Datascope® is a U.S. registered trademark of Datascope Corp. Microsoft® is a U.S. trademark of the Microsoft Corporation. fantastik® is a U.S. trademark of the SC Johnson Corporation Copyright © Datascope Corp., 2007. Printed in U.S.A. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Datascope Corp. Due to the continuous evolution of our products, all capabilities documented in this manual may not be currently available.
Table of Contents Foreword ....................................................................................................................................................... iii Warnings, Precautions and Notes..................................................................................................................... iii Indications for Use ..........................................................................................................................................
Table of Contents Authentication ......................................................................................................................................... 4 - 10 Troubleshooting .............................................................................................................................................. 4 - 11 Operations ....................................................................................................................... 5 - 1 Introduction ................
Foreword Introduction Foreword The NetGuard Operating Instructions are intended to provide information for proper operation. General knowledge of monitoring and an understanding of the features and the functions of the Datascope NetGuard Monitor are prerequisites for proper use. Do not operate this system before reading these instructions. Information for servicing this instrument is contained in the NetGuard Auto Clinician Alert System Service Manual, (P/N 0070-00-0685).
Introduction Warnings, Precautions and Notes Warnings WARNING: Only qualified and trained personnel or Datascope Service personnel should attempt to service Datascope equipment. Service is defined as any activity requiring the cover to be removed for internal adjustments, parts replacements, repairs or software upgrades of any kind to insure compatibility. WARNING: To insure compatibility with the operating system and applications software, use only Datascope Corp.
Warnings, Precautions and Notes Introduction Cautions CAUTION: For proper operation use only with UL agency approved ethernet cables. CAUTION: For proper operation, do not use the equipment with a frayed or damaged power cord or ethernet cable. CAUTION: Do not use a damaged or broken unit or accessory. CAUTION: For proper operation never place fluids on top of the server. In case of accidental spillage, wipe clean immediately and have the system serviced to ensure no hazard exists.
Introduction Indications for Use Indications for Use The NetGuard Automated Clinician Alert System is intended for use by licensed clinicians, within a health care facility, to provide notification of life threatening cardiac events in ambulatory adult patients including: • Asystole • Ventricular-Fibrillation NetGuard monitors a patient's ECG and issues an alert whenever these arrhythmias are detected. The NetGuard system also provides notification for high and low heart rates.
Symbols and Descriptions Introduction Symbols and Descriptions SYMBOL DESCRIPTION Attention, Consult Accompanying Documents / Refer to Manual Protection against splashing water Do not dispose of this product as unsorted municipal waste. Mark of compliance with U.S. and Canadian safety standards requirement.
Introduction Technical Support Technical Support For technical assistance, contact your area or regional Datascope Patient Monitoring Representative. Additional information relating to the installation, servicing and repair of the NetGuard Device is provided in the following documents: • Instructions for installing the NetGuard system in clinical environments are provided in the NetGuard System Installation Guide (P/N 0070-00-0687 and P/N 0070-00-0686).
1.0 Overview The NetGuard Network is an ambulatory monitoring system that issues alerts automatically to clinicians when it recognizes potentially life-threatening cardiac rhythms in monitored patient’s. The system monitors patient ECG and heart rate and issues alerts whenever specific arrhythmias are detected or the measured values deviate from acceptable ranges.
Components of the NetGuard Network Overview This Overview briefly describes each of the NetGuard Network components and provides references to the detailed discussions that follow later in this manual. 1.1 Components of the NetGuard Network This section provides an overview of the principal NetGuard system components including the: • NetGuard Devices • Telemetry Infrastructure • NetGuard Central Server • Terminals 1.1.
Overview 1.1.2 Components of the NetGuard Network Telemetry Infrastructure The NetGuard telemetry infrastructure consists of a network of ceiling-mounted access point devices (shown in FIGURE 1-3). FIGURE 1-3 Access Point Device Each access point is connected via wireless subnet to the NetGuard devices in its sector. For proper coverage, the access points should be spaced in contiguous sectors, each having a maximum 30-foot radius. NOTE: Subnets operate in accordance with the 802.15.
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2.0 NetGuard Device The NetGuard patient-worn device (shown in FIGURE 2-2) consists of a wireless, reusable patient monitor that is attached to the patient, by a disposable adhesive patch, at the sternum. In the event of a low or high heart rate, ventricular fibrillation, or asystole, the device transmits a radio alarm signal to alert clinicians that the patient may be experiencing a significant event. Along with each transmitted alarm, the device transmits 20 seconds of the patient’s ECG waveform. 2.
Electrode Placement 2.1.2 NetGuard Device Skin Preparation Proper skin preparation is essential to obtain accurate ECG data. Electrode sites should be clean, dry and should provide a smooth flat surface. Incidental electrical activity and inaccurate readings may occur due to incorrect skin preparation. The following skin preparation is recommended for secure patch application: 1. Shave the chest hair in a 2-4 inch diameter of the electrode site. 2.
NetGuard Device 2.2 NetGuard Device Components NetGuard Device Components The principal components of the device are identified in FIGURE 2-2 and described in Table 2-1. 2 3 4 1 8 5 6 7 FIGURE 2-2 NetGuard Device TABLE 2-1 NO. PART NAME DESCRIPTION 1. Reusable Radio Transmitter The reusable radio transmitter pack continuously monitors the patient’s ECG and heart rate and transmits the heart rate together with the device status once every second.
Operating Instructions NetGuard Device TABLE 2-1 (Continued) NO. PART NAME DESCRIPTION 4. Patient LED The patient LED turns green to indicate that the patient’s heartbeat has been detected. When a lethal physiological alarm condition is detected, the patient LED flashes red. 5. Battery Pack* The battery pack attaches to the transmitter pack and powers the unit. 6. Adhesive Patch* An elongated adhesive patch under the transmitter pack contains two electrodes. 7.
NetGuard Device Operating Instructions 2.3.2 Power-Up Sequence Each time the Reusable and Disposable sections are connected together, the assembled device goes through the power-up sequence. The LED indications that occur during the power up sequence follow and are summarized in Table 2-2. NOTE: For information regarding the location of the device LED’s, refer to ‘‘NetGuard Device Components’’ on page 2-3.
Cleaning and Disinfecting the Device 2.4 NetGuard Device Cleaning and Disinfecting the Device Cleaning and disinfecting the Reusable section of the NetGuard device is strongly recommended before and after each patient’s use. The approved device cleaning solutions are: • Ultra Clorox germicidal bleach with sodium hypochlorite 6.15% in a mix of 1:10 ratio • LpHSE germicidal detergent in a mix of 1/2 fl oz.
NetGuard Device 2.7 Disposal and Reuse of the NetGuard Device Disposal and Reuse of the NetGuard Device The Disposable section of the NetGuard device is intended for use on one patient and should not be reused for multiple patient’s. The Reusable section of the device may be reused until the battery is depleted. There are no special instructions for discarding the NetGuard Disposable. The NetGuard Reusable may be subject to local regulations regarding disposal.
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3.0 NetGuard Alarms 3.1 General Alarm Behavior The NetGuard system uses alarms to send notification when a patient’s physiological status changes or a device has a specific technical issue. When a patient is first admitted, the alarm settings configured by the NetGuard System Administrator are in effect. Individual patient heart rate settings can be configured by an individual NetGuard user if the NetGuard System Administrator has enabled this functionality.
System Level Alarms 3.2 NetGuard Alarms System Level Alarms System level alarms indicate that a monitored patient's alarm thresholds have been violated. By default, System level alarms are latched and use factory installed threshold settings. These settings cannot be disabled or changed, even by the NetGuard System Administrator. NOTE: Alarm configuration settings are retained when the NetGuard system is reset or restarts. An ECG waveform is produced whenever a System level alarm is triggered.
NetGuard Alarms 3.2.3 System Level Alarms System Level Alarm Types Non-lethal System level alarm types are generally not life threatening and include: HR Above Heart rate value exceeds the system high heart rate threshold. The System high heart rate threshold is between 130-200 bpm. The factory default is value is 130 bpm. HR Below Heart rate value drops below the system low heart rate threshold. The System low heart rate threshold is between 30-45 bpm. The factory default is value is 45 bpm.
Patient Level Alarms 3.3 NetGuard Alarms Patient Level Alarms Patient level alarms use configured heart rate alarm thresholds but only affect low and high heart rate alarms. Depending on the system configuration settings, Patient level alarm thresholds can be configured globally for all patient’s or may be defined on an individual patient basis. Patient level alarms are unlatched. Patient level alarms are detected at the NetGuard server using the transmitted heart rate. 3.3.
NetGuard Alarms 3.4 Technical Alarms Technical Alarms Technical alarms are patient specific and are related to technical issues that occur with cables, leads, battery status, and device status. 3.4.1 Alarm Behaviors The visual and audio indicators associated with a Technical level alarm are: Visual Indicators Technical alarms are automatically displayed in the Deferred Application Bar beside the NetGuard Monitor view.
Technical Alarms NetGuard Alarms Disposable Expired A Disposable Expired alarm indicates that the Disposable needs to be replaced. The NetGuard Server tracks the time a device has been connected to a battery and raises the technical alarm when the time exceeds the 70 hour limit. Not Active The NetGuard device is not sending status messages to the server. The server removes the Not Active condition once message are received from the device.
NetGuard Alarms 3.5 Acknowledging Alarms Acknowledging Alarms The steps to acknowledge or stop a System or Patient alarm are different. 3.5.1 Lethal System Level Alarm Acknowledge a latched lethal System level alarm at the device by pressing the two buttons located on both sides of the reusable device.
Alarm Types Summary 3.6 NetGuard Alarms Alarm Types Summary The different alarm types are summarized in Table 3-1.
4.0 Getting Started 4.1 Introduction This chapter describes the Monitor Application and its components. 4.2 Starting the Monitor Application The Monitor Application automatically starts after a successful Microsoft® Windows login. When the application is running, the Monitor Application icon appears in the Windows System tray (shown in FIGURE 4-1). FIGURE 4-1 Windows System Tray Right-click the Monitor Application icon in the Windows System Tray to view the menu.
Monitor Application 4.3 Getting Started Monitor Application The Monitor Application consists of the NetGuard Monitor view and an Alarm Alert view. The NetGuard Monitor view organizes patient’s into groups and displays their current alarm status. The Alarm Alert view displays system level and patient level alarm notifications. For additional information regarding alarm notification, refer to the NetGuard Alarms chapter.
Getting Started Monitor Application Use the NetGuard Monitor view to admit patient’s, edit patient information, transfer patient’s, discharge patient’s, and print reports. Unless one of the previously mentioned patient maintenance functions in use, the NetGuard Monitor view is minimized and only visible in the Windows System tray. The NetGuard Monitor view consists of the following components: • Monitor Groups • Room Status Indicator • Waiting Indicator • Print Button • Help Tab 4.3.1.
Monitor Application Getting Started COLOR INDICATES Red System or Patient level physiological alarm NOTE: Yellow 4.3.1.3 Patient level alarms may also display in yellow if configured by the NetGuard System Administrator.
Getting Started 4.3.2 Monitor Application Alarm Alert View The Alarm Alert view displays physiological and technical alarm events. This view is only seen when an alarm is triggered or when the mute duration for an alarm has expired. The Alarm Alert view consists of the Primary Alarm window and the Deferred Alarm Application Bar. Alarm Tile List Deferred Alarm Application Bar Frame Region Primary Alarm Window FIGURE 4-4 Alarm Alert View - System Alarms (multiple alarm tiles) 4.3.2.
Monitor Application Getting Started Frame Region The Frame Region surrounds the Primary Alarm window and displays the Datascope logo, the current date and time, and the product logo. Alarm Tile List The Alarm Tile list displays the alarms in highest to lowest priority.
Getting Started Monitor Application Heart Rate Indicator Event Name Patient Level Alarm Window Buttons Alarm Priority Indicator Room Name Bed Number Patient Name FIGURE 4-6 Patient Level Alarm Tile Components NOTE: The primary difference between FIGURE 4-5 and FIGURE 4-6 is that the Patient Level alarm window contains a DEFER button and the System Level alarm window does not.
Monitor Application Getting Started • The icon indicates that the alarm tone was muted. • The Elapsed Time indicates the amount time that has passed since the alarm was called. HH:MM:SS is the time format displayed. • The ECG button indicates that there is an ECG waveform associated with the selected alarm tile. Selecting the ECG button opens the ECG Waveform window (shown in FIGURE 4-8). The ECG Waveform window contains 20 seconds of waveform data.
Getting Started Monitor Application Mini-Alarm Tiles Alarms in the Deferred Alarm Application Bar are represented by mini-alarm tiles (shown in FIGURE 4-9). Patient level alarms appear in red or yellow depending on system configuration settings. Technical alarms appear in blue. The mini-alarm tiles are sorted from highest to lowest priority and each alarm priority is sorted by the most recently alarmed. Up to three (3) columns of alarms may be displayed in the Deferred Alarm Application Bar.
Monitor Application Getting Started Technical Mini-Alarm Tiles Technical mini-alarm tiles display the room name, bed number, and the event name abbreviation. Typically, technical mini-alarm tiles are displayed in the Deferred Application Bar unless the display resolution is less than 1024 x 768 (i.e, 800 x 600). If the display resolution is less than the minimum requirement, an error message displays and the technical alarms opens in the Primary Alert view window. 4.3.2.
Getting Started 4.4 Troubleshooting Troubleshooting This section lists some of the potential messages and issues that may occur while using the Monitor Application. MESSAGE/ISSUE * REASON SOLUTION Datascope Patient Monitor cannot communicate with the server. Contact the administrator. The NetGuard devices are not communicating with the server. Contact the system administrator. The application is not communicating with the server. Contact the system administrator.
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5.0 Operations 5.1 Introduction The NetGuard Monitor application is a collection of views that enable the clinician to monitor a patient’s heart rate from a terminal.
Introduction 5.1.1 Operations Admitting a Patient Patient’s are admitted to the NetGuard system by accessing the Admit Patient form (shown in FIGURE 5-1). Admitted patient’s are continuously monitored, provided they wear an active NetGuard device and are within range of an access point. FIGURE 5-1 Admit Patient Form WARNING: Place the NetGuard device on the patient after admitting the patient to the system.
Operations 5.1.2 Introduction Readmitting Patient’s Patient’s may be readmitted to the NetGuard system once they have been discharged by accessing the Discharged Patient list (shown in FIGURE 5-2). The Discharged Patient list includes all the discharged patient’s currently saved at the NetGuard server. The list is sorted by most recent discharge date and time. NOTE: The number of days a discharged patient remains in the system is determined by the NetGuard System Administrator.
Introduction 5.1.3 Operations Patient Detail Form Detailed patient data can be viewed by accessing the Patient Details form (shown in FIGURE 5-3). This form provides access to a patient’s heart rate trends, events data, ECG waveforms, and patient reports. It also provides access to the Patient Menu form where patient functions are available.
Operations Introduction To access the Patient Detail form from the NetGuard Monitor view: 1. In the NetGuard Monitor view, select the applicable Monitor Group tab. 2. Select an active patient or a patient in a Not Active or Lost Communication state. The Patient Detail form is displayed. To access the Patient Detail form from the Deferred Alarm Application Bar: 1. Right-click on any of the mini-alarm tiles contained in the Deferred Alarm Application Bar. 2. Select View Details from the menu.
Introduction Operations Summary Trend Graph Window The Summary Trend Graph window (shown in FIGURE 5-5) displays a compressed view of the trend data over a 24 hour period. Use the trend slider to view the waveform at a different time period and trend time interval (for example, 10 minutes, 20 minutes, or 30 minutes). Dragging the slider to the left scrolls to an earlier time, and dragging the slider to the right scrolls to a more current time.
Operations 5.1.3.2 Introduction ECG Tab The ECG tab (shown in FIGURE 5-7) displays a 20 second ECG waveform for the selected physiological alarm event and a ECG Event Waveform window. Above the ECG Waveform window is the Summary Trend Graph window. The ECG Waveform window includes the event name, event date, event time, and event duration. The waveform scale is displayed beside the waveform and the event time (displayed in a 24 hour format) is displayed above the waveform.
Introduction Operations FIGURE 5-8 Events Tab 5.1.3.4 Patient Detail Form Buttons The Patient Detail form contains four (4) buttons. Each button is described in Table 5-1: TABLE 5-1 BUTTON DESCRIPTION Close View Closes the Patient Detail form and returns to the NetGuard Monitor view Request ECG Retrieves a current ECG strip for the selected patient Print Generates a Patient Detail Report for the selected patient Menu Accesses the Patient Menu form for the selected patient NOTE: 5.1.
Operations 5.1.4.1 Introduction Accessing the Patient Menu Form 1. Select an active patient (indicated by a green oval) in the NetGuard Monitor view. 2. Select the Menu button in the Patient Details form. 3. In the Patient Menu form, select one of the buttons described in Table 5-2. TABLE 5-2 BUTTON 5.1.
Introduction 5.1.6 Operations Transferring Patient’s Patient’s can be transferred to a room within the same Monitor Group or to new room in a different Monitor Group by accessing the Transfer Patient form (shown in FIGURE 5-10). The following gives instructions for performing both transfer types. FIGURE 5-10 Transfer Patient Form (Patient Level Alarms Enabled) 5.1.6.
Operations Introduction 8. Select the Yes button in the confirmation dialog box. The patient is now assigned to the new room. 9. Optional - select the Close View button to close the form and return to the NetGuard Monitor view. NOTE: 5.1.6.2 For alternative steps to transferring a patient, refer to “Accessing Monitor View Quick Menus” on page 5-15.
Introduction 5.1.7 Operations Editing Patient Information Patient information can be changed after admission by accessing the Patient Edit form (shown in FIGURE 5-11). FIGURE 5-11 Patient Edit Form (Patient Level Alarms Enabled) To edit an admitted patient’s information: 1. In the NetGuard Monitor view, select the applicable Monitor Group tab. 2. Select the patient’s bed. 3. In the Patient Detail form, select the Menu button. 4. In the Patient Menu form, select the Edit button. 5.
Operations 5.1.8 Introduction Placing a Patient in Standby Patient’s can be placed in the Standby mode to temporarily suspend remote patient monitoring while maintaining the patient’s historical data. When a patient is in the Standby mode, the device continues to monitor the patient without raising remote on-screen alerts. If a lethal alarm occurs while a patient is in the Standby mode, the NetGuard device will still alarm. To place a patient into Standby mode: 1.
Introduction 5.1.9 Operations Changing Patient Alarms If configured by the NetGuard System Administrator, Patient level heart rate alarm thresholds may be configured on an individual patient basis by accessing the Patient Alarms form (shown in FIGURE 5-12). This form allows heart rate thresholds for an individual patient to be different from the System level and Patient level alarm thresholds, which are both configured by the NetGuard System Administrator.
Operations Accessing Monitor View Quick Menus 9. Select the Yes button in the confirmation dialog box. The alarm thresholds are reset. 10. Optional - select the Close View button to close the form and return to the NetGuard Monitor view. NOTE: 5.2 For alternative steps to accessing the Patient Alarms Form, refer to Accessing Monitor View Quick Menus. Accessing Monitor View Quick Menus Right-clicking on an active bed in the Monitor view opens a quick menu.
Troubleshooting 5.3 Operations Troubleshooting This section lists some of the potential messages and issues that may occur while using the NetGuard Monitor view. MESSAGE/ISSUE * REASON SOLUTION The patient ID is already in use in the system. If the patient was previously discharged, select the patient using the Readmit button. The patient ID entered is already in use by another patient. Verify the patient ID. The device ID is currently in use by another patient.
6.0 Patient Reports 6.1 Introduction This chapter describes how to view and print patient reports from a NetGuard terminal. The two reports available are the Patient Detail Report and the Patient Report. Each report prints in portrait orientation on and is formatted to use 8.5 x 11 size paper unless otherwise specified. 6.1.
Introduction 6.1.1.3 Patient Reports Patient History The Patient History section displays the patient’s admit, transfer, discharge, and readmit dates. 6.1.1.4 Event History The Event History section displays the selected patient events. A 20 second waveform is displayed for each physiological event. If the Include Technical Alarms checkbox was selected in the Print Options form, the alarm event description, date, time and duration of the technical alarm is also shown. 6.1.1.
Patient Reports Introduction FIGURE 6-1 Patient Detail Report (Page 1) NetGuard™ Operating Instructions 0070-10-0678-01 6-3
Introduction Patient Reports FIGURE 6-2 Patient Detail Report (Page 2) 6-4 0070-10-0678-01 NetGuard™ Operating Instructions
Patient Reports 6.1.3 Introduction Printing the Patient Detail Report To print a Patient Detail Report from the Patient Detail form, access the Patient Print Options form (shown in FIGURE 6-3). FIGURE 6-3 Patient Print Options Form 1. In the Patient Detail form, click the Print button. 2. Follow steps 3-7 in the Patient Report section on page 6-5. For instructions to access the Patient Detail form, refer to ‘‘Patient Detail Form’’ on page 5-4. 6.1.
Introduction 6.1.5 Patient Reports Printing the Patient Report To print a Patient Report from the NetGuard Monitor view, access the System Print Options form (shown in FIGURE 6-4). 1. In the NetGuard Monitor view, click the Print button. FIGURE 6-4 System Print Options Form 2. In the System Print Options form, select either Current Monitor Group or Selected Monitor Group. 3. Select an event time. The choices are: EVENT TIME OPTIONS DESCRIPTION Since Admission Based on the most recent admit date.
Patient Reports Troubleshooting For instructions to access the NetGuard Monitor view, refer to ‘‘NetGuard Monitor View’’ on page 4-2. 6.2 Troubleshooting This section lists some of the potential messages and issues that may occur while trying to print a NetGuard report. MESSAGE/ISSUE * REASON SOLUTION Report does not print No printer available. Configure a printer for the workstation and try again.
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7.0 Technical Description 7.1 Basic Technical Specifications CLASSIFICATION Protection Class Internally powered equipment Type of protection against electric shock Type CF applied part Ambient temperature 36º C or 97º F Mode of operation Continuous operation Degree of protection against ingress of water IPX4 For use in environments where no flammable anesthetics are present 7.
FCC Labels Technical Description • Any changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 7.3 FCC Labels 7.3.1 Access Point • Access Point FCC ID:DXXNG1400AP 7.3.
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Printed in U.S.A.