Requirement 1: Must take in information from user
| Verification |
| Input test strip information into device screen and confirm it saves. |
| Pass/Fail | Pass |
| Validation |
| Survey users on how easy it was for them to input the test strips information. | Results |
| Acceptance criteria | 9/10 positive surveys | 10/10 |
| Pass/ Fail | Pass |
Requirement 2: Must return output/test strip reading
| Verification |
| Test | Acceptance Criteria | Result | Pass/Fail |
| Screen size | > 4in x 7in | 4in x 7in | Pass |
| Font size | > 6.75mm | 8mm | Pass |
| Font Type | Courier | Courier | Pass |
| Validation |
| Acceptance criteria | 9/10 |
| User Interface | Pass |
| Display Results | Fail |
Requirement 3: The device must detect color
Verification:
- Must pass 8 different colors out of the 10 that will be tested
- In order to pass each color the right value for each needs to be outputted at least 8 times out of the 10
| Parameters | Correct results out of 10 | Passing (Yes: 1, No: 0) |
| pH 5 | 8 | 1 |
| pH 8.5 | 9 | 1 |
| Leukocytes Negative | 10 | 1 |
| Leukocytes 125 cells/uL | 9 | 1 |
| Nitrite positive | 7 | 0 |
| Urobilinogen 128 umol/L | 10 | 1 |
| Protein Negative | 10 | 1 |
| Protein 20.0 g/L | 8 | 1 |
| Ketone 16.0 mmol/L | 10 | 1 |
| Ascorbate 0 mmol/L | 10 | 1 |
| | Total | 9/10 |
Requirement 4: Must must have a power source – Passed
Requirement 5: Must be able to be sanitized
| Verification |
| Test | Acceptance Criteria | Results | Pass/Fail |
| Test strip | Visually clean 10/10 | 10/10 | Pass |
| Orange Juice | Visually clean 10/10 | 10/10 | Pass |
| Validation |
| Acceptance criteria | 9/10 Positive Scores |
| Easily cleaned | Pass |
| Visually clean | Pass |
Requirement 6: Must meet electrical safety standards IEC 60601
Verification
| | T1 | T2 | T3 | T4 | T5 | T6 | T7 | T8 | T9 | T10 | Avg. |
| Leakage current (uA) | 80 | 20 | 70 | 50 | 40 | 30 | 40 | 20 | 30 | 20 | 40 |
| Threshold: 100 uA | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
Requirement 7: Must have a data storage
| Verification |
| Acceptance Criteria | Memory Space | Specification | Pass/Fail |
| > 4.5KB bytes | 16GB | 4.5KB | Pass |
| Validation |
| Acceptance criteria 9./10 positive scores | Results | Pass/ Fail |
| User Interface | 10/10 | Pass |
| Retrieve Results | 9/10 | Pass |
