IntelliVue TRx/TRx+ Transceivers for the ITS4840A/ITS4850A IntelliVue Telemetry System Notice (ITS4840A) This system complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. Operation of this equipment in the United States requires the prior coordination with a frequency coordinator designated by the Federal Communications Commission (FCC) for the Wireless Medical Telemetry Service (WMTS).
Printing History Notice Document number: M4841-9001J, First Edition Printed in the USA. © Copyright 2004, 2005, 2006 Koninklijke Philips Electronics N.V. All Rights Reserved. Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder. Philips Medical Systems Nederland B.V.
About this Book The document part number changes when extensive technical changes are incorporated. First Edition...............................................................................December 2006 IntelliVue TRx4841A Transceivers are compatible with: IntelliVue Telemetry System, Revision A.00 IntelliVue Information Center, Software Revisions F.00, G.00, H.00 and J.00 M2636C TeleMon Companion Monitor, Revision A.00, B.00 and C.00 IntelliVue MP5 Patient Monitor, Revision E.
About this Book • IntelliVue MP5 Patient Monitor Instructions for Use For preventive maintenance, repair, and test methods for verification of device performance, refer to the IntelliVue Telemetry System Service Kit.
About this Book Document Conventions The following document conventions are used throughout this manual to identify specific safety and operational information. Warnings Warning Warnings are information you must know to avoid injuring patients and personnel. Cautions Caution Cautions are information you must know to avoid damaging your equipment and software. Notes Note—Notes contain additional information on use of the IntelliVue Telemetry System.
About this Book vi
Contents 1. Introducing IntelliVue Telemetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 The IntelliVue Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transceiver Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transceiver Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adjustable Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12 Service Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13 4. Basic Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Transceiver Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6-Wire Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cable Disconnection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Verifying Electrode Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
When Connected to TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . When Connected to the MP5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Turning SpO2 Monitoring Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SpO2 Enable/Disable at Information Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SpO2 Auto ON at Information Center . . . .
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2 Rx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2 Patient Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2 Safety Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adapter Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7 Monitor Interface Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 Wristband . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 B. Sales and Support Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This chapter introduces the IntelliVue TRx and TRx+ Transceivers, the patientworn device of the IntelliVue Telemetry System with Smart-Hopping Technology. It includes the following sections: • • • • The IntelliVue Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 IntelliVue Telemetry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 IntelliVue Clinical Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The IntelliVue Transceiver The IntelliVue Transceiver The IntelliVue Transceiver is a patient-worn device for monitoring ECG and SpO2 on adult and pediatric patients within the IntelliVue Telemetry System. The transceiver combines traditional transmitter features with communication to and from the IntelliVue Information Center.
The IntelliVue Transceiver .
IntelliVue Telemetry System IntelliVue Telemetry System The IntelliVue Telemetry System with Smart-Hopping Technology uses cellular architecture to provide two-way communication between transceivers and the IntelliVue Information Center. Smart-hopping technology dodges interference and seeks out the strongest available signal to achieve seamless connections wherever patients roam on the clinical network.
IntelliVue Telemetry System Bi-directional Signal Flow in the IntelliVue Telemetry System Smarthopping Technology Smart-hoppingTM technology provides dynamic management of the RF spectrum used by each transceiver. This technology allows a virtually unlimited number of transceivers to operate simultaneously within the IntelliVue Telemetry System by creating a frequency-agile system that changes frequency without user involvement or awareness whenever interference occurs.
IntelliVue Telemetry System Smart-hopping enables the signal to avoid wireless interference. When baseline noise is low (see illustrations following), telemetry signals reside in their frequency/time slot locations. If excessive interference occurs, degrading the signal, the telemetry signal then “hops” over the interference to a location that provides optimal signal-to-noise performance.
IntelliVue Telemetry System Excessive Interference ’Hop’ to New Frequency/Time Slot Introducing IntelliVue Telemetry 1-7
IntelliVue Clinical Network Spectrum Sharing The ITS4840A IntelliVue Telemetry System operates in the Wireless Medical Telemetry Service bands (WMTS - USA only). WMTS uses radio frequency spectrum which was allocated by the FCC for medical telemetry applications, with a reduced potential for harmful interference.
Transceiver Use with Other Equipment between the transceivers and the Information Center. • M3150B IntelliVue Information Center for centralized monitoring. • M3154A IntelliVue Database Server (optional) for centralized data management. • M2636C TeleMon Companion Monitor (optional) for local alarms, NBP measurement, and bedside display of patient data. • M8105A MP5 IntelliVue Patient Monitor (optional) for bedside display of patient data being sourced from the transceiver.
Transceiver Use with Other Equipment Patient Bedside Monitors Remote control of monitoring parameters such as NBP, SpO2, Alarm Suspend, and Relearn, as well as limited overview of waves and data are supported through Patient Bedside Monitors equipped with a bi-directional radio interface. Please refer to the Instructions for Use for the specific Patient Monitor for operating information. Patient Data can be sourced directly from the transceiver to the M8105 MP5 Patient Monitor.
This chapter consolidates the safety warnings that apply to use of the IntelliVue Transceivers in a IntelliVue Clinical Network. These warnings are repeated throughout the book in context where relevant. The chapter includes the following sections: • • • • • • • • General Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 ECG . . . . . . . . . . . . .
General Safety General Safety Warning The IntelliVue Telemetry System should not be used for primary monitoring in applications where the momentary loss of the ECG is unacceptable. Warning For 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. Warning Do not touch the patient, or table, or instruments, during defibrillation. The battery door must be closed during defibrillation.
General Safety Warning Do not use patient cables with detachable lead wires that have exposed male pins. Electrocution could result if these pins are plugged into AC power. Warning The system is not completely immune from radio interference although it is designed to minimize interference through smart hopping. Sources of interference that may be a problem include failing fluorescent lights and construction equipment. See “Electromagnetic Compatibility” on page 12-5.
General Safety Warning If the Alarms Suspend indicator on the transceiver remains illuminated after the button combination to unsuspend alarms is pressed, a transceiver malfunction may have occurred. (Alarms resume automatically after the configured alarm suspend duration, 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.
Battery Battery Warning The battery door must be closed during defibrillation. Warning Use Duracell Alkaline Batteries, size AA, MN 1500, 1.5V, 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. Warning Certain failure conditions, such as short circuits, can cause a battery to overheat during use.
ECG Warning 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 11. Maintenance, Cleaning & Troubleshooting”. Wash hands.
ECG Warning 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. Warning EASI derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs.
ST/AR Arrhythmia For Paced Patients Warning 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.
ST/AR Arrhythmia Warning 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. Warning Relearning Arrhythmia relearning is initiated whenever the transceiver is powered down for one minute or longer or whenever it is directly connected/ disconnected to an IntelliVue MP5 Patient Monitor.
ST/AR Arrhythmia For Paced Patients Warning Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Keep pacemaker patients under close observation.
ST/AR ST Segment Warning It is possible that pacemaker pulses will not be detected when the ECG analog output of a defibrillator is plugged into a bedside monitor. This can result in the arrhythmia algorithm’s failure to detect pacemaker noncapture or asystole. ST/AR ST Segment Warning This device provides ST level change information; the clinical significance of the ST level change information should be determined by a physician.
SpO2 Warning Do not use disposable sensors on patients who exhibit allergic reactions to the adhesive. Warning Prolonged, continuous SpO2 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.
SpO2 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. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxia and tissue malnutrition.
Cleaning Warning Removal of the SpO2 sensor during Continuous SpO2 monitoring results in a "No Sensor" technical alarm. Silencing this technical alarm turns the SpO2 measurement off. There is no technical alarm for a “No Sensor” condition in Spot Check mode. Warning This equipment is not suitable for use in the presence of a flammable anesthetic mixture or oxygen concentrations greater than 25% (or partial pressures greater than 27,5 kPa /206.27 mmHg).
Cleaning Warning Comply 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 environmental regulations. (If the mixture is captured, it can be separated commercially and the component gases reused.) * See “References” on page 11-9. Warning To avoid chemical burns and toxic effects, the equipment must be aerated after sterilization, as described.
Accessories Accessories Warning Use only Philips-approved accessories. Use of product accessories (ECG leadsets, SpO2 sensors, etc.) other than those specified in this manual may: - lead to patient injury - result in increased electromagnetic emissions or decreased immunity of the product Warning 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.
This chapter describes the clinical controls of the transceiver. These controls include buttons, visual and auditory indicators, ports, and safety labelling located on the front and back of the device. The chapter includes the following sections: • • • Transceiver Controls - Front. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 •Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 •Power On/Off . . . . . . . . . . . . . . . . . . . .
Transceiver Controls - Front Transceiver Controls - Front P1 L1 P2 TRx4851A I1 I2 B1 I3 I4 B2 L2 L3 P3 O1 The labeled items in the diagram include: • • • • • Buttons (B1-B2) Power On/Off (O1) Indicators (I1-I4) Labels (L1-L3) Ports (P1-P3) IntelliVue TRx+ Transceiver - Front View 3-2 Transceiver Controls
Transceiver Controls - Front Buttons IntelliVue TRx+ M4841A EASI, 3 5,6 Callout B1 B2 Button Definition B1 Telemetry Button • Depending on configuration, directs the Information Center to generate a Nurse Call alarm, remote recording, both Nurse Call alarm and recording, or none. See “Telemetry Functions at the Information Center” on page 9-2. Note—Delayed recordings generated by the Telemetry button are stored in Alarm Review at the Information Center.
Transceiver Controls - Front Power On/ Off IntelliVue TRx+ M4841A EASI, 3 5,6 Callout Battery Door to Access O1 Power On/Off O1 Definition Power On/Off Insertion of batteries turns transceiver power on; removal of batteries turns power off. See “Turning the Transceiver On/Off” on page 4-2.
Transceiver Controls - Front Callout Indicator I2 EASI Definition 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 alarm pause period initiated at transceiver, Information Center, or TeleMon. I4 Battery Gauge Illuminates when the Check button is pressed, indicating the amount of power remaining in the batteries.
Transceiver Controls - Front Callout Label Definition L2 Device Identification Label Identifies the device to the IntelliVue Clinical Network. L3 Unit Identification Label Uses one of seven color-coded labels for visual identification of a clinical unit. Ports P2 P1 IntelliVue TRx+ M4841A P3 EASI, 3 5,6 Callout Definition P1 ECG Leadset Port Connection for 3-, 5-, or 6-wire leadset. P2 SpO2 Sensor Port (IntelliVue TRx+ only) Connection for SpO2 sensor. See Note.
Transceiver Controls - Back Transceiver Controls - Back S8-S13 not shown (inside battery compartment) EASI EASI L1 L2 S1 S6 S2 S4 S3 S5 S7 The labeled items in the diagram include: • Labels (L1-L2) • Safety symbols and other marks (S1-S13) IntelliVue TRx+ Transceiver - Back View Transceiver Controls 3-7
Transceiver Controls - Back Labels L1 Callout EASI EASI L2 Definition S A I E 12 6 345 Safety Symbols & Other Marks L1 Electrode Placement Diagram for EASI See “5-Wire Placement (EASI Mode)” on page 6-16. L2 Electrode Placement Diagram for Standard ECG See “5-Wire Placement (Standard Mode)” on page 6-14.
Transceiver Controls - Back Callout S5 Label Definition Rx Prescription Device S6 Canadian and American standards compliance Complies with applicable Canadian and American standards. S7 Defibrillation Proof Patient connections are protected against defibrillation (DEFIBRILLATIONPROOF) and are a TYPE CF APPLIED PART. Labels on Inside of Battery Compartment S8 REF Catalog Number Use to identify the equipment during a call to the Philips Response Center.
Audible Tones Callout Label Definition S11 Date of manufacture S12 Battery Polarity S13 Attention! See Instructions for Use. Audible Tones The transceiver produces six different auditory information signals to inform you of measurement and transceiver conditions during normal use. Most are generated automatically.
Audible Tones Clinical Use Auditory Information Signal Sound How Used Sound 1 beep • Indicates successful Self-Test at power on. • Indicates successful SpO2 Spot Check measurement when measurement is initiated at the transceiver. • If the Check button is pressed, confirms that the transceiver is in contact with the Information Center (e.g., when transceiver is brought back into range). Indicates pulse detected during Spot Check SpO2 measurement.
Audible Tones Auditory Information Signal Adjustable Sounds How Used Sound 5 beep beep every 5 seconds Indicates transceiver is out of range or not associated with a sector. Sound stops when contact is re-established with the Information Center, or it can be silenced by pressing the Check button for six seconds. Sound 6 beep beep every 2 seconds Indicates that the leadset is not inserted correctly.
Audible Tones Service Sounds Two additional sounds that you may hear occur during the labelling of transceiver devices within the IntelliVue Clinical Network. The volume of these sounds is not adjustable, and cannot be turned off. See “Label Assignment for Replacement Transceiver” on page 11-2. Service Sound Description beep beep repeated every 3 seconds, and all visual indicators flashing Unlabeled Device. Equipment Label needs to be assigned at Information Center. No monitoring.
Audible Tones 3-14 Transceiver Controls
This chapter describes the basic operation of the transceiver. It includes the following sections: • • • • • Transceiver Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Turning the Transceiver On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Briefing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Testing Transceiver Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transceiver Safety Information Transceiver Safety Information Warning The system is not completely immune from radio interference although it is designed to minimize interference through smart hopping. Sources of interference that may be a problem include failing fluorescent lights and construction equipment. See “Electromagnetic Compatibility” on page 12-5. Warning Place the transceiver in a pouch or over clothing, or both, during patient use.
Turning the Transceiver On/Off c. cessation of sounds, indicating a successful association with the Information Center. Sounds at Successful Start-up Transceiver performs self-test Insert batteries One beep Test passed Transceiver searches for Information Center Transceiver connected with Information Center Two beeps every 5 seconds Beeping stops d.
Turning the Transceiver On/Off To restart monitoring, insert batteries (if needed), attach leads to the patient, insert the SpO2 sensor cable in the SpO2 sensor port and press the Check button to verify association with the Information Center. This feature must be enabled by your service provider. Standby Mode Standby mode is used to temporarily suspend monitoring at the Information Center, for example, when a patient goes out of access point range or is discharged.
Turning the Transceiver On/Off Step 4 Action Select the appropriate location, then select Suspend Monitoring. The message “Telemetry Standby” and location, if selected, are displayed in the sector. Note—If the transceiver is paired with an IntelliVue Patient Monitor, monitoring will be suspended at both the transceiver and the IntelliVue Patient Monitor as well as at the Information Center. The messages "Monitor Standby" and "Telemetry Standby" will be displayed in the patient sector.
Briefing the Patient Briefing the Patient Warning Patients should be instructed not to open the battery compartment while the transceiver is in use. If the Telemetry button has been configured to generate a Nurse Call, recording at the Information Center, or both, instruct the patient to use the button when needed. If desired, you can turn off patient use of the button at the Information Center. See “Patient Configurable Settings in Telemetry Setup” on page 9-4.
Briefing the Patient Pouch Use The transceiver is not intended 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 with clear front is an appropriate means for holding the transceiver. See Appendix A, “Accessories” for ordering information.
Briefing the Patient Step 2 Action Turn the pouch so that the opening is facing downward. This protects the transceiver from fluid and debris. Secure the pouch on the patient with the upper ties around the patient’s head and arm and the lower ties around the patient’s torso. Warning To avoid the risk of strangulation, do not tie a pouch solely around the patient’s neck. Place Tie arm. a under the a b Place Tie b around the neck. Tie a and b together around the neck.
Briefing the Patient Step 3 Action Check that the patient is comfortable wearing the pouch with transceiver.
Briefing the Patient Showering Warning When the patient is showering, signal quality and leads off detection may be compromised due to significant 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 and secured on the patient as described above. The combination of the transceiver and pouch will withstand showering for up to 10 minutes.
Testing Transceiver Functionality Testing 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. Self Test Warning Do not use the transceiver for patient monitoring if it fails the Power On Self Test. Caution Do not insert a leadset during a self-test. The leadset can be inserted before or after the self-test.
Testing Transceiver Functionality Status Check You can check the status of the transceiver indicators at any time. Initiating a Status Check Step 1 Action Press the Check button. The following indicators should illuminate for as long as the Check button is depressed.
Battery Information Battery Information Battery Safety Information Warning The battery door must be closed during defibrillation. Warning Use Duracell Alkalaine batteries, size AA, MN 1500, 1.5V, 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.
Battery Information Warning 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 11. Maintenance, Cleaning & Troubleshooting”. Wash hands.
Battery Information Inserting the Batteries Insert batteries into the transceiver using the following procedure. Step Action 1 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. 3 Close the battery compartment door.
Battery Information Removing the Batteries To remove the batteries, 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.
Battery Information Step 2 Action If 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.
Battery Information Battery Gauge Approximate Battery Life* Remaining Approximate Operating Time* Remaining Functionality * Battery life times are based on use of Duracell MN 1500 batteries in a TRx transceiver. Times for TRx+ are somewhat lower. Life times when other battery brands are used may be different. Note—For the TRx+ transceiver, SpO2 functionality is disabled when the red light (Battery Low) is lit.
This chapter lists Physiologic (Patient) Alarms and Technical (Inoperative Condition) Alarms. It also describes how to pause/suspend alarms temporarily. It includes the following sections: • • • • Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Suspending/Pausing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Physiologic Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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. Alarm behavior specific to the use of the transceiver paired with an IntelliVue Patient Monitor is described in “Chapter 10.
Suspending/Pausing Alarms If the transceiver is connected to TeleMon or the MP5 IntelliVue Patient Monitor, alarms can be suspended only from TeleMon, and not from the Information Center. The Alarms Suspend icon on the transceiver is lit (see “Transceiver Controls - Front” on page 3-2), and an "Alarms Suspended" message appears at TeleMon and the Information Center. Patient monitoring (display of patient waveforms and numerics) continues for the duration of Alarm Suspend/Pause.
Physiologic Alarms duration time has expired from the transceiver (see following directions) or from the Information Center. Step 1 Action Press the Telemetry and Check buttons simultaneously until the indicator turns off. • • 2 The Alarm Suspend icon is turned off. The message "Alarms Suspended" (or "Alarms Paused") is removed from the Information Center display. Alternately, you can unsuspend alarms at the Information Center.
Physiologic Alarms NBP alarms are listed in the TeleMon Instructions for Use and the Information Center Online Help. In the following table, Red (***) alarms are listed alphabetically, followed by the Yellow (**) alarms, and 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.
Physiologic Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition Source ** MULTI ST Lx, Ly Yellow Two ST leads (Lx and Ly) exceed alarm limit elevation or depression for > 60 seconds (EASI mode or when selected). ST/AR ST ** NURSE CALL Yellow The Telemetry button on the transceiver has been pressed (and the system is configured to alarm and the Telemetry button is on.
Physiologic Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition Source * IRREGULAR HR Yellow Consistently irregular rhythm (irregular R-R intervals). ST/AR Enhanced Arrhythmia * MISSED BEAT Yellow No beat detected for 1.75 x average R-R interval for Heart Rate greater than 120, or no beat for 1 second with Heart Rate greater than 120 (non-paced patient only).
Physiologic Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition Source * PVCs >xxx/MIN Yellow PVCs within one minute exceed by the PVCs/min limit (xxx). ST/AR Basic & Enhanced Arrhythmia * R-ON-T PVCs Yellow For Heart Rate less than 100, a PVC with R-R interval less than 1/3 the average interval followed by a compensatory pause of 1.25 x average R-R interval, or 2 such Vs without a compensatory pause occurring within 5 minutes of each other.
Technical Alarms (INOPs) Technical Alarms (INOPs) Technical Alarms, or INOPs (inoperative conditions), are sourced at the transceiver, the ST/AR algorithm running at the Information Center, or TeleMon Companion Monitor. They identify inoperative conditions (that is conditions where the system is not operating properly and therefore cannot measure or detect alarm conditions reliably). There are four levels of Technical Alarms: • • • • Severe - Monitoring and alarms disabled.
Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) Alarm Text Priority Condition What to do 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 ISO and J points. ECG EQUIP MALF Hard Failure of the ECG equipment or failure to calibrate ECG. • • • ECG LEADS OFF Note—This INOP may also be configured to display as a Red or Yellow Technical Alarm.
Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) Alarm Text Priority NO SIGNAL Hard Condition • • • • Patient is out of range, or No batteries in transceiver, or Transceiver has failed, or Connection to Database Server has failed. What to do • • • • Make sure that the transceiver is in range and has good batteries. Replace the transceiver if Power On Self Test fails. Put bed in Standby. Contact Service.
Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) Alarm Text Priority Condition What to do SpO2T EXTD UPDATE Numeric 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.
Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) Alarm Text Priority Condition What to do 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.
Technical Alarms (INOPs) 5-14 Alarms
This chapter covers the specifics of ECG measurement. It includes the following sections: • • • • • • • ECG Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Measuring ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 Positioning ECG Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9 Connecting the ECG Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ECG Safety Information ECG Safety Information Warning Always confirm Information Center observations with clinical observation of the patient before administering interventions. Warning 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.
ECG Safety Information For Paced Patients Warning 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.
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. In order 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 are used.
Measuring ECG transceiver usage. If the transceiver senses the insertion of a leadset not matching the current configuration, the transceiver will source the ECG per the leadset detected and issue and auditory signal to indicate the condition. An INVALID LEADSET INOP is generated at the Information Center. There is no cardiotach within the transceiver; cardiotach analysis resides in the arrhythmia algorithm at the Information Center.
Measuring ECG If you are using ... 5-wire (EASI mode) these leads can be selected at the Information Center I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 In EASI mode, the sourced (raw) waves are received as: • Channel 1 = Vector 1 (A-I) • Channel 2 = Vector 2 (A-S) • Channel 3 = Vector 3 (E-S) Defaults are II, V2, III, V5.
Measuring ECG If you are using ... 6-wire (Vb is not supported on TeleMon and is only supported on MP5 Patient Monitors with 12-Lead option) these leads can be selected at the Information Center I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R. Sourced (raw) waves are received as: • Channel 1 = II • Channel 2 = III • Channel 3 = Va • Channel 4 = Vb Defaults are II, Va = V2, III,Vb = V5.
Measuring ECG Reconstructed Leads 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.
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 Non-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.
Positioning ECG Electrodes The labels and colors of the ECG electrodes differ according to the standards that apply for your hospital. The electrode placement references and illustrations in this chapter use the AAMI labels and colors. See the table below for additional label and color information.
Positioning ECG Electrodes Step Action 1 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.
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-Wire Placement RA LA 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 ECG Monitoring 6-13
Positioning ECG Electrodes 5-Wire Placement (Standard Mode) RA LA V1 V2 V3 V4 V5 V6 RL 6-14 ECG Monitoring 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 typical position is V1, although this may vary according based on your hospital’s protocol.
Positioning ECG Electrodes Lead Placement V1 on the fourth intercostal space at the right sternal border 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 midaxillary line, horizontal with the V4 electrode position ECG Monitoring 6-15
Positioning ECG Electrodes 5-Wire Placement (EASI Mode) S I A E 6-16 ECG Monitoring Lead Corresponds to Standard Lead E V on the lower sternum at the level of the fifth intercostal space A LL on the left midaxillary line at the same level as the E electrode S LA on the upper sternum I RA on the right midaxillary line at the same level as the E electrode Placement
Positioning ECG Electrodes Lead Corresponds to Standard Lead N Reference Placement can be anywhere, usually below the sixth rib on the right hip Note—Make sure that the S and E electrodes line up vertically on the sternum, and that the I, E and A electrodes align horizontally.
Positioning ECG Electrodes 6-Wire Placement 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. The lead placement for the Va and Vb lead labels must be appropriate.
Positioning ECG Electrodes Lead Placement 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 (see below). The default position is V2. For other positions, relabel the lead at the Information Center. Vb on the chest, the position depends on your required lead selection (see below). The default position is V5.
Positioning ECG Electrodes 6-20 ECG Monitoring Lead Placement V1 on the fourth intercostal space at the right sternal border 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 V7 on the left posterior axillary line, straight line from V6 V8 on the left midscapular line, straight line from V7 V9 on the left paraspinal line, straight line from V8 V3R midway between the V1 and V4R electrode positions V4R on the fifth intercostal space at the right midclavicular line V5R on the right anterior axillary line, straight line from V4R ECG Monitoring 6-21
Connecting the ECG Cable Connecting the ECG Cable Caution Do not insert a leadset in the transceiver during a self-test. The leadset should be inserted either before the transceiver is powered up, or after the device has established connection with the Information Center. 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.
Connecting the ECG Cable Step Action 5-wire Standard 3 Match the arrow on the cable with the right arrow (labeled 5, 6) on the Leadset Insertion Guide. colored line line 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. colored line IntelliVue TRx M4841A EASI, 3 5.
Connecting the ECG Cable Step 4 Action 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 6-25. • When using 5-lead standard, the EASI indicator does not illuminate. When using EASI, the EASI indicator illuminates momentarily. 5 6-wire Match the arrow on the cable with the right arrow (labeled 5,6) on the Leadset Insertion Guide.
Verifying Electrode Connections Verifying Electrode Connections The electrode indicators enable you to verify that the leads are available for the desired monitoring. 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.
Verifying Electrode Connections Step 2 Action Expected Response: • • • • • 3 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.
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. Note—Should the lead in the reference lead placement position (standard mode - RL; EASI mode - green) become disconnected, the ECG signal is lost entirely.
Monitoring during Leads Off Fallback for EASI Extended Monitoring 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).
Optimizing ECG Measurement Performance 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 Warning Telemetry should not be used for primary monitoring in applications where the momentary loss of the ECG is unacceptable.
Optimizing ECG Measurement Performance Clinicians will tend to see more motion related artifact on the ECG of ambulatory patients than on patients that are restricted to a bed. Proper skin preparation and electrode application are very important in reducing this problem. Problems with the ECG signal stem from two main sources: 1. Frequency-related sources resulting in dropouts from signal disturbances and loss of signal. 2.
Optimizing ECG Measurement Performance disassociation/reassociation with the Information Center, events in the Clinical Review application can reflect loss of data for up to 1 minute in the worst case. Problem Cause Dropouts Signal Strength Remedy Low signal strength See “Signal Strength” below. RF interference See “Radio Frequency Interference” below.
Optimizing ECG Measurement Performance Telemetry System is designed to resist these effects and Smart-hopping enables the system to avoid most instances of interference. The 2.4 GHz ISM band used by the ITS4850A IntelliVue Telemetry System is used by many different radio technologies, (e.g. microwave ovens, wireless phones, Bluetooth devices). Therefore, there is increased potential for interference. The system has the ability to detect whether the spectrum is too congested.
Optimizing ECG Measurement Performance Problem Cause Remedy 60-Cycle (AC) Interference Poor electrode placement. Re-apply electrodes, using good skin preparation (see “Positioning ECG Possible non-grounded Electrodes” on page 6-9). instrument near patient. 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. Diaphoresis.
Optimizing ECG Measurement Performance Problem Baseline Wander Cause Remedy Movement of patient. Make sure patient is comfortable. Improperly applied electrodes. Re-apply electrodes, using good skin preparation (see “Positioning ECG Electrodes” on page 6-9). Check that patient cable is not pulling electrodes. Respiratory interference. Move electrodes away from areas with greatest movement during respiration. Poor Electrode Contact Loose electrodes. Defective cables. Leadset not firmly connected.
This chapter describes the ST/AR algorithms used for telemetry at the IntelliVue Information Center. It includes the following sections: • • ST/AR Arrhythmia Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 ST/AR ST Segment Algorithm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ST/AR Arrhythmia Algorithm ST/AR Arrhythmia Algorithm Safety Information Warning 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. Warning Learning If you initiate learning during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex.
ST/AR Arrhythmia Algorithm Warning Relearning Arrhythmia relearning is initiated whenever the transceiver is powered down for one minute or longer or whenever it is directly connected/ disconnected to an IntelliVue MP5 Patient Monitor. Be sure to check your patient’s arrhythmia annotation for accuracy whenever relearn has occurred. Since Relearn happens automatically, if learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex.
ST/AR Arrhythmia Algorithm Warning 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. Warning For 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.
ST/AR Arrhythmia Algorithm 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. Instead, the arrhythmia cardiotach at the Information Center is used.
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 needs to be determined by a physician. The ST/AR ST algorithm at the Information Center 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. R-WAVE PEAK AT 0 MSEC J POINT T P DIFFERENCE = ST VALUE Q S ST ISO ELECTRIC POINT MEASUREMENT DEFAULT = POINT -80 MSEC DEFAULT = J+60 MSEC 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.
ST/AR ST Segment Algorithm 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).
ST/AR ST Segment Algorithm Adjusting ST Measurement Points The 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.
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 • 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 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.
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 7-14 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 Pulse Oximetry Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Selecting a SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6 Applying the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SpO2 Safety Information SpO2 Safety Information Warning Always confirm Information Center observations with clinical observation of the patient before administering interventions. Warning 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.
SpO2 Safety Information Warning 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. Warning This equipment is not suitable for use in the presence of a flammable anesthetic mixture or oxygen concentrations greater than 25% (or partial pressures greater than 27,5 kPa /206.27 mmHg).
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.
Pulse Oximetry Measurement during a pulsation. Correct placement of the sensor is essential for accurate measurements (see “Applying the Sensor” on page 8-10). Note—Because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements can be expected to fall with ± Arms of the value measured by a CO-oximeter.
Selecting a SpO2 Sensor Selecting a SpO2 Sensor Warning Use only Philips-approved accessories. Use of product accessories (ECG leadsets, SpO2 sensors, etc.) other than those specified in this manual may: - lead to patient injury - result in increased electromagnetic emissions or decreased immunity of the product Warning Reuse: Never reuse disposable sensors, accessories and so forth that are intended for single use, or single patient use only.
Selecting a SpO2 Sensor Philips reusable sensors in adult, pediatric and infant models can be used, as well as Philips and Nellcor® disposable sensors. If you are using Nellcor® sensors, see the Directions for Use supplied with these sensors. 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.
Selecting a SpO2 Sensor The following table and chart will help you in selecting the correct sensor type. . Sensor Type When to Use 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.
Selecting a SpO2 Sensor To use the chart: 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.
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 Sensor Application • 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 restraints that are too tight). These result in venous pulsations and inaccurate measurement, and may severely obstruct circulation.
Applying the Sensor Follow the sensor’s instructions for use, adhering to all warnings and cautions. To apply the sensor, use the following directions. Step Action 1 Select the site and appropriate sensor (see “Selecting a SpO2 Sensor” on page 8-6). 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.
Applying the Sensor Small Adult/ Pediatric Finger 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. 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.
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 Adjust SpO2 alarms in the Patient Window (see “Telemetry Controls in the Patient Window” on page 9-2).
Measuring SpO2 Measuring SpO2 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. 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.
Measuring SpO2 Note—Spot Check measurements cannot be made when the transceiver is connected to TeleMon or the IntelliVue MP5 Patient Monitor, because only Continuous measurement is available with these devices. Step Action 1 Attach the sensor to the patient. 2 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).
Measuring SpO2 Step 3 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. 4 To discontinue SpO2 monitoring, uncheck the Enable SpO2 box at the Information Center. Note— If the sensor is removed without discontinuing SpO2 monitoring in the Telemetry Setup Window at the Information Center, an SpO2T 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 When Connected to the MP5 Mode when Transceiver is Disconnected Continuous Continuous 5-minute Continuous 1-minute Continuous Manual Spot Check When the transceiver is sourcing the display of patient data on an MP5 bedside monitor: • The SpO2 measurement mode is always Continuous.
Measuring SpO2 SpO2 Enable/ Disable at Information Center You can enable/disable SpO2 monitoring at the Information Center. See “Patient Configurable Settings in Telemetry Setup” on page 9-4. When SpO2 is enabled, the Patient Sector and Patient Window of the Information Center display a “T” next to the SpO2 numeric (for example, “SpO2T 90%”) to indicate that the measurement was made via telemetry.
Understanding SpO2 Alarms Understanding SpO2 Alarms Physiologic SpO2 alarms are 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 desaturation limit is set automatically at 10 below the Low Limit. The SpO2 high alarm limit can be set between 51 and 100% inclusive, in 1% increments.
Optimizing SpO2 Measurement Performance Arterial Blood Flow The 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 anemia Wavelength Absorption The measurement also depends on the absorption of particular light wavelengths by the oxyhemoglobin and reduced hemoglobin.
Optimizing SpO2 Measurement Performance 8-22 SpO2 Monitoring • 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.
This chapter describes the telemetry functions at the Information Center and IntelliVue Patient Monitor, as well as the differences in transceiver operation when connected to TeleMon. It includes the sections listed below. For additional information, consult the IntelliVue Information Center Instructions for Use and TeleMon Instructions for Use. • • Telemetry Functions at the Information Center . . . . . . . . . . . . . . . . . . 9-2 •Telemetry Controls in the Patient Window . . . . . . . . . . . . . . .
Telemetry Functions at the Information Center Telemetry Functions at the Information Center1 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.
Telemetry Functions at the Information Center To Initiate a Spot Check Measurement Move the cursor over the SpO2 label. Then click on the Spot Check icon. . Note—There is no audio feedback at the transceiver (pulse tone or successful/ failed measurement) when Spot Check is initiated at the Information Center. To Initiate Standby See instructions under “Standby Mode” on page 4-4.
Telemetry Functions at the Information Center To silence the sound Step 1 Action Press and hold the Check button for 6 seconds to turn off the sound. OR Remove the batteries. Viewing Device Location in the Patient Window (optional) You can see the location of a transceiver in the Patient Window. The Device Location information is identified in the Patient Window by a compass icon followed by the location name configured by your hospital for your system.
Telemetry Functions at the Information Center Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Telemetry Button Determine the Information Center response when Telemetry Button is pressed. Nurse Call - generate nurse call alarm Factory Default Nurse Call Record - generate a recording strip Nurse Call and Record generate nurse call alarm and recording strip None Telemetry Device: Volume Set the volume level for all adjustable sounds on the transceiver.
Telemetry Functions at the Information Center Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Factory Default SpO2 Enabled Enable/disable the SpO2 measurement at the Information Center or Telemon. enable enable SpO2 Mode Determine the transceiver SpO2 behavior. Spot Check - Provides manual measurements so the clinician can check as needed.
Telemetry Functions at the Information Center Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Factory Default Suppress SpO2 INOPs with NBP Enable/disable the SpO2 algorithm to suppress sending technical alarms from the transceiver during an NBP measurement 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.
Telemetry Functions at the Information Center Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Factory Default SpO2 Alarm Turn SpO2 alarms on/off at the Information Center. enable (on) enable Change current settings back to last saved clinical unit settings. (none) Unit Settings UnitConfigurable Settings disable (off) Unit Settings provide access to clinical configuration items that affect all patients on an Information Center.
Telemetry Functions at the Information Center Unit Settings - Telemetry Setup Control Function Settings Telemetry Button Determine the Information Center response when Telemetry Button is pressed. Nurse Call - generate nurse call alarm Factory Default Nurse Call Record - generate a recording strip Both - generate nurse call alarm and recording strip None Telemetry Device: Volume Set the volume level for all adjustable sounds on the transceiver.
Telemetry Functions at the Information Center Unit Settings - Telemetry Setup Control Function Settings Factory Default Suspend Duration Sets the alarm suspend duration time for each assigned device on the Information Center. 1, 2, or 3 minutes 2 minutes Battery Gauge on Information Center Display/disable a battery gauge for each assigned device on the Information Center.
Telemetry Functions at the Information Center Unit Settings - Telemetry Setup Control Function Settings SpO2 Mode Determine the transceiver SpO2 behavior. Spot Check - Provides manual measurements so the clinician can check as needed. Measurement initiated by plugging the SpO2 cable into the transceiver or by selecting Spot Check SpO2 icon in the Patient Window. No pulse or successful/failed measurement tones are generated when measurement is initiated at Information Center.
Telemetry Functions at the Information Center Unit Settings - Telemetry Setup Control Function Settings Factory 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.
Telemetry Functions at the Information Center Unit Settings - Telemetry Setup Control Function Settings Factory Default SpO2 Alarm Turn SpO2 alarms on/off at the Information Center. enable (on) enable SpO2 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 %).
Telemetry Functions at the Information Center Unit Settings - Telemetry Setup Factory Default Control Function Settings 5-wire EASI, ECG3 Set the unit default lead. I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6 III 5-wire EASI, ECG4 Set the unit default lead. I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6 V5 6-wire, ECG1 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R II 6-wire, ECG2 Set the unit default lead.
Telemetry Functions at the Information Center Unit Settings - Alarms Control Function Settings Factory Default Nonarrhythmia Yellow Alarms Set latched/non-latched status for SpO2, ST, and other nonarrhythmia yellow alarms. Latched Latched Leads Off Adjust the severity level of this technical alarm (INOP). Low Non-latched Low Medium High Replace Battery Adjust the severity level of this technical alarm (INOP).
Transceiver Operation when Connected to TeleMon Transceiver Operation when Connected to TeleMon When connected to TeleMon, the following differences in transceiver operation will be in effect. Important—The transceiver must have good batteries installed before being connected to TeleMon. Alarms • Alarm Suspend/Pause and Standby can be initiated only from TeleMon, not from the transceiver or the Information Center.
Transceiver Operation when Connected to TeleMon Battery • The transceiver battery status is not available. When the Check button is pressed, the battery gauge on the transceiver and at the Information Center indicates full power, regardless of actual battery strength. Defibrillation • In the event of patient defibrillation, it may take several seconds for the ECG trace to reappear on the screen. Telemetry Overview • If NBP is being monitored, NBP values will be displayed at the Overview window.
Transceiver Operation when Connected to TeleMon 9-18 Telemetry Functions at the Information Center & TeleMon
You can display measurement data from IntelliVue TRx and TRx+ Transceivers on IntelliVue Patient Monitors. The transceiver and the monitor must be assigned to the same patient; this is called "pairing". Once paired, the ECG source is automatically detected at the Information Center. Should you subsequently switch the ECG source between the two devices, the change is also automatically detected at the Information Center.
Pairing with a Direct Connection to the MP5 Patient Monitor Pairing with a Direct Connection to the MP5 Patient Monitor When the transceiver, assigned to a patient sector at the Information Center, uses an interface cable to connect to an MP5 Patient Monitor, the Information Center automatically pairs (if configured to do so) the two devices. Pairing using this method provides 4 ECG waves at the MP5, along with SpO2 measurements and a pleth wave.
Pairing at the Information Center Pairing at the Information Center You can pair an IntelliVue Patient Monitor (Release B.1 or higher) with the transceiver at the Information Center. The telemetry data automatically displays as a permanent overview session in the Telemetry Data Window on the IntelliVue Patient Monitor. At the Information Center, the telemetry data and any patient monitor data (e.g. NBP) are integrated in the patient sector.
Alarm Behavior with Telemetry Overview Alarm Suspend/ Pause When alarms are suspended/paused, the messages and types of alarms affected depend on where the suspend/pause was initiated. If alarms are suspended/ paused from....
Alarm Behavior with Telemetry Overview Warning If the remote Silence key in the Overview window is enabled for IntelliVue monitors connected to the Information Center, remote silencing for these beds may be enabled in other clinical units. Alarm Source Where Silenced Effect at Paired Bedside Effect at Information Center Bedside alarm Bedside Silence button Alarm is silenced Bedside alarm is silenced.
Alarm Behavior with Telemetry Overview Alarm Source Where Silenced Effect at Paired Bedside Effect at Information Center Bedside and/or Information telemetry alarm Center Bedside and/or Bedside and/or telemetry alarm telemetry alarm is silenced is silenced Bedside and/or Bedside telemetry alarm Silence button Bedside and/or Bedside and/or telemetry alarm telemetry alarm is silenced is silenced (if Global Silence is enabled at the Information Center) Note—If the transceiver is connected to TeleMon,
Paired Device Synchronized Alarm Settings Paired Device Synchronized Alarm Settings If the patient’s ECG is initially being measured with a patient monitor, and then the patient is connected to the transceiver for monitoring, the Information Center will use the patient monitor settings for the transceiver.
Paired Device Synchronized Alarm Settings 10-8 Pairing with IntelliVue Patient Monitors
All installation tasks are performed by Service personnel and are described in detail in the service documentation accompanying the system. This chapter provides procedures for maintaining the equipment after installation including 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 IntelliVue transceiver for any monitoring procedure on a patient if you identify features which demonstrate impaired functioning of the instrument.
Maintenance Re-assigning an Equipment Label The following instructions enable you to reassign an equipment label from a lost device to a replacement transceiver. Note—If the leadset is attached during this procedure, the label assignment will fail. Step 1 Action At the Information Center, clear the sector that the original Equipment Label was assigned to. (Patient Window -> Sector Setup -> Clear Sector -> OK).
Cleaning and Sterilization Step 8 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 starting with step 5. When the label assignment is complete, the assignment will be verified in the “Status” field. 9 Go back into Sector Setup, and select the Bed Label and Equipment Label, followed by OK.
Cleaning and Sterilization Cleaning the Transceiver Caution Use of abrasive cleaning materials, or disinfectants or cleaning agents not listed herein, on any part or component of the IntelliVue TRx or TRx+ transceiver may damage the components. The use of Sterrad® and Virex® is not supported. Caution When cleaning the TeleMon/Service port, do not use any stiff, rigid instruments, tools, or other devices to clean debris in the port, as such actions will damage the connector pins.
Cleaning and Sterilization EO Sterilization The transceiver can be subjected to EO sterilization four times per year for 2 years. Equipment must first be cleaned (see “Cleaning the Transceiver” on page 11-5) before this procedure is performed. 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.
Cleaning and Sterilization Use the following equipment and material to process the transceiver: 1. Ethylene Oxide gas (Allied Signal Oxyfume-2002™ or equivalent). 2. Gas sterilizer manufactured by American Sterilizer Company or other appropriate manufacturer.
Cleaning and Sterilization Step 9 Action Process the equipment to be processed as follows: Pressure: 11 +/- 1 psig (established in the preceding step). Time: 2-3 hours Temperature: 54.4 +/- 2.8oC (130 +/- 5oF) 10 Extract the gas mixture from the sterilizer as follows: Warning Comply 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 environmental regulations.
Cleaning and Sterilization Aeration Procedure Warning To 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 11-9.
Cleaning and Sterilization Test Procedure Caution You must perform this test each time you put a transceiver through the EO sterilization process. 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.
Cleaning and Sterilization Step 3 Action Test the transceiver: a. Put fresh batteries in the transceiver (without a leadset attached) 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 SpO2 sensor 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 6-29. “Using EASI Leads to Troubleshoot” on page 628. “Technical Alarms (INOPs)” on page 5-9. • SpO2 measurement “Optimizing SpO2 Measurement Performance” on page 8-20. “Technical Alarms (INOPs)” on page 5-9. • Batteries “Battery Information” on page 4-13. “Self Test” on page 4-11. • Nurse call Nurse Call may have been turned off for the patient.
Troubleshooting in the system message area on the Information Center where the affected wireless patient monitoring device(s) (transceiver, access point, access point controller, sync unit, or router) 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.
Troubleshooting 11-14 Maintenance, Cleaning & 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5 Battery Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8 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. Indications for Use Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Regulatory Information 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.
Regulatory Information System Classification The TRx4841A and TRx4851A Transceivers are FDA Class II devices. They have the following characteristics. Characteristic Definition Internally Powered Equipment The TRx4841Aand TRx4851A transceivers are internally powered devices.
Electromagnetic Compatibility AC Power Source The system is not intended for connection to the public mains as defined in CISPR11. Software Hazard Prevention Potential hazards arising from errors in the software program have been identified. Mitigations applied to reduce the associated risk of such hazards are included as part of the Risk Management, Clinical Evaluation, and Verification and Validation phases of the product’s development.
Electromagnetic Compatibility Warning The use of accessories, transducers and cables other than those specified in the product service and user documentation can result in increased electromagnetic emissions or decreased immunity of the product. Warning The product should not be used next to or stacked with other equipment. If you must stack the product, you must check that normal operation is possible in the necessary configuration before the product is used on patients.
Electromagnetic Compatibility Reducing Electromagnetic Interference The 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.
Battery Specifications Battery Specifications Battery Type Equipment Battery Type Battery Life Specification 2 fresh AA disposable alkaline batteries Note—The battery life specifications listed below are based on Duracell MN 1500 batteries. Battery life for other brands may differ.
Radio Specifications Radio Specifications TRx4841A Parameter Frequency Ranges Specification Bands: 1395-1400 MHz and 1427-1432 MHz Channel Spacing: 1.6 MHz RF Output Power 8 dBm +2/-3 dB (3.
Radio Specifications TRx4851A Parameter Frequency Range Specification ISM Band: 2400 - 2483.5 MHz Channel Spacing: 1.728 MHz RF Output Power FCC: 17 dBm +/- 1 dB (40 mW to 63 mW, nominal 50 mW), into antenna load @ nominal battery voltage ETSI: 12 dBm +/- 1 dB (13 mW to 20 mW, nominal 16 mW), into antenna load @ nominal battery voltage ARIB: 13.
Radio Specifications WMTS Channel Frequencies 1395 to 1400 MHz Band 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.
Physical Specifications 1427 to 1432 MHz Band Parameter Specification Lower band edge 1427 MHz Channel 4 1427.8979 MHz Channel 4a (*) 1430.2410 MHz Channel 5 (**) 1429.4972 MHz Channel 6 (**) 1431.0965 MHz Upper band edge 1432 MHz * Available in special geographic area only. ** Not available in special geographic areas. Physical Specifications ECG-only Transceiver Parameter 12-12 Specification Height 140 mm (5.6 in) Width 75 mm (3 in) Depth 28.5 mm (1.
Physical Specifications Parameter Weight • without batteries or leadset • with batteries only • with batteries and 3wire leadset Specification • <165 g (5.8 oz.) • • <210 g (7.4 oz) <284 g (10 oz.) 215 cm3 Volume ECG/SpO2 Transceiver Parameter Specification Height 140 mm (5.6 in) Width 88 mm (3.52 in) Depth 37 mm (1.48 in) Weight • without batteries or leadset • with batteries only • with batteries and 5wire leadset Volume • <205 g (7.2 oz.) • • <255 g (9.0 oz) <324 g (11.5 oz.
Environmental Specifications Environmental Specifications Parameter Temperature • Operating • Storage • 0 t 37 oC (32 to 99o F) • -40o C to 60o C (-40 to 140o F) without batteries Humidity • Operating • Storage • < 95% RH at 37o C (99o F) non-condensing • < 90% RH at 60o C (140o F) without batteries Altitude • Operating & Non-operating 12-14 Specification Safety Standards & Specifications 0 to 3,048 m (10,000 ft)
Measurement Specifications 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 = Va-i Channel #2 = Va-s Channel #3 = Ve-s Channel #1= II Channel #2 = III Channel #3 = Va Channel #4 = Vb Resolution 5 μV ECG Input Differential, defibrillator protected against 360 joules discharge into a 100 ohm load Inp
Measurement Specifications Parameter Specification Gain Accuracy +/- 5% at 25 oC (77 oF) Noise Referred to ECG Input AAMI: 30 μV Lead Wires 3, 5 or 6-wire leadset. 5-lead compatible with IntelliVue Patient Monitor, AAMI/IEC color codes Time 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).
Measurement Specifications SpO2 Parameter Specification SpO2 Measurement Range (Calibration and Display) 0 to 100% SpO2 Accuracy See table following. SpO2 Resolution 1% SpO2 Numerics Averaging 10 seconds Note—The update rate for the SpO2 pulse oximetry value and pulse rate is typically 1 second. This can be extended to a max. 60 s when NIBP is measured on the same limb, with a corresponding INOP message after a max. of 30 s, indicating that the displayed values are not current values.
Measurement Specifications Parameter Wavelength Range Specification 500 to 1000 nm Note—Information about wavelength range can be especially useful to clinicians (e.g., clinicians performing photodynamic therapy). 12-18 Pulse Rate Measurement (available only with Continuous SpO2) Range: 30 to 300 bpm Accuracy: +/- 2% Resolution: 1 bpm Display of SpO2 numerics SpO2 values are displayed as xxx % SpO2T to meet ISO/EN standard EN 865.
Measurement Specifications SpO2 Sensor Accuracy . Type Philips Reusable Sensors Description Model Number Accuracy% Arms (70-100% Range) Adult Finger M1191A 2.0 Adult Finger M1191AL 2.0 Adult Finger M1191ANL 2.0 Adult Finger* M1191T 3.0 Adult Finger M1196A 3.0 Adult Finger M1196T 3.0 Pediatric Finger M1192A 2.0 Pediatric Finger* M1192T 3.0 Pediatric Finger M1192AN 2.0 Adult/Pediatric Ear M1194A 3.0 Adult/Pediatric Ear M1194AN 3.
Measurement Specifications Type Philips Disposable Sensors 12-20 Description Model Number Accuracy% Arms (70-100% Range) Adult Finger M1901B 3.0 Pediatric Finger M1903B 3.0 Adult Finger M1904B 3.
Measurement Specifications Type Nellcor Disposable Sensors (not available from Philips) 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 10-50 kg (22110 lb) N/A 3.0 Oxisensor II D-20, Pediatric 10-50 kg (22110 lb) N/A 3.
Measurement Specifications 12-22 Safety Standards & Specifications
This appendix lists the accessories for use with the Transceiver. Accessories are subject to change. Some accessories are not supplied by Philips. To order accessories, visit the Philips Medical Supplies website located at the following web address: http://shop.medical.philips.com, or contact your local Philips representative.
Accessory Safety Accessory Safety Warning Use only Philips-approved accessories. Use of product accessories (ECG leadsets, SpO2 sensors, etc.) other than those specified in this manual may: - lead to patient injury - result in increased electromagnetic emissions or decreased immunity of the product Warning 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 Monitor Interface Cable Order Number Description 989803140431 Protective Cover for TeleMon/Service Port (ECGonly Transceiver), package of 10 989803140451 Protective Cover for TeleMon/Service Port (ECG/ SpO2Transceiver), package of 10 989803140441 Protective Cover for SpO2 Port (ECG/SpO2 Transceiver), package of 10 Order Number M1688A A Sales and Support Protective Covers Description Monitor Interface Cable for use with IntelliVue MP5 Patient Monitor ECG Accessories Electrodes O
ECG Accessories Leadsets Order Number A-4 Accessories Description 989803133831 AAMI 3-wire Leadset, Snap, 79 cm (30 ”) 989803133841 AAMI 3-wire Leadset, Grabber ,79 cm (30 ”) 989803133871 AAMI 5-wire Leadset, Snap, 79 cm (30 ”) 989803133881 AAMI 5-wire Leadset, Grabber, 79 cm (30 ”) 989803137241 AAMI 5-wire Color Leadset, Snap, 79 cm (30 ”) 989803137251 AAMI 5-wire Color Leadset, Grabber, 79 cm (30 ”) 989803133911 AAMI 6-wire Leadset, Snap, 79 cm (30 ”) 989803133921 AAMI 6-wire Leadset,
SpO2 Accessories Order Number Description 989803140401 Single ECG Alignment Guide, package of 10 989803140411 Single ECG Alignment Guide, tethered, package of 10 989803140421 Double ECG Alignment Guide, package of 10 Order Number Description 989803134771 Skin Preparation Sheets, 10 preps/sheet, package of 10 sheets A Sales and Support Alignment Guides Skin Prep Paper SpO2 Accessories Reusable Sensors Order Number Description M1191A Philips Adult Finger Sensor, 2 m (6.
SpO2 Accessories Order Number A-6 Accessories Description M1192T Philips Pediatric Finger Sensor, 0.45 m (1.5 feet) M1194A Philips Adult & Pediatric Ear Sensor, 1.5 m (4.9 feet) M1194AN Philips Adult & Pediatric Ear Sensor, 1.5 m (4.9 feet) M1196A Philips Adult Finger Clip Sensor (8-pin), 3 m (9.8 feet) M1196T Philips Adult Finger Clip Sensor (9-pin), 0.90 m (2.
SpO2 Accessories Note—OxiCliq, OxiMax and Oxisensor II sensors are not available from Philips in the USA or Canada. In those countries, contact Nellcor Incorporated directly.
SpO2 Accessories Wristband Order Number M1627A A-8 Accessories Description Wristband, package of 10
Please call your local Philips Medical Systems sales office listed in your telephone directory or a Philips Medical Systems regional office listed below for the location of your nearest sales office. On the web www.medical.philips.com Via email medical@philips.com By fax +31 40 27 64 887 By postal service Philips Medical Systems Global Information Center P.O.
B-2 Sales and Support Offices
Index D A alarms behavior with paired bedsides, indicators, 5-2 physiologic, 5-5 SpO2, 8-20 technical, 5-9 testing indicators, 5-2 testing, 11-2 audible tones definitions, 3-10 start-up, 4-3 turn off, 9-9 auditory information signals see audible tones, 3-10 B battery inserting, removing, life, 4-16, 12-8 safety, 2-5, 4-12 storing, 4-15 type, 4-13 4-13 C configuration group settings, 11-12 label assignment, 11-2 Telemetry Setup, 9-4 unit settings, 9-8 controls buttons, 3-3 indicators, 3-4 labels,back,
transceiver supplies, P A-2 paired bedsides alarm behavior 10-3 patient window, 9-2 pause alarms, 5-2 pleth wave display on/off, 9-7, 9-12 pouch, 4-7 pulse rate display on/off, 9-7, 9-12 pulse tone on/off, 3-12, 9-5 R RF auto shutoff 9-10, RF interference, 6-30 9-16 S safety battery, 2-5, 4-12 ECG, 2-6 general, 2-2 paced, 2-11, 7-4 SpO2 sensor, 8-10 SpO2, 2-11, 8-2 ST/AR, 2-8, 7-2 symbols, 3-8 transceiver, 4-2 self-test alarm indicators, 5-2 sensors applying, 8-10 optimizing use, 8-20 selecting, 8-8
troubleshooting 6-31 TRx (ECG-only) see transceiver models, TRx+ (ECG + SpO2) see transceiver models, U unit settings, V 1-2 1-2 9-8 volume, 9-5 Index-3
Index-4
