op y ft C D ra IntelliVue MX40 Instructions for Use
Notice Proprietary Information This document contains proprietary information, which is protected by copyright. Copyright Copyright © 2011 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.
FCC This device complies with Part 15 and/or Part 95 of the FCC Rules. Operation is subject to the following two conditions: (1) these devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation.
Cautions Caution A Caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. Notes D ra ft C op y A Note contains additional information on the product's usage.
Contents 1. Introducing the IntelliVue MX40 1-1 MX40 Features-------------------------------------------------------------------------- 1-2 MX40 Models ---------------------------------------------------------------------------- 1-3 MX40 Compatibility -------------------------------------------------------------------- 1-4 2.
Pausing or Switching Off Alarms----------------------------------------------- 4-6 Alarm Limits ------------------------------------------------------------------------- 4-7 Reviewing Alarms ------------------------------------------------------------------ 4-8 Latching Alarms -------------------------------------------------------------------- 4-8 Alarm Latching Behavior --------------------------------------------------------- 4-9 Alarm Behavior at Power On-------------------------------------------------
EASI ST Analysis ----------------------------------------------------------------- 5-34 Turning ST Monitoring On/Off ------------------------------------------------- 5-34 QT Interval Monitoring --------------------------------------------------------------- 5-35 Intended Use ----------------------------------------------------------------------- 5-36 How the QT Analysis Algorithm Works ------------------------------------- 5-36 6.
12.
Pouches ------------------------------------------------------------------------------ A-2 Miscellaneous----------------------------------------------------------------------- A-2 ECG Accessories----------------------------------------------------------------------- A-3 Electrodes --------------------------------------------------------------------------- A-3 Leadsets and Patient Cables --------------------------------------------------- A-3 SpO2 Accessories -------------------------------------------------
op y ft C D ra Contents - 6
1. Introducing the IntelliVue MX40 This section introduces the IntelliVue MX40 wearable monitor. MX40 Features ........................................................................................... 1-2 MX40 Models ............................................................................................. 1-3 D ra ft C op y MX40 Compatibility ..................................................................................
MX40 Features Easy for clinicians to use and comfortable for patients to wear. 2.8" color, touch sensitive display. Smart, multi-measurement cable system available for use with reusable and single-patient use supplies. FAST SpO2 (continuous, or manual measurement). EASI or standard ECG selectable in one device. 6-lead with two V-leads for diagnosing multiple cardiac abnormalities, including wide-QRS complex tachycardias and acute myocardial ischemia/infarction. op y Local measurement trend/alarm history.
MX40 Models D ra ft C op y The MX40 is available in three models (ECG only, ECG and FAST SpO2, or ECG and SpO2 Ready (for future upgrade).
MX40 Compatibility The MX40 is compatible for use with IntelliVue Information Center Release N. Limited compatibility is offered when used with IntelliVue Information Center Release L or M. See the "Operating with Release L or M" chapter for more information. The MX40 is compatible for use with IntelliVue Patient Monitors Release G or later when wirelessly connected. The MX40 is compatible for use with IntelliVue Cableless Measurements Release A.1.
2. Product Safety This section consolidates the general safety warnings associated with the IntelliVue MX40. These warnings are repeated throughout the book in context where relevant. Safety symbols and other markings on the MX40 are also described here. General Safety ............................................................................................ 2-2 D ra ft C op y Safety Symbols & Other Marks ...............................................................
General Safety Warnings The IntelliVue MX40 should not be used for primary monitoring in applications where the momentary loss of the ECG is unacceptable at the Information Center. 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. Do not touch the patient, or table, or instruments, during defibrillation. The battery door must be closed during defibrillation.
If the MX40 enters a continuous "boot-up" cycle, or the main display does not appear or update, remove the device from service and contact your service personnel. Place the MX40 in a pouch or over clothing, or both, during patient use. The device should not touch the patient’s skin during use. Patients should be instructed not to open the battery compartment while the MX40 is in use.
Safety Symbols & Other Marks The table below describes the safety symbols and other markings present on the MX40 and the lithium-ion battery.
Label Definition Prescription Device Canadian and American standards compliance Complies with applicable Canadian and American safety standards. Defibrillation Proof op y Patient connections are protected against defibrillation (DEFIBRILLATION-PROOF) and are a TYPE CF APPLIED PART. Product Number D ra ft C Serial Number Used to identify the equipment during a call to the Philips Healthcare (Service).
Label Definition Service Identification Number Used to identify the equipment during a call to the Philips Healthcare (Service). D ra ft C op y Attention! See Instructions for Use.
3. Basic Operation This section gives you an overview of the IntelliVue MX40 and its functions. It tells you how to perform tasks that are common to all measurements, such as turning a measurement on and off, adjusting wave size and information in preparation for use. op y Familiarize yourself with all instructions including warnings and cautions before starting to monitor patients. Read and keep the Instructions for Use that come with any accessories as these contain additional important information.
Controls, Indicators and Connectors This section describes the clinical controls of the IntelliVue MX40. These controls include buttons, display icons, visual and auditory indicators, ports, and safety labeling located on the front and back of the device. MX40 Controls and Indicators 1. Patient Cable 2. Patient Information Area op y 3. Active Alarms Area 4. INOP Area 5. Measurement Area 1 6. Measurement Area 2 D ra ft C 7. Waveform 1 3-2 Basic Operation 8. Waveform 2 9.
Multi-Function Button Button Function Depending on configuration at the Information Center: generates a Nurse Call; Initiates a Delayed Recording; Both, or; None Note — the Multi-Function Button does not operate Silence Alarm Button Button op y when paired with an IntelliVue Patient Monitor via the short-range radio connection. Function ft C Initiates a local silence/acknowledgment of all active alarms when enabled. Silences the "Find Device" sound.
Main Screen Button Button Function Activates the Touch Display if touched for two seconds. Cycles through the display screens if touched repeatedly. Resumes from Standby. SmartKeys op y The following table lists the SmartKeys available on the display of the MX40. Note—gray text on a SmartKey signifies that the item is unavailable. SmartKey Function Start SpO2 Starts a manual SpO2 measurement. ft C Note — This D ra SmartKey is unavailable when SpO2 mode is continuous.
Function Standby Puts the device into standby locally and at the Information Center. Displays purchased/enabled product options. Add/Remove Displays available monitors and IntelliVue Cableless Measurements to assign to via the short-range radio. Print Reports Prints the pre-configured report as designated at the Information Center. Vitals Trends (Optional) View up to 24 hours of tabular trend data. Screen Setup Determines time period that the display remains active after user interaction.
Patient Information Area Touching the Patient Information Area displays the following information: Bed Label Patient Name (up to 15 characters will display) Paced Status (see Paced Status below) Time Gender/Type (Male/Female and Adult/Pediatric) op y MRN (Lifetime ID, Encounter ID) Note — If you use an alternative ID, it will display at the Information Center and on printed reports. It will not display at the MX40. 1. Pacing algorithm is on. 2. Pacing algorithm is off.
Operating and Navigating The principle method of operating your MX40 is via the Touch Display. Almost every element on the is interactive. Display elements include measurement numerics, information fields, alarm fields, waveforms, SmartKeys and menus. Power-On Self Test op y Once battery power is supplied, the MX40 performs a power-on self test to check operational status prior to start-up.
Selecting Display Elements Touch a display element to get to the actions linked to that element. For example, touch the Patient Information element to call up the Patient Info window, or touch the HR numeric to call up the Setup ECG menu. Touch the ECG waveform to call up the wave selection menu. Locking the Display op y To provide additional protection against accidental patient access to the MX40, the display can be locked using the Lock SmartKey.
Portrait - Viewable Chest Diagram and two Numerics Connecting/Disconnecting the Patient Cable ft C op y The patient cable is connected to the MX40 as shown in the illustration below. When connecting to the MX40, there is a slight clicking sound that signifies the the cable is securely connected. D ra Disconnect the patient cable as shown below. Caution Never disconnect the patient cable by pulling on the leadwires, as this may damage wires over time.
Understanding Settings Each aspect of how the MX40 works and looks is defined by a setting. There are a number of different categories of settings, including: Screen Settings - to define the selection and appearance of elements on each individual display screen. Measurement Settings - to define setting unique to each measurement, e.g. high and low alarm limits. Monitor Settings -including settings that affect more than one measurement or display screen, for example alarm volume and alarm pause time.
Description ECG Set ECG On/Off New Lead Setup When IntelliVue Patient Monitor lead sets are in use, selects 3-wire, or 5-wire. Va Lead Shows position of Va, Vb or C1, C2 electrodes. Choices are V1-V9, v3R, V4R, V5R. Vb Lead Shows position of Va, Vb or C1, C2 electrodes. Choices are V1-V9, v3R, V4R, V5R. Change Numeric Selects parameter numeric to display in place of current HR numeric.
Battery Information Battery Safety Information Warnings The battery compartment door must be closed during defibrillation. Use the Philips Rechargeable Lithium-ion Battery or 3 Duracell Alkaline batteries, size AA, MN 1500, 1.5V, to ensure specified performance and correct battery gauge reporting. Outdated, mismatched, or poor-quality batteries can give unacceptable performance (e.g., insufficient Battery-Low warning time).
Lithium-ion Rechargeable Battery Care Care of the rechargeable battery begins when you receive a new battery for use and continues throughout the life of the battery. The table below lists battery care activities and when they should be performed. When to Perform Perform a visual inspection. Before inserting a battery in the MX40. Charge the battery. Upon receipt, after use, or if a low battery state is indicated.
If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not: discontinue use. dispose of the battery in accordance with the disposal instructions. Lithium-ion Rechargeable Battery Storage When storing rechargeable batteries, make sure that the battery terminals do not come into contact with metallic objects or other conductive materials.
The battery compartment is located on the back of the MX40, accessible by opening the compartment door from the bottom. It accommodates three AA 1.5V Alkaline batteries or the Philips Rechargeable Lithium-ion battery. Only these batteries should be used. Note— Lithium-ion batteries should be fully charged prior to first use. Important— Do not use other rechargeable batteries.
If using the rechargeable lithium-ion battery, remove the AA battery tray if present. 5 Insert the battery pack so that the raised tab is aligned with the cutout in the base of the battery compartment. Close the battery compartment door. D ra ft C op y 4 6 Watch for the start-up screen on the front of the MX40 to illuminate briefly. Removing the Batteries Batteries should be removed when the MX40 is not in use or is being stored.
If you remove good AA batteries to turn off the MX40, keep them together as a set for later re-use so that all batteries will have the same level of power remaining. Important— Do not "store" disposable AA batteries by leaving them in the incorrect polarity position in the MX40. Be careful not to short circuit the batteries. Batteries can get hot when shorted. Short circuits are caused when a piece of metal touches both the positive and negative terminals simultaneously.
Approximate Time Remaining (ECG only) Approximate Time Remaining (ECG & Spo2 Continuous) Functionality Battery Indicator Disabled LCD Segments Low battery < 30 minutes level to replace/charg e battery level < 30 minutes SpO2 and short-range radio are disabled.
Pouch Use The MX40 is not intended for direct contact with the patient’s skin. During normal use, the MX40 should be worn over clothing, in a pocket or, preferably, in a pouch. The Waterproof Carry Pouch with clear front is an appropriate means for holding the MX40. See Appendix A, "Accessories" for ordering information. Securing the Pouch See the Carry Pouch, Waterproof, Instructions for Use, P/N 453564267571, for more information.
Seal the pouch. 4 Secure the pouch on the patient with the ties around the patient’s shoulder and under the arm. D ra ft C op y 3 5 Check that the patient is comfortable wearing the pouch with the MX40. Warning To avoid the risk of strangulation, do not tie a pouch solely around the patient’s neck.
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. Caution Because the touchscreen display is sensitive to water impact, the display should be locked when showering. op y The MX40 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.
Accidental Liquid Exposure D ra ft C op y If the MX40 is accidentally immersed in liquid, no damage to the device and no electrical safety issues for the patient will result. Remove the device, dry it off, and follow the procedure for cleaning/sterilization under "Cleaning and Sterilization" as needed.
Telemetry Mode Use D ra ft C op y To minimize patient disruption, the MX40 operates in Telemetry Mode when connected to the Information Center. In Telemetry Mode, the local volume is set to zero and the display is off. You can activate the display at any time by touching the Main Screen button for two seconds. All active alarms can be viewed when the display is on. Regardless of the display status, all measurement data is being sent to the Information Center.
Monitoring Mode Use You may find the use of Monitoring Mode helpful when spending extended time directly with your patient, e.g. during transport, showering, dressing change. The display is always on for easy viewing and should an alarm condition occur, it will be announced locally at the MX40 and at the Information Center if networked connected. If the MX40 is not network connected, the alarm is only announced locally. To use Monitor Mode: Press the SmartKeys Button.
Briefing the Patient Warning Patients should be instructed not to interact with the with display of the device and to not open the battery compartment while the MX40 is in use. Note — Pausing alarms at the Information Center activates the MX40 display. Patients should be notified that this is normal operation and not cause for any concern.
op y ft C D ra 3-26 Basic Operation
4. Alarms The section provides alarm information that applies to all measurements. Measurement-specific alarm information is discussed in the sections on individual measurements. Alarms Overview ...................................................................................... 4-2 Physiologic Alarms ................................................................................. 4-10 D ra ft C op y Technical Alarms (INOPs) .....................................................................
Alarms Overview The MX40 has two different types of alarms: physiological alarms and INOPs. For MX40 devices operating with IntelliVue Information Center Release L and M, physiological alarms are not available locally on the MX40. INOPs are displayed as described here. For MX40 devices operating with IntelliVue Information Center Release N, physiological alarms are available locally on the MX40 when network connected to the Information Center, and as configured by the Information Center.
The MX40 is designed to achieve visual alarm notification at a distance of up to one meter, which is consistent with its intended use model as a wearable monitor. Alarms are indicated after the alarm delay time. This is made up of the system delay time plus the trigger delay time for the individual measurement. For more information see ECG Performance Disclosure/Specifications p. 13-22 . If more than one alarm is active, the highest priority alarm is shown.
Alarm Indicator An Alarm Indicator on the MX40 main display communicates alarm/INOP conditions that have not been acknowledged. The alarm indicator is divided into two sections and appears in the upper right hand corner normally occupied by the time display. The right section flashes for a physiological alarm, except for short yellow alarms where the indicator will light for approximately six seconds. The color is yellow or red corresponding to the highest priority alarm currently present.
Audible Alarm Indicators when in Monitoring Mode The audible alarm indicators configured for your monitor depend on which alarm standard applies in your hospital. Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). Warning op y Do not rely exclusively on the audible alarm system for patient monitoring.
Acknowledging Alarms To acknowledge all active alarms and INOPs, touch the Silence Alarm button. This switches off the audible alarm indicators, if present, and alarm messages. A check mark beside the alarm message indicates that the alarm has been acknowledged . If the condition that triggered the alarm is still present after the alarm has been acknowledged, the alarm message stays on the screen with a check mark symbol beside it, except for NBP alarms and alarms from other intermittent measurements.
No alarms are sounded and no alarm messages are shown. INOP messages are shown but no INOP tones are sounded. The only exceptions are the INOPs CUFF NOT DEFLATED, NBP CUFF OVERPRESS and INOPs relating to empty, missing and malfunctioning batteries. These INOPs switch the alarms on, and the INOP tones are sounded, even if alarms are paused or off. You need to remove the INOP condition first before you can switch the alarm tones off again.
Changing Alarm Limits To change individual measurement alarm limits using the measurement's Setup Menu: 1 In the measurement's setup menu, select the alarm limit you want to change. This calls up a list of available values for the alarm limit. 2 Select a value from the list to adjust the alarm limit. Reviewing Alarms You can see which alarms and INOPs are currently active in the respective alarms and INOPs fields at the top of the screen.
Alarm Latching Behavior Red & Yellow Measurement Alarms Alarm has not been acknowledged. Visual and Audible Latching Alarm condition still Alarm tone on. Alarm Alarm tone on. message. Flashing Alarm message. present. numerics. Flashing numerics. Alarm condition no longer present. All audible and visual Alarm tone on. alarm indicators Alarm message . automatically stop. Flashing numerics. Alarm condition still Alarm tone off. Alarm message with check present. mark. Flashing numerics.
Physiologic Alarms Physiologic alarms indicate a life-threatening situation or a less urgent situation such as heart rate beyond limits. Warning Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.
Priority Condition *** TACHY yyy > xxx Red Extreme Tachycardia. ST/AR Heart Rate (yyy) greater than Extreme Basic & Enhanced Tachy limit Arrhythmia *** V-FIB/TACH Red Ventricular Fibrillation. Fibrillatory wave (sinusoidal wave between 2-10 Hz) for 4 consecutive seconds ST/AR Basic & Enhanced Arrhythmia *** V-TACH Red Ventricular Tachycardia.
Alarm Text Priority Condition Source * MULTIFORM PVCs Yellow The occurrence of two differently shaped Vs, each occurring at least twice within the last 300 beats as well as each occurring at least once within the last 60 beats. ST/AR Enhanced A run of Vs having a ventricular Heart Rate greater than V-Tach limit but lasting for less than the V-Tach Run limit. ST/AR Enhanced * NON-SUSTAIN VT Yellow Yellow The patient has pressed the Multi-Function Button on the MX40.
Alarm Text Priority Condition Source * SVT Yellow Run of SVPBs greater than or equal to SVT Run limit and with SVT Heart Rate greater than the SVT Heart Rate limit. ST/AR Enhanced Arrhythmia * VENT BIGEMINY Yellow A dominant rhythm of N, V, N, V (where N= supraventricular beat, V=ventricular beat). ST/AR Enhanced A dominant rhythm of adjacent Vs greater than Vent Rhythm limit and ventricular Heart Rate less than V-Tach limit.
Technical Alarms (INOPs) Technical Alarms, or INOPs (inoperative conditions), are sourced at the MX40, the ST/AR algorithm running at the Information Center, or the IntelliVue Patient 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 alarm generation are disabled. Visual alarm indicator on the MX40.
Alarm Text Priority Condition What to do CANNOT ANALYZE ECG Hard Arrhythmia algorithm cannot reliably analyze the ECG data on any monitored leads. Assess the lead selections, initiate relearn, and validate analyzed rhythm. Check other INOPs for possible source of problem. CHECK ECG SETTINGS Hard Synchronization of ECG settings between the monitor and the Information Center has failed. Check that the ECG settings from the ECG source are appropriate.
Alarm Text Priority Condition cl NBP DISCONNECT Hard CL NBP Pod is not connected with the MX40. Source - Cableless Measurement Device cl SpO2 Batt Low What to do Resolve interference condition. Reduce range between CL NBP Pod and MX40. Hard CL SpO2 Pod weak battery condition. Charge battery. Severe CL SpO2 Pod empty battery condition. Charge battery. Monitoring is not possible. Hard CL SpO2 Pod is not connected with the MX40.
Alarm Text Priority LEADSET UNPLUGGED Hard Source - MX40 LOCAL AUDIO OFF Soft Source - MX40 Condition What to do Leadset has been unplugged from the MX40. Re-attach the ECG leadset. There is no alarm audio notification when operating in Telemetry Mode. Change to Monitor Mode. Note — This is normal operation in Telemetry Mode.
Alarm Text Priority NO SIGNAL (appears at the Information Center only) Hard, Latched Condition The MX40 is outside the coverage area, or No batteries in the MX40, or Source - Information Center The MX40 has failed. Source - MX40 Note — This INOP may Dead battery. No monitoring is occurring. Replace the MX40 if Power On Self Test fails. Put bed in Standby. Replace batteries.
Alarm Text Priority Condition %SpO2T INTERFERENCE Hard Level of ambient light Reduce ambient light to or level of electrical sensor or electrical noise interference are so sources. high that the SpO2 sensor cannot measure SpO2 and pulse rate. Soft Accuracy may be reduced due to low perfusion. Data displayed with ?. Increase perfusion. Change sensor site. Avoid site distal to BP cuff or intra-arterial line. Warm the site. Hard No sensor attached to SpO2 device Attach SpO2 sensor.
Alarm Text Priority Condition What to do TELE BATT EMPTY Hard, Latched Lithium-ion battery level is critically low. A 10-minute countdown begins. The MX40 will shutdown if the condition is not cleared. Insert a charged lithium-ion battery pack. Note — This INOP may also be configured to display as a Red or Yellow Technical Alarm. Source - MX40 Note — For Information Center Release L or M, this INOP will appear as "REPLACE BATTERY T". TELE BATTERY TEMP Hard Replace the lithium-ion battery.
Alarm Text Priority Condition What to do TELE REMOVE BATT Hard, Latched The temperature of the lithium-ion battery is o >60 C and the battery must be removed. Replace the lithium-ion battery. Source - Monitor Note — For Information Center Release L or M, this INOP will appear as "REPLACE BATTERY T". Hard The lithium-ion battery has exceeded the maximum charge cycle limit. Soft Patient is at outer range of the radio coverage area.
op y ft C D ra 4-22 Alarms
5. ECG and Arrhythmia Monitoring This section covers the specifics of ECG measurement and the ST/AR Arrhythmia, ST, and QT algorithms used for arrhythmia monitoring. ECG Safety Information ........................................................................... 5-2 op y Measuring ECG ......................................................................................... 5-5 Connecting and Positioning ECG Electrodes ........................................
ECG Safety Information Warnings Always confirm MX40 and Information Center observations with clinical observation of the patient before administering interventions. To avoid patient injury, assure that the patient cable is not positioned where leads could become entangled around the patient, or cause choking, strangulation, or inhibit circulation in extremities. Every lead must be secured to an electrode on the patient. Conductive parts of electrodes must not contact earth or other conductive parts.
Note— When switching from EASI to standard monitoring, there is a momentary loss of data. For Paced Patients Warnings The output power of the MX40 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.
D ra ft C op y Note— During defibrillation, monitoring may be temporarily interrupted or distorted. It may take several seconds for the ECG trace to reappear on the screen. After defibrillation, the device will continue to monitor as before; the device settings will not be affected.
Measuring ECG The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the MX40 and the Information Center as a waveform and a numeric. In order to compare measured ECG signals, the electrodes (or patient cables) are placed in standardized positions, forming "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.
Connecting and Positioning ECG Electrodes Correct lead placement is always important for accurate diagnosis. Especially in the precordial leads, which are close the heart, QRS morphology can be greatly altered if an electrode is moved away from its correct location. Each electrode is color-coded. Use the placement diagrams available on the display of the MX40 and in this section for guidance. Additional lead placement information is available in the Online Help at the IntelliVue Information Center.
Selecting the Primary and Secondary ECG Leads The MX40 uses the primary and secondary lead selected at the Information Center to compute HR and to analyze and detect cardiac arrhythmias. They are also available for recordings and for display on the Information Center. The secondary lead is used if your device is configured for multi-lead (instead of single-lead) arrhythmia analysis.
Checking Paced Status It is important to set the paced status correctly when you start monitoring ECG. When Paced is set to Yes: Pacer Algorithm is switched on. This means that pacemaker pulses are not counted as extra QRS complexes. The pacer spikes are shown in white. The paced symbol is displayed. op y When Paced is set to No and your patient has a pacemaker, pace pulses may be counted as regular QRS complexes, which could prevent an asystole event from being detected.
Understanding the ECG Display op y Your display may be configured to look slightly different. 1. Lead label of the displayed wave 4. Current heart rate 2. 1 mV calibration bar 5. Current heart rate alarm limits 3. Pacer spikes 6. EASI lead placement label (located here when active) ft C ECG HR numeric: This is the heart rate derived from the monitored ECG. D ra Pacer Spikes: The pacer spikes are shown in white.
Monitoring Paced Patients An ECG optimized for monitoring a paced patient should look like this: 1. Normal Beats 2. Pace Pulses/Beats You should choose a lead as primary or secondary lead that has these characteristics: op y the normal QRS complex should be either completely above or below the baseline and it should not be biphasic. For paced patients, the QRS complexes should be at least twice the height of pace pulses.
Changing the Size of the ECG Wave If any of the displayed ECG waves is too small or clipped, you can change the size of the ECG waves on the screen. Changing the adjustment factor only changes the visual appearance of the ECG wave on the MX40. It does not affect the ECG signal analyzed by the algorithm. Comparing the wave size to the 1 mV calibration bar on the ECG wave segment can help you to get an idea of the true ECG signal strength.
Selecting Positions of Va and Vb Chest Leads D ra ft C op y The two chest leads for the 6-lead placement can be positioned at any two of the V1 to V9 and V3R, V4R and V5R positions. Select the positions you have used in the Patient Window at the Information Center, so that the chest leads will be correctly labeled.
Choosing EASI or Standard Lead Placement Choose either standard lead placement or EASI lead placement: 1 In the Setup ECG menu, select Lead Placement to toggle between Standard or EASI. 2 Select Standard or EASI. Note — When changing lead placement, the patient cable must be attached to the MX40. EASI is shown beside the 1 mV calibration bar on the ECG wave on the display, and EASI is marked on any recorder strips and printouts.
ECG Configuration The MX40 supports 3-, 5-, and 6-wire patient cables. The 5-wire patient cable can be used for either standard or EASI electrode configurations. The MX40 detects the patient cable type attached and automatically determines the ECG measurement and transmitted leads. Note—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.
ECG Leads Monitored Depending on the patient cable connected to the MX40, a different set of viewable leads are available at the MX40 and the Information Center. The MX40 can source up to four raw ECG waves to the Information Center. If you are using ... these leads can be selected at the MX40 and the Information Center 3-wire I, II, III Sourced (raw) waves are received as: Channel 1 = I, II, or III Default is II.
If you are using ... 6-wire these leads can be selected at the MX40 and 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. op y The two chest leads, Va and Vb, can be placed on the patient in any of the V lead positions (V1 through V9, V3R, V4R, V5R). Lead assignment is available at the Information Center.
Reconstructed Leads Reconstruction of leads from the sourced wave is defined by the calculations in the following table.
3-Wire Placement 1. RA - directly below the clavicle and near the right shoulder 2. LA -directly below the clavicle and near the left shoulder D ra ft C op y 3.
5-Wire Placement (Standard Mode) 1. RA directly below the clavicle and near the right shoulder 2. LA directly below the clavicle and near the left shoulder 3. RL on the left lower abdomen 4. LL on the right lower abdomen op y 5. 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.
5-Wire Placement (EASI Mode) 1. E (V) on the lower sternum at the level of the fifth intercostal space 2. A (LL) on the left midaxillary line at the same level as the E electrode 3. S (LA) on the upper sternum 4. I (RA) on the right midaxillary line at the same level as the E electrode ft C op y 5.
6-Wire Placement 6-lead placement uses the same positions from as the 5-lead standard placement described above , along with two precordial leads - referred to 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. D ra ft C op y The lead placement for the Va and Vb lead labels must be appropriate.
Chest Electrode 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 op y V3R-V6R on the right side of the chest in positions corresponding to those on the
Monitoring during Leads Off ECG Fallback and Extended monitoring states are supported for the MX40 when the primary and/or secondary leads are in a "Leads Off" INOP condition. Both of these states are entered into after 10 seconds of "Leads Off" in an attempt to maintain monitoring and arrhythmia analysis. ECG Fallback ECG Fallback occurs when the primary lead is in "Leads Off" for 10 seconds and a secondary lead is available.
Ensure that the arrhythmia algorithm is labeling beats correctly.
ST/AR Arrhythmia Monitoring ST/AR Arrhythmia Algorithm Indications for Use The ST/AR Arrhythmia Algorithm is indicated for use in instances where the clinician decides to monitor cardiac arrhythmias of adult and pediatric patients and/or the ST segment of adult patients to gain information for treatment, monitor the adequacy of treatment, or to exclude causes of symptoms. How the ST/AR Algorithm Works op y ST/AR multi-lead analysis is performed on the user-selected primary and secondary leads.
Aberrantly-Conducted Beats As P-waves are not analyzed, it is difficult and sometimes impossible for the monitor to distinguish between an aberrantly-conducted supraventricular beat and a ventricular beat. If the aberrant beat resembles a ventricular beat, it is classified as ventricular. You should always select a lead where the aberrantly-conducted beats have an R-wave that is as narrow as possible to minimize incorrect calls. Ventricular beats should look different from these 'normal beats'.
Alarms with Basic Arrhythmia Option Additional Alarms with Enhanced Arrhythmia Option ***Ventricular Tachycardia **Irregular HR **High heart rate **Ventricular Rhythm **Low heart rate **Run PVCs High **Pacer Not Capture (if Pacing set to Yes) **Pair PVCs **Pacer Not Pacing (If Pacing set to Yes) **R-on-T PVCs **PVCs/min HIGH (PVC > limit/min) **Ventricular bigeminy **Ventricular trigeminy op y **Non-sustain VT **Multiform PVCs ft C Using ECG Alarms D ra ECG alarms can be switched on and o
Arrhythmia Alarm Settings Some arrhythmia alarms can be turned off at the Information Center. They are: Non-Sustain, Vent Rhythm, Run PVCs, Pair PVCs, R-On-T PVCs, V.Bigeminy, V.Trigeminy, Multif.PVCs, Pause, SVT, Irregular HR, Missed Beat, PVCs/min and Afib. It is also possible to turn all yellow arrhythmia alarms off at the Information Center.
To return to the normal ECG primary lead display: 1 Select Annotate Arrhy. 2 Change to Off. 3 Exit from the Setup ECG menu. Arrhythmia Beat Labels Arrhythmia beat labels tell you how the monitor is classifying beats.
Asystole, Vfib, and HR alarms (when there are enough beats to compute the HR) are active. All other alarms are not active. Single Lead Analysis If single lead analysis is selected, the arrhythmia system begins alearning whenever: ECG monitoring is initiated. The Relearn key is activated (see Initiating Arrhythmia Relearning Manually p. 5-31). The ECG Lead or Lead Label is changed manually, or when Fallback occurs (see ECG Fallback p. 5-23).
EASI ECG Monitoring Whenever there is an INOP condition, the arrhythmia algorithm performs a Relearn, using the available lead. Warning Since Relearn happens automatically, if learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent events of V-Tach and V-Fib. For this reason, you should: Respond to the INOP message (for example, re-connect the electrode(s).
ST/AR ST Analysis Algorithm Intended Use The intended use of the ST/AR ST Analysis algorithm is to monitor an adult patient’s ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST Analysis algorithm is capable of monitoring paced and non-paced adult patients. Note—The ST Analysis algorithm does not analyze ventricularly paced or ventricular ectopic beats.
The Measurement ft C op y The ST measurement for each beat complex is the vertical difference between two measurement points. The isoelectric point provides the baseline for the measurement and the ST point provides the other measurement point. It is positioned with reference to the J-point. Algorithm Processing D ra 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.
Displayed ST Data ST data displays as values in the Patient Sector and Patient Window at the Information Center. 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. Note — ST data and alarms are not displayed at the MX40.
QT Interval Monitoring Of special concern for QT monitoring is the administration of QT prolonging drugs to patients identified with risk factors for Torsade de Pointe. Females, older patients and patients with bradycardia, impaired left ventricular function (ischemia, left ventricular hypertrophy), hypokalemia and hypomagnesemia are in this increased risk category. D ra ft C op y QT interval monitoring can assist in the detection of prolonged QT interval syndrome.
Intended Use The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.
Adjusting QT Settings For patients being monitored by the MX40, you can adjust QT settings in the QT Setup window at the Information Center. Turn QT analysis on by clicking in the QT Analysis On check box. QT analysis is on when a checkmark displays in the check box. When the QT measurement is on, a QT status message is displayed in the QT Setup window, along with the current values for QT, QTc, dQTc and QT-HR.
op y ft C D ra 5-38 ECG and Arrhythmia Monitoring
6. Monitoring Pulse Rate This section provides an introduction to the Pulse measurement and its application. Pulse Rate Measurement .......................................................................... 6-2 D ra ft C op y Displaying the Pulse Rate Measurement at the MX40 .........................
Pulse Rate Measurement The pulse rate measurement counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute (bpm). The pulse rate is derived from the SpO2 measurement. Displayed results can range from 30 to 300 bpm. There is no alarm function for pulse rate. D ra ft C op y The pulse numeric is displayed at the Information Center only when SpO2 is being measured continuously. Manual measurements are displayed at the MX40 with a time stamp.
Displaying the Pulse Rate Measurement at the MX40 To display the pulse rate measurement at the MX40: If not already selected, press the Main Screen button and select the 1 waveform with 4 numerics display. 2 If pulse is not already displayed, touch a numeric. 3 Select Change Numeric. 4 Select Pulse.
op y ft C D ra 6-4 Monitoring Pulse Rate
7. SpO2 Monitoring This section provides an introduction to the SpO2 measurement and its application. SpO2 Safety Information ........................................................................... 7-2 D ra ft C op y Pulse Oximetry Measurement .................................................................
SpO2 Safety Information Warnings Always confirm monitor observations with clinical observation of the patient before administering interventions. op y Prolonged, continuous monitoring can increase the risk of changes in skin characteristics, such as irritation, reddening, blistering or pressure necrosis, particularly on patients with impaired perfusion and varying or immature skin morphology.
At elevated ambient temperatures, be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41o C on the skin if the initial skin temperature does not exceed 37o C. Avoid placing the sensor on extremities with an arterial catheter or intravascular venous infusion line. Sensors connected to the MX40 but not applied to the patient, can produce an error measurement.
Physiological SpO2 alarm signals will be generated. For adult patients, the SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments, and the SpO2 high alarm limit can be set between 51 and 100% inclusive, in 1% increments. For pediatric patients, the SpO2 low limit can be set between 30 and 99% inclusive, in 1% increments, and the high alarm limit can be set between 31 and 100% inclusive, in 1% increments.
Pulse Oximetry Measurement The MX40 supports an SpO2 sensor connection using Fourier Artifact Suppression Technology (FAST). The FAST algorithm overcomes many of the issues associated with traditional pulse oximetry such as sensitivity to patient movement and intense ambient light. The algorithm offers improved motion artifact rejection as well as performance improvements for patients with low perfusion.
SpO2 Sensors Familiarize yourself with the instructions for use supplied with your sensor before using it. In particular, check that the sensor being used is appropriate for your patient category and application site. See Appendix A, Accessories, for a complete listing of supported sensors for the MX40. Selecting an SpO2 Sensor Warning op y Use only Philips-approved accessories. Use of product accessories (patient cables, SpO2 sensors, etc.
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 four hours or in accordance with your clinical practice guidelines. See the Directions for Use supplied by Nellcor® Incorporated for instructions on preparation and application of reusable sensors.
Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation, which can severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: Never apply an SpO2 sensor at ambient temperatures above 37 oC (99 oF) because this can cause severe burns after prolonged application. Extremities to Avoid: Avoid sites distal to NBP cuff, intra-arterial line, or intravascular venous infusion line.
The level to which the triangle is filled shows the quality of the signal. The signal quality is at a maximum when the triangle is completely filled. Measuring SpO2 Warning Removal of the SpO2 sensor from the MX40 patient cable during Continuous SpO2 monitoring results in a "No Sensor" technical alarm. Silencing this alarm turns the SpO2 measurement off, however the SpO2 module is still operating in the background and consuming battery power.
Understanding SpO2 Alarms SpO2 monitoring offers high and low limit alarms, and a high priority (red level) oxygen desaturation alarm. For adult patients, the SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments. For pediatric patients, the SpO2 low limit can be set between 30 and 99% inclusive, in 1% increments. The desaturation limit is set automatically at 10 below the Low Limit. You cannot set the low limit below the desaturation limit.
8. Monitoring with other Assigned Devices This section provides information about the use of the MX40 when it is assigned to other monitoring devices. The MX40 can be assigned to IntelliVue Patient Monitors or IntelliVue Cableless Measurements for SpO2 and NBP. The connection to these other devices is done by pairing networked devices or using the integrated short-range radio of the MX40.
Assigning Devices Device Assignment at the Information Center You can assign an MX40 to a patient monitor at the Information Center. The data from the MX40 automatically displays as a permanent overview session in the Telemetry Data window on the patient monitor. At the Information Center the MX40 data and the patient monitor data are integrated in the patient sector. Warning op y All data presented in the Telemetry Data window are delayed for several seconds. If you need realtime data, e.g.
When connected the icon appears at the Information Center. The MX40 is assigned to the monitor. A "Tele Device Assigned" message appears on the monitor. If the ECG wave now appears on the monitor, the signal from the MX40 is successfully transmitting to the monitor. To confirm that the correct MX40 has been assigned, open the ECG Setup menu by touching the ECG waveform or HR numeric. The title of the menu contains the equipment label of the MX40. Check that this is the correct label.
D ra ft C op y When the devices are networked, all data is sent to the Information Center. When non-networked, only the additional parameters measured at the patient monitor (NBP, SpO2, and predictive temperature) are sent to the Information Center. The Telemetry Data window is not displayed when devices are non-networked.
Controls Available when Assigned to IntelliVue Cableless Measurements At the MX40 At the IntelliVue At the IIC Cableless Measurement Device Start SpO2 Yes Yes Yes Change SpO2 Mode Yes Yes Yes Select SpO2 Repetition Time No Yes No Assign SpO2 Pod Yes Yes No Remove SpO2 Pod Yes Yes Yes Change Alarm Limits No No Yes Place Device in Standby No No No Alarm Silence Yes (local only) No Yes Yes No (if enabled) Yes Start/Stop/Stat NBP Yes Yes Yes Change NBP Mode Yes Yes No
Controls Available when Assigned to IntelliVue Patient Monitors At the MX40 At the IntelliVue Patient Monitor At the IIC Start SpO2 Yes Yes Yes Change SpO2 Mode Yes Yes Yes Select SpO2 Repetition Time No Yes No Assign SpO2 Pod Yes Yes No Remove SpO2 Pod Yes Yes Yes Action Change Alarm Limits No Yes Yes No No No Yes (local only) Yes Yes Yes Yes (if enabled) Yes Start/Stop/Stat NBP Yes Yes Yes Change NBP Mode Yes Yes No Change NBP Repetition Time No Yes No Chang
MX40 Display when Wirelessly Connected to a Patient Monitor D ra ft C op y When the MX40 is wirelessly connected to a patient monitor via the short-range radio, its display is primarily inactive. There is no viewable patient data on the display, however, battery status information is available if the display is turned on.
op y ft C D ra 8-8 Monitoring with other Assigned Devices
9. Monitoring with the MX40 at the Information Center This section describes the behavior of the MX40 as it relates to what is displayed at the Information Center. MX40 Controls in the Patient Window .................................................. 9-2 op y Locating the MX40 (Find Device) ............................................................ 9-4 Viewing Device Location and Location History (optional)................. 9-5 Using the Device Location Client (optional) ..............................
MX40 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 MX40 operations. For detailed instructions on these operations, see the IntelliVue Information Center Instructions for Use or the Online Help. To View ECG or SpO2 Alarm Limits 1 Move the cursor over the HR or SpO2 label to display the current high and low alarm limits.
Important — Do not set the primary and secondary channels to the same lead. To Initiate a Spot Check (Manual) Spo2 Measurement Move the cursor over the SpO2 label. 2 Click on the Spot Check (Manual) icon. op y 1 D ra ft C .
Locating the MX40 (Find Device) The Find Device feature enables you to generate an alternating pitch repeated tone at the MX40 to assist in locating a missing device. This function is initiated in the Telemetry Setup Window. Find Device requires that the MX40 has sufficient battery power and is within the coverage area. To locate an MX40: 1 From the Patient Window, select Telemetry Setup. 2 Select Find Device to generate a repeated tone at the MX40.
Viewing Device Location and Location History (optional) You can see the location of an MX40 in the Patient Window. The Device Location information is identified in the Patient Window by a compass icon followed by the location name of the access point that the MX40 is currently connected to. If the location of the device changes, the Patient Window is updated within 5 seconds of the location change.
Using the Device Location Client (optional) The Device Location Client application is an optional software application that allows you to display and locate devices visually, using Floor Plans associated with your hospital’s layout. Device location history is also available. The application is accessible using a separate PC’s web browser. For additional installation information, see the IntelliVue Device Location Installation Guide.
Patient Configurable Settings in Telemetry Setup The Telemetry Setup window enables you to configure the MX40 for patient-specific settings. All patient-specific settings will be reset to the unit defaults upon patient discharge. To access the window, from the Patient Window click Telemetry Setup.
Patient-Configurable Settings in Telemetry Setup Control Function Telemetry/ Determines the Multi-Function Information Center Button response when the Multi-Function Button is pressed. Setting Choices Nurse Call - generate nurse call alarm that can be retrieved from Alarm Review for later use.
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 MX40 during an NBP measurement for 60 seconds. enable enable disable Warning Enable/disable the transmission of the Pleth wave (and its subsequent display) to the Information Center. For Continuous SpO2 mode only.
op y ft C D ra 9-10 Monitoring with the MX40 at the Information Center
Unit Configurable Settings Unit Settings provide access to clinical configuration items that affect all patients on an Information Center. Changes in unit settings take effect upon discharge, except for Standby duration and SpO2 mode, which take effect immediately. D ra ft C op y Access to unit settings requires a password, and the displays are in English. Telemetry specific settings are accessed through All Controls -> Unit Settings -> Telemetry Setup.
Unit Settings - Telemetry Setup Control Function Settings Factory Default Patient Type Set patient type used for SpO2 and NBP alarm limits. Adult Adult Telemetry/ Determine the Information Multi-Function Center response when Button Telemetry Button is pressed. Pediatric Nurse Call - generate nurse call alarm that can be retrieved from Alarm Review for later use.
Unit Settings - Telemetry Setup Control Function Settings RF Auto Shutoff Enable/disable RF operation during an extended situation of all leads off for more than 10 minutes and the SpO2 is not being measured continuously. enable Fixed Pacer Amplitude Sets the appearance of the pacer spikes to a fixed size as they appear in the patient window. enable Autopair Enable/disable the autopairing of the MX40 and the IntelliVue Patient Monitor at the Information Center.
Unit Settings - Telemetry Setup Settings Factory Default Control Function SpO2 Mode Determine the MX40 SpO2 Spot Check (Manual)Spot Check Provides manual measurement behavior. (Manual) measurements so the clinician Note — Pulse Rate and can check as needed. Pleth Wave are not Measurement can be initiated available in Spot Check from the SmartKeys menu, the (Manual) mode. SpO2 Setup menu or by selecting the Spot Check SpO2 icon in the Patient Window.
Unit Settings - Telemetry Setup Factory Default Control Function Settings Pleth Wave Enable/disable the transmission of the Pleth wave and its subsequent display to the Information Center. For Continuous mode only. enable Enable/disable the transmission of the Pulse rate and its subsequent display to the Information Center. For Continuous mode only. enable Turn SpO2 alarms on/off at the Information Center. enable (on) Increment/decrement SpO2 high alarm limit by 1 (in %). Limit maximum is 100.
Unit Settings - Default Leads Control Function Settings Factory Default 3-wire Set the unit default lead. I, II, III II 5-wire, ECG1 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V II 5-wire, ECG2 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V V 5-wire, ECG3 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V III Set the unit default lead. I, II, III, AVR, AVL, AVF, V1, II V2, V3, V4, V5, V6 5-wire EASI, ECG2 Set the unit default lead.
Unit Settings - NBP Setup Settings Factory Default Control Function Patient Type Set patient type used for NBP Adult alarm limits. Pediatric Adult NBP Alarm Set NBP alarm notification. Systolic or Diastolic Systolic or Diastolic Systolic Diastolic Mean Off Increment/decrement NBP low alarm limit by 1. Limit Maximum is 155 Limit Minimum is 28 (Adult) ft C Systolic Low Limit Maximum is 260 160 Adult Limit Minimum is 160 (Adult) 120 Pediatric Limit Maximum is 260 Limit Minimum is 75 (Ped.
Unit Settings - Alarms Control Function Non-arrhythmia Yellow Alarms Set latched/non-latched Latched status for SpO2, ST, and Non-latched other non-arrhythmia yellow alarms. Latched Leads Off Adjust the severity level of this technical alarm (INOP). Cyan Cyan Adjust the severity level of this technical alarm (INOP).
10. Operating with Information Center Release L or M This section covers performance differences when operating the MX40 with previous releases of the Information Center (Release L or M). Display ...................................................................................................... 10-2 D ra ft C op y Alarms .......................................................................................................
Display D ra ft C op y An MX40 operating with either Release L or M of the Information Center has a fixed display showing either one measurement waveform and four numeric parameter values or the ECG lead placement chest diagram along with two numeric parameter values, depending on configuration.
Alarms An MX40 operating with Release L or M of the Information Center does not have physiological alarm capability locally at the device (networked or non-networked). A No Alarm Display message is present along with the Alarms Paused icon. Technical alarms (INOPs) are communicated and can be silenced using the Alarm Silence button. Technical alarms can be reviewed using the Alarms SmartKey.
op y ft C D ra 10-4 Operating with Information Center Release L or M
11. Trends (Optional) This section covers the trend functionality of the MX40. Trends are patient data collected over time and displayed in tabular form to give you a picture of how your patient's condition is developing. Trend information is stored in the MX40 for continuously-monitored measurements, such as ECG, as well as for aperiodically-measured parameters, such as SpO2. D ra ft C op y Viewing Vital Trend Information .........................................................
Viewing Vital Trend Information To view Vital Trend information: 1 Touch the SmartKeys button. 2 From the SmartKeys menu, select Vitals Trend. To change the time columns: Touch the time column. 2 Select a different time period.
12. Maintenance This section provides procedures for maintaining the MX40 after installation, including equipment label assignment, cleaning, and troubleshooting information for common problems. Cleaning .................................................................................................... 12-2 Label Assignment for Replacement MX40........................................... 12-5 D ra ft C op y Charging Lithium-ion Rechargeable Batteries ....................................
Cleaning The procedure in this section keeps the MX40 and its accompanying patient cable clean and provides protection against infectious agents and bloodborne pathogens. Both the outside and the inside of the MX40 battery compartment and the patient cable must be kept free of dirt, dust, and debris. Important — After exposure, the MX40 and the patient cable must be cleaned as per the instructions contained herein. Sterilization of the MX40 has been qualified using the STERRAD 100NX System.
Sharp or pointed instruments should not be used to remove soil from recessed areas on the MX40. Approved Cleaners Cleaner Active Ingredient Isopropyl Alcohol based Isopropyl Alcohol (>70%) Hydrogen Peroxide Hydrogen Peroxide (3%) Chlorine Bleach Sodium Hypochlorite (1:10 concentration, mixed < 24 hours) Caltech Dispatch 5200 Wipes Sodium hydroxide (<0.2%) op y Sodium metasilicate (<0.6%) Sodium hypochlorite (<1.0%) Incidin Liquid Propanol-2 (20%) Ethanol (10%) Benzalkoniumchlorid (<1.
Cleaner Active Ingredient Sanicloth Plus Quaternary ammonium (0.25%) 2-Butoxyethol (1-4%) Isopropyl alcohol (14.85%) Super Sanicloth Quaternary ammonium (<1%) Isopropyl alcohol (55%) Carpe Diem TM/ MC Tb Wipes Hydrogen peroxide (0.5%) Benzyl alcohol (3.1%) D ra ft C op y Note —The cleaners listed above are also suitable for cleaning the patient cable and the lithium-ion battery.
Label Assignment for Replacement MX40 During installation, an equipment label is assigned to each MX40 in a clinical unit so that the device can be identified during operation within the wireless system. If an MX40 is lost, the Assign Label function at the Information Center enables you to unassign the label from a lost device, and re-assign its label to a replacement device. Labels are limited to those available in an individual clinical unit.
10 Wait for the new_device label to change to the selected equipment label. D ra ft C op y 11 In Sector Setup, select the Bed Label and Equipment Label and then press OK.
Charging Lithium-ion Rechargeable Batteries The li-ion rechargeable battery is recharged using the IntelliVue CL Charging Station. To charge a battery, place it onto a charger slot on the charging station. The battery power indicators will supply information about the charge status. Warning Always use the supplied power cord with the grounded mains plug to connect the charging station to a grounded AC mains socket. Never adapt the mains plug from the power supply to fit an ungrounded AC mains socket.
Status LED no battery on charger slot off battery put on charger slot flashing yellow battery not properly recognized, error cyan battery recognized, battery charging yellow battery recognized, battery full (>90%) green The AC Power / Error LED is green when the charging station is connected to AC power op y cyan during startup or to indicate a general charging station error ft C Note — Wiping of battery contacts with an alcohol solution after cleaning is recommended.
To check the number of charge-discharge cycles: Touch the battery gauge on the display. The number of cycles is listed as xx/500 on the Device Status menu. Battery Disposal D ra ft C op y Discharge the battery and insulate the terminals with tape before disposal. Dispose of used batteries promptly and in accordance with local recycling regulations.
op y ft C D ra 12-10 Maintenance
13. Safety Standards & Specifications This section describes the regulatory standards that the IntelliVue MX40 complies with, along with product and measurement specifications. Regulatory Information .......................................................................... 13-2 op y Electromagnetic Compatibility .............................................................. 13-6 Battery Specifications ............................................................................
Regulatory Information 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. AC Power Source op y The system is not intended for connection to the public mains as defined in CISPR-11.
EN ISO 9919:2005 Pulse Oximeters IEC 60601-1-2:2001 Electromagnetic Compliance IEC 60601-1-4:1999 +A1 Requirements for Programmable Electrical Medical Systems IEC 60601-1-6:2006 General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-8:2006 General Requirements for Safety for Alarm Systems IEC 60601-2-49:2001 Particular Requirements for Safety for Patient Monitoring Equipment op y IEC 60601-2-27:2005 Particular Requirements for Safety for Electrocardio
Intended Uses of MX40 The MX40 is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.
Essential Performance The IntelliVue MX40 provides Essential Performance (EP) under normal operating conditions (includes EMC exposure) only as a complete Medical Electrical System, consisting of the MX40, MPx companion monitor (Optional), IntelliVue CL SpO2 and NBP Cableless Measurement devices(Optional), IntelliVue Telemetry Network Infrastructure, and the M3290 Information Center Software.
Electromagnetic Compatibility Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 60601-1-2:2001, the international standard for EMC for medical electrical equipment. This IEC standard has been adopted in the European Union as the European Norm, EN 60601-1-2:2001.
Reducing Electromagnetic Interference The MX40 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.
Warning Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment. Electromagnetic Emissions Compliance Avoiding Electromagnetic Interference Radio Frequency (RF) emissions Group 1 TheMX40 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Guidance Power frequency (50/60 Hz) magnetic field 3 A/m 3 A/m Power frequency magnetic fields should be a t levels characteristic of a typical location in a typical commercial and/or hospital environment IEC 61000-4-8 Recommended Separation Distance Warning op y The MX40, equipped with a wireless network interface, intentionally receives RF electromagnetic energy for the purpose of its operation.
Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Guidance Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m Recommended separation distance: 80 MHz to 800 MHz d = 1.2√P 800 MHz to 2.5 GHz d = 2.3√P op y Field strengths from fixed transmitters, such as base stations for radio (cellular, cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Frequency of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 10 W 3.8 m 3.8 m 7.3 m 100 W 12.0 m 12.0 m 23.0 m Electrosurgery Interference/Defibrillation/Electrostatic Discharge Restart Time op y The equipment returns to the previous operating mode within 10 seconds without loss of any stored data. Measurement accuracy may be temporarily decreased while performing electrosurgery or defibrillation. This does not affect patient or equipment safety.
Battery Specifications Battery Life The battery life specifications listed below are based on the use of three Duracell MN 1500 batteries. Battery life for other brands may differ. Telemetry Mode Networked Battery Life 24.7 hours ECG/SpO2 Continuous (using legacy SpO2 cable/sensors. Only one radio active.) 8.9 hours ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life.
Monitor Mode Non-networked Battery Life ECG Only (only one radio active) 8.6 hours ECG/SpO2 Continuous (using legacy SpO2 cable/sensors. Only one radio active.) 7.0 hours ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. Nominal Current Nominal Current op y Operating Mode 67 mA @ 3.6V ECG/SpO2 Continuous (Display inactive) 136 mA @ 3.
Lithium-ion Battery Charge Time Charging Method Charge Time Battery pack charge time from 90% depletion state The Lithium-ion Battery Pack is charged on a separate external charging station. It must be removed from the MX40 to charge. 6.
Physical Specifications Parameter Specification Height 126.8 mm (4.99 in) Width 69.9 mm (2.75 in) Depth 31.5 mm (1.24 in) Weight Without batteries, includes SpO2 and Short-range radio 1.4 GHz - 240 g (8.5 oz) With 3 AA batteries, includes SpO2 and Short-range radio 1.4 GHz - 298 g (10.5 oz) With lithium-ion battery, includes SpO2 and Short -range radio 1.4 GHz - 279 g (9.8 oz) ft C op y 2.4 GHz - 215 g (7.6 oz) 2.4 GHz - 324 g (11.4 oz) 2.4 GHz - 305 g (10.8 oz) Display 2.
MX40 1.4 GHz Radio Parameter Specification Frequency Ranges Bands: 1395-1400 MHz and 1427-1432 MHz Channel Spacing: 1.6 MHz 8 dBm +2/-1.5 dB (4.
MX40 2.4 GHz Radio Parameter Specification Frequency Range ISM Band: 2400 - 2483.5 MHz Channel Assignment 48 radio channels assigned from 2401.056 MHz - 2482.272 MHz Channel Spacing: 1.728 MHz RF Output Power FCC: Channels 0-46 -17 dBm +/- 1 dB (40 mW to 63 mW, nominal 50 mW), into antenna load. Channel 47 only - 14.5 dBm +/- 1 dB. ETSI: 12 dBm +/- 1 dB (13 mW to 20 mW, nominal 16 mW), into antenna load op y ARIB: 13.
The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications Terminal Equipment Directive). Class 2 radio equipment. Member states may apply restrictions on putting this device into service or placing it on the market. This product is intended to be connected to the Publicly Available Interfaces (PAI) and used throughout the EEA.
MX40 Short-Range Radio Parameter Specification Frequency Ranges ISM Band: 2400-2483.5MHz Radio Channel assignment 16 Radio Channel assigned, Fc= 2405 +5*(k-11)MHz, k=11,12,…,26 Frequency Control Configured via the bedside monitor. RF Output Power - MX40 Frequency Accuracy during normal operation <+/-40ppm, includes temperature compensation & aging effects Modulation Type Direct Sequence Spread Spectrum (DSSS), O-QPSK with half sine pulse shaping modulation (1M40Q7D) 1.5 to 4.5 dBm +0/-3dB (0.
Environmental Specifications Parameter Specification Temperature Operating 0 to 37o C (32 to 99o F) Storage -30o C to 50o C (-22o F to 122o F) without batteries Humidity Operating < 95% RH at 37o C (98.
Measurement Specifications ECG Parameter Specification ECG channel transmitted Leads Channel #1 = I, II, or III 5 electrodes Channel #1 = II Channel #2 = III Channel #3 = MCL 5 electrodes, EASI Channel #1 = Va-i Channel #2 = Va-s Channel #3 = Ve-s 6 electrodes Channel #1= II Channel #2 = III Channel #3 = Va Channel #4 = Vb 5 V ft C Resolution op y 3 electrodes Differential, defibrillator protected against 360 joules discharge into a 100 ohm load Input Impedance > 5 megohms (@ 10 Hz D ra ECG
Parameter Specification Pacer Rejection Performance Positive pacers (Pace pulses with no tails). +2 to +700 mV 0.1, 0.2, 0.5 and 1.0 ms +2 to +500 mV 1.5 ms 1 Amplitude Width +2 to +400 mV Negative pacers 2 ms 1 Width -2 to -700 mV ms 0.1, 0.2, 0.5 and 1.0 -2 to -500 mV 1.5 ms -2 to -400 mV 2 ms op y Amplitude Philips does not claim, verify, or validate support for all available pacemakers. 1 Meets Essential Performance.
Characteristic Performance Disclosure/Specification (in italics) Heart Rate Meter Accuracy and Response to Irregular Rhythm Provides correct heart rates (80, 60, 120, 90 b/min) using test waveforms as indicated in ANSI/AAMI EC13 Sec. 3. 1. 2. 1 (5). Response Time of Heart Rate Meter to For a rate increase, the average time to reach the specified heart rate using test waveforms as indicated in Change in Heart Rate ANSI/AAMI EC13 Sec. 3. 1. 2. 1 (6) is 8.6 seconds. For a rate drop, the average time is 8.
Characteristic Performance Disclosure/Specification (in italics) Channel Width 40 mm. Meets the ANSI/AAMI EC13 Section 3.2.9.7(a) standard: minimum = 30mm. Trace Width 0.3 mm. Meets the ANSI/AAMI EC13 Section 3.2.9.7(b) standard: maximum = 1.0mm. Aspect Ratio 0.4s/mV. Meets the ANSI/AAMI EC13 Section 3.2.9.7(f) standard: 0.4s/mV. Input Signal Reproduction Accuracy: -2.9%. Meets the ANSI/AAMI EC13 Section 3.2.9.8(a) standard: maximum = +/- 20%. Overall Error Frequency Response: Sinusoidal 0.
Parameter Specification SpO2 Numerics Averaging 5 - 20 seconds (default = 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 NBP 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. The effect of SpO2 pulse oximetry on data averaging is internally controllable by the patient worn monitorMX40, with no user controls.
Type Description Model Number Accuracy % A rms (70-100% Range) Adult Finger, 2m cable M1191B 2.0 Adult Finger, 3m cable M1191BL 2.0 Adult Finger, 0.45m cable M1191T 3.0 op y SpO2 Sensor Accuracy Reusable Sensors M1192A 2.0 Pediatric, Small Adult Finger, 0.45m cable M1192T 3.0 Adult &Pediatric Ear Clip, 1.5m cable M1194A 3.0 Adult Finger Clip, 3m cable M1196A 3.0 Adult Finger Clip, 2m cable M1196S 3.0 Adult Finger Clip, 0.9m cable M1196T 3.
Model Number Accuracy % A rms (70-100% Range) Adult Finger, > 40kg M1901B 3.0 Pediatric 3-20kg M11902B 3.0 Pediatric Finger, 10-50kg M1903B 3.0 Adult Finger, >30kg M1904B 3.0 Adult, Pediatric > 20kg M1131A 3.0 Adult Finger, > 30kg Nellcor OxiMax Max-A 3.0 Adult Finger, > 30kg Nellcor OxiMax Max-AL 3.0 Adult Finger > 40kg op y Type Nellcor OxiMax Max-N 3.0 Nellcor OxiMax Max-P 3.0 Nellcor OxiMax Max-I 3.0 Nellcor Oxisensor II D-25 3.0 Nellcor Osixensor II N-25 3.
op y ft C D ra 13-28 Safety Standards & Specifications
A. Accessories This section lists the accessories for use with the MX40. Accessories are subject to change. Some accessories are not supplied by Philips. You can order parts and accessories from Philips at www.medical.philips.com or consult your local Philips representative for details. Warning op y Use only Philips-approved accessories. Use of product accessories (patient cables, SpO2 sensors, etc.
MX40 Accessories Pouches Description 989803174141 Carry Pouch, Waterproof, box of 50 989803174151 Carry Pouch, Waterproof, box of 200 9300-0768-050 Disp tele pouch w/snaps, 50/box 9300-0768-200 Disp tele pouch w/snaps, 200/box Miscellaneous Order Number Protective caps, adapter cable, MX40 989803176491 Protective caps, Reusable leads, MX40 989803174131 MX40 Lithium-ion battery, pkg 3 989803176201 MX40 Lithium-ion battery, pkg 1 MX40 AA Battery adapter, pkg 3 989803174891 A-2 Description
ECG Accessories Electrodes Description M4612A Solid gel ECG electrode 5/pouch 300/case M4613A Solid gel ECG electrode 30/pouch 300/case 40489E Adult paper tape ECG electrode, disp. 300/case 40493D Adult foam ECG electrode, disp. 300/case 40493E Adult foam ECG electrode, disp. 300/case M1935A Disposable EEG/ECG snap electrode 100/case 989803148801 Small adult solid gel snap electrode 1500/case ft C op y Order Number Adult cloth ECG electrode, disp.
Order Number Description 989803171841 ECG 5 lead snap AAMI + SpO2 .85m (35") 989803171831 ECG 5 lead grabber AAMI .85m (35") 989803171851 ECG 5 lead grabber AAMI + SpO2 .85m (35") 989803171861 ECG 6 lead grabber AAMI .85m (35") 989803171871 ECG 6 lead grabber AAMI + SpO2 .85m (35") MX40 Extender Cable, including Bed Sheet Clip, p/n 989803172241 Reusable Leadsets for Use with IntelliVue Patient Monitors Description 989803151991 ECG 3 lead snap, gray, AAMI .
SpO2 Accessories Philips/Nellcor Disposable Sensors Description 989803105481 (A) M1904B Adult Finger, >30 kg 989803128551 M1133A Neo/Infant/Adult, <3, 10-20 kg, >40 kg 989803164921 M1134A Adh.
Order Number Description All sold as one piece each. A - Sensors plug directly into MX40. B - Supports use of M1941A extension cable. C - Not for use with M1941A extension cable. D - Requires M1943A/AL adapter cable. Order Number Description 989803105691 M1943A Adapter Cable, 1. m 989803128651** M1943AL Adapter Cable, 3 m 989803105681** op y Adapter Cables M1020-61100** Massimo Adapter Cable for LNOP sensors,3.
B. Default Settings D ra ft C op y This section documents the most important default settings of your MX40 as it is delivered from the factory. For a comprehensive list and explanation of default settings, see the IntelliVue Information Center Release N Configuration Guide. The MX40's configuration settings can be changed permanently in Configuration Mode.
Alarm Default Settings Alarm Setting Factory Default Alarm Volume On Network: 0 Off Network: 10 0 Tone Modulation On Alarm Sound Traditional Alarm Pause Time 2 min. Alarm Reminder (Red, Yellow) On Alarm Reminder (INOP) On Reminder Time 3 min.
ECG, Arrhythmia, ST and QT Default Settings ECG Settings Factory Defaults Adult On Primary Lead II Secondary Lead 6-lead: V2 5-lead (Standard): V 5-lead (EASI): V2 Default ECG Size x1 Lead Placement Standard Leadset Type AAMI Analysis Mode High Limit Low Limit op y ECG Pedi Multi-lead 120 bpm 160 bpm 50 bpm 75 bpm 4.0 sec Arrhythmia Settings Factory Defaults ft C Asystole Threshold D ra Adult Arrhythmia On Pause Threshold 2.
Arrhythmia Settings Factory Defaults Adult On V.Bigeminy On V.Trigeminy On PVCs/min On Multif. PVCs On Pacer N. Cap On Pacer N.
Configuration Default Settings at the MX40 Setting Factory Default Touch Tone Volme 0 - 10 Default Screen 1 Wave (Portrait) 2 Waves (Portrait) 2 Waves (Landscape) Chest Diagram Screen Color Blue Gray Green Pink* Purple* Yellow* (*only display in Standby Mode) op y 4 Alarm Sounds Traditional ISO Confirm to restore to unit default settings D ra ft C Unit Defaults Default Settings B-5
op y ft C D ra B-6 Default Settings
C. MX40 2.4GHz WLAN Radio The MX40 2.4GHz WLAN Radio conforms to the 802.11 b/g standard, operating in the 2.4GHz ISM band. The Radio characteristics are defined below. WLAN Radio RF Specs Specification 802.11b 2.4 to 2.483GHz Transmitter Power 14 to 17 dBm into antenna load op y Frequency Range Spectrum Mans (relative to max power spectral density) <-30 dBr @ +/-11MHz offset Modulation Type CCK modulation <-50 dBr @ +/-22MHz offset ft C 802.11g 2.4 to 2.
op y ft C D ra C-2 MX40 2.
D. Sales and Support Offices Please call your local Philips Healthcare sales office listed in your telephone directory or a Philips Healthcare regional office listed below for the location of your nearest sales office. On the web www.healthcare.philips.com By fax +31 40 27 64 887 op y Via email healthcare@philips.com ft C By postal service Philips Healthcare Global Information Center P.O.
op y ft C D ra D-2 Sales and Support Offices
Index A Accessories ECG • A-3 MX40 • A-2 SpO2 • A-5 C Charging Lithium-ion Rechargeable Batteries • 3-13 D alarms • B-2 ecg, arrhythmia, ST and QT • B-3 E I ft C ECG Fallback • 5-30 ECG Performance Disclosure/Specifications • 4-3 Electromagnetic Compatibility • 2-2 Initiating Arrhythmia Relearning Manually • 5-30 P op y Default Settings • B-1 D ra Patient Configurable Settings in Telemetry Setup • 3-25
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op y ft C D ra Part Number 453 564 242 441 Printed in USA June 2011 First Edition 453 564 242 441
