CE marked medical device (European MDR/previously MDD framework, depending on production date and region)
Designed to meet or exceed IEC 60601 1 general requirements for basic safety and essential performance
Designed to meet or exceed IEC 60601 2 25 requirements for electrocardiographs
Class I, Type CF defibrillation Proof applied parts (classification per IEC standards)
Compliance with DICOM communication standards for modality worklist and ECG data exchange (where configured)
Description
The ELI 150c Resting Electrocardiograph is a compact, lightweight 12-lead resting ECG system designed for adult and paediatric patients. It features a high-resolution colour LCD for preview and post-acquisition review, an integrated thermal printer and an alphanumeric keyboard with one-touch keys for ECG acquisition, rhythm printing and transmission/order retrieval. Using the Welch Allyn VERITAS resting ECG interpretation algorithm with sex- and age-specific criteria, it provides a preliminary interpretation to assist clinicians. This configuration includes the WAM wireless acquisition module, wireless LAN connectivity and DICOM support, enabling cable-free ECG acquisition and bidirectional communication with ECG management systems and EMRs.
Bnefits
Compact, lightweight 12-lead resting ECG suitable for inpatient and outpatient settings
High-resolution colour display for 12-lead ECG preview and post-acquisition review
VERITAS resting ECG interpretation algorithm with sex- and age-specific criteria for adults and children
"Best 10" feature automatically selects the highest-quality 10-second ECG segment to reduce repeat tests
Non-invasive electronic medical device (diagnostic cardiology system), not a medicinal or topical formulation
Packaging
ELI 150c resting electrocardiograph base unit
Wireless patient cable module (WAM) with 12-lead ECG patient cable (configuration as per listing)
Integrated wireless LAN connectivity (where configured)
DICOM-enabled communication (where configured)
Mains power supply with UK plug
User documentation (user manual and/or quick reference guide; exact contents may vary by region and distributor)
Usage
Use only by trained, medically qualified personnel in accordance with the official ELI 150c user manual.
Connect the device to mains power or ensure the internal battery is adequately charged before use.
Prepare the patient’s skin and place ECG electrodes according to standard 12-lead ECG placement guidelines.
Connect the 12-lead patient cable (via the WAM wireless module for this configuration) to the electrodes, ensuring correct lead identification.
Verify good signal quality on the high-resolution colour display and confirm patient demographics as required by local protocol.
Initiate ECG acquisition using the dedicated acquisition key; allow the device to capture the required 10-second resting ECG.
Review the ECG on screen and print or transmit the ECG using LAN/WLAN/DICOM or other configured connectivity options as per institutional workflow.
Interpret ECG results only by or under the supervision of a suitably qualified healthcare professional; device interpretations are supportive and must be confirmed clinically.
Clean and disinfect the patient cable, WAM and device surfaces between patients following manufacturer-approved cleaning and disinfection procedures.
Store the device and accessories in a clean, dry environment when not in use and keep the battery charged according to manufacturer recommendations.
Contraindications
The device itself has no specific clinical contraindications for recording a standard 12-lead resting ECG; use is at the discretion of a qualified physician.
Do not use the device in the presence of flammable anaesthetic mixtures with air, oxygen or nitrous oxide.
Do not use the device in environments where strong electromagnetic interference (for example, certain electrosurgical units or MRI scanners) may compromise ECG signal quality.
Do not modify cables, connectors or accessories or use non-approved ECG cables and accessories, as this may compromise safety and performance.
Adverse Effects
Mild transient skin irritation, erythema or discomfort at electrode sites due to adhesives or skin preparation.
Discomfort related to prolonged immobility during ECG acquisition in some patients.
Very rare risk of allergic reaction to electrode materials or skin preparation products (related to consumables rather than the ECG device itself).
Storage Conditions
Store the device in a clean, dry, dust-free environment away from direct sunlight.
Keep within the manufacturer-specified temperature and humidity ranges as outlined in the official technical/user documentation.
Do not expose the device to extreme temperatures, excessive moisture, corrosive substances or mechanical shock.
When storing for extended periods, follow manufacturer guidance for battery maintenance to preserve battery capacity.
Duration
Per resting ECG test, data acquisition typically captures a 10-second ECG interval; total procedure time including patient preparation and lead placement is usually a few minutes.
Onset
Immediate \u2013 ECG signal acquisition, display and printing occur during and immediately after the 10-second recording period.
