United Kingdom
Indications
HeartLab is a cloud-based software image management system intended to receive, process, review, display, archive, and report on cardiac imaging data (including echocardiography) for adult and paediatric patients. Images and data can be stored, communicated, and displayed across computer systems. HeartLab runs on a web-enabled computer and may be interfaced with other PACS. Diagnosis is not performed by the software but by qualified clinicians.
HeartLab is used to:
- Review exams and reports.
- Take user-initiated measurements on cardiac images.
- Share exams and reports with other HeartLab users.
- Send reports to EMR and EHR systems.
Intended Users
The intended users of HeartLab are qualified medical professionals trained in the use of this system, such as clinicians, sonographers, nurses, and medical technicians.
Contraindications
HeartLab is not to be used for mammography. HeartLab is also not intended for primary image acquisition, for use in time-critical or emergency diagnosis, or for use by patients or other lay users.
- Clinicians must review exams to determine acceptable image quality prior to use.
- Users must review all information for proper data population and clinical accuracy.
- It is the clinician's responsibility to make diagnoses or interpretations based on all available information. HeartLab is not intended to perform diagnosis.
- The use of browsers or hardware other than those supported by HeartLab is not recommended as it may result in errors.
- Read these Instructions for Use in full to understand the software before clinical use.
- HeartLab is intended for use by trained, qualified healthcare professionals only.
- Do not use computers or browsers that do not meet the minimum requirements published by HeartLab.