Hillrom Welch Allyn UTK User Manual
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Hillrom Welch Allyn UTK User Manual

Hillrom Welch Allyn UTK User Manual

Diagnostic cardiology suite wireless acquisition
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Welch Allyn
®
Diagnostic Cardiology
Suite Wireless Acquisition
Module™ and UTK™
User Manual

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Summary of Contents for Hillrom Welch Allyn UTK

  • Page 1 Welch Allyn ® Diagnostic Cardiology Suite Wireless Acquisition Module™ and UTK™ User Manual...
  • Page 2 For information about any Welch Allyn product, visit: https://www.welchallyn.com/en/about-us/locations.html For patent information, please visit www.welchallyn.com/patents Customer Service and Technical Support: https://www.welchallyn.com/en/other/contact-us.html 1.888.667.8272, mor_tech.support@hillrom.com This manual applies to the 901128 CARDIOPULMONARY ECG SYSTEM and 901095 ECG ACQUISITION MODULE 9515-174-60-ENG Rev B Revision date: 2019-07 EU IMPORTER Welch Allyn, Inc.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS NOTICES ................................. 1 ’ ............................ 1 ANUFACTURER ESPONSIBILITY ............................ 1 ESPONSIBILITY OF THE USTOMER ............................. 1 QUIPMENT DENTIFICATION ..........................1 OPYRIGHT AND RADEMARK OTICES ............................. 1 THER MPORTANT NFORMATION WARRANTY INFORMATION ........................... 3 ............................3 ELCH LLYN ARRANTY USER SAFETY INFORMATION ..........................
  • Page 4 TABLE OF CONTENTS ................................... 27 LED I ................................27 NDICATORS MAINTENANCE ..............................29 ..............29 LEANING AND ISINFECTING THE ELCH LLYN IRELESS CQUISITION ODULE ............................. 29 ISPOSAL OF ASTE ATERIALS APPENDIX ................................31 ................................31 UMBERS ..................32 ELCH LLYN IRELESS CQUISITION ODULE...

  • Page 5: Notices

    NOTICES Manufacturer’s Responsibility Welch Allyn is responsible for the effects on safety and performance only if: • Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons authorized by Welch Allyn. • The device is used in accordance with the instructions for use. Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule.
  • Page 6 NOTICES...

  • Page 7: Warranty Information

    WARRANTY INFORMATION Your Welch Allyn Warranty WELCH ALLYN, INC. (hereafter referred to as “Welch Allyn”) warrants that components within Welch Allyn products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Welch Allyn, or if not otherwise noted, for a period of twelve (12) months from the date of shipment.
  • Page 8 WARRANTY INFORMATION EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST WELCH ALLYN FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND WELCH ALLYN IS NOTIFIED WITHIN THE WARRANTY PERIOD.

  • Page 9: User Safety Information

    USER SAFETY INFORMATION WARNING: Means there is the possibility of personal injury to you or others. Caution: Means there is the possibility of damage to the device. Note: Provides information to further assist in the use of the device. WARNING(S) ...
  • Page 10 USER SAFETY INFORMATION  To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.  This device was designed to use the electrodes specified in this manual. Proper clinical procedure must be employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or other adverse reactions.

  • Page 11: Caution(S)

    USER SAFETY INFORMATION Caution(s)  To prevent possible damage to the device, do not use sharp or hard objects to depress buttons, only use fingertips.  The device and lead wires should be cleaned between each use. Inspect connections for damage or excessive wear prior to each use.

  • Page 12: Notes

    USER SAFETY INFORMATION Notes  Proper patient preparation is important to proper application of ECG electrodes and operation of the device.  If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged, display will indicate a lead fault for the lead(s) where the condition is present.

  • Page 13: Equipment Symbols And Markings

    EQUIPMENT SYMBOLS AND MARKINGS Documentation Symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. In addition, when used on a patient applied part, this symbol indicates defibrillation protection is in the cables. Warning symbols will appear with a grey background in a black and white document.
  • Page 14 EQUIPMENT SYMBOLS AND MARKINGS DFU can be ordered from Welch Allyn for delivery within 7 calendar days. Non-Ionizing Electromagnetic Radiation Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM).

  • Page 15: General Care

    GENERAL CARE Precautions  Turn off the device before inspecting or cleaning.  Do not immerse the device in water.  Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage equipment surfaces. Inspection Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized service person to make the repairs.
  • Page 16 GENERAL CARE...

  • Page 17: Electromagnetic Compatibility (Emc)

    ELECTROMAGNETIC COMPATIBILITY (EMC) Electromagnetic compatibility with surrounding devices should be assessed when using the device. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the device according to the international standard for EMC for medical devices (IEC 60601-1-2).

  • Page 18: Uidance And Anufacturer Declaration Electromagnetic Emissions

    ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment: Guidance...

  • Page 19: Uidance And Anufacturer Declaration Electromagnetic Immunity

    ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. IEC 60601 Test Compliance Emissions Test...
  • Page 20 ELECTROMAGNETIC COMPATIBILITY (EMC) Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment.

  • Page 21: Regulatory Radio Compliance

    ELECTROMAGNETIC COMPATIBILITY (EMC) Regulatory Radio Compliance Federal Communications Commission (FCC) This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:  This device may not cause harmful interference.  This device must accept any interference received, including interference that may cause undesired operation.
  • Page 22 ELECTROMAGNETIC COMPATIBILITY (EMC) Industry Canada (IC) Emissions RF Radiation Hazard Warning Using higher gain antennas and types of antennas not certified for use with this product is not allowed. The device shall not be co-located with another transmitter. Cet avertissement de sécurité est conforme aux limites d'exposition définies par la norme CNR-102 at relative aux fréquences radio.
  • Page 23 ELECTROMAGNETIC COMPATIBILITY (EMC) European Union Welch Allyn tímto prohlašuje, ze tento WLAN device je ve shodě se Czech základními požadavky a dalšími příslušnými ustanoveními směrnice 2014/53/ES. Danish Undertegnede Welch Allyn erklærer herved, at følgende udstyr WLAN device overholder de væsentlige krav og øvrige relevante krav i direktiv 2014/53/EF Dutch Bij deze verklaart Welch Allyn dat deze WLAN device voldoet aan de essentiële eisen en aan de overige relevante bepalingen van Richtlijn...
  • Page 24 ELECTROMAGNETIC COMPATIBILITY (EMC) Swedish Härmed intygar Welch Allyn att denna WLAN device står I överensstämmelse med de väsentliga egenskapskrav och övriga relevanta bestämmelser som framgår av direktiv 2014/53/EG.
  • Page 25 ELECTROMAGNETIC COMPATIBILITY (EMC) International Radio Compliance Argentina Ente Nacional de las Comunicaciones (ENACOM) H-22661 (WAM) H22622 (UTK) Australia Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM). Brazil Agência Nacional de Este equipamento opera em caráter Telecomunicações (ANATEL) secundário, isto é, não tem direito a Modelo: WAM proteção contra interferência 01142-14-05187...
  • Page 26 ELECTROMAGNETIC COMPATIBILITY (EMC) Date of approval: 13-SEP-2018 Oman Telecommunications Regulatory Authority WAM : R/6168/18 D172250 UTK: R/6164/18 D172250 Paraguay Comisión Nacional de NR:121/2019 (WAM) Telecomunicaciones NR:122/2019 (UTK) Pakistan Pakistan Telecom Authority Philippines National Telecommunications WAM: ESD-18-18399C Commission UTK: ESD-19-19449C Singapore Info-Communications Media Development Authority (IMDA) South...

  • Page 27: Introduction

    INTRODUCTION Manual Purpose This manual is intended to provide the user with information about:  Using and understanding the Welch Allyn Wireless Acquisition Module, the operator buttons, and the LED indicators.  Preparing the Welch Allyn Wireless Acquisition Module for use. ...

  • Page 28: Welch Allyn Wireless Acquisition Module With Lead Wires

    INTRODUCTION Welch Allyn Wireless Acquisition Module with Lead Wires Figure 1-1 Feature Description Replaceable lead wires Connector from the device to the electrode Power On/Off Push button to turn the device on and off LED indicators Displays the device status 12-lead ECG acquisition Press the 12-lead ECG acquisition button to complete the acquisition of the 12-lead ECG...

  • Page 29: Approved Battery Models

    INTRODUCTION Approved Battery Models Description Manufacturer Part Numbers Alkaline, AA-type, 1.5V Various Various WARNING: Use of other cells may present a risk of fire or explosion. To order additional supplies, contact a customer service representative. USB Transceiver Key (UTK) The UTK connects to an open USB port on the computer where the Welch Allyn Diagnostic Cardiology Suite is installed and receives ECG signals from the paired WAM.

  • Page 30: Battery Installation

    INTRODUCTION Battery Installation The Welch Allyn Wireless Acquisition Module is powered with a single AA battery. When the battery contains sufficient voltage to operate and the patient is properly connected, an LED on the front of the device will appear solid green indicating proper pairing and communication with the UTK. A battery with low voltage or a lead fail will result in a flashing green or yellow LED.

  • Page 31: Lead Fail

    INTRODUCTION Lead Fail Lead fail is done automatically through visual communication with the LEDs located on the front of the device. A yellow LED (solid or flashing) indicates a lead fail condition is present. A solid green LED indicates proper lead connection as well as adequate battery voltage for ECG acquisition. LED Indicators + Audio MODE...
  • Page 32 INTRODUCTION...

  • Page 33: Maintenance

    MAINTENANCE Check the Welch Allyn Wireless Acquisition Module and lead wires before each use to ensure they are not damaged or broken. Cleaning and Disinfecting the Welch Allyn Wireless Acquisition Module 1. Remove all lead wires and the power source from the device before cleaning. 2.
  • Page 34 MAINTENANCE...

  • Page 35: Appendix

    APPENDIX Part Numbers Description Part Numbers WAM CC ACCESSORY KIT WITH AHA BANANA LEADS 41000-031-54 WAM CC ACCESSORY KIT WITH IEC BANANA LEADS 41000-031-55 WAM CC ACCESSORY KIT WITH AHA CLIP LEADS 41000-031-56 WAM CC ACCESSORY KIT WITH IEC CLIP LEADS 41000-031-57 BATTERY CAP ASSEMBLY WAM 8356-008-51...

  • Page 36: Welch Allyn Wireless Acquisition Module Specifications

    APPENDIX Welch Allyn Wireless Acquisition Module Specifications Feature Specification* Instrument Type 12-lead wireless acquisition module for resting ECG Input Channels 12-lead signal acquisition and transmission ECG Leads Transmitted I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 Transmission Protocol Bidirectional and frequency hopping;...

  • Page 37: Utk Specifications

    APPENDIX Battery 1 AA alkaline battery typically powers the device for acquisition of 250 resting ECGs *Specifications subject to change without notice. UTK Specifications Feature Specification Frequency 2403.38 MHz to 2479.45 MHz Channel spacing 1MHz RF output power <10dBm Antenna Type PCB inverted F Antenna Gain -4.12dBi...

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