{"id":83,"date":"2023-10-04T14:08:20","date_gmt":"2023-10-04T14:08:20","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/modified-vac-assisted-male-external-catheter-system\/?page_id=83"},"modified":"2024-04-18T00:25:01","modified_gmt":"2024-04-18T00:25:01","slug":"design-inputs","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/modified-vac-assisted-male-external-catheter-system\/design-inputs\/","title":{"rendered":"Design Inputs"},"content":{"rendered":"\n
Requirement<\/strong><\/td>Justification<\/strong><\/td>Specification<\/strong><\/td>Justification<\/strong><\/td><\/tr>

1. The device must stay secure for a clinically acceptable period.<\/td>		It is necessary to ensure the device does not leak and adapts to daily usage.<\/td>
Must be able to withstand a displacement force of 25.51 \u00b1 17.90 lbs for 24 hours.<\/td>		The attachment site component needs to be changed every 24 hours for sanitary purposes while accommodating daily usage.<\/td><\/tr>
2. The Device Must Collect Urine Outputs.<\/td>Minimizes patient cleaning efforts for nursing staff, and ensures that patients are staying dry, and urine outputs are accurate.<\/td>Can collect a flow rate of 4.5-21.6 mL\/sec for up to a minute.<\/td>
Uroflowmetry indicates these values to be the normal ranges for a urination cycle among males.<\/td><\/tr>
3. Can accommodate 95% of males.<\/td>The device can be used for at least 95% of male patients who would benefit.<\/td>Can accommodate 6-16.5 cm in length, and 7.5-13.5 cm in girth.<\/td>The range includes 95% of penis sizes; 6-12.5cm in length and 7.5-11 cm girth for flaccid, and 10-16.5cm in length and 9.5-13.75 cm girth erect.<\/td><\/tr>
4. Clinical staff must be able to easily collect a clean urine sample from the canister.<\/td>Allows urine samples to be obtained for urinalysis.<\/td>The urine collection point is sterile (SAL 10-6<\/sup>), and the device provides a non-mixed sterile sample that was voided less than 1 hour ago.<\/td>Prevents urine sample contamination via the device, and provides an adequate sample for urinalysis (mixed samples and samples over 1 hour old are not used for urinalysis unless refrigerated).<\/td><\/tr>
5. Must provide a warning to clinical staff when the canister is full.<\/td>Allows clinicians to empty the canister before a leakage event since urine is considered a biohazard.<\/td>Detect volume between 0 – 2000 ml \u00b1 50 ml at any arbitrary time, then trigger an alarm to alert staff.<\/td>2000ml is the full canister volume and an overflowing urine canister is a biohazard.<\/td><\/tr>
6. The device must be able to regulate the negative pressure based on the urination cycle.<\/td>Necessary to reduce vac-related injuries and improve patient\/user comfort.<\/td>Turn on negative pressure from 40-80 mmHg \u00b15 mmHg using a urination sensor.<\/td>Current vac-assists operated 40-80 mmHg.<\/td><\/tr>
7. The device must ensure proper house vacuum settings.<\/td>Necessary that clinical staff does not set vac to outside the accepted range.
<\/td>		Detect negative pressure set to >80 mmHg or <40 mmHg \u00b1 5.<\/td>Negative pressure >80 mmHg or <40 mmHg is outside the acceptable range.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Requirement<\/strong><\/td>Specification<\/strong><\/td><\/tr>
8. The collected volume must be visible to clinical staff.<\/td>Contains measuring lines per every 50 mL or digital display of volume \u00b1 50 ml.<\/td><\/tr>
9. The canister must hold normal urine volume output during the clinically relevant time.<\/td>2000 ml to accommodate the upper range.<\/td><\/tr>
10. Must pass electrical safety standards for hospital-based systems.<\/td>500 microamps for leakage current, and less than 0.1 ohms for ground resistance (IEC 6060).<\/td><\/tr>
11. The device captures 90% of moisture passing to the vacuum.<\/td>The device captures 90% of moisture passing to the vacuum[13]<\/sup>.<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"

Requirement Justification Specification Justification 1. The device must stay secure for a clinically acceptable period. It is necessary to ensure the device does not leak and adapts to daily usage. Must be able to withstand a displacement force of 25.51 \u00b1 17.90 lbs for 24 hours. The attachment site component needs to be changed every … <\/p>\n

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