Individual Licence for Welch Allyn CardioPerfect PC Based Pro Resting ECG
Welch Allyn
Diagnostic cardiologyPC-based resting ECG software licence
Certifications
- 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.
