Cardiosleeve, Attatchment to Stethocope that does EKG, Approved by FDA
(ED: This wonderful device, added to a Stethoscope, increases the range of the trusty ole scope; the following comes from the products webpage at http://rijuven.com/company.html. It should be noted that you need a prescription to get this device. It also has an app that helps to accurately analyze the cardiac sounds, including a prolonged Q-T interval, which is note-worthy. The app has a huge database of cardiac sounds)
Simple. Heart. Care.
Bring your stethoscope into the digital age. Acquire and assess 3-Lead ECG and Digital Auscultation at any point of care with confidence.
CardioSleeve is the first FDA cleared stethoscope accessory device for clinicians to acquire 3-Lead ECG and Digital Auscultation at any point of care. CardioSleeve enhances the traditional stethoscope by recording, displaying and analyzing electrical and acoustical footprints of the heart in real time via any connected portable device.
3 Lead ECG, Digital Auscultation and clinical decision support capability are now just an attachment to any stethoscope. Since CardioSleeve is paired with portable devices, clinicians patient data can be archived and retrieved in the cloud EMR.*
*Supported paired devices include smartphones, tablets, laptops and desktop PCs.
|“Nothing better epitomizes Rijuven’s DNA and unique innovative and epic spirit than the CardioSleeve, and conveys our responsible and imaginative vision of the future of health care.” – Raj Kapoor, MD, FCCP|
CardioSleeve attaches to any stethoscope to provide:
- Digital Auscultation with ECG
- 3- Lead ECG
- Cardiac Index
- Murmur Detection and Analysis
- Smartphone, tablet, laptop and PC wireless connectivity
- Cloud EMR Archival
CardioSleeve is FDA cleared and will be commercially available in the United States soon. Contact us to receive email updates on CardioSleeve, including news, release dates and other developments.
How it Works
|Once you’ve attached CardioSleeve to your stethoscope, Digital Auscultation and ECG is as simple as Place, Record, Analyze.|
1. Select Patient and Diagnostic
(Digital Auscultation with ECG, 3 Lead ECG) 2. Place Device
(Aortic, Pulmonary, Tricuspid and Mitral Valve, Lead I,II,III) 3. Record
(Waveforms, Audible Heart Sound and ECG) 4. Analyze
(Waveforms, Heart Sounds, Heart Rate, Cardiac Index, Caliper, Position)
CardioSleeve’s patent pending hardware and software were created with confidence and simplicity in mind. Cardiosleeve acquires and transmits the acoustic and electrical footprints of the heart to its server, then returns real time waveforms to the connected portable device.
*CardioSleeve software then analyzes waveforms at all leads and locations, and provides pathology alerts and further diagnostic tools to the clinician. Each encounter is stored in the cloud EMR for later retrieval.
Advanced technologies and reliance on specialist referrals have become so much the standard in the practice of cardiac medicine that physicians have abandoned basic cardiac assessment techniques and are unable to acquire the cardiac findings that may be obtained with the stethoscope. CardioSleeve solves this problem while providing more benefits:
- Timely and objective
- Repeatable reliable results
- Increased confidence and efficiency
- Reduced unnecessary referrals
- Enhanced care coordination
- Accessible at any point of care
- Immediately actionable results to the patient
- Safer, streamlined diagnostic acquisition
- Reduced costs of unnecessary referrals
- Increased outcomes
- Better patient care experience and continuum
With CardioSleeve, clinicians can hear, view, record and analyze real time waveforms. CardioSleeve’s simultaneous analysis of the heart’s electrical and acoustical footprints allow for simple, quick and accurate diagnosis support for murmur and other heart pathologies. CardioSleeve also provides heart assessment tools such as zoom, caliper and Cardiac Index.
- Digital Auscultation with ECG
- 3- Lead ECG
- Attachment to any stethoscope
- Digital Heart Sound and Waveforms on any device
- Smartphone, tablet, laptop and PC wireless connect ability
- Heart Rate
- Murmur Detection with Confidence Interval Analysis
- Cardiac Index
- Digital Caliper
- Patient list and Schedule Upload Capability
- Cloud based EMR record
- Rechargeable Lithium-ion Battery
- Bluetooth Connectivity
|Digital Auscultation with ECG- CardioSleeve records the digital heart sound and ECG at the Pulmonary, Tricuspid, Aortic and Mitral Locations. Waveforms, pathology (murmur detection) heart rate and Cardiac Index provide decision support delivered via any connected device.|
|3 Lead ECG- CardioSleeve records Lead I, II and III and provides waveforms, heart rate and a digital caliper for decision support delivered to any physician’s connected device.|
|Cloud Based EMR- All patient recorded results including audio sound, visual waveforms, caliper measurements and Cardiac Index are stored in the cloud for HIPAA compliant viewing by the physician at any time.|
|Cardiac Index- Version 1.0 includes a Cardiac Index calculator. Simple record a digital auscultation with ECG, and enter height, weight and age of patient to view CI results.|
A cloud connection provides clinicians with real time waveform presentations on a paired mobile device (smartphone, tablet, PC or laptop). CardioSleeve stores all data in this cloud for later retrieval and review. Access to CardioSleeve analysis of any patient in a clinician’s care is supported by patient list uploads to the cloud EMR.
CardioSleeve Indications for Use
The CardioSleeve System consisting of the CardioSleeve Front-End stethoscope with integrated ECG device, mobile heart sound and ECG recording application and the remote diagnostic heart murmur software is a decision support device intended to be used on a single patient to assist the qualified clinician in analyzing cardiac sounds and electrical signals for the identification and classification including of suspected murmurs. It is used to distinguish between normal/physiological and pathological heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and analyzing these signals. The acoustic heart signal is analyzed to identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs.
CardioSleeve indicates whether or not a recorded heart sound contains a suspected heart murmur. The device must be used in a clinical setting by trained personnel with the prescribed accessories and all relevant patient information must be taken into consideration before a diagnosis is made.
The interpretations of heart sounds offered by the CardioSleeve device are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
CardioSleeve is not intended to be a diagnostic device. It does not supersede the judgment of the clinician. The device is intended to aid the physician in the evaluation of heart sounds. The clinicians are responsible for reviewing and interpreting the results, along with the auscultatory findings and medical history, when making a referral decision.
Caution: Federal (USA) law restricts this device to sale by or on the order of a clinician.