CE marked Class IIa medical device under Directive 93/42/EEC (via Mortara Instrument, Inc.)
Designed to comply with IEC 60601 series standards for medical electrical equipment (safety and EMC)
Manufacturer quality system certified to ISO 13485 (medical devices – quality management systems)
ECG Machines / Resting Electrocardiograph
Description
The Welch Allyn ELI150c Resting Electrocardiograph is a compact, portable 12-lead ECG system that provides comprehensive resting ECG functionality for adult and paediatric patients. It features the VERITAS™ resting ECG interpretation algorithm with gender-specific criteria, real-time 12-lead preview, and automatic selection of the cleanest 10 seconds of ECG data to minimise repeat recordings. This configuration includes the WAM™ Wireless Acquisition Module, Ethernet LAN connectivity, and support for XML and full-colour PDF export via Eli Link software, with a UK mains plug.
Bnefits
Compact and lightweight 12-lead resting ECG for use in clinics, wards and outpatient areas
VERITAS resting ECG interpretation algorithm with gender-specific adult and paediatric criteria for a silent second opinion
Wireless data acquisition via WAM module, improving workflow and patient access by removing cable clutter at the bedside
Automatic selection of the best 10 seconds of ECG data from an extended acquisition period to reduce artefact and repeat ECGs
Real-time preview of multiple ECG leads on a colour display to confirm signal quality before printing
Bidirectional connectivity and data exchange via Ethernet LAN and XML/PDF formats for integration with ECG management systems and electronic records
Onboard memory (up to approximately 200 ECGs depending on configuration) to store and review ECG records
Full-size ECG printouts using integrated thermal printer for paper records and chart review
Indications
Acquisition and recording of 12-lead resting electrocardiograms in adult patients
Acquisition and recording of 12-lead resting electrocardiograms in paediatric patients
Diagnostic evaluation of cardiac rhythm and conduction abnormalities in a clinical setting
Baseline and follow-up ECG monitoring in outpatient, inpatient and pre-operative assessments
Use in clinics, hospitals and other healthcare facilities requiring resting ECG diagnostics
Non-invasive diagnostic medical device (resting electrocardiograph)
Configurable for wired or wireless acquisition; this product configuration includes WAM wireless acquisition module
Packaging
One ELI150c resting electrocardiograph main unit
One WAM wireless patient cable module (wireless acquisition module)
UK mains power cable/plug
User documentation and accessories as supplied by manufacturer or distributor (refer to current packing list)
Usage
Use only by trained healthcare professionals familiar with ECG acquisition and interpretation.
Connect and power on the ELI150c, ensuring the device completes its self-checks before use.
Pair or connect the WAM wireless acquisition module to the ELI150c according to the manufacturer’s instructions.
Prepare the patient and apply ECG electrodes in standard 12-lead positions, then attach the patient cable leads.
Use the display to preview ECG waveforms in real time and verify adequate signal quality and lead placement.
Initiate ECG acquisition using the dedicated controls; the device will capture and store the best 10 seconds of ECG data.
Print the ECG and/or export ECG records via Ethernet LAN using XML or PDF formats as required by local workflows.
Clean and maintain the device, WAM module and patient cables according to the manufacturer’s cleaning and maintenance guidelines.
Contraindications
Do not use where application of ECG electrodes or cables is contraindicated due to severe skin injury, burns or infection at electrode sites.
Do not use in environments that do not meet the electrical safety or electromagnetic compatibility conditions specified in the user manual.
Do not modify the device or use non-approved accessories or patient cables.
Adverse Effects
Potential for mild skin irritation or redness at electrode sites.
Discomfort from electrode removal, particularly on sensitive or fragile skin.
Very rare risk of misdiagnosis if electrodes are incorrectly placed or ECG artefact is not recognised; device must be used by trained professionals.
Storage Conditions
Store the electrocardiograph and wireless module in a clean, dry environment.
Protect from dust, excessive humidity, direct sunlight and extremes of temperature as outlined in the manufacturer’s manual.
Disconnect from mains power when not in use for extended periods and store cables neatly to avoid damage.
Duration
Per resting ECG test, data are acquired over a short period (up to several minutes) with automatic selection of the cleanest 10-second segment for recording and interpretation.
Onset
Not applicable (diagnostic device). ECG waveforms and measurements are available in real time during acquisition.
