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070-2567-03 Rev. A

iii

written permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by

U.S. and foreign patents and/or pending patents. Specifications and price change privileges are

reserved.
Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and perfor-

mance of the equipment only if:

• Assembly operations, re-adjustments, modifications or repairs are carried out by per-

sons authorized by Spacelabs Healthcare, and

• The electrical installation of the relevant room complies with the requirements of the

standard in force, and

• The equipment is used in accordance with the operations manual.

Spacelabs Healthcare will make available, on request, such circuit diagrams, component part lists,

descriptions, calibration instructions or other information which will assist appropriately quali-

fied technical personnel to repair those parts of the equipment which are classified by Spacelabs

Healthcare as field repairable.
Spacelabs Healthcare is committed to providing comprehensive customer support beginning with

your initial inquiry through purchase, training, and service for the life of your Spacelabs Health-

care equipment.

CORPORATE OFFICES

Spacelabs Healthcare Inc
35301 SE Center St,
Snoqualmie, WA 98065.
USA

Tel: +1 425 396 3300
Fax: +1 425 396 3301

Spacelabs Healthcare Ltd
Unit B, Foxholes Centre,
John Tate Road, Hertford.
SG13 7DT. UK

Tel: +44 (0) 1992 507700
Fax: +44 (0) 1992 501213

Brands and product names are trademarks of their respective owners.

Caution:

US Federal law restricts the devices documented herein to sale by, or on the

order of, a physician.

CE marked in accordance with the Medical Device Directive, 93/42/EEC.

This manual was developed to provide key concepts about safety precautions.

Warnings:

Alert the user to potential serious outcomes (death, injury, or serious adverse

events) to the patient or user.

Cautions:

or precautions alert the reader to exercise special care necessary for the safe

and effective use of the device. They may include actions to be taken to avoid

effects on patients or users that may not be potentially life threatening or

result in serious injury, but about which the user should be aware. Cautions

may also alert the user to adverse effects on the device of use or misuse and

the care necessary to avoid such effects

Note:

A Note provides useful information about a function, or a procedure.

Содержание 98000

Страница 1: ...Pathfinder SL v1 9 98000 Ambulatory ECG Analysis System O P E R A T I O N S M A N U A L 070 2567 03 Rev A www spacelabshealthcare com...

Страница 2: ...Further instances of this symbol within this manual may be represented in black and white WARNING Actions or circumstances that may result in personal injury or death NOTE Further instances of this s...

Страница 3: ...ehensive customer support beginning with your initial inquiry through purchase training and service for the life of your Spacelabs Health care equipment CORPORATE OFFICES Spacelabs Healthcare Inc 3530...

Страница 4: ...Pathfinder SL v1 9 Operations Manual iv This page is intentionally blank...

Страница 5: ...sclaimer 1 4 1 7 Installation Information 1 4 1 8 Working with Pathfinder SL 1 4 1 8 1 Sitting Properly 1 5 1 8 2 Arranging the Equipment 1 5 1 9 UDI Identifier 1 5 2 Pathfinder SL System 2 1 The Time...

Страница 6: ...L Workflow 5 1 Triage the recording 5 1 5 2 Scan the Recording 5 3 5 3 Full Disclosure ECG Scan 5 3 5 4 Superimposition AVSEP Scan 5 3 5 4 1 Arrythmiagraph Markers 5 4 5 5 Starting ECG Scan 5 4 5 5 1...

Страница 7: ...it Patient Details Diary Events 9 4 9 5 1 Patient Events 9 4 9 6 Atrial Fibrillation AF 9 4 9 6 1 Manual Creation of AF Events 9 5 9 6 2 Editing AF 9 5 9 6 3 Mark Entire Recording as AF 9 5 10 Report...

Страница 8: ...n Analysis 15 2 15 5 Frequency Analysis 15 2 15 6 Viewing On screen Epoch Reports 15 3 15 7 HRV Screens 15 4 15 8 Summary Statistics Screen 15 4 15 9 Multi Epoch Analysis of HRV Screen 15 5 15 9 1 To...

Страница 9: ...QT analysis 18 2 18 3 Prospective QT Analysis 18 3 18 4 QT Histogram 18 5 18 5 QTc Histogram 18 5 18 6 Trends 18 6 18 7 Scatter Plot 18 7 18 8 QT Strips 18 7 18 9 Summary Report 18 8 18 10 Hourly Rep...

Страница 10: ...Pathfinder SL v1 9 Operations Manual x 19 4 ST Graphs 19 4 19 5 ST Event Table 19 4 19 6 Not ST Button 19 5 19 7 12 Lead ST 19 5 19 8 ST Reports 19 5 20 Signs and Symbols...

Страница 11: ...ion by polysomnography based on the patient s score The EGG recording may be obtained at any location specified by a physician including home hospital or clinic Subjects screened for sleep apnea shoul...

Страница 12: ...act the Service Department Do not drop the equipment or subject it to excessive bumping or jarring Do not obstruct cover or poke objects into the equipment 1 2 3 FCC Compliance and Advisory Notice Thi...

Страница 13: ...System testing should be entrusted to a trained service engineer Please contact your supplier if you require the system checkout procedure The supporting PC should be regularly serviced maintained and...

Страница 14: ...e installing the software This equipment must be earthed grounded The equipment should be installed in an area that is well ventilated clean dry and where the ambient temperature is between 10 C to 32...

Страница 15: ...e supported 1 8 2 Arranging the Equipment Ensure that the operating environment is free from interruptions to prevent operator error during analysis Glare and reflections from lights and windows shoul...

Страница 16: ...Pathfinder SL v1 9 Operations Manual 1 6 This page is intentionally blank...

Страница 17: ...of the screen can be split into several sections Title Bar The bar across the very top of the screen shows the patient s name and ID Main Menu Click on these text titles to open operational menus Thes...

Страница 18: ...rposes Switching between screens is simple as the time being displayed is consistent on all screens that support any idea of a current time Screen Selector Icon Description Full disclosure This displa...

Страница 19: ...CG ST ST data analysis and graphs QT Statistical QT data HRV Statistical Heart Rate Variability data and graphs Advanced HRV Time Domain data and spectral frequency HRV analysis Advanced QT Beat to Be...

Страница 20: ...the Back or Forward buttons found on the Time Bar to navigate time cursor positions Print a page direct This will not be included in the final report but is useful for immediate print out review Prin...

Страница 21: ...rs over the same action occurs requiring less mouse moves during the analysis This setting can also group three adjacent buttons on the control panel to respond to the three buttons on a 3 Button Mous...

Страница 22: ...rkers A green line under an Event yellow for currently selected events Grid The ECG grid Calibration Pulse The cal pulse icon shown on the left of every ECG strip The operator may also change the beat...

Страница 23: ...open them Depending on the screen you are in there will be different options on the context menus Context menus are also available from within tables of data 3 4 Other controls and buttons There are o...

Страница 24: ...Sentinel network This includes the special New Analysis Setup which is the initial default for all Pathfinder SL analyzers Local Setups contains setups that are only visible to this analyzer These set...

Страница 25: ...operator is informed when creating a Global setup that the setup will be visible to all other Pathfinder SL analyzers in the Sentinel network Overwrite setup Saved named setups can be modified by the...

Страница 26: ...Activated Dongle Reader This enables the operator to view which options have been activated on their Pathfinder SL system To launch this utility All Programs Spacelabs Healthcare Pathfinder SL Dongle...

Страница 27: ...ted areas in order to check that important events have not been missed The recorder instruction manuals define the conditions for a good hook up When severe artifact is present in one or more channels...

Страница 28: ...ling RR Interval On Bigeminy 2 cycles On Trigeminy 2 cycles On IVR 3 beats at 40 bpm On V Run AIVR 3 beats at other rates On VT 3 beats at 100 bpm until rate 90 bpm On Rate Dependant Events Dropped Be...

Страница 29: ...and select Manage Setups Select Create New Setup and enter a new name Close the dialogue The new settings have now been stored When starting a new analysis if the operator wishes to use them go to Man...

Страница 30: ...s Event duration Highest HR SVE Couplet Event duration SVE SV Escape Interval Tachycardia Max HR Number of intervals Event duration Highest HR Sinus Rhythm Number of beats Event duration Max Min Heart...

Страница 31: ...ct Exit or click on the red X in the top right corner of the screen A dialogue will prompt the operator to select Save to store any analysis completed so far Pathfinder SL will close taking the operat...

Страница 32: ...n the recording to the end All Apply the changes from the beginning of the recording to the end Cancel Not apply any changes The screen is split into sections by channel At the bottom of the screen th...

Страница 33: ...was previously sinus then the subsequent beat will now be labelled S 4 9 Enable Disable Channels Where excessive noise or channel dropout has occurred the section of the trace may be selected and the...

Страница 34: ...Pathfinder SL v1 9 Operations Manual 4 8 This page is intentionally blank...

Страница 35: ...SL analyzer Note Previously started Pathfinder SL analyses can also be re opened from this screen 5 1 Triage the recording Step One The first screen displayed is the Full Disclosure Note The Operator...

Страница 36: ...ssifications on off using the trigger icon From the Full Disclosure toolbar select the ECG channels leads to be displayed by clicking on the channel selection icons 1 2 3 for 3 Lead recordings or 12 C...

Страница 37: ...in either Full Disclosure or Superimposition AVSEP Both of these ECG scan mode displays can be configured by the operator Once a suitable configuration has been set these can be stored as the default...

Страница 38: ...and dP there are also fixed markers for the Min Max Mean HR in the recording The Page Up and Page Down buttons on the control panel allow the operator to move through the Arrythmiagraph one page at a...

Страница 39: ...er The ECG scan will automatically resume Print This both confirms the event as correct and will print it in the final report The ECG scan will automatically resume Review For operators who are not co...

Страница 40: ...create a custom event These events will be added to the Event Review screens for the operator to select for printing Note Creating a Max or Min Heart Rate event will overwrite the analyser defined Max...

Страница 41: ...de all channels or what is displayed on screen 5 9 Periodic Strips The Periodic Strips function allows the analyzer to automatically create an ECG strip for each hour of the recording The purpose of t...

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Страница 43: ...Control Shift End You can use Shift Page Up and Page Down keys to select a page of ECG at once To move a single lead up and down 1 Hold down the left Alt key on the keyboard 2 With the mouse cursor po...

Страница 44: ...it is difficult to click in the middle of it without being so near one of its ends that a re size is done instead 6 2 Keyboard There are a number of Windows based keyboard commands in the analyzer Com...

Страница 45: ...Decreases ECG row height by 5 mV Alt Alt comma Go to previous ECG marker Ctrl Alt Go to first ECG marker Mnemonic The comma key is also the key Alt Alt period Go to next ECG marker Ctrl Alt Go to last...

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Страница 47: ...pause the analysis The screen is split into several sections The top half of the screen shows the different morphology or form types by tab The default tabs are Ventricular Normal SV Unclassified Remo...

Страница 48: ...d in their normal colors Re classify Forms Beats in Forms Select the form or beat Either select the new classification from the left control panel or right click and select it from the menu Where you...

Страница 49: ...n a Form The operator can select single or multiple beats by holding the Ctrl key or right clicking on a beat and selecting Select Similar beats Use the create new form to add the beats to a new form...

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Страница 51: ...they refer to the Spacelabs Healthcare Glasgow Algorithm Interpretation Guide for more information about the statements made and their individual criteria When evaluating risk of Left Ventricular Hyp...

Страница 52: ...on at the top of the screen If interpretation is enabled on the systems right click on a region of the ECG and select Twelve Lead Interpretation This opens the 12 Lead ECG Viewer and displays the ECG...

Страница 53: ...will reappear Note Enabling either of the marker options adds they relevant menu option to the right mouse context menu 8 3 3 Making Measurements with Markers These are single vertical measurement mar...

Страница 54: ...he mouse is over the line and drag to the new position The values of time interval in msec and of deviation in mV are updated as the caliper moves 8 3 7 Markers Caliper and keyboard shortcuts Left Arr...

Страница 55: ...y selected marker caliper if any from the currently se lected ECG trace PgDn Select the next ECG trace PgUp Select the previous ECG trace Left Arrow Move currently selected marker left by one sample R...

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Страница 57: ...interval length is shown along the X axis in ms with the frequency of the interval up the Y Axis Look to the left of the histogram for short intervals fast heart rates and to the right for long inter...

Страница 58: ...creen Across the top of the display there are 3 tabs The default view is the event as an 8 second strip However the Event can also be viewed in Multiline ECG and the Event Strips that will be printed...

Страница 59: ...own to re frame the ECG displayed Use the Print Confirm Artifact icons on the left control panel to work through the list When the operator is satisfied that representative strips have been selected f...

Страница 60: ...the Patient diary and event correlated ECG events Click on the Settings cog to switch on or off event correlation and the time window before or after that the operator wishes events to be displayed Ot...

Страница 61: ...from the Event Editing Screen using the tools described above Where the operator does not agree that AF is present they may either 1 Click on the button Not AF 2 Highlight the ECG and select the menu...

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Страница 63: ...can be displayed throughout the analysis for typed comments and review The screen displays the basic patient demographics and event reporting that will be in the final printed report As the analysis...

Страница 64: ...cations field on the Diary Events tab of the Pathfinder SL Patient Details dialog Test Comments These can either be entered on the Sentinel Test Details page or on the Patient details dialog 10 2 Prev...

Страница 65: ...an be set in the Report Settings menu Report sections can be set including a selection of two different front page reports Section settings Patient details event order and channel selection in a full...

Страница 66: ...ions are created every time 10 3 Exporting Data It is possible to export analysis data from Pathfinder SL by selecting the Analysis Export menu option Data can be exported in the following formats As...

Страница 67: ...was programmed so it is unable to determine if any detected pacing behavior is correct or not Pathfinder SL can detect triggers and based on the relative position of pacing pulses recorded by the reco...

Страница 68: ...ications are correct 11 3 Pacing Histograms This section show 3 tables RR Intervals Pace spike to Pace spike intervals and Trigger to pace spike intervals Each table has rows showing a variety of deta...

Страница 69: ...pike 11 3 3 Trigger to Pace spike Intervals This table displays the number of pace spikes by interval length from the Trigger R in ms As an Atrial Ventricular pace spikes should precede a trigger the...

Страница 70: ...rding Un paced Atrial Paced Ventricular Paced Dual Paced and Unknown beats The sum of other these is then shown in the 3rd table 11 7 Paced Event Table This presents a list of Paced Events that have b...

Страница 71: ...he same marker point will be shown in all 3 graphs Customers who purchased the 2nd display option will find it a useful tool when reviewing the graphs Use the Right mouse to zoom in out of the trends...

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Страница 73: ...ll instances of that event in the recording will be displayed chronologically Use the event editing control panel on the left of the screen to Print Confirm Artifact events Next to just display each o...

Страница 74: ...e You should only edit the Trend Table once the analysis is complete and you want to make a final correction to the values If you decide that the edits are incorrect you can right click and select Und...

Страница 75: ...are calculated and their definitions The HRV Analysis option enables you to have a detailed look at the Heart Rate Variability and operates in parallel with Arrhythmia analysis Note It is important t...

Страница 76: ...the total at the bottom SDNN Standard deviation of all NN intervals per hour and 24 hours Increases and decreases SDNNi The average of the standard deviations of each consecutive 5 minute segment in...

Страница 77: ...the screen to view the HRV Graphs The HR and NN graphs are displayed on the top of the screen The bottom of the screen show the NN Interval distribution histogram and 2 scatter plots NN to NN Interval...

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Страница 79: ...lity of the heart Parasympathetic which causes a decreased HR This phenomenon is also referred to as vasovagal tone or sympathovagal balance Changes in the balance of sympathetic parasympathetic contr...

Страница 80: ...y 7 Click Time Domain 8 Click on the down arrow for the length in minutes 1 5 10 15 30 60 or user entered of the epoch s to be defined for analysis The current standard is 5 minutes 9 Click on the dow...

Страница 81: ...screen to enable and view different parts of the Report 4 The screen defaults with the Details button enabled which shows details of the report 5 If you wish to change the duration of the epoch click...

Страница 82: ...cribed on the following pages Summary Statistics Multi Epoch HRV Scatter Plot NN Scatter Plot All NN Interval Histogram RR Intervals Frequency 3 D 15 8 Summary Statistics Screen The Summary Statistics...

Страница 83: ...view on the left click Multi Epoch HRV 2 Click in the Mean Epoch RR Interval Standard Deviation chart to select a time of interest When you click in this chart the corresponding ECG displays above the...

Страница 84: ...R to R intervals of different beat types n compared to intervals of following beats n 1 This plot is for all beats A color coded chart is shown on the right side of the screen Each color indicates a s...

Страница 85: ...ion of Normal to Normal TINN represents the minimum square difference interpolation of the frequency distribution histogram of the Normal to Normal R R histogram The TINN value shown in the upper righ...

Страница 86: ...or forward at 30 second intervals 7 To reset the chart to its original state click the Reset button 15 12 Frequency 3D Screen The Frequency 3D screen shows the results of an automatic multi epoch freq...

Страница 87: ...currently rotated 7 To change the format of how the epoch PSD values are drawn click either Line or Bar as appropriate 15 13 HRV Terms and calculations NN 50 This is the count of successive normal to...

Страница 88: ...period For each period there must be at least a minimum amount of valid interval time otherwise the rate is set to 0 for that period See the table below for details Analysis Period Minimum Interval Ti...

Страница 89: ...rdiogram ECG Apnea reports the Estimated Apnea Hypopnea Index Est AHI indicating the probability that the patient suffers from Sleep Disordered Breathing The recording must include at least 4 continuo...

Страница 90: ...curacy will be compromised if the QRS is very low amplitude noisy or if there is significant artifact in the recording Apnea calculates an estimated Apnea Hypopnea Index which may differ from the true...

Страница 91: ...nd color of a bar represents the probability 0 100 of there having been an apnea event in that minute segment Red Probability 50 or more Apnea is indicated Green Probability less than 50 Apnea was not...

Страница 92: ...ows the Sleep Period Number followed by the mean Estimated AHI EDR Estimated Dervied Respiratory The EDR graph values is derived from the sleep apnea algorithm it is intended to approximate the signal...

Страница 93: ...wave QT Prolongation of the QT interval may occur at any time regardless of heart rate QT correction QTc takes into account the fact that the QT is longer at rest than in activity Automated analysis a...

Страница 94: ...for each channel 17 3 1 QT Graphs There are graphs of the 1 minute average heart rate and the 1 minute average QT The QT graph can be changed to QTc by clicking on the Corrected icon on the toolbar Th...

Страница 95: ...g the selected correction formula Min 1 minute HR bpm The shortest QQ intervals expressed as an equivalent BPM Max 1 minute HR bpm The longest QQ intervals expressed as an equivalent BPM Percent analy...

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Страница 97: ...s 18 1 QT Option Overview Advanced QT analysis is performed only on analyzed ECG active in the Pathfinder SL Holter system Click on the Adv QT icon If the recording is more than 24 hours the analyzer...

Страница 98: ...iginal position or negative move cursor to the left of the original position The value of the offset is in n milliseconds The system pro vides default values which can be changed as needed c For R wav...

Страница 99: ...Advanced Options This will allow you to see and correct any analysis problems using the Beat manipulation options If you select None the analysis will be performed non stop 3 Select the Active Channel...

Страница 100: ...lidated and the measurement cursors repositioned when analysis is halted as previously described 7 At the end of analysis press the End Analysis button and at the next screen click on OK to accept the...

Страница 101: ...button located above the graph The validation buttons toggle depending on the beat you select The buttons will show Make Valid for invalid beats or Make Invalid f or Valid beats If you change the val...

Страница 102: ...blue the QT is pink To see the ECG click on the Beat icon at the top of the screen The ECG will display at the top of the Trend reports Then click the desired Trends report to see the corresponding EC...

Страница 103: ...Arrow and or Zoom icons on the toolbar at the top of the screen No editing can be performed in this view 18 8 QT Strips Click on the QT Strips title to view the strips Corrections may be made in this...

Страница 104: ...mary Report Click on Summary Report to see the recording statistics The criteria used for analysis are included in this report 18 10 Hourly Reports Click on QT and QTc Hourly Report to see the mean ma...

Страница 105: ...sis is not enabled in your system the section entitled Prospective Analysis will be greyed out The remaining hourly reports have a similar appearance to that shown above 18 12 QT Detection Criteria If...

Страница 106: ...exceptionally long or short using the QT Value Range QT analysis becomes unreliable at high heart rates due to the P wave encroaching on the end of the T wave The Max HR should be set at 150 or less f...

Страница 107: ...ning the maximum minimum and standard deviation values reported in the report summary and tables Threshold Levels Intervals over the user defined thresholds are reported as a over QT RR Ratio NN Filte...

Страница 108: ...native form Note The QT text file is large 18 17 To Print the QT Report 1 Go to the File Menu and select Exit 2 A dialog will open advising that the configured files xml and xls have been exported and...

Страница 109: ...click on the ST screen selector icon 19 1 The ST Screen The ST screen is split into 2 parts On the left there is a single ST complex shown in all 3 channels You can show hide a channels by clicking o...

Страница 110: ...ion depression and elevation and shown in red on these graphs 19 2 ST Action Replay Display The ST Action Replay Display allows the operator to playback the ECG in a superimposition mode so they make...

Страница 111: ...an event Event Minimum Duration This is the shortest time the deviation must last to qualify as an event Event Hysteresis Thresholds To qualify as the end of the event the deviation must fall below t...

Страница 112: ...t channel from the report This can also be done from the ST Action replay display by right clicking on the ST graph for a specific channel and selecting Disable ST analysis for this channel The channe...

Страница 113: ...ion within the Pathfinder SL report contains a summary of the ST segment shifts including the total number of ST episodes the max ST Deviation the time of the max deviation and the Ischemic Burden of...

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Страница 115: ...onsult Documents THIS SYMBOL MEANS YOU MUST READ THE ACCOMPANYING DOCUMENTS WARNING Actions or circumstances that may result in personal injury or death Caution hazardous voltages To reduce risk of el...

Страница 116: ...ent applied part which contains an adequate degree of protection against electric shock and is defibrillator proof IEC 60601 1 Type BF equipment The unit displaying this symbol is an F Type isolated f...

Страница 117: ...Infra Red Communications Port PRINT REPORT Key Universal Serial Bus USB Network Connection Power Indicator LED Audio Output Speaker HELP Explain Prior Screen Key Data Input Output Keypad Arterial Puls...

Страница 118: ...emperature imitations Environmental Shipping Storage Humidity Limitations This Way Up Fragile Handle with Care Environmental Shipping Storage Altitude Limitations Recycle All batteries should be dispo...

Страница 119: ...s and Abbreviations Abbreviations used as symbols are shown below CH ch ECG Channel ECG Channels CH1 CH2 CH3 CH4 C O CO co Cardiac Output DIA dia Diastolic ECG Ecg Electrocardiogram ESIS Electrosurgic...

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Страница 121: ......

Страница 122: ...425 396 3300 1 800 522 7025 Unit B Foxholes Centre John Tate Road Hertford SG13 7DT UK T 44 0 1992 507700 F 44 0 1992 501213 www spacelabshealthcare com 2018 Spacelabs Healthcare Specifications subje...

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