The Cardionics E-Scope electronic stethoscope amplifies heart, breath, bruit, bowel or Korotkoff sounds up to 30 times louder than normal acoustic stethoscopes. For improved listening, it has controls for volume up-down and heart-breath sounds frequency selection. The E-Scope automatically shuts off after 90 seconds and restarts with the touch of a button to the same volume setting. It has a sounds output that allows for connection to a PC or other device for recording. Under normal use, it operates approximately 4 months on a AAA battery. Cardionics offers a selection of bells, diaphragms and ear tips. The E-Scope comes in clinical, hard-of-hearing and EMS models.
Cooper Consulting Service (CCS) designed several generations and all of the offered models of the Cardionics E-Scope. CCS performed the following engineering design functions for the E-Scope.
Documentation
- Developed complete FDA design controls documentation package which passed through FDA inspections
- Wrote operator’s manual
- Developed device master record (schematics, drawings, component specifications, BOMs, labels, etc.)
Analog Design
- Designed microphone interface
- Designed speaker drive amplifier for low power drain and high audio power
- Designed switching regulator for low power operation
- Designed power timer and battery monitor with audible and visual indicators
- Designed volume adjust and filter frequency selection circuitry
- Designed EMC protection to meet standards
Enclosure Design
- Worked with plastics designer to develop body and chest piece housing designs
- Worked with plastics molding vendor to develop and qualify molds for housings.
- Designed membrane switch on chest piece
- Designed labels for body housing
- Developed packaging for shipping and storage
Testing
- Developed test fixture for acoustic input to chest piece
- Developed test fixture for measuring acoustic output from speaker
- Performed verification testing
- Worked with test laboratory to get product to pass medical electrical safety and EMC standards
- Performed environmental and drop shock tests
- Performed packaging drop shock test
Design Transfer and Production
- Wrote assembly procedure for system
- Developed production test procedure
- Released DMR and provided support for vendor qualification