Welch Allyn Hillrom H12+ User Manual
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Welch Allyn Hillrom H12+ User Manual

Welch Allyn Hillrom H12+ User Manual

12-lead holter
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Welch Allyn
H12+™
®
12-lead Holter

User Manual

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

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  • Page 1: User Manual

    Welch Allyn H12+™ ® 12-lead Holter User Manual CAUTION: Federal law restricts this device to sale by or on the order of a physician.
  • Page 2 © Copyright 2019, 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

    TABLE OF CONTENTS SERVICE AND SPARE PARTS ........................... 1 ..............................1 SSISTANCE AND ARTS ..................................1 EPAIRS : ..............................1 ACKING NSTRUCTIONS NOTICES ................................. 3 ’ ............................ 3 ANUFACTURER ESPONSIBILITY ............................ 3 ESPONSIBILITY OF THE USTOMER ............................. 3 QUIPMENT DENTIFICATION ..........................
  • Page 4 TABLE OF CONTENTS SD C ..........................29 NSERTING AND EMOVING ARDS ............................29 TTACHING THE ATIENT ABLE ..............................30 PTIONS ............................ 31 TARTING A ECORDING ESSION ............................34 NDING A ECORDING ESSION CONFIGURING THE RECORDER ..........................35 ................................35 ONFIGURATION ...............................

  • Page 5: Service And Spare Parts

    For parts order, the required spare or replacement part number(s) Repairs All repairs on products under warranty must be performed or approved by Welch Allyn. Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty, any product repair shall exclusively be performed by Welch Allyn certified service personnel.
  • Page 6 SERVICE AND SPARE PARTS...

  • Page 7: Notices

    Failure to do so may cause undue failure and possible health hazards. Equipment Identification Welch Allyn equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced.
  • Page 8 NOTICES...

  • Page 9: Warranty Information

    Welch Allyn will, at its discretion, repair or replace the defective Product or accessory free of charge. 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.
  • Page 10 WARRANTY INFORMATION...

  • Page 11: User Safety Information

    Any serious incident that has occurred in relation to the H12+ should be reported to Welch Allyn and the competent authority of the Member State in which the user or patient is established.
  • Page 12 USER SAFETY INFORMATION  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 13 USER SAFETY INFORMATION Caution(s)  The H12+ recorder is not waterproof. It may be placed in an optionally available sealed, clear pouch that will protect it from moisture, but should not be submerged in water.  To prevent possible damage to the device, do not use sharp or hard objects to depress buttons, only use fingertips.
  • Page 14 The device will automatically turn off (blank screen) if the batteries have been severely discharged.  No preliminary or ongoing scheduled periodic calibration by the user or Welch Allyn personnel is required. The design for the device is such that the system contains no elements requiring calibration.

  • Page 15: Equipment Symbols And Markings

    Follow 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 calendar days. Defibrillator-proof type CF applied part Do not dispose as unsorted municipal waste.
  • Page 16 EQUIPMENT SYMBOLS AND MARKINGS Global Trade Item Number Battery orientation and size Medical Device...

  • Page 17: General Care

    GENERAL CARE Precautions  Turn off the device before inspecting or cleaning.  The H12+ recorder is not waterproof. It may be placed in an optionally available sealed, clear pouch that will protect it from moisture, but should not be submerged in water. ...
  • Page 18 GENERAL CARE...

  • Page 19: Electromagnetic Compatibility (Emc)

    See appropriate EMC table for recommended separation distances between the radio equipment and the device. The use of accessories and cables other than those specified by Welch Allyn may result in increased emissions or decreased immunity of the device.

  • Page 20: Uidance And Anufacturer Declaration Electromagentic Emissions

    ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagentic 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 21: 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 Immunity Test...
  • Page 22 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 23: Introduction

    INTRODUCTION Manual Purpose This manual explains how to operate the 12-lead H12+™ digital Holter recorder. It shows the user how  Prepare the patient  Use the recorder  Configure the recorder  Troubleshoot Audience This manual is written for clinical professionals who are expected to have a working knowledge of medical procedures and terminology as required for monitoring cardiac patients.

  • Page 24: H12+ Recorder Description

    INTRODUCTION H12+ Recorder Description An LCD screen allows for checking the settings for recording duration, ECG sampling rate, impedance and lead quality during patient hook-up; a keypad allows for entering of patient ID, setup of configuration parameters, and starting of recording. The keypad can also be used to enter event markers in the patient record during recording.

  • Page 25: Recorder Setup

    INTRODUCTION Recorder Setup Opening and Closing the Battery Door The SD card slot and the battery compartment are accessible via the battery door of the H12+ recorder. To open the battery door, hold the latch (1) down and then depress and slide the battery door (2) until it stops.

  • Page 26: Using The Keypad

    INTRODUCTION Using the Keypad The keypad is located on the front, right side of the H12+ recorder. Three keys are available for navigating through the LCD screens and for entering the patient ID and event markers during the recording: Up/Right, Down, and Enter. During patient hook-up, Down and Up/Right are used to scroll through the main menu options to enter the patient ID and to set the date/time and language.

  • Page 27: H12+ Recorder In Carrying Case

    INTRODUCTION H12+ Recorder in Carrying Case...

  • Page 28: Part Numbers

    INTRODUCTION Part Numbers Description Part Numbers H12+ 24-Hour Recorder with Standard SD Card H12PLUS-LXX-XXXXX H12+ 48-Hour Recorder with Standard SD Card H12PLUS-MXX-XXXXX H12+ 24-Hour Standard SD Card 107503 H12+ 48-Hour Standard SD Card 107505 H12+ 24-Hour Recorder with High-Fidelity SD Card H12PLUS-NXX-XXXXX H12+ 48-Hour Recorder with High-Fidelity SD Card H12PLUS-OXX-XXXXX...

  • Page 29: Specifications

    INTRODUCTION Specifications Feature Specifications Instrument Type 12-lead digital Holter recorder Input Channels Simultaneous acquisition of all leads Standard Leads Acquired I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 +/- 300 mV with a resolution of 2.5 µV/LSB Input Dynamic Range 0.05 to 60 Hz for standard recording Frequency Response...
  • Page 30 INTRODUCTION Environment Specifications +10˚ to +45˚C Operating Temperature -40˚ to +70˚C Storage Temperature Operating Humidity 10% to 95%, non-condensing 10% to 95%, non-condensing Storage Humidity H12+ will operate normally from 700 to 1060 millibars Operating Altitude (Pressure) Storage Altitude (Pressure) 500 to 1060 millibars Water Ingress IPX0...

  • Page 31: Patient Preparation

    PATIENT PREPARATION Patient Hookup Skin Preparation Good skin preparation prior to electrode attachment is very important to ensure good signal quality when recording patient data. Poor electrode-to-skin contact may cause artifact (noise) to be included in the recording which can affect the analysis of the ECG data. Low-amplitude signals may also be the result of poor electrode-to-skin contact.
  • Page 32 PATIENT PREPARATION NOTE AND CAUTION: Placement of the Left Leg (LL) electrode in the original Mason-Likar position increases the similarity of the acquired ECG with a standard 12-lead ECG and is therefore recommended; however, clothing may interfere with this position and increase the amount of artifact. The modified position may decrease the sensitivity of inferior ECG leads and cause axis shift with respect to the standard 12-lead ECG.

  • Page 33: Using The Recorder

    USING THE RECORDER Inserting and Removing SD Cards To insert an SD card, open the battery door of the recorder. Position the card above the empty card slot with the label facing front as shown below. Place the SD card in the slot and gently push down on the SD card until it is firmly engaged and can move no further.

  • Page 34: Main Menu Options

    USING THE RECORDER Main Menu Options The recording set duration from 1 to 48 hours (or 1 to 24 hours) and the Holter ECG sampling rate are initially displayed upon insertion of the SD card and AA battery once the battery door closed and initialization has completed.

  • Page 35: Starting A Recording Session

    USING THE RECORDER Starting a Recording Session 1. Insert a proprietary Welch Allyn SD card and a new AA battery. 2. After the battery door is closed, H12+ will power up and perform software and battery tests. This takes a few seconds while the Hillrom splash screen is displayed. When finished, the duration and sample rate are displayed.
  • Page 36 USING THE RECORDER Displaying ECG Leads DISPLAY ECG is used to visually inspect leads I, II, III, V1, V2, V3, V4, V5, and V6 before starting a recording. Check the signal quality and ECG amplitude for each lead. From the main menu, scroll to DISPLAY ECG, press Enter. Lead I is the first lead displayed on the screen.
  • Page 37 NOTE: If the battery door is removed during recording, the H12+ recorder stops recording. A new proprietary Welch Allyn SD card and fresh battery must be inserted to continue recording. NOTE: In the event of a lead fail condition occurring during recording, the appropriate lead fail indicator(s) is displayed below the Recording message and will replace the displayed patient ID number until resolved.

  • Page 38: Ending A Recording Session

    USING THE RECORDER Ending a Recording Session At the end of the set recording duration, the time is automatically cleared from the LCD screen and a “Recording Complete” message is displayed. To proceed: 1. Remove the battery door of the H12+ recorder.

  • Page 39: Configuring The Recorder

    CONFIGURING THE RECORDER Configuration CONFIGURE is used to set the current date and time, the date format, the recording duration from 1 to 48-hours or 1 to 24-hours, language defaults, and to display the software version number. Note: A maximum recording duration of 24 hours or 48 hours is a feature of the SD card selected. Also, when a High-Fidelity SD card is used, the Holter ECG sampling rate can be set at 1000 samples per second or 180 samples per second.
  • Page 40 CONFIGURING THE RECORDER...

  • Page 41: Setting Date And Time

    CONFIGURING THE RECORDER Setting Date and Time DATE/TIME is used to set the current date and time and to set an alternative format for the displayed date. From the configuration menu, scroll to DATE/TIME, press Enter. The DATE/TIME menu includes the following options: ...

  • Page 42: Changing Sample Rate (High-Fidelity Sd Card Only)

    CONFIGURING THE RECORDER Changing Sample Rate (High-Fidelity SD card only) The sample rate is selectable only when using the High-Fidelity SD card which can be set to 1000 or 180 samples per second. From the CONFIGURE menu, scroll to SAMPLE RATE, press Enter. Scroll to the sample rate desired; press the Enter key to select and return to the SAMPLE RATE menu.

  • Page 43: Maintenance

    MAINTENANCE Cleaning and Disinfecting This section describes the procedures for cleaning and disinfecting the H12+ and accessories. WARNING: Follow these instructions to clean and disinfect the H12+ and its accessories. Improper cleaning may cause damage that is not immediately apparent, leading to possible safety hazards, device malfunction, and/or spread of infectious agents between persons.
  • Page 44 MAINTENANCE Cleaning and Disinfecting Accessories ECG Cables Approved Cleaning Agents  Enzymatic detergent such as ENZOL (US) or CIDEZYME (outside the US).  Distilled water.  Disinfectant solution (such as CIDEX OPA, or a 10% solution of household bleach (5.25% sodium hypochlorite) in distilled water). ...

  • Page 45: Periodic Maintenance

    The H12+ has a defined product life of 5 years excluding accessories, cables and batteries. As required, product service, accessories and spare parts are available through Welch Allyn or its authorized partners. Using the Holter recorder or its accessories and components beyond their defined life may lead to damage to the equipment or a safety hazard to the user.
  • Page 46 MAINTENANCE...

  • Page 47: Troubleshooting

    Solution Replace existing battery with a fully charged battery. ‘LOW BATTERY’ If checksum does not match the stored checksum at power up. Contact Welch Allyn ‘CHECKSUM ERROR’ Technical Support Group. SD card error. SD card product capabilities identification file is missing. Contact ‘CARD ERROR’...
  • Page 48 TROUBLESHOOTING...

  • Page 49: Translations

    TRANSLATIONS Table of Translations Italian Spanish German Dutch English ITALIANO ESPAÑOL DEUTSCH NETHERLANDS RECORD INIZIO GRABAR AUFNAHME OPNAME DURATION DURATA DURACIÓN DAUER DUUR LEAD CHECK DERIVAZIONI TEST ELECT ABL.TEST LEAD DISPLAY ECG MOSTRA ECG MOSTRAR ECG EKG-ANZEIGE TOON ECG ENTER ID ID PAZIENTE INTRO ID PATIENT ID...
  • Page 50 TRANSLATIONS Table of Translations (continued) French Polish Finnish Portuguese English FRANÇAIS POLSKI SUOMI PORTUGUES RECORD ENREGISTRER START TALLENNUS REGISTO DURATION DURÉE CZAS_TRWANIE KESTO DURAÇÃO LEAD CHECK DÉRIVATIONS ELEKTRODY ELEKTRODIT DERIVAÇÕES DISPLAY ECG AFFICH. ECG NÄYTÄ EKG MOSTRAR ECG ENTER ID ID PATIENT OPIS SYÖTÄ...
  • Page 51 TRANSLATIONS Table of Translations (continued) Swedish Danish English SVENSKA DANSK RECORD SPELA IN OPTAG DURATION VARAKTIGHET VARIGHED LEAD CHECK LEDN.KONTR. AFLED CHECK DISPLAY ECG VISA EKG DISPLAY EKG ENTER ID ANGE ID INDTAST ID DATE & TIME DATUM/TID DATO/TID CONFIGURE KONFIGURERA KONFIGURER VERSION...

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