ZOE 740 SELECT User Manual

Multi-parameter monitor
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Multi-Parameter Monitor
User Manual Addendum - ECG & Resp Parameters
This User Manual Addendum describes the features and operations of
the
740
SELECT
21-22-0335 Rev D
740
SELECT
Multi-Parameter monitor: Software Version 2.3 or above.
Page 1 of 40

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Summary of Contents for ZOE 740 SELECT

  • Page 1 ™ SELECT Multi-Parameter Monitor User Manual Addendum - ECG & Resp Parameters This User Manual Addendum describes the features and operations of Multi-Parameter monitor: Software Version 2.3 or above. SELECT 21-22-0335 Rev D Page 1 of 40...
  • Page 2: Overview

    Zoe Medical, Inc. ™ SELECT is a trademark of Zoe Medical, Inc. Refer to the SELECT User Manual, Zoe Medical PN 21-22-0316, for a list of trademarks. 21-22-0335 Rev D Page 2 of 40...
  • Page 3: Contact Addresses

    Overview SELECT CONTACT ADDRESSES Zoe Medical, Inc. 460 Boston Street Topsfield, MA 01983 U.S.A. Phone: (978) 887-4013 Fax: (978) 887-1406 E-Mail: customersupport@zoemedical.com Web: www.zoemedical.com 21-22-0335 Rev D Page 3 of 40...
  • Page 4: Conventions Used In This Manual

    This Manual addresses all optional ECG parameters of the SELECT monitor. Read this Manual carefully before patient use of the Monitor. Zoe Medical reserves the right to make changes to this Manual and improvements to the product it describes at any time without notice or obligation. © Copyright 2021 Zoe Medical.
  • Page 5: Table Of Contents

    Overview SELECT TABLE OF CONTENTS Overview ......................2 TRADEMARKS ......................2 CONTACT ADDRESSES ..................... 3 CONVENTIONS USED IN THIS MANUAL ..............4 REVISION HISTORY ....................4 WARRANTY ........................ 4 INTENDED USE ....................8 INTENDED USE ......................8 OVERVIEW OF HEART RATE MONITORING ............8 OVERVIEW OF RESPIRATION RATE MONITORING ..........
  • Page 6 Overview SELECT RESPIRATION SETUP ....................28 RESPIRATION WAVEFORM ................. 28 RR PARAMETER SETUP ..................29 RR ALARM LIMITS: ....................29 RR AUTO (set) ALARM LIMITS ................29 TESTING RR ALARMS ....................30 RESPIRATION RATE MONITORING MESSAGES ............ 31 ACCESSORIES ....................32 ECG - AAMI .......................
  • Page 7 Overview SELECT TABLES Table 1: HR Auto Alarm Limit Adjustment Table 2: HR Monitoring Messages Table 3: RR Auto Alarm Limit Adjustment Table 4: Resp Monitoring Message Table 5: AAMI ECG parts and accessories Table 6: IEC ECG parts and accessories Table 7: ECG - HR &...
  • Page 8: Intended Use

    INTENDED USE Full Indications for Use and Contraindications may be found in the User SELECT Manual, Zoe Medical PN 21-22-0316. monitor facilitates the monitoring of: SELECT  ECG and heart rate (HR) with the ECG option for adult and pediatric patients;...
  • Page 9: Overview Of Respiration Rate Monitoring

    RR from the CO waveform. In this case the Resp/RR feature from ECG is disabled. Refer to User Manual Addendum - ETCO Parameter, Zoe Medical PN 21-22-0333 for more information. PEDIATRIC CONSIDERATIONS Cardiogenic artifact (heart rate pulsations that appear as "breaths" in the respiration signal) can be quite pronounced in Pediatric patients.
  • Page 10: Ecg Monitoring

    Additionally, proper placement of defibrillator paddles in relation to the ECG electrodes is required to minimize harm to the patient. Only use accessories approved by Zoe Medical for use with the monitor.
  • Page 11: Cautions

    Read safety instructions provided with a defibrillator. The monitor is designed to withstand defibrillation and will recover within 5 seconds, per IEC 60601-1. Only use accessories approved by Zoe Medical for use with the monitor. Warning: Operating the monitor with HR/PR limit alarms disabled means that no low or high HR/PR alarm conditions will produce alarm notifications.
  • Page 12: Getting Started With Ecg

    ECG MONITORING SELECT GETTING STARTED WITH ECG To begin monitoring ECG, use the following procedure: 1. Connect the ECG Patient Cable to the Monitor Locate the ECG Patient Cable Receptacle on the side of the Monitor. Refer to Figure 1. ECG Patient Receptacle on Monitor Receptacle key Figure 1: ECG Patient Cable Receptacle on left side of Monitor...
  • Page 13: Figure 2: Ecg Patient Cable Connected On Monitor

    ECG MONITORING SELECT Insert the ECG Patient Cable to the ECG Patient Cable Receptacle located on the on the left side of the Monitor. Refer to Figure 2. Note: The ECG Receptacle is keyed so that the ECG Patient Cable can only be inserted into the monitor in one orientation.
  • Page 14: Figure 3: Ecg Lead Set Connected On Ecg Patient Cable Yoke

    ECG MONITORING SELECT 2. Connect the ECG Lead Set to ECG Patient Cable Connect an appropriate ECG 3-Lead Set (1 meter length) to the ECG Patient Cable (2 meter length). ECG 3-Lead Sets are available in AAMI or IEC colors, snaps (adult/pediatric), or mini-clip (neo) lead sets that to attach to the ECG electrodes.
  • Page 15: Checking The Ecg Signal

    ECG MONITORING SELECT CHECKING THE ECG SIGNAL When you have connected the patient following the steps listed above, you should be able to see a clean ECG signal similar to the Figure 4 below on the monitor display. If the ECG contains artifact or noise, review the steps for proper electrode site preparation and placement (see following pages).
  • Page 16: Electrode Placement

    ECG MONITORING SELECT ELECTRODE PLACEMENT STANDARD PLACEMENT (AHA) For ECG cable lead sets with AHA (USA) lead designations, position the electrodes as shown in Figure 5 below: RA (White) LA (Black) LL (Red) Figure 5: Standard AHA Electrode Placement 1. Position the right arm (RA) electrode on the right mid-clavicular line, directly below the clavicle.
  • Page 17: Placement For Paced Patients (Aha)

    ECG MONITORING SELECT PLACEMENT FOR PACED PATIENTS (AHA) For ECG cable lead sets with AHA (USA) lead designations, the optimal electrode placement for patients with pacemakers may be as illustrated in Figure 7 below: LA (Black) RA (White) LL (Red) Figure 7: Paced AHA Electrode Placement 1.
  • Page 18: Verifying Proper Pacemaker Handling

    ECG MONITORING SELECT VERIFYING PROPER PACEMAKER HANDLING For paced patients, proper electrode placement results in pacer tick marks along the top of each ECG waveform channel. These tick marks occur at the point where the monitor detects a pacer pulse. The monitor rejects pacer pulses rather than calling them a QRS complex (per IEC 60601-2-27).
  • Page 19: Ecg Setup

    ECG MONITORING SELECT ECG SETUP To begin ECG monitoring use the following procedure: ECG LEAD WAVEFORM a. Touch the left side of the waveform area b. Touch the adjacent to the Waveform 1 selection (Refer to Figure 10); b. Touch I (II or III) and touch OK; and c.
  • Page 20: Ecg Cascade

    ECG MONITORING SELECT ECG CASCADE Touch the left side of the waveform area Touch the Yes adjacent to the ECG Cascade selection to Enable; k. Touch the No adjacent to the ECG Cascade selection to Disable; Touch Home to return to the Main screen. Figure 11: ECG Cascade Enabled 21-22-0335 Rev D Page 20 of 40...
  • Page 21: Parameter Setup

    ECG MONITORING SELECT HR PARAMETER SETUP Table 11 on page 38 lists the Default HR Alarm Limits for Adult, Pediatric, and Neonatal. Table 12 on page 39 lists the Default ECG & HR Parameter Setting for Adult, Pediatric, and Neonatal. HR Alarm Limits and Parameter settings will operate for the current monitor patient mode.
  • Page 22: Source

    ECG MONITORING SELECT Note: When Auto Limits adjust the Lower Limit, the adjustment shall not be allowed to be set to anything less than the Lower Limit, and when Auto Limits adjust the Upper Limit, the adjustment shall not be allowed to be set to anything greater than the Upper Limit. HR SOURCE The user-selectable HR Source feature allows the clinician to select the desired source of the Heart Rate numeric and associated alarm limit annunciation.
  • Page 23: Analyze Pacers

    ECG MONITORING SELECT ANALYZE PACERS Touch the On adjacent to the Analyze Pacers selection to Enable. Touch the Off adjacent to the Analyze Pacers selection to Disable. When Analyze Pacers is set to On, the monitor will display white pace detect marks at the top of the ECG waveform to indicate where pacer pulses were detected.
  • Page 24: Ecg Filter

    ECG MONITORING SELECT ECG FILTER The user-selectable ECG Filter feature allows the clinician to select the desired filtering of the displayed ECG waveform. User Selectable settings: Monitor (0.67 - 40 Hz) (Default) & Diagnostic (0.05 - 40 Hz) CAL PULSE The user-selectable Cal Pulse feature allows the clinician to insert a 1 mV pulse onto the currently selected ECG waveform.
  • Page 25: Ecg And Heart Rate Monitoring Messages

    Inoperable ECG circuit wires. Intentional removal by Turn monitor off, then back on clinician If message persists, contact Zoe technical support. Press ALARM SILENCE in the event of intentional removal by clinician. Calm the patient. Isolate the patient from auxiliary equipment, if Patient movement possible.
  • Page 26: Respiration Monitoring

    The following Warnings and Cautions are directed toward the Respiration monitoring function. Additional Warnings and Cautions for the monitor are found in the SELECT User Manual, Zoe Medical PN 21-22-0316. SELECT WARNINGS Warning: Operating the monitor with RR limit alarms disabled means that no low or high RR alarm conditions will produce alarm notifications.
  • Page 27: Enabling Display Of Respiration

    ACCESSORIES SELECT ENABLING DISPLAY OF RESPIRATION To enable the display of Respiration (Waveform and Numeric) use the following procedure: a. Touch the Setup button on the right side of the Main Screen b. Touch the Home Screen button and the Setup Home Screen will be displayed. Refer to Figure 15.
  • Page 28: Freezing Waveforms

    ACCESSORIES SELECT The Respiration Rate Monitoring settings and specifications may be found in the SPECIFICATIONS chapter of this manual. Procedures for changing configuration settings, such as enabling alarms, or adjusting alarm limits, may be found in the RESPIRATION SETUP chapter. FREEZING WAVEFORMS In some clinical environments the user may want to freeze the displayed waveforms.
  • Page 29: Rr Parameter Setup

    ACCESSORIES SELECT RR PARAMETER SETUP Table 11 on page 38 lists the Default RR Alarm Limits for Adult and Pediatric. Table 12 on page 39 lists the Default RR Parameter Setting for Adult and Pediatric. RR Alarm Limits and Parameter settings will operate for the current monitor patient mode. RR ALARM LIMITS: 1) Touch RR Numeric field and the Setup RR menu will be displayed (refer to Figure 18);...
  • Page 30: Testing Rr Alarms

    ACCESSORIES SELECT Note: When Auto Limits adjust the Lower Limit, the adjustment shall not be allowed to be set to anything less than the Lower Limit, and when Auto Limits adjust the Upper Limit, the adjustment shall not be allowed to be set to anything greater than the Upper Limit. TESTING RR ALARMS To manually test Respiration monitoring alarm functionality on a daily basis, you may use the following approach:...
  • Page 31: Respiration Rate Monitoring Messages

    Press ALARM SILENCE in the event of intentional Intentional removal by removal by clinician. clinician Turn monitor off, then back on If message persists, contact Zoe technical support. Calm the patient. Patient movement Isolate the patient from auxiliary equipment, if Electrical noise from possible.
  • Page 32: Accessories

    01-02-0923 AAMI 3-Lead Snap Set, 1M SELECT 01-02-0921 AAMI 3-Lead Mini-Clip Set, 1M SELECT 01-02-0891 740 SELECT AAMI 3-Lead ECG Adult/Peds Kit  01-02-0920 AAMI 3-Lead ECG Patient Cable, 2M SELECT  01-02-0923 AAMI 3-Lead Snap Set, 1M SELECT  21-03-0379...
  • Page 33: Ecg - Iec

    01-02-0927 IEC 3-Lead Snap Set, 1M SELECT 01-02-0925 IEC 3-Lead Mini-Clip Set, 1M SELECT 01-02-0893 740 SELECT IEC 3-Lead ECG Adult/Peds Kit  01-02-0929 IEC 3-Lead ECG Patient Cable, 2M SELECT  01-02-0927 IEC 3-Lead Snap Set, 1M SELECT  21-03-0379...
  • Page 34: Disposal

    Refer to Warnings and Cautions at the start of the User Manual, Zoe Medical PN 21-22-0316 for further precautions. SELECT GUIDANCE Contact your local waste disposal agency for guidance on the proper recycling or disposal of these components.
  • Page 35: Maintenance

    MAINTENANCE SELECT 7. MAINTENANCE The following table shows the recommended maintenance procedures for the SELECT monitor and its accessories. The monitor does not require periodic recalibration. However, it is a good idea to check that the monitor is in good working order, as described in the following table. These functional tests should be done every 12 months, and they can be performed by clinicians or qualified service personnel.
  • Page 36: Cleaning

    CLEANING SELECT 8. CLEANING Caution: Always disconnect the monitor from AC mains before cleaning. Do not use harsh chemicals for cleaning – in particular, do not use disinfectants that Caution: contain phenol as they can spot plastics. Do not steam autoclave, gas sterilize, irradiate, subject to intense vacuum, or immerse in water or cleaning solution.
  • Page 37: Specifications

    SPECIFICATIONS SELECT 9. SPECIFICATIONS ECG AND HR Table 9 indicates the Specifications associated with ECG and HR Parameter. DEVICE MARKINGS Type CF Equipment (Defibrillation-proof) 3 wire ECG connector GENERAL Patient Populations Adult and Pediatric Accessories 3-lead cable Input Connector 7-pin connector Displayable Leads 3-lead cable: I, II, III HR Resolution...
  • Page 38: Respiration And Rr

    SPECIFICATIONS SELECT RESPIRATION AND RR Table 10 indicates the Specifications associated with Respiration and RR Parameter. Patient Populations Adult, adolescent, child and infants Method Impedance Pneumography Input Connector Same as ECG Sensing Lead RR Resolution 1 rpm (breaths per minute) Measurement Range 0 to 120 rpm Measurement Accuracy...
  • Page 39: Table 12: Ecg, Hr & Rr Parameter Setting Ranges

    SPECIFICATIONS SELECT Table 12 lists the ECG, HR & RR Parameter settings and Ranges. Defaults Parameter Range Adult Pediatric Neonatal ECG Lead I, II, III (ECG Lead) Size 10 mm/mV 10 mm/mV 10 mm/mV 2.5, 5, 10, 15 mm/mV HR Source Auto Auto Auto...
  • Page 40 SPECIFICATIONS SELECT NOTES: 21-22-0335 Rev D Page 40 of 40...

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