Welch Allyn H3+ Service Manual
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Welch Allyn H3+ Service Manual

Welch Allyn H3+ Service Manual

Digital holter recorder
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Welch Allyn
®
H3+™
DIGITAL HOLTER RECORDER
SERVICE MANUAL
Manufactured by Welch Allyn, Inc., Skaneateles Falls, NY U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

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  • Page 1 Welch Allyn ® H3+™ DIGITAL HOLTER RECORDER SERVICE MANUAL Manufactured by Welch Allyn, Inc., Skaneateles Falls, NY U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
  • Page 2 Welch Allyn, Inc. Welch Allyn is a registered trademark of Welch Allyn, Inc. H3+ is a trademark of Welch Allyn, Inc.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS NOTICES ....................................3 ’ ..............................3 ANUFACTURER ESPONSIBILITY ..............................3 ESPONSIBILITY OF THE USTOMER ................................3 QUIPMENT DENTIFICATION ............................3 OPYRIGHT AND RADEMARK OTICES ..............................3 THER MPORTANT NFORMATION EU U ............................3 OTICE TO SERS AND ATIENTS WARRANTY INFORMATION ..............................
  • Page 4 H3+ O ..................................20 VERVIEW H3+ S .................................. 22 PECIFICATIONS DISASSEMBLY ..................................23 ....................................23 ARTS ..................................24 PENING THE ................................25 NSERTING THE ATTERY ..............................26 TTACHING THE ATIENT ABLE USB D ............................27 TTACHING THE OWNLOAD ABLE ..................................28 OVER EMOVAL &...

  • Page 5: Notices

    Failure to do so may cause undue failure and possible health hazards. Equipment Identification Welch Allyn, Inc. 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 6: Warranty Information

    Welch Allyn or an authorized distributor or representative of Welch Allyn, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Welch Allyn is limited and that Welch Allyn does not function as an insurer.

  • Page 7: User Safety Information

    • A possible explosion hazard does exist; therefore do not use the device in the presence of flammable anesthetics. Defibrillation protection is guaranteed only if a Welch Allyn, Inc. Patient Cable is used. • Simultaneous connection to other equipment may increase leakage current.

  • Page 8: Caution(S)

    USER SAFETY INFORMATION Caution(s) To prevent possible damage to the Enter button, do not use sharp or hard objects to depress the button; use • fingertips only. Do not attempt to clean the device or patient cable by submerging into a liquid, autoclaving or steam cleaning. •...
  • Page 9 USER SAFETY INFORMATION • The device conforms to the following standards: IEC 601-1 General Requirements for Safety IEC 601-2-47 Particular Requirements for Safety, including Essential Performance IEC 601-1-2 Electromagnetic Compatibility ANSI/AAMI EC38 Ambulatory Electrocardiographs 93/42/EEC Medical Device Directive • The device is UL classified: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH IEC 60601-1, CAN/CSA C22.2 No.

  • Page 10: Equipment Symbols And Markings

    EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death.

  • Page 11: Electromagnetic Compatibility (Emc)

    If such use is necessary, observe the device and other equipment to verify that they are operating normally. WARNING Use only accessories recommended by Welch Allyn for use with the device because they have been assessed for EMC compatibility. Replacing any accessories which are not recommend by Welch Allyn could adversely affect the EMC emissions or immunity.

  • Page 12: S Declaration : Electromagnetic Emissions

    ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Emissions IEC 60601-1-2 (EMC International Standard, Edition 4.1) 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 13: Uidance And Anufacturer Declaration Electromagnetic Immunity

    ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Immunity IEC 60601-1-2 (EMC International Standard, Edition 4.1) 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. Electromagnetic Environment: Immunity Test IEC 60601 Test Level...

  • Page 14: Uidance And Anufacturer Declaration Electromagnetic Immunity

    ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Immunity IEC 60601-1-2 (EMC International Standard, Edition 4.1) 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 15 ELECTROMAGNETIC COMPATIBILITY (EMC) Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a.

  • Page 16: Test Specifications For Enclosure Port Immunity To Rf Wireless Communications Equipment

    ELECTROMAGNETIC COMPATIBILITY (EMC) Test Specifications for Enclosure Port Immunity to RF Wireless Communications Equipment IEC 60601-1-2 (EMC International Standard, Edition 4.1) Test Maximum Immunity Band Distance Frequency Service Modulation Power Test Level (MHz) (MHz) (V/m) 380 - 390 Pulse TETRA 400 modulation 18 Hz 430 - 470...

  • Page 17: Test Specifications For Enclosure Port Immunity To Proximity Magnetic Fields

    ELECTROMAGNETIC COMPATIBILITY (EMC) Test Specifications for Enclosure Port Immunity to Proximity Magnetic Fields IEC 60601-1-2 (EMC International Standard, Edition 4.1) Test Frequency Modulation Immunity Test Level (A/m) 30 kHz Pulse modulation ᵃ⁾ 134.2 kHz 65 ᵇ⁾ 2.1 kHz Pulse modulation ᵃ⁾ 13.56 MHz 7.5 ᵇ⁾...

  • Page 18: General Care

    Manufacturer's Warranties and/or responsibilities. If you are not able to correct the H3+ Holter Recorder’s operation using the Troubleshooting guide in the Operator's Manual, contact an authorized Welch Allyn service representative for repair assistance. Periodic Safety Inspections Follow the recommended maintenance schedule. Inspect the patient cable(s) periodically for fraying or other damage and replace as needed.

  • Page 19: Maintenance And Cleaning

    MAINTENANCE AND CLEANING Introduction This section provides maintenance and cleaning instructions for the H3+ Holter Recorder. Recommended Cleaning Supplies Anti-static mat & wrist band, properly grounded Clean, lint-free cloth Hospital grade germicidal solution DRY, low pressure, compressed air (30 psi) NOTE: The equipment and solvent mentioned above are standard shop commodities that are available from commercial sources.

  • Page 20: Interior Visual Inspection

    MAINTENANCE AND CLEANING Interior Visual Inspection Check all connectors for loose, bent or corroded contact points Check wire, harnesses and cables for signs of wear or deterioration. Inspect leads for security of mounting, or deterioration. Check terminals and connections for proper installation, loss or wear. Inspect chassis and covers for warping, bending, surface damage or missing captive hardware.
  • Page 21 MAINTENANCE AND CLEANING Remove the Battery. Check battery connection terminals for debris and/or corrosion. CAUTION Be sure that the polarity of the battery is correct. Use only Welch Allyn approved Alkaline replacement battery (Welch Allyn part #4800-009). Install the battery.

  • Page 22: Technical Description

    TECHNICAL DESCRIPTION H3+ Overview System Description The H3+ Digital Recorder, software version V3.0.0 or newer provides three channels of continuous ECG data recorded over an extended period of time. An LCD screen and Enter button allow for checking the lead quality during patient hook-up and starting the recording.
  • Page 23 TECHNICAL DESCRIPTION H3+ Digital Recorder Diagram...

  • Page 24: H3+ Specifications

    TECHNICAL DESCRIPTION H3+ Specifications FEATURE Specifications INSTRUMENT TYPE Digital Holter Recorder INPUT CHANNELS • V3.0.0- Simultaneous acquisition of three channels Prior to V3.0.0- Simultaneous acquisition of two or • three channels LEADS ACQUIRED • V3.0.0- Modified I, II, III, aVR, aVL, aVF and V Prior to V3.0.0- Modified I, II and V or Bipolar Channel 1 and Channel 2 INPUT IMPEDANCE...

  • Page 25: Disassembly

    Manufacturer's Warranties and/or responsibilities. If you are not able to correct the H3+ Holter Recorder’s operation using the Troubleshooting guide in the Operator's Manual, contact an authorized Welch Allyn service representative for repair assistance. Parts List H3+ Digital Recorder Assembly...

  • Page 26: Opening The Unit

    Opening and Closing the Battery Door Pictures shown are of the latest Welch Allyn H3+ design. Parts should be ordered based on the model being serviced. Please ensure that the appropriate parts are ordered based on your model color and function (cool grey model shown below).

  • Page 27: Inserting The Battery

    DISASSEMBLY Lift battery door to access the battery compartment. Inserting the Battery The H3+ Recorder is powered with a single AAA alkaline battery. To insert a new battery into the battery compartment, open the battery door of the H3+. If a battery is present in the compartment, remove and discard the battery.

  • Page 28: Attaching The Patient Cable

    DISASSEMBLY Attaching the Patient Cable The patient cable attaches to the unit by sliding onto the input connector of the H3+. Each leadwire terminates in a snap connector. H3+ Patient Cable...

  • Page 29: Attaching The Usb Download Cable

    DISASSEMBLY Attaching the USB Download Cable The USB download cable uses the same connector as the patient cable does. Remove the patient cable from the H3+. The USB download cable, item 10, attaches to the unit much like the patient cable, sliding onto the input connector of the H3+.

  • Page 30: Cover Removal

    If the cover is glued to the case please contact Welch Allyn Technical Support Group for details about repair. NOTE: Open the battery door and remove the battery prior to opening the unit.

  • Page 31: Keypad Removal & Back Label

    Back Labels – Legal Entity Change (Item 9) – Like for like replacement label should be used until stock is exhausted, newer Welch Allyn legal entity labels may be used once older labels are no longer available (example of legal entity label change shown below).

  • Page 32: Board Removal

    DISASSEMBLY Board Removal To remove the board and LCD assemblies from the unit first open the unit as described in the Cover Removal section. Locate the battery spring of the unit and compress this spring and push the board and LCD assemblies through the opening of the Upper Housing, item 5.

  • Page 33: Lcd Removal

    DISASSEMBLY LCD Removal With the LCD and Board assemblies removed from the unit the LCD (item 4) can be replaced by locating the cable connector, lifting up on the retaining latch and sliding the LCD cable out of its connector. IMPORTANT: A new LCD (part # 774398) was introduced in June of 2022.

  • Page 34: Board Separation

    DISASSEMBLY Board Separation With the LCD, item 4, removed from the board assembly, locate the connectors holding the Front End board (item 2) and Digital Board (Item 1) together. Gently separate the two boards. Reassemble unit in reverse order.

  • Page 35: Printed Circuit Boards

    This section provides block diagram illustrations of the H3+ Holter Recorder Printed Circuit boards. Due to the proprietary nature of this product schematics of the boards are not provided. There is no user serviceable parts for the H3+, replacement units are available. Please contact Welch Allyn Technical Support via phone at 1-888-667-8272 or via email at mor_tech.support@hillrom.com...

  • Page 36: H3+ Front End Pc Board

    PRINTED CIRCUIT BOARDS H3+ Front End PC Board Block Diagram of H3+ Front End Board...

  • Page 37: H3+ Digital Pc Board

    PRINTED CIRCUIT BOARDS H3+ Digital PC Board Block Diagram of H3+ Digital Board...

  • Page 38: Troubleshooting

    Manufacturer's Warranties and/or responsibilities. If you are not able to correct the H12+ Digital Recorder questionable operating state using the Troubleshooting guide in this manual, do not attempt to service the unit, contact Welch Allyn Service at 1-888- 667-8272 or via email at mor_tech.support@hillrom.com.

  • Page 39: Device Log Files

    H3+ recorder using Windows Explorer. The files, DEVICE.LOG and RECORD.LOG can be copied and e-mailed to Welch Allyn for troubleshooting purposes. These files are erased when the recorded ECG data is erased in preparation for the next recording.
  • Page 40 DEVICE.LOG Recorder information to assist Mortar Technical Support during complaint investigations. Used for Welch Allyn Engineering level investigations. NAND logical block data may continue for many pages. Data can be used to confirm when a NAND block has been skipped and...
  • Page 41 TROUBLESHOOTING RECORD.LOG Recorder setup and recording start details. Data point at each hour interval will be logged to show the date, time and corresponding battery voltage. Indicates a lead failure during the Holter recording. The corresponding date and time will be logged for each occurrence.

  • Page 42: Conformance Testing

    Manufacturer's Warranties and/or responsibilities. If you are not able to correct the H12+ Digital Recorder questionable operating state using the Troubleshooting guide in this manual, do not attempt to service the unit, contact Welch Allyn Service at 1-888- 667-8272 or via email at mor_tech.support@hillrom.com.
  • Page 43 CONFORMANCE TESTING 3. Initial Setup 3.1 Set up the test configuration per the instructions in Appendix A.1 Test Configuration Set Up. This includes the Attenuation Box (TF-0423) switch settings. 3.2 Ensure the Signal Generator contains the programmed waveforms (or can be configured for appropriate output) as defined in Appendix A.2 Test Signal Waveforms.
  • Page 44 CONFORMANCE TESTING Verify the following items: • There is “No Recording Available”. If there is, select the Clear Memory button to erase the recording. • System Status: “FwVers”- Applicable released firmware version. • System Status: “Bad” is typically 0 or 1 bad blocks. Limit <80 Note: “Total Recordings”...
  • Page 45 CONFORMANCE TESTING 8. Test Data Acquisition 8.1 Induce each of the test waveform signals (e.g., Flat line, 0.5Hz Sine Wave, 20Hz Sine Wave, Pace Pulses, DC Offset). This is approximately 2 minutes of test data. 8.2 Connect the signal generator to the Attenuation box (TF-0423) as described in appendices A.1 and A.2.
  • Page 46 CONFORMANCE TESTING Select the Browse button and highlight the desired folder. Select OK 9.5 Select Start Acquisition to get the data from the DUT. The “Report” field should indicate “Transfer Complete” when done. Select Close.
  • Page 47 CONFORMANCE TESTING 9.6 Open the ECG Viewer by clicking on the applicable DESKTOP ICON. Select File; Open. Leave the P.M. File Name, File Format, Sample Format and Rec. Mode settings at the default values. 9.7 Get the Data for review. Select the Browse button.
  • Page 48 CONFORMANCE TESTING 9.9 DC Recovery Verification Scroll to the 0.05 DC Recovery Data Settings- Samples/Pxl: 1; Gain (mm/mV): 10; Scroll by: 5 Seconds • Verify each channel: The signal does not exceed +4 division from the center of the square wave. •...
  • Page 49 CONFORMANCE TESTING 9.11 High-Frequency Gain Verification Scroll to the 20.0 Hz data. Settings- Samples/Pxl: 1; Gain (mm/mV): 10; Scroll by: 5 Seconds • Verify each channel: 20Hz Sine Wave, 1mV (within 1.5-2.5 divisions). 9.12 Low-Frequency Gain Verification Scroll to the 0.5 Hz data. Settings- Samples/Pxl: 1;Gain (mm/mV): 10;...
  • Page 50 CONFORMANCE TESTING 9.13 Signal Noise & Event button test Settings- Samples/Pxl: 1; Gain (mm/mV): 160; Scroll by: 5 Seconds • Verify the noise in each channel is less than 30uV (within 1 division • ie. 0uV +/- 15uV) • Verify EVENT button detection as indicated by the GREEN MARK at the top display at the time the event button was pressed.
  • Page 51 CONFORMANCE TESTING Safety Testing - Dielectric Strength (patient Input to enclosure) Required Equipment Shorting Bar for ECG Patient Cable H3+ 3-Lead Patient Cable DC High Voltage Power supply or DC HIPOT Test Equipment TF-0424 H3+ HI-POT Strength Test Fixture 20026145 H3+ HIPOT Strength Test Fixture (new back housing) Test Criteria: Item...
  • Page 52 CONFORMANCE TESTING H3+ Conformance Test Data Record UNIT SERIAL # Perform Visual Inspection of Unit Pass Fail Initial Power Up, Self Test Firmware Version Operating Current (<7.4mA) Pass Fail Patient Cable & Lead-Fail Check 3-Lead Patient Cable Detected Pass Fail Shorting Bar Flat Line Observed Pass Fail...
  • Page 53 CONFORMANCE TESTING A.0 Appendices A.1 Test Configuration Set Up A.1.1 Connect Signal Generator (Agilent 33220A (20MHz Function/Arbitrary Waveform Generator or equivalent) output to the Attenuation Box TF-0423 via a 50ohm Coax Cable. A scope may be connected in-line using a T-splitter. Note: The Attenuation box (TF-0423) must be at the end of the connection as it contains a 50ohm matching impedance to properly load the Signal Generator output.

  • Page 54: Uidance And Anufacturer Declaration Electromagnetic Emissions

    APPENDIX Guidance and Manufacturer’s Declaration: Electromagnetic Emissions IEC 60601-1-2 (EMC International Standard, 3 Edition) 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 55: Uidance And Anufacturer Eclaration Lectromagnetic Mmunity

    APPENDIX Guidance and Manufacturer’s Declaration: Electromagnetic Immunity IEC 60601-1-2 (EMC International Standard, 3 Edition) 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 56: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Equipment

    APPENDIX 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.

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