Individual Licence for Welch Allyn CardioPerfect PC Based Pro Resting ECG

Welch Allyn

Diagnostic cardiology

PC-based resting ECG software licence

CE Mark for medical electrical equipment and associated accessories, including Resting ECG systems and software modules (Class II categories as specified in manufacturer documentation)
Developed and managed in accordance with IEC 62304 Medical device software – Software life cycle processes (for medical device software)
ECG safety and performance aligned with IEC 60601 2 25 Medical electrical equipment – Particular requirements for the basic safety and essential performance of electrocardiographs, as referenced in regulatory documentation
Subject to FDA 510(k) clearance in the United States for Welch Allyn CardioPerfect Workstation Software (CPWS) as diagnostic ECG software (predicate to later Welch Allyn Diagnostic Cardiology Suite submissions)
Intended for use only by trained healthcare professionals and in compliance with local medical device regulations and institutional policies

CE Mark for medical electrical equipment and associated accessories, including Resting ECG systems and software modules (Class II categories as specified in manufacturer documentation)
Developed and managed in accordance with IEC 62304 Medical device software – Software life cycle processes (for medical device software)
ECG safety and performance aligned with IEC 60601 2 25 Medical electrical equipment – Particular requirements for the basic safety and essential performance of electrocardiographs, as referenced in regulatory documentation
Subject to FDA 510(k) clearance in the United States for Welch Allyn CardioPerfect Workstation Software (CPWS) as diagnostic ECG software (predicate to later Welch Allyn Diagnostic Cardiology Suite submissions)
Intended for use only by trained healthcare professionals and in compliance with local medical device regulations and institutional policies

PC-based resting ECG software licence

Description

The Individual Licence for Welch Allyn CardioPerfect PC-Based Pro Resting ECG is a single-computer software licence for the CardioPerfect Workstation Resting ECG module. When installed on a compatible Windows PC and used with supported Welch Allyn ECG acquisition hardware (such as the AM12 recorder or Wireless Acquisition Module), it transforms the computer into a full-featured 12-lead resting electrocardiograph. The software enables acquisition, display, analysis, interpretation (with optional algorithms), storage and printing of resting ECGs, and supports integration with electronic medical record (EMR/EHR) systems as part of the CardioPerfect Workstation suite.

Bnefits

Enables a PC-based 12-lead resting ECG system using Welch Allyn CardioPerfect Workstation software
Supports acquisition, viewing, analysis, storage and printing of resting ECGs on a standard Windows PC
Part of the CardioPerfect Workstation suite, allowing consolidation of cardiopulmonary data in a single database
Facilitates transfer of patient data and ECG results into many EMR/EHR systems to reduce manual data entry and transcription errors
Allows clinicians to view, compare and manage multiple ECGs for a patient within one workstation
Optional interpretive algorithms provide advisory ECG measurements and statements to support clinical decision-making (physician review still required)
Digital workflow reduces reliance on paper ECG records and supports long-term archiving and retrieval
Scalable solution that can be extended with additional CardioPerfect modules such as stress ECG or spirometry
Designed for use in outpatient clinics, physician offices and hospital departments
Backed by Welch Allyn’s diagnostic cardiology platform and technical documentation

Indications

Use as a prescription diagnostic tool in medical clinics, physician offices and hospital settings to acquire, analyse, display, transmit, print and store 12-lead resting ECGs
Routine cardiac screening in primary care and occupational health environments
Diagnostic evaluation of patients with suspected or known cardiac disease in cardiology and internal medicine departments
Serial comparison of ECGs over time to monitor changes in cardiac status
Integration of resting ECG data into electronic medical record systems as part of a digital cardiology workflow

Composition

Software licence for Welch Allyn CardioPerfect Workstation Resting ECG module (PC-based Pro Resting ECG)
Associated software binaries and installation media or download (CardioPerfect Workstation with Resting ECG module)
Licence entitlement tied to a single PC or installation instance as specified by the manufacturer and distributor

Formulation

Intangible software product (licence key/activation for CardioPerfect Workstation Resting ECG module)
PC-based application designed for Microsoft Windows operating systems
Used in combination with compatible Welch Allyn ECG acquisition hardware (e.g. AM12 ECG recorder, WAM wireless module) and a suitable PC

Packaging

Software licence associated with SKU SW-CCW-LIC (no conventional medicinal packaging)
Delivery as electronic licence or documentation (for example, activation details or registration information) as provided by the distributor
May be supplied alongside or in addition to existing CardioPerfect Workstation installations depending on local configuration

Usage

Ensure you have compatible Welch Allyn ECG acquisition hardware (such as the AM12 ECG recorder or Wireless Acquisition Module) and a supported Windows PC that meets the CardioPerfect Workstation system requirements.
Install Welch Allyn CardioPerfect Workstation software, including the Resting ECG module, according to the official installation manual supplied by the manufacturer.
Apply the Individual Licence for the PC-Based Pro Resting ECG module as instructed (for example, by entering the licence or activation code, or completing the registration process within CardioPerfect Workstation).
Configure CardioPerfect Workstation Resting ECG settings (such as recorder model, acquisition parameters, filters and printing options) in line with the installation and user manuals and local clinical protocols.
Create or select a patient record within CardioPerfect Workstation before recording a new ECG, ensuring patient demographics are accurate and complete.
Connect ECG electrodes to the patient and acquisition module according to the Resting ECG user manual, following standard 12-lead electrode placement guidelines and local clinical procedures.
From within CardioPerfect Workstation, start a new resting ECG recording, ensure adequate signal quality, and acquire the ECG following the on-screen instructions and the user manual.
Review the recorded ECG on-screen; if interpretive software is enabled, review automated measurements and advisory statements, and always confirm or modify them based on clinical judgement.
Print, store or export ECG reports as required, including transfer to EMR/EHR systems where integration is configured.
Maintain the software by following manufacturer guidance on updates, backups and data management, and ensure users are trained and authorised in accordance with institutional policies.

Contraindications

There are no known contraindications for recording a standard resting ECG when using this software; however, ECG acquisition should follow general clinical contraindications and precautions for electrocardiography as per local guidelines.
Use only with compatible Welch Allyn-approved ECG hardware and within the environmental and electrical safety specifications defined by the manufacturer.
Do not use the software as a substitute for clinical judgement; automated interpretations are advisory only and must always be reviewed and confirmed by a qualified clinician.
Not intended for use as a continuous physiological vital signs monitor or in high-risk environments (such as mobile medical environments, MR suites or operating theatres) unless explicitly supported in the manufacturer’s documentation.

Adverse Effects

The software itself has no direct physiological adverse effects on patients, as it is a non-invasive diagnostic application.
Potential risks relate to misinterpretation or misapplication of ECG data (for example, over-reliance on automated interpretations, incorrect patient identification or improper lead placement), which may contribute to diagnostic error if clinical procedures and user training are inadequate.
Improper configuration, unrecognised poor signal quality or failure to follow the user manual may result in poor-quality ECG recordings that could affect clinical decision-making.
Users should follow all safety, configuration and operating instructions in the manufacturer’s manuals to minimise the risk of use-related errors.

Storage Conditions

Store any physical media or documentation containing the software or licence information in a secure, dry environment, protected from excessive heat, moisture and direct sunlight.
Maintain the host PC and connected ECG hardware within the operating temperature, humidity and electrical specifications defined in the manufacturer’s documentation.
Back up CardioPerfect Workstation databases and configuration files regularly according to institutional IT policies to protect patient data and maintain system availability.
Secure licence keys and activation details in accordance with local IT security and data protection policies, limiting access to authorised personnel only.

Duration

Not applicable \u2013 this product is a diagnostic software licence for resting ECG acquisition and does not constitute a pharmacological or therapeutic treatment.

Onset

Immediate upon correct installation, activation and configuration of the software and connection of compatible ECG hardware; the system then acquires and displays resting ECGs in real time.