Component of a CE Marked and UK Distributed medical device system (Welch Allyn Holter Systems) classified as medical device software when used with compatible recorders.
Developed and manufactured under ISO 13485 Compliant quality management system for medical devices (Welch Allyn/Hillrom/Baxter cardiopulmonary portfolio).
Designed to operate in compliance with applicable IEC 60601 1 and related collateral/particular standards for electromedical systems when integrated with Welch Allyn Holter hardware as part of the complete system.
Component of a CE Marked and UK Distributed medical device system (Welch Allyn Holter Systems) classified as medical device software when used with compatible recorders.
Developed and manufactured under ISO 13485 Compliant quality management system for medical devices (Welch Allyn/Hillrom/Baxter cardiopulmonary portfolio).
Designed to operate in compliance with applicable IEC 60601 1 and related collateral/particular standards for electromedical systems when integrated with Welch Allyn Holter hardware as part of the complete system.
Subject to manufacturer obsolescence and lifecycle notifications, with formal documentation indicating discontinuation and replacement pathways for affected Holter and exercise ECG systems.
Description
The Welch Allyn PCH-200 LAN - 3 User License for Holter ECG (part number 101513) is a network (LAN) license for the PCH-200 Expert Holter software. It enables up to three concurrent users on a local area network to access, review and analyse 24–48 hour (or longer) Holter ECG recordings acquired with compatible Welch Allyn Holter recorders such as the HR-100 and HR-300. This software-only configuration does not include a Holter recorder or PC; it is intended to be installed on customer-supplied Windows workstations and servers running Welch Allyn CardioPerfect-based Holter applications. The PCH-200 LAN license supports multi-user workflows such as recording upload, automatic analysis, editing, report generation and storage of Holter ECG studies within a networked environment, improving efficiency and enabling shared access to patient data across the cardiology or diagnostic department. The product has since been discontinued by Welch Allyn, but existing installations continue to be supported within the lifecycle policies defined by the manufacturer.
Bnefits
Enables up to three concurrent users on a local area network to access and use PCH-200 Expert Holter software with a single license package.
Supports multi-user workflows for uploading, analysing, editing and reporting Holter ECG recordings across several networked PCs.
Designed to work with Welch Allyn HR-100 and HR-300 Holter recorders, providing a complete ambulatory ECG solution when combined with appropriate hardware.
Offers advanced Holter analysis capabilities including automatic beat detection, arrhythmia analysis and report generation (as provided by the PCH-200 Expert Holter software).
Network version allows data sharing, central storage and access from multiple review stations, supporting efficient clinical operations and teleconsultation workflows.
Integrates with Welch Allyn CardioPerfect Workstation environment, allowing Holter data to be managed alongside other cardiopulmonary modules where installed.
Software-only model preserves investment in existing PCs and IT infrastructure by allowing installation on customer-supplied Windows systems that meet minimum requirements.
Indications
Intended for use by healthcare professionals for acquisition, analysis, review and reporting of long-term ambulatory ECG (Holter) recordings.
Subject to manufacturer obsolescence and lifecycle notifications, with formal documentation indicating discontinuation and replacement pathways for affected Holter and exercise ECG systems.
Use in cardiology departments, outpatient clinics and diagnostic centres where multiple clinicians or workstations need networked access to Holter ECG studies.
Support of diagnostic evaluation of cardiac rhythm disturbances such as atrial fibrillation, ventricular ectopy, bradyarrhythmias, tachyarrhythmias and ST-segment changes, when used with compatible Welch Allyn Holter recorders and appropriate clinical interpretation.
Integration into PC-based cardiology workflows where Holter results are stored, reviewed and archived within a local network environment.
Composition
Software license for Welch Allyn PCH-200 Expert Holter software, LAN network version (3 concurrent users).
Electronic license file / activation key and associated installation media or download, as supplied by Welch Allyn or authorised distributor.
Designed to be used with compatible Welch Allyn Holter recorders (e.g. HR-100, HR-300) and Windows-based PCs meeting the minimum system requirements.
Formulation
Non-physical software product (medical device software) supplied as a network license for installation on customer IT infrastructure.
PCH-200 Expert Holter software network version (3-user) operating over a TCP/IP LAN as part of the Welch Allyn Holter System.
Software-only configuration without hardware; recorders, PCs and accessories are ordered separately.
Packaging
Software license (PCH-200 LAN – 3-user) referenced as part number 101513 in Welch Allyn Holter system catalogues.
Typically supplied with installation media (CD/DVD or download), license documentation and instructions for LAN configuration and activation.
No physical clinical hardware is included with this license.
Usage
Verify that all PCs and servers intended to run the PCH-200 LAN Holter software meet the minimum system requirements specified by Welch Allyn (supported Windows operating systems, processor, RAM, disk space, display resolution, USB ports, network connectivity and printer).
Install the underlying Welch Allyn CardioPerfect Workstation / Holter application on the designated server or main PC using the provided installation media and following the official PCH-100/PCH-200 LAN installation guide.
During installation, select the LAN system type and configure server and client roles as instructed in the installation guide.
Apply the PCH-200 LAN – 3 User license (101513) using the license key or license file (e.g. License.xml) supplied with the Additional License CD or download, via the software’s license management screen.
Configure LAN communication settings (TCP/IP parameters, server name/address, data directories and user access rights) in line with IT policies and the manufacturer’s installation manual.
Install client components on up to three (or more, depending on configuration) networked workstations and verify that a maximum of three concurrent users can access the Holter software at any one time, as permitted by the license.
Connect compatible Welch Allyn Holter recorders (HR-100, HR-300) via appropriate interfaces (e.g. USB card reader, Bluetooth adapter, SD card reader) to upload recordings into the PCH-200 Holter software.
Use the software to perform automatic analysis, manual review, event tagging, editing, and report generation for Holter ECG recordings, following clinical protocols and training.
Regularly back up the Holter database and configuration settings according to institutional IT policies and Welch Allyn guidance, ensuring data protection and business continuity.
Ensure all users are trained on software operation, network use, data security and privacy requirements (e.g. HIPAA/GDPR, where applicable).
Apply software updates, patches and service packs only as provided or approved by Welch Allyn/Baxter to maintain compatibility and regulatory compliance.
Contraindications
Not intended for use with non-compatible Holter recorders or ECG hardware from other manufacturers unless explicitly stated by Welch Allyn.
Do not use on IT systems that do not meet the minimum hardware and operating system requirements, as this may impair performance or reliability.
Not suitable for use in environments lacking appropriate network security, data protection measures or IT support for medical software.
Use is limited to trained healthcare professionals; the software is not intended for layperson operation or self-diagnosis by patients.
Adverse Effects
As software, the product has no direct physiological adverse effects; potential risks relate to inaccurate or delayed diagnosis if the system is misconfigured, misused or not maintained.
Incorrect installation, configuration or network issues may lead to data loss, corrupted Holter recordings or inability to access or analyse patient data in a timely manner.
User error in editing or interpreting Holter data may contribute to misdiagnosis; adequate training and clinical oversight are essential.
IT or cybersecurity incidents (e.g. malware, unauthorised access) could compromise data integrity or confidentiality if general best practices and institutional policies are not followed.
Storage Conditions
Store installation media, license keys and documentation in a secure, access-controlled location in accordance with institutional IT and data security policies.
Maintain software and patient data on secure servers or workstations with regular backups, antivirus protection and operating system security updates as per IT governance.
Protect license information from unauthorised access, copying or misuse in line with the end-user license agreement (EULA).
Ensure environmental conditions for PCs/servers (temperature, humidity, power stability) comply with hardware manufacturer recommendations.
Duration
Not applicable \u2013 this is diagnostic Holter ECG software; duration relates to length of patient recordings and the period for which data are stored and reviewed, as determined by clinical protocols.
Onset
Not applicable in a pharmacological sense \u2013 functionality is available once the software is correctly installed, licensed and connected to compatible Holter recorders and network infrastructure.
