M2636B TeleMon B Monitor
Transcription
M2636B TeleMon B Monitor
M2636B TeleMon B Monitor Instructions for Use Part Number M2636-9201B Printed in the U.S.A. January 2003 First Edition Notice This document contains proprietary information which is protected by copyright. All Rights Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under the copyright laws. © Copyright Philips Medical Systems 2001-2003 All rights reserved. Printed in U.S.A. January 2003 Part No. M2636-9201B First Edition Warranty The information contained in this document is subject to change without notice. We make no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. We shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material. Printing History Printing History New editions of this document incorporate all material updated since the previous edition. Update packages may be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Pages that are rearranged due to changes on a previous page are not considered revised. The documentation printing date and part number indicate its current edition. The printing date changes when a new edition is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document part number changes when extensive technical changes are incorporated. All Editions and Updates of this manual and their publication dates are listed below. M2636-9001B, First Edition....................................................... December 2001 M2636-9201B, First Edition....................................................... January 2003 About this Book This document covers the use of TeleMon B, model M2636B, a monitoring device for use with the Telemetry System Series C. The document contains information on performing day-to-day tasks and troubleshooting common problems as well as detailed information about all clinical applications. It includes lists of information messages and configuration choices. Your purchased system may not include all the functionality described in this document. User information for the TeleMon Monitor is also contained in the TeleMon Monitor On-line Info. Info focuses on how to complete basic tasks and troubleshoot problems. For operating information about the transmitter, ECG and SpO2 measurements, and the Telemetry System in general, please refer to the Telemetry System Series About this Book C User’s Guide. See also the Information Center User’s Guide for operating information on the Information Center. Document Conventions Warnings Warning Warnings are information you should know to avoid injuring patients and personnel. Cautions Caution Cautions are information you should know to avoid damaging your equipment and software. Notes Note—Notes contain additional information on the Telemetry System usage. Procedures Procedures are indicated in the text by the heading “Task Summary” followed by the following table: Step 1 2 3 Action Contents 1. About TeleMon B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 What’s New . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Introducing the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Stand-Alone Monitoring Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Telemetry Extension Device Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Safety Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 A Quick Look at TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 The Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 2. Monitor Basics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Powering the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 More About Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Docking & Undocking the Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Docking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8 Undocking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 General Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Online Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13 Monitor Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13 Pacing Safety Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15 To Change Monitor Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15 To Save Current Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16 To Restore Unit Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 Antenna Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 3. Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Measuring ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 ST/AR Arrhythmia Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 ECG Fallback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Changing Wave or Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Measuring %SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 Displaying the Pleth Wave . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Changing the %SpO2 Sample Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Contents-1 Measuring NBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Measurement Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 NBP Safety Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12 NBP Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13 Start/Stop Manual NBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15 Change Repeat Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16 Select NBP Alarm Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16 Recordings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17 4. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Recognizing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Alarm Types & Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Alarm Behavior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Alarm Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7 Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Red & Yellow Alarm Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 INOP Alarm Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9 Interacting with Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15 Turning Alarms On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15 Adjusting Alarm Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16 Setting Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16 Silencing an Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17 Suspending Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18 5. Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Service Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accessing Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Restoring Standard Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Displaying Demo Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Change Date & Time, Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Viewing Transmitter Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 5-2 5-3 5-3 5-4 5-5 6. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Testing TeleMon’s Critical Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfecting the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfection Safety Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning the NBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibrating NBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reconditioning the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contents-2 6-2 6-3 6-5 6-5 6-6 6-7 6-8 Changing Date & Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10 Ordering Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10 7. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Safety Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 NBP Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Authorized Europe/ Middle East/Africa Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Electrical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 NBP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 Pulse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8 ST/AR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8 HR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10 Additional Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11 Electro-magnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11 Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13 A. Sales and Support Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 8. Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-i Contents-3 In this chapter, you’ll find instructions for getting started with the monitor right away, a brief introduction to the monitor, a summary of general safety considerations for this product, and a discussion of some key monitor features. • • • • • What’s New. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Introducing the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Safety Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 A Quick Look at TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 About TeleMon B 1-1 Introduction 1 About TeleMon B 1 About TeleMon B What’s New What’s New The major new features of TeleMon B are: New features include: • • • • • • • 1-2 About TeleMon B Stand-Alone monitoring; local alarms at TeleMon B (see “Stand-Alone Monitoring Mode” on page 1-5 and “Alarm Types & Indicators” on page 4-2) – Local alarms can be configured differently at TeleMon and central (if centrally monitored) – Alarm limits and sources can be set by the user – Alarm limits shown on screen when local alarms are on – Alarm limits are configurable – Alarm settings are saved through docking and undocking of transmitter and are set to unit settings when TeleMon is turned off and then on Local alarms for patient and inoperative conditions (INOPS) that prevent monitoring (see “Stand-Alone Monitoring Mode” on page 1-5 and “Alarm Types & Indicators” on page 4-2) Alarms include: – %SpO2 – NBP – ECG Alarm sounds can be either Philips or IEC 60601-1-8 Alarms sounds can be disabled by lowering volume to off Basic arrhythmia analysis, including PVC count see “ST/AR Arrhythmia Analysis” on page 3-3 and “Service Mode” on page 5-2) Transmitter configuration capability, including undocked SpO2 sample rate see “Service Mode” on page 5-2 and “Changing the %SpO2 Sample Rate” on page 3-9) Online demo mode assists in user training (see “Displaying Demo Mode” on page 5-3) Before You Begin Before you begin using TeleMon B, be sure you have completed the following steps: 1. Power the monitor by either: a. attaching the AC power cord, or b. installing the battery, attaching the AC power cord, and charging for up to 4 hours. See “Powering the Monitor” on page 2-2. 2. Review the Safety Messages on page 1-6. 3. Insert the transmitter. See “Docking & Undocking the Transmitter” on page 2-7. Note—A functioning battery must be inserted in the transmitter before docking to enable TeleMon B monitoring. Also, a lead set must be connected to the transmitter before docking. Learn Basic Operation New clinical users should review the Quick Guide before using TeleMon B on a patient. The Quick Guide gives a brief summary of the most commonly performed monitoring tasks and can be used as a training tutorial. Introducing the Monitor The M2636B TeleMon B Monitor is part of the Telemetry System. With a docked transmitter, TeleMon B provides local display of two waves— ECG waveforms, pleth wave or a delayed/annotated arrhythmia wave—and numerics for heart rate, %SpO2, and NBP. Simultaneously, the docked transmitter sends the ECG and %SpO2 signal to the Information Center. NBP, recording, suspend requests, and TeleMon Inops are transmitted through a unidirectional, RF telemetry link from TeleMon through the transmitter, to the Information Center. This capability is provided by TeleMon B within the antenna system coverage area. At the central station, a “docked transmitter” indication is displayed to distinguish data being sourced from a transmitter docked with TeleMon B. About TeleMon B 1-3 1 About TeleMon B Before You Begin Introducing the Monitor When the transmitter is undocked, NBP information is no longer available at central. The “docked transmitter” symbol reverts to the “telemetry” symbol , and the NBP parameter will disappear from the Information Center display. Central recordings can be initiated manually at TeleMon B. There are no automatically-generated recordings from TeleMon B. TeleMon B incorporates functions formerly provided by the Wave Viewer, and includes context-sensitive online information. TeleMon B can be powered either by battery or AC line power. Use of the latter helps to conserve battery life. The Series C transmitter for either conventional or EASITM leads can be used with TeleMon B. The communication from the transmitter to the TeleMon B is via the infrared port on the transmitter. There must be a battery inserted in the transmitter; TeleMon B does not perform monitoring functions if the transmitter battery is weak or dead. Transition to ambulatory monitoring is seamless, given that the same transmitter continues to source patient data and no user interaction is required to continue monitoring. The clinician needs only to remove the transmitter from TeleMon B. TeleMon B can function in two modes: stand-alone monitoring or telemetry extension. 1-4 About TeleMon B Introducing the Monitor This mode is a Decentralized model, with Central and Local Alarms, or Local Alarms Only. As a stand alone monitor, TeleMon B offers single lead basic arrhythmia, along with alarming from HR, SpO2, and NBP. All alarm sources and limits can be individually configured by the user. Alarms are generated and displayed at both TeleMon B and the Information Center. Data from TeleMon B is transmitted via radio frequency (RF) to the Information Center in this mode. The system provides only one-way communication from TeleMon B to Information Center via the transmitter. When alarms are enabled, both TeleMon B and Information Center generate independent alarms based on the patient’s condition. The alarm limits at TeleMon B and Information Center are independent, and Information Center alarm limits can be controlled only from central. Users can silence local alarms at TeleMon B; central alarms can be silenced only from the central station. Though the alarming is independent between central and TeleMon B, alarms at central can be temporarily suspended from TeleMon B for 3 minutes. • • Alarms are audible and visible at central and TeleMon B. Alarms at central and TeleMon B may not be identical because they are generated separately. • INOPS (inoperative alerts) continue to be audible and visible at TeleMon. • If the monitor is out of antenna range, only local alarms can be generated. No alarms will be available at central. Note—The alarm algorithm that TeleMon uses is different from the Information Center’s. Therefore, timing and alarming of events and alarms will be different. Telemetry Extension Device Mode This mode is a Central-based model, with Central Alarms Only, Local Alarms Off. When local alarms are disabled, TeleMon B functions as a telemetry extension device. Patient alarms are generated and annunciated at the Information Center only. There are no audible alarms generated at TeleMon B. TeleMon B displays information messages; these messages are also displayed in the patient sector at the Information Center, along with the ECG waveforms and SpO2 and NBP readings. • • Alarms are audible and visible at central only, not at TeleMon B. INOPS are audible and visible at central, visible only at TeleMon B (no sound) About TeleMon B 1-5 1 About TeleMon B Stand-Alone Monitoring Mode Safety Messages • If the monitor is out of antenna range, there will be no alarms. Inoperative alerts will continue to be available at TeleMon B. Safety Messages The following safety messages inform you about the correct use of this product. Other important safety information is located throughout this book where appropriate. Warnings Explosion Hazard. Do not use the monitor in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide. Do not touch the patient, bed, transmitter, or TeleMon during defibrillation. Do not use this device during electrosurgery. Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. If TeleMon is out of antenna range, there is no indication at TeleMon of this state. In addition, no signal will be received at central, and the message NO SIGNAL will be displayed at the central. Although this equipment is shielded against Electromagnetic Interference (EMI), avoid the use of other electrically radiating devices in close proximity to this equipment. Transmitters or TeleMons with transmitters having frequency settings that are <25 kHz apart interfere with one another at distances of 1-3 feet. This situation is aggravated by ECG cable proximity. Symptoms include dropout (at the Information Center), waveform artifact of the ECG (at central and TeleMon), and screen freeze (at TeleMon). To avoid this situation, maintain a frequency spacing of >25 kHz between channels or a physical distance of >1 m (3 ft) between devices. 1-6 About TeleMon B A Quick Look at TeleMon A Quick Look at TeleMon Front View Display Handle NBP Connector Transmitter Recess Control Panel Battery Compartment About TeleMon B 1-7 1 About TeleMon B U.S. Law restricts this device to sale by or on the order of a physician. This product is intended for use in health care facilities by trained healthcare professionals. It is not intended for home use. A Quick Look at TeleMon Rear View Vent NBP Cuff Holder Power ON/OFF Switch Product Label Upgrade Port (underneath) Control Panel 1-8 AC Power Connector (18V DC, 1.83A) Speaker All operational interactions except power on/off and the docking/undocking of the transmitter are performed using the seven keys on the control panel. In monitoring mode, there are three types of keys: • Direct Action keys (SILENCE/RECORD, SUSPEND, and NBP) enable immediate actions. The action is defined in the screen text directly above the key. • Input keys ( , , and ) - enable you to navigate through a menu of choices. • ? key - provides access to “how to” and other online operational information during monitor use. About TeleMon B A Quick Look at TeleMon SILENCE/ RECORD SUSPEND AC Power Status Keys On-Line Info Input Keys NBP Battery Charge Status The function of each key state is described in the following table. Key Silence/Record Screen Label Silence SUSPEND All Alarms Silences the current active alarm or INOP sound on TeleMon Initiates central recording. A flashing strip above the label indicates a recording is in progress. Suspends all alarms at TeleMon and Central for 3 minutes. SUSPEND at Central Suspends telemetry alarms at Central for 3 minutes. xx:xx min to UN SUSPEND Reactivates suspended alarms. Record at Central Suspend Function About TeleMon B 1-9 1 About TeleMon B Below the keys, two indicators provide information on the power status of the monitor. A Quick Look at TeleMon Key ? Input Keys Screen Label none none none NBP Function Provides access to “how to” and other operational information during monitor use. Displays context sensitive information on the selected element. Also scrolls and dismisses info window. Arrow Keys • Select an element on the display. • Select a choice in a task window. • Adjust a setting, such as an alarm limit, in increments. • Activate a selection in Monitor Setup window. Check Key • Opens or closes a window for the selected element START Starts an individual NBP measurement. STOP Stops an individual NBP measurement. Scheduled measurements continue uninterrupted. Indicators The meaning of each indicator state is described in the following table. Indicator 1-10 About TeleMon B Meaning On (Green) AC power cable is connected to TeleMon Off No AC power is connected. A Quick Look at TeleMon Meaning On (Yellow) Battery being charged The Display On (Blinking Yellow) Initiating communication with the battery, or error condition Off No charging because either no battery or battery already fully charged In monitoring mode, the display presents clinical data in graphical and alphanumeric format on the Main Screen. The general layout of a typical Main Screen is shown below, with each icon or measurement identified in the following table. 14 13 1 12 2 3 11 4 10 9 5 8 7 6 About TeleMon B 1-11 1 About TeleMon B Indicator A Quick Look at TeleMon Icon/Measurement 1 Alarm Mode Local Alarms On or Central Alarms Only 2 Alarm Message Patient alarms are on the left; equipment alarms (INOPs) are to the right. An up arrow indicates that there is more than one active message. 3 The text EASI is displayed above the primary wave channel when an EASI transmitter is docked. 4 Lead Label 1mV Calibration Bar Size of ECG signal Waves: One or two ECG waves - or - one ECG and one pleth wave - or - one ECG and one annotated delayed ECG wave 5 Volume of the local alarm tones. Also used to turn local alarms off. 6 Key label describing current function of the Direct Action key directly below 7 NBP Schedule: NBP measurement rate, or Manual mode. Also used to turn NBP off. 8 NBP measurement time: time remaining until the next automatic measurement, or time of the most recent manual measurement. 9 10 1-12 About TeleMon B A bell with an X through it indicates that the alarm for this parameter is OFF. Numerics and Alarm Limits • Heart Rate (b/min); PVC Count • SpO2 (% saturation); PULSE (b/min) • NBP Systolic/Diastolic (Mean) (mmHg) • NBP Alarm parameter(s) • SpO2 sample rate that will take effect when the transmitter is undocked. A Quick Look at TeleMon Icon/Measurement Battery icon indicating the remaining minutes of TeleMon battery power or absence of transmitter battery. When the AC power cord is not attached, the battery operating time is also displayed. Plug icon appears when the monitor is operating on AC power (not shown). For more information, refer to “More About Batteries” on page 2-4. 12 Monitor Setup displays a menu of general purpose parameters. From this menu you can select the patient type, turn pacing on/off, initiate arrhythmia relearning, and save the current settings. Save Current Settings is password protected. 13 Current Date and Time 14 Patient Category and Pacing Status About TeleMon B 1-13 1 About TeleMon B 11 Introduction 2 Monitor Basics In this chapter, you’ll find instructions for powering the monitor, docking and undocking the transmitter, how to navigate through menus, how to setup the monitor, and information about antenna coverage. This chapter includes the following sections: Powering the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Docking & Undocking the Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 General Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Monitor Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13 Antenna Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 Monitor Basics 2-1 2 Monitor Basics • • • • • Powering the Monitor Powering the Monitor TeleMon can be powered by AC power or by a rechargeable battery. The two indicators on the front panel give you information about the power status. If TeleMon is connected to an AC power module, the left indicator on the front panel will be lit, and a plug icon will appear next to the battery gauge on the upper right corner of the display to indicate that the power module is connected. The right indicator on the front panel lights when the battery is being charged, and the battery gauge on the display shows the percentage of charge available. While powered only by battery, TeleMon reports the minutes remaining until discharge next to the battery gauge. This time is calculated by the battery itself, and fluctuates based on system load, age of battery, and battery percent charge. TeleMon uses one rechargeable 10.8V nickel metal hydride (NiMH) battery. When %SpO2 is being monitored and four NBP measurements are made per hour, battery life is >3.5 hours. At 25o C (77o F), the typical battery life for the same configuration is 5 hours. When TeleMon is powered on, it goes through a self-test routine that tests for correction functioning of critical system functionality, including battery charge, the display and alarm sound.(For more information about the self-test, see “Testing TeleMon’s Critical Functions” on page 2.) If power is interrupted to the TeleMon and it does not have a battery installed, TeleMon’s settings revert to the unit settings. Note—If no time is shown in the date/time area of the display, the coin cell battery on the processor board may need to be replaced. Check with your Service Provider for assistance. Warning Use only a TeleMon-specific power supply of the appropriate voltage and amperage for this device. See “Ordering Accessories” on page 6-10 for accessory information. 2-2 Monitor Basics Powering the Monitor Task Summary To power the monitor, use these directions: Step 1 Action Connect the cable between the power supply and TeleMon; then connect the cable between the power supply and the AC power source. 2 Monitor Basics - OR Insert a fully charged the battery - with the CE mark facing up (the charge indicator facing down)—into the battery compartment. Close the door. Insert with CE mark facing up. Monitor Basics 2-3 Powering the Monitor Step More About Batteries Action 2 Turn the On/Off switch to the ON position. 3 Observe the self-test screen for diagnostic messages. If any appear, contact your service provider for assistance. Otherwise, monitoring mode begins automatically. When the Battery gauge on the display indicates a charge of < 25%, the battery needs to be recharged. Use only batteries supplied by us (see “Ordering Accessories” on page 6-10). Fully recharging from the shut-off point (15% remaining capacity as indicated on the battery) takes approximately 4 hours, with TeleMon ON or OFF. The battery charge is also indicated on the self-test display upon power-up. Over time, the battery loses its ability to fully charge. When the battery’s capacity drops by 10%, reconditioning is needed to optimize battery performance. For more information about battery reconditioning, see “Reconditioning the Battery” on page 6-8 <25% -Time to Recharge Attach AC power or use charged battery. 2-4 Monitor Basics Powering the Monitor This indicator can apply to the TeleMon battery, the transmitter battery, or both. Check the informational messages to determine which battery is low. If TeleMon battery: Critically Low — The monitor will shut down in 5 minutes if no action is taken. Attach AC power or use new battery. After plugging in AC power, this icon will remain for a short time until battery begins to charge. If icon remains longer, the battery may need reconditioning. has a critically low charge. If Transmitter battery: Weak battery in transmitter. Five minutes or less remain until transmitter is disconnected. Undock the transmitter, and insert fresh battery into transmitter. Battery reconditioning is required. For instructions, see “Reconditioning the Battery” on page 6-8. Monitor Basics 2-5 2 Monitor Basics Note—No new NBP measurements can be made when the battery Powering the Monitor Warning Do not mutilate or puncture battery; do not dispose of battery in fire. The battery can burst or explode, releasing hazardous chemicals. Replace battery with only the type recommended. If battery leakage should occur, use caution in removing the battery. Avoid contact with skin. Clean the battery compartment according to instructions in this manual. (See “Disinfecting the Monitor” on page 6-5.) Certain failure conditions, such as extended short circuiting, can cause a battery to overheat during normal use. High temperatures can cause burns to the patient and/or user, or cause the battery to flame. If TeleMon becomes hot to the touch, unplug the AC power, turn the device off, and place it aside until it cools. Then remove and discard the battery. It’s a good idea to place a piece of tape across the contacts of the battery to prevent inadvertent shorting. Remove the TeleMon from service and have its operation checked by qualified service personnel to identify the cause of overheating. Recharging the Battery To recharge the TeleMon battery, use this procedure: Step Action 1 Be sure the battery is in place (inserted in battery compartment with the connector slots facing up) and the battery door is closed. 2 Plug in the AC power connector. Recharging starts immediately, and is indicated by a yellow light on the charge indicator on the control panel. Leave the power cord connected until the yellow light goes out and the battery gauge indicates a full charge. This takes approximately 4 hours. Note—The battery may get warm during charging, particularly as it approaches full charge. This is normal behavior. 2-6 Monitor Basics Docking & Undocking the Transmitter Note—For information about the transmitter battery, see the Telemetry System Instructions for Use. Auto Shutoff If TeleMon is on battery power and the battery is at 15% charge or below, TeleMon will automatically shut down in 5 minutes. A count down timer displayed next to the battery gauge shows the time remaining to shutdown. To stop the shutdown, either plug in the AC power module or swap the battery with another that has a charge of more than 15%. If the monitor is not connected to AC power and one battery is replaced with another, the TeleMon will power down and restart. Cycling power repeatedly when the battery is critically low may harm TeleMon or the transmitter. If the battery is critically low, do not attempt to cycle power (reboot) the monitor until the either the battery has been replaced or AC power has been applied. Docking & Undocking the Transmitter The transition between stationary (docked transmitter) and ambulatory (undocked transmitter) monitoring is seamless because the transmitter continues to source ECG and %SpO2 patient data to the central station in both states. There is no interruption to monitoring, and no user interaction is required to continue monitoring when switching between states. Only M2601A Series C and higher transmitters can be docked with TeleMon Note—The transmitter must have a “good” battery inserted before docking. TeleMon B does not allow monitoring if the transmitter is docked with a weak or dead battery. Also, a lead set must be connected to the transmitter before docking. Monitor Basics 2-7 2 Monitor Basics Warning Docking & Undocking the Transmitter Docking When the transmitter is docked: • The docked icon ( ) is displayed in the patient sector at central. • %SpO2 is sampled at a continuous rate. If a different sampling setting was programmed into the transmitter prior to docking, that rate will resume when the transmitter is undocked. • NBP measurements can be made. The transmitter must be in the docked position to measure NBP. Note—The transmitter battery is not recharged when the transmitter is docked. Task Summary To dock the transmitter, follow this procedure: Step 2-8 Monitor Basics Action 1 Ensure that the transmitter is ready for use with TeleMon. The transmitter must meet the following criteria: a. Series C or higher b. Good battery inserted in the transmitter. c. Lead set connected. d. Battery door closed. e. No obvious soiling or debris. 2 Turn TeleMon ON (move switch to the ON position ). Docking & Undocking the Transmitter Step 3 Action Insert the transmitter with the infrared window up into the docking recess at the side of TeleMon. Infrared Window 2 Monitor Basics Chest Diagram After about 6 seconds, the Transmitter Disconnected message on the display will be erased and patient data will be displayed at TeleMon. 4 Verify that Telemon is being actively monitored at central. The docked symbol will be displayed at central. Monitor Basics 2-9 Docking & Undocking the Transmitter Undocking Caution Do not leave a transmitter docked in TeleMon when monitoring is not active. The transmitter should be removed from TeleMon prior to storing to prevent battery drainage. When the transmitter is undocked: • The undocked icon ( ) is displayed in the patient sector • No new NBP measurements will be made. (Previous NBP values are stored and available in trends at central.) • %SpO2 reverts to its sample rate prior to docking or sample rate selected at TeleMon when the transmitter was docked (Manual, 5-min, 1-min, or Continuous). • Alarms are unsuspended at central if in suspend mode. Suspend alarm capability reverts to the telemetry setting available at central. • The message Transmitter Disconnected is shown across the Main Screen, and all parameters and key labels on the display are hidden. The input keys ( ) remain active, however, so you can preconfigure TeleMon without a transmitter. Most settings are unaffected by undocking/docking. However, when the transmitter is docked or redocked, the lead selections are set to the following defaults: Transitioning from some leadset to … Wave 1 Lead 5-wire II 5-wire EASI II 3-wire Lead Selection Disabled II 2-10 Monitor Basics Wave 2 Lead V V2 None Docking & Undocking the Transmitter Transitioning from some leadset to … 3-wire Lead Selection Enabled Wave 1 Lead Wave 2 Lead {I, II, or III based on transmitter setting} None Note—When Lead Selection is enabled for 3-wire transmitters, lead selection at TeleMon is stored in the transmitter. Note—Transmitters must be undocked from TeleMon prior to changing leadsets. Task Summary To undock the transmitter, use the following directions. 1 Remove the NBP cuff from the patient, if present. 2 Turn the TeleMon B power switch to Off. 3 Holding the leadset combiner block, pull the transmitter out with one hand. Note—There is no release mechanism. 4 Verify undocking at central. The undocked symbol the Information Center. will be displayed in the patient sector at Monitor Basics 2-11 2 Monitor Basics See “To Save Current Settings” on page 2-16 and “Changing Wave or Size” on page 3-7 for more details. General Navigation General Navigation Entering alarm and parameter settings, such as NBP repeat time, is accomplished using the Input Keys (see “Keys” on page 1-9). The following process applies to all operations in monitoring mode except Monitor Setup; it is summarized here for your convenience. For entering patient settings, such as pacing status, see “Monitor Setup” on page 2-13. 1. Select an element (a) using the arrow keys. The highlighted element is shown in the active element (b) position at the bottom center of the display. 2. Open the task window (c) for that element by pressing the check key. 3. Make a choice on the task list using the arrow keys. The selected choice becomes active immediately. 4. Close the window and save the information by pressing the check key. a d b 2-12 Monitor Basics c Monitor Setup Online Info The Online Info feature provides TeleMon operating information during active monitoring. Press the ? key when no element is active to display Basic Operating guidelines. • Press ? when an element (a, b - see diagram) is active to bring up a window providing a brief description of the function. • Press ? when a task window (c) is open to show information about that task. Monitoring will continue uninterrupted. For example, when the element Wave 1 Lead is highlighted, a lead placement diagram for the selected lead is shown (d). Use the ? key to scroll through additional pages. • 2 Monitor Basics To exit from Online Info, press the ? key again, or wait 5 seconds until the window closes automatically. Monitor Setup Monitor Setup provides adjustment of two basic monitor settings: Patient Type and Pacer Detection Status. Setting Positions Patient Type Adult, Pediatric Pacer Detection Status Not Paced, Paced Warning Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and misdetection of cardiac arrest or some arrhythmias. Keep pacemaker patients under close observation. The patient type affects the settings in the NBP measurement algorithm. Monitor Basics 2-13 Monitor Setup If Local alarms are on, two controls are also available: Control Function Arrhythmia Relearn Initiates a relearn of the patient’s primary ECG waveform by the ST/AR algorithm. Note—Initiate learning only during periods of predominantly normal rhythm and when the ECG signal is relatively noise-free. Warning If you initiate learning during ventricular rhythm the ectopics may be incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent events of V-Tach and V-Fib. Save Current Settings Saves the current settings as the startup settings for subsequent patients (“unit defaults”). Note—The Pacer Detection Status is not saved and the default setting is Not Paced. Note—When you select Save Current Settings, a dialog box appears prompting you to enter the password. When this dialog box is open, you cannot suspend or unsuspend alarms, silence any active alarms, start a recording at central, nor start or stop an NBP reading. 2-14 Monitor Basics Monitor Setup Pacing Safety Messages Warning Pacemakers can be susceptible to radio frequency (RF) interference which may temporarily impair their performance. The output power of telemetry transmitters and other sources of radio frequency energy, when used in the proximity of a pacemaker, may be sufficient to interfere with the pacemaker’s performance. Due to the shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patient. 2 Monitor Basics Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the telemetry transmitters. In order to minimize the possibility of interference, position electrodes, electrode wires, and transmitter as far away from the pacemaker as possible. Caution During defibrillation, monitoring may be temporarily interrupted or distorted. After defibrillation, TeleMon will continue to monitor as before; the monitor settings will not be affected. The TeleMon NBP may not operate correctly if used or stored outside the relevant temperature or humidity ranges. To Change Monitor Settings Note— In the Monitor Setup window, the arrow and check keys behave slightly differently. Here you must first select the function you want, using the arrow keys, then activate your choice by pressing the check key. To exit from the Monitor Setup window, select Main Screen and press the check key. Monitor Basics 2-15 Monitor Setup Task Summary To change the monitor settings, use the following directions: Step Action 1 Select the Monitor Setup element and open the task list. 2 Using the arrow keys, highlight the patient type: Adult or Pediatric. The highlighted choice will turn brown. 3 Press the check mark key to activate your choice. A check will be displayed in the box next to your choice. 4 Move the highlight to the pacing choice (Patient Paced or Patient NOT Paced). 5 Press the check key to activate your choice. 6 To exit from Monitor Setup, use the arrow keys to move the highlight to Main Screen, then press the check key. Note—You cannot exit from this window by pressing the check key unless Main Screen is highlighted. 7 To Save Current Settings Then, with the transmitter docked, be sure to check the leads and wave size, adjusting as necessary, and check the alarm limits. Caution Most current settings will survive a power cycle or reboot only if they have been saved. When power is recycled, the monitor resets to either the standard unit settings or current settings that have been saved. The following table lists the standard unit settings. If these settings are changed, the changes can be saved for use with other patients. Current settings will survive a power cycle or reboot only if they have been saved. 2-16 Monitor Basics Monitor Setup Entered settings will be retained if the transmitter is undocked and redocked, but they will not be transferred to the Information Center or stored with the transmitter. If power is recycled, they will be reset to the standard settings unless they were saved. Settings are password protected; see your Service Provider to obtain the password for your institution. If setting changes are not saved, the changes will be lost and the monitor will revert to the standard settings. Standard (Default) Unit Settings Wave 1 and Wave 2 Size Local Alarms On/Off Alarm Volume Level Alarm Suspend Time HR Alarm Limits SpO2 Alarm Limits NBP Alarm Source NBP Alarm Limits NBP Schedule Ability to Turn Off Alarms Adult NOT Paced II EASI: V2 5-lead: V 3-lead: None x1 CareNet: Off (configurable in Service Mode) IEC/ISO: On (configurable in Service Mode) 5 [58 dB(A)] 3 minutes High - 120 b/min; Low - 50 b/min High - 100%; Low - 90% Systolic Systolic: High - 150 mmHg; Low - 90 mmHg Diastolic: High - 120 mmHg; Low - 50 mmHg Manual Enabled for US only Disabled for IEC countries Monitor Basics 2-17 2 Monitor Basics Patient Type Pacing Wave 1 Lead (Primary Lead) Wave II Lead Antenna Range Task Summary To save current settings for subsequent patients, use the following procedure: Step Action 1 Modify the settings using Steps 1-6 under “To Change Monitor Settings” on page 2-15. 2 Adjust other settings (such as alarm limits) as necessary. Note—All screen settings except ECG leads will be preserved. To Restore Unit Settings 3 Under Monitor Setup, select Save Current Settings and press the check key. Note—When Save Current Settings is open, you cannot suspend or unsuspend alarms, start a recording at central, nor start or stop an NBP reading. 4 Enter the password as prompted using the arrow keys. Start from the left digit; press the check key to move to the next digit. 5 After the settings are saved and the password window closes, select Main Screen and press the check key to exit from Monitor Setup. See “Restoring Standard Settings” on page 5-3. Antenna Range When TeleMon B is used with a docked transmitter within the antenna coverage area, the following physiological and status information is transmitted via the associated telemetry receiver and mainframe to the Information Center. • • • 2-18 Monitor Basics ECG waveform and HR value Pace Pulses (not paced status) SpO2 value Antenna Range • • • • • • • Pulse Rate (pulse must be on at central) NBP Values SpO2 and NBP On/Off INOPs, including Transmitter Battery INOPs Transmitter “Docked” status Alarm Suspend TeleMon Record Monitor Basics 2-19 2 Monitor Basics When TeleMon is used with a docked transmitter outside antenna coverage, the NO SIGNAL message is displayed at central, and no values, waveforms, or alarms from TeleMon are available at central. If TeleMon is in Central Alarms Only mode, no alarms are available for this patient. If Local Alarms are active, alarms are available at TeleMon only, and current ECG, SpO2, and NBP measurement values are also available. Introduction 3 Measurements In this chapter, you’ll find instructions for measuring ECG, %SpO2, and NBP. This chapter also discusses making recordings. • • • • Measuring ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Measuring %SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 Measuring NBP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Recordings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17 Warning Before monitoring a patient, verify that you have selected the patient type (Adult or Pediatric) that is suitable for your patient. See “Monitor Setup” on page 2-13 for directions. 3 Measurements Note—For all measurements, use only the recommended accessories. Recommended accessories are listed under “Ordering Accessories” on page 610. Measurements 3-1 Measuring ECG Measuring ECG TeleMon acquires raw ECG sent via the infrared connection from the transmitter and combines this data into two 4-second ECG waveforms displayed in separate wave sectors. Wave Sector 1, the top sector, is designated the primary lead and is used by the ST/AR algorithm for cardiotach derivation and beat classification of the delayed/annotated wave. The raw ECG signals are received from a conventional 5- or 3-lead transmitter as: • Channel 1 = Lead II • Channel 2 = Lead III (5-lead only) • Channel 3 = MCL (5-lead only) When an EASI transmitter is sourcing the waves, the signal is received as • Channel 1 = vector 1 (A-I) • Channel 2 = vector 2 (A-S) • Channel 3 = vector 3 (E-S) The label EASI is displayed above the Wave 1 sector when an EASI transmitter is docked. TeleMon implements a fixed 0.5 Hz high-pass filter on the ECG signal to minimize baseline wander and improve baseline recovery. The scaling of all displayed ECG waves is indicated by a 1 mv calibration bar drawn to the left of each wave sector. 3-2 Measurements Measuring ECG Warning ST/AR Arrhythmia Analysis FOR ALL PATIENTS During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) may be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest. If you initiate learning during ventricular rhythm, the ectopics may be incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent events of V-Tach and V-Fib. When using EASI ECG monitoring, Relearn happens automatically when there is a LEADS OFF INOP. If learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent events of VTach and V-Fib. Be sure to check the beat labels and initiate a relearn to correct. 1. Respond to the INOP message [for example, reconnect the electrode(s)]. 2. Ensure that the arrhythmia algorithm is labeling beats correctly. FOR PACED PATIENTS Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Keep pacemaker patients under close observation. * During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) may be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest. * When arrhythmia monitoring paced patient who exhibit only intrinsic rhythm, the monitor may erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest. Measurements 3-3 3 Measurements Pacemaker pulses may not be detected when the output of a defibrillator or telemetry unit is plugged into a bedside monitor. This may result in the arrhythmia algorithm’s failure to detect pacemaker non-capture or asystole. Measuring ECG For patients who exhibit intrinsic rhythm only, the risk of missing cardiac arrest may be reduced by monitoring these patients with the low heart rate limit at or slightly above the basic/demand pacemaker rate. A low heart rate alarm alerts you when the patient begins pacing. Proper detection and classification of the paced rhythm can then be determined. * When an external pacemaker is being used on a patient, arrhythmia monitoring is severely compromised due to the high energy level in the pacer pulse. This may result in the arrhythmia algorithm’s failure to detect pacemaker noncapture or asystole. The intended use of the ST/AR basic arrhythmia analysis algorithm is to monitor the patient’s ECG for heart rate and ventricular arrhythmias and to produce events/alarms simultaneously for one or more ECG leads. The arrhythmia algorithm is capable of monitoring both paced and non-paced patients in a clinical environment. ST/AR provides Heart Rate and PVC Rate numerics. When Local alarms are on, it also provides alarm detection for the following conditions: • Asystole • Vent Fib/Tach • V Tach • Extreme Brady • Extreme Tachy • High HR • Low HR • PVCs > 30/min • Pacer Not Capturing • Pacer Not Pacing Beat classification determined by the ST/AR algorithm is shown on the delayed wave, which can be displayed in Wave 2 Sector, the lower sector. The 3-4 Measurements Measuring ECG annotation can help you determine the appropriateness of the heart rate determination and the need for relearning. Annotation A I L M N P S V ? ‘ Beat Classification Color Artifact Inoperative Learning Missed Beat Normal Paced Beat Supraventricular Premature Ventricular Premature Questionable Pacer Mark Blue Red Red Red Blue Blue Blue Red Red Blue When Local alarms are off, Heart Rate and PVC are the only pieces of information from the basic ST/AR algorithm that are provided at TeleMon. For more information on the ST/AR algorithm, please see the Information Center Instructions for Use. Also refer to the ST/AR Arrhythmia Application Note. Note—TeleMon’s ST/AR algorithm has fixed inhibitory periods for the yellow arrhythmia alarms. The inhibitory period for High/Low HR, Pacer Not Capture (PNC) and Pacer Not Pace (PNP) is five minutes. The inhibitory period for PVCs/min is ten minutes. The High/Low HR is a rate alarm, PNC/PNP is a beat detection alarm, and PVCs/min is a PVC alarm; all share the same priority. The most recently detected alarm will be visually displayed by TeleMon until the Silence/Suspend key is pressed or a higher (Red) priority alarm is detected. ECG Fallback ECG Fallback monitoring is available for EASI and 5-wire standard transmitters when Local alarms are on or off. There is no ECG fallback for 3-wire transmitters. Measurements 3-5 3 Measurements When monitoring is initiated at TeleMon or the Wave 1 lead is changed, TeleMon displays a question mark (?) next to HR and displays “L” on the annotated wave until the HR is calculated and the rhythm is learned. Measuring ECG ECG Fallback for EASI Transmitters If one of the EASI leads has an INOP condition, no standard leads can be derived because each lead is a linear combination of all three EASI leads. A lead off in the primary lead results in a flat line being displayed on TeleMon, and a LEADS OFF INOP is displayed. After 10 seconds, if the primary lead still cannot be derived, then one of the directly acquired EASI raw leads (A1, AS, or ES, depending on availability) will be displayed with the lead label ECG. Warning TeleMon automatically initiates arrhythmia Relearning when the lead is changed during ECG fallback and when then the primary lead becomes available again after a Leads Off condition. When all leads become available, TeleMon returns to the original ECG lead selection prior to ECG fallback. ECG Fallback for 5-wire Standard Transmitters For 5-wire standard transmitters, ECG fallback occurs if there is a lead off in the primary lead for more than 10 seconds. A lead off in the primary lead results in baseline data on TeleMon, and a LEADS OFF INOP is displayed. After 10 seconds, if the primary lead still cannot be derived, TeleMon will display one of the directly acquired ECG leads from the transmitter that is not in leads off; it will be displayed in channel 1 with a lead label ECG. TeleMon automatically initiates arrhythmia Relearning when the lead is changed during ECG fallback and when then the primary lead becomes available again after a Leads Off condition. When all leads are available, TeleMon returns to the original ECG lead selection prior to ECG fallback for both primary and secondary wave sectors. 3-6 Measurements Measuring ECG Warning Non-manufacturer supplied accessories and supplies may corrupt the performance of the equipment. Use only EC-12 compliant electrodes with this device. Use of electrodes that are non-compliant may provide erroneous results. Do not mix transmitter leadsets and transmitter ECG trunk cables. Only use a 5-wire leadset with a 5-lead trunk cable or a 3-wire leadset with a 3lead trunk cable. If a 5-wire leadset is plugged into a 3-lead trunk cable, only one lead will be monitored by both the Information Center and TeleMon, and there will be no informational notification displayed. If a 3-wire leadset is plugged into a 5-lead trunk cable, a LEADS OFF information message will be displayed, and no monitoring will occur at TeleMon or the Information Center. Use only one trunk cable per transmitter; do not use additional cables to extend the cable length. Use the trunk cable only with the TeleMon device. Do not use with other telemetry monitoring systems or other bedside monitors. When local alarms are on, and a non-EC13 compliant signal is present, false asystole can result; this could lead to a real asystole being ignored. 3 Measurements Changing Wave or Size To change a wave (lead) or waveform size, follow the steps below. Step Action 1 Highlight Wave (1or 2) Lead or Wave (1 or 2) Size using the arrow keys. 2 Press the check key to open the task list. 3 Make a selection using the arrow keys. 4 Press the check key to close the list. Measurements 3-7 Measuring %SpO2 Measuring %SpO2 TeleMon B can display the %SpO2, Pulse Rate, and a pleth wave acquired from a patient connected to a docked transmitter. The Pleth wave is displayed in the Wave 2 channel. The %SpO2 and Pulse Rate are also transmitted via RF to central for display in the patient sector. The SpO2 sample rate is automatically set to Continuous while the transmitter is docked; when the transmitter is undocked, monitoring resumes at the previous sampling rate.TeleMon B also enables you to change the sample rate for use with an undocked transmitter. If there is no transducer attached to a docked transmitter, TeleMon turns %SpO2 and pulse rate off at TeleMon. At the Information Center, pulse will be displayed as -?-. The docked transmitter remains in continuous mode, and if a transducer is inserted into the transmitter, the parameter will automatically turn on at TeleMon and the information center. Note—The standard alarm limit settings for %SpO2 shown in the following table. These limits can be adjusted (see “Setting Alarm Limits” on page 4-16). There is no alarm associated with Pulse Rate. %SpO2 Standard Alarm Settings High Limit (see Note) Low Limit 100% 90% Note—If the SpO2 value is 100% and the High Limit is set to 100, no alarm will be generated. Note that the %SpO2 algorithm in TeleMon B differs from the algorithm at other bedside monitors in that the TeleMon B algorithm does not include screening of motion artifact in the pleth signal. If the pulse rate is <30 b/min, the pulse rate numeric shows -?-. 3-8 Measurements Measuring NBP Displaying the Pleth Wave To display the pleth wave in channel 2, use the instructions under “Changing Wave or Size” on page 3-7 and select “Pleth” in Step 3. Changing the %SpO2 Sample Rate When the %SpO2 sample rate is changed at TeleMon B, the sample rate does not take effect until the window is closed and the transmitter is undocked. Task Summary To change the sample rate at the transmitter, use the following procedure. Step Action 1 Highlight the %SpO2 Sample Rate element using the arrow keys. 2 Press the check key to open the task list. 3 Select the sample rate using the arrow keys. 4 Wait until the task list is erased, then turn TeleMon off and undock the transmitter. The new sample rate will be come effective when the transmitter is undocked. 3 Measurements Caution Do not turn TeleMon off until the task list is closed. 5 Press the check key to close the task window. Measuring NBP TeleMon measures the blood pressure using the oscillometric method for both adult and pediatric patients. Two modes of measurement are available: Measurements 3-9 Measuring NBP automatic and manual. Each mode displays the diastolic, systolic, and mean blood pressure. • In the manual mode, only one measurement is taken. • In the automatic mode, the measurement is repeated. You can select the repetition time to be one of the following: 5, 10, 15, 30, 60, 120 minutes. NBP measurements can be made only when the transmitter is docked with TeleMon. When the transmitter is undocked, any NBP measurement will be removed from the TeleMon main screen and the patient window at the Information Center. For automatic measurements, the cycle starts immediately when the time is selected from the task list. The first measurement will be made at the end of the cycle. A manual measurement can be started between automatic measurements. Note— NBP alarms cannot be turned off at the Information Center. You may see an indication on the information center display that NBP alarms are off, when in fact they are always on. Measurement Limitations The oscillometric measurement method has some limitations according to the patient’s condition. The measurement looks for a regular arterial pressure pulse; in circumstances where the patient’s condition makes this hard to detect, the measurement becomes unreliable and measurement time increases. The user should be aware that the following conditions can interfere with the measurement method, making the measurement unreliable or longer to derive. In some cases, the patient’s condition will make the measurement impossible. • • • • 3-10 Measurements Patient Movement. Measurement may be unreliable or not possible if the patient is moving, shivering, or having convulsions because these activities may interfere with the detection of the arterial pressure pulses. In addition, measurement time may be increased. Cardiac Arrhythmias. Measurements will be unreliable or may not be possible if the patient displays cardiac arrhythmias causing an irregular heart beat. The measurement time may be increased. If the measurement time exceeds the maximum measurement time, no reading will be made. Heart-lung Machine. Measurements will not be possible if the patient is connected to a heart-lung machine. Pressure Changes. Measurements will be unreliable or may not be possible if the patient’s blood pressure is changing rapidly over the period of time during which the arterial pressure pulses are being analyzed to obtain the measurement. Measuring NBP • • • Severe Shock. If the patient is in severe shock or hypothermia, measurements will be unreliable since reduced blood flow to the peripheries will cause reduced pulsation of the arteries. Heart Rate Extremes. Measurements cannot be made at a heart rate of less than 40 b/min or greater than 300 b/min. Obese and Edematous Patients. A thick layer of fat or extra-cellular fluid surrounding a limb tends to dampen oscillations coming from the artery and stops them from reaching the cuff. Accuracy may be lower than normal. Another limitation is the presence of irregular heart rate, erratic oscillometric signal, or motion artifact. In these cases, the NBP numerics at Telemon will be preceded by a question mark (?), indicating that physiological conditions existed that may have interfered with TeleMon’s ability to obtain a reliable measurement. The patient should be clinically evaluated, and the measurement repeated as necessary. If any of these conditions exist, evaluate the patient and (1) re-initiate NBP measurement, (2) discontinue automatic NBP measurements, or (3) take NBP measurements using a manual method. Note—Should a measurement with a question mark (?) be obtained, the questionable nature of the value is not broadcast to the central station or stored in the historical data. 3 Measurements Measurements 3-11 Measuring NBP NBP Safety Messages Warning Do not perform noninvasive blood pressure measurements on patients with sickle-cell disease or any condition where skin damage has occurred or is expected. Use clinical judgement to decide whether or not to perform automatic blood pressure measurements on patients with severe blood clotting disorders, because of the risk of hematoma in the limb wearing the cuff. Do not apply the cuff to a limb that has an intravenous infusion or catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. Use only approved cuffs and tubing in order to prevent inaccurate data, injury, or damage. All specified cuffs and the TeleMon are protected against the effects of the discharge of a defibrillator. Prolonged series of non-invasive blood pressure measurements in automatic mode may be associated with purpura, ischemia, and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color, warmth, and sensitivity. If any abnormality is observed, stop the blood pressure measurements immediately. Blood pressure readings may be affected by the position of the subject, his/her physiologic condition, and other factors. To obtain accurate blood pressure readings, the cuff must be the correct size and also be correctly fitted to the patient. Incorrect size or incorrect fitting may result in incorrect readings. Caution All specified cuffs and the TeleMon are protected against the effects of the discharge of a defibrillator. 3-12 Measurements Measuring NBP Do not compress or restrict pressure tubes during an NBP measurement. NBP Setup Task Summary To prepare for NBP measurement, follow the steps below: Step 1 Action Attach the cuff to the air tubing, making sure that air can pass through the tubing and that the tubing is not squeezed or kinked. Warning Use only approved cuffs and tubing in order to prevent inaccurate data, injury, or damage. 2 Insert the NBP cable into the NBP connector. 3 Measurements Measurements 3-13 Measuring NBP Step 3 Action Apply the blood pressure cuff to the patient’s arm or leg as follows: a. Select the appropriate sized cuff for the patient. – The cuff width should be either 40% of the limb circumference or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 50-80% of the limb. The wrong size of cuff may give false and misleading results. If you do not have the correct cuff size, use a larger one to minimize error. b. Ensure that the cuff is completely deflated. c. Wrap the cuff around the arm, making sure that the Artery Marker is aligned over the brachial artery. – Ensure that the cuff is not wrapped tightly around the limb. Excessive tightness may cause discoloration and eventual ischemia of the extremities. Also ensure that the air hose from the monitor to the cuff is not compressed, crimped, or damaged. d. Check that the edge of the cuff falls within the range marked <--->. If it does not, use a larger or smaller cuff that fits better. 3-14 Measurements Measuring NBP Step 4 5 Action Place the limb used for taking the measurement at the same level as the patient’s heart. The cuff should not be placed on the same extremity as the %SpO2 sensor. Press the START key. Note—If you are in doubt about the accuracy of any reading(s), check the patient’s vital signs by an alternative method before checking the functioning of the monitor. Start/Stop Manual NBP Task Summary To start or stop a manual NBP measurement, follow the steps below. Step 1 Action If an NBP reading is not in progress, START is displayed. 2 3 Measurements Press START to initiate a reading immediately. If an NBP reading is in progress, STOP is displayed. Press STOP to end a reading. Note—Pressing STOP has no affect on the Auto Mode Timer. To stop a cycle of measurements, select either Manual or NBP OFF on the NBP Schedule task list. Measurements 3-15 Measuring NBP Change Repeat Time Task Summary To change the NBP automatic repeat time, use manual mode only, or turn the NBP function off, use the following procedure: Step Action 1 Use the arrow keys to select NBP Schedule. 2 Press the check mark to open the task list. 3 Use the arrow keys to select the measurement repeat time, manual mode, or turn the NBP function off. Note—For automatic measurements, the timer starts immediately. The next automatic reading will be taken at the end of the time period. 4 Select NBP Alarm Setting Press the check mark to close the task list. The NBP repeat time will be saved as a unit setting. When Local alarms are enabled, the NBP alarm can be based on the systolic, diastolic or both systolic and diastolic non-invasive pressures. The standard settings are listed in the following table: NBP Alarm Limit 3-16 Measurements Standard Setting Systolic High 150 mmHg Systolic Low 90 mmHg Diastolic High 120 mmHg Diastolic Low 50 mmHg Recordings Task Summary To change the NBP Alarming setting, use the following procedure: Step Action 1 Highlight the NBP Alarming element using the arrow keys. 2 Press the check key to open the task list. 3 Select the alarm settings using the arrow keys. 4 Press the check key to close the task window. The NPB Alarming setting will be saved as a unit setting. Recordings Delayed timed recordings at central can be initiated at TeleMon. Delayed recordings follow the settings at central and are recorded where the transmitter is assigned. Note—If there is a problem at the recorder, there is no notification at TeleMon. TeleMon indicates only that the recording request was sent. Task Summary To initiate a delayed waveform recording, use the following procedure. Step 1 Action Press RECORD at Central to initiate a delayed waveform recording at the Information Center. A recording strip icon flashes above the key label to indicate that a recording is in progress. Note—Recording requests made while the recording strip icon is flashing will be ignored. Measurements 3-17 3 Measurements Real-time recordings can be initiated only at the central. Introduction 4 Alarms In this chapter you’ll find information on TeleMon B’s alarm structure, a list of alarms, and instructions for responding to alarms. • • • Recognizing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Interacting with Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15 4 Alarms Alarms 4-1 Recognizing Alarms Recognizing Alarms TeleMon B provides basic alarming capabilities for both physiological and technical conditions. Physiological alarms indicate a life-threatening situation or a less urgent situation such as heart rate beyond limits. Technical alarms or INOPs (inoperative condition) indicate that the monitor cannot measure or detect alarm conditions reliably. TeleMon B can be used in two modes: Local alarms on, or central alarms only. Alarms and alarm-related controls are available at TeleMon B only when local alarming is enabled. INOP text is available at all times, regardless of alarm mode. Alarm Types & Indicators Alarm Types 4-2 Alarms Alarm conditions are announced in two forms: messages and sounds. Messages on the screen inform you visually of a condition. See “The Display” on page 111 for the screen position of alarm messages. If multiple alarms are active, an up arrow (↑) will be displayed to the right of the message area, and messages will cycle at a rate of one every two seconds. Sounds alert you to a condition in the monitor. Sounds are generated at TeleMon B only when Local alarms are on (see “Turning Alarms On/Off” on page 4-15). Only the sound of the most severe alarm is provided at any one time. The monitor will be configured for either Traditional sounds or IEC/ISO sounds depending on the geography where it will be used. There are six types of alarms; they are listed in the following table in order of descending priority. Alarm Type Alarm Description *** Red Patient potentially in life-threatening situation, for example, “Asystole” ** Yellow Continuous/non-continuous condition which might require response by the medical staff but of less critical importance than red alarms Recognizing Alarms Alarm Indicators Alarm Type Alarm Description ** Short Yellow PVC rate Less critical than ** Yellow Severe INOP Technical defect of a measurement which could cause harm to the patient’s health. Alarms are automatically unSUSPENDED during a severe INOP. Hard INOP Technical or signal condition which disables the parameter algorithm that derives numerical values Soft INOP Signal condition or measurement state which makes the result of a parameter algorithm questionable TeleMon B indicates the priority of an alarm by: • Alarm sound. Depending on the geography of the clinical institution, the alarm sounds are configured for Traditional or IEC/ISO standard alarm sounds. • Color of the message: red, yellow, or cyan • Number of stars in the alarm message: three-star ***, two-star **, or none The following table summarizes the indicators for each alarm type. Alarm Indicators Message *** Red Traditional Sound: Continuous highpitch rapid tone IEC/ISO Sound: Repeated bursts of five rapid high-pitch beeps Flashing red message; three stars *** preceding the alarm text ** Yellow Traditional Sound: Continuous medium- pitch tone IEC/ISO Sound: Repeated bursts of three rapid low-pitch beeps Flashing yellow message; two stars ** preceding the alarm text Alarms 4 Alarms Sound 4-3 Recognizing Alarms Alarm Indicators Sound Message ** Short Yellow Traditional Sound: Noncontinuous medium-pitch tone for about 8 seconds IEC/ISO Sound: Two rapid low-pitch beeps Steady yellow message; two stars ** preceding the alarm text Severe INOP Traditional Sound: Continuous highpitch rapid sound IEC/ISO Sound: Repeated bursts of five rapid high-pitch beeps Flashing red message (no stars) Note—At central, severe INOPs sound and display in the same manner as Hard INOPs. Hard INOP Traditional Sound: Continuous slow low-pitch tone IEC/ISO Sound: Repeated bursts of three slow low-pitch beeps Steady cyan message Soft INOP None Steady cyan message When a yellow ECG alarm is announced audibly and visually, a 5-minute timeout period begins for that alarm. If this alarm condition recurs during the timeout period, it will not be announced audibly. Other indications include a flashing parameter numeric displayed during an alarm event for HR, SpO2, NBP, and PVC arrhythmia events. The HR numeric flashes for Asystole, Vfib/Tach, Brady, Tachy, and HR rate alarms. The PVC numeric flashes when a Vtach or PVC rate alarm occurs. The flashing stops only when the condition goes away. 4-4 Alarms Recognizing Alarms Alarm Behavior Action Taken Alarm behavior is summarized in the following tables for ECG alarms, SpO2 & NBP limit alarms, and INOP alarms. Alarm Condition Yellow ECG Alarm condition still exists • Audible alarm silenced. • Message stops flashing • Message changes to inverse video • Numeric flashes Alarm condition ceases to exist • Audible alarm silenced • All ECG Messages cleared • Numeric stops flashing Alarm condition still exists • Audible alarm continues • Message flashes • Numeric flashes Silenced Key pressed No Action Alarm condition ceases to exist Action Taken Red ECG Alarm Condition Short Yellow ECG • Audible alarm continues • Message flashes • Numeric flashes • Audible alarm silenced after a few seconds • Message flashes • Numeric flashes • Audible alarm silenced • Message flashes • Numeric flashes • Audible alarm silenced after a few seconds • Message flashes • Numeric flashes Yellow NBP Yellow SpO2 • Audible alarm silenced. • Message stops flashing • Message changes to inverse video • Numerics stop flashing Alarm condition ceases to exist • Audible alarm silenced • Message cleared • Numeric stops flashing Silenced Key pressed 4 Alarms Alarm condition still exists Alarms 4-5 Recognizing Alarms Action Taken Alarm Condition • Audible alarm continues • Message flashes • Numeric flashes Alarm condition ceases to exist • Audible alarm silenced • Message cleared • Numeric stops flashing Alarm Condition Severe INOP Hard INOP Alarm condition still exists • Audible alarm silenced • Message continues • Numeric flashes (if applicable) • Audible alarm silenced. • Message changes to inverse video • No Audible alarm • Message continues Alarm condition ceases to exist • Audible alarm silenced • Message cleared • Numeric stops flashing (if applicable) • Audible alarm silenced • Message cleared • Numeric stops flashing • No Audible alarm • Message cleared Silence Key pressed 4-6 Alarms Yellow SpO2 Alarm condition still exists No Action Action Taken Yellow NBP Soft INOP Recognizing Alarms Action Taken Alarm Condition Severe INOP Hard INOP Alarm condition still exists • Audible alarm continues • Message continues • Numeric flashes (if applicable) • Audible alarm continues • Message flashes • Numeric flashes • No Audible alarm • Message continues • Numeric flashes Alarm condition ceases to exist • Audible alarm silenced • Message continues • Numeric flashes (if applicable) • Audible alarm silenced • Message cleared • Numeric stops flashing • No Audible alarm • Message cleared No Action Soft INOP Suspending alarms or turning off Local alarms silences audible alarms and clears all alarm messages. If a severe INOP occurs when alarms are suspended, the alarms will be unsuspended automatically. The alarm message will be cleared when you initiate a new NBP measurement. Alarm Modes TeleMon B provides two alarm modes — Local alarms on or off. When Local alarms are off The messages CENTRAL ALARMS ONLY and Local Alarms OFF are displayed at the top left of the screen. Patient alarms are generated, displayed, recorded, and silenced only at the Information/Surveillance Center, and alarm adjustments must be made at central. Severe, Hard, and Soft INOPs in the form of text messages will be available at TeleMon. There is no sound associated with INOP alarms when Local alarms are disabled. A bell symbol with an X through it displays next to the volume icon. Alarms 4-7 4 Alarms When Local alarming is enabled The message Local Alarms ON is displayed at the top left of the screen. Alarms are generated, displayed and silenced at TeleMon B. Alarm adjustments can also be made at TeleMon B, and user-adjustable alarm limits on all physiological parameters can be made. TeleMon B provides a Silence key, and the alarm tone volume can be adjusted over a ten-step range. Alarm Messages Warning The default configuration for IEC is that local alarms are on and cannot be disabled. The setting to change this is behind the password-protected area of Service Mode. Only qualified service personnel should change this setting. Warning TeleMon B transmits only numeric values and waveforms to central; it does not transmit alarm conditions. Alarm limits and arrhythmia settings are set independently at TeleMon B and central. The algorrithm used for alarms is different at TeleMon from that used at central. Because of these independent settings, an alarm may be announced locally but not at central, or vice versa. Alarm Messages Red & Yellow Alarm Messages The following table lists the possible alarm messages (in order of decreasing severity) that could appear on TeleMon when local alarms are turned on. They are displayed in the alarm message area near the top of the display Note—In the following table, xxx is the parameter limit and yyy is the parameter value. TeleMon B Red & Yellow Alarms 4-8 Alarms Alarm Message Severity Explanation *** ASYSTOLE Red No QRS for 4 consecutive seconds *** BRADY yyy < xxx Red HR below extreme Brady HR limit *** TACHY yyy > xxx Red HR above extreme Tachy HR limit Alarm Messages TeleMon B Red & Yellow Alarms Severity Explanation *** V-FIB/TACH Red Fibrillatory waveform (sinusoidal wave between 2-10 Hz) for 4 consecutive seconds *** V-TACH Red Sustained run of PVCs accompanied by a high heart rate ** HR High Short Yellow HR above high HR limit ** HR Low Short Yellow HR below low HR limit **NBP High Yellow NBP above high limit for systolic or diastolic pressure **NBP Low Yellow NBP below low limit for systolic or diastolic pressure ** PACER NOT CAPT Short Yellow Missed beat with pace pulse (paced patient) ** PACER NOT PACE Short Yellow Missed beat without pace pulse (paced patient) ** PVC > yy/min Short Yellow PVCs above PVC limit For more information about PVC alarms, see “ST/AR Arrhythmia Analysis” on page 3-3. **SpO2 High Yellow SpO2 value greater than high SpO2 limit **SpO2 Low Yellow SpO2 value lower than low SpO2 limit The following table lists all of the INOP alarms (in alphabetic order) that could be displayed on TeleMonB. They appear in the INOP message area at the top center of the display. Severe INOP text messages are displayed in red, and hard and soft INOP text is displayed in cyan. All INOP text is displayed whether Local alarms are on or off. INOP sounds for Severe and HARD INOPs are Alarms 4-9 4 Alarms INOP Alarm Messages Alarm Message Alarm Messages annunciated only when Local alarms are on. There is no audible sound at TeleMon associated with any INOP message when local alarms are turned off (under Volume control). Note—INOP messages at TeleMon are sent to the Information Center, except where specified in the table. TeleMonB INOP Alarms Message CANNOT ANALYZE ECG CHARGE MON BAT Level Hard Hard Note—Not displayed at central if Xmtr BATTERY WEAK INOP is also in effect, but both INOPs will be displayed at Telemon. CHARGE MON BAT Explanation ST/Arrhytymia algorithm cannot reliably analyze the ECG data on the monitored lead because of noise or INOP for 2/3 time over last 30 seconds. Change lead selected for primary wave. TeleMon battery has critically low charge. Connect to AC power and charge battery, or insert battery with >25% charge. TeleMon will start a 5-minute shutdown counter, and if no action is taken to clear the condition, TeleMon will shutdown the device. You will not be able to power on TeleMon unless you connect AC power and insert a charged battery. Change electrodes. Change position of electrodes. Soft TeleMon battery is <= 25%. Connect to AC power and charge battery, or insert battery with >25% charge. Soft Selectable lead unavailable due to leads off Reattach electrode Hard Failure in IR link or TeleMon caused monitor to reboot and settings to return to default. Check patient category, paced setting, alarm limits and NBP schedule. Reset as needed. Note—Not displayed at central if Xmtr BATTERY WEAK INOP is also in effect, but both INOPs will be displayed at Telemon. CHECK LEADS Note—INOP not sent to Corrective Action information center CHECK SETTINGS 4-10 Alarms Alarm Messages TeleMonB INOP Alarms Message Level Explanation Corrective Action CUFF NOT DEFLATED Severe Cuff pressure is greater than a specified safety limit for a period of time. Remove cuff from patient and disconnect from tubing. Gently expel any air. [If water in cuff, replace cuff.] Reconnect and reapply cuff to patient. Note—If the alarms are suspended, this INOP alarm unsuspends them at the Information Center and TeleMon B. To clear the message, initiate a new NBP measurement. ECG EQUIP MALF Hard ECG PC board in the transmitter is malfunctioning Replace transmitter. Contact your service provider. INVALID LEADSET Hard EASI transmitter has a 3-wire leadset or no leadset attached to it. Undock transmitter and attach a 5-wire leadset. LEADS OFF Hard Lead(s) not connected, or 3-wire leadset is connected to a 5-lead transmitter trunk cable. Reconnect lead(s). Cuff pressure increased above overpressure safety limits Remove cuff from patient and disconnect from tubing. Gently expel any air. [If water in cuff, use new cuff.] Reconnect and reapply cuff to patient. Note—If the alarms are suspended, this INOP alarm unsuspends them at the Information Center and TeleMon B. To clear the message, initiate a new NBP measurement. NBP CUFF OVERPRESS Severe Attach 3-lead trunk cable. 4-11 4 Alarms Alarms Alarm Messages TeleMonB INOP Alarms Message NBP EQUIP MALF Level Hard Explanation The tube in the cuff may be kinked or disconnected, or there is a malfunction in the NBP hardware. Corrective Action Unkink and/or connect tubing. Reconnect the transmitter by redocking. Take another measurement. If problem persists, contact your service provider. NBP INTERRUPTED Hard The preset maximum time for total measurement has been exceeded because of motion artifact or arrhythmia activity. Reapply cuff. Ask patient to refrain from moving during measurement. User pressed STOP during a measurement. NBP MEASURE FAILED Hard No measurement values can be derived because no pulse or inconstant pulse is sensed. Reapply cuff, or choose a new location. Reconnect the transmitter by redocking. Obtain a manual measurement. If problem persists, contact your service provider. NBP USE COUNT HIGH Note—This appears only Soft The relative NBP use count has exceeded count limit detected in self-test mode. Contact Service to replace the NBP module. Soft Only basic cardiotach alarms (high/ low limits, asystole, Vfib) are active. Turn on arrhythmia in Monitor Setup (adds alarms for Vtach, extreme limits, pacer, and PVC limit. on the self-test screen. NO ARRHYTHMIA 4-12 Alarms Alarm Messages TeleMonB INOP Alarms Message SPO2 EQUIP MALF SPO2 ERRATIC Level Hard Hard Explanation Corrective Action Malfunction in the %SpO2 hardware, or transducer/adapter cable damaged Change transducer or adapter cable. Erratic %SpO2 measurements, often due to a faulty transducer or incorrect positioning of the transducer Line up light source and photodetector - they must be opposite each other and light must pass through the arteriolar bed. May also be caused by optical shunting if sensor too big or too small. If message persists, replace transmitter. Reposition transducer to site with higher perfusion. Replace transducer or adapter cable. Use different sensor with correct fit. SPO2 INTERFERENCE Hard Cover sensor with non-white opaque material (for example, pulse oximeter probe wraps Posey wrap or equivalent) to reduce ambient light. Transducer or adapter cable is damaged. If message persists, inspect and replace transducer or adapter cable as needed. May also be due to electrical interference. Reduce sources of electrical interference. May also be generated by a defective transmitter. If the above corrective actions are ineffective, use a different transmitter, and call service provider to replace the defective one. Alarms 4-13 4 Alarms Level of ambient light is so high that the %SpO2 transducer cannot measure %SpO2 or pulse rate. Alarm Messages TeleMonB INOP Alarms Message SPO2 NOISY SIGNAL Level Hard Explanation Excessive patient movement or electrical or optical interference is causing irregular pulse patterns Corrective Action Locate sensor at site with less movement. Reduce sources of electrical or optical interference. If problem persists, contact your service provider. SPO2 NON PULSATILE Hard Pulse too weak or not detectable May also be generated by a defective transmitter. NPB measurement being made on the same extremity as %SpO2 Relocate sensor to site with improved circulation. Warm area to improve circulation. Try another sensor type. If the problem consists, contact your service provider. SPO2 TRANS MALF Xmtr BATTERY DEAD Hard Hard The %SpO2 transducer is malfunctioning. Replace the transducer or adapter cable. %SpO2 connector on the transducer or transmitter is dirty or corroded. Change the transmitter and call service to repair. If the transmitter communicates with TeleMon, the transmitter was docked with a dead 9-volt battery. Undock transmitter and replace transmitter battery. Transmitter eprom may be damaged; ECG monitoring may stop. 4-14 Alarms Interacting with Alarms TeleMonB INOP Alarms Message Level Xmtr BATTERY WEAK Hard Note—Overrides CHARGE MON BAT INOP at central, but both INOPs will be displayed at Telemon. Explanation Transmitter battery has become weak during monitoring. This initiates a 5-minute shutdown timer. Corrective Action Turn TeleMon Off. Undock transmitter and replace transmitter battery. If transmitter was docked with a weak 9-volt battery, Xmtr BATTERY WEAK appears immediately along with Transmitter Disconnected. No monitoring occurs. XMTR FAIL Note—INOP not sent to Hard Error writing TeleMon data to transmitter. Replace transmitter. Contact your service provider. Hard Transmitter malfunctioning Turn Telemon off and undock the transmitter. Replace with a different transmitter. information center XMTR MALF Contact your service provider. Interacting with Alarms Turning Alarms On/ Off To turn Local alarms on or off, use the following procedure: Step Action Using the arrow keys, highlight the Volume icon. 2 Press the check key. 3 Select the Volume level, or Alarms OFF. 4 Press the check key to close the window. 4 Alarms 1 Alarms 4-15 Interacting with Alarms Adjusting Alarm Volume To change the volume of the alarm sound, use the following procedure: Step Action 1 Using the arrow keys, highlight the Volume icon. 2 Press the check key. 3 Select the alarm volume. A sample tone will sound to aid you in selecting an appropriate volume level. 4 Setting Alarm Limits Press the check key to close the window. Alarm limits for ECG, %SpO2, and NBP measurements can be adjusted at TeleMon when local alarms are enabled. Alarm limits at central cannot be controlled from TeleMon. If the %SpO2 High Limit is set to 100 and the SpO2 value is 100%, no alarm will be generated. Note—For standard limit settings, see “To Save Current Settings” on page 2-16. For alarm limit ranges, please refer to “Measurement Specifications” on page 76 or sections on individual measurements in Chapter 3. Task Summary To adjust alarm limits, use the following procedure. Step 4-16 Alarms Action 1 Using the arrow keys, select the limit to be changed. 2 Press the check key. 3 From the task window, use the arrow keys to choose the limit. 4 Press the check key to close the task window and activate the new limit. Interacting with Alarms Note—It is recommended that you power cycle (turn off and then on) the TeleMon when connecting to a new patient. This causes TeleMon to reestablish the default alarm settings. Warning—Refer to “Safety Messages” on page 1-6 for information on maintaining patient safety. Silencing an Alarm When a Local alarm occurs, the sound can be silenced by pressing the Silence key. After you silence an alarm, the function of the Silence key quickly reverts to Record so that you can capture a central recording of the alarm event. The alarm message remains active on the main screen until one of the following occurs, at which time the alarm will be reset: • • • • • the physiological alarm condition goes away. you adjust the alarm limits you turn the alarms off you initiate a Relearn (for ST/AR generated alarms only) you suspend alarms. Note—Silencing a local alarm does not affect any active alarms at the Information Center. Task Summary To silence a Local alarm, press the SILENCE key. 4 Alarms Alarms 4-17 Interacting with Alarms Suspending Alarms The suspend capability enables you to prevent false alarms during a change of electrodes or other activity that could cause movement artifact alarms. Suspending alarms turns telemetry alarms off temporarily for 3 minutes at central, and if local alarms are enabled, at TeleMon also. The number of minutes and seconds remaining in the suspend period is displayed above the UNSUSPEND key label. When alarms are unsuspended, either automatically or manually, or when the transmitter is undocked, the ST/AR arrhythmia timeouts are reset. If a severe INOP occurs, the suspend period will be cancelled and the INOP will be annunciated. Task Summary To suspend alarms, press the SUSPEND All Alarms or SUSPEND at Central key. This action suspends all telemetry alarms at TeleMon B and central or, if local alarms are off, at a central only. To cancel the suspend, press the UNSUSPEND key. 4-18 Alarms This chapter describes the capabilities of Service Mode. • • • • • Accessing Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Restoring Standard Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Displaying Demo Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Change Date & Time, Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . 5-4 Viewing Transmitter Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 Note—TeleMon & Transmitter Service functions are covered in the TeleMon B Service Guide. Service Mode 5-1 Introduction 5 Service Mode 5 Service Mode Service Mode Service Mode Service mode enables you to perform non-clinical and configuration activities on the monitor. Some of these functions are password-protected to prevent inadvertent setting changes. All settings selected in service mode are saved once you exit the and are retained after a power cycle. Note that you do not need the transmitter while in Service Mode unless you are configuring a transmitter. Service mode enables you to: • • • • • Restore standard unit settings Enter Demo mode Adjust the display contrast, and date & time. View transmitter information. Perform service functions on TeleMon and the transmitter (recommended for qualified service personnel only). Note—Alarm sounds and the software that controls alarms are checked during the TeleMon power-on self test. See ‘Testing TeleMon’s Critical Functions” on page 6-2 for more information. Accessing Service Mode Service Mode is accessed through the power-up screen. Task Summary To access service mode, use the following instructions: Step 5-2 Service Mode Action 1 Turn TeleMon on (with or without a transmitter docked). 2 After the logo displays at the center of the screen, and the message Push button for Service appears, press the Check button below the display. Service Mode To exit Service Mode: • Restoring Standard Settings For more information on display settings, see ‘Monitor Setup” on page 2-13. When you restore standard settings, all setting revert to the factory default, except for alarm sound type, NPB calibration date and use count, and the ability to turn off local alarms. Task Summary To restore standard settings, use the following instructions. Step 1 5 Service Mode Turn the monitor off. - or Select Exit from the Device Setup Menu. Action From the Device Setup Menu, select Restore Standard Settings. Caution Current settings will be lost when standard unit settings are restored. Displaying Demo Mode 2 Press Go. 3 Press Accept or Cancel at the confirmation dialog box. If you press Accept, a message appears when the restore completes. 4 Press Done to return to the Device Setup menu. Demo mode facilitates learning how to use TeleMon. It shows sample wave forms for a 5-lead transmitter and helps you familiarize yourself with the controls. Service Mode 5-3 Service Mode Task Summary To enter demo mode, follow these instructions. Step 1 Action From the General Configuration Menu, select Demo Mode. Note—Once you enter Demo mode, you must power off and restart TeleMon to enter monitoring mode. 2 Press Go. 3 Press Accept or Cancel at the confirmation dialog box. 4 To exit Demo mode, power off and restart TeleMon. Warning If the transmitter is docked to TeleMon while in Demo Mode, the transmitter continues to transmit information to the Information Center, but that information doesn’t display on TeleMon, nor does the demo data go to the Information Center. While in Demo Mode TeleMon displays only the pre-programmed demonstration. Change Date & Time, Display Contrast This selection allows you to change the contrast of the display to better suit your viewing conditions. It also allows you to verify or change the date and time. Task Summary To adjust the display contrast or work with the date and time, follow these instructions. Step 5-4 Service Mode Action 1 From the General Configuration Menu, select Date & Time, Display Contrast. 2 Press Go. Service Mode Step Action Select either Adjust Display Contrast or Set or Verify Time and Date. 4 To adjust the display contrast: Use the arrow keys to adjust the contrast. The screen sample displays the result of the selection. Press Done. To set the date and time: Use the arrow keys to adjust each number and use the Next Setting key to move among fields. Press Done after you complete the changes. Viewing Transmitter Information This selection allows you to view the current settings of the docked transmitter. Task Summary To view the transmitter information, follow these steps. Step Action 1 From the General Configuration Menu, select View Transmitter Information. 2 Press Go. 3 Press View SpO2 Hardware to view the SpO2 hardware information. 4 If you remove the transmitter and insert a different one, press Update to update the display with information from the new transmitter. 5 Press Done to exit. Service Mode 5-5 5 Service Mode 3 Introduction 6 Maintenance By performing the maintenance activities described in this chapter, you can keep your Telemon in the best working condition. This chapter includes the following sections: Testing TeleMon’s Critical Functions . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Disinfecting the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5 Cleaning the NBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6 Calibrating NBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 Reconditioning the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8 Changing Date & Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10 Ordering Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10 Maintenance 6-1 6 Maintenance • • • • • • • Testing TeleMon’s Critical Functions Testing TeleMon’s Critical Functions TeleMon B provides self-test capabilities for critical functionality at power-on. This test is run automatically when the unit is turned on, and presents a checklist of critical components. The self-test should be performed at least once a month. The self-test includes: • • • • • • • • • Reporting the application and operating system Software Revision Numbers Checking system files to ensure the application software and the operating system are functioning correctly. The operating system driver returns an error if the file system is corrupt and will attempt to repair the file system like a standard PC disk checking mechanism. Reporting the TeleMon mainboard Hardware Revision Number Testing the speaker for alarm sounds Checking the clock Testing the keypad Reporting the internal NBP module Software Revision Number, NBP Calibration status, and Use Count Reporting the Battery Charge and Battery Reconditioning status Reporting the Transmitter battery status (if docked) In addition, since the test results are presented on the display, by implication the display is also tested. If during the power-on self-test you do not hear the alarm sound, turn off the monitor and turn it back on again. If the alarm sound still cannot be heard, contact your service representative. 6-2 Maintenance Testing TeleMon’s Critical Functions Test Results Self-Test Passed Upon completion of the test, the message “Self-test passed” indicates a successful test (see the example below). 6 Maintenance Maintenance 6-3 Testing TeleMon’s Critical Functions Self-Test Failed 6-4 Maintenance If a problem is detected, the message “Self-test failed!!!” is displayed as shown below. Follow the instructions on the screen and turn the monitor off then on again. If the problem persists, call your technical support personnel. An Event Log in Service Mode allows technical support personnel to view an information log documenting TeleMon operation. Disinfecting the Monitor Disinfecting the Monitor Disinfection Safety Messages Warning To prevent fire, provide adequate ventilation and do not permit smoking when cleaning or disinfecting the equipment. 6 Maintenance Disconnect line power and remove battery from TeleMon to prevent electrical shock and accidental turn-on during cleaning. Exposure of electrical contacts or connections to saline or other liquids is dangerous. Electrical contacts and connections such as cable connectors, power supplies, and plug-in connections must be kept clean and dry. Do not immerse this device in water. Caution Do not use any abrasive cleaning materials on any part or component of the TeleMon. Do not clean any part or component of the TeleMon in any overly vigorous or abrasive fashion. Using abrasive cleansers and abrasive cleaning actions will damage the components. Use only a 10% solution of sodium hypochlorite (bleach) in water as a cleaning fluid. Do not use any other cleansers, such as betadine. Remove the battery and any cables or accessories before you clean TeleMon. Under normal operation, the transmitter recess and TeleMon exterior should be disinfected between patients. Maintenance 6-5 Cleaning the NBP Cuff Task Summary To disinfect the TeleMon exterior, battery compartment, and transmitter recess, use the following directions: Step Action 1 Turn TeleMon OFF. 2 Disconnect the power cord, and remove the battery. 3 Undock the transmitter, and detach the NBP cable. 4 Wipe the outside surface, the battery compartment, and the transmitter recess with a pad dampened with a solution of 10% sodium hypochlorite (bleach) in water. Do not use any other cleaning agents. 5 Wipe all cleaned surfaces dry with a clean, dry pad. 6 If further cleaning is necessary a. Lightly spray surfaces with cleaning solution. b. Scrub down surfaces with a cotton swab, sponge applicator, or stiff brush. The area under the power contacts should be carefully cleaned such that all visible contamination is removed. c. Tip TeleMon to allow excess fluid to run out of recess and battery compartment. d. Wipe cleaned surfaces dry with a clean, dry pad. Note—Do not immerse the monitor in cleaning solution. 7 Allow TeleMon to air-dry for 1/2 hour before reuse. Cleaning the NBP Cuff The cuff can be disinfected by immersion in a decontamination solution of 7085% isopropyl alcohol, but remember to remove the rubber bag if you use this method. The cuff should not be dry cleaned. 6-6 Maintenance Calibrating NBP The cuff can also be machine-washed or hand-washed as recommended by the manufacturer; the latter method will prolong the service life of the cuff. Before washing, remove the latex rubber bag and, for machine-washing, close the Velcro fastening. Allow the cuff to dry thoroughly after washing, then reinsert the rubber bag . 6 Maintenance Calibrating NBP NBP calibration should be performed once a year or every 10,000 measurements, whichever comes first. The calibration procedure is done in the Service Mode of TeleMon. See M2636B TeleMon Service Guide for instructions, or your service provider for assistance. Maintenance 6-7 Reconditioning the Battery Reconditioning the Battery Warning Do not use the battery reconditioner in the patient vicinity. Be sure there is no contact between the patient and the charger, including no contact from the charger to a medical care giver to the patient. The Battery Reconditioner can be used for charging or reconditioning the TeleMon battery. During normal operating conditions, the battery is recharged while TeleMon is connected to an AC power source. However, over time the battery loses its ability to fully charge. When the battery’s capacity changes by 10% from the last time it was reconditioned, a microchip inside the battery indicates that it needs reconditioning to optimize performance. During the reconditioning process, the battery is discharged, charged, discharged again, and then charged again. The following table lists the definition for each LED state on the reconditioner. LED State Icon Definition Off No battery detected in bay Green Flash Charging Green Solid Fully charged Yellow Flash Reconditioning Yellow/Green Flash Reconditioned and fully charged Yellow Solid Standby: battery in bay waiting to be charged 6-8 Maintenance Reconditioning the Battery LED State Icon Definition Error: • Check the battery reconditioner bays to ensure that they are clean of foreign objects. • Ensure that the correct type of battery has been inserted. • Check to see if a battery is defective. The reconditioner indicates an error if a battery reaches a temperature higher than 65°C (149°F). Red Flash Task Summary (Recondition) 6 Maintenance 'HWHUPLQLQJZKHQWRUHFRQGLWLRQRUFKDUJHWKHEDWWHU\ The TeleMon monitor checks the battery during self-test, and the display indicates when the battery needs reconditioning or charging. To recondition a battery, use the following procedure. Step Action 1 Connect the conditioner to power. a. Plug the power supply into an outlet. b. Insert other end of the power cable into the power jack on the conditioner. 2 Insert the battery to be reconditioned into the LEFT bay. Note—Only the LEFT bay can be used for reconditioning. 3 Press the recondition button. The recondition button is the blue button with the symbol. During reconditioning, the LED flashes yellow. When reconditioning is complete, the LED flashes between yellow and green. Note—Reconditioning a battery can take over twelve hours. When reconditioning is complete, the battery is fully charged. Maintenance 6-9 Changing Date & Time Task Summary (Recharge) To charge a battery using the Reconditioner, use the following procedure. Step 1 Action Insert the battery to be charged into either bay. During charging, the LED flashes green. When charging is complete, the LED stays green. Changing Date & Time The date and time displayed at the upper right of the display can be adjusted in Service Mode. Refer to ‘Change Date & Time, Display Contrast” on page 5-4 or the M2636B TeleMon Service Guide for directions. The date/time format is: Weekday, Month DD, YYYY HH:MM where the Weekday and Month are spelled out in full. The hours range from 1 to 24. For example, Friday, February 09, 2001 15:32 Ordering Accessories The performance specifications and tolerance of TeleMon are established using manufacturer-supplied accessories and supplies. Non-manufacturer-supplied accessories and supplies may corrupt the performance of the equipment. We assume no liability for poor performance or injury caused by non-manufacturersupplied accessories and supplies. 6-10 Maintenance Ordering Accessories The following accessories are available for use with the TeleMon Monitor. Description Order Number Power Supply M4792A 10.8V Nickel Metal Hydride Battery NI1030AG, rechargeable M4790A Battery Reconditioner, Universal M4791A ECG Transmitter Trunk Cable M4793A 5-lead IEC M4794A 3-lead AAMI M4795A 3-lead IEC M4796A ECG/%SpO2 Cable Clip 6 Maintenance 5-lead AAMI M1509A 3-wire ECG Lead Set Snap, AAMI for M2601A, 0.7 m (30 inch) M2590A Grabber, AAMI for M2601A, 0.7 m (30 inch) M2591A Snap, IEC for M2601A, 0.7 m (30 inch) M2594A Grabber, IEC for M2601A, 0.7 m (30 inch) M2595A 5-wire ECG Lead Set Snap, AAMI for M2601A, 0.7 m (30 inch) M2592A Grabber, AAMI for M2601A, 0.7 m (30 inch) M2593A Snap, IEC for M2601A, 0.7 m (30 inch) M2596A Grabber, IEC for M2601A, 0.7 m (30 inch) M2597A Maintenance 6-11 Ordering Accessories Description Order Number Combiner Shield Replacement Kit 3-wire M2598A 5-wire M2599A ECG Electrode Kit ECG radiotranslucent foam electrode kit, 5/pack, 300/case M2202A Paper tape electrodes, 30/pack, 300/case 40489E Foam electrodes, 5/pack, 300/case 40493D Foam electrodes, 30/pack, 300/case 40493E SpO2 Transducer Reusable Adult Finger M1191A Reusable Pediatric/Small Adult Finger M1192A Reusable Adult/Pediatric Ear Clip M1194A SpO2 Extender Cable (2 meters) M1941A Wristband (ten straps per pack) M1627A Nellcor Oxisensor™ D-20 M1903B D-25 M1904B Adapter Cable for use with Nellcor Oxisensor™ disposable transducers 6-12 Maintenance M1943A Ordering Accessories Description Order Number NBP Cuff 40401B Traditional Multi-Patient—Adult 40401C Traditional Multi-Patient—Large Adult 40401D Latex-Free, Long-Life Multi-Patient—Pediatric M1572A Latex-Free, Long-Life Multi-Patient—Small Adult M1573A Latex-Free, Long-Life Multi-Patient—Adult M1574A Latex-Free, Long-Life Multi-Patient—Large Adult M1575A 6 Maintenance Traditional Multi-Patient—Pediatric NBP Cuff Connect Tubing Standard, 1.5m (5 ft) M1598B Long, 3.0m (10 ft) M1599B OXISENSOR II™ is a trademark of NELLCOR® Incorporated. Note—Disposable transducers are not available as manufacturer parts in the USA or Canada. In those countries, contact NELLCOR® Incorporated directly. Maintenance 6-13 Introduction 7 Specifications This chapter provides information on regulatory compliance with safety standards, product specifications and other safety information. It includes the following sections: • • • • • System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 Additional Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11 7 Specifications Specifications 7-1 System Specifications System Specifications Intended Use TeleMon is indicated for use in the monitoring, recording, and alarming of multiple physiologic parameters in adult and pediatric patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. TeleMon is a prescription device for use in healthcare facilities by trained healthcare professionals. TeleMon is not intended for home use. Safety Standards 0123 The M2636B TeleMon B Monitor complies with the Council Directive 93/42/ EEC of 14 June, 1993 concerning medical devices, and carries CE marking accordingly (CE 0123). The following accessories and system components are independently CEmarked: • Power Supply accessory • Battery and Battery Reconditioner accessory • Telemetry System Note—The Battery Reconditioner is not for use in the patient vicinity. The M2636B TeleMon B also complies with the following international safety regulations for medical electrical equipment: • IEC 60601-1/ EN 60601-1 • IEC 60601-1-1/ EN 60601-1-1 • IEC 60601-1-2/ EN 60601-1-2 • CAN/ CSA C22.2 No. 601.1-M90 • UL 2601-1 This CISPR-11 Class A, Group 1 device is not suitable for use in a domestic establishment or one that is connected directly to the low voltage public mains. The monitor is a Class 1 device and has an IPX 1 rating (excluding the power supply). The device has BF and CF applied parts. The system provides continuous operation when in use. 7-2 Specifications System Specifications NBP Standards Non-invasive blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or automated sphygmomanometers. Diastolic values correspond to Phase 5 Korotkoff sounds. The NPB portion of the device also meets all relevant parts of the following safety standards: • ANSI/AAMI SP10 • IEC 60601-2-30 NBP internal operating software ensures that: • • Authorized Europe/ Middle East/ Africa Representative Maximum cuff inflation time is limited to 60 seconds. Duration of blood pressure reading is limited to 170 seconds. Philips Medizinsysteme Böblingen GmbH Hewlett Packard Str. 2 71034 Böblingen Germany FAX: (+49) 7031 464 4297 7 Specifications Specifications 7-3 Electrical Specifications Electrical Specifications Line Power Power Input An external power supply is used. Input 100-250 VAC +6%/-10%; 50-60 Hz +/-6% Input Power Average (36 Watts, 64 VA), Max (39 Watts, 81 VA) Output 18 VDC Battery 7-4 Specifications Type 10.8V Nickel Metal Hydride Battery NI1030AG (NiMH Smart Battery, package style DR 35), M4790A Operating Time Typical 5 hours at 25º C (77º F) With %SpO2 and NBP measurements 4 times/ hour: up to 3.5 hours Charge Time From 15% of capacity to fully charged: 2-3 hours typical at 25º C (77º F), TeleMon on or off Electrodes Compatible with EC-12 electrodes only Environmental Specifications Environmental Specifications Operating Temperature Range Monitor without NBP Cuff: 0º C to 35º C (32º F to 95º F) Monitor with NBP Cuff: 10º C to 35º C (50º F to 95º F) Altitude Range Up to 3048 m (10,000 ft.) Humidity Range < 90% relative humidity at 35º C (95º F), noncondensing Shipping & Storage 0º C to 60º C (32º F to 140º F) / without battery 0 to 50º C (32 to 122º F) / with battery Altitude Range Up to 3048 m (10,000 ft.) Humidity Range < 90% relative humidity, non-condensing Specifications 7 Specifications Temperature Range 7-5 Measurement Specifications Measurement Specifications In the following tables, the default values for each measurement are denoted in brackets {}. SpO2 Item Range of Values {default} SpO2 Limit Alarms High Range: 51 to 100 %SpO2 Low Range: 50 to 99 %SpO2 Adjustment: 1% steps Alarm Severity: Yellow Alarm Delay: Maximum 10 seconds after value goes above the high or below the low alarm limit. SpO2 Measurement Range 0 to 100% Pulse Rate Measurement 30 to 300 b/min Accuracy: ±2 % Resolution: 1 b/min Note—SpO2 pulse rate performance is only specified to 30 b/min. Below 30 b/min, pulse rate is displayed as -?-. (No Alarm Limit) NBP 7-6 Specifications Item Range of Values {default} Measurement Range Systolic: 40 to 260 mmHg Diastolic: 25 to 200 mmHg Initial Inflation Pressure Adult: 160 mmHg Pediatric: 120 mmHg Measurement Specifications Range of Values {default} Maximum Pressure 280 mmHg Overpressure Safety Limit 300 mmHg (max) Accuracy ±3 mmHg or 5% of reading (whichever is greater) Heart Rate Range 40 to 200 b/min Cuff Deflation Rate 6 mmHg/step NBP Alarm Range at Central 10 to 260 mmHg Rated Life 30,000 measurement cycles (36/day for 2.3 years) Cuff Inflation Time 60 sec maximum Limitations on Use Not for use on neonates. When used on patients suffering from cardiac arrhythmias, information presented will have undefined accuracy. See safety warning and caution messages under “Measuring NBP” on page 39. Auto Mode Repetition Time 5, 10, 15, 30, 60 or 120 minutes Measurement Time (average @ HR > 60 b/ min) Auto/Manual mode: 30 sec (average) Auto/Manual mode: 170 sec (maximum) Specifications 7-7 7 Specifications Item Measurement Specifications Pulse Item Range of Values {default} Default Alarm Limits at TeleMon Systolic high limit: 150 mmHg Systolic low limit: 90 mmHg Diastolic high limit: 120 mmHg Diastolic low limit: 50 mmHg NBP Alarm Ranges at TeleMon Systolic high alarm: 15 - 260 mmHg Systolic low alarm: 10 - 255 mmHg Diastolic high alarm: 15 - 260 mmHg Diastolic low alarm: 10 - 255 mmHg NBP Alarm Delay from TeleMon B to Central (Information Center) < 10 sec Item Range of Values {default} Pulse Measurement Range 30 - 300 b/min Item Range of Values {default} Primary Monitoring Lead I, {II}, III, AVF, AVL, AVR, V, or MCL Multi-Lead/Single-Lead (not configurable) Single-Lead only Patient Type {Adult}, Pediatric Paced/Not Paced Paced or {Not Paced} . ST/AR 7-8 Specifications Measurement Specifications Item Range of Values {default} Arrhythmia Alarms {ON} when local alarms are on, {Off} when local alarms are off Note—When local alarms are turned off, there are no local arrhythmia alarms at TeleMon; arrhythmia alarms will be present only at the Information Center. Heart Rate Range 15 - 300 b/min; if fewer than 15 b/min heart rate is set to zero Limit Alarms for Heart Rate Heart Rate High Limit: 20 - 300 b/min, increments of 5 b/min Heart Rate Low Limit: 15 - 295 b/min, increments of 5 b/min for heart rates greater than or equal to 50 b/min; increments of 1 b/ min for heart rates less than 50 b/min; {fixed at 4sec} Extreme Brady Min (not configurable) {40 b/min; adult & ped} Extreme Brady Difference 0 to 50 b/min {20 b/min} Extreme Tachy (not configurable) Difference to High Limit: {20 b/min} Clamping at: {200 b/min; adult}, {220 b/min; ped} Vent Tach HR (not configurable) Adult:{100 b/min} Pediatric: {120 b/min} Vent Tach Run (not configurable) High Limit: {>=5 PVCs} 7 Specifications Asystole (not configurable) Specifications 7-9 Measurement Specifications Item Range of Values {default} PVC rate (not configurable) High Limit: {30 PVCs/min} Timeout Period First Level (not configurable) Fixed: 5 minutes (used for HR rate & Pace alarms) Timeout Period Second Level (not configurable) Fixed: 10 minutes (used for PVC rate alarm) Alarm Reminder No reminder active in TeleMon Heart Rate Parameter Defaults HR High Limit {120} HR Low Limit {50} HR 7-10 Specifications Additional Safety Information Additional Safety Information Electromagnetic Compatibility The electromagnetic compatibility (EMC) validation of the TeleMon Monitor included tests performed according to the international standard for EMC with medical devices. See the Manufacturer’s Declaration of Conformity for details. During the test program, the TeleMon was subjected to many EMC tests, both international standard and proprietary tests. During most of the testing, no anomalies were observed, except for some immunity tests which required reduced levels of the external influence for compliance. EN 61000-4-3 specifies that the product be subjected to an electromagnetic field of 3 V/m over a frequency range of 26 to 1000 MHz with no degradation of performance. At most of the test frequencies in this specified range, no anomalies were observed. However, at the product transmit/receive frequency, and a few others, the radiated field imposed caused interference with a resultant drop-out of ECG and pleth signal. For frequencies in the range of 108.89 MHz to 223 MHz a reduced level of 1.0 V/m was met, and in the range of 311 MHz to 601 MHz a reduced level of 1.6 V/m was met, with no anomalies. IEC 801-2 The IEC 801-2 Electrostatic Discharge Test calls for the product to withstand air discharges at up to 8 kV, and contact discharges to exposed metal on the TeleMon or to a nearby metal plate at voltage settings up to 4 kV with no change of operating state. The Telemon passes the air discharge test and contact discharge tests at a reduced level. Air discharges of more than 6 kV to the screws on the rear of the TeleMon housing, or to the bottom of the housing, may cause an instrument reset, whereby the product goes through Power-on Self-Test (as if the TeleMon were just powered on). Some settings revert to default selections. Lower levels of air discharge, or the contact discharge test, may cause a momentary ECG information message to occur, but with no change of state. Avoiding Electromagnetic Interference If electromagnetic interference (EMI) is encountered, there are a number of actions that can be taken to mitigate the problem. Specifications 7-11 7 Specifications EN 61000-4-3 Additional Safety Information • • • • 7-12 Specifications Eliminate the source. Possible sources of EMI can be turned off or moved away to reduce their strength. Attenuate the coupling. If the coupling path is through the patient leads, the interference may be reduced by moving and/or rearranging the leads. If the coupling is through the power cord, plugging the TeleMon into a different circuit or moving the power supply away from the monitor may help. Add external attenuators. If EMI becomes an unusually difficult problem, external devices such as an isolation transformer or a transient suppressor may be of help. A service representative or designee can be of help in determining the need for external devices. Cellular telephones and other wireless devices are a possible source of signal interference with patient monitors and telemetry transmitters. Our recommendation is to keep an operating cell phone at least 30 cm (1 ft) away from the TeleMon. Additional Safety Information Explanation of Symbols The following icons can be found on the TeleMon exterior and/or in this User’s Guide. Symbol Explanation Warning! Consult accompanying documents (including this User’s Guide) and particularly any warning messages before use. 0123 This device complies with the Council Directive 93/ 42/EEC of 14 June 1993 concerning medical devices. This device complies with Canadian Standards Association and nationally recognized testing lab requirements. Prescription Device IPX1 Degrees of protection provided by enclosures; protected against vertically falling water drops Applies to the NBP Module; indicates that the module is Type BF Defibrillation Proof and is designed to have special protection against electric shocks for intra-cardiac application, particularly regarding allowable leakage currents by having an F-type isolated or floating applied part. Electrical Power Input Specifications 7-13 7 Specifications Applies to the transmitter, indicates that the instrument is Type CF Defibrillation Proof and is designed to have special protection against electric shocks for intra-cardiac application (particularly regarding allowable leakage current by having an F-type isolated or floating applied part), and is defibrillator proof. Additional Safety Information Power ON Power OFF Battery Insertion Port Date of Manufacture Direct Current Contains Nickel Metal Hydride (NiMH) Battery. Battery must be recycled. TRANSLATION: FOR NETHERLANDS ONLY. OTHER COUNTRIES, OMIT THIS SYMBOL & EXPLANATION. The following telemetry icons can be displayed at the information center. They are also found in this User’s Guide. Symbol Explanation Undocked transmitter Transmitter docked in TeleMon 7-14 Specifications Additional Safety Information The following icons can be found on the Battery Reconditioner and in this User’s Guide. Symbol Explanation No battery detected in bay LED State: Off Charging LED State: Green Flash Fully charged LED State: Green Solid Reconditioning LED State: Yellow Flash Reconditioned and fully charged LED State: Yellow/Green Flash Standby: battery in bay waiting to be charged LED State: Yellow Solid Specifications 7-15 7 Specifications Error: • Check the battery reconditioner bays to ensure that they are clean of foreign objects. • Ensure that the correct type of battery has been inserted. • Check to see if a battery is defective. The reconditioner indicates an error if a battery reaches a temperature higher than 65°C (149°F). LED State: Red Flash Additional Safety Information The following symbols can be found on the M2601A Transmitter. Symbol Explanation Compliance to Council Directive 93/42/EEC (MDD) 0123 Compliance to Council Directive 1999/5/EC (R&TTE) when transmitter is used with the M2611A Battery Extender device. (This marking is on the M2601A transmitter only.) Considered Class 2 radio equipment per Directive 1999/5/EC for which Member States may apply restrictions on putting the device into service or placing it on the market. This device is intended to be connected to the publicly available interfaces (PAI) for use throughout the EEA: AT, BE, DE, DK, ES, FI, FR, GK, IE, IS, IT, LI, LU, NL, NO, PT, SE, UK Compliance to Council Directive 1999/5/EC (R&TTE) when transmitter is used with the M2636B TeleMon B Monitor. (This marking is on the M2601A transmitter only.) IPX0 7-16 Specifications The M2600A is rated as IPX0 in degrees of protection provided by enclosures; not protected against ingress of water. Please call your local sales office listed in your telephone directory or a regional office listed below for the location of your nearest sales office. CORPORATE HEADQUARTERS: Philips Medical Systems Netherlands B.V. Postbus 10.000 5680 DA Best Netherlands UNITED STATES: Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 (800) 934-7372 CANADA: Philips Medical Systems 2660 Matheson Blvd. E. Mississauga, Ontario L4W 5M2 (800) 291-6743 EUROPE, MIDDLE EAST AND AFRICA: Philips Medizinsysteme Böblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Str. 2 71034 Böblingen Germany Fax: (+49) 7031 463 1552 A-1 Introduction 1 About TeleMon B A Sales and Support Offices LATIN AMERICA HEADQUARTERS: Philips Medical Systems 5200 Blue Lagoon Drive 9th Floor Miami, FL 33126 (305) 267-4220 ASIA PACIFIC HEADQUARTERS: Philips Medical Systems 24F Cityplaza One 1111 King’s Road Taikoo Shing, Hong Kong (+852) 3197 7777 A-2 Index A accessories 6-10 alarm sounds 4-3 alarms indicators 4-3 INOP 4-9 limits 4-16 local 4-15 messages 4-8 mode 4-7 patient 1-5 red 4-8 setting limits 4-16 silencing 4-17 suspending 4-18 turning on/off 4-15 types 4-2 volume 4-15 yellow 4-8 antenna range 2-18 arrhythmia ST/AR algorithm 3-3 arrhythmia relearn 2-14 auto shutoff 2-7 B battery 2-2 charge indicator 1-10 general information 2-4 inserting 2-3 insertion 2-6 recharging 2-6, 6-10 reconditioning 6-8, 6-9 battery reconditioner LED state 6-8 bell icon 1-12 C calibration NBP 6-7 cellular telephone interference 7-12 changing contrast 5-4 date 5-4 time 5-4 cleaning cautions 6-5 contrast 5-4 D date 5-4 demo mode 5-3 disinfecting 6-5 display details 1-11 display icons 1-12 docking the transmitter 2-7–2-9 E ECG 3-2 fallback 3-5 information messages 4-11 measuring 3-2 electromagnetic compatibility 7-11 electro-magnetic interference avoiding 7-11 element 2-12 Index i EMC 7-11 EN 61000-4-3 7-11 F fallback EASI transmitter 3-6 ECG 3-6 standard transmitter 3-6 front panel indicators 2-2 I icons 1-12 IEC 801-2 7-11 information messages 4-10 ECG 4-11 NBP 4-11 SpO2 4-13 transmitter 4-14 INOP alarms 4-9 K keys defined 1-9 M Main Screen 1-11 maintenance 6-1–6-13 measurement specifications 7-6 measurements 3-1–3-17 messages alarm 4-8 safety 1-6, 2-15, 3-3 monitor connecting power supply 2-3 diagrams 1-7 disinfecting 6-5 front panel 1-8 inserting battery 2-3 intended use 7-2 main display 1-11 overview 2-13 ii Index powering 2-2, 2-3 setup 2-13 monitor settings changing 2-15 monitoring stand-alone 1-5 telemetry extension mode 1-5 monitoring mode stand-alone 1-5 telemetry extension 1-5 N NBP alarm setting selection 3-16 calibration 6-7 cautions 3-12 information messages 4-11 measurement limitations 3-10 measuring 3-9–3-16 repeat time 3-16 safety warnings 3-12 setup 3-13 standards 7-3 start or stop 1-10 starting and stopping 3-15 NBP cuff cleaning 6-6 non-invasive blood pressure measuring 3-9 start or stop reading 1-10 O on/off switch 1-8 online information 2-13 ordering supplies 6-10 P pacer detection 2-13 pacing safety messages 2-15, 3-3 parameters changing 2-12 patient type 2-13 pleth wave displaying 3-9 R range antenna 2-18 reconditioning the battery 6-8 recording at central 3-17 restore standard settings 5-3 stand-alone monitoring 1-5 standards NBP 7-3 safety 7-2 supplies 6-10 suspend alarms 4-18 symbols battery reconditioner 7-15, 7-16 defined 7-13 information center 7-14 transmitter 7-16 T S safety standards 7-2 safety message pacing 2-15, 3-3 ST/AR arrhythmia 3-3 safety messages 1-6 save current settings 2-14, 2-16 self-test 6-2 service mode 5-1–5-5 accessing 5-2 setup 2-13 shutdown 2-5 specifications electrical 7-4 environmental 7-5 measurement 7-6 NBP 7-6 SpO2 7-6 system 7-2 SpO2 3-8 accessories 6-12 alarm settings 3-8 information messages 4-13 measuring 3-8 SpO2 sample rate changing 3-9 ST/AR 3-3 task list 2-12 telemetry extension 1-5 time 5-4 transmitter docked 2-8 information messages 4-14 undocked 2-10 viewing information 5-5 trunk cable 3-7 U undocking the transmitter 2-10 unit settings 2-17 restore 2-18 W wave changing 3-7 waveform size changing 3-7 Index iii