Part of a CE Marked and UK Distributed medical device system (Welch Allyn Holter Systems) when used with compatible HR 100/HR 300 recorders.
Developed under an ISO 13485 Compliant quality management system for medical devices within Welch Allyn/Hillrom/Baxter cardiopulmonary portfolio.
Intended to operate within systems designed to comply with IEC 60601 1 and related collateral/particular standards when integrated with Welch Allyn Holter hardware.
Part of a CE Marked and UK Distributed medical device system (Welch Allyn Holter Systems) when used with compatible HR 100/HR 300 recorders.
Developed under an ISO 13485 Compliant quality management system for medical devices within Welch Allyn/Hillrom/Baxter cardiopulmonary portfolio.
Intended to operate within systems designed to comply with IEC 60601 1 and related collateral/particular standards when integrated with Welch Allyn Holter hardware.
Administrative login and password controls designed to support HIPAA and similar data Protection programmes when configured appropriately.
Description
The Welch Allyn PCH-200 Standalone software for Holter ECG is the Expert Holter single-workstation configuration of Welch Allyn’s Holter analysis platform. Designed for use with HR-100 and HR-300 digital Holter recorders, it provides advanced review, editing and reporting tools for long-term ambulatory ECG recordings. In addition to all of the features offered in the PCH-100 Office Holter software, the PCH-200 Expert Holter software adds beat-by-beat editing from multiple review modes, flexible relabelling of beats and forms, manual strip and event insertion, artefact marking, clinical limit adjustment and reanalysis functions. The standalone license (part number 101512) is installed on a single PC and is intended for diagnostic cardiology and ambulatory ECG workflows that do not require networked multi-user access.
Bnefits
Expert-level Holter ECG analysis tools that extend the functionality of the PCH-100 Office Holter software.
Standalone single-user license for installation on one PC, ideal for smaller practices or dedicated Holter analysis workstations.
Works with both HR-100 and HR-300 digital Holter recorders from Welch Allyn, enabling flexible configuration of ambulatory ECG solutions.
Multiple review modes (Forms, Arrhythmias, Heart Rate and FD review) provide detailed access to results from different clinical perspectives.
Beat-level editing from every review mode allows precise correction of classification and rhythm interpretation.
Ability to relabel beats individually or as part of a wider beat form to refine automated analysis results.
Manual marking, labelling and insertion of ECG strips and events to document clinically relevant findings.
Marking and labelling of artefact regions to exclude non-diagnostic sections from analysis and reporting.
Adjustment of clinical limits, selected leads and filters to tailor analysis to patient-specific or institution-specific protocols.
Autopaging function that controls speed and resolution of full-disclosure review, helping clinicians scan long recordings efficiently.
Floating report interpretation window allows users to record conclusions and notes continuously during the editing process.
Reanalyse function to remove or replace a poor-quality channel and re-run automated analysis without repeating the full workflow.
Administrative features with password log-on controls to support programmes for HIPAA and general data protection compliance.
Use by trained healthcare professionals for the analysis, review and reporting of ambulatory (Holter) ECG recordings.
Diagnostic evaluation of arrhythmias, conduction disturbances, heart rate variability and ST-segment changes using long-term ECG recordings.
Ambulatory ECG monitoring in cardiology departments, hospital diagnostic units and specialist clinics where single-workstation Holter analysis is appropriate.
Integration into PC-based cardiology workflows where Holter results are archived, reviewed and printed from a single dedicated PC.
Expert Holter application module that runs within the Welch Allyn Holter/PC cardiopulmonary platform on Windows PCs.
Software designed specifically to import, analyse, edit and report data recorded with Welch Allyn HR-100 and HR-300 Holter recorders.
Formulation
Non-sterile, non-physiological medical device software product.
Standalone, single-user Holter ECG analysis software installed locally on one Windows PC.
Part of the Welch Allyn Holter Systems portfolio (Expert Holter tier).
Packaging
Software product referenced as PCH-200 Standalone Holter Software without Recorder, part number 101512.
Supplied as a license with installation media (e.g. CD/DVD) or secure electronic download plus license/activation details.
Does not include a PC, printer or Holter recorder; these are ordered separately or via dedicated kits/systems.
Usage
Confirm that the target PC meets the minimum system requirements specified by Welch Allyn (supported Windows version, processor, memory, hard-disk space, screen resolution and available USB ports or card readers).
Install the PCH-200 Expert Holter application following the official Holter Software PCH100/PCH200 Installation Guide, including any required CardioPerfect or cardiopulmonary framework components.
Activate the standalone license for PCH-200 using the provided key or license file and verify that the application opens correctly.
Configure data directories, user accounts and password-protected log-ons to support information governance and data protection policies.
Connect compatible HR-100 or HR-300 Holter recorders (or their SD cards/flash media) via the appropriate USB SD card reader or Bluetooth adapter, and upload recordings into the PCH-200 software.
Use the various review modes (Forms, Arrhythmias, Heart Rate, FD review) to examine automated results and navigate the recording at different levels of detail.
Perform beat-by-beat editing where necessary, relabelling beats or beat forms to correct classification and refine rhythm analysis.
Manually mark and label strips, events and artefact regions; adjust clinical limits, leads and filters to align with institutional protocols.
Use the floating report interpretation window to document findings as you edit, then generate and print or export final Holter reports for inclusion in the patient record.
Use the Reanalyse function to rerun analysis when channels are removed or parameters are changed, validating final results before sign-off.
Back up the Holter database and configuration regularly in accordance with local IT and data-protection policies.
Ensure all users receive appropriate training and that software updates or patches from Welch Allyn/Baxter are applied in a controlled manner.
Contraindications
Not intended for use with Holter recorders or ECG hardware from other manufacturers unless explicitly stated as compatible by Welch Allyn.
Do not use on PCs or operating systems that do not meet the specified minimum requirements, as performance and reliability may be compromised.
Not suitable for environments without appropriate data security, back-up and IT governance for medical software.
Use only by trained clinicians or technicians; the software is not intended for patient self-use or self-diagnosis.
Adverse Effects
No direct physiological adverse effects, as the product is software-only.
Potential clinical risk if installation, configuration or use errors lead to incorrect analysis, missed arrhythmias or misinterpretation of ECG data.
Risk of data loss or unavailability if adequate back-up procedures and IT security measures are not maintained.
User fatigue or error from poor screen ergonomics or inadequate training when reviewing long, complex recordings.
Storage Conditions
Store installation media, license keys and documentation securely in accordance with institutional IT and information-governance policies.
Maintain installed software and patient databases on secure, access-controlled PCs with regular back-ups and anti-malware protection.
Ensure hardware hosting the software is operated within manufacturer-recommended environmental conditions (temperature, humidity, power stability).
Protect license credentials from unauthorised access or copying as required by the end-user license agreement.
Duration
Not applicable \u2013 this is diagnostic software; duration relates to recording length and analysis time as determined by clinical protocols.
Onset
Not applicable in pharmacological terms \u2013 software functionality is available as soon as installation, licensing and configuration are completed.
