Philips Medical Systems North America M4842A IntelliVue Access Point User Manual Animation IFU

Philips Medical Systems North America Co. IntelliVue Access Point Animation IFU

Instructions for Use

Instructions for UseIntelliVue TRx/TRx+ Transceivers for the Philips IntelliVue Telemetry System with Smart-Hopping TechnologyPart Number: M4841-91001Printed in the U.S.A. November 2004First Edition NoticeOperation of this equipment in the United States re-quires the prior coordindation with a frequency coor-dinator designated by the Federal CommunicationsCommission (FCC) for the Wireless Medical Teleme-try Service.
Printing HistoryiiNotice Equipment specifications are subject to alteration without notice. All changes will be in compliance with regulations governing manufacture of medical equipment.Printed in the USA.Document number: M4841-91001© Copyright 2004 Koninklijke Philips Electronics N.V. All Rights Reserved.OxiCliq and OxiMax are registered trademarks of Nellcor® Incorporated.Printing HistoryNew editions of this document will incorporate all material updated since the previous edition. Update packages can be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Note that pages which 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.First Edition ...............................................................................November 2004Philips IntelliVue Telemetry System with Smart Hopping Technology is compatible with:Philips Information Center, software revision F.00Philips TeleMon Companion Monitor, #A02/A03
About this Book iiiAbout this BookThis book contains operating instructions for use of the IntelliVue TRx and TRx+ Transceivers as used with the Philips IntelliVue Telemetry System with Smart-hopping Technology. It also includes operational information for the Telemetry functions of the IntelliVue Information Center. The intended audience is the clinician who uses and/or teaches others to use the equipment in a healthcare environment. For operating information on other functionality of the Information Center, see IntelliVue Information Center Instructions for Use. For preventive maintenance, repair, and test methods for verification of device performance, refer to the Philips IntelliVue Telemetry System Service Kit.This book does not address the Philips M2601B Transmitter or the M2600B Philips Telemetry System. For information on those products, refer to the manual Philips Telemetry System Instructions for Use.Note—Use this product in conjunction with Philips IntelliVue Information Center Instructions for Use and Online Help, and with Philips TeleMon A02/A03 Companion Monitor Instructions for Use. See also the Philips IntelliVue Telemetry Training Program.Document Conventions WarningsWarningWarningWarnings are information you should know to avoid injuring patients and personnel. CautionsCautionCautions are information you should know to avoid damaging your equipment and software.
Product Safety InformationivNotesNote—Notes contain additional information on use of the Philips IntelliVue Telemetry System.ProceduresProcedures are indicated in text by the heading “Task Summary” followed by the following table:Bold TypefaceObjects of actions in procedures appear in bold typeface. Note the following example:Select the Standby button.Product Safety InformationThe following general warnings and cautions apply to use of the Philips IntelliVue Transceivers in a Philips IntelliVue Wireless Network. Additional warnings and cautions specific to a particular feature are provided in the appropriate section.GeneralWarningWarningFor continued safe use of this equipment, it is necessary that the listed instructions are followed. Instructions in this manual in no way supersede established medical procedures.Step Action123
Product Safety Information vWarningWarningDo not touch the patient, or table, or instruments, during defibrillation.The battery door must be closed during defibrillation. These steps protect the clinician from high defibrillator voltage.WarningWarningThis device is not to be used in the vicinity of electrosurgical units because use may interrupt or interfere with the transmission of signals from the transceiver.WarningWarningThis equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxideWarningWarningDo not use patient cables with detachable lead wires that have exposed male pins. Electrocution could result if these pins are plugged into AC power.WarningWarningUse of product accessories (e.g., ECG leadsets, SpO2 sensors) other than those prescribed by Philips could lead to patient injury.WarningWarningTo avoid strangulation, do not tie a pouch solely around the patient’s neck.
Product Safety InformationviECG/ Arrhythmia -All Patients WarningWarningECG SAFETY FOR ALL PATIENTSAlways confirm Information Center observations with clinical observation of the patient before administering interventions.Every lead must be secured to an electrode on the patient. Conductive parts of electrodes must not contact earth or other conductive parts.Philips recommends that you change the lead label only to reflect the physical placement of electrodes. This will ensure a match between the monitored lead and the label, and prevent any possible confusion.When switching between EASI and standard monitoring, there is a loss of data for 30 seconds.
Product Safety Information viiWarningWarningST/AR ARRHYTHMIA SAFETY FOR ALL PATIENTSDuring complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest.Learning/Relearning- If you initiate learning during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can 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 technical alarm. If learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. Be sure to check the beat labels and initiate a relearn to correct. Therefore, when a technical alarm is generated:1. Respond to the technical alarm [for example, reconnect the electrode(s)].2. Ensure that the arrhythmia algorithm is labeling beats correctly.
Product Safety InformationviiiECG/Arrhythmia - Paced Patients WarningWarningECG SAFETY FOR PACED PATIENTSThe output power of the transceiver and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker 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. In order to minimize the possibility of interference, position electrodes, electrode wires, and the transceiver as far away from the pacemaker as possible. Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the Philips IntelliVue Telemetry System. See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced patients.
Product Safety Information ixWarningWarningST/AR ARRHYTHMIA SAFETY FOR PACED PATIENTSIt is possible that pacemaker pulses will not be detected when the ECG analog output of a defibrillator or telemetry unit is plugged into a bedside monitor. This can result in the arrhythmia algorithm’s failure to detect pacemaker non-capture or asystole.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) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest.-- When arrhythmia monitoring paced patients who exhibit only intrinsic rhythm, the monitor can erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest.For patients who exhibit intrinsic rhythm only, the risk of missing cardiac arrest can 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 alarms 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 can result in the arrhythmia algorithm’s failure to detect pacemaker non-capture or asystole.
Product Safety InformationxSpO2WarningWarningSpO2 SAFETYAlways confirm Information Center observations with clinical observation of the patient before administering interventions.Prolonged, continuous monitoring can increase the risk of changes in skin characteristics, such as irritation, reddening, blistering or pressure necrosis, particularly on patients with impaired perfusion and varying or immature skin morphology. Specific attention must be given to sensor site inspection for changes in skin quality, proper optical path alignment and attachment. Check the application site at regular intervals and change the site if any compromise in skin quality should occur. More frequent checking can be required due to an individual patient's condition.Using a sensor during MR imaging can cause severe burns. To minimize this risk, ensure that the cable is positioned so that no inductive loops are formed. If the sensor does not appear to be operating properly, remove it immediately from the patient.Do not use disposable sensors on patients who exhibit allergic reactions to the adhesive.Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin can lead to inaccurate (over-estimated) measurements.Interference leading to inaccurate measurements can be caused by:- High levels of ambient light (Hint: cover application site with opaque material)- Electromagnetic interference- Excessive patient movement and vibration.
ContentsContents-1General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ivECG/ Arrhythmia -All Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-viECG/Arrhythmia - Paced Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-viiiSpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-x1. Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1The Philips IntelliVue Telemetry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 The IntelliVue Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Transceiver Controls - Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7Transceiver Controls - Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11Turning the Transceiver On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15Turning the Transceiver Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16Testing intelliVue Transceiver Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17Status Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18Battery Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19Battery Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19Inserting/Removing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20Checking the Battery Power Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22Briefing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24Pouch Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24Securing the Pouch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25Showering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26Transceiver Use with TeleMon A02/A03. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-272. Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Testing Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Suspending/Pausing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Resuming/ Unsuspending Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5Alarm Behavior with Own Bed Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7Physiologic Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9Technical Alarms (INOPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Contents-23. ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1ECG Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2Measuring ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3EASI ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3ECG Leadsets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3ECG Leads Monitored . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Positioning ECG Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8Electrode Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19Verifying Electrode Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22Monitoring during Leads Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23ECG Fallback. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23Extended Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24Relearning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24Using EASI Leads to Troubleshoot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24Optimizing ECG Measurement Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25The Telemetry Signal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25Trouble- shooting Signal Disturbances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26Dropouts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26Muscle and Movement Artifact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-274. ST/AR Arrhythmia & ST Segment Monitoring. . . . . . . . . . . . . . . . . . . . . . . . 4-1ST/AR Arrhythmia Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2ST/AR Arrhythmia Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3ST/AR ST Segment Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6The Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6Algorithm Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8Displayed ST Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8EASI ST Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8ST Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9ST Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-115. SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1SpO2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2SpO2 Information for the User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3Pulse Oximetry Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4Pulse Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5Selecting a SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 Applying the Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Contents-3Sensor Application Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9Sensor Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10Connecting the SpO2 Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-14Measuring SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15Spot Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-15 Continuous. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16SpO2 Measurement when Connected to TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17Turning SpO2 Monitoring Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18Turning the SpO2 Parameter On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19SpO2 Parameter Auto ON. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19Understanding SpO2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20Optimizing SpO2 Measurement Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21Optimizing Sensor Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-226. Telemetry Functions at the Information Center . . . . . . . . . . . . . . . . . . . . . . . 6-1Telemetry Controls in the Patient Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2Locating the Transceiver (Find Device) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3To locate a transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3 To silence the sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3 Patient-Configurable Settings in Telemetry Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3Unit-Configurable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-87. Maintenance & Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2Basic Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2Label Assignment for Replacement Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2Transceiver Cleaning, Disinfection, & Cross-Infection Prevention . . . . . . . . . . . . . . . . . . . . . . .7-4Cleaning the Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-5Disinfecting the Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6Cross-Infection Prevention for the Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15Basic Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15Testing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15Information Signals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-158. Safety Standards & Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
Contents-4Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2Rx. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2Patient Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2Safety Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3System Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3FCC Compliance (USA only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4AC Power Source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5Battery Life Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6Restrictions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8Radio Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8M4841A Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8WMTS Channel Frequencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11ECG-only Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11ECG/SpO2 Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12M4841A Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12 Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-13ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15SpO2 Sensor Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16A. Accessory List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1Accessory Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2ECG Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2Leadsets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2Trunk Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3Pouches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3Skin Prep Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3Alignment Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4Gunk Guards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4SpO2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4Disposable Sensors - Single Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5Wristband. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6B. Sales and Support Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Basic Operation 1-1Introduction1Basic OperationThis chapter introduces the Philips IntelliVue Telemetry System with Smart-hopping Technology and the IntelliVue TRx and TRx+ Transceivers. It includes the following sections:• The Philips IntelliVue Telemetry System. . . . . . . . . . . . . . . . . . . . . . . 1-2• The IntelliVue Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3• Turning the Transceiver On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15• Testing intelliVue Transceiver Functionality . . . . . . . . . . . . . . . . . . . 1-17• Battery Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19• Pouch Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24• Transceiver Use with TeleMon A02/A03. . . . . . . . . . . . . . . . . . . . . . 1-27• Transceiver Use with TeleMon A02/A03. . . . . . . . . . . . . . . . . . . . . . 1-27
The Philips IntelliVue Telemetry System1-2 Basic Operation The Philips IntelliVue Telemetry SystemThe Philips IntelliVue Telemetry System with Smart-hopping Technology provides ambulatory and bedside monitoring of ECG and SpO2 parameters over the radio frequency (RF) spectrum newly allocated for medical telemetry applications by the Federal Communications Commission (FCC). The System enables clinically significant data and control information for adult and pediatric patients in healthcare facilities to be received from and sent to the transceiver, a patient-worn device, via a bi-directional RF link over the Wireless Medical Telemetry Service (WMTS) spectrums 1395-1400 MHz and 1427-1432 MHz.The System uses smart-hopping technology to dynamically manage the RF spectrum utilization per transceiver, thus allowing a virtually unlimited number of simultaneously operating transceivers within the Philips IntelliVue Telemetry System. The frequency-agile system changes frequency without user involvement or awareness whenever interference occurs.The System encompasses a number of individual units which connect together to form a complete method of transporting ambulatory patient data to a central repository for subsequent distribution to clinical staff. An installation typically consists of the following components:• M4841A Transceivers, bi-directional patient-worn devices• M4842A Access Points (AP), centers for bidirectional communication between the transceivers and the Information Center.• IntelliVue Wireless Network (IWN) infrastructure (including M4843A Access Point Controllers, M4844A Sync Units, M4845A Power Supply Units)• M3150A IntelliVue Information Center for centralized monitoring• M3154A IntelliVue Database Server (optional) for centralized data management• M2636A TeleMon A02/A03 Companion Monitor (optional) for local display, NBP measurement and local alarms.The network interconnects Access Points to the Information Center and other central equipment via the same network that connects IntelliVue bedsides to the Information Center. Access points receive signals, and unlike traditional antenna systems, can communicate bidirectionally. Access Points are powered, controlled and managed remotely via the IWN.
The IntelliVue Transceiver Basic Operation 1-3System Features • Full patient mobility within the areas defined by the wireless coverage provided by multiple Access Points.• Expanded geographic coverage area for a a given patient assigned to an IntelliVue Clinical Network. Physiological data is transported from the transceiver; a reverse data channel enables data to be transported to the transceiver.• 3-minute Alarm Pause/Suspend initiated at the transceiver.• Standby mode when a patient is away from the unit and not being monitored by the Philips IntelliVue Telemetry System.• Find Device feature for locating a lost transceiver within the coverage area. • Access Points operating concurrently with the networked bedside wireless capability while sharing some of the ICN infrastructure. • Use of the radio spectrums newly allocated by the FCC specifically for medical telemetry applications.• Connectivity to TeleMon for display of patient measurements - including NBP - at the bedside. The IntelliVue TransceiverThe Philips IntelliVue transceiver is a patient-worm device for monitoring ECG and SpO2 on adult and pediatric patients in the IntelliVue Telemetry System System Information Flow/Smart-hopping diagram to come
The IntelliVue Transceiver1-4 Basic Operation with Smart-Hopping Technology, a cellular infrastructure network. The transceiver combines traditional transmitter features with two-way communication capability with the IntelliVue Information Center. The transceiver is designed to be easy for clinicians to use and comfortable for patients to wear. Colored labels provide departmental identifiers. The leadsets are optimized for ambulating patients, with a cable length of 79 cm (30 inches). Protective covers prevent dirt from accessing unused ECG and SpO2 cable ports, thus simplifying cleaning. The transceiver is available in two models, the ECG only called the IntelliVue TRx, and the ECG-SPO2 version, called the IntelliVue TRx+. The models are listed below and illustrated on the following pages in this chapter. Subsequent tables describe the buttons, indicators, labels, ports, safety symbols & other markings, and auditory information signals of the transceiver respectively.The transceiver comes with a start-up kit of batteries, electrodes, and pouches.Transceiver Model(M4841A) MeasurementsIntelliVue TRx ECGIntelliVue TRx+ ECG, SpO2
The IntelliVue Transceiver Basic Operation 1-5Note— The IntelliVue Transceiver and M2601B Transmitter are similar in appearance. If your hospital uses both, you can distinguish between them by:• Name on the front of the device• Label background color (pale gray for transceivers, dark gray for transmitters)TransceiverFeatures • Clinician-selectable 5-lead Standard or EASI leads in same device, at the bedside• 6-leadset with two V leads for diagnosing multiple cardiac abnormalities, including wide-QRS complex tachycardias and acute myocardial ischemia/infarction• Powered by two AA Alkaline batteries• Spot-Check SpO2 without using any control buttons IntelliVue TRx Transceiver - ECG onlyEASI, 3 5M2601BEASI, 3 5,6IntelliVue TRx+M4841AIntelliVue TRx+M4841A
The IntelliVue Transceiver1-6 Basic Operation •FAST-SpO2 (Fourier Artifact Suppression Technology) for improved motion artifact rejection and low-perfusion performance• Audio feedback for Spot Check SpO2 completion and other common tasks• Simultaneous operation in system with M2601A Transmitter• Two sizes - smaller ECG only version and larger ECG/SpO2 version• Battery gauge on transceiver and, if configured, at Information Center• Colored labels provide clinical unit identifiers.• Leadsets are optimized for ambulating patients, with a cable length of 79 cm (30 in).• Gunk guards prevent debris from accessing unused ECG and SpO2 cable ports and the unused TeleMon/Service port, thus simplifying cleaning.• Pouch with clear front and flap.Use withInformationCenterThe bi-directional capability enables remote control from the Information Center of the following transceiver operations:• From the Telemetry Setup Window:–SpO2 measurement mode (Spot Check, Continuous, or Off)– Display and storage of real-time pleth wave (enable/disable)– Volume of audible transceiver information signals– Find device– Suppression of SpO2 technical alarms during NBP measurement• From the Patient Window– Standby mode– Filter bandwidth for ST measurement on/off– Alarm Pause/Suspend (enable/disable)• From Unit Settings– Display of battery gauge (enable/disable)– 3-wire Lead SelectionThe system supports Own Bed Overview, the pairing of a telemetry bed with an IntelliVue Patient Monitor (Release B or higher) for a single patient. Own Bed Overview provides the telemetry-monitor data (waveforms, numerics and alarms) in an integrated form both on the bedside monitor and at the IntelliVue Information Center.Use withTeleMonA02/A03The transceiver can employ the full functionality of the TeleMon A02/A03 companion monitor, including NBP measurement and local display of alarms. Connection is made through an interface cable, or tether, at the TeleMon service
The IntelliVue Transceiver Basic Operation 1-7port. Please refer to the TeleMon A02/A03 Instructions for Use for general operating instructions and “Transceiver Use with TeleMon A02/A03” on page 1-27 for an operational summary.Transceiver Controls - FrontIntelliVue TRx+ Transceiver - Front ViewI3I2I1I4B1B2B3EASI, 3 5,6IntelliVue TRx+M4841AL3P1P2P3L1L2The labeled items in the diagram include: Buttons (B1-B3);Indicators (I1-I4); Labels (L1-L4); Ports (P1-P3). AdditionalLabels, and Safety Symbols & Other Markings (S1-S12, ap-pear on the back of the transceiver.
The IntelliVue Transceiver1-8 Basic Operation ButtonsB1B2B3EASI, 3 5,6IntelliVue TRx+M4841ACallout Button DefinitionB1 Telemetry Button: Depending on configuration, directs the Information Center to generate a Nurse Call alarm, remote recording, Nurse Call alarm and recording, or none. See “Patient-Configurable Settings in Telemetry Setup” on page 6-3. Note—Delayed recordings generated by the Telemetry button are stored in Alarm Review at the Information Center.When pressed simultaneously with the Check button, turns Alarm Suspend/Pause on/off (not when tethered to TeleMon). See “Suspending/Pausing Alarms” on page 2-2. B2 Check Button. Initiates a Status Check of the Transceiver. See “Status Check” on page 1-18.When pressed simultaneously with the Telemetry Button, turns Alarm Suspend/Pause on/off (not when tethered to TeleMon). See “Suspending/Pausing Alarms” on page 2-2.Silences the Find Device tone.See “Telemetry Controls in the Patient Window” on page 6-2.B3 Power On/Off Battery Compartment. Insertion of batteries turns transceiver power on; removal of batteries turns power off. See “Turning the Transceiver On” on page 1-15.
The IntelliVue Transceiver Basic Operation 1-9IndicatorsEASI, 3 5,6IntelliVue TRx+M4841AI3I4I2I1 Callout Indicator DefinitionI1 Lead Indicator. Illuminates momentarily during leadset insertion to indicate attached leads.Illluminates when Check button is pressed to indicate attached leads.During a Leads Off condition, illuminates to indicate the lead(s) that need to be reapplied.Momentarily illuminates three alternate lights, indicating the transceiver has no Equipment Label assigned.I2 EASI Indicator. Illuminates momentarily upon insertion of leadset in EASI position.Illuminates when Check button is pressed if EASI is in use.I3 Alarms Suspend/Pause Indicator. Illuminates during 3 minute alarm pause initiated at transceiver or Information Center.I4 Battery Gauge. Illuminates when the EHck button is pressed to indicate the amount of power remaining in the batteries. Valid only for recommended battery type. See “Checking the Battery Power Level” on page 1-22.EASI
The IntelliVue Transceiver1-10 Basic Operation LabelsPortsNote— Ports can be covered with protective covers (gunk guards) when not in use. See “Gunk Guards” on page -4.EASI, 3 5,6IntelliVue TRx+M4841AL1L2L3Callout Label DefinitionL1 Leadset Insertion Guide. Assist in aligning the ECG cable for different leadsets. See “Connecting the ECG Cable” on page 3-19.Note—If your unit uses only one monitoring configuration, the transceiver may have special "lock out" plugs that allow only one way to insert the leadset.L2 Device Identification Label. Identifies the device within the IntelliVue Wireless Network.L3 Unit Identification Label. Uses one of seven color-coded labels to identify a clinical unit.EASI, 3 IntelliVue TRx5,6M4841AEASI, 3 5,6IntelliVue TRx+M4841AP1 P2P3Callout DefinitionP1 ECG Leadset Port. Connection for 3-wire or 5-wire leadset.P2 SpO2 Sensor Port. Connection for SpO2 sensor. (IntelliVue TRx+ only)P3 TeleMon/Service Port. Connection for cable to TeleMon Companion Monitor or to Service Tool.
The IntelliVue Transceiver Basic Operation 1-11Transceiver Controls - Back IntelliVue TRx+ Transceiver - Back ViewEASIEASI EASIIEAS123456 S2S3S4S5S6FCCID: XXXXXXXX(inside batterycompartment) S1L4S7-S11 not shown
The IntelliVue Transceiver1-12 Basic Operation LabelsSafetySymbols &Other MarksEASI EASIIEAS123456L4 Callout DefinitionL4 Electrode Placement Diagrams (See “Positioning ECG Electrodes” on page 3-8.)Callout Label DefinitionS1FCCID: XXXXXXXXFederal Communications Commission (FCC) (PTT) labelS2 Patient connections are protected against defibrillation (DEFIBRILLATION-PROOF) and are a TYPE CF APPLIED PART.S3 Prescription device.S4 Non-Ionizing Radiation. Interference to electronic equipment may occur in the vicinity of devices marked with this symbol.S5 Complies with all applicable Canadian and American standards.Rx
The IntelliVue Transceiver Basic Operation 1-13AuditoryInformationSignalsThe transceiver produces auditory feedback to inform you of measurement and battery conditions. Adjustable sounds can be set to 5 different volume levels or turned off per patient at the Information Center (see “Patient-Configurable Settings in Telemetry Setup” on page 6-3). Adjustable sounds include Check S6 Follow operating instructions.S7 Philips Catalog NumberS8 Serial Number (inside battery compartment). Needed to identify the equipment during a call to the Response Center.S9 MAC Address of deviceS10 Date of manufactureS11 Battery PolarityCallout Label DefinitioniREFSNMAC
The IntelliVue Transceiver1-14 Basic Operation button Standby functions, SpO2 measurement complete, outside of coverage area warning, and the pulse detection tone. Auditory Information Signal Definition Volume/Mute Adjustable Single Tone Self Test passed SpO2 Spot Check measurement successfulnoyesSingle Tone, low pitch Pulse detection successful (when locally initiated) yesDouble Tone Self Test failedSpO2 Spot Check measurement failednoyesDouble Tone repeated every 5 seconds Out of range yesContinuous Double Tone, two pitches Find Device noSingle Tone (when Check button pressed) Transceiver is associated with sector at Information Center (after Standby). yesDouble Tone (when Check button pressed) Transceiver not associated with sector at Information Center (after Standby). yesDouble Tone and all indicators flashing No equipment label is assigned from Information Center. No monitoring. noFast Double Tone and alternate Leads Off indicators flashingEquipment label is received from Information Center and is awaiting local acknowledgment by Check button press.no
Turning the Transceiver On Basic Operation 1-15TransceiverSafetyInformation WarningWarningIf another radio medical device is operating at the same frequency as an IntelliVue Transceiver, it is possible that either device will not function properly. WarningWarningAlthough the transceiver is shielded against Electromagnetic Interference (EMI), avoid the use of other electrically radiating devices in close proximity to the transceiver because they might interfere with transceiver operation.WarningWarningPlace the transceiver in a pouch or over clothing, or both, during patient use. The transceiver should not touch the patient’s skin during use.Turning the Transceiver OnWarningWarningArrhythmia relearning is initiated whenever the transceiver is powered down for one minute or longer. Be sure to check your patient’s arrhythmia annotation for accuracy whenever relearn has occurred.The transceiver is powered by two AA alkaline batteries. To turn the transceiver on, insert both batteries. Remove the batteries to turn the power off.The configuration data set by the Service Provider prior to transceiver use is retained after battery removal.
Turning the Transceiver On1-16 Basic Operation When the transceiver is turned on, all indicators illuminate briefly and a sequence of sounds indicates the instrument is ready for use. You should hear a single beep indicating that the self test was passed, followed by a series of double beeps while the transceiver attempts to associate with the Information Center. The cessation of sounds indicates a successful association. If you hear a single double beep or any other sound sequence, the automatic self-test of the device has not passed, or there is another problem. Contact your Service Provider. Turning the Transceiver OffTurn off the transceiver by removing the batteries. A NO SIGNAL technical alarm will be in effect at the Information Center until the device is turned on or until Standby is initiated.Telemetry monitoring can be turned off in the following ways:• Manually, by activating Monitoring Standby at the Information Center (see “Standby Mode” on page 2-5).• Automatically, if Transceiver RF Auto Shutoff is enabled and there is no ECG signal for 10 minutes.Note—Turning off telemetry monitoring does not turn off the transceiver.Auto Shutoff Automatic Shutoff causes the transceiver to stop broadcasting a radio signal if there is no ECG signal for 10 minutes. This prevents interference with other transceivers in use. The technical alarm text at the Information Center is Transmitter Off. To conserve battery power, remove batteries. Sounds at successful start-up insert batteriesSelf-test Transceiver looking for Info Center beep beep repeated every 3 seconds1 beep (pass)Connectedno beep
Testing intelliVue Transceiver Functionality Basic Operation 1-17To restart monitoring, insert batteries if necessary, attach leads to the patient and press the Check button to verify association with the Information Center.Testing intelliVue Transceiver FunctionalityThere are two tests of IntelliVue Transceiver functionality:•Self Test -performed automatically each time the transceiver is turned on•Status Check - initiated manually by the clinician.Self TestWarningWarningDo not use the transceiver for patient monitoring if it fails the Power On Self Test.A self test of the transceiver functions is automatically performed each time that the transceiver is turned on (that is, batteries are inserted). In Case ofFailure If any portion of the self test fails, the transceiver will attempt to report the failure to the monitoring system. In case of failure, use another transceiver, and contact your Service Provider.Self Test StatusAuditory Signal (if configured on) Visual IndicatorsPassed Single beep All indicators illuminate for 3 secondsFailed Double beep One or more indicators do not light up.
Testing intelliVue Transceiver Functionality1-18 Basic Operation Status Check You can check the status of the transceiver indicators at any time.To initiate a Status Check, use the following instructions.Step Action1Press the Check button.The following indicators should illuminate for as long as the Check button is depressed.• Battery gauge• Type of leadset• EASI (if in use)2 If one or more of the expected indicators do not light up, check the following:• Lead block insertion. Make sure the leadset is correctly inserted in the transceiver and the orange line at the base of the cable is not visible (see “Connecting the ECG Cable” on page 3-19).• Power and position of batteries (see “Checking the Battery Power Level” on page 1-22)• Lead positions and connections (see “Verifying Electrode Connections” on page 3-22)If there is still a problem, contact your Service Provider for assistance.
Battery Information Basic Operation 1-19Battery InformationBattery Safety Information WarningWarningUse Duracell MN 1500 AA 1.5V Alkaline batteries to ensure specified performance. Outdated, mismatched or poor-quality batteries can give unacceptable performance (e.g., insufficient Battery-Low warning time). The use of fresh high-quality alkaline batteries is strongly recommended.Batteries should be removed from the transceiver at the end of the battery’s useful life to prevent leakage. If battery leakage should occur, use caution in removing the battery. The leaked substance may cause eye or skin irritation. Avoid contact with skin. Clean the battery compartment according to instructions in “Chapter 7. Maintenance & Troubleshooting”. Wash hands.Certain failure conditions, such as short circuits, can cause a battery to overheat during normal use. High temperatures can cause burns to the patient and/or user. If the transceiver becomes hot to the touch, place it aside until it cools. Then remove the batteries and discard them. Have the transceiver operation checked by your Service Provider to identify the cause of overheating.The battery door must be closed during defibrillation.If you receive a BATTERY LOW alarm, the batteries must be promptly replaced. A "Battery Low" condition that is not corrected will result in a transceiver shutdown and cessation of monitoring.
Battery Information1-20 Basic Operation Disposal ofBatteries CautionThe batteries must be removed if a transceiver will be stored for an extended period of time.Important—When disposing of batteries, follow local laws for proper disposal. Dispose of batteries in approved containers. If local regulations require you to recycle batteries, recycle batteries in accordance with those regulations.Battery Life Battery life is dependent upon:• Condition of the batteries• Parameters being monitored - ECG only, ECG and Spot Check SpO2, or ECG and Continuous SpO2.By observing the following guidelines, you can optimize battery life in the transceiver: • REMOVE the batteries when the transceiver is not in use. • Disconnect the SpO2 extender cable (if used). (When the SpO2 sensor is disconnected, the SpO2 functionality is automatically powered down, but an extender cable will continue to drain power from the SpO2 electronics.)Inserting/Removing Batteries WarningWarningArrhythmia relearning is initiated whenever the transceiver is powered down for one minute or longer. Be sure to check your patient’s arrhythmia annotation for accuracy whenever relearn has occurred.CautionRemove the batteries before storing a transceiver for an extended period of time.
Battery Information Basic Operation 1-21The battery compartment is located at the bottom of the transceiver behind a swinging door. It accommodates a pair of AA 1.5V Alkaline batteries. Only this type of disposable battery shall be used.Important—Do not use rechargeable batteries. Use of this type of battery will adversely affect:• Battery gauge performance• Battery low warnings• Battery life performanceInsert batteries into the transceiver using the following procedure.Step Action1 Open the battery compartment by swinging the compartment door 90o counterclockwise into an open hinged position.2 Insert two AA 1.5V Alkaline batteries, matching the polarity with the +/- indications inside the compartment.Note— Both batteries are inserted with the + polarity in the same direction.++
Battery Information1-22 Basic Operation Removing theBatteries Batteries should be changed in sets, that is, if you change one battery, change them both. To remove the batteries, simply open the battery compartment door and push from the opening at the back of the compartment to pop the batteries out. Transceiver settings (ECG leadset type, SpO2 mode, volume, etc.) are retained indefinitely when the batteries are removed.If you remove good batteries to turn off the transceiver, keep them together as a set for later re-use so that both batteries will have the same level of power remaining.Batteries should be removed when the transceiver is not in use or is being stored. DO NOT "STORE" BATTERIES BY LEAVING THEM IN THE INCORRECT POLARITY POSITION IN THE TRANSCEIVER. Be careful not to short circuit the batteries. Short circuits are caused when a piece of metal touches both the positive and negative terminals simultaneously (for example, by carrying batteries in a pocket with loose change). More than a momentary short circuit will generally reduce the battery life. In case of a short circuit, discard both batteries in a pair, or just the shorted one if the batteries are new.Checking the Battery Power LevelWhen the Check button is pressed, the battery gauge on the transceiver indicates the battery power level. It is reliable only when specified batteries (i.e., AA 1.5V Alkaline) are used. The battery gauge is also displayed in the Patient Sector at the Information Center to enable you to closely monitor battery status, for example, at change of shift.3 Close the battery compartment door.4 Listen for the start-up sounds.Watch for the indicators on the front of the transceiver to illuminate briefly.5 Connect/reconnect the patient cables to the transceiver.Step Action
Battery Information Basic Operation 1-23Important— In the following table, battery life times are based on Duracell MN 1500 batteries. Battery life for other brands may be different.To check the power level:Battery Gauge Approximate Battery Life RemainingApproximate Operating Time RemainingFunctionality 4 green indicators > 75% > 34.7 hours Normal operation3 green indicators > 50% > 23.1 hours Normal operation2 green indicators > 25% > 11.6 hours Normal operation1 green indicator 25% to Low Battery level > 15 minutes Normal operation1 red indicator Battery Low level to Replace Battery level < 15 minutes SpO2 disabledno indicator Replace Battery level(Check batteries for correct polarity)none Transceiver shutdown/RF shutdownStep Action1Press the Check button to determine the level.2If no indicators flash: 1. Check that the batteries are inserted properly.2. Replace both batteries. 3. If there are still no indicators on the battery gauge, contact your Service Provider.If the indicators illuminate but do not behave as described above, the transceiver has malfunctioned. Contact your Service Provider.
Briefing the Patient1-24 Basic Operation Briefing the PatientWarningWarningPatients should be instructed not to open the battery cover while the transceiver is in use.If the Telemetry button has been configured to generate a Nurse Call, remote recording, or both, instruct the patient to use the button when needed.Note—If desired, you can turn off patient use of the button at the Information Center. See “Patient-Configurable Settings in Telemetry Setup” on page 6-3.Pouch Use The transceiver is not designed for direct contact with the patient’s skin. During normal use, the transceiver should be worn over clothing, in a pocket or, preferably, in a pouch. The carrying pouch is an appropriate means for holding the transceiver.
Briefing the Patient Basic Operation 1-25Securing the Pouch Step Action1 Secure the pouch on the patient with upper ties around the patient’s head and arm, and lower ties around the patient’s lower torso.WarningWarningTo avoid strangulation, do not tie a pouch solely around the patient’s neck.2 Insert the transceiver into the pouch with lead wires and SpO2 sensor cable, if used, exiting from the same side. Important—Do not coil the cables inside the pouch. They are part of the wireless system, and need to be freely exposed.
Briefing the Patient1-26 Basic Operation ShoweringWarningWarningSignal quality and leads off detection may be compromised when showering due to significant patient movement. Appropriate clinical precautions must be taken.The transceiver can be used to monitor a patient in the shower, but only when placed inside a Philips carrying pouch with the flap closed and the snaps secured. The combination of the transceiver and pouch will withstand showering for up to 10 minutes.3 Fold the flap down and snap closed. 4 Check that the patient is comfortable wearing the pouch with transceiver.Step Action
Transceiver Use with TeleMon A02/A03 Basic Operation 1-27Drying theTransceiverafterShoweringAfter showering, perform the following steps to continue monitoring:1. Pat dry the leadset connections at the electrodes.2. Wipe the lead wires with care.3. If wet, dry the outside of the transceiver with a non-lint producing cloth.4. If wet, wipe the inside of the battery compartment dry. Dry the batteries.5. If wet, disconnect the ECG lead block and shake out any water. Dry the connector pin area with a cotton swab.Note—The transceiver should not be used for monitoring if the battery compartment is wet. Remove the batteries and wipe the compartment dry before continued monitoring use.AccidentalWetting If the transceiver is accidentally immersed in liquid for up to 5 minutes, no damage to the device and no electrical safety issues for the patient will result. Remove the device, dry it off, and follow the procedure for cleaning/disinfection or cleaning/cross-infection prevention under “Troubleshooting” on page 7-15 as appropriate.Transceiver Use with TeleMon A02/A03When tethered to TeleMon, the following transceiver operational behavior will be in effect.Alarms• 3 minute alarm pause/suspend can be initiated only from TeleMon, not from the transceiver or from the Information Center. The Alarm Suspend/Pause indicator on the transceiver will accurately reflect the current state of alarm pause.• Standby mode is not available.ECG Operation• Vb, the second V-lead in 6-wire lead-set, is not supported.• After a change in leadset, the TeleMon returns to the default ECG settings, and arrhythmia relearn occurs automatically. Be sure to check the monitoring leads after you switch leads.SpO2 Operation
Transceiver Use with TeleMon A02/A031-28 Basic Operation •SpO2 is always in continuous mode.• Changes in SpO2 mode do not take effect until after the transceiver is disconnected from TeleMon. Mode settings are defined in the following table:• After a change in SpO2 sensor, TeleMon returns to the default ECG settings, and arrhythmia relearn occurs automatically. Be sure to check the monitoring leads after you change the sensor.Transceiver Operational Controls & Indicators• When you press the Telemetry button, a Nurse Call alarm, recording, alarm and recording, or neither will be generated, depending on the configuration at the Information Center.• When you press the Check button, the transceiver battery gauge indicates full power, regardless of actual battery strength.• When you press the Telemetry and Check buttons together, there is no action; a 3-minute alarm pause/suspend can be initiated only from TeleMon. The alarm pause indicator on the transceiver will accurately reflect the current state of alarm pause.• When the transceiver is connected to TeleMon, the battery gauge on the transceiver and displayed at the Information Center always indicates "full" regardless of actual battery power. To update the gauge, disconnect the transceiver and wait several seconds for the updated battery strength to be displayed.Defibrillation• In the event of patient defibrillation, it may take several seconds for the ECG trace to reappear on the screen.Mode at TeleMon Mode at Disconnected TransceiverContinuous Continuous5-min. Continuous1-min. ContinuousManual Spot Check
Alarms 2-1Introduction2AlarmsThis chapter describes how to pause/suspend alarms temporarily. It also lists Physiologic (Patient) Alarms and Technical (Inoperative Conditions) Alarms. Both types of alarms are listed alphabetically.• Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2• Suspending/Pausing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2• Standby Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5• Alarm Behavior with Own Bed Overview . . . . . . . . . . . . . . . . . . . . . . 2-7• Physiologic Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9• Technical Alarms (INOPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Alarm Indicators2-2 Alarms Alarm IndicatorsA description of visual and auditory information signals for patient and technical alarms on the Information Center is located in the IntelliVue Information Center Instructions for Use and the Information Center Online Help.The Information Center documentation also includes the default alarm settings and physiological alarm limit ranges Testing Alarm IndicatorsThe visual alarm information signal on the transceiver is the Alarms Suspend icon. During self test, the Alarm Suspend indicator illuminates, and a single tone indicates association with the Information Center. These positive test results indicate that the Alarm Suspend icon on the transceiver is functioning correctly (see “Status Check” on page 1-18).Suspending/Pausing AlarmsWarningWarningIf the Alarms Suspend indicator on the transceiver remains illuminated after the button combination to unsuspend alarms is pressed, a the transceiver malfunction may have occurred. Alarms resume automatically after the 3 minute suspension period, or you can resume them manually at the Information Center. The transceiver should be replaced, and the malfunctioning unit should be sent to your Service Provider.All alarms for a patient can be suspended/paused from the Information Center, from the TeleMon Companion Monitor, or, depending on transceiver configuration, from the transceiver itself. The Alarm Suspend/Pause duration is fixed at 3-minutes. Alarms automatically resume after 3 minutes, and can be reactivated manually earlier.
Suspending/Pausing Alarms Alarms 2-3If connected to TeleMon, alarms can be suspended only from TeleMon, and not from the Information Center, and the Alarms Suspend icon on the transceiver is lit (see “Transceiver Controls - Front” on page 1-7), and an ALARMS SUSPENDED message appears at TeleMon and the Information Center.Important—Patient monitoring (display of patient waveforms and numerics) continues for the duration of Alarm Suspend/Pause.Step Action1 To activate Alarm Pause/Suspend at the transceiver, press the Telemetry and Check buttons simultaneously. While alarms are suspended:• The transceiver illuminates the Alarms Suspend icon. • The message ALARMS SUSPENDED (or ALARMS PAUSED) is displayed in the Patient Sector at the Information Center.2 For instructions on how to pause/suspend alarms from the Information Center, see the IntelliVue Information Center Instructions for Use and the Information Center Online Help.
Suspending/Pausing Alarms2-4 Alarms Resuming/ Unsuspending AlarmsAlarms will be resumed automatically after 3 minutes. You can cancel alarm suspend manually before the 3-minute period has expired from the transceiver (see following directions) or from the Information Center.Step Action1Press the Telemetry and Check buttons simultaneously.• Auditory alarm indication at the transceiver is switched on.• The Alarm Suspend icon is turned off.• The message ALARMS SUSPENDED (or ALARMS PAUSED) is removed from the display.2 Alternately, you can unsuspend alarms at the Information Center. See IntelliVue Information Center Instructions for Use or Online Help for directions.
Standby Mode Alarms 2-5Standby ModeStandby mode is useful when the transceiver is temporarily removed from a patient or when a patient is intentionally moved out of range of an Access Point. Standby suspends monitoring so you won’t get any patient alarms or waveforms. It also disables the out of range audio signal. Patient data and current settings are preserved during the Standby period.Standby also serves to turn telemetry monitoring off when a patient is discharged. Patient data is not erased and unit default settings are not in effect until the discharge operation is performed. A bed should be put into Infinite standby until a new patient is connected to the transceiver. Monitoring can then be restarted by a click of the Resume Monitoring button. Note—To discharge a patient:1. Disconnect the patient.2. Remove batteries from the transceiver.3. Put bed in Standby.You place a patient in standby mode at the Information Center. You can select the duration of the standby period (Infinite, 4, 3, 2, or 1 hours, 30, 20, or 10 minutes). The approximate time of resumption of monitoring will be displayed. To restart monitoring, click on Resume Monitoring in the Patient Sector. Note—Unless you are discharging a patient, keep the leads attached until the patient is in Standby. If you remove the leads before putting a patient into Standby, you’ll get an ECG LEADS OFF technical alarm, as well as reminders, if configured.InitiatingStandbyStep Action1 In the Patient Window or All Controls at the Information Center, select the Standby button.2 Select the patient destination from the pre-defined list.
Standby Mode2-6 Alarms ResumingMonitoringNote—When you take an EASI patient out of Standby, the lead settings will be reset to the Information Center’s default lead settings.3 Depending on your equipment configuration, select the duration of the standby period (30, 20 or 10 minutes; 2, 3 or 4 hours; or infinite).4 Select the Suspend Monitoring button. This suspends all monitoring and displays the following messages in the Patient Sector: PATIENT LOCATION:xxx (for example, X-ray) and TELEMETRY STANDBY. The approximate time of resumption is also displayed.Step ActionStep Action1If the standby period has expired when the patient returns to the unit, monitoring will resume automatically. To verify the resumption of monitoring, press the Check button. You should hear a single beep.2If the standby period has not expired when the patient returns to the unit, monitoring must be reactivated manually. Either click Resume Monitoring at the Information Center or press the Check button on the transceiver to establish reassociation. The audible tone (single beep) at the transceiver verifies that monitoring has resumed.
Alarm Behavior with Own Bed Overview Alarms 2-7Alarm Behavior with Own Bed OverviewBoth the IntelliVue Patient Monitor and the telemetry system source alarms. The following tables summarize alarm behavior when Own Bed Overview is used. For detailed information, see the IntelliVue Patient Monitor Instructions for Use and the IntelliVue Information Center Instructions for Use.Alarm Pause/SuspendWhen alarms are paused/suspended, the messages and types of alarms affected depend on where the pause/suspend was initiated.If alarms are paused/suspended from....these alarms are paused/suspended and this message appearsInformation Center both bedside and telemetry measurementsInformation Center: ALARMS PAUSED or ALARMS SUSPENDEDBedside: ALARMS OFF in Overview window and ALARMS PAUSED or ALARMS OFF on the monitor (depending on configuration)IntelliVue Patient Monitor bedside measurements only Information Center: BED ALARMS PAUSED or BED ALARMS SUSPEND (depending on configuration)Bedside: ALARMS PAUSED or ALARMS OFF
Alarm Behavior with Own Bed Overview2-8 Alarms Alarm SilenceWhen an active alarm is silenced, the types of alarms that are silenced depend on the alarm source and where the silence was initiated.Note—If tethered to TeleMon, silencing an active alarm at TeleMon silences the alarm at TeleMon only. It has no effect on the paired bedside monitor or the Information Center.Alarm Source Where SilencedEffect at Paired BedsideEffect at Information CenterBedside alarm Bedside Alarm is silenced Bedside alarm is silenced. There is no effect on telemetry alarmsTelemetry alarm Bedside No effect on telemetry alarmsNo effect on telemetry alarmsBedside and/or telemetry alarm Overview Silence Control Bedside or telemetry alarm is silencedBedside alarm is silenced (if Silence Overview Alarms is configured)Bedside and/or telemetry alarm Information Center Bedside or telemetry alarm is silencedBedside or telemetry alarm is silenced
Physiologic Alarms Alarms 2-9Alarm/INOPs at the Information CenterThe alarms and INOPs that are displayed, recorded and stored at the Information Center depend on the type of alarm.Physiologic AlarmsPhysiologic alarms indicate a life-threatening situation or a less urgent situation such as heart rate beyond limits. There are no physiologic alarm signals generated by the transceiver. All physiologic alarms are generated at the IntelliVue Information Center, and all alarm signals must be acknowledged at the Information Center.Arrhythmia alarm chaining and other aspects of alarm behavior, such as alarm levels, setting alarm limits, customizing arrhythmia alarm settings on a per patient basis, switching individual measurement alarms on/off, and reviewing alarm messages, are described in IntelliVue Information Center Instructions for Use. There are two levels of arrhythmia analysis available at the Information Center: Basic and Enhanced. Enhanced analysis includes Basic alarms. Type of Alarm/INOP Effect at Information CenterAll ECG telemetry alarms and INOPsNote—ECG is generated from telemetry when paired.Displayed, recorded (if configured), and storedBedside ECG INOPs and RESP INOPs Ignored. Not displayed, recorded, or storedBedside non-ECG alarms and non-ECG INOPs Displayed, recorded (if configured), and stored
Physiologic Alarms2-10 Alarms In the table, Red (***) alarms are listed alphabetically, followed by the Yellow (**) alarms, the Yellow (*) arrhythmia alarms.Physiologic (Patient) Alarms Alarm Text Priority Condition Source***ASYSTOLE Red Asystole. No QRS for 4 consecutive seconds ST/AR Basic & Enhanced Arrhythmia*** BRADY yyy < xxx Red Extreme Bradycardia. HR less than extreme Brady HR Limit ST/AR Enhanced Arrhythmia*** DESAT Red Very Low SpO2 Saturation. SpO2 value below desaturation limit (10% or 10 "points" below low limit).SpO2*** EXTREME BRADY Red Extreme Bradycardia. HR less than extreme Brady HR Limit ST/AR Basic & Enhanced Arrhythmia*** EXTREME TACHY Red Extreme Tachycardia. HR greater than extreme Tachy HR Limit ST/AR Basic & Enhanced Arrhythmia*** TACHY yyy > xxx Red Extreme Tachycardia. HR greater than extreme Tachy HR Limit ST/AR Enhanced Arrhythmia*** VFIB/TACH Red Ventricular Fibrillation. Fibrillatory waveform for 4 consecutive seconds ST/AR Basic & Enhanced Arrhythmia
Physiologic Alarms Alarms 2-11*** VTACH Red Ventricular Tachycardia. Sustained run of PVCs accompanied by a high heart rate ST/AR Basic & Enhanced Arrhythmia** NURSE CALL Yellow Patient or nurse button press on the transceiver (when configured for Nurse Call operation)Also initiated if the installation includes a paging system and if the Information Center is configured for paging upon receipt of Nurse Call signal.Clinician-initiated at transceiver or by paging subsystem** SpO2 HIGH Yellow High SpO2. SpO2 value greater than high SpO2 Limit. SpO2** SpO2 LOW Yellow Low SpO2. SpO2 value less than low SpO2 Limit. SpO2** SpO2 yyy > xxx or Yellow High SpO2. SpO2 value greater than high SpO2 Limit. SpO2** SpO2 yyy < xxx or Yellow Low SpO2. SpO2 value less than low SpO2 Limit. SpO2* HR HIGH Yellow High Heart Rate. HR greater than high HR Limit ST/AR Basic & Enhanced Arrhythmia* HR LOW Yellow Low Heart Rate. HR less than low HR Limit ST/AR Basic & Enhanced ArrhythmiaPhysiologic (Patient) Alarms Alarm Text Priority Condition Source
Physiologic Alarms2-12 Alarms * HR yyy > xxx Yellow High Heart Rate. HR greater than high HR Limit ST/AR Enhanced Arrhythmia* HR yyy < xxx Yellow Low Heart Rate. HR less than low HR Limit ST/AR Enhanced Arrhythmia* IRREGULAR HR Yellow Irregular Heart Rate. Constantly irregular HR. ST/AR Enhanced Arrhythmia* MISSED BEAT Yellow Missed Beat. Beat omitted ST/AR Enhanced Arrhythmia* MULTI ST Lx, Ly Yellow Multi ST Leads exceeding Limit (EASI mode or when selected). Two ST leads (Lx=Lead X and Ly=Lead Y) exceed alarm limit elevation or depression for > 60 secondsST/AR Arrhythmia* MULTIFORM PVCs Yellow Multiform PVCs ST/AR Enhanced Arrhythmia* NON-SUSTAIN VT Yellow Non-Sustained VT. Non-sustained Ventricular Tachycardia ST/AR Enhanced Arrhythmia* PACER NOT CAPT Yellow Pacer Not Capture. Missed beat with pace pulse (paced patient). ST/AR Basic & Enhanced ArrhythmiaPhysiologic (Patient) Alarms Alarm Text Priority Condition Source
Physiologic Alarms Alarms 2-13* PACER NOT PACE Yellow Pacer Not Pacing. Missed beat without pace pulse (paced patient). ST/AR Basic & Enhanced Arrhythmia* PAIR PVCs Yellow Pair of PVCs. ST/AR Enhanced Arrhythmia* PAUSE Yellow Pause. No QRS for more than x seconds ST/AR Enhanced Arrhythmia* PVC > xx/min Yellow PVCs > xx/min. PVCs greater than Rate Limit ST/AR Basic & Enhanced Arrhythmia* R-ON-T PVCs Yellow R-on-T PVCs ST/AR Enhanced Arrhythmia* RUN PVCs Yellow Run PVCs. Run of PVCs length >= 2 ST/AR Enhanced Arrhythmia* ST lead > xxx Yellow STx > Elevation limit. ST segment is elevated ST/ARArrhythmia* ST lead < xxx Yellow STx < Depression limit. ST segment is depressed. ST/ARArrhythmia* SVT Yellow Supra Ventricular Tachycardia. SVT for > 15 seconds ST/AR Enhanced ArrhythmiaPhysiologic (Patient) Alarms Alarm Text Priority Condition Source
Technical Alarms (INOPs)2-14 Alarms Technical Alarms (INOPs)Technical Alarms, or INOPs, are sourced at the transceiver, the ST/AR algorithm running at the Information Center, or TeleMon Companion Monitor, and identify inoperative conditions (that is conditions where the system cannot measure or detect alarm conditions reliably). There are three levels of Technical Alarms:•Severe - Monitoring and alarms disabled. Audible tone at the Information Center. Must be acknowledged by a clinician.•Hard - Monitoring and alarms are disabled. Audible tone at the Information Center. •Soft - Monitoring and alarms remain active. No audible tones are generated.* VENT BIGEMINY Yellow Ventricular Bigeminy. Predominant Bigeminy rhythm present. ST/AR Enhanced Arrhythmia* VENT RHYTHM Yellow Ventricular Rhythm. Ventricular rhythm present. ST/AR Enhanced Arrhythmia* VENT TRIGEMINY Yellow Ventricular Trigeminy. Predominant Trigeminy rhythm present. ST/AR Enhanced ArrhythmiaNotes: xxx = limit that was exceeded; yyy = current value. * NBP alarms are processed independently at the Information Center. The alarm delay from TeleMon to the Information Center is not more than 10 seconds.Physiologic (Patient) Alarms Alarm Text Priority Condition Source
Technical Alarms (INOPs) Alarms 2-15Technical Alarms (Inoperative Conditions) (in alphabetic order)Alarm Text Priority Condition What to doBATTERY LOW Soft Power is low. Replace batteries promptly to avoid transceiver shutdown and cessation of monitoring.CANNOT ANALYZE ECG Hard Arrhythmia algorithm cannot reliably analyze the ECG data on any monitored leads.Assess the lead selections, initiate relearn, and validate analyzed rhythm.CANNOT ANALYZE ST Soft ST algorithm cannot reliably generate any valid ST values on any monitored lead.Review the ECG signal quality and correct if necessary. Reposition the Is and J points.CHARGE MON BAT Hard TeleMon battery charge is less than or equal to 25%. Connect TeleMon to AC power and charge battery, or insert battery with charge greater than 25%.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 will unsuspends them at the Information Center and TeleMon. To clear the INOP message, initiate a new NBP measurement.
Technical Alarms (INOPs)2-16 Alarms ECG EQUIPMENT MALF Hard Failure of the ECG equipment or failure to calibrate ECG.Replace the transceiver or calibrate ECG with Service Tool.ECG LEADS OFF Hard Multiple leads off Reattach ECG leads to patient.<electrode> LEAD OFF Hard Primary lead is off.Note—If primary lead is MCL, lead will be identified as V in INOP text.Reattach ECG lead to patient.<electrode> LEAD OFF Soft Non-primary lead is off. Reattach ECG lead to patient.INVALID LEADSET Hard Bad lead selection switches in the transceiver Replace transceiver case. Use supported leadset.Contact Service.NO SIGNAL Hard Patient is out of range, radio board has failed, ICN connection failure, or no batteries in transmitter.Make sure that the transceiver is in own care-group range and has good batteries. Replace the transceiver if Power On Self Test fails, and notify Service Provider.REPLACE BATTERY Hard, LatchedMessage remains until acknowledged by clinician.Dead battery. No monitoring is occurring. Replace batteries. Technical Alarms (Inoperative Conditions) (in alphabetic order)Alarm Text Priority Condition What to do
Technical Alarms (INOPs) Alarms 2-17SOME ECG ALRMS OFF Soft Some yellow arrhythmia alarms have been turned off for this patient. For information only.SpO2T EQUIP MALF Hard Malfunction in the SpO2 equipment SpO2 board needs to be replaced. Call Service.SpO2T ERRATIC Hard Erratic SpO2 measurements, often due to a faulty sensor or invalid SpO2 measurements, or incorrect transducer positionRepeat measurement, reposition sensor on patient, or finally, replace sensor.SpO2T EXTD UPDATENumeric is replaced by a -?-.Soft The update period of displayed values is extended due to an NBP measurement on the same limb or an excessively noisy signal. If NBP is not active, check the sensor placement. Reposition the sensor on patient, or replace sensor.SpO2T INTERFERENCE Hard Level of ambient light or level of electrical interference are so high that the SpO2 sensor cannot measure SpO2 and pulse rate.Reduce ambient light to sensor or electrical noise sources.SpO2T LOW PERFUSION Soft Accuracy may be reduced due to low perfusion. Data displayed with ?. Warm the site.Increase perfusion. Change sensor site. Avoid site distal to BP cuff or intra-arterial line.SpO2T NO SENSOR Hard No sensor attached to SpO2 device Attach SpO2 sensor.Technical Alarms (Inoperative Conditions) (in alphabetic order)Alarm Text Priority Condition What to do
Technical Alarms (INOPs)2-18 Alarms SpO2T NOISY SIGNAL Hard Excessive patient movements or electrical interference are causing irregular pulse patternsReduce movement or electrical noise sources.SpO2T NON-PULSATILE Hard Pulse is too weak or not detectable Check connection to patient. Change sensor site. Avoid site distal to BP cuff or intra-arterial line.SpO2T SENSOR MALF Hard Malfunction of the SpO2 sensor/adapter-cable Replace sensor.TELEMETRY STANDBY Soft Information Center standby mode timer is active, or patient was not returned to telemetry coverage area. There is no data from bed.Cancelled when patient is removed from Standby.TRANSMITTER MALF Hard Transceiver malfunction Replace and notify Service Provider.TRANSMITTER OFF Hard RF shut off after 10 minutes of leads off Reattach ECG leads to patient.WEAK SIGNAL Soft Patient is at outer range of the radio coverage area. Telemetry pack is receiving a weak signal with high data loss from the AP.Return patient to the radio coverage area. If patient is in close proximity to AP, replace telemetry pack. If condition exists for multiple devices in a specific area, the AP in that area is suspect. Contact Service.Technical Alarms (Inoperative Conditions) (in alphabetic order)Alarm Text Priority Condition What to do
ECG Monitoring 3-1Introduction3ECG MonitoringThis chapter covers the specifics of ECG measurement. It includes the following sections:• ECG Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2• Measuring ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3• Positioning ECG Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8• Connecting the ECG Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19• Verifying Electrode Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22• Monitoring during Leads Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23• Optimizing ECG Measurement Performance. . . . . . . . . . . . . . . . . . . 3-25
ECG Safety Information3-2 ECG Monitoring ECG Safety InformationWarningWarningFor ALL Patients:Always confirm Information Center observations with clinical observation of the patient before administering interventions.Every lead must be secured to an electrode on the patient. Conductive parts of electrodes must not contact earth or other conductive parts.Philips recommends that you change the lead label only to reflect the physical placement of electrodes. This will ensure a match between the monitored lead and the label, and prevent any possible confusion.When switching from EASI to standard monitoring, there is a loss of data for 30 seconds. For PACED Patients:The output power of the transceiver and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker 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. In order to minimize the possibility of interference, position electrodes, electrode wires, and the transceiver as far away from the pacemaker as possible. Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the Philips IntelliVue Telemetry System. See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced patients.
Measuring ECG ECG Monitoring 3-3Measuring ECGThe electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the Information Center as a waveform and a numeric. There is no cardiotach within the transceiver; cardiotach analysis resides in the arrhythmia algorithm at the Information Center. Arrhythmia analysis is always turned on for telemetry patients. Arrhythmia analysis is either basic or enhanced, depending on the product configuration.EASI ECG EASI® derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not exactly identical to the 12-lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic interpretations. ECG Leadsets The IntelliVue Transceiver supports 3-, 5-, and 6-wire leadsets. It detects the inserted leadset type and automatically determines the ECG measurement and transmitted leads. The Leadset Insertion Guide on the device will assist you in ensuring the correct measurement during transceiver usage (see “Connecting the ECG Cable” on page 3-19). The 5-wire leadset can be used for either standard or EASI electrode configurations. The leadsets are compatible with the 5- and 3-wire leadsets used with the IntelliVue family of monitors and with M2601B transmitters. The electrode placements for the illustrations in this chapter use the AAMI labels and colors and are summarized in the following table.Leadset Electrode Color (AAMI) Electrode Location3-wire BlackWhiteRedLARALL
Measuring ECG3-4 ECG Monitoring ECG Leads Monitored Depending on the leadset connected to the transceiver, a different set of viewable leads are available at the Information Center. The transceiver can 5-wire (Standard mode) BlackWhiteRedGreenBrownLARALLRLV5-wire (EASI mode) BlackWhiteRedGreenBrownSIARLE6-wire BlackWhiteRedBrownGreenBrown/WhiteLARALLVaRLVbLeadset Electrode Color (AAMI) Electrode Location
Measuring ECG ECG Monitoring 3-5source up to four raw ECG waves. The transceiver automatically recognizes the leadset connected. If you are using ... these leads can be selected at the Information Center3-wire I, II, IIIIf lead selection is enabled, sourced waves are received as:• Channel 1 - I• Channel 2 = II• Channel 3 = IIIIf lead selection is disabled, the sourced wave is II.Default is II.5-wire (Standard mode) I, II, III, aVR, aVL, aVF, MCL and VSourced waves are received as:• Channel 1 - I• Channel 2 = II• Channel 3 = IIIDefaults are II, V, III.5-wire (EASI mode) I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6In EASI mode, the sourced waves are received as:• Channel 1 = Vector 1 (A-I)• Channel 2 = Vector 2 (A-S)• Channel 3 = Vector 3 (E-S)Note—Arrhythmia monitoring is performed only on the primary and secondary leads selected at the Information Center, although you can view and perform ST analysis on all 12 EASI derived leads.
Measuring ECG3-6 ECG Monitoring ReconstructedLeads Reconstruction of leads from the sourced wave is defined by the calculations in the following table. EASI reconstructed leads are a linear combination of all three raw EASI leads. Default labels/leads are shown in bold text.6-wire(not supported in TeleMon) I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R. Sourced waves are received as: • Channel 1 = II• Channel 2 = III• Channel 3 = Va• Channel 4 = VbThe two chest leads, Va and Vb, can be placed on the patient in any of the V lead positions (V1 through V9, V3R, V4R, V5R). Lead assignment is available at the Information Center. When unassigned, the chest leads use the defaults.Defaults are II, III, Va=V2, Vb=V5.Note—When display of the pleth wave is enabled at the Information Center, the second chest lead (Vb) is not available for monitoring due to bandwidth limit. That is, the lead label assigned to Vb cannot be selected for Va even though Vb does not appear to be used.If you are using ... these leads can be selected at the Information CenterECG LeadClinical Calculationsin terms of electrodes3-Lead 5-Lead Standard 6-LeadII ILA-RA
Measuring ECG ECG Monitoring 3-7II II II LL-RAIII III III LL-LA-MCL - Va-LA, C=Va (see Note)-aVR aVR RA-(LA+LL)/2-aVL aVL LA-(RA+LL)/2-aVF aVF LL-(LA+RA)/2-VC-(RA+LA+LL)/3, where C=VVa C-(RA+LA+LL)/3, where Va=V2 positionVb Vb-(RA+LA+LL)/3, where Vb =V5ECG LeadClinical Calculationsin terms of electrodes3-Lead 5-Lead Standard 6-Lead
Positioning ECG Electrodes3-8 ECG Monitoring Positioning ECG ElectrodesWarningWarningDo not mix and match electrodes of different types. In particular, do not use electrodes of dissimilar metals. This helps ensure optimal signal quality.WarningWarningWhen you are connecting the electrodes or the patient cable, make sure that the connectors never come into contact with other conductive parts, or with earth. In particular, make sure that all of the ECG electrodes are attached to the patient, to prevent them from contacting conductive parts or earth.WarningWarningNon-manufacturer supplied accessories and supplies can corrupt the performance of the equipment. Use only AAMI EC-12 compliant electrodes with this device. Use of electrodes that are non-compliant may provide erroneous results.CautionTo protect the transceiver from damage during defibrillation, to ensure accurate ECG information, and to provide protection against signal noise and other interference, use only ECG electrodes and cables specified by Philips.To make it possible to compare measured ECG signals, the electrodes (or leadsets) are placed in standardized positions, forming so-called "leads". To obtain ECG signals optimized for use in diagnosis and patient management in different care environments, different leadsets in varying lead placements can be used. You can use either standard lead placements or EASI lead placements with the transceiver.
Positioning ECG Electrodes ECG Monitoring 3-9When placing electrodes on the patient, choose a flat, non-muscular site where the signal will not be impacted by either movement or bones. Correct lead placement is always important for accurate diagnosis. Especially in the precordial leads, which are close the heart, QRS morphology can be greatly altered if an electrode if moved away from its correct location.In addition to correct positioning of the electrodes, optimal skin preparation prior to electrode placement will help ensure a clear signal for diagnosis.Step Action1 Prepare the patient’s skin. Good electrode-to-skin contact is important for a good ECG signal, as the skin is a poor conductor of electricity.• Select sites with intact skin, without impairment of any kind.• Clip or shave hair from the site as necessary.• Wash site with soap and water, leaving no soap residue. Note--Philips does not recommend using ether or pure alcohol, because they dry the skin and increase the resistance.• Dry thoroughly.• Use ECG skin preparation paper (abrasive) to remove dead skin cells and to improve the conductivity of the electrode site.
Positioning ECG Electrodes3-10 ECG Monitoring Electrode Placement Diagrams for 5-lead standard and EASI electrode placement are located on the back of the transceiver. Additional lead placement information is available in the Online Help in the IntelliVue Information Center. Philips recommends that electrodes be changed every 24 hours.2 Check electrodes for moist gel, and attach to the clips. If you are not using pre-gelled electrodes, apply electrode gel to the electrodes before placement.Note—Gel must be moist to provide a good signal.3 Place the electrodes on the patient according to the lead placement you have chosen (see Electrode Placement following). Place the edge down, then "roll down" the rest of the pad. Press firmly around the adhesive edge toward the center.Note—When placing electrodes, choose a flat, non-muscular site where the signal will not be interfered with by either movement or bones. Correct lead placement is always important for accurate measurement, especially in the precordial leads, which are close to the heart. QRS morphology can be greatly altered if an electrode is moved away from its correct location.Step Action
Positioning ECG Electrodes ECG Monitoring 3-11Locating theFourthIntercostalSpaceFor accurate chest electrode placement and measurement, it is important to locate the fourth intercostal space. This can be done using the Angle of Lewis.1. Locate the second intercostal space by first palpating the Angle of Lewis (the bony protuberance where the body of the sternum joins the manubrium). This rise in the sternum is where the second rib is attached, and the space just below this is the second intercostal space.2. Palpate and count down the chest until you locate the fourth intercostal space.Angle of Lewis
Positioning ECG Electrodes3-12 ECG Monitoring 3-LeadPlacementLead PlacementRA directly below the clavicle and near the right shoulderLA directly below the clavicle and near the left shoulderLL on the left lower abdomenRA LALL
Positioning ECG Electrodes ECG Monitoring 3-135-LeadPlacement(StandardMode)Lead PlacementRA directly below the clavicle and near the right shoulderLA directly below the clavicle and near the left shoulderLL on the left lower abdomenRL on the right lower abdomenV on the chest, the position depends on your required lead selection. The default position is V2.V1 on the fourth intercostal space at the right sternal borderV2V3 V4 V5 V6V1RA LALLRL
Positioning ECG Electrodes3-14 ECG Monitoring V2 on the fourth intercostal space at the left sternal borderV3 midway between the V2 and V4 electrode positionsV4 on the fifth intercostal space at the left midclavicular lineV5 on the left anterior axillary line, horizontal with the V4 electrode positionV6 on the left anterior axillary line, horizontal with the V4 electrode positionLead Placement
Positioning ECG Electrodes ECG Monitoring 3-155-LeadPlacement(EASI Mode) WarningWarningEASI derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not exactly identical to the 12-lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic interpretations.EASI lead placement is supported for adult patients onlyLead Corresponds to Standard Lead PlacementE V on the lower sternum at the level of the fifth intercostal spaceA LL on the left midaxillary line at the same level as the E electrodeESAI
Positioning ECG Electrodes3-16 ECG Monitoring Note—Make sure that the D and E electrodes line up vertically on the sternum, and that the I, E and A electrodes align horizontally.6-LeadPlacement A 6-lead placement uses the same four limb leads as 5-lead standard placement, and two precordial leads - referred to at the Information Center as Va and Vb.The default position of Va - the brown lead - is at the V2 position.The default position for Vb - the brown/white lead - is at the V5 position.Your unit may use other precordial leads for Va and Vb. In that situation, you need to assign those new positions in the Patient Window at the Information Center. The Va and Vb default positions can be changed in the configuration at the Information Center on a per patient basis.S LA on the upper sternumI RA on the right midaxillary line at the same level as the E electrodeN Reference can be anywhere, usually below the sixth rib on the right hipLead Corresponds to Standard Lead Placement
Positioning ECG Electrodes ECG Monitoring 3-17Lead PlacementRA directly below the clavicle and near the right shoulderLA directly below the clavicle and near the left shoulderRL on the right lower abdomenLL on the left lower abdomenVa on the chest, the position depends on your required lead selection. The Philips default position is V2. For other positions, relabel the lead at the Information Center.V2V3 V4 V5 V6V1LARALLRL
Positioning ECG Electrodes3-18 ECG Monitoring Vb on the chest, the position depends on your required lead selection. The Philips default position is V5. For other positions, relabel the lead at the Information Center.V1 on the fourth intercostal space at the right sternal borderV2 on the fourth intercostal space at the left sternal borderV3 midway between the V2 and V4 electrode positionsV4 on the fifth intercostal space at the left midclavicular lineV5 on the left anterior axillary line, horizontal with the V4 electrode positionV6 on the left anterior axillary line, horizontal with the V4 electrode positionLead Placement
Connecting the ECG Cable ECG Monitoring 3-19Connecting the ECG CableNote—Your transceiver may have alignment guides to assist you in leadset insertion.Step Action1 Match the arrow on the ECG cable with the arrow on the Lead Insertion Guide according to the lead type you have chosen, and insert the ECG cable into the transceiver.Important—Make sure that the cable is pushed completely into the transceiver. When correctly inserted, the orange line at the base of the cable is not visible.3-wireMatch the arrow on the cablewith the left arrow (labeledEASI, 3) on the Leadset In-sertion Guide.Note—Leadset is keyed for only one insertion position.EASI, 3 5.6IntelliVue TRx+M4841A
Connecting the ECG Cable3-20 ECG Monitoring 5-wire Standard5-wire EASINote—If you are using a 5-wire leadset in both Standard and EASI modes, insert the protective plug into the open lead port with the wide lip facing the leads. Then, press down firmly so that the plug is securely under the leadset and the orange line is not visible.Step ActionMatch the arrow on the cablewith the right arrow (labeled 5,6) on the Leadset InsertionGuide.EASI, 3 5.6IntelliVue TRx+M4841AMatch the arrow on the cablewith the left arrow (labeledEASI, 3) on the Leadset In-sertion Guide.EASI, 3 5.6IntelliVue TRx+M4841A
Connecting the ECG Cable ECG Monitoring 3-21CableDisconnection When disconnecting the leadset from the transceiver, grasp the leadset firmly and pull free. Do not pull on the lead wires.6-wire2 Check that the correct Electrode Indicators are lit for the leadset you are using, and that the EASI indicator light is illuminated appropriately. See “Verifying Electrode Connections” on page 3-22. • When using 5-lead standard, the EASI indicator does not illuminate.• When using EASI, the EASI indicator illuminates momentarily.3 For 3-lead, select the lead label(s) at the Patient Window.Step ActionEASI, 3 5.6IntelliVue TRx+M4841AMatch the arrow on the cablewith the right arrow (labeled5,6) on the Leadset InsertionGuide.
Verifying Electrode Connections3-22 ECG Monitoring Verifying Electrode ConnectionsThe electrode indicators enable you to verify that the leads are available for the desired monitoring. Each electrode is color-coded. Pressing and holding the Check button enables you to view the leadset status. During routine use of the transceiver for monitoring, all lead indicators are off.To verify electrode connections, use the following procedure:Step Action1 Press and hold the Check button for 2 seconds2Expected Response:• If 3-wire cable is attached: Red, White and Black indicators illuminate, then all turn off.• If 5-wire cable in Standard mode is attached: Red, White, Black, Green & Brown indicators illuminate, then all turn off.• If 5-wire cable in EASI mode is attached: Red, White, Black, Green & Brown indicators illuminate, then all turn off. The EASI indicator also illuminates briefly.• If 6-wire cable is attached: Red, White, Black, Green, Solid Brown and Brown/White indicators illuminate, then all turn off.• If no leadset is attached: all indicators are off.3Unexpected Response:Any other response indicates a problem with the transceiver. Check the leadset connection and/or use a new leadset. If the problem is not corrected, contact your Service Provider.
Monitoring during Leads Off ECG Monitoring 3-23During routine monitoring, the electrode indicators also notify you if one or more leads are not functioning. When a LEADS OFF condition occurs, the transceiver automatically illuminates the indicator corresponding to the missing lead.Monitoring during Leads OffECG Fallback and Extended monitoring states are supported for the transceiver when the primary and/or secondary leads are in a Leads Off INOP condition. Both these states are entered into after 10 seconds of Leads Off in an attempt to maintain monitoring and arrhythmia analysis.ECG Fallback ECG Fallback occurs when the primary lead is in Leads Off for 10 seconds and a secondary lead is available. ECG Fallback must be configured on by your Service Provider.MultileadAnalysis If there is a LEADS OFF technical alarm in the primary lead for > 10 seconds, the active secondary lead becomes the primary lead. The arrhythmia algorithm switches the leads on the display, but relearn does not occur. When the Leads Off condition is corrected, the leads are switched back to their original state.Single LeadAnalysis For single lead analysis, if there are two leads available, the secondary lead is made the primary lead until the Leads Off condition is corrected. The arrhythmia algorithm performs a relearn using the available lead.Fallback forEASI If one of the derived EASI leads is in a technical alarm condition, a flat line is displayed. After 10 seconds, the directly acquired EASI AI, AS, or ES lead, depending on which is available, is displayed with the label "ECG". Arrhythmia relearn is performed with transition to or from EASI Fallback monitoring using the available lead(s).
Monitoring during Leads Off3-24 ECG Monitoring Extended Monitoring Extended monitoring occurs when both the primary and secondary leads are in Leads Off for 10 seconds and another lead is available. It becomes the primary lead and the arrhythmia algorithm performs a relearn. Extended Monitoring applies if:• Telemetry is configured for Extended Monitoring ON.• The leas set provides more than two leads (e.g., when using a 5-wire leadset ).The leadset must provide more than two leads, and Extended monitoring must be configured on by your Service Provider.Relearning Whenever there is a Leads Off condition, the arrhythmia algorithm performs a Relearn, using the available leads.WarningWarningSince Relearn happens automatically, if learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. For this reason, you should:1. Respond promptly to any technical alarm.2. Ensure that the arrhythmia algorithm is labeling beats correctly.Using EASI Leads to TroubleshootIf there is artifact in the ECG waves or a CANNOT ANALYZE ECG technical alarm condition is in effect, you can use the three EASI leads to troubleshoot:1. Click 12-Lead ECG on the Patient Window, then on 3 EASI Leads.2. The three directly acquired EASI leads will be displayed so that you can determine which electrodes are causing the problem and need to be replaced.
Optimizing ECG Measurement Performance ECG Monitoring 3-25Optimizing ECG Measurement PerformanceWhile telemetry monitoring offers many advantages, it can be a challenge. The reliability and quality of the signal transmission through the air and hospital walls is governed by a number of variables which can be difficult to control. A telemetry system cannot be as dependable as a hardwired bedside monitor that transmits its signal through a wire. The effect of interference on the Philips IntelliVue Telemetry System ranges from a momentary loss of ECG to complete inoperability, depending on the situation. The strength, frequency, and proximity of the source of interference to the transceiver devices or the access point system are factors that determine the degree of severity. In cases where the source of interference is known - for example, cellular phones, magnetic equipment such as MRI, other radio or motorized equipment - removing or moving away from the source of interference will increase the equipment's dependability. WarningWarningPhilips IntelliVue Telemetry System should not be used for primary monitoring in applications where the momentary loss of the ECG is unacceptable. In this section, we'll investigate some of the problems affecting ECG signal clarity and when possible, show you how you can greatly enhance performance.Important—Philips IntelliVue Telemetry System also emits radio frequencies that can affect the operation of other devices. Contact the manufacturer of other equipment for possible susceptibility to these frequencies.The Telemetry SignalThe transceiver worn by the patient acquires the patient's physiological data, amplifies and digitizes it, detects pace pulses and broadcasts this information via radio waves to the Philips IntelliVue Telemetry System. Since the signal passes through the air, it is susceptible to interference from many sources.
Optimizing ECG Measurement Performance3-26 ECG Monitoring Trouble- shooting Signal DisturbancesDropouts Because Philips IntelliVue Telemetry System is a wireless system, under certain conditions RF (Radio Frequency) “dropouts” can occur. Dropouts result from a weak signal or RF interference. There will be signal drops to the bottom of channel for a minimum of 200 ms to indicate to the clinical user that it is a non-physiological event. If dropouts are frequent enough to affect the heart rate count, the CANNOT ANALYZE ECG or CANNOT ANALYZE ST technical alarm occurs. The following recording strip is an example of dropouts.If frequent dropouts are occurring, the following section describes some steps you can take to improve performance.SignalStrength The Philips IntelliVue Telemetry System is custom designed for your unit, so reliable signal reception is only possible where there are receiving access points. When the signal is too low, the following technical alarms occur:• CANNOT ANALYZE ECG• CANNOT ANALYZE ST• WEAK SIGNAL• NO SIGNALTo correct, first check the location of the patient. If the patient is not in the coverage area, do one of the following.• Return the patient to the specified coverage area.• Put telemetry in Standby Mode. See “Standby Mode” on page 2-5.• If the patient is in the coverage area and is stationary, try moving the location of the transceiver from its original location by about 15 cm (6 inches).
Optimizing ECG Measurement Performance ECG Monitoring 3-27RadioFrequencyInterferenceRadio frequency (RF) interference is caused by anything that intrudes into the transmitted electrical signal, such as paging transmitters. You are probably familiar with electrical interference in our homes and cars when it causes signal loss or static with cell phones. These same types of interference can occur with the transmitted telemetry signal. Even though the Philips IntelliVue Telemetry System is designed to resist these effects, interference can occasionally be seen in the form of “dropouts”. To improve performance, the source of the interference must be identified and eliminated.Muscle and Movement ArtifactMuscle and movement artifact differ from radio frequency interference since you can prevent much of the occurrence. Noise on the ECG signal can be caused by many sources, such as interference from other electrical equipment, muscle artifact and respiratory variation. It is up to the clinician to use certain techniques to minimize these types of noise. Use the following table to help you troubleshoot the most common sources of ECG noise.Troubleshooting Common Causes of ECG NoiseProblem Cause Remedy60-Cycle (AC) Interference Poor electrode placement.Possible non-grounded instrument near patientApply fresh electrodes after recommended skin preparation.Disconnect electrical appliances near patient (one at a time) by pulling wall plugs, to determine faulty grounding. Have engineering check grounding.Muscle Artifact Tense, uncomfortable patient.Poor electrode placement.Tremors.DiaphoresisMake sure patient is comfortable.Check that electrodes are applied on flat non-muscular areas of the torso; apply fresh electrodes after recommended skin preparation if necessary (see “Positioning ECG Electrodes” on page 3-8).
Optimizing ECG Measurement Performance3-28 ECG Monitoring Irregular Baseline Poor electrical contact.Respiratory interference.Faulty electrodes.Dry electrodes.Apply fresh electrodes after recommended skin preparation if necessary (see “Positioning ECG Electrodes” on page 3-8).Move electrodes away from areas with greatest movement during respiration.Baseline Wander Movement of patient.Improperly applied electrodes.Respiratory interference.Make sure patient is comfortable.Apply fresh electrodes after recommended skin preparation if necessary (see “Positioning ECG Electrodes” on page 3-8). Check that patient cable is not pulling electrodes.Move electrodes away from areas with greatest movement during respiration.Poor Electrode Contact Loose electrodes.Defective cables.Leadset not firmly connected.Apply fresh electrodes after recommended skin preparation if necessary (see “Positioning ECG Electrodes” on page 3-8). Replace cables.Troubleshooting Common Causes of ECG NoiseProblem Cause Remedy
ST/AR Arrhythmia & ST Segment Monitoring 4-1Introduction4ST/AR Arrhythmia & ST SegmentMonitoringThis chapter describes the ST/AR algorithms used for telemetry at the Philips Information Center. It includes the following sections:• ST/AR Arrhythmia Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2• ST/AR provides Heart Rate and PVC Rate numerics and alarm detection for the conditions listed in the following table. There are two detection levels: Basic and Enhanced. Enhanced includes the Basic alarms. . . . 4-4• The Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6• Adjusting ST Measurement Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9• Establishing ST Reference Beats (Baseline) . . . . . . . . . . . . . . . . . . . 4-11• ST Alarm Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11• ST Alarm Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
ST/AR Arrhythmia Algorithm4-2 ST/AR Arrhythmia & ST Segment MonitoringST/AR Arrhythmia AlgorithmSafety InformationWarningWarningFOR ALL PATIENTSDuring complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest.Learning/Relearning- Learning: If you initiate learning during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib.- Relearning: When using EASI ECG monitoring, Relearn happens automatically when there is a LEADS OFF technical alarm. If learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. Be sure to check the beat labels and initiate a relearn to correct.1. Respond to the technical alarm [for example, reconnect the electrode(s)].2. Ensure that the arrhythmia algorithm is labeling beats correctly.
ST/AR Arrhythmia AlgorithmST/AR Arrhythmia & ST Segment Monitoring 4-3WarningWarningFOR PACED PATIENTSIt is possible that pacemaker pulses will not be detected when the ECG analog output of a defibrillator or telemetry unit is plugged into a bedside monitor. This can result in the arrhythmia algorithm’s failure to detect pacemaker non-capture or asystole.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) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest.-- When arrhythmia monitoring paced patients who exhibit only intrinsic rhythm, the monitor can erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest.For patients who exhibit intrinsic rhythm only, the risk of missing cardiac arrest can 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 alarms 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 can result in the arrhythmia algorithm’s failure to detect pacemaker non-capture or asystole.ST/AR Arrhythmia AnalysisFor information on arrhythmia detection, refer to the following documentation:•ST/AR Algorithm - Arrhythmia Monitoring Application Note (4522 981
ST/AR Arrhythmia Algorithm4-4 ST/AR Arrhythmia & ST Segment Monitoring93051)• IntelliVue Information Center Instructions for Use and Online HelpThe 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 effective when monitoring both paced and non-paced patients in a clinical environment.IntelliVue Telemetry does not have a dedicated cardiotach. Instead, the arrhythmia cardiotach at the Information Center is used. Therefore, the ST/AR Arrhythmia algorithm is always on for all IntelliVue Telemetry patients, and cannot be turned off.ST/AR provides Heart Rate and PVC Rate numerics and alarm detection for the conditions listed in the following table. There are two detection levels: Basic and Enhanced. Enhanced includes the Basic alarms.Basic & Enhanced Arrhythmia DetectionBasic Arrhythmia Detection Enhanced Arrhythmia DetectionAsystole Tachy yyy > xxx Vent BigeminyVent Fib/Tach Brady yyy < xxx Vent TrigeminyV tach Non-Sustain VT Multiform PVCsExtreme Brady Vent Rhythm HR yyy > xxxExtreme Tachy Run PVCs HR yyy < xxxHigh HR Pair PVCs Irregular HRLow HR PausePVCs > 30/min Missed BeatPacer Not Capturing SVTPacer Not Pacing R-on-T PVCs
ST/AR Arrhythmia AlgorithmST/AR Arrhythmia & ST Segment Monitoring 4-5Beat classification determined by the ST/AR algorithm is shown on the primary delayed wave in the Arrhythmia Analysis window at the Information Center. To access this window, select Arrhythmia Analysis from the Patient Window. The annotation requires clinical validation of the analyzed heart rhythm. If the analysis is inaccurate, perform a relearn of the rhythm.When monitoring is initiated, when the Wave 1 lead is changed, or if Relearn is selected, a question mark (?) is displayed next to HR and the annotation “L” appears on the annotated wave until the HR is calculated and the rhythm is learned. Annotation Beat Classification ColorAArtifact BlueIInoperative RedLLearning RedMMissed Beat RedNNormal BluePPaced BlueSSupraventricular Premature BlueVVentricular Premature Red?Questionable Red‘Pacer Mark Blue
ST/AR ST Segment Algorithm4-6 ST/AR Arrhythmia & ST Segment MonitoringST/AR ST Segment AlgorithmWarningWarningThis device provides ST level change information; the clinical significance of the ST level change information should be determined by a physician.The ST/AR ST algorithm at the Information Center (not available for M3153A) monitors ST segment elevation or depression for each available telemetry ECG lead and produces events/alarms simultaneously. ST values update with every measurement period and enunciate, depending upon the severity of the change, events and alarms as they are detected.The ST/AR ST algorithm is approved for use only with non-paced and atrially-paced adult telemetry-monitored patients. With EASI monitoring, ST analysis is performed on up to 12 leads, and an additional value of ST index is calculated and displayed (see “EASI ST Analysis” on page 4-8). Assessment of EASI-derived 12-lead ST measurement is recommended for adult patients that meet the following parameters:• Ages: 33-82 years• Heights: 147 to 185 cm (58 to 73 in)• Weights: 53 to 118 kg (117 to 261 lbs)• Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)All ST analysis and ST alarms for telemetry patients are performed by the Information Center.For additional information on ST monitoring, refer to the following documentation:•ST/AR Algorithm - ST Segment Monitoring Application Note (4522 981 92851)•Information Center Online Instructions for Use and Online HelpThe Measurement The ST measurement for each beat complex is the vertical difference between two measurement points. The isoelectric point provides the baseline for the
ST/AR ST Segment AlgorithmST/AR Arrhythmia & ST Segment Monitoring 4-7measurement and the ST point provides the other measurement point. It is positioned with reference to the J-point.R-WAVE PEAK AT 0 MSECJ POINTISO ELECTRIC POINT DEFAULT = -80 MSECMEASUREMENT POINT DEFAULT = J+60 MSECDIFFERENCE = ST VALUEPQSSTT
ST/AR ST Segment Algorithm4-8 ST/AR Arrhythmia & ST Segment MonitoringAlgorithm Processing ST analysis analyzes ECG signals to classify the heart beats. Only beats classified as normal or Supraventricular (atrially paced) are used to calculate ST elevations and depressions.The ST/AR ST algorithm processing includes special ST filtering, beat selection and statistical analysis, calculation of ST segment elevations and depressions, and lead reconstruction and wave generation. When ST analysis is being performed on two leads, the averaged derived and reconstructed ST waves and associated ST segment values are given for up to six leads, depending on the type of patient cable:• 3-wire: one lead• 5-wire: up to two leads if monitoring a chest and a limb lead• 5-wire: up to six leads if monitoring two limb leads with the Philips Transmitter (without EASI monitoring)• 5- wire: up to 12 leads if monitoring using EASINote—No ST analysis is done on a patient if an electrode falls off.Displayed ST Data ST data displays as values in the Patient Sector and Patient Window. A positive value indicates ST segment elevation; a negative value indicates ST segment depression. You can view ST data in ST Review, Trend Review, and Event Review windows.EASI ST Analysis The Information Center generated ST values presented in the patient sector and Patient Window for EASI derived leads is STindx (ST Index). STindx is a summation of three ST segment measurements, using the leads that can indicate ST segment changes in the different locations of the heart:• anterior lead V2• lateral lead V5• inferior lead aVFCautionBe sure not to duplicate the lead labels. This can result in incorrect ST values being displayed for those leads.
ST/AR ST Segment AlgorithmST/AR Arrhythmia & ST Segment Monitoring 4-9ST OperationTurning STMonitoring On/OffThe ST Setup Window allows you to turn ST monitoring on or off for all available ECG leads. To turn ST monitoring on at the Information Center, perform the following steps:You would turn ST monitoring off if:• You are unable to get any lead that is not noisy.• Arrhythmias such as atrial fib/flutter cause irregular baseline.• The patient is continuously ventricularly paced.• The patient has left bundle branch block.Adjusting STMeasurementPointsThe ST Setup Window enables you to adjust the ST measurement points to ensure accurate data.There are three measurement cursors: • The ISO measurement cursor positions the isoelectric point in relation to the R-wave peak. • The J-point cursor positions the J-point in relation to the R-wave peak. The purpose of the J-point is to correctly position the ST measurement point.• The ST measurement cursor positions the ST point a fixed distance from the J point.Note—The ST measurement points may need to be re-adjusted if the patient's heart rate or ECG morphology changes significantly.Step Action1From the Patient Window, click the All Controls button.2From the All Controls Window, click the ST Setup button.3From the ST Setup Window, click ST On.
ST/AR ST Segment Algorithm4-10 ST/AR Arrhythmia & ST Segment MonitoringPerform the following steps at the Information Center to adjust the ST measurement points:Step Action1Access the ST Setup window by clicking on the All Controls button in the Patient Window, then clicking on the ST Setup button.2If you need to adjust the ISO (isoelectric) point, place the cursor over the ISO button to access the adjustment arrows. Then use the arrows to position the bar in the middle of the flattest part of the baseline (between the P and Q waves or in front of the P wave).TRPISO point QS
ST/AR ST Segment AlgorithmST/AR Arrhythmia & ST Segment Monitoring 4-11EstablishingST ReferenceBeats(Baseline)After adjusting the measurement points, you can establish baseline reference beats for all available leads in the ST Review window at the Philips Information Center. Reference beats enable you to compare waveform changes, for example from admission, or prior to or after treatment. The reference continues to be saved beyond the 24 hour review window, but you can update it to any beat within the last 24 hours. Please refer to the Philips Information Center Instructions for Use18 or on-line Help for directions.ST Alarm Settings All Philips Information Center alarm settings (limits and on/off status) have unit default settings. The Philips Information Center however, lets you set the high and low ST alarm limits for individual patients based on:3Adjust the J point, if necessary, by placing the cursor over the J-point button to access the adjustment arrows. Then use the arrows to position the bar at the end of the QRS complex and the beginning of the ST segment.4Adjust the ST point, if necessary, by using the J point as an “anchor” and placing the bar at the midpoint of the ST segment. Choices are J+0, J+20, J+40, J+60, or J+80.Step ActionTRPSQJ pointTRPSQST point
ST/AR ST Segment Algorithm4-12 ST/AR Arrhythmia & ST Segment Monitoring• Your assessment of the patient's clinical condition.• Unit protocols.• Physician orders or medication specified limits.You can make the following adjustments to ST alarm limits to accommodate the clinical condition of individual patients:• Turn all alarms off/on.• Adjust the alarm limits:– to specific high and low limits– to Smart Limits (see the Philips IntelliVue Information Center Instructions for Use for information on Smart Limits)– back to unit default settings.You adjust the ST alarm limits in the ST Alarms Window. Each ST parameter has its own alarm limit. The alarm is triggered when the ST value exceeds its alarm limit for more than 1 minute. The alarm will be a yellow alarm. When more than one ST parameter is in alarm, only one alarm message displays. For multilead alarms when using an EASI transmitter, an alarm is generated if two or more ST leads exceed the alarm limits. The default setting is +/-1.0. The alarm message indicates the two leads that are in greatest violation of the limits, for example, “**MULTI ST AVR, V6”. If another lead becomes deviant, the message changes but it is considered the same alarm (no new alarm sounds and it is not listed as a new event). See “Physiologic Alarms” on page 2-9 for a list of all ST alarms.See IntelliVue Information Center Instructions for Use for specifics on alarm management and behavior.Adjusting STAlarms Make adjustments to ST alarms on the ST Alarms window at the Information Center. Step Action1From the Patient Window, select the All Controls button.
ST/AR ST Segment AlgorithmST/AR Arrhythmia & ST Segment Monitoring 4-132 From the All Controls window, select the ST Alarms button under Alarm Management and Setup.3In the ST Alarms window, adjust alarms as needed. Choices for setting the ST alarm limits are:Unit Settings—Click on this button if want to have the specific limits that are pre-set for your unit.Smart Limits—Click on this button to set high and low limits around your patient's current ST value. The difference above and below the patient's ST value are pre-set for your unit. Note—Smart Limits can be configured to automatically be activated when the patient is connected. See the IntelliVue Information Center Instructions for Use for additional information on using smart limits.Specified limits—Use these to set the high and low alarm limits based on your assessment of the patient's clinical condition, unit protocols, or physician orders or medication specified limits. A good guideline is + 1.0 mm or - 1.0 mm from the patient's ST, or follow your unit protocol.Step Action
ST/AR ST Segment Algorithm4-14 ST/AR Arrhythmia & ST Segment Monitoring
SpO2 Monitoring 5-1Introduction5 SpO2 MonitoringThis chapter provides an introduction to the SpO2 measurement and its application. It includes the following sections:• SpO2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2• Pulse Oximetry Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4• Selecting a SpO2 Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5• Applying the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9• Connecting the SpO2 Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14• Measuring SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15• Understanding SpO2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20• Optimizing SpO2 Measurement Performance . . . . . . . . . . . . . . . . . . 5-21
SpO2 Safety Information5-2 SpO2 Monitoring SpO2 Safety InformationWarningWarningAlways confirm Information Center observations with clinical observation of the patient before administering interventions.Prolonged, continuous monitoring can increase the risk of changes in skin characteristics, such as irritation, reddening, blistering or pressure necrosis, particularly on patients with impaired perfusion and varying or immature skin morphology. Specific attention must be given to sensor site inspection for changes in skin quality, proper optical path alignment and attachment. Check the application site at regular intervals and change the site if any compromise in skin quality should occur. More frequent checking can be required due to an individual patient's condition.Using a sensor during MR imaging can cause severe burns. To minimize this risk, ensure that the cable is positioned so that no inductive loops are formed. If the sensor does not appear to be operating properly, remove it immediately from the patient.Do not use disposable sensors on patients who exhibit allergic reactions to the adhesive.Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin can lead to inaccurate (over-estimated) measurements.Interference leading to inaccurate measurements can be caused by:- High levels of ambient light (Hint: cover application site with opaque material)- Electromagnetic interference- Excessive patient movement and vibration.
SpO2 Safety Information SpO2 Monitoring 5-3WarningWarningRemoval of the SpO2 sensor during Continuous SpO2 monitoring results in a NO SENSOR technical alarm. There is no technical alarm for a "No Sensor" condition in Spot Check mode.SpO2 Information for the User1The pulse oximeter is calibrated to indicate fractional oxyhemoglobin, and displayed results can range from 0 to 100%.A 10 second averaging filter is used in the calculation of the result. Displayed results are typically updated every second, but the update period can be automatically delayed by up to 30 seconds in the presence of noise.Physiological SpO2 alarm signals will be generated at the central station. The SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments. The SpO2 high alarm limit can be set between 51 and 100% inclusive, in 1% increments. The maximum delay between the physiological alarm condition and alarm signal generation at the central station is 10 seconds.Pulse rate is also derived from the pulsatile SpO2 measurement, and displayed results can range from 30 to 300 bpm. There is no alarm function for pulse rate.The pleth wave is auto-scaled to maximum display size. It decreases only when the signal quality becomes marginal. Pleth wave size is NOT directly proportional to the pulse volume.1. A functional tester cannot be used to assess the accuracy of a pulse oximeter sensor or a pulse oximeter monitor. If there is independent demonstration that a particular calibration curve is accurate for the combination of a pulse oximeter monitor and a pulse oximeter sensor, then a functional tester can measure the contribution of a monitor to the total error of a monitor/sensor system. The functional tester can then measure how accurately a particular pulse oximeter monitor is reproducing that calibration curve.
Pulse Oximetry Measurement5-4 SpO2 Monitoring Pulse Oximetry MeasurementThe ECG-SpO2 TRx+ Transceiver supports an SpO2 sensor connection using Fourier Artifact Suppression Technology (FAST). The FAST algorithm overcomes many of the issues associated with traditional pulse oximetry such as sensitivity to patient movement and intense ambient light. The algorithm offers improved motion artifact rejection as well as performance improvements for patients with low perfusion. SpO2 can be measured continuously, where a value is sent to the Information Center every second, or as a single, individual measurement (Spot Check). The Spot Check measurement will be removed from the Information Center display after 24 hours. If 1-minute or 5-minute sampling rate is selected at TeleMon, the transceiver will provide Continuous SpO2 measurement after disconnection (see “Transceiver Use with TeleMon A02/A03” on page 1-27).The SpO2 parameter measures the arterial oxygen saturation, that is, the percentage of oxygenated hemoglobin in relation to the total hemoglobin.If, for example, a total of 97% of the hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has an oxygen saturation of 97%. The SpO2 numeric that appears on the monitor will read 97%. The SpO2 numeric indicates the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin.• The oxygen saturation is measured using the pulse oximetry method. This is a noninvasive method of measuring the arterial hemoglobin oxygen saturation. It measures how much light, sent from light sources on one side of the sensor, travels through patient tissue (such as a finger or an ear), to a receiver on the other side of the sensor.• The amount of light passing through depends on many factors, most of which are constant, such as tissue or venous blood. However one of the factors, the blood flow in the arterioles, varies with time - because it is pulsatile.This measurement principle is used to derive the SpO2 measurement. The numeric that is displayed at the Information Center is the oxygen saturation of the arterial blood - the measurement of light absorption
Selecting a SpO2 Sensor SpO2 Monitoring 5-5during a pulsation. Correct placement of the sensor is essential for accurate measurements (see “Applying the Sensor” on page 5-9).Pulse Indication During Spot Check measurement, the pulse signal is detected and communicated to you via an auditory signal. The indicator is a single low-pitch tone for each pulse detected. The tone is controlled by the Volume and Mute controls at the Information Center. The pulse indication stops when a measurement is complete. However, since it is possible to have a strong pulse but fail an SpO2 measurement, you should listen for the successful completion of a measurement (single beep), or a double beep if the measurement fails.The pulse indicator is for information only, and should not be used as an indication for treatment. The indicator is not functional in Continuous measurement mode.Clinical Note: If the transceiver is in Spot Check mode and the sensor light is illuminated but you do not hear a low-pitch sound synchronized with the pulse, readjust the sensor, or move the sensor to another site to provide better detection.Selecting a SpO2 SensorPhilips reusable sensors in adult, pediatric and infant models can be used, as well as Philips and Nellcor disposable sensors. Use only specified sensors (probes) and cables.The following chart and figure “Selecting an SpO2 Sensor” on page 5-7 guide you in selecting the correct sensor type. To use the figure, find the patient’s weight on the vertical axes. On the horizontal axis at this weight, the shaded areas indicate that the sensor is a "best choice" for the patient. Unshaded areas indicate a "good choice." For example, the best reusable sensor for a 50 kg patient is the M1191A, applied to the finger or toe. Alternatively, you could use M1194A applied to the ear.Sensor Type When to Use
Selecting a SpO2 Sensor5-6 SpO2 Monitoring WarningWarningWhen the specified Nellcor® sensors are used, the application must be consistent with the sensor manufacturer's own guidelines.Reusable You can use reusable sensors on different patients after cleaning and disinfecting them. For care and cleaning instructions, see the instructions accompanying the sensors. Reusable sensors should be changed to another site every 2-3 hours or in accordance with your clinical practice guidelines. See the Directions for Use supplied by Nellcor® Incorporated for instructions on preparation and application of reusable sensors.Disposable Use disposable sensors only once and then discard. However, you can relocate them to a different patient-site if the first location does not give the desired results. Do not reuse disposable sensors on different patients.See the Directions for Use supplied by Nellcor® Incorporated for instructions on preparation and application of disposable sensors.
Selecting a SpO2 Sensor SpO2 Monitoring 5-7Selecting an SpO2 SensorPreferred sensor typesAlternative sensor typesReuseable sensor Disposable sensorM1192A M1191A M1194APhilips Part #M1901B N-25 NM1903B D-20 PM1904B D-25 A11088664433227Infant Pedi AdultPatientWeight( kg )504030201510 3PediAdult AdultPediAdultPatientWeight( lb )PediInfantPediPediAdultNeoOxisensorOxiCliq/OxiMax
Selecting a SpO2 Sensor5-8 SpO2 Monitoring CautionDo not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids. These can contaminate sensor and electrical connections, and thereby cause unreliable or intermittent measurements.Do not use disposable sensors on patients who have allergic reactions to the adhesive.If you are using Nellcor® sensors, see the directions for use supplied with these sensors.
Applying the Sensor SpO2 Monitoring 5-9 Applying the SensorSensor Application Safety InformationWarningWarningFailure to apply a sensor properly can reduce the accuracy of the SpO2 measurement.Loose/Tight sensor: If a sensor is too loose, it can compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure can be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxia and tissue malnutrition. Skin irritations or ulcerations can occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and ulcerations, inspect the sensor application site every 2-3 hours, and change the application site at least every 4 hours or according to clinical practice guidelines.Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation and can severely obstruct circulation and lead to inaccurate measurements.Ambient Temperature: Never apply an SpO2 sensor at ambient temperatures from above 37 oC (99 oF) because this can cause severe burns after prolonged application.Extremities to Avoid: Avoid sites distal to BP cuff or intra-arterial line.Site Selection • Avoid sites with impaired perfusion, skin discoloration, excessive motion or nail polish.• Avoid placing the sensor in an environment with bright lights (if necessary, cover the sensor with opaque material).• Avoid use of excessive pressure at the application site (e.g., sensor applied too tightly, excessive adhesive tape to secure the sensor, clothing or
Applying the Sensor5-10 SpO2 Monitoring restraints that are too tight). These result in venous pulsations and inaccurate measurement, and may severely obstruct circulation.Sensor Application A minimum pulsatile flow must be present at the application site of your patient to obtain measurements. Select an appropriate sensor and apply the sensor properly to avoid incorrect measurements. Applying a small amount of pressure at the application site can improve the measurement. Use one of the preferred application sites for your sensor. Selecting the most suitable sensor and application site will help you to ensure that:• The light emitter and the photo detector are directly opposite each other and that all the light from the emitter passes through the patient's tissues,• The application site is of the correct thickness for light to pass through. If the application site is too thick or too thin, an SpO2 NON-PULSATILE technical alarm will occur. You should then select another site as appropriate.Positioning of the Light Emitters and Photo DetectorInspect the application site every 2 to 3 hours or according to clinical practice guidelines to ensure skin integrity and correct optical alignment. If skin integrity changes, move the sensor to another site.Follow the sensor’s instructions for use, adhering to all warnings and cautions.Light EmitterPhoto Detector
Applying the Sensor SpO2 Monitoring 5-11To apply the sensor, use the following directions.Adult Fingersensor(M1191A)Push the sensor over the fingertip in such a way that the fingertip touches but does not protrude from the end of the sensor. The fingertip must be uppermost and the cable must lie on the back of the hand. This ensures that the light sources cover the base of the fingertip giving the best measurement results. The cable can be held in place by the accompanying wristband.Step Action1 Select the site and appropriate sensor (see “Selecting a SpO2 Sensor” on page 5-5).2 Apply the sensor to the appropriate part of the patient’s body. Note—The application site should match the sensor size so that the sensor can neither fall off nor apply excessive pressure.3 Check that the light emitter and the photo detector are directly opposite each other. All light from the emitter must pass through the patient’s tissue.
Applying the Sensor5-12 SpO2 Monitoring WarningWarningFailure to apply the sensor properly can cause incorrect measurement of SpO2. For example, not pushing the sensor far enough over the finger can result in inaccurate SpO2 readings. Pushing the sensor too far, so that the finger protrudes from the sensor, can pinch the finger, resulting in inaccurately low SpO2 readings. Small Adult/PediatricFinger sensor(M1192A)Push the sensor over the fingertip in such a way that the fingertip touches but does not protrude from the end of the sensor.Note—When using an M1195A Infant Finger/Toe Sensor, select a finger or toe with a diameter of between 7 and 8 mm (0.27 and 0.31 inches).
Applying the Sensor SpO2 Monitoring 5-13Ear Clipsensor(M1194A)Clip the probe onto the fleshy part of the ear lobe as shown in the diagram below. The plastic fixing mechanism helps to minimize artifact generated by patient motion. Do not position the probe on cartilage or where it presses against the head.The clip sensor can be used as an alternative if the adult finger sensor does not provide satisfactory results. The preferred application site is the ear lobe, although other application sites with higher perfusion (such as the nostril) can be used. Due to the physiologically lower perfusion in the ear lobe, you should be aware of the reduced accuracy of the measurement and more frequent technical alarms.
Connecting the SpO2 Cable5-14 SpO2 Monitoring Connecting the SpO2 CableCautionExtension cables: Do not use extension cables with the IntelliVue TRx+.Step Action1 Connect the sensor cable to IntelliVue TRx+. • Connect reusable sensors directly into the transceiver.• Connect disposable sensors into the adapter cable, then connect the adapter cable to the transceiver. Remove the protective backing. 2 Ensure that the sensor and connector are positioned away from power cables, to avoid electrical interference.3 Adjust SpO2 alarms in the patient Window (see “Telemetry Controls in the Patient Window” on page 6-2).4 Make other adjustments in the Telemetry Setup Window (see “Patient-Configurable Settings in Telemetry Setup” on page 6-3).
Measuring SpO2 SpO2 Monitoring 5-15Electrical Interference: Position the sensor cable and connector away from power cables, to avoid electrical interference.Measuring SpO2SpO2 measurements can be made continuously in Continuous mode or manually on an as-needed basis in Spot Check mode, depending on the transceiver configuration. While operating in continuous mode, you can also measure pulse, and display the pleth wave at the Information Center. The SpO2 parameter is turned on by inserting/removing the sensor cable into the transceiver, or by control from the Information Center. SpO2 monitoring consumes considerable electrical energy. If the battery power is not at least 25% full, no measurements of SpO2 can be made.Setting the mode at Continuous or Spot Check is done at TeleMon or is configured using the Service Tool. Spot Check When the transceiver is configured for Spot Check measurement, use the following instructions to take an individual, manual SpO2 reading from the transceiver. You can also initiate a Spot Check measurement in the Patient Window at the Information Center by selecting the STAT SpO2 icon.Note—Spot Check measurements from the transceiver are inactive when the transceiver is connected to TeleMon. Step Action1Set SpO2 mode to Spot Check in the Telemetry Setup window.2 Attach the sensor to the patient.
Measuring SpO25-16 SpO2 Monitoring Continuous When the transceiver is configured for Continuous SpO2 measurement, use the following directions to initiate Continuous SpO2 monitoring. 3 Connect the SpO2 cable to IntelliVue TRx+, and check that:•The SpO2 sensor light turns on.• A low-pitch tone detecting each pulse is audible (unless sounds are muted).4 After approximately 30 seconds, a tone from the transceiver indicates that a measurement has been taken.The value, with the measurement time, is displayed at the Information Center.The sensor light extinguishes. If the measurement was unsuccessful, you’ll hear a double beep. Remove the sensor cable and reinsert it to retake the measurement.Note—The SpO2 value and time stamp will remain on the Information Center for 24 hours or until another measurement is taken, with one exception. If the batteries are removed from the transceiver, the Spot Check measurement will be erased from the display, but the SpO2 measurements will be available in Trend Review.5To repeat a Spot Check measurement at the bedside, disconnect then reconnect the SpO2 cable to the transceiver.Step ActionStep Action1Set SpO2 mode to Continuous in the Telemetry Setup window.2 Insert the SpO2 cable into the IntelliVue TRx+, and check that the sensor light turns on.3 Attach the sensor to the patient.
Measuring SpO2 SpO2 Monitoring 5-17Note— If the sensor is removed without discontinuing SpO2 monitoring in the Telemetry Setup Window at the Information Center, an SpO2 NO SENSOR technical alarm will result.DisplayingPulse When operating in Continuous mode, you can view pulse measurements at the Information Center. See “Patient-Configurable Settings in Telemetry Setup” on page 6-3.Note—If pulse is turned on, the Patient Sector and Patient Window of the Information Center display the label with "T" (for example, Pulse T) to indicate that the measurement was made via telemetry.DisplayingPlethWave The transceiver can be configured to transmit the pleth wave for display at the Information Center. See “Patient-Configurable Settings in Telemetry Setup” on page 6-3.SpO2 Measurement when Connected to TeleMonWhen the transceiver is connected to TeleMon:• The SpO2 measurement mode is always Continuous. 4 After approximately 15 seconds, the value, with the measurement time, is displayed at the Information Center.Note—There are no sounds associated with continuous SpO2 measurement.5 To discontinue monitoring, set SpO2 mode to off at the Information Center. Step Action
Measuring SpO25-18 SpO2 Monitoring • You can change the mode. Changes to the mode take effect when the transceiver is disconnected from TeleMon. The following settings will be used:Turning SpO2 Monitoring OffTo turn SpO2 monitoring off, disconnect the sensor cable (or adapter cable) from the transceiver. SpO2 enters a power-down mode after the cable is disconnected from the transceiver, thereby conserving battery life. SpO2 should also be turned off at the Information Center. If the transmitter is configured for Continuous SpO2 measurement and the sensor is removed without turning SpO2 off, a SpO2 NO TRANSDUCER technical alarm will result. See Important—It is important to disconnect the sensor from the transceiver. Unplugging the sensor from an adapter cable that is connected to the transceiver does NOT provide SpO2 power-down mode. Mode Set at TeleMon Mode when Transceiver is DisconnectedContinuous Continuous5-minute Continuous1-minute ContinuousManual Spot Check
Measuring SpO2 SpO2 Monitoring 5-19Turning the SpO2 Parameter On/OffYou can turn SpO2 monitoring on/off at the Information Center. S ee “Patient-Configurable Settings in Telemetry Setup” on page 6-3.When SpO2 is turned on, the Patient Sector and Patient Window of the Information Center display a "T" next to the SpO2 numeric (for example, SpO2 T 90%) to indicate that the measurement was made via telemetry.If the transceiver is connected to the TeleMon Companion Monitor, after you turn SpO2 on, be sure to adjust the sample rate to match your patient’s acuity. When SpO2 monitoring is turned off, setting the sample rate to Spot Check at TeleMon will help you conserve the transmitter’s battery life. SpO2 Parameter Auto ONThe SpO2 parameter is automatically turned on at the IntelliVue Information Center if a manual SpO2 measurement is initiated at the transceiver while in Spot Check mode or if the SpO2 sensor is inserted into the transceiver while the transceiver is in Continuous SpO2 mode.When a patient is discharged and the transceiver is in Continuous mode, the SpO2 parameter is turned off. To reactivate the SpO2 parameter Auto ON feature from the transceiver, remember to do one of the following when a patient is discharged:– remove the SpO2 cable from the transceiver, wait 15 seconds, then reinsert the cableor– if using TeleMon, reset the transceiver to Manual mode.Note—The SpO2 parameter Auto ON feature only needs to be reactivated when the transceiver is in Continuous mode at discharge.Note— SpO2 can always be turned on and off at the IntelliVue Information Center.
Understanding SpO2 Alarms5-20 SpO2 Monitoring Understanding SpO2 AlarmsWarningWarningIf you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur. If the monitor is configured to suppress this alarm, there can be a delay of up to 60 seconds in indicating critical patient status, such as sudden pulse loss or hypoxia.Physiologic SpO2 alarms will be generated and displayed at the Information Center. SpO2 offers high and low limit alarms, and a high priority (red level) oxygen desaturation alarm. The SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments. The low alarm limit cannot be set below the desat alarm limit. The SpO2 high alarm limit can be set between 51 and 100% inclusive, in 1% increments.The maximum delay between the physiologic alarm condition and alarm annunciation at the central station is 10 seconds. This means that the monitor will generate an alarm if the averaged numeric value on the display exists beyond the alarm limit for more than 10 seconds.Setting the high SpO2 alarm limit to 100% is equivalent to switching off the high alarm limit. Therefore the upper alarm limit for oxygen saturation must be carefully selected in accordance with accepted clinical practices.The desaturation limit is set automatically at 10 below the Low Limit.SpO2 alarms are non-latching. That is, when an SpO2 limit is exceeded, if the alarm is not silenced, it will reset automatically if the patient’s alarm condition returns within the limits. This reduces the number of times you will need to reset alarms at the Information Center when an alarm condition has been corrected at the patient’s side (for example, movement-induced artifact alarms). See Chapter 2, “Alarms” for a list of all SpO2 alarms.
Optimizing SpO2 Measurement Performance SpO2 Monitoring 5-21Optimizing SpO2 Measurement PerformanceRefer to this section on problem situations if you have difficulty getting a signal or obtaining accurate measurements.DistortionAmbient light, motion, perfusion or incorrect sensor placement can affect the accuracy of the derived measurements. Arterial Blood FlowThe measurement depends on the pulsatile nature of blood flow in the arteries and arterioles; with the following conditions arterial blood flow can be reduced to a level at which accurate measurements cannot be made:• shock• hypothermia • use of vasoconstrictive drugs • anemiaWavelength AbsorptionThe measurement also depends on the absorption of particular light wavelengths by the oxyhemoglobin and reduced hemoglobin. If other substances are present which absorb the same wavelengths, they will cause a falsely high, or falsely low SpO2 value to be measured. For example:• carboxyhemoglobin • methemoglobin • methylene blue • indocyanine green*• indiocarmine**These chemicals are used in dye dilution cardiac output calculations.Ambient LightVery high levels of ambient light can also affect the measurement; an SpO2 INTERFERENCE message will appear on the display. The measurement quality can be improved by covering the sensor with suitable opaque material.Care and CleaningFor care and cleaning instructions, see the instructions accompanying the sensors.
Optimizing SpO2 Measurement Performance5-22 SpO2 Monitoring Optimizing Sensor PerformanceTo get the best results from your SpO2 reusable sensor:• Always handle the sensor and cable with care. The soft finger sleeve houses a sensitive electronic device that can be damaged by harsh treatment. Always protect the cable from sharp-edged objects.• Use the wristband that is supplied with your M1191A sensor. By keeping the cable between the finger sensor and the wristband fairly loose, you will maintain good monitoring conditions. Normal wear and tear associated with patient movement and regular sensor cleaning naturally mean that your sensor will have a limited lifetime. However, provided you handle the sensor and its cable with care, you can expect useful service from it for up to two years. Harsh treatment will drastically reduce the lifetime of the sensor. Moreover, Philips Medical Systems’ warranty agreement shall not apply to defects arising from improper use.
Telemetry Functions at the Information Center 6-1Introduction6Telemetry Functions at theInformation CenterThis chapter describes the telemetry-specific functions at the Information Center. It includes the following sections. For additional information regarding the operation of the Information Center, consult IntelliVue Information Center Instructions for Use.Note—ST functions performed at the IntelliVue Information Center are described in Chapter 4.• Telemetry Controls in the Patient Window . . . . . . . . . . . . . . . . . . . . . 6-2• Telemetry Controls in the Patient Window . . . . . . . . . . . . . . . . . . . . . 6-2• Patient-Configurable Settings in Telemetry Setup . . . . . . . . . . . . . . . . 6-3• Unit-Configurable Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Telemetry Controls in the Patient Window6-2 Telemetry Functions at the Information Center Telemetry Controls in the Patient WindowThe Patient Window at the Information Center (accessed from the Patient Window control in the Patient Sector) includes controls for a number of telemetry operations. For detailed instructions on these operations, see the IntelliVue Information Center Instructions for Use or the Online Help.To View ECG, SpO2 or NBP Alarm LimitsMove the cursor over the HR or SpO2 label to display the current high and low alarm limits.To Change ECG, SpO2 or NBP Alarm LimitsMove the cursor over the High or Low numeric to display up/down arrow controls for adjusting the limit. After adjusting the limit, move the cursor away from the area to dismiss the limit controls.To Change ECG Waveform SizeMove the cursor over the ECG waveform to display the ECG Waveform Size popup. Select the label from the label list.To Select Lead LabelMove the cursor over the ECG waveform to display the Lead Selection popup. Select the label from the label list.Important—Do not set the primary and secondary channels to the same lead.To Change Va and Vb Lead Default Settings (6-lead only)Move the cursor over the ECG waveform to display the Lead Selection popup. Select the label from the label list. For Va or Vb, select Va or Vb, then select the lead to be assigned.Important—Do not set the primary and secondary channels to the same lead.To Initiate a Spot Check MeasurementMove the cursor over the SpO2 label. Then click on the Spot Check icon (finger with sensor).To Initiate Monitor StandbySee instructions under “Standby Mode” on page 2-5.
Locating the Transceiver (Find Device) Telemetry Functions at the Information Center 6-3Locating the Transceiver (Find Device)The Find Device feature enables you to generate a continuous double tone (two pitches) at the transceiver to assist in locating a missing device. This function is initiated in the Telemetry Setup Window at the Information Center. Find Device requires that the transceiver has good working batteries and is within the coverage areaTo locate a transceiver To silence the sound Patient-Configurable Settings in Telemetry SetupThe Telemetry Setup window enables you to configure the transceiver for patient-specific settings. To access this window, from the Patient Window click All Controls, then Telemetry Setup.Step Action1 From the Patient Window, select All Controls -> Telemetry Setup.2 Click the Find Device button to generate a repeated tone at the transceiver.Step Action1 Press both the Check button to turn off the sound.
Patient-Configurable Settings in Telemetry Setup6-4 Telemetry Functions at the Information Center The following settings can be adjusted in this window. Patient-Configurable Settings in Telemetry SetupControl Function Setting Choices DefaultTelemetry Button Determine the Information Center response when Telemetry Button is pressed.Nurse Call - generate nurse call alarmRecord - generate a recording stripNurse Call and Record - generate nurse call alarm and recording stripNoneNurse CallTelemetry Device VolumeSet the volume level for all adjustable sounds on the transceiver.Note—This control is grayed out if configured as such in Unit settings how is this done?.1 (low), 2, 3, 4, 5 (high) 3Telemetry Device Volume MuteEnable/disable all adjustable sounds on the transceiver.This control is grayed out if disabled in Unit Settings.enabledisable (mute)enable
Patient-Configurable Settings in Telemetry Setup Telemetry Functions at the Information Center 6-5SpO2 Mode Determine the transceiver SpO2 behavior.Note—For Off or Spot Check mode, Pulse is automatically set to disable.Off - Stops monitoring of the SpO2 parameterSpot Check - Provides manual measurements so the clinician can check as needed. Measurement initiated by plugging the SpO2 cable into the transceiver or by selecting STAT SpO2 icon in the Patient Window.Continuous - Sends an SpO2 parameter value to the Information Center every second.Spot CheckPatient-Configurable Settings in Telemetry SetupControl Function Setting Choices Default
Patient-Configurable Settings in Telemetry Setup6-6 Telemetry Functions at the Information Center Suppress SpO2 INOPs with NBPEnable/disable the SpO2 algorithm to detect NBP running and suppress sending technical alarms from the transceiver for 60 seconds.WarningWarningIf you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur. If the monitor is configured to suppress this alarm, there can be a delay of up to 60 seconds in indicating critical patient status, such as sudden pulse loss or hypoxia.enabledisableenablePleth Wave Enable/disable the transmission of the Pleth wave (and its subsequent display) to the Information Center. For Continuous SpO2 mode only.Note—When enabled, the Pleth wave will replace the Vb wave in the Patient Window during 6-lead monitoringenabledisabledisable (Pleth is not displayed.)Pulse Enable/disable the transmission of the Pulse parameter (and its subsequent display) to the Information Center. For Continuous SpO2 mode only. enabledisabledisable (Pulse is not displayed.)Patient-Configurable Settings in Telemetry SetupControl Function Setting Choices Default
Unit-Configurable Settings Telemetry Functions at the Information Center 6-7Unit-Configurable SettingsUnit Settings provide access to clinical configuration items that affect all patients on an Information Center. When unit settings are changed, in general they do not affect current patient settings. A discharge is needed for the settings to take effect, with the following exceptions: standby duration and telemetry frequency. Telemetry specific settings are listed in the following table. They are accessed through All Controls -> Unit Settings -> Telemetry Setup. All other unit settings are described in IntelliVue Information Center Instructions for Use.Unit Settings require a password, and the displays are in English.SpO2 Alarm Enable/disable the display of SpO2 alarms on the Information CenterenabledisableenableUnit Settings Change current settings back to last saved clinical unit settings (none)Patient-Configurable Settings in Telemetry SetupControl Function Setting Choices Default
Unit-Configurable Settings6-8 Telemetry Functions at the Information Center Unit Settings - Telemetry SetupControl Function Settings DefaultPatient Type Set patient type used for alarm limitsAdultPediatricAdultTelemetry Button Determine the Information Center response when Telemetry Button is pressed.Nurse Call - generate nurse call alarmRecord - generate a recording stripBoth - generate nurse call alarm and recording stripNone - ignore buttonNurse CallTelemetry Device VolumeSet the volume level for all adjustable sounds on the transceiver.1 (low) to 5 (high) 3Telemetry Device Volume MuteEnable/disable all adjustable sounds on the transceiver. enable (unchecked) = sounddisable (checked) = mutemuteStandby Duration Sets the standby duration on the device. Infinite10 minutes20 minutes30 minutes1 hour2 hours3 hours4 hoursInfinite
Unit-Configurable Settings Telemetry Functions at the Information Center 6-9Enable Remote SuspendEnable/disable alarm pause/suspend at the transceiver. enabledisabledisableBattery Gauge on Information CenterDisplay/disable a battery gauge for each assigned device on the Information Center.Note—Do not enable if rechargeable batteries are being used.enabledisableenable (battery gauge is displayed)SpO2 Mode Determine the transceiver SpO2 behavior.Note—When the mode is set to Off or Spot Check, Pulse is automatically set to disable.Off - Stops monitoring of the SpO2 parameterSpot Check - Provides manual measurements so the clinician can check as needed. The SpO2 measurement is initiated by plugging the SpO2 cable into the transceiver or initiated by selecting STAT SpO2 icon in the Patient Window.Continuous - Sends an SpO2 parameter value to the Information Center every second.Spot CheckUnit Settings - Telemetry SetupControl Function Settings Default
Unit-Configurable Settings6-10 Telemetry Functions at the Information Center Suppress SpO2 Inops with NBPEnable/disable the SpO2 algorithm to detect NBP running and suppress sending technical alarms from the transceiver for 60 seconds.WarningWarningIf you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur. If the monitor is configured to suppress this alarm, there can be a delay of up to 60 seconds in indicating critical patient status, such as sudden pulse loss or hypoxia.enabledisableenablePleth WaveNote— When Pleth Wave display is enabled, the Pleth wave will replace the Vb wave in the Patient Window during 6-lead monitoring.Enable/disable the transmission of the Pleth wave (and its subsequent display) to the Information Center. For Continuous Mode only.enabledisabledisable (Pleth is not displayed.)Unit Settings - Telemetry SetupControl Function Settings Default
Unit-Configurable Settings Telemetry Functions at the Information Center 6-11Pulse Enable/disable the transmission of the Pulse parameter (and its subsequent display) to the Information Center. For Continuous Mode only. enabledisabledisable (Pulse is not displayed.)SpO2 Alarm Enable/disable the display of SpO2 alarms on the Information CenterenabledisableenableSpO2 Limits High Increment/decrement SpO2 high alarm limit by 1 (in %). Limit maximum is 100. Limit minimum is 51 (adult) or 31 (pediatric). High and low limit must be at least 1% apart.100 (adult, pediatric)SpO2 Limits Low Increment/decrement SpO2 low alarm limit by 1 (in %). Limit maximum is 99. Limit minimum is 50 (adult) or 30 (pediatric). High and low limit must be at least 1% apart.90 (adult, pediatric)3-wire Set the unit default lead label. I, II, III II5-wire, ECG1 Set the unit default lead label. I, II, III, MCL, AVR, AVL, AVF, V II5-wire, ECG2 Set the unit default lead label. I, II, III, MCL, AVR, AVL, AVF, V V5-wire, ECG3 Set the unit default lead label. I, II, III, V IIIUnit Settings - Telemetry SetupControl Function Settings Default
Unit-Configurable Settings6-12 Telemetry Functions at the Information Center 6-wire, Va Set the unit default lead label. V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5RNote—If ECGx matches Va, then as Va is changed, ECGx changes also.V26-wire, Vb Set the unit default lead label. V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5RNote—If ECGx matches Vb, then as Vb is changed, ECGx changes also.V56-wire, ECG1 Set the unit default lead label. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5RII; V lead choice is determined by Va and Vb settings.6-wire, ECG2 Set the unit default lead label. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5RV2; V lead choice is determined by Va and Vb settings.6-wire, ECG3 Set the unit default lead label. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5RIII; V lead choice is determined by Va and Vb settings.Unit Settings - Telemetry SetupControl Function Settings Default
Unit-Configurable Settings Telemetry Functions at the Information Center 6-136-wire, ECG4 Set the unit default lead label. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5RV5; V lead choice is determined by Va and Vb settings.5-wire EASI, ECG1 Set the unit default lead label. I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6II5-wire EASI, ECG2 Set the unit default lead label. I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6V2Unit Settings - Telemetry SetupControl Function Settings Default
Unit-Configurable Settings6-14 Telemetry Functions at the Information Center
Maintenance & Troubleshooting 7-1Introduction7 Maintenance & TroubleshootingAll installation tasks are performedy by Service personel and are described in detail in the service documentation accompanying the system. This chapter provides procedures for maintaining the equipment, assigning labels for replacement transceivers, keeping the transceiver clean, and troubleshooting common problems. It includes the following sections:• Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2• Transceiver Cleaning, Disinfection, & Cross-Infection Prevention. . . 7-4• Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Maintenance7-2 Maintenance & Troubleshooting MaintenanceBasic Monitoring Before beginning monitoring on a patient:• Check for any mechanical damage.• Check all the external leads, plug-ins and accessories.• Check all the functions of the instrument which are needed to monitor the patient.• Ensure that the instrument is in good, working order.Do not use the Philips IntelliVue Telemetry Monitoring System for any monitoring procedure on a patient if you identify features which demonstrate impaired functioning of the instrument. Contact the Service Provider.WarningWarningFailure 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.Label Assignment for Replacement TransceiverIn order to operate within the wireless system, each telemetry device must have an equipment label assigned at the Information Center. The Assign Label function enables you to unassign a label from a lost transmitter, and re-assign that label to a replacement transmitter. Labels are limited to those available in an individual clinical unit. The Label Assignment function requires a password for access, and its controls are available in English only.
Maintenance Maintenance & Troubleshooting 7-3To Re-assign a Label from a (Lost) Device to a Replacement Transceiver Step Action1 Clear the sector that the original Equipment Label was assigned to. (Patient Window -> Sector Setup -> Clear the Sector).Note—This step ensures that no patient is being monitored by the original (lost) device.2 Select All Controls, then Label Assignment.3 Enter password. Note—The remaining screens will be in English only.4Insert batteries into the replacement device. You should hear a double beep, indicating that the transceiver has no Equipment Label assigned.5 Select the MAC address of the replacement device from the “New Devices” list.Note—The transceiver MAC address is located inside the battery compartment.6 Select the Equipment Label that was assigned to the unit’s former device from “Devices Labels” list.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention7-4 Maintenance & Troubleshooting Transceiver Cleaning, Disinfection, & Cross-Infection PreventionThe procedures in this section keep the transceiver clean and provide protection against infectious agents and bloodborne pathogens. Both the outside of the transceiver and the inside of the battery compartment must be kept free of dirt, dust, and debris. The procedures in this section cover the following activities:•Cleaning: removing visible surface decontamination from the device7 Select Assign Label to initiate programming of the Equipment Label into the replacement telemetry device - AND -within 10 seconds, press the Check button on the telemetry device.Note—If 10 seconds pass without a button push, then repeat this step.What about clicking OK at the prompt? THIS LABEL HAS ALREADY BEENASSIGNED TO A PWD WITH A DIFFERENT MAC ADDRESS.When the telemetry device has completed the normal power-up sequence, an “Assignment Complete” message is displayed and the the label is marked as being assigned. The device is now ready to connect to the wireless network.8 Go back into Sector Setup, and select the Bed Label and Equipment Label, followed by OK. The transceiver is now ready for patient monitoring.Step Action
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Maintenance & Troubleshooting 7-5•Disinfection: protecting cleaned devices against infectious agents and bloodborne pathogens by a chemical agent. •Cross-Infection Prevention: using ETO gas treatment to decontaminate cleaned equipment.Important—After exposure, the transceiver must be cleaned, followed by either Disinfection or Cross-Infection Prevention procedures according to hospital protocols, before continued use in monitoring. Cleaning the TransceiverCautionDo not use any abrasive cleaning materials or overly vigorous cleaning actions on any part or component of the IntelliVue TRx or TRx+ transceiver. Use of abrasive cleansers and abrasive cleaning actions will damage the components. Perform the following steps to clean the transceiver of visible surface contamination.Step Action1 Remove the batteries and any cables or accessories.2 Soak the transceiver in water for up to 5 minutes to soften any dried debris, if necessary.3 Rinse the transceiver in water.4 Flush device orifices with a forceful water stream to remove any residue in the openings.5 Allow to air-dry, or dry with a non-lint producing cloth.6 Continue with either Disinfection or Cross-Infection Prevention procedure, according to your hospital’s protocol.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention7-6 Maintenance & Troubleshooting Disinfecting the TransceiverWarningWarningTo prevent fire, provide adequate ventilation and do not permit smoking when disinfecting the device with a flammable liquid, such as alcohol.CautionRemove the batteries and any cables or accessories before you disinfect the transceiver.The transceiver can be disinfected by two methods: wiping or soaking. If the device has areas that are difficult to disinfect, soaking for up to five minutes is recommended. The approved disinfection agents are:• Isopropryl Alcohol, >70%• Sodium Hypochlorite, 10% solution prepared within 24 hours (for wiping only)Equipment must be cleaned (see “Cleaning the Transceiver” on page 7-5) before this disinfection by wiping or soaking is performed.Wiping theTransceiver Step Action1 Remove the batteries and any cables or accessories.2 Wipe the transceiver clean by using a cloth dampened modestly with one of the following approved cleaning agents:• Isopropyl Alcohol (> 70%)• Sodium Hypochlorite (chlorine bleach), 10% solution prepared within 24 hours.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Maintenance & Troubleshooting 7-7Soaking theTransceiverCautionDo not soak the equipment in cleansers other than Isopropyl Alcohol, or soak longer than five minutes. Soaking the transceiver for longer than five minutes or in cleansers other than Isopropyl Alcohol can severely damage the device.Cross-Infection Prevention for the TransceiverThe transceiver can be subjected to one ETOH cross-infection prevention process four times per year for 2 years. Completion of this procedure achieves a cross-infection prevention assurance level of 10E-6. Equipment must be cleaned (see “Cleaning the Transceiver” on page 7-5) before this procedure is performed.3 Wipe all disinfected surfaces with distilled water to remove any residue.4 Allow to air-dry, or dry with a non-lint producing cloth.Step ActionStep Action1 Remove the batteries and any cables or accessories.2 Soak the device in Isopropyl Alcohol (> 70%) for up to five minutes. Note—The battery compartment can be closed or open during soaking.3 Dip all cleaned surfaces in bowl of distilled water to remove any residue.4 Dry the equipment with a non-lint producing cloth.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention7-8 Maintenance & Troubleshooting Note—If there is concern over cross-contamination due to leadsets or sensors, new leadsets or sensors should be used.Equipment andMaterialsWarningWarningEO is highly explosive, toxic, and a potential occupational carcinogenic and reproductive hazard. Handle it with extreme care, following U.S. Occupational Safety and Health Administration (OSHA) standards for EO (29 CFR 1910.1047)*. Personnel exposure and/or room air must be monitored per OSHA standards.Vent sterilizer gas outdoors or to a suitable, evacuated container for reprocessing, depending upon state, provincial, or country environmental regulations. Do not vent sterilant indoors.Vent aerator exhaust only to the outdoors.* See “References” on page 7-12.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Maintenance & Troubleshooting 7-9Use the following equipment and material to process the transceiver:1. Ethylene Oxide (Allied Signal Oxyfume-2002™), heretofore referred to as EO.2. Gas sterilizer, made by American Sterilizer Company or other manufacturers.3. Mechanical aerator. The intake air for the aeration chamber must be routed through bacterial filters, and the exhaust air must be vented outside the building.Note—Available combination sterilizer/aerators bypass the problem of personnel exposure to EO during transfer of treated material to a separate aeration cabinet.Cross-InfectionProcessThe following generic procedure can be used to supplement the sterilizer and aerator manufacturers’ instructions, although the processing times, temperatures, and pressure must be the same as those given in this procedure.Important—In order to complete this stage of the process safely, harmful residue gas must be dissipated through aeration. Step Action1Remove any obvious contamination from the equipment to be processed using approved cleaners.2Individually package each transceiver in standard central supply room (CSR) wrapping material secured with EO color-change indi-cator tape.3Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the empty sterilizer chamber two times, to remove any residual EO or mois-ture. Vent the vacuum pump to the outdoors to avoid toxic hazards to personnel.4Insert the equipment to be processed into the gas sterilizer.5Heat the chamber and its contents to 54.4 +/- 2.8oC (130 +/- 5oF).6Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the sterilizer chamber.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention7-10 Maintenance & Troubleshooting 7Humidify the chamber at 50% +/- 10% relative humidity for 20 to 30 minutes.8Taking a minimum of five minutes, slowly introduce EO sterilant until the sterilizer unit pressure gauge reaches 11 +/- 1 psig.Note—At this pressure, the concentration of sterilant in the chamber will be 600 +/- 50 mg/liter, regardless of the chamber size.9Process the equipment to be processed as follows:Pressure: 11 +/- 1 psig (established in the preceding step).Time: 2-3 hoursTemperature: 54.4 +/- 2.8oC (130 +/- 5oF)10 Extract the gas mixture from the sterilizer as follows:WarningWarningComply with OSHA standards*. Do not vent sterilizer gas to the room, but vent only outdoors or to a suitable, evacuated container, depending upon state, provincial, or country environ-mental regulations. (If the mixture is captured, it can be sepa-rated commercially and the component gases re-used.)* See “References” on page 7-12.a. Pump the gas mixture out of the chamber until you ob-tain a vacuum of -26 inHg +/- 1 (-12.77 psig +/-.49), re-turning the mixture to a suitable evacuated container.b. Return the sterilizer chamber to ambient pressure by in-troducing air that has been bacterially filtered.Step Action
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Maintenance & Troubleshooting 7-11AerationProcedureWarningWarningTo avoid chemical burns and toxic effects, the equipment must be aerated after sterilization, as described. The aerator must have bacterial filters and outdoor venting.*See “References” on page 7-12. 11 Air-wash the chamber and material as follows:a. Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the chamber and processed material again, to remove residu-al EO. The vacuum pump must be vented to the out-doors.b. Return the sterilized chamber to ambient pressure by in-troducing air that has been bacterially filtered.12 Continue with the “Aeration Procedure” (following).Step Action
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention7-12 Maintenance & Troubleshooting Aerate the processed equipment by performing the following steps:1 These values will produce EO and Ethylene Chlorohydrin residual levels in the transceiver and patient cable plastic that meet ISO 10993-7 in conjunction with AAMI Technical Information Report 19, that the FDA currently endorses. References OSHA: Standard for acceptable levels of personnel exposure to Ethylene Oxide Gas: 1 ppm on an eight-hour time-weighted average basis.Reference: U.S.A. Federal Regulations 49 FR 25734/29 CFR Part 1910.1047, June 22, 1984; final approval 50 FR 9800/2- CFR Part 1910.1047, March 12, 1985.Test ProcedureCautionYou must perform this test each time you put a transceiver through the cross-infection prevention procedure. This test allows you to verify that patient information for both ECG and SpO2 (if you are monitoring pulse oximetry) appear at the information center and at the bedside. You can use this procedure with a patient simulator.Step Action1To dissipate residual EO, aerate the processed equipment with air that has been bacterially filtered, using a mechanical aerator or combination sterilizer/aerator as follows:1Time: 8-9 hoursTemperature: 54.4 +/- 2.8oC (130 +/- 5oF)Ventilation Frequency: At least 30 air exchanges per hour.2 Continue with the “Test Procedure” (following).
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Maintenance & Troubleshooting 7-13Note—This test assumes that the telemetry system and Information Center are fully installed, and that you have performed the procedure to learn the transceiver identity code. Test the transceiver by performing the following steps. If the test indications do not appear, refer to your Service Provider.Step Action1Perform a mechanical inspection of the transceiver (connectors, battery door opening and closing, Telemetry and Check buttons). 2At the Information Center, select the telemetry bedside you are testing.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention7-14 Maintenance & Troubleshooting 3Test the transceiver:a. Put fresh batteries in the transceiver and close the bat-tery doorResult: All six lead lights should flash, and one light should remain on.b. Attach a leadset to the ECG port, and attach an SpO2 sensor to the SpO2 port. If an ECG simulator is avail-able, attach the ECG leads to the simulator and the SpO2sensor to yourself. At TeleMon, set the SpO2 sam-ple rate to Continuous.Result: An ECG trace and SpO2 information should be visible on the Information Center display. All transceiv-er lights should be off.c. Disconnect the Right Arm lead for standard ECG or the “I” electrode for EASI. Result: The RA LED or the “I” lead LED should turn on, and a Leads Off INOP should appear on the display at the Information Center.d. Reconnect the electrode.4a. Connect the transceiver to TeleMon and observe the ECG waveform and SpO2 numerics on the TeleMon dis-play. Result: The ECG waveform and SpO2 numerics should be displayed on the TeleMon screen.Step Action
Troubleshooting Maintenance & Troubleshooting 7-15TroubleshootingBasic TroubleshootingTesting AlarmsVisual and auditory alarms appear at the Information Center. One method of verifying visual and auditory alarms at the Information Center is to connect the transceiver to an ECG or ECG/SpO2 simulator. By varying the ECG rate and SpO2 value, alarms can be generated and confirmed for proper operation.Information Signals If there is a connection failure within the IWN/Philips IntelliVue Telemetry System, an information signal will be generated. This information signal will be displayed on the Information Center where the affected wireless patient For problems with... see... • ECG measurement “Optimizing ECG Measurement Performance” on page 3-25“Technical Alarms (INOPs)” on page 2-14•SpO2 measurement “Optimizing SpO2 Measurement Performance” on page 5-21“Optimizing Sensor Performance” on page 5-22“Technical Alarms (INOPs)” on page 2-14• Batteries “Battery Information” on page 1-19“Self Test” on page 1-17• Nurse call Nurse Call may have been turned off for the patient. See “Patient-Configurable Settings in Telemetry Setup” on page 6-3 for directions on how to turn it on.
Troubleshooting7-16 Maintenance & Troubleshooting monitoring device(s) (transceiver, access point, access point controller, portable bedside monitor) is assigned, as well as on all other Information Centers connected to a common Database Server.The condition causing the failure will be described in the Wireless Status Log, which is available in Service Mode. See the tables below. .Information SignalInformation Signal Description What to DoWireless monitoring loss - Contact ServiceNote—This information signal appears on ALL Information Centers connected to a common Database Server.Intermittent disruption or failure in communications between one or more patient monitoring wireless devices and the Information Center.Contact Service. Note—Details about the communication disruption are available in the Wireless Status Log (see following table).Wireless Status Log MessagesNote: CTS refers to Philips IntelliVue Telemetry System.Wireless Status Log Text Cause NotesCTS Near Area Capacity <ap name> AP is near usable capacity. Alert cleared when number of connects is below configured threshold.CTS Tele AP Malfunction <ap name> Alert sent when AP DECT processor fails or when a software fault is detected.No alert is sent when AP ethernet fails.
Troubleshooting Maintenance & Troubleshooting 7-17CTS TELE APC Malfunction <apc name> Alert sent when this AP detects that its partnered APC has failed.Alert cleared when master APC sees the keep-alive or registration message from that APC again.CTS Tele Duplicate IP Address <device name> Duplicate IP address has been detected on the CTS network.Alert cleared when all AP have unique IP addressCTS Excessive ARQ retries <device name> Sent when the number of retries at ARQ level exceeds the specified threshold.CTS Tele Excessive Handover <ap name> Excessive handover of the transceiver. Alert cleared when handovers per minute is below configured threshold.CTS Tele Master APC Malfunction Alert sent when the AP cannot find a master APC.Alert cleared when AP receives an announcement packet again.CTS Tele Max Area Capacity <ap name> Alert sent when the AP reaches maximum capacity. Alert cleared when number of connects is reduced below maximum limit.CTS Tele NO SYNC <ap name> Loss of local or remote sync to Access PointsExcessive Data Loss <ap name> Excessive data loss on link. Alert cleared when data loss is below configured threshold.Wireless Status Log MessagesNote: CTS refers to Philips IntelliVue Telemetry System.Wireless Status Log Text Cause Notes
Troubleshooting7-18 Maintenance & Troubleshooting
Safety Standards & Specifications 8-1Introduction8Safety Standards & SpecificationsThis chapter describes the regulatory standards that the product complies with, along with product and measurement specifications. It includes the following sections:• Regulatory Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2• Battery Life Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5• Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6• Radio Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8• Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11• Measurement Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Regulatory Information8-2 Safety Standards & Specifications Regulatory InformationIntended Use The device is intended to provide ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in professional healthcare facilities. It is intended to be used by trained healthcare personnel. It is not intended for home use.This device is a US-only device and is not for use in Canada or the European Union.Indications for Use Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adult and pediatric patients in transport and hospital environments.Rx Federal Law restricts this device to sale by or on the order of a physician.Patient Population This device is not for use with infant or neonatal patients.Use of the transceiver is restricted to one patient at a time.The transceiver and related accessories are in compliance with the relevant requirements of EN ISO 10993-1 for Biocompatibility. The transmitter is not designed for direct contact with the patient’s skin. The accompanying pouch is the appropriate means for holding the transmitter.Safety Standards The device complies with the following safety requirements for medical electrical equipment:• IEC 601-1:1988 + A1:1991 + A2:1995 General Requirements for Safety (with worldwide deviations, including U.S. deviations)• IEC 60601-1-1:2000 System Safety• IEC 60601-1-2:2001 Electromagnetic Compliance• IEC 60601-1-4:1996 Safety for Programmable Electrical Medical Systems• IEC 60601-2-49:2001 Multi-parameter Monitor Safety
Regulatory Information Safety Standards & Specifications 8-3• ISO 10993-1:2003 Biocompatibility (for lead wires and pouch)• ISO 9919:1992 Pulse Oximeters• EN 865:1997 Particular Requirements for Pulse Oximeters• AAMI EC 13:2002 Performance Standard, Cardiac MonitorsEssential PerformanceThe IntelliVue Telemetry System provides Essential Performance (EP) under normal operating conditions (includes EMC exposure) only as a complete Medical Electrical System, consisting of the M4841A Transceiver, the M2636 TeleMon with Option A02/A03 Companion Monitor (optional), the IntelliVue Telemetry Network Infrastructure, and the M3150A Information Center. The Philips IntelliVue Telemetry System achieves its Essential Performance exclusively through alarm generation at the M3150 Information Center.The Philips IntelliVue Telemetry System protects the patient from unacceptable immediate clinical risk by generating specific Physiological Alarms when appropriate. If the System cannot generate Physiological Alarms, then relevant Severe or Hard Technical Alarms (Inoperative Conditions) will be created.System ClassificationThe M4841A Transceiver is an FDA Class II device. It has the following characteristics.Characteristic DefinitionInternally Powered Equipment The M4841A transceiver is an internally powered device.Continuous Operation All equipment is Ordinary Equipment, IPX0, and provides continuous operationType CF Defibrillation Proof The M4841A transceiver is Type CF Defibrillation Proof relative to ECG and SpO2 patient applied parts.
Regulatory Information8-4 Safety Standards & Specifications FCC Compliance (USA only)Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service.The transceiver and the Philips IntelliVue Telemetry System are subject to radio frequency interference. In the event of suspected radio frequency interference with your device, contact your Service Provider. The FCC requires the following statement for this device:The Philips IntelliVue Telemetry System complies with Part 15 of the Federal Communications Commission (FCC) Rules. Operation is subject to the following two conditions:1. This device may not cause harmful radio frequency interference to a a primary licensed user (radio and television stations), and2. This device must accept any interference received from a primary licensed user, including interference that may cause undesired operation.Water Resistance When placed inside a Philips carrying pouch with the flap closed and snaps secured, the M4841A transceiver is rated IPX3 as per IEC 60529:1989 (+A1:1999): Protected against spraying water.The combination of the transceiver and pouch will withstand showering for up to 10 minutes.The transceiver will not be damaged if it is accidentally immersed in liquid for up to 5 minutes.WarningWarningIf the transceiver is used while showering a patient or is accidentally submerged in liquid, detection of leads off conditions may be compromised. Appropriate clinical precautions must be taken.Characteristic Definition
Battery Life Specifications Safety Standards & Specifications 8-5Pursuant to Part 15.21 of the FCC Rules, any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference, and void your authority to operate this equipment.AC Power Source The system is not intended for connection to the public mains as defined in CISPR11.Battery Life SpecificationsBattery TypeBattery Life Note—The battery life specifications listed below are based on Duracell MN 1500 batteries. Battery life for other brands may differ.Equipment SpecificationBattery Type 2 fresh AA disposable alkaline batteriesOperating Mode Battery LifeECG Only 48.7 hours ECG/SpO2 Continuous 16.8 hoursECG/SpO2 Spot Check between 16.8 hours and 48.7 hours, depending on usage rate
Electromagnetic Compatibility8-6 Safety Standards & Specifications Battery Gauge Electromagnetic CompatibilityMedical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 60601-1-2:2001, the international standard for EMC for medical electrical equipment. This IEC standard has been adopted in the European Union as the European Norm, EN 60601-1-2:2001. Battery Gauge Approximate Battery Life RemainingApproximate Operating Time RemainingDisabled Functions4 green indicators > 75% > 34.7 hours ___3 green indicators > 50% > 23.1 hours ___2 green indicators > 25% > 11.6 hours ___1 green indicator 25% to Low Battery level > 15 minutes ___1 red indicator Low Battery level to Replace Battery level< 15 minutes SpO2no indicator Replace Battery level(Check batteries for correct polarity)none Transceiver shutdown/RF shutdown
Electromagnetic Compatibility Safety Standards & Specifications 8-7Radio frequency (RF) interference from nearby transmitting devices can degrade performance of the product. Electromagnetic compatibility with surrounding devices should be assessed prior to using the product.Fixed, portable, and mobile radio frequency communications equipment can also affect the performance of medical equipment. See your Service Provider for assistance with the minimum recommended separation distance between RF communications equipment and the product.The cables, sensors/transducers, and other accessories for which compliance is claimed are listed in the Service and User documentation accompanying the product.WarningWarningThe use of accessories, transducers and cables other than those specified in the product service and user documentation can result in increased emissions or decreased immunity of the product.WarningWarningThe product should not be used next to or stacked with other equipment. If you must stack the product or , you must check that normal operation is possible in the necessary configuration before the product is used.Reducing Electromagnetic InterferenceThe transceiver and associated accessories can be susceptible to interference from other RF energy sources and continuous, repetitive, power line bursts. Examples of other sources of RF interference are other medical electrical devices, cellular products, information technology equipment, and radio/television transmission. If interference is encountered, as demonstrated by artifact on the ECG or dramatic variations in physiological parameter measurement values, attempt to locate the source. Assess the following:• Is the interference due to misplaced or poorly applied electrodes or sensors? If so, re-apply electrodes and sensors correctly according to directions in Chapter 3. ECG Monitoring.
Radio Specifications8-8 Safety Standards & Specifications • Is the interference intermittent or constant?• Does the interference occur only in certain locations?• Does the interference occur only when in close proximity to certain medical electrical equipment?• Do parameter measurement values change dramatically when the AC line cord is unplugged?Once the source is located, attempt to attenuate the interference by distancing the transceiver from the source as much as possible. If assistance is needed, contact your local service representative.Restrictions for Use Artifact on ECG and other physiological waveforms caused by electromag-netic interference should be evaluated by a physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treat-ment.Radio SpecificationsM4841A Transceiver Parameter SpecificationFrequency Ranges Bands 1395-1400 MHz and 1427-1432 MHzChannel Spacing: 1.6 MHzRF Output Power 8 dBM +2/-3 dB (3.2 mW to 10 mW), into Antenna load @ nominal battery voltageRF Output Power control • Transceiver chain gain shall be calibrated at time of manufacture (env temp 25+/- 5 oC)• Over power algorithm deployed to prevent excess power and also includes temperature compensation.
Radio Specifications Safety Standards & Specifications 8-9RF Overpower trip point > 10 dBmTransceiver Frequency Accuracy during normal operation+/- 15 kHz relative to channel frequency, includes temperature compensation and aging effectsReference Frequency Calibration < 4 ppm set a time of manufacture (env temp 25 +/- 5 oC)Modulation Type FSK with Root Raised Cosine filteringModulation Deviation Bit 1: +288 kHz +/- 25 kHz relative to channel frequencyBit 0: -288 kHz +/- 25 kHz relative to channel frequencyTransmitter Output Broadband Noise <-58.9 dBm in 1 MHz band, outside channel in useOut of Band Spurious Emission Levels<= 1394 MHz, >= 1401 MHz<= 1428 MHz, >= 1433 MHz<-41 dBm in 1 MHz bandwidth for FCC limitLimits measured into 50 Ohms load:(< -43 dBc referred to transceiver power of +8 dBm over 25 oC to 55 oC, excluding duty cycle effects defined below)(< -40 dBc over 0 oC to <25 oC, excluding duty cycle effects defined below)Transceiver duty cycle reduces effective spurious emissions:Transceiver RM at 1/64 duty cycle = 18 dB reductionAccess Point RM at 16 connections, 50% duty cycle = 6 dB reductionParameter Specification
Radio Specifications8-10 Safety Standards & Specifications WMTS Channel Frequencies 1395 to 1400MHz1427 to 1432MHzParameter SpecificationLower band edge 1395 MHzChannel 1 1395.8977 MHz Channel 2 1397.4970 MHzChannel 3 1399.0963 MHzUpper band edge 1400 MHzChannel spacing 1.6 MHzParameter SpecificationLower band edge 1427 MHzChannel 4 1427.8979 MHzChannel 4a (*) 1429.2410 MHzChannel 5 (**) 1429.4972 MHzChannel 6 (**) 1431.0965
Physical Specifications Safety Standards & Specifications 8-11Physical SpecificationsECG-only TransceiverUpper band edge 1432 MHz* Available in special geographic area only** Not available in special geographic areasParameter SpecificationParameter SpecificationHeight 140 mmWidth 75 mmDepth 28.5 mmWeight• without batteries or leadset• with batteries and 5-wire leadset• <165 g (5.8 oz.)• <284 g (10 oz.)Volume 215 cm3
Environmental Specifications8-12 Safety Standards & Specifications ECG/SpO2 Transceiver Environmental SpecificationsM4841A TransceiverParameter SpecificationHeight 140 mmWidth 88 mmDepth 37 mmWeight• without batteries or leadset• with batteries and 5-wire leadset• <205 g (7.2 oz.)• <324 g (11.5 oz.)Volume 300 cm3Parameter SpecificationTemperature• Operating•Storage •0 to 37 oC (32 to 99 oF)• -40 oC to 60 oC (-40 to 120 oF) without batteriesHumidity• Operating•Storage •< 95% RH at 40 oC (104 oF) non-condensing•< 90% RH at 60 oC (120 oF) without batteries
Measurement Specifications Safety Standards & Specifications 8-13 Measurement SpecificationsECGAltitude• Operating & Non-operating 0 to 3,048 m (10,000 ft)Parameter SpecificationParameter SpecificationECG channel transmitted Leads• 3 electrodes• 5 electrodes• 5 electrodes, EASI• 6 electrodes• Channel #1 - I, II, or III• Channel #1 - IIChannel #2 - IIIChannel #3 - MCL• Channel #1 - VaiChannel #2 - VasChannel #3 - Ves• Channel #1 - IIChannel #2 - IIIChannel #3 - VaChannel #4 - VbResolution 5 µVECG Input Differential, defibrillator protected against 400 joules discharge into a 50 ohm loadInput Impedance > 5 megohms (@ 10 Hz
Measurement Specifications8-14 Safety Standards & Specifications Input Dynamic Range +/- 9 mVDC Offset Range +/- 320 mVCMRR > 90 dB @ 50, 60 HzBandwidth +/- 3 dB 0.05 to 40 HzGain Accuracy +/- 5% at 25 oC (77 oF)Noise Referred to ECG Input AAMI: 30 µVLead Wires 3, 5 or 6-wire leadset. 5-lead compatible with IntelliVue Patient Monitor, AAMI or IEC color codeTime to baseline from Defibrillator AAMI: 5 s max (until ECG wave is on display but not yet centered, monitoring bandwidth)Pacer Rejection Performance (Pace pulses with no tails)Positive pacersAmplitude Width+2 to +700 mV 0.1, 0.2, 0.5 and 1.0 ms+2 to +500 mV 1.5 ms+2 to +400 mV 2 msNegative pacersAmplitude Width-2 to -700 mV 0.1, 0.2, 0.5 and 1.0 ms-2 to -500 mV 1.5 ms-2 to -400 mV 2 msEMC Performance limits, radiated immunity46.262 to 55.326 MHz pass at reduced level is 0.4336 V/m.165 to 195.6 MHz pass at reduced level is 2.4 V/m. Parameter Specification
Measurement Specifications Safety Standards & Specifications 8-15SpO2 Parameter SpecificationSpO2 Measurement Range 0 to 100%SpO2 Accuracy • +/- 2.5% (1 Standard deviation) with Philips reusable sensor (M1191A, M1192A): 70 - 100 %• +/- 4% (1 Standard deviation) with Philips reusable sensor (M1194A): 70 - 100 %• +/- 3% (1 Standard deviation) with Nellcor Oxisensor D-25 and D-20 sensors: 80 - 100 %SpO2 Resolution 1%SpO2 Numerics - Averaging 10 secondsSpO2 & Pulse Numerics - Update Rate Transmitted once per secondPleth Wave - sampling rate 125 spsTechnical Alarms (INOPs) Triggered if the sensor is disconnected, if a pulse is not detected, if the signal is noisy, if light interference is detected, if the sensor is defective, if the measurement is erratic, or if the module is malfunctioningPulse Rate Measurement (available only with Continuous SpO2)Range: 30 to 300 bpmAccuracy: +/- 2%Resolution: 1 bpm
Measurement Specifications8-16 Safety Standards & Specifications SpO2 Sensor Accuracy.Display of SpO2 numerics SpO2 date values are displayed as xxx % SpO2 to meet ISO/EN standard EN 865NIBP INOP suppression feature If enabled, detection of a NIBP measurement on the same limb and the corresponding suppression of SpO2 inops (for max of 60 seconds)Parameter SpecificationType Description Model NumberAccuracy% Arms (70-100% Range)Philips Reusable SensorsAdult Finger M1191A 2.0Adult Finger M1191AL 2.0Adult Finger M1191NL 2.0Pediatric Finger M1192A 2.0Pediatric Finger M1192N 2.0Adult/Pediatric Ear M1194A 3.0Adult/Pediatric Ear M1194N 3.0
Measurement Specifications Safety Standards & Specifications 8-17Type Description Model NumberAccuracy% Arms (70-100% Range)Philips Disposable SensorsAdult Finger M1901B 3.0Pediatric Finger M1903B 3.0Adult Finger M1904B 3.0
Measurement Specifications8-18 Safety Standards & Specifications Nellcor Disposable Sensors (not available from Philips)OxiCliq A, Adult N/A 3.0OxiCliq N, Adult >40 kg (88 lb) N/A 3.0OxiCliq P, Pediatric N/A 3.0OxiMax MAX-A, Adult >30 kg (66 lb) N/A 3.0OxiMax MAX-AL, Adult >30 kg (>66 lb) N/A 3.0OxiMax MAX-N, Adult >40 kg (>88 lb) N/A 3.0OxiMax MAX-P, Pediatric N/A 3.0Oxisensor II D-20, Pediatric 10-50 kg (22-110 lb)N/A 3.0Oxisensor II D-25, Adult >30 kg (>66 lb) N/A 3.0Oxisensor II N-25, Adult >40 kg (>88 lb) N/A 3.0Type Description Model NumberAccuracy% Arms (70-100% Range)
Accessory List A-1IntroductionAAccessory ListThis appendix lists all accessories that can be used with the transceiver.For additional information on connecting and using the clinical accessories, see the individual parameter chapters. Note—Accessories are subject to change. To get the latest accessories, visit the Philips Medical Supplies website located at the following address: http://shop.medical.philips.com.or your local Philips representative.
Accessory SafetyA-2 Accessory List Accessory SafetyWarningWarningPhilips’s approval: Use only Philips-approved accessories.Reuse: Never reuse disposable sensors, accessories and so forth that are intended for single use, or single patient use only.Packaging: Do not use a sterilized accessory if the packaging is damaged.ECG AccessoriesElectrodesLeadsetsOrder Number DescriptionM2202A Radio Translucent Foam Electrodes, 60 packages of 5 (300 per box)40489E Paper Tape Electrodes, 10 packages of 30 (300 per box)40493D Foam Electrodes, 60 packages of 5 (300 per box)40493E Foam Electrodes, 10 packages of 30 (300 per box)Order Number Description9898 031 33831 AAMI 3-wire Leadset, Snap 79 cm (30 ”)
ECG Accessories Accessory List A-3A Sales and SupportTrunk CablesPouchesSkin Prep Paper9898 031 33841 AAM 3-wire Leadset, Grabber 79 cm (30 ”)9898 031 33871 AAMI 5-wire Leadset, Snap 79 cm (30 ”)9898 031 33881 AAMI 5-wire Leadset, Grabber 79 cm (30 ”)9898 031 37241 AAMI 5-wire Color Leadset, Snap 79 cm (30 ”)9898 031 37251 AAMI 5-wire Color Leadset, Grabber 79 cm (30 ”)9898 031 33911 AAMI 6-wire Leadset, Snap 79 cm (30 ”)9898 031 33921 AAMI 6-wire Leadset Grabber 79 cm (30 ”)9898 031 37281 AAMI 6-wire Color Leadset, Snap 79 cm (30 ”)9898 031 37291 AAMI 6-wire Color Leadset, Grabber 79 cm (30 ”)Order Number DescriptionOrder Number Description9898 031 37841 5-lead Trunk CableOrder Number Description9898 031 37831 Telemetry Pouch, with flap, box of 509898 031 40371 Telemetry Pouch, with flap, case of 200Order Number Description9898 031 34771 Skin Preparation Sheets, 10 preps/sheet, package of 10 sheets
SpO2 AccessoriesA-4 Accessory List Alignment GuidesGunk GuardsSpO2 AccessoriesReusable SensorsOrder Number Description9898 031 40401 Single Alignment Guide, package of 109898 031 40411 Single Tethered Alignment Guide, package of 109898 031 40421 Double Alighment Guide, package of 10Order Number Description 9898 031 40431 ECG Gunk Guard, package of 109898 031 40441 SpO2 Gunk Guard, package of 109898 03140451 Serial SpO2 Gunk Guard, package of 10Order Number DescriptionM1191A Philips Adult Finger Sensor, 2 m (6.6 feet)M1191AL Philips Adult Finger Sensor, 3 m (9.8 feet)M1191NL Philips Adult Finger Sensor, 3 m (9.8 feet)M1192A Philips Pediatric Finger Sensor, 1.5 m (4.9 feet)
SpO2 Accessories Accessory List A-5A Sales and SupportDisposable Sensors - Single UseNote—OxiCliq, OxiMax and Oxisensor II sensors are not available from Philips in the USA or Canada. Adapter cables are not available from Philips in Canada or Japan. In those countries, contact Nellcor Incorporated directly.M1192N Philips Pediatric Finger Sensor, 1.5 m (4.9 feet)M1194A Philips Adult & Pediatric Ear Sensor, 1.5 m (4.9 feet)M1194N Philips Adult & Pediatric Ear Sensor, 1.5 m (4.9 feet)Order Number DescriptionOrder Number DescriptionM1901B Philips Adult >40 kg (>88 lb)M1903B Philips Pediatric 10-50 kg (22-110 lb)M1904B Philips Adult >30 kg (>66 lb)N/A from Philips *Nellcor Adhesive OxiCliq A, AdultN/A from Philips *Nellcor Adhesive OxiCliq N, Adult >40kg (>88 lb)N/A from Philips *Nellcor Adhesive OxiCliq P, PediatricN/A from Philips *Nellcor OxiMax MAX-A, Adult >30 kg (>66 lb)N/A from Philips *Nellcor OxiMax MAX-AL, Adult >30 kg (>66 lb)N/A from Philips *Nellcor OxiMax MAX-N, Adult >40 kg (>88 kg)N/A from Philips *Nellcor OxiMax MAX-P, Pediatric 10-50 kg (22-110 lb)N/A from Philips *Nellcor Oxisensor II D-20, Pediatric 10-50 kg (22-110 lb)N/A from Philips *Nellcor Oxisensor II D-25, Adult >30 kg (>66 lb)N/A from Philips *Nellcor Oxisensor II N-25, Adult >40 kg (>88 lb)M1943A Adapter cable for Nellcor SpO2 sensor, 2 m (6.6 ft)M1943AL Adapter cable for Nellcor SpO2 sensor, 3 m (9.8 ft)
SpO2 AccessoriesA-6 Accessory List Wristband* Uses reusable OC-3 Sensor Cable.Order Number DescriptionOrder Number DescriptionM1627A Wristband, package of 10
Sales and Support Offices B-1IntroductionBSales and Support OfficesPlease 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 SystemsNetherlands B.V.Postbus 10.0005680 DA BestNetherlandsUNITED STATES:Philips Medical Systems3000 Minuteman RoadAndover, MA 01810(800) 934-7372CANADA:Philips Medical Systems2660 Matheson Blvd. E.Mississauga, Ontario L4W 5M2(800) 291-6743EUROPE, MIDDLE EAST AND AFRICA:Philips Medizinsysteme Böblingen GmbHCardiac and Monitoring SystemsHewlett-Packard Str. 271034 BöblingenGermanyFax: (+49) 7031 463 1552
B-2 Sales and Support OfficesLATIN AMERICA HEADQUARTERS:Philips Medical Systems5200 Blue Lagoon Drive9th FloorMiami, FL 33126(305) 267-4220ASIA PACIFIC HEADQUARTERS:Philips Medical Systems24F Cityplaza One1111 King's RoadTaikoo Shing, Hong Kong(+852) 3197 7777
Index-1IndexAalarmsbehavior with Own Bed Overview 2-7indicators, 2-2physiologic, 2-10SpO2, 5-20technical, 2-15testing, 7-15auditory info signals, 1-13Bbatterylife, 1-23, 8-5safety, 1-19type, 1-21Ccontinuous SpO2, 5-16Controls 1-28controlsbuttons, 1-8indicators, 1-9labels,back, 1-12labels,front, 1-10on/off, 1-15other marks, 1-12ports, 1-10volume, 6-4, 6-8controls, 1-7Ddropouts, 3-26Eelectromagnetic interference, 8-6Ffind device, 6-3IInformation Centertransceiver use with, 1-6INOP messagesST 4-11INOPs, see technical alarms 2-15intended useST/AR, 4-3transceiver, 8-2Llead placement, 3-12Nnoiseeliminating, 3-27Oon/off, 1-15ordering informationECG supplies, A-2SpO2 supplies, A-4Own Bed Overviewalarm behavior 2-7own bed overview, 6-2, 6-3Ppacing safety, 1-ixpatient window, 6-2pause, 2-2pleth wave display, 5-17, 6-6, 6-10pouch, 1-24pulse on/off, 6-6, 6-11pulse wave display, 5-17, 6-6, 6-11RRF interference, 3-27Ssafetybattery, 1-19ECG, 1-vigeneral, 1-iv
Index-2 paced, 1-viii, 4-3pouch, 1-25SpO2 sensor, 5-9SpO2, 1-x, 5-2ST/AR arrhythmia, 1-viiST/AR, 1-vii, 4-2symbols, 1-12transceiver, 1-15sensorear clip, 5-13finger, 5-11sensorsselecting 5-22service log, 7-16signal strength, 3-26soundssee auditory info signals 1-13start-up, 1-16SpO2auto on/off 5-19continuous, 5-16on/off, 5-18sensor application, 5-9sensor selection, 5-5spot check, 5-15turn parameter on/off 5-19SpO2 inop suppression, 6-6, 6-10SpO2 mode, 6-5, 6-9SpO2 monitoring, 5-4spot check, 5-15ST adjusting measurement points, 4-9alarm adjustments, 4-12measurement, 4-6smart limits, 4-13turning on/off monitoring, 4-9ST/ARintended use, 4-3STanalysis, 4-6standby mode, 2-5suspend, 2-2symbols, 1-11system messagessee information signals, 7-15Ttechnical alarms, 2-15telemetry setup, 6-3TeleMonSpO2 measurement modes 5-17transceiver use with, 1-6testingalarm indicators, 2-2alarms, 1-17self test, 1-17status check, 1-18transceiverauditory info signals, 1-13controls, 1-7troubleshooting 3-27information signals, 7-15SpO2, 5-21TRx, TRx+definition, 1-4turn on/offSpO2 parameter 5-19Vvolumesetup, 6-4, 6-8volume, 6-4, 6-8

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