- Shirt Size: Must fit the size range between a standard medium male and standard medium female according to ASTM (American Society for Testing and Materials) standards.
- Machine Washable: Must withstand being washed with conductive fabric-friendly detergent for at least 365 washes.
- Waterproof: Must withstand the pressure of being submerged in at least 114.3 cm of water for at least an hour.
- Electrical Component Removal: Must be easily removed by a person with at least 6th grade level physical and cognitive abilities within 1 minute.
- Monitor Battery Life: Monitor must be able to hold charge for at least 10 hours.
- Connector Security: Connectors must stay securely attached for at least 12 hours.
- Connector Usage: Electronics connectors must withstand being removed and reattached at least 1100 times (3 times a day for a year).
- Signal Quality from Connectors: Connectors must provide an uninterrupted signal.
- Data Collection Mode: Data collected through a 3 lead ECG.
- PCB Size: Must be less than 40 cm2.
- Sweat Resistant: Must be functional after exposure to sweat for at least 12 hours.
- Biocompatibility: No presence of skin irritation on patients after at least 12 hours.
- Signal Reading from Electrodes: Electrodes must provide a clear and uninterrupted signal without the use of conductive gel.
- Data Storage: ECG data must be wirelessly transmitted to an existing database and data visualization software.
- Patient Confidentiality: Data storage and transmission must be HIPAA compliant.
- Allergen Friendly: Shirt material must be hypoallergenic.
ASTM Sizes
Below are the standard size ranges for medium bodies according to the ASTM. Sizes range from a standard medium female to a standard medium male.
Location | Measurement (cm) |
Bust Circumference | 91.44 – 101.6 |
Waist Circumference | 71.12 – 87.63 |
Upper Arm Circumference | 28.58 – 33.66 |
Arm Length Center Neck Back | 78.74 – 84.15 |
Across Shoulder | 39.37 – 45.09 |
Across Back | 38.1 – 42.23 |
Back Waist Length | 41.91 – 45.72 |
Neck Circumference at Base | 37.15 – 42.23 |