Nx-300 system and the phone number on which the patient can be contacted, When new patient information has been entered (as discussed on the previous page) the new data is presented for review in the following screen. Figure 6: Patient Information screen showing the entered information This screen allows further data to be added to the patient information in the following areas: • Additional Patient Details - Patient Height and Weight. From this information a Body Mass Index (BMI) is automatically calculated (A warning will be displayed if the calculated BMI figure is greater than 45). 300-USM-103 US Issue 1.0 • Additional Details - Study Description, Comments, Medications and Diagnoses. When changes are made to this screen, remember to click the Save Changes button in order to update the patient record. Section 4 - Setting up and using the TMS Page 31 of 51 To locate existing patient records: 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 the database using various criteria: • Patient Name • Patient Number • Patient Initials • HCP/Physician • Patient Study Code • All Patient Notes (search on any patient details) Click on the Search by: drop down list to select the required search criteria. Figure 7: Search Patient dialog showing the database search criteria Now enter additional search information into the text box labelled 2. Enter what you’re looking for: Click the Search button to interrogate the database. 300-USM-103 US Issue 1.0 The patient details that match your search criteria will be displayed in the Results section. To view a summary for a patient: Click on the patient entry in the list - the summary is displayed in the yellow box below. To view a complete patient record: Double-click on the patient entry in the list - the complete patient record is displayed in a new window. Page 32 of 51 Figure 8: Search results Section 4 - Setting up and using the TMS Using the Calendar function to set a download schedule Once a new patient has been added, or an existing patient located, the next step is to organise a download schedule. This defines the dates and times when the TeleMonitoring Station (TMS) will dial the Base Station (installed at the patient’s premises) in order to download the recorded data. To set a download schedule: Display the record page for the required patient (see ‘To locate existing patient records’). Click the Calendar button on the toolbar. A calendar screen will be displayed: 300-USM-103 US Issue 1.0 Figure 9: One month calendar view Optionally, use the Show: drop down list to select an alternative calendar view. To change the current day: Click the smaller arrow buttons above the hourly view. To change the current month: Click the larger arrow buttons above the day by day view. Section 4 - Setting up and using the TMS Page 33 of 51 4 Right-click on the first required data collection day and then left-click on the Add Scheduled Data Collection option to display the Add Scheduled Download dialog. Enter the required Start Time and Date. Next, select the required Download Type from the following options: • Summary Report Only, • Summary Report and Waveforms, or • Summary Report and All Raw Data If only a single download is required, click the OK button. Set the required Recurrence pattern by selecting a Daily, Weekly, Monthly or Yearly base interval as appropriate. In the Range of recurrence section, set either the End after: or the End by: options as required. When all details of the download schedule have been entered, click the OK button. The Add Scheduled Download dialog will now be visible again, click its OK button to apply the changes. The download schedule will be summarised in the previously selected calendar view as shown on the next page. Page 34 of 51 Section 4 - Setting up and using the TMS 300-USM-103 US Issue 1.0 If a series of data downloads are required, click the Recurrence... button to display the Download Recurrence dialog: Figure 10: Calendar view showing summary of scheduled downloads 300-USM-103 US Issue 1.0 To edit or delete a download schedule: Display the record page for the required patient (see ‘To locate existing patient records’). Click the Calendar button on the toolbar. A calendar screen will be displayed. Right-click on the appropriate data collection day and then left-click on either: • Edit scheduled download... option to display an editable summary of the selected download settings, • Remove scheduled download... option to display the Confirm Delete dialog: Select either the Delete all occurrences or the Delete this one option as appropriate and click the OK button. Section 4 - Setting up and using the TMS Page 35 of 51 Initiating an immediate download The system provides an option to make an immediate connection to the Base Station in order to download data (in addition to, or instead of any programmed download schedule) To initiate an immediate download: Display the record page for the required patient (see ‘To locate existing patient records’). Click the Fetch button on the toolbar. The Download Data dialog will be displayed: Click the Connect button to open a connection between the TMS and the selected Base Station. Once connected, the Download Data dialog provides a number of options: • The Fetch the latest available summary reports option allows you to select which of the reports (that are stored in the Base Unit) should be downloaded and in what form: • The View Live Data option allows you to view real time data as it is collected by the Base Unit. When all required options have been set, click the Fetch Data button to begin the download. A dialog provides an indication of progress. Once complete, you will be prompted to refresh the patient - click Yes. Page 36 of 51 Note: Click Stop Download if you need to quit the download. Section 4 - Setting up and using the TMS 300-USM-103 US Issue 1.0 • The Fetch raw data between option allows you to download stored data from monitoring sessions defined by date and time limits: Viewing Downloaded Data Once data has been downloaded for a particular user you can view various aspects of the information in a graphical form. To view raw data on screen: Display the record page for the required patient (see ‘To locate existing patient records’). Click the Raw Data button on the toolbar. A Raw Data View dialog will be displayed with one or more channels enabled: 300-USM-103 US Issue 1.0 Figure 11: Raw data view with two channels enabled Section 4 - Setting up and using the TMS Page 37 of 51 To alter the viewed data: Channels The channels to be displayed are controlled by the toolbar buttons shown on the left 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 changes in 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’ and rearranged to suit: 300-USM-103 US Issue 1.0 Figure 12: Raw data view and channel toolbar undocked Page 38 of 51 Section 4 - Setting up and using the TMS Printing Information The system allows you to print various types of information, such as patient details, raw data graphs, etc. To print patient information: Display the record page for the required patient (see ‘To locate existing patient records’). Click the Print button on the toolbar. A print preview screen will be displayed: Figure 13: Print preview showing patient information 300-USM-103 US Issue 1.0 Ensure that the printer is switched on and ready to receive, then click the Print button on the preview toolbar. Section 4 - Setting up and using the TMS Page 39 of 51 To print raw data channels: Display the required raw data view (see ‘To view raw data on screen’). Click the Print button on the toolbar. A print preview screen will be displayed: Figure 14: Print preview showing raw data Ensure that the printer is switched on and ready to receive, then click the Print button on the preview toolbar. 300-USM-103 US Issue 1.0 Page 40 of 51 Section 4 - Setting up and using the TMS On-line help The Nexoft system incorporates an extensive on-line help system. To access on-line help: 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 locate related topics. The help screen will be displayed with either the Contents, Index or Search tab selected on the left-hand side depending on which option was selected. 300-USM-103 US Issue 1.0 Choose the required item from the Contents/Index list or enter your keyword to perform a search. Figure 15: Help screen showing the Contents listing on the left-hand side Note: The help system is web-enabled so that you can transfer directly to the Nexan website for futher details. Click the Nexan Website button on the help toolbar. Section 4 - Setting up and using the TMS Page 41 of 51 Shutting down the TMS CAUTION: If you exit Nexoft or shut down the computer, scheduled downloads will not occur. In the main Nexoft window, click the Exit button. The Nexoft window will close, leaving the standard Windows desktop. Click the Windows Start button. Choose the Shut Down option and, in the dialog that appears, check that the Shut down the computer? option is selected. Click the Yes button. After a short while the sceen will display the message It is now safe to turn off your computer. On the front panel of the TMS Computer, press the button marked to set the computer to standby. If required, switch off the computer at the mains supply. 300-USM-103 US Issue 1.0 Page 42 of 51 Section 4 - Setting up and using the TMS SECTION 5 General Information Technical Description System comprising: a) The on-body equipment, comprising the Nexi and the Nexi-Clip processing electronics. The Nexi is a disposable element, containing ECG electrodes, bioelectric impedance electrodes for respiration measurement, and a connector for an additional ECG electrode. It is a disposable item, designed to be worn for up to 24 hours. The Nexi-Clip takes measurements via the electrodes, and transmits them to the Portable Data Assistant (PDA.) The NexiClip 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-body equipment. c) The Base Station Unit (BSU) which stores up to 14 days worth of data received from the PDA. d) The Tele-Monitoring Station (TMS) which is used to interrogate the BSU, and to interpret and display the data. 300-USM-103 US Issue 1.0 Nexan Ltd will make available on request circuit diagrams, component parts lists, descriptions, calibration instructions or other information which will assist the user’s appropriately qualified technical personnel to repair those parts of equipment which are designated by the manufacturer as repairable. Section 5 - General Information Page 43 of 51 Technical Specifications General Nexi Two lead ECG sensors providing a modified Lead II view and modified CM5. Respiration impedance waveform. Optional 3rd flying lead with ECG electrode. Nexi-Clip Contains: PCB Europe- Radio TX UHF 868 MHz US- Radio TX UHF 916.5 MHz PDA: Contains: PCB, Storage device (memory card) EU- Radio RX operating in unlicensed Band of 869.7-870MHz US- 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 PDA Desktop charger unit Computer Mother Board with Pentium Processsor and Hard Disk storage device, Call discriminator,LCD Touchscreen. Contains: PCB 700MHz Pentium III Computer with DVD Drive, backup tape drive, modem. Printer HP Deskjet 840C. See manufacturer’s instructions for details. 300-USM-103 US Issue 1.0 TMS Computer Page 44 of 51 Section 5 - General Information Power requirements Nexi-Clip and Nexi: Shared 3V requires 2 x 1.5V alkaline AAA cells. (fitted during manufacture to the Nexi -Not user replaceable) PDA: 3.6V 1600mAh Re-chargeable Lithium Ion Cell. (No User Access) Recharge using only the following Nexan supplied charger units: a. Nx-300 Base Station Unit (PDA docking slot) b. Nx-300 PDA Desktop Charger Unit PDA Desktop charger Requires 7.5VDC 1A . Use only (Model No.JOD-48-09) supplied by Nexan for use with the with the Nx-300 system. Base Station Omron ® IC Blood Pressure monitor: Requires 100-240V 50-60Hz~ Power consumption 2A-1A. Two UL approved fuses rated T2AH (250V). 6V requires 4 x AA LR6 1.5V Alkaline batteries. Micro Plus Spirometer 9V requires 1 x PP3 9V dry cell battery. 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 1.0 TMS Computer Section 5 - General Information Page 45 of 51 Transport and Storage conditions CAUTION: These devices may not meet their performance criteria if stored outside the ranges stated below. Nexi and Nexi-Clip Temperature* Humidity* Ambient pressure* Base Station Unit Temperature* Humidity* Ambient pressure* *Set by EC38 as per -20 to + 65°C 5 to 90% non-condensing 700 to 1060 mbar -20 to +65°C 5 to 90% non-condensing 700 to 1060 mbar ‘Stationary Equipment’. PDA and PDA Desktop Charger Temperature* -20 to +65°C Humidity* 5 to 90% non-condensing Ambient pressure* 700 to 1060 mbar *Set by EC38 as per ‘Stationary Equipment’. Operating Conditions CAUTION: These devices may not meet their performance criteria if stored outside the ranges stated below. Nexi Temperature Humidity Ambient pressure +10 to +40°C 30 to 75% non-condensing 700 to 1060 mbar Nexi-Clip Temperature Humidity Ambient pressure +10 to +40°C 30 to 75% non-condensing 700 to 1060 mbar Page 46 of 51 Section 5 - General Information 300-USM-103 US Issue 1.0 Base Station Unit, PDA and PDA Desktop Charger Temperature +10 to +40°C Humidity 30 to 75% non-condensing Ambient pressure 700 to 1060 mbar Cleaning, Maintenance, Storage and Calibration It is intended that maintenance is carried out between patient use by a suitably trained person. It is not intended that the patient will carry out any maintenance or repair (including Base Station fuse replacement) and there are no patient replaceable parts. If a fault occurs when using the system, first read the Trouble shooting guide. If the fault is still present then contact Customer Support as detailed 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-Clip WARNING: REMOVE MAINS POWER FROM THE BASE STATION BEFORE CLEANING. WARNING: DO NOT ALLOW THE CLEANING SOLUTION OR WATER TO RUN INTO CREVICES OR OPENINGS. The Base Station, PDA and Nexi-Clip can be wiped with a nearly-dry cloth containing warm water and detergent. Thoroughly wipe off any excess residual cleaning solution from the Nx-300 system and allow to dry. While cleaning the Base Station, PDA and Nexi-Clip, they should be checked for unusual wear or possible damage from an accident. Re calibration of the Base Station, PDA and Nexi-Clip are not required. Power Cables WARNING: DO NOT OPERATE THE EQUIPMENT FROM MAINS POWER WITH A DAMAGED POWER CORD OR PLUG. The Base Station mains power supply cable supplied is intended to be used only with the Nextation and should not be used for any other electrical equipment. 300-USM-103 US Issue 1.0 Disconnect the power cable from mains power before inspecting the power cord periodically for fraying or other damage, and replace as needed. Section 5 - General Information Page 47 of 51 Replacing the Base Station fuses The Base Station contains two fuses that can easily be replaced by service personnel if necessary. CAUTION: Replace each fuse only with the specified type - as indicated on the Base Station label adjacent to the fuse holder. Note: Both fuses should be replaced at the same time, even if only one fuse is found to be unserviceable due to an over current situation. The other fuse may have become stressed and could become unreliable. To replace the Base Station fuses: Unplug the power cord from the ac mains supply outlet then unplug the removable cord from the ac mains inlet of the Base Station. Locate the fuse holder, which protrudes from below the mains inlet socket of the Base Station. Using a flat bladed screwdriver, depress the centre tab, then carefully withdraw the fuse holder. Replace both fuses with the specified type. Refit the fuse holder. 300-USM-103 US Issue 1.0 Page 48 of 51 Section 5 - General Information Regulatory Markings Federal Communications Commission (FCC) Compliance and Advisory Notice This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions for use, 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 to radio or television reception which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: · 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 which the 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 the following two conditions: (1) this device may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. 300-USM-103 US Issue 1.0 FCC ID: PCPNX-300 CAUTION: Changes or modifications not expressly approved in writing by Nexan Ltd may void the user’s authority to operate this equipment.. Section 5- General Information Page 49 of 51 Warranty The warranty for the ‘Product’ extends for ninety (90) days from the date of purchase by the customer. The warranty for the installed/supplied software extends for ninety (90) days from the date of purchase by the customer. Nexan Ltd shall be under no liability in respect of any defect arising from fair wear and tear, wilful damage, negligence, abnormal working conditions, failure to follow Nexan Ltd’s Instructions (whether conveyed orally or in writing), misuse, improper installation or alteration or repair of the Products without Nexan Ltd’s approval. The above warranty does not extend to parts, materials or equipment not manufactured by Nexan Ltd, in respect of which the Customer shall only be entitled to the benefit of any such warranty or guarantee as is given by the manufacturer to Nexan Ltd. Subject as expressly provided here, all warranties, conditions or other items implied by statute or common law are excluded to the fullest extent permitted by law. Any claim by the Customer which is based on any defect in material or workmanship of the products shall be notified to Nexan Ltd immediately after discovery 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 shall have no liability to the Customer. Where any valid claim in respect of any of the Products which is based on any defect in the materials or workmanship of the Products is notified to Nexan Ltd, Nexan Ltd shall be entitiled to replace with new or refurbished replacement items or repair (at Nexan Ltd’s sole discretion, either at the customers premises or at Nexan Ltd’s premises in the UK) the Products (or part in question) but Nexan Ltd shall have no further liability to the Customer. Repaired, refurbished or replacement ‘Product’ is warranted for the balance of the warranty period. 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 for any consequential loss or damage (whether for loss of profit or otherwise), costs, expenses or other claims for consequential compensation whatsoever arising out of or in connection with any act or omission of Nexan Ltd relating to the manufacture or supply of the Products or use by the Customer. Page 50 of 51 Section 5 - General Information 300-USM-103 US Issue 1.0 Nexan Ltd. warrants to the original purchaser that the Nx-300 (Product), provided in the sales packaging, is free from defects in material and workmanship, under normal installation and use, according to the following terms and conditions: Troubleshooting guide Base 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 is plugged 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 on PDA Status screen. If no radio signal is present, check the Nexi-Clip is correctly 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 skin preparation 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; 300-USM-103 US Issue 1.0 • may indicate a faulty connection within the Nexi-Clip - try another. Section 5 - General Information Page 51 of 51
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