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Welch Allyn Connex ECG Module Directions For Use Manual

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Welch Allyn Connex
Module
Directions for use
For use with compatible Connex® devices running software version 2.3X
or higher
®
Devices ECG

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Summary of Contents for Welch Allyn Connex ECG Module

  • Page 1 ® Welch Allyn Connex Devices ECG Module Directions for use For use with compatible Connex® devices running software version 2.3X or higher...
  • Page 2 © 2018 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.

  • Page 3: Table Of Contents

    Contents Introduction ..................... 1 Intended use ......................1 Indications for use ....................1 Contraindications ....................2 Symbols ....................3 Screen elements ..................5 About warnings and cautions ..............7 General warnings and cautions ................7 ECG module warnings and cautions ..............10 Setup ......................
  • Page 4 ® iv Contents Welch Allyn Connex Devices ECG Module...

  • Page 5: Introduction

    Introduction This manual describes the capabilities and operation of the Welch Allyn ECG/Impedance Respiration module. This module is designed as an option for the Welch Allyn Connex® Vital Signs Monitor (VSM) and the Connex® Integrated Wall System (IWS). This module might not be available in your region.

  • Page 6: Contraindications

    Welch Allyn Connex Devices ECG Module Contraindications The Welch Allyn ECG/Impedance Respiration module is not intended for infants weighing less than 10 Kg (22 lbs) or neonatal patients. This module is not designed for direct cardiac application. This module is not suitable for transport.

  • Page 7: Symbols

    Follow the operating instructions/directions for use (DFU) — mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 days. Miscellaneous symbols IOIOI...
  • Page 8 ® 4 Symbols Welch Allyn Connex Devices ECG Module Recycle the product separate from China RoHS markings for control of other disposables pollution caused by electronic information products. XX indicates Environmentally Friendly Use Period in years. Reorder number Serial number...

  • Page 9: Screen Elements

    Screen elements ECG, Heart rate/Pulse rate, and Impedance respiration ECG frame and lead selector Heart rate / Pulse rate Beats per minute (to represent heart rate / pulse rate) Saved waveform icon Saved waveform icon, alarm (Review tab) condition (Review tab) Waveform snapshot button...
  • Page 10 ® 6 Screen elements Welch Allyn Connex Devices ECG Module...

  • Page 11: About Warnings And Cautions

    In addition, you must review the warnings and cautions presented in the Welch Allyn Connex® Devices directions for use that pertain to using a connected ECG module.
  • Page 12 Improper installation can result in the equipment falling off the wall and injuring someone. Welch Allyn is not responsible for the integrity of any installation not performed by authorized Welch Allyn service personnel.
  • Page 13 Directions for use About warnings and cautions 9 WARNING For operator and patient safety, peripheral equipment and accessories that can come in direct patient contact must comply with all applicable safety, EMC, and regulatory requirements. WARNING Cross-contamination or nosocomial infection risk. Clean and disinfect the ECG module on a routine basis according to your facility's protocols and standards or local regulations.

  • Page 14: Ecg Module Warnings And Cautions

    ® 10 About warnings and cautions Welch Allyn Connex Devices ECG Module ECG module warnings and cautions In addition to the preceding warnings and cautions, consider the following when using the ECG module. WARNING Liquids can damage electronics inside the ECG module.
  • Page 15 Keep pacemaker patients under close observation. WARNING Inspect device and accessories before each use. Use only Welch Allyn approved accessories. Peripheral equipment and accessories that touch the patient must comply with all appropriate safety, EMC, and regulatory requirements.
  • Page 16 Refer to the accessory list or www.welchallyn.com. WARNING Patient injury risk. Use only ECG cables supplied or specified by Welch Allyn. Use of any other ECG cables can negate defibrillator protection and can create a risk of patient injury due to shock.
  • Page 17 Directions for use About warnings and cautions 13 WARNING Do not operate this product with MRI (Magnetic Resonance Imaging) equipment. WARNING When using ECG Wrist Clip electrodes, although a normal Lead I QRS waveform is produced on the monitor, this waveform should not be used for serious clinical interpretation because the electrodes are not properly triangulated around the patient 's heart.
  • Page 18 WARNING Personal/patient injury risk. Welch Allyn is not responsible for the integrity of any wall structure or wall mounting interface. Welch Allyn recommends that you contact your Biomedical Engineering Department or maintenance service to ensure professional installation, safety, and reliability of any mounting accessory.

  • Page 19: Setup

    Setup Controls, indicators, and connectors The ECG/Impedance respiration assembly includes the ECG acquisition module, an ECG patient cable with either 3 or 5 leads to snap connectors, a built-in clip to facilitate mounting the module, and a USB cable to connect to the host device. No.

  • Page 20: Mount And Connect The Ecg Module

    Ensure that the device is seated firmly on the bracket, then tighten the screw on the bracket into the screw hole on the back of the device. (See "Mount the monitor on a stand" in the Welch Allyn Connex® Devices directions for use for more detail.)

  • Page 21: Alarms

    The module can communicate alarms to the monitor and an external Nurse Call, if available, in the Continuous Monitoring profile. Technical alarms occur in all profiles. See the Welch Allyn Connex® Devices directions for use for detailed descriptions of alarm behavior, controls, and messages. Physiological alarm summary...
  • Page 22 ® 18 Alarms Welch Allyn Connex Devices ECG Module...

  • Page 23: Ecg Acquisition

    ECG acquisition For details on how the ECG module operates with the host device, see the ECG section of the the Welch Allyn Connex® Devices directions for use. Lead placement overview WARNING Patient safety risk. To minimize interference and the danger of burns to the patient, use only approved ECG cables.
  • Page 24 ® 20 ECG acquisition Welch Allyn Connex Devices ECG Module Lead placement, 3-lead R - Red L - Yellow F - Green RA - White LA - Black LL - Red Lead placement, 5-lead N - Black R - Red...
  • Page 25 Directions for use ECG acquisition 21 RL - Green RA - White LA - Black V - Brown LL - Red Impedance respiration In some patients, impedance respiration detection may be inadequate using the standard ECG electrode placement. In these cases, change the LL and RA electrode placement to the mid-axillary line on each side of the chest as shown in the illustrations.

  • Page 26: Attach The Leads To The Patient

    ® 22 ECG acquisition Welch Allyn Connex Devices ECG Module Attach the leads to the patient Proper lead attachment is important for a successful ECG. The most common ECG problems are caused by poor electrode contact and loose leads. Follow your local procedures for attaching the leads to the patient.
  • Page 27 Directions for use ECG acquisition 23 WARNING Respiration Rate must be disabled when using ECG wrist clip electrodes. To attach the leads to the patient 1. Prepare the patient. • Describe the ECG procedure. Explain the importance of holding still during the test.
  • Page 28 ® 24 ECG acquisition Welch Allyn Connex Devices ECG Module To maintain the quality of signals during long-term Note monitoring, replace the electrodes at least every 48 hours. Over longer periods, the electrode gel can dry out and the patient's skin can be irritated by the gel or adhesive. When...

  • Page 29: Maintenance

    Maintenance Clean the equipment WARNING Keep the ECG module, reusable electrodes, and the patient cable clean. Patient contact with contaminated equipment can spread infection. CAUTION Never use acetone, ether, freon, petroleum derivatives, or other solvents to clean the ECG module or patient cable. Never immerse the ECG module or the patient cable in liquid.

  • Page 30: Inspect The Equipment

    Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. For more specific disposal information, see www.welchallyn.com/weee. Troubleshooting See the Welch Allyn Connex® Devices directions for use for troubleshooting information.

  • Page 31: Emc Guidance And Manufacturer's Declarations

    This device complies with IEC EN 60601-1-2:2007. • All medical electrical equipment must be installed and put into service in accordance with the EMC information provided in this document and the Welch Allyn Connex Devices Directions for Use. •...
  • Page 32 ® 28 EMC guidance and manufacturer’s declarations Welch Allyn Connex Devices ECG Module...

  • Page 33: Specifications

    Specifications Physical specifications Characteristic Specification Length 101.6 mm (4.00 in.) Width 57.15 mm (2.25 in.) Height 27.94 mm (1.10 in.) Weight 73.71 g (2.60 oz.) Protection against the ingress of liquid IPX0 = No protection against liquid ingress. Device classification EMC Class Class IIB IEC Type...
  • Page 34 ® Specifications Welch Allyn Connex Devices ECG Module ECG specifications Characteristic Specification Heart rate detection range 20 to 300 beats per minute Heart rate accuracy ±3 beats per minute or ±3%, whichever is greater QRS detection amplitude ≥0.3 mV and ≤5.0 mV with QRS width of between 40 ms and 120 ms Tall T wave rejection Rejects Tall T waves less than 1.4 mV...
  • Page 35 Directions for use Specifications 31 Characteristic Specification Mains filter 50 Hz, 60 Hz, off (default = 60 Hz) Frequency range 0.5 to 70 Hz Power source USB (4.5 V to 5.5 V) Digital data interface Serial (USB – Full Speed) Monitoring period Continuous ECG channels...
  • Page 36 ® Specifications Welch Allyn Connex Devices ECG Module Characteristic Specification Noise suppression – DC current of 200nA max for RL Software and alarm specifications Characteristic Specification Ventricular tachycardia threshold default 120 beats per minute ±3 beats per minute for 6 consecutive beats Variable ventricular tachycardia settings 100 beats per minute to 150 beats per minute ±3 beats per minute for 6...
  • Page 37 Directions for use Specifications 33 Protection against electrosurgical Electrosurgical protection per EN60601-2-27:2011. ECG device will resume as per the table below. Parameter Initial report after Maximum time to Note defibrillation recover HR value Acquiring 10 sec +5 beats Depends on patient heart rate ECG waveform Waveform...
  • Page 38 ® Specifications Welch Allyn Connex Devices ECG Module Characteristic Specification Gain 10 mm/mV Arrhythmia detection Enabled Impedance Respiration Disabled Print on V-Tach, V-Fib, and Asystole alarms Enabled Pacer Disabled Regulatory compliance The ECG module complies with the following standards IEC 60601-1...

  • Page 39: Appendix

    Module + USB + Patient cable 5L IEC 6000-ECG5A Module + USB + Patient cable 5L AHA 106550 ECG mounting accessory, stand or wall 6200-11 Electrode pads (30 pads/pack, 20 packs/box) 106560 Connex ECG Module CD, Directions for Use, Quick Reference Cards, Multi-language...

  • Page 40: Limited Warranty

    Product or accessory free of charge with a like-new Product. You must obtain a return authorization from Welch Allyn to return your Product before you send it to Welch Allyn’s designated service center for repair. Contact Welch Allyn Technical Support.

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