IntelliVue TRx/TRx+ Transceivers for the Philips IntelliVue Telemetry System with Smart-Hopping Technology Notice Operation of this equipment in the United States requires the prior coordindation with a frequency coordinator designated by the Federal Communications Commission (FCC) for the Wireless Medical Telemetry Service. Instructions for Use Part Number: M4841-91001 Printed in the U.S.A.
Printing History Notice 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 History New editions of this document will incorporate all material updated since the previous edition.
About this Book About this Book This 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.
Product Safety Information Notes Note—Notes contain additional information on use of the Philips IntelliVue Telemetry System. Procedures Procedures are indicated in text by the heading “Task Summary” followed by the following table: Step Action 1 2 3 Bold Typeface Objects of actions in procedures appear in bold typeface. Note the following example: Select the Standby button.
Product Safety Information Warning Do 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. Warning This 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.
Product Safety Information ECG/ Arrhythmia All Patients Warning ECG SAFETY FOR 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.
Product Safety Information Warning ST/AR ARRHYTHMIA SAFETY FOR ALL PATIENTS During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) 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.
Product Safety Information ECG/ Arrhythmia Paced Patients Warning ECG SAFETY 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.
Product Safety Information Warning ST/AR ARRHYTHMIA SAFETY FOR PACED PATIENTS It 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.
Product Safety Information SpO2 Warning SpO2 SAFETY Always 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.
Contents General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-iv ECG/ Arrhythmia -All Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-vi ECG/Arrhythmia - Paced Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-viii SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3. ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 ECG Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Measuring ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 EASI ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sensor Application Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9 Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9 Sensor Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10 Connecting the SpO2 Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 Rx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 Patient Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 Safety Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This chapter introduces the Philips IntelliVue Telemetry System with Smarthopping 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Philips IntelliVue Telemetry System The Philips IntelliVue Telemetry System The 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 IntelliVue Transceiver System 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.
The IntelliVue Transceiver 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).
The IntelliVue Transceiver M2601B IntelliVue TRx+ M4841A EASI, 33 5 EASI, 5,6 IntelliVue TRx Transceiver - ECG only Note— The IntelliVue Transceiver and M2601B Transmitter are similar in appearance.
The IntelliVue Transceiver • • • • • • • • • Use with Information Center 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.
The IntelliVue Transceiver port. 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 - Front P1 L1 P2 IntelliVue TRx+ M4841A EASI, 3 5,6 I1 I2 B1 I3 I4 L2 B2 L3 P3 B3 The labeled items in the diagram include: Buttons (B1-B3); Indicators (I1-I4); Labels (L1-L4); Ports (P1-P3).
The IntelliVue Transceiver Buttons IntelliVue TRx+ M4841A EASI, 3 5,6 Callout B1 B2 Button B1 Definition 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. B3 Note—Delayed recordings generated by the Telemetry button are stored in Alarm Review at the Information Center.
The IntelliVue Transceiver Indicators IntelliVue TRx+ I1 I2 I3 I4 M4841A EASI, 3 5,6 Callout Indicator I1 Definition 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.
The IntelliVue Transceiver Labels L1 IntelliVue TRx+ M4841A EASI, 3 5,6 Callout Label Definition L1 L2 L3 IntelliVue TRx M4841A Leadset Insertion Guide. Assist in aligning the ECG cable for different leadsets. See “Connecting the ECG Cable” on page 3-19. EASI, 3 5,6 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.
The IntelliVue Transceiver Transceiver Controls - Back EASI L4 EASI EASI S A I E 1 2 6 345 S1 FCCID: XXXXXXXX S7-S11 not shown (inside battery compartment) S6 S2 S4 S3 S5 IntelliVue TRx+ Transceiver - Back View Basic Operation 1-11
The IntelliVue Transceiver Labels L4 EASI EASI Callout Definition S A I E 12 6 345 Safety Symbols & Other Marks L4 Callout S1 Electrode Placement Diagrams (See “Positioning ECG Electrodes” on page 3-8.) Label Definition FCCID: XXXXXXXX Federal Communications Commission (FCC) (PTT) label S2 Patient connections are protected against defibrillation (DEFIBRILLATIONPROOF) and are a TYPE CF APPLIED PART. S3 Prescription device. Rx S4 Non-Ionizing Radiation.
The IntelliVue Transceiver Callout Label Definition S6 Follow operating instructions. i S7 Philips Catalog Number REF S8 SN S9 Serial Number (inside battery compartment). Needed to identify the equipment during a call to the Response Center. MAC Address of device MAC Auditory Information Signals S10 Date of manufacture S11 Battery Polarity The transceiver produces auditory feedback to inform you of measurement and battery conditions.
The IntelliVue Transceiver button Standby functions, SpO2 measurement complete, outside of coverage area warning, and the pulse detection tone.
Turning the Transceiver On Transceiver Safety Information Warning If another radio medical device is operating at the same frequency as an IntelliVue Transceiver, it is possible that either device will not function properly. Warning Although 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.
Turning the Transceiver On 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.
Testing intelliVue Transceiver Functionality To 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 Functionality There 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.
Testing intelliVue Transceiver Functionality Status Check You can check the status of the transceiver indicators at any time. To initiate a Status Check, use the following instructions. Step 1 Action Press 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 1-18 Basic Operation If one or more of the expected indicators do not light up, check the following: • Lead block insertion.
Battery Information Battery Information Battery Safety Information Warning Use 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.
Battery Information Disposal of Batteries Caution The 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 Information The 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 performance Insert batteries into the transceiver using the following procedure.
Battery Information Step Action 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 Removing the Batteries Connect/reconnect the patient cables to the transceiver. Batteries should be changed in sets, that is, if you change one battery, change them both.
Battery Information Important— In the following table, battery life times are based on Duracell MN 1500 batteries. Battery life for other brands may be different. Battery Gauge Approximate Battery Life Remaining Approximate Operating Time Remaining Functionality 4 green indicators > 75% > 34.7 hours Normal operation 3 green indicators > 50% > 23.1 hours Normal operation 2 green indicators > 25% > 11.
Briefing the Patient Briefing the Patient Warning Patients 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.
Briefing the Patient Securing the Pouch Step 1 Action 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. Warning To 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 Patient Step Action 3 Fold the flap down and snap closed. 4 Check that the patient is comfortable wearing the pouch with transceiver. Showering Warning Signal 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.
Transceiver Use with TeleMon A02/A03 Drying the Transceiver after Showering After showering, perform the following steps to continue monitoring: 1. 2. 3. 4. 5. Pat dry the leadset connections at the electrodes. Wipe the lead wires with care. If wet, dry the outside of the transceiver with a non-lint producing cloth. If wet, wipe the inside of the battery compartment dry. Dry the batteries. If wet, disconnect the ECG lead block and shake out any water. Dry the connector pin area with a cotton swab.
Transceiver Use with TeleMon A02/A03 • • 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: Mode at TeleMon • Mode at Disconnected Transceiver Continuous Continuous 5-min. Continuous 1-min. Continuous Manual Spot Check After a change in SpO2 sensor, TeleMon returns to the default ECG settings, and arrhythmia relearn occurs automatically.
This 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm Indicators Alarm Indicators A 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 Indicators The visual alarm information signal on the transceiver is the Alarms Suspend icon.
Suspending/Pausing Alarms If 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.
Suspending/Pausing Alarms Resuming/ Unsuspending Alarms Alarms 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 1 Action Press the Telemetry and Check buttons simultaneously. • • • 2 2-4 Alarms Auditory alarm indication at the transceiver is switched on. The Alarm Suspend icon is turned off.
Standby Mode Standby Mode Standby 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.
Standby Mode Step Action 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.
Alarm Behavior with Own Bed Overview Alarm Behavior with Own Bed Overview Both 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 Behavior with Own Bed Overview Alarm Silence When an active alarm is silenced, the types of alarms that are silenced depend on the alarm source and where the silence was initiated. Effect at Paired Bedside Effect at Information Center Bedside Alarm is silenced Bedside alarm is silenced.
Physiologic Alarms Alarm/INOPs at the Information Center The alarms and INOPs that are displayed, recorded and stored at the Information Center depend on the type of alarm. Type of Alarm/INOP Effect at Information Center All ECG telemetry alarms and INOPs Note—ECG is generated from telemetry when paired. Displayed, recorded (if configured), and stored Bedside ECG INOPs and RESP INOPs Ignored.
Physiologic 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.
Physiologic Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition Source *** 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.
Physiologic Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition Source * 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.
Physiologic Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition Source * 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.
Technical Alarms (INOPs) Physiologic (Patient) Alarms Alarm Text Priority Condition Source * 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 Arrhythmia Notes: xxx = limit that was exceeded; yyy = current value.
Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) (in alphabetic order) Alarm Text Priority Condition What to do BATTERY 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.
Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) (in alphabetic order) Alarm Text Priority Condition What to do 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. LEAD OFF Hard Primary lead is off. Reattach ECG lead to patient. Note—If primary lead is MCL, lead will be identified as V in INOP text.
Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) (in alphabetic order) Alarm Text Priority Condition What to do SOME 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.
Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) (in alphabetic order) Alarm Text Priority Condition What to do SpO2T NOISY SIGNAL Hard Excessive patient movements or electrical interference are causing irregular pulse patterns Reduce 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 intraarterial line.
This 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ECG Safety Information ECG Safety Information Warning For 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.
Measuring ECG Measuring ECG The 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.
Measuring ECG ECG Leads Monitored 3-4 ECG Monitoring Leadset Electrode Color (AAMI) Electrode Location 5-wire (Standard mode) Black White Red Green Brown LA RA LL RL V 5-wire (EASI mode) Black White Red Green Brown S I A RL E 6-wire Black White Red Brown Green Brown/White LA RA LL Va RL Vb Depending on the leadset connected to the transceiver, a different set of viewable leads are available at the Information Center.
Measuring ECG source 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 Center 3-wire I, II, III If lead selection is enabled, sourced waves are received as: • Channel 1 - I • Channel 2 = II • Channel 3 = III If lead selection is disabled, the sourced wave is II. Default is II.
Measuring ECG If you are using ... these leads can be selected at the Information Center 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 = Vb The 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.
Measuring ECG ECG Lead 3-Lead 5-Lead Standard II II II LL-RA III 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 - V 6-Lead Clinical Calculations in terms of electrodes C-(RA+LA+LL)/3, where C=V Va C-(RA+LA+LL)/3, where Va=V2 position Vb Vb-(RA+LA+LL)/3, where Vb =V5 ECG Monitoring 3-7
Positioning ECG Electrodes Positioning ECG Electrodes Warning Do not mix and match electrodes of different types. In particular, do not use electrodes of dissimilar metals. This helps ensure optimal signal quality. Warning When 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.
Positioning ECG Electrodes When 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.
Positioning ECG Electrodes Step 2 Action 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.
Positioning ECG Electrodes Locating the Fourth Intercostal Space Angle of Lewis For 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).
Positioning ECG Electrodes 3-Lead Placement RA LA LL 3-12 ECG Monitoring Lead Placement RA directly below the clavicle and near the right shoulder LA directly below the clavicle and near the left shoulder LL on the left lower abdomen
Positioning ECG Electrodes 5-Lead Placement (Standard Mode) RA LA V1 V2 V3 V4 V5 V6 RL LL Lead Placement RA directly below the clavicle and near the right shoulder LA directly below the clavicle and near the left shoulder LL on the left lower abdomen RL on the right lower abdomen V on the chest, the position depends on your required lead selection. The default position is V2.
Positioning ECG Electrodes 3-14 ECG Monitoring Lead Placement V2 on the fourth intercostal space at the left sternal border V3 midway between the V2 and V4 electrode positions V4 on the fifth intercostal space at the left midclavicular line V5 on the left anterior axillary line, horizontal with the V4 electrode position V6 on the left anterior axillary line, horizontal with the V4 electrode position
Positioning ECG Electrodes 5-Lead Placement (EASI Mode) Warning 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.
Positioning ECG Electrodes Lead Corresponds to Standard Lead Placement S LA on the upper sternum I RA on the right midaxillary line at the same level as the E electrode N Reference can be anywhere, usually below the sixth rib on the right hip 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.
Positioning ECG Electrodes RA LA V1 V2 V3 V4 V5 V6 RL LL Lead Placement RA directly below the clavicle and near the right shoulder LA directly below the clavicle and near the left shoulder RL on the right lower abdomen LL on the left lower abdomen Va 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.
Positioning ECG Electrodes 3-18 ECG Monitoring Lead Placement 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.
Connecting the ECG Cable Connecting the ECG Cable Note—Your transceiver may have alignment guides to assist you in leadset insertion. Step 1 Action 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.
Connecting the ECG Cable Step Action 5-wire Standard Match the arrow on the cable with the right arrow (labeled 5, 6) on the Leadset Insertion Guide. IntelliVue TRx+ M4841A EASI, 3 5.6 5-wire EASI Match the arrow on the cable with the left arrow (labeled EASI, 3) on the Leadset Insertion Guide. IntelliVue TRx+ M4841A EASI, 3 5.6 Note—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.
Connecting the ECG Cable Step Action 6-wire Match the arrow on the cable with the right arrow (labeled 5,6) on the Leadset Insertion Guide. IntelliVue TRx+ M4841A 2 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. • • 3 Cable Disconnection EASI, 3 5.6 When using 5-lead standard, the EASI indicator does not illuminate.
Verifying Electrode Connections Verifying Electrode Connections The 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.
Monitoring during Leads Off During 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 Off ECG Fallback and Extended monitoring states are supported for the transceiver when the primary and/or secondary leads are in a Leads Off INOP condition.
Monitoring during Leads Off 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: • • Relearning Telemetry is configured for Extended Monitoring ON. The leas set provides more than two leads (e.g., when using a 5-wire leadset ).
Optimizing ECG Measurement Performance Optimizing ECG Measurement Performance While 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.
Optimizing ECG Measurement Performance Trouble- shooting Signal Disturbances Dropouts 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 nonphysiological event.
Optimizing ECG Measurement Performance Radio Frequency Interference Muscle and Movement Artifact Radio 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.
Optimizing ECG Measurement Performance Troubleshooting Common Causes of ECG Noise Problem Irregular Baseline Cause Poor electrical contact. Respiratory interference. Faulty electrodes. Baseline Wander Remedy Apply fresh electrodes after recommended skin preparation if necessary (see “Positioning ECG Electrodes” on page 3-8). Dry electrodes. Move electrodes away from areas with greatest movement during respiration. Movement of patient. Make sure patient is comfortable. Improperly applied electrodes.
This 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 . . . . . . . . . . . . . . . . . . .
ST/AR Arrhythmia Algorithm ST/AR Arrhythmia Algorithm Safety Information Warning FOR ALL PATIENTS During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) 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.
ST/AR Arrhythmia Algorithm Warning FOR PACED PATIENTS It 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.
ST/AR Arrhythmia Algorithm • 93051) IntelliVue Information Center Instructions for Use and Online Help The intended use of the ST/AR basic arrhythmia analysis algorithm is to monitor the patient’s ECG for heart rate and ventricular arrhythmias and to produce events/alarms simultaneously for one or more ECG leads. The arrhythmia algorithm is effective when monitoring both paced and non-paced patients in a clinical environment. IntelliVue Telemetry does not have a dedicated cardiotach.
ST/AR Arrhythmia Algorithm Beat 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.
ST/AR ST Segment Algorithm ST/AR ST Segment Algorithm Warning This 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/AR ST Segment Algorithm measurement and the ST point provides the other measurement point. It is positioned with reference to the J-point.
ST/AR ST Segment Algorithm Algorithm 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.
ST/AR ST Segment Algorithm ST Operation Turning ST Monitoring On/ Off The 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: Step Action 1 From the Patient Window, click the All Controls button. 2 From the All Controls Window, click the ST Setup button. 3 From the ST Setup Window, click ST On.
ST/AR ST Segment Algorithm Perform the following steps at the Information Center to adjust the ST measurement points: Step Action 1 Access the ST Setup window by clicking on the All Controls button in the Patient Window, then clicking on the ST Setup button. 2 If you need to adjust the ISO (isoelectric) point, place the cursor over the ISO button to access the adjustment arrows.
ST/AR ST Segment Algorithm Step 3 Action Adjust the J point, if necessary, by placing the cursor over the Jpoint 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. R T P Q 4 S J point Adjust 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.
ST/AR ST Segment Algorithm • • • 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.
ST/AR ST Segment Algorithm Step Action 2 From the All Controls window, select the ST Alarms button under Alarm Management and Setup. 3 In 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.
ST/AR ST Segment Algorithm 4-14 ST/AR Arrhythmia & ST Segment Monitoring
This 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SpO2 Safety Information SpO2 Safety Information Warning Always 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.
SpO2 Safety Information Warning Removal 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 User1 The 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.
Pulse Oximetry Measurement Pulse Oximetry Measurement The 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.
Selecting a SpO2 Sensor during 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.
Selecting a SpO2 Sensor 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.
Selecting a SpO2 Sensor Patient Weight ( lb ) Patient Weight ( kg ) Adult Adult Adult Adult Adult 110 50 40 Pedi Pedi Pedi Pedi Pedi 30 66 20 44 15 33 Infant 10 Infant 88 Pedi 22 3 Neo 7 Philips Part # M1192A M1191A M1194A M1901B M1903B M1904B Oxisensor OxiCliq/OxiMax N-25 N Reuseable sensor D-20 P D-25 A Disposable sensor Preferred sensor types Alternative sensor types Selecting an SpO2 Sensor SpO2 Monitoring 5-7
Selecting a SpO2 Sensor Caution Do 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 Applying the Sensor Sensor Application Safety Information Warning Failure 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.
Applying the Sensor 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.
Applying the Sensor To apply the sensor, use the following directions. Step Action 1 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 Adult Finger sensor (M1191A) Check that the light emitter and the photo detector are directly opposite each other.
Applying the Sensor Warning Failure 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.
Applying the Sensor Ear Clip sensor (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.
Connecting the SpO2 Cable Connecting the SpO2 Cable Step Action 1 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.
Measuring SpO2 Electrical Interference: Position the sensor cable and connector away from power cables, to avoid electrical interference. Measuring SpO2 SpO2 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.
Measuring SpO2 Step Action 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.
Measuring SpO2 Step 4 Action 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. Note— 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.
Measuring SpO2 • You can change the mode. Changes to the mode take effect when the transceiver is disconnected from TeleMon. The following settings will be used: Mode Set at TeleMon Turning SpO2 Monitoring Off Mode when Transceiver is Disconnected Continuous Continuous 5-minute Continuous 1-minute Continuous Manual Spot Check To turn SpO2 monitoring off, disconnect the sensor cable (or adapter cable) from the transceiver.
Measuring SpO2 Turning the SpO2 Parameter On/Off You can turn SpO2 monitoring on/off at the Information Center. S ee “PatientConfigurable 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.
Understanding SpO2 Alarms Understanding SpO2 Alarms Warning If you measure SpO2 on a limb that has an inflated NBP cuff, a nonpulsatile 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.
Optimizing SpO2 Measurement Performance Optimizing SpO2 Measurement Performance Refer to this section on problem situations if you have difficulty getting a signal or obtaining accurate measurements. Distortion Ambient light, motion, perfusion or incorrect sensor placement can affect the accuracy of the derived measurements.
Optimizing SpO2 Measurement Performance Optimizing Sensor Performance To 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.
This 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 . . . . . . . . . . . .
Telemetry Controls in the Patient Window Telemetry Controls in the Patient Window The 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 Limits Move the cursor over the HR or SpO2 label to display the current high and low alarm limits.
Locating the Transceiver (Find Device) Locating 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.
Patient-Configurable Settings in Telemetry Setup The following settings can be adjusted in this window. Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Default Telemetry Button Determine the Information Center response when Telemetry Button is pressed.
Patient-Configurable Settings in Telemetry Setup Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Default SpO2 Mode Determine the transceiver SpO2 behavior. Off - Stops monitoring of the SpO2 parameter Spot Check Note—For Off or Spot Check mode, Pulse is automatically set to disable. Spot Check - Provides manual measurements so the clinician can check as needed.
Patient-Configurable Settings in Telemetry Setup Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Default Suppress SpO2 INOPs with NBP Enable/disable the SpO2 algorithm to detect NBP running and suppress sending technical alarms from the transceiver for 60 seconds. enable enable disable Warning If you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur.
Unit-Configurable Settings Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Default SpO2 Alarm Enable/disable the display of SpO2 alarms on the Information Center enable enable Change current settings back to last saved clinical unit settings (none) Unit Settings disable Unit-Configurable Settings Unit Settings provide access to clinical configuration items that affect all patients on an Information Center.
Unit-Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Default Patient Type Set patient type used for alarm limits Adult Adult Determine the Information Center response when Telemetry Button is pressed.
Unit-Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Default Enable Remote Suspend Enable/disable alarm pause/ suspend at the transceiver. enable disable Battery Gauge on Information Center Display/disable a battery gauge for each assigned device on the Information Center. enable SpO2 Mode Determine the transceiver SpO2 behavior. Off - Stops monitoring of the SpO2 parameter Note—When the mode is set to Off or Spot Check, Pulse is automatically set to disable.
Unit-Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Default Suppress SpO2 Inops with NBP Enable/disable the SpO2 algorithm to detect NBP running and suppress sending technical alarms from the transceiver for 60 seconds. enable enable disable Warning If you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur.
Unit-Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Default Pulse Enable/disable the transmission of the Pulse parameter (and its subsequent display) to the Information Center. For Continuous Mode only. enable disable disable (Pulse is not displayed.) Enable/disable the display of SpO2 alarms on the Information Center enable enable SpO2 Limits High Increment/decrement SpO2 high alarm limit by 1 (in %). Limit maximum is 100.
Unit-Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Default 6-wire, Va Set the unit default lead label. V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R V2 Note—If ECGx matches Va, then as Va is changed, ECGx changes also. 6-wire, Vb Set the unit default lead label. V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R V5 Note—If ECGx matches Vb, then as Vb is changed, ECGx changes also. 6-wire, ECG1 Set the unit default lead label.
Unit-Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Default 6-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, V5R V5; 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, V6 II 5-wire EASI, ECG2 Set the unit default lead label.
Unit-Configurable Settings 6-14 Telemetry Functions at the Information Center
All 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maintenance Maintenance Basic 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.
Maintenance To Re-assign a Label from a (Lost) Device to a Replacement Transceiver Step 1 Action 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. 4 Insert batteries into the replacement device.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step 7 Action 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.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention • 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.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Disinfecting the Transceiver Warning To prevent fire, provide adequate ventilation and do not permit smoking when disinfecting the device with a flammable liquid, such as alcohol. Caution Remove the batteries and any cables or accessories before you disinfect the transceiver. The transceiver can be disinfected by two methods: wiping or soaking.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step Action 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. Soaking the Transceiver Caution Do 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.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Note—If there is concern over cross-contamination due to leadsets or sensors, new leadsets or sensors should be used. Equipment and Materials Warning EO 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)*.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Use 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.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step Action 7 Humidify the chamber at 50% +/- 10% relative humidity for 20 to 30 minutes. 8 Taking 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.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step 11 Action 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 residual EO. The vacuum pump must be vented to the outdoors. b. Return the sterilized chamber to ambient pressure by introducing air that has been bacterially filtered. 12 Continue with the “Aeration Procedure” (following).
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Aerate the processed equipment by performing the following steps: Step 1 Action To dissipate residual EO, aerate the processed equipment with air that has been bacterially filtered, using a mechanical aerator or combination sterilizer/aerator as follows:1 Time: 8-9 hours Temperature: 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 Note—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.
Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step 3 Action Test the transceiver: a. Put fresh batteries in the transceiver and close the battery door Result: 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 available, attach the ECG leads to the simulator and the SpO2sensor to yourself. At TeleMon, set the SpO2 sample rate to Continuous.
Troubleshooting Troubleshooting Basic Troubleshooting For problems with... • ECG measurement see... “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.
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.
Troubleshooting Wireless Status Log Messages Note: CTS refers to Philips IntelliVue Telemetry System. Wireless Status Log Text Cause Notes CTS TELE APC Malfunction 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 Duplicate IP address has been detected on the CTS network.
Troubleshooting 7-18 Maintenance & Troubleshooting
This 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 . . . . . . . .
Regulatory Information Regulatory Information Intended 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.
Regulatory Information • • • • 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 Monitors Essential Performance The 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 Compan
Regulatory Information Characteristic Water Resistance Definition 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.
Battery Life Specifications Pursuant 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.
Electromagnetic Compatibility Battery Gauge Battery Gauge Approximate Battery Life Remaining Approximate Operating Time Remaining Disabled Functions 4 green indicators > 75% > 34.7 hours ___ 3 green indicators > 50% > 23.1 hours ___ 2 green indicators > 25% > 11.
Electromagnetic Compatibility Radio 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.
Radio 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.
Radio Specifications Parameter Specification RF Overpower trip point > 10 dBm Transceiver Frequency Accuracy during normal operation +/- 15 kHz relative to channel frequency, includes temperature compensation and aging effects Reference Frequency Calibration < 4 ppm set a time of manufacture (env temp 25 +/- 5 oC) Modulation Type FSK with Root Raised Cosine filtering Modulation Deviation Bit 1: +288 kHz +/- 25 kHz relative to channel frequency Bit 0: -288 kHz +/- 25 kHz relative to channel frequ
Radio Specifications WMTS Channel Frequencies 1395 to 1400 MHz Parameter Specification Lower band edge 1395 MHz Channel 1 1395.8977 MHz Channel 2 1397.4970 MHz Channel 3 1399.0963 MHz Upper band edge 1400 MHz Channel spacing 1.6 MHz 1427 to 1432 MHz Parameter 8-10 Specification Lower band edge 1427 MHz Channel 4 1427.8979 MHz Channel 4a (*) 1429.2410 MHz Channel 5 (**) 1429.4972 MHz Channel 6 (**) 1431.
Physical Specifications Parameter Upper band edge Specification 1432 MHz * Available in special geographic area only ** Not available in special geographic areas Physical Specifications ECG-only Transceiver Parameter Specification Height 140 mm Width 75 mm Depth 28.5 mm Weight • without batteries or leadset • with batteries and 5wire leadset Volume • <165 g (5.8 oz.) • <284 g (10 oz.
Environmental Specifications ECG/SpO2 Transceiver Parameter Specification Height 140 mm Width 88 mm Depth 37 mm Weight • without batteries or leadset • with batteries and 5wire leadset • <205 g (7.2 oz.) • <324 g (11.5 oz.
Measurement Specifications Parameter Altitude • Operating & Non-operating Specification 0 to 3,048 m (10,000 ft) Measurement Specifications ECG Parameter ECG channel transmitted Leads • 3 electrodes • 5 electrodes Specification • • • 5 electrodes, EASI • • 6 electrodes • Channel #1 - I, II, or III Channel #1 - II Channel #2 - III Channel #3 - MCL Channel #1 - Vai Channel #2 - Vas Channel #3 - Ves Channel #1 - II Channel #2 - III Channel #3 - Va Channel #4 - Vb Resolution 5 µV ECG Input Diffe
Measurement Specifications Parameter Input Dynamic Range +/- 9 mV DC Offset Range +/- 320 mV CMRR > 90 dB @ 50, 60 Hz Bandwidth +/- 3 dB 0.05 to 40 Hz Gain Accuracy +/- 5% at 25 oC (77 oF) Noise Referred to ECG Input AAMI: 30 µV Lead Wires 3, 5 or 6-wire leadset.
Measurement Specifications SpO2 Parameter SpO2 Measurement Range SpO2 Accuracy Specification 0 to 100% • +/- 2.
Measurement Specifications Parameter SpO2 Sensor Accuracy Display of SpO2 numerics SpO2 date values are displayed as xxx % SpO2 to meet ISO/EN standard EN 865 NIBP 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) . Type Philips Reusable Sensors 8-16 Specification Description Model Number Accuracy% Arms (70-100% Range) Adult Finger M1191A 2.0 Adult Finger M1191AL 2.
Measurement Specifications Type Philips Disposable Sensors Description Model Number Accuracy% Arms (70-100% Range) Adult Finger M1901B 3.0 Pediatric Finger M1903B 3.0 Adult Finger M1904B 3.
Measurement Specifications Model Number Accuracy% Arms (70-100% Range) OxiCliq A, Adult N/A 3.0 OxiCliq N, Adult >40 kg (88 lb) N/A 3.0 OxiCliq P, Pediatric N/A 3.0 OxiMax MAX-A, Adult >30 kg (66 lb) N/A 3.0 OxiMax MAX-AL, Adult >30 kg (>66 lb) N/A 3.0 OxiMax MAX-N, Adult >40 kg (>88 lb) N/A 3.0 OxiMax MAX-P, Pediatric N/A 3.0 Type Nellcor Disposable Sensors (not available from Philips) 8-18 Description Oxisensor II D-20, Pediatric 10-50 kg (22-110 lb) N/A 3.
This 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 Safety Accessory Safety Warning Philips’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 Accessories Description 9898 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 0
SpO2 Accessories Alignment Guides Order Number Description 9898 031 40401 Single Alignment Guide, package of 10 9898 031 40411 Single Tethered Alignment Guide, package of 10 9898 031 40421 Double Alighment Guide, package of 10 Order Number Description 9898 031 40431 ECG Gunk Guard, package of 10 9898 031 40441 SpO2 Gunk Guard, package of 10 9898 03140451 Serial SpO2 Gunk Guard, package of 10 Gunk Guards SpO2 Accessories Reusable Sensors Order Number A-4 Accessory List Description M1191
SpO2 Accessories Disposable Sensors Single Use Description 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) Note—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.
SpO2 Accessories Order Number Description * Uses reusable OC-3 Sensor Cable.
Please call your local sales office listed in your telephone directory or a regional office listed below for the location of your nearest sales office. CORPORATE HEADQUARTERS: Philips Medical Systems Netherlands B.V. Postbus 10.000 5680 DA Best Netherlands UNITED STATES: Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 (800) 934-7372 CANADA: Philips Medical Systems 2660 Matheson Blvd. E.
LATIN AMERICA HEADQUARTERS: Philips Medical Systems 5200 Blue Lagoon Drive 9th Floor Miami, FL 33126 (305) 267-4220 ASIA PACIFIC HEADQUARTERS: Philips Medical Systems 24F Cityplaza One 1111 King's Road Taikoo Shing, Hong Kong (+852) 3197 7777 B-2 Sales and Support Offices
Index A alarms behavior with Own Bed Overview indicators, 2-2 physiologic, 2-10 SpO2, 5-20 technical, 2-15 testing, 7-15 auditory info signals, 1-13 2-7 transceiver use with, 1-6 INOP messages ST 4-11 INOPs, see technical alarms 2-15 intended use ST/AR, 4-3 transceiver, 8-2 L lead placement, 3-12 B N battery life, 1-23, 8-5 safety, 1-19 type, 1-21 noise eliminating, on/off, 1-15 ordering information ECG supplies, A-2 SpO2 supplies, A-4 Own Bed Overview alarm behavior 2-7 own bed overview, 6-2, 6-3
paced, 1-viii, 4-3 pouch, 1-25 SpO2 sensor, 5-9 SpO2, 1-x, 5-2 ST/AR arrhythmia, 1-vii ST/AR, 1-vii, 4-2 symbols, 1-12 transceiver, 1-15 sensor ear clip, 5-13 finger, 5-11 sensors selecting 5-22 service log, 7-16 signal strength, 3-26 sounds see auditory info signals 1-13 start-up, 1-16 SpO2 auto on/off 5-19 continuous, 5-16 on/off, 5-18 sensor application, 5-9 sensor selection, 5-5 spot check, 5-15 turn parameter on/off 5-19 SpO2 inop suppression, 6-6, 6-10 SpO2 mode, 6-5, 6-9 SpO2 monitoring, 5-4 spot che
