Philips HeartStart MRx M3535A, HeartStart MRxM3536A User manual

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M3535A/M3536A

Instructor Guide

HeartStart MRx

About This Edition

Publication number 453564045041

Edition 1

Printed in the USA

To determine the product level version to which this guide applies to, refer to the version level on the back cover of this book or on the label of the User Documentation CD-ROM that accompanied the device. This information is subject to change without notice.

Philips shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

Edition History

Edition	Print Date

1	September, 2006

Koninklijke Philips Electronics N.V.

All rights are reserved. Permission is granted to copy and distribute this document for your organization’s internal educational use. Reproduction and/or distribution outside your organization in whole or in part is prohibited without the prior written consent of the copyright holder.

SMART Biphasic is a registered trademark of Philips.

Microstream® and FilterLine® are registered trademarks of Oridion Medical Ltd. Smart CapnoLine™ is a trademark of Oridion Medical Ltd.

Q-CPR™ is a trademark of Laerdal Medical.

The HeartStart MRx contains an Ezurio PC Card with Bluetooth® wireless technology. The Bluetooth wordmark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Ezurio is under license. Coverage Plus® and Coverage Plus NPD® are registered trademarks of Steris Corp.

CidexPlus® is a registered trademark of Advanced Sterilization Products.

Other trademarks and trade names are those of their respective owners.

Notice

Use of supplies or accessories other than those recommended by Philips may compromise product performance.

THIS PRODUCT IS NOT INTENDED FOR HOME USE.

IN THE U.S., FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHYSICIAN.

Medical Device Directive

The HeartStart MRx complies with the requirements of the Medical Device Directive 93/42/EEC and carries the 0123 mark accordingly.

Manufacturer:

Philips Medical Systems

3000 Minuteman Road

Andover, MA 01810

Authorized EU-representative:

Philips Medizin Systeme Böblingen GmbH

Hewlett Packard Str. 2

71034 Böblingen

Germany

Canada EMC:ICES-001

China:

After Sales Service: Beijing MEHECO-PHILIPS Medical Equipment Service Center.

After Sales Service Address: No. 208, 2nd District, Wang Jing Li Ze Zhong Yuan, Chao Yang District, Beijing. Postal code: 100102.

Telephone: 010-64392415.

Registration number: SFDA(I)20043211207. Product Standard number: YZB/USA 52-21.

For the Declaration of Conformity Statement, please see the Philips Medical web site at http:// incenter.medical.philips.com/PMSPublic. Scroll over the Quality and Regulatory Tab located in the upper left corner of the window. Click to select Regulatory by Modality. Then click to select Defibrillators and select the entry for Declaration of Conformity (DoC).

Warning

Radio frequency (RF) interference from nearby transmitting devices may degrade the performance of the HeartStart MRx. Electromagnetic compatibility with surrounding devices should be assessed prior to using the monitor/defibrillator.

This Instructor Guide contain the following conventions:

“Voice”	represents voice prompt messages
Text	represents messages that appear on the display
Text	represents bolded directions to the instructor that appear in the guide and
	options that appear on MRx menus
[Soft key]	represents soft key labels that appear on the display above the
	button to which they correspond.

Table of Contents

1 Introduction	1
2 Getting Acquainted	5

Lesson Introduction	5
Objectives	5
Time	5
Accessories Recommended	5
Lesson Presentation	6
Overview	6
Basic Orientation	6
Display View	10
Continued Use	15
Printing Waveforms	16
Return to Owner	16
Carrying Case and Accessory Pouch Assembly	18
Storing Accessories	20
Review	23
3 ECG and Arrhythmia Monitoring	25

Lesson Introduction	25
Objectives	25
Time	25
Accessories Recommended	25
Clinical Resources	25
Lesson Presentation	26
Overview	26
Monitor View	26
Preparation	27
Heart Rate and Arrhythmia Alarms	30
Displaying an Annotated ECG	35
Arrhythmia Learning/Relearning	36
Review	37
4 Semi-Automated
External Defibrillation	39

Lesson Introduction	39
Objectives	39
Time	39
Accessories Recommended	39

iii

Clinical Resources	39
Lesson Presentation	40
Overview	40
AED View	40
Preparation	41
AED Mode	42
Review	47

5 Manual Defibrillation
and Cardioversion	49

Lesson Introduction	49
Objectives	49
Time	49
Accessories Recommended	49
Clinical Resources	49
Lesson Presentation	50
Manual Mode	50
Code View	50
Manual Defibrillation Preparation	51
Manual Defibrillation	52
Synchronized Cardioversion	54
Synchronized Shock Delivery	55
Review	57
6 Q-CPR™	59

Lesson Introduction	59
Objectives	59
Time	59
Accessories Recommended	59
Clinical Resources	59
Lesson Presentation	60
Overview	60
Q-CPR Preparation	61
Q-CPR in Manual Defib Mode	64
Q-CPR in AED Mode	67
Review	69
7 Noninvasive Pacing	71

Lesson Introduction	71
Objectives	71
Time	71
Accessories Recommended	71
Clinical Resources	71
Lesson Presentation	72
Pacer Mode	72

	Pacing View	73
	Demand vs. Fixed Mode	74
	Preparation	75
	Demand Mode Pacing	76
	Fixed Mode Pacing	78
	Defibrillating During Pacing	79
	Review	80
	8 Pulse Oximetry Monitoring	81

	Lesson Introduction	81
	Objectives	81
	Time	81
	Accessories Recommended	81
	Clinical Resources	81
	Lesson Presentation	82
	Overview	82
	Selecting a Sensor	82
	Applying the Sensor	83
	Monitoring SpO2	84
	Pleth Wave	85
	Setting SpO2 Alarms	86
	Setting Pulse Rate Alarms	88
	Disabling the SpO2 Monitoring Function	88
	Review	90
	9 Noninvasive Blood Pressure Monitoring	91

	Lesson Introduction	91
	Objectives	91
	Time	91
	Accessories Recommended	91
	Clinical Resources	91
	Lesson Presentation	92
	Overview	92
	Preparing to Measure NBP	93
	Measuring NBP	94
	Alarms	96
	Review	98
10 Carbon Dioxide Monitoring		99

	Lesson Introduction	99
	Objectives	99
	Time	99
	Accessories Recommended	99
	Clinical Resources	99
	Lesson Presentation	100
	Overview	100

	Preparing to Measure EtCO2	101
	Measuring EtCO2	102
	Setting Up the EtCO2 and AwRR Alarms	102
	Disabling EtCO2 Monitoring	104
	Review	105
11 Invasive Pressures Monitoring		107

	Lesson Introduction	107
	Objectives	107
	Time	107
	Accessories Recommended	107
	Clinical Resources	107
	Lesson Presentation	108
	Overview	108
	Pressure Measurement Set-up	108
	Selecting a Pressure to Monitor	109
	Pressure Waves	110
	Zeroing the Pressure Transducer	111
	Calibration	113
	Alarms	114
	Wedge	116
	Pulse	116
	Review	119
12 Temperature Monitoring		121

	Lesson Introduction	121
	Objectives	121
	Time	121
	Accessories Recommended	121
	Lesson Presentation	122
	Overview	122
	Selecting a Temperature Label	122
	Monitoring Temperature	123
	Alarms	124
	Disabling the Temperature Function	125
	Review	126
13 12-Lead ECG Monitoring		127

	Lesson Introduction	127
	Objectives	127
	Time	127
	Accessories Recommended	127
	Clinical Resources	127
	Lesson Presentation	128
	Overview	128
	Preview Screen	128

	Preparation	129
	Acquiring the 12-Lead ECG	130
	12-Lead Report	131
	Accessing Stored Reports	131
	Adjusting Wave Size	132
	12-Lead Filters	132
	Review	133
14 12-Lead ECG via Bluetooth Transmission		135

	Lesson Introduction	135
	Objectives	135
	Time	135
	Accessories Required	135
	Technical Resources	135
	Lesson Presentation	136
	Overview	136
	Setting Up for Bluetooth Transmission	137
	Transmitting to a Configured Site using Bluetooth	140
	Transmitting to a Fax Number	140
	Transmitting Stored 12-Lead Reports	140
	Transmission Status	141
	Cancelling Transmission	141
	Review	142
15 Vital Signs Trending		143

	Lesson Introduction	143
	Objectives	143
	Time	143
	Accessories Recommended	143
	Lesson Presentation	144
	Overview	144
	Reviewing Trending Data	144
	Trending Report Intervals	145
	Scrolling in the Trending Report	145
	Printing the Trending Report	145
	Exiting the Trending Report	145
	Review	147
16 Data Management		149

	Lesson Introduction	149
	Objectives	149
	Time	149
	Accessories Recommended	149
	Lesson Presentation	150
	Overview	150
	Marking Events	151

vii

	Printing Events	151
	Printing the Event Summary	152
	Printing the Vital Signs Trending Report	152
	Using Data Management - Internal Memory	153
	Using Data Management - Data Card	153
	Review	155
17 Maintenance		157

	Lesson Introduction	157
	Objectives	157
	Time	157
	Accessories Recommended	157
	Maintenance Resources	157
	Lesson Presentation	158
	Overview	158
	Automated Tests	159
	Ready For Use Indicator	160
	Shift Check	161
	Weekly Shock Test	162
	Operational Check	163
	Battery Maintenance	170
	Cleaning Instructions	171
	Review	174

viii

Instructor Guide

Introduction

This instructor guide is designed to assist you in the delivery of end-user training on the HeartStart MRx. It provides directions and suggestions for teaching the safe and proper operation of the device, and is intended only for ACLS personnel thoroughly trained in the use of the device.

Instruction Time

It is estimated that this course will require 2-5 hours to complete, depending on class size, location, number of devices available for training, optional device parameters purchased, and student knowledge and needs.

Guide Structure

This guide is divided into sixteen (16) lessons, as follows:

•Getting Acquainted

•ECG and Arrhythmia Monitoring

•Semi-Automated External Defibrillation

•Manual Defibrillation and Cardioversion

•Q-CPR™*

•Noninvasive Pacing*

•Pulse Oximetry*

•Noninvasive Blood Pressure*

•Monitoring Carbon Dioxide*

•Invasive Pressures*

•Temperature*

•12-Lead ECG*

•12-Lead ECG via Bluetooth Transmission*

•Vital Signs Trending

•Data Management

•Maintenance

* This is an optional parameter with the MRx, so ensure you teach only the lessons that match the organization’s device configuration.

1 Introduction

Preparation

Prior to each class:

•Contact the organization’s training coordinator to schedule training, if applicable. Suggest train-the- trainer sessions. Make sure students understand that they must be free from other responsibilities at the scheduled time for the duration of the course. A maximum of 10 students is recommended for each class.

•Talk to the training coordinator (if applicable) about which device functions students will be using

on the job (AED Mode, Manual Mode, Pacing, SpO2, etc.). Use this information to select the appropriate lessons and determine your lesson presentation.

•Recommend to the training coordinator that students watch the latest version of the HeartStart MRx User Training Video or DVD prior to the instructor-based training, if available. Also, suggest taking the HeartStart MRx Web-based User Training prior to or after the instructor-based training.

•Determine the number of devices needed for training and make arrangements to have them set up at the scheduled time, if possible. Try not to exceed grouping 2-3 students per device.

•Determine who in the organization makes decisions about configuration. Arrange a time to discuss the organization’s desired configuration and set up the devices used in training to that configuration. Use the configuration worksheet available on the User Documentation CD-ROM to help you complete the configuration procedure.

•Perform an Operational Check on each device to be used in training prior to training. Refer to the latest version of the HeartStart MRx Instructions For Use to complete the Op Check, if necessary.

•Try to have fully charged batteries and external power available if needed.

•Try to have one simulator for each device to be used in training, as well as extra batteries for the simulators.

•Try to have appropriate sets of parameter accessories, cables, etc. for each device.

•Try to have one copy of the latest HeartStart MRx User Training Workbook available for each student, if possible. The workbook contains a similar lesson flow to the guide, but only a summary of the content. Students can use the workbook to follow your instruction. Be sure to familiarize yourself with the workbook before you teach. It is available on the User Documentation CD-ROM that comes with the MRx.

•As appropriate and if possible, try to have one copy of each application note available for each student either before, during, or after the training. These notes relate to several lessons in the guide. They can be found on the User Documentation CD-ROM, as well as:

– www.medical.philips.com/goto/productdocumentation

•If possible, try to have one set of latest version of the HeartStart MRx Quick Reference Cards available for the training.

1 Introduction

Teaching Guidelines

Consider the following guidelines for delivering the MRx training.

•Have students identify themselves and their role and/or responsibilities. This information gives you a better idea of what lessons/topics are suitable or most important for your audience.

•Provide a brief overview of the course structure and what is covered in each lesson.

•Advise students to read the HeartStart MRx Instructions For Use for details on device features and information not covered in the classroom:

–Device intended use

–Device and accessory set-up

–Configuration

–Device disposal

–Troubleshooting

–Specifications and safety

•For each lesson:

–Introduce the learning objectives (as listed in the guide), advise on how much time it will take to complete a lesson, and point out what related resources (e.g., application notes) are available to students for further education.

–Present the lesson content. Annotate and/or highlight material (in your copy of the guide) to ensure you stress information that you feel is important to your students’ needs. Note that instructor directions are in bold. Look for suggestions that raise the level of student interaction. There is also space for additional points or notes to be made at a topical level, depending on students’ needs.

–Review the content presented by completing the review questions at the end of each lesson. Note that answers to the questions are in bold.

•Periodically ask for questions to ensure comprehension.

•Periodically ask questions to engage students and increase learning effectiveness.

•Take breaks over the course of the training (if time allows) to ensure learning effectiveness.

•At the completion of a class, use the Skills Checklist to test students on various functions and features of the MRx.

Safety Considerations

Some warnings and cautions specific to a particular feature of the HeartStart MRx are provided in this guide; however, you and students should reference the Instructions For Use for a complete description of all safety warnings and cautions. Nonetheless, reinforce the fact that the MRx is a live device that can deliver high-energy therapy and should not be used by untrained personnel. Operation by untrained personnel can result in injury or death.

1 Introduction

Additional Documentation and Training

Available documentation and training for the HeartStart MRx includes:

•HeartStart MRx Instructions for Use - provides the most comprehensive review of MRx functionality and operation for students. It is available on the User Documentation CD-ROM or may be purchased in hardcopy form.

•HeartStart MRx Quick Reference Cards - provide visual, step-by-step summaries of key functions, parameters, and related operation

–Controls, Connections and Indicators

–Ready For Use Indicator

–Using Alarms

–Monitoring ECG

–Monitoring SpO2

–Monitoring NBP

–Monitoring CO2

–Monitoring Invasive PressuresNoninvasive Pacing

–Q-CPR

–12-Lead ECG

–Operational Check

•HeartStart MRx Web-based User Training - provides a comprehensive self-paced training on the same content found in the instructor guide. It is located on Philips Medical Systems’ web site at: www.medical.philips.com/goto/mrxtraining.

Students need to enter the training access password meetMRx to get started.

•HeartStart MRx User Training Video - provides a 50-minute overview of MRx functions, features, and operation. The video serves as valuable preparation for the classroom or as a refresher after the training.

•Application Notes

–Arrhythmia Monitoring Algorithm

–AED Algorithm

–SMART Biphasic

–Noninvasive Pacing

–Philips Pulse Oximetry

–Noninvasive Blood Pressure Monitoring

–Uses of Capnography - The Microstream® Method

–Q-CPR™ Measurement and Feedback

•12-Lead Algorithm Data Sheet

•Philips 12-Lead Algorithm Physician’s Guide, available from IntelliVue Information Center - User Materials under Patient Monitoring at http://www3.medical.philips.com/en-us/doc_downloads/ docdownload.asp

Instructor Guide

Getting Acquainted

Lesson Introduction

Introduce the lesson, including the learning objectives, estimated time to complete, and applicable resources.

This lesson provides an overview of the HeartStart MRx controls, indicators, operational modes, and display views. It also provides general information on use of the device.

Objectives

Upon completion of this lesson, students should be able to:

1.Identify the physical features, controls, and indicators of the MRx.

2.Identify the purpose of various controls and indicators.

3.Identify the display view characteristics associated with MRx’s operating modes.

4.Identify the correct procedure for responding to an alarm.

Time

15-25 minutes

Accessories Recommended

•Simulator

•Hands-free cable

•Multifunction electrode pads

•3-, 5-, or 10-Lead monitoring electrodes

•Optional Pacing, SpO2, CO2, NBP, invasive pressure, temperature, and/or Q-CPR parameter accessories

2 Getting Acquainted

Lesson Presentation

Overview

Describe the high-level features of the MRx.

•It is designed for a variety of needs.

•It has controls, indicators, and menus organized to facilitate ease of use.

•It displays information specific to the current task.

Basic Orientation

Introduce the physical features, controls, and indicators on the front, left, right, top, and back panels of the MRx. Also, discuss the lithium ion battery.

Suggestion: Have students identify the features, controls, and indicators on their devices and the battery while following your orientation.

NOTE: Consider not turning on the MRx during your initial orientation so students focus on each panel and NOT the display. Then, turn on the device to illustrate display output of features and controls.

Front Panel

Controls and indicators on the front panel are organized by function, with the most general function buttons located along the left and bottom sides of the display, defibrillation controls to the right of the display, and soft keys immediately below the display.

Therapy Knob

Serves as the MRx power switch and can be set to:

•AED - to enable AED Mode for semi-automated external defibrillation and optional Q-CPR parameter.

•Off

•Monitor - to enable Monitor Mode for 3- or 5-Lead ECG monitoring, optional 12-Lead ECG acquisition, or monitoring of optional parameters such as SpO2, CO2, and NBP.

•Pacer (optional) - to enable Pacer Mode for demand or fixed mode pacing.

•Manual Defib - to enable Manual Mode for asynchronous or synchronous defibrillation (cardioversion) at the selected energy setting and optional Q-CPR parameter.

Energy settings are 1-9, 10, 15, 20, 30, 50, 70, 100, 120, 150, 170, and 200 Joules. If the device is equipped with optional Pacing, energy settings are 1-10, 15, 20, 30, 50, 70, 100, 120, 150, 170, and 200 Joules.

Lesson Presentation

2 Getting Acquainted

General Function Buttons

Control monitoring or non-critical resuscitation activities

•Mark Event - inserts a time-stamped annotation in the Event Summary Report to note events as they occur, including drug administration. A Mark Event button label appears at the top left corner of the display.

•Lead Select - changes the ECG lead in Wave Sector 1; cycles through the available ECG waves, changing the displayed wave and label. The list of available ECG waves is based on the current lead set and device configuration, and includes pads or paddles if the corresponding cable is connected to the MRx.

•Alarm Pause - pauses all visual and audible physiological alarms and audible inops for the configured time interval. At the end of the pause interval, each alarm returns to its previous setting (On or Off). Also returns alarms to their previous settings.

•Print - initiates a continuous print-out of the primary ECG and the waveform displayed in Wave Sector 2, either real-time or with a 10-second delay, depending on device configuration.

•Summary - displays a menu from which you can print the current or most recent Event Summary report or Vital Signs Trending Report.

•Menu Select - brings up the current menu or confirms a menu selection.

•Navigation - display the current menu just like Menu Select button does; move to the next or previous item in a list; increase or decrease numbers or values in a sequence; may be held down to accelerate through the available choices.

Defibrillation Controls

•Therapy Knob - enables AED or selects an energy for Manual Mode defibrillation or cardioversion.

•Charge - charges the defibrillator to the selected Manual Defib energy setting. Used only in Manual Mode. Defibrillator charges automatically in AED Mode.

•Shock

–delivers a shock through multifunction electrode pads or switchless internal paddles. In AED Mode, a 150J shock is delivered. In Manual Mode, the shock is delivered at the selected energy setting.

–When external paddles or switched internal paddles are used, once the MRx is fully charged, the shock is delivered by pressing the Shock button(s) on the paddles.

NOTE: Internal paddles should only be discussed with clinicians dealing with open chest defibrillation.

• Sync - toggles between asynchronous and synchronous (cardioversion) defibrillation.

Soft Keys

Perform functions presented as labels appearing immediately above the keys on the display. Labels (and related functions) change based on the mode of operation.

2 Getting Acquainted

Lesson Presentation

Indicators

Provide a visual display of device status

Ready For Use (RFU)

•A blinking black hourglass symbol indicates:

–Shock, pacing, and ECG functions are ready for use.

–Sufficient battery power is available for device operation.

–An installed battery is being charged, assuming the presence of external power (AC or DC).

•A blinking red “X” and a periodic audio chirp indicate:

–No battery is present or a low battery condition.

–The device can be used in a low battery condition, but its operation time is limited. If the device is running only on external power, it takes longer to charge. If a battery is inserted and charging, the audio chirp is not present.

•A solid red “X” and a periodic audio chirp indicate:

–A failure that may prevent delivery of defibrillation therapy, pacing, or ECG acquisition. When turned on, the device displays an error message for the first critical failure detected. Consider doing an Operational Check if the device is in this state to isolate the failure.

•A solid red “X” without periodic audio chirps indicates:

–Either no power is available or a catastrophic failure has occurred.

–The device cannot power on. If, after power is supplied, the indicator reverts to the blinking black hourglass symbol, the device is once again ready for use.

Note the following: The RFU indicator may briefly display a solid red "X" when initially turning the device on, when switching between clinical and non-clinical operating modes, and at the start of any automated test.

External Power - lights green if power is being provided by an external AC or DC power source; momentarily goes out when charging for defibrillation with a charged battery installed, as the device switches power source to the battery for a faster charge time.

The front panel also includes the printer door and latch, speaker (for audible alarms and AED voice prompts), and the display (covered in detail later).

Side Panels

•The left panel has:

–Ports for monitoring cables (if ordered), including ECG (for 3-, 5-, or 10-Lead patient cable), pulse oximetry (SpO2), noninvasive blood pressure (NBP), two invasive pressures, temperature, and carbon dioxide (CO2)*.

*For CO2, there is an Inlet port for monitoring tubing and an Outlet port when administering anesthetic gases.

–An ECG Out jack to connect to an external monitor.

•The right panel has:

–A therapy port for paddles (external or internal) or multifunction electrode pads and/or Q-CPR Compression Sensor.

–A slot for a data card to transfer patient information.

Lesson Presentation

2 Getting Acquainted

Top Panel

The top panel has a handle and basic operating instructions. Optional external (adult/pedi) paddles also reside here, if present.

NOTE: Be sure to demonstrate access to the pediatric paddles.

Back Panel

The back panel has:

•Two compartments for lithium ion batteries. Compartment B also used to connect an AC power module.

NOTE: Be sure to demonstrate how to take batteries in and out of the compartments.

•A DC Power Input port.

•An RS-232 serial port for 12-Lead ECG transmission.

•A LAN port for future use.

M3538A Lithium Ion Battery

•Has a fuel gauge with 5 LED indicators, each representing a charge of approximately 20% of capacity. Press the fuel gauge button to illuminate the fuel gauge.

•Should be used as the primary power source, with AC/DC as a secondary source, if desired. If an AC/DC power module is used as the only power source, the MRx takes longer to charge to the desired energy level and, in the event of power loss, all settings reset to the default settings and a new incident is created when power is returned. All stored data remains intact and can be found by retrieving the previous incident. Keep your unit charged.

•A new, fully-charged M3538A battery, operating at room temperature 25oC(77oF), provides

approximately 5 hours of monitoring, with ECG, SpO2, CO2, temperature, two invasive pressures monitored continuously, NBP measured every 15 minutes, and 20 200J discharges. A fully charged

new battery provides approximately 3.5 hours of monitoring, with ECG, SpO2, CO2, temperature, two invasive pressures monitored continuously, NBP measured every 15 minutes, and pacing at

180ppm at 160mA.

•Battery life depends on the frequency and duration of use. When properly cared for, useful life is approximately 2 years. To optimize performance, a fully (or nearly fully) discharged battery should be charged as soon as possible.

2 Getting Acquainted

Lesson Presentation

Additional points/notes:

________________________________________________________________________________

Display View

Introduce the display view characteristics of the MRx, starting with a brief look at the various operating modes. Attach a simulator (set to a normal sinus rhythm), 3-, 5-, or 10-Lead ECG set, and all available parameter accessories to the MRx. Feel free to switch between modes to illustrate display view characteristics; however, consider spending most of your time in Monitor Mode, as it provides the most comprehensive view. You will cover details of the AED, Code, and Pacing views in related lessons later in this guide.

Suggestion: Have students set up their devices with accessories they will use and turn them on to the operating mode(s) you cover to follow your display view introduction. Ask students what they see in each display view you cover versus just telling them what they see.

Operating Modes

The MRx has four clinical modes of operation, each with a customized display view function being performed:

Mode of Operation	Display View	Description

Monitor Mode	Monitoring View or	Monitors ECG, takes an optional 12-lead
	12-Lead View	ECG, and monitors optional parameters
	12-Lead View	such as SpO2, EtCO2, NBP, Invasive
		such as SpO2, EtCO2, NBP, Invasive
		Pressures, and Temperature, and for
		viewing Vitals Signs Trending data

AED Mode	AED View	Analyzes ECG and, if necessary, performs
		semi-automated external defibrillation and
		optional Q-CPR

Manual Defib Mode	Code View	Performs asynchronous and synchronous
		defibrillation (cardioversion) and optional
		Q-CPR, and monitors ECG

Pacer Mode	Pacing View	Performs demand or fixed mode pacing,
		and monitors ECG

Note: Upon returning to a clinical mode from a non-clinical mode such as Configuration or Data Management, all settings are re-set to the device’s default values.

Lesson Presentation

2 Getting Acquainted

Password Security

Access to Manual Defib Mode and Pacer Mode may be password protected if configured. If enabled, you are prompted to enter the password when you move the Therapy Knob to either the Pacer position or an energy selection. Use the Navigation buttons to select the password numbers, select Done, and then press Menu Select to complete the entry. The Charge button and the [Start Pacing] soft key remain inactive until the password is entered. AED Mode is always available without a password.

Note the following: Use of the Manual Therapy Security password requires the clinician to know and remember the password, as defined in Configuration. Failure to enter the correct password prevents manual defibrillation delivery or pacing therapy. Prior to selecting this Configuration option, review this potential risk with your Risk Manager.

Display Layout

The MRx display layout is segmented as follows:

General Status

At the top, this area contains:

•Mark Event button label

•Date and time

•Battery icons

–Labeled “A” and “B” to match battery compartments on back panel.

–Display current available battery power, ranging from hollow (fully discharged) to full (fully charged). If an AC Power Module is in Compartment B, the No Battery icon is displayed.

•Audio recording icon - If the option is enabled, an audio recording icon displays to the left of the battery icons in all clinical modes to indicate the audio recording status.

•Patient information

Some modes of operation permit patient information entry via a menu choice. If no information is entered, the patient category is defaulted to Adult, unless configured otherwise, and the pacing status is set to Non-Paced, unless the Paced status has been previously set to Paced for an internally paced

patient or the MRx is pacing the patient. In Pacer Mode, Paced status is not displayed.

•Patient name -If entered, the patient’s name will appear above the patient type and paced status.

•Inop statements - appear in top left of display if equipment problems occur

•ECG/HR alarm status - alarm messages communicate arrhythmia alarms, as well as overall alarm status (alarms off, alarms paused)

•Event Timer - communicates elapsed time for the current patient incident

Wave Sectors

•MRx displays up to 4 wave sectors with a predetermined waveform, when powered on in Monitor, Manual, or Pacer Mode.

•A dashed line (in a wave sector) or empty wave sector indicates waveform source not connected to MRx.

•Sectors may contain a variety of information, as appropriate to the parameter, view, and task; ECG wave sectors contain a calibration bar.

2 Getting Acquainted

Lesson Presentation

Wave Sector 1

•Will only contain an ECG waveform (used by the arrhythmia, heart rate derivation, and AED analysis algorithms); the waveform may be acquired through the therapy port for pads/paddles or the monitoring port for 3-, 5-, or 10-Lead electrodes.

•If the configured source is not connected to the device when turned on, the first valid ECG source is displayed in Wave Sector 1. Once the source is available, it automatically populates Wave Sector 1.

•The displayed lead/source is controlled primarily by the Lead Select button, although the Displayed Waves menu can be used.

•This sector includes R-wave detection.

•When monitoring using a 3-lead ECG set, the MRx displays only one ECG lead at a time.

•If Pads are configured as the primary ECG source for Wave Sector 1, the ECG patient cable must be connected to the MRx and to the monitoring electrodes in order to change the ECG source to a Leads selection.

Wave Sectors 2-4

•Automatically populate when parameter sources (cables/tubing) are connected to the MRx. Q-CPR compression waveform automatically populates on 150J Manual Defib Mode setting.

•If parameter source is the configured choice of a particular wave sector, it is displayed in that sector.

•If you connect a parameter source that is not configured to be displayed, it displays in the first empty wave sector. If you subsequently connect the configured parameter source, it replaces the current parameter. For invasive pressures, you should label your waveforms as they are connected to avoid possible confusion..

•Displayed lead/source is controlled by the Displayed Waves menu.

•Wave Sectors 2 and 4 may contain a cascaded ECG.

Parameter Blocks

•Provide measurements for displayed waveforms and monitored parameters. The position of most parameters are in fixed locations depending upon the options which were included in your HeartStart MRx.

•Block 1 always contains heart rate and HR alarm settings; may display Pulse, Temp, and NBP schedule, measurements, and alarm settings.

•Block 2 may contain Invasive Pressures, SpO2, EtCO2, and Airway Respiration Rate (AwRR) measurements and related high/low alarm limit settings; “-?-” is displayed until a valid measurement

is obtained; settings may contain the Alarms Off icon. Block 2 may also contain Q-CPR compression and ventilation values.

•Invasive Pressures, Temp, SpO2, and EtCO2 measurements are activated when associated cable/ tubing is connected; if a cable/tubing is disconnected, a prompt message requests approval to turn

off the measurement.

•Alarm messages appear in the space above each numeric value, replacing a parameter label.

Suggestion: Have students disconnect and reconnect parameter accessories to see how parameter blocks are affected. Ask students what they see when detaching and attaching an accessory cable or tubing.

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2 Getting Acquainted

Soft Key Labels

•Correspond to soft key buttons.

•Change according to the current display view and function.

•Grey text labels indicate inactive soft keys (e.g., Disarm in Manual Mode).

Suggestion: Switch between modes to show different labels, with students following along.

Display Menus

•Provide controls and options specific to each function.

•Accessible through Menu Select and Navigation buttons.

•Used to adjust volume, select waveforms for display, set alarms, schedule measurements, enter patient information, perform an Operational Check, generate reports, etc.

•Press Menu Select button to activate selections; select Exit to close menus without activating selections.

Suggestion: Access different menu options to illustrate various menu functionality (e.g., changing waveform for a sector, the patient’s age, alarm limits, etc.). If you access the Patient Info menu, point out that a patient’s full name is entered using 2 alphabetical lists, one to enter last name, followed by another to enter first name. When each name is complete, select Done. When entering names, follow your organization’s or HIPPA regulations.

Message Windows

•Provide status information.

•Alert you to an error or a potential problem.

•Direct you to take action.

•Use the Navigation and Menu Select buttons to respond to messages.

High Contrast Display

•Provides a High Contrast view to optimize visibility of the MRx display when used in bright sunlight.

•Display appears with a yellow background and all other screen elements appearing in black or shades of gray.

•Select High Contrast On from the Main Menu to enable the feature.

Note the following: The High Contrast view does not display the colors red or blue, therefore, be sure the MRx is configured correctly with the appropriate parameter color settings.

Suggestion: Have students set their devices to the High Contrast view any time during your discussion.

2 Getting Acquainted

Lesson Presentation

Additional points/notes:

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Responding to Alarms

Create an alarm condition and cover the following steps to respond to the condition.

1.Attend to the patient.

2.Identify the alarm(s) indicated.

3.Silence the alarm(s). When a physiological alarm is announced, the Audio Pause label displays above the Navigation and Menu Select buttons. Pressing any of these buttons silences the audio for all active alarms while you are attending to the patient. If the alarming condition continues to exist, it will re-alarm in two minutes. Silencing a specific alarm does not prevent another alarm condition from sounding. If you also silence the second alarm, it resets the two-minute audio pause for all active alarms.

When an INOP is announced without a concurrent physiological alarm, the Audio Off label displays above the Navigation and Menu Select buttons. Pressing any of these buttons silences the audio for all active alarms while you are attending to the patient. INOPs do not reannunciate after pressing audio off.

4.Address the alarm condition with one of the following options:

–Acknowledge - For latching alarms, acknowledge clears the alarm condition when the condition no longer exists.

–New Limits - Adjust the parameter limits accordingly.

–Alarms Off - Turns the monitoring parameter’s alarms off and prevents real-time print strips. The alarm message is no longer displayed, and the Alarm Off icon appears next to the parameter value.

Note the following: Turning off alarms turns them off indefinitely.

–Although the Alarm Pause button can be used when responding to alarms, the response procedures described above are recommended. Alarm Pause removes audio and visual indications of active alarm conditions as well as inhibiting indications of new alarm conditions.

–A potential hazard exists if different alarm limits are used for the same or similar equipment in any single area.

–Confirm the alarm limits are appropriate for the patient each time there is a new patient incident.

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2 Getting Acquainted

– Do not set alarm limits to such extreme values that render the alarm system useless.

Suggestion: Note that you will also cover alarm limits in detail in the ECG and Arrhythmia Monitoring lesson later in the training and students will be able to practice with alarm conditions at that time.

Additional points/notes:

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Continued Use

Cover the characteristics associated with MRx’s continued use feature.

•Activated once a patient event is started.

•Facilitates continued treatment of the same patient by retaining current settings and the patient record when the MRx is turned off for less than 10 seconds or switching between modes (e.g., Monitor, AED, and Manual Defib).

•MRx retains the most recent settings, including:

–Alarm settings

–Wave Sector settings

–Event Timer

–QRS, alarm tone, and voice prompt volumes

–ECG gain

–Pacing settings

–Patient record in the Event Summary Report; new data is appended to the record

•This feature will not function if all power sources (battery and external AC/DC power modules) are removed from the device, even briefly.

Suggestion: Have students shut off MRx and turn it back on within 10 seconds. Then, ask them to state some of the settings that are retained. Consider having students complete this task before giving them the above list of retained settings.

2 Getting Acquainted

Lesson Presentation

Printing Waveforms

Describe waveform printing characteristics and procedures.

•Obtain a continuous printout of the primary ECG and one additional waveform on a 50mm printer.

•Obtain a continuous printout of the primary ECG and two additional waveform on a 75mm printer.

•Certain waveforms (including invasive pressures and CO2) include scale indications on the printout.

•Printouts are generated either real-time or with a 10-second delay, depending on your configuration.

To change wave forms for the second wave printed with a 50mm printer:

1.Press the Menu Select button.

2.Using the Navigation buttons, select the Printed Waves option and press Menu Select.

3.Using the Navigation buttons, select the wave form you want to print in Wave 2 and press Menu Select.

To change wave forms for the second or third wave printed with a 75mm printer:

1.Press the Menu Select button.

2.Using the Navigation buttons, select the Printed Waves option and press Menu Select.

3.Using the Navigation buttons, select Wave 2 or Wave 3 and press Menu Select.

4.Using the Navigation buttons, select the wave form you want printed and press Menu Select.

5.Repeat Steps 2 through 4 for the other printed wave.

Return to Owner

Discuss the Return to Owner feature and demonstrate how to enable and disable it.

•Lets the MRx owner specify a loan period, after which the MRx borrower is reminded to return the device to its owner.

•Password protected in Configuration. Each device should have a unique password.

•Monitoring and defibrillation functions are suspended while the Return to Owner set-up screen is displayed. Alarms Off is indicated on the display. Monitoring and defibrillation functions will return when exiting the Return to Owner screen

•The appearance of the loan expiration message does not disable monitoring and defibrillation functionality.

To enable this feature:

1.Press the Menu Select button.

2.Select Other and press Menu Select.

3.Select Return To Owner and press Menu Select.

4.Press the [Activate] soft key.

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2 Getting Acquainted

5.Enter the number of days in the loan period and press Menu Select.

6.Press the [Exit Return-To] soft key.

To disable this feature:

1.Press the Menu Select button.

2.Select Other and press Menu Select.

3.Select Return To Owner and press Menu Select.

4.Press the [Deactivate] soft key.

5.Enter the password and press Menu Select.

6.Press the [Exit Return-To] soft key.

Additional points/notes:

________________________________________________________________________________

2 Getting Acquainted

Lesson Presentation

Carrying Case and Accessory Pouch Assembly

This topic should be covered for only customers who have carrying cases and accessory pouches, as appropriate. Discuss the following procedures for carrying case assembly and recommended accessory placement.

1.Disconnect all external power and remove all batteries.

2.Lower the device into the sleeve of the carry case. The rear base of the device fits in the sleeve socket.

Paddle Tray

a.If paddles are connected, disconnect them from the Therapy port and remove them from the paddle tray.

b.Remove the four T-15 screws from the tray plates.

c.Gently lift the paddle tray up, leaving all wires connected.

Handle Only

a.Remove the handle cover by pushing in on either side of the handle cover and lifting up.

b.Remove the two T-15 screws.

c.Remove the handle.

d.Gently lift the cap plate up.

3.Fold the two sleeve flaps over the top of the device, positioning them so that the screw holes are exposed.

4.Replace the paddle tray or cap plate, as appropriate, so that the molded openings fit over the sleeve flaps.

5.Secure the front and rear cinch straps using the metal rings provided.

6.Perform an Operational Check on the MRx.

7.Attach the side pouches using the snaps located inside the pouch pockets.

The following illustrations show carrying case and accessory pouch assembly.

Lesson Presentation		2 Getting Acquainted

Philips HeartStart MRx M3535A, HeartStart MRxM3536A User manual

2 Getting Acquainted

Lesson Presentation

Storing Accessories

1. Store parameter cabling and accessories as shown below.

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2.Attach the Therapy cable and route it through the cable fastener loop, securing the cable just below the strain relief. (See below left.)

3.Attach the rear pouch using the buckles provided. (See below right.)

Note: Depressions are provided on the inside of the rear pouch should you wish to make a cut-out to accommodate external power.

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