{"id":262,"date":"2025-02-08T23:40:01","date_gmt":"2025-02-08T23:40:01","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/arthrorecover\/?page_id=262"},"modified":"2025-04-16T00:39:59","modified_gmt":"2025-04-16T00:39:59","slug":"requiremments-specifications-and-justifications","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/arthrorecover\/requiremments-specifications-and-justifications\/","title":{"rendered":"Requirements, Specifications and Justifications"},"content":{"rendered":"\n
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Requirement<\/strong><\/td>Specification<\/strong><\/td>Justification<\/strong><\/td><\/tr>
1.The device must monitor the motion of the knee within a clinically acceptable range of motion (ROM) for rehabilitation.<\/td>The device must be able to achieve ROM between 0 and 105 degrees with an accuracy of \u571f 1.5 degrees<\/td>Full knee range of motion is defined as 0 degrees extension to 105 degrees flexion, with electrogoniometers measuring ROM accurately within \u00b11.7 degrees3<\/sup>.<\/td><\/tr>
2.The device must be assistive.<\/td>A) The device should exert forces from 5-60N, with a tolerance of \u571f 5% on the knee.\u00a0\u00a0

B)\u00a0 Bending moments should stay within 4 N\u22c5m \u00b1 1 N\u22c5m in sagittal plane within the specified force range.
<\/td>		In a study on a rehabilitative knee brace, a force of 58.86 N was applied to reduce posterior lag of the posterior cruciate ligament (PCL). The bending moment stayed below 4 N\u00b7m, varying by no more than 1 N\u00b7m during activity 4<\/sup>.<\/td><\/tr>
3.The device must provide thermal energy.<\/td>The temperature of the skin surrounding the site of injury will be maintained at a temperature between 38-42\u00b0C.<\/td>When local heat application between 40-42\u00b0C was applied, knee stiffness significantly decreased5<\/sup>. Another study, found that there was a decrease in knee stiffness between the ranges of 38-40 \u00b0C when heat was applied6<\/sup>.<\/td><\/tr>
4.The device must be able to maintain therapeutic temperature for a specified amount of time.<\/td>A)\u00a0 <\/strong>The device should reach therapeutic temperature within 5 minutes.

B)\u00a0 <\/strong>The device is able to maintain therapeutic temperature for up to 30 minutes.<\/td>		A study found applying local heat to the site of injury for 20 minutes lead to a decrease in knee stiffness and pain5<\/sup>. Another study found that knee stiffness decreased when patients had 15-30 minutes of local heat application6<\/sup>.<\/td><\/tr>
5.The device must measure temperature.<\/td>The device should measure the temperature of the surrounding skin with an accuracy of \u00b1 0.5\u00b0C.<\/td>An accuracy of \u00b10.5\u00b0C reduces the risk of burn injuries.<\/td><\/tr>
6.The device must track data.<\/td>A) Repetitions: 1-100
B) Duration: 10-30 minutes
C) ROM: 0-105\u00b0
D) Temperature: 38-42\u00b0c<\/td>		Tracking data allows healthcare professionals to monitor progress and input certain parameters to enhance the patient\u2019s outcome7<\/sup>.<\/td><\/tr>
7. The device must store data.<\/td>The device will store all data collected in a online database.<\/td>Using a web-based storage system allows unlimited storage capacity, real-time backup and accessibility for users and healthcare providers, supporting long-term data tracking.<\/td><\/tr>
8. The device must transmit data.<\/td>The device will transmit all collected data through the ArthroRecover Website<\/td>Data collected will be transmitted at a rate of 0.5 seconds through the Arthro Recover Website, ensuring real-time data transfer, and multiple data points without delays or loss.<\/td><\/tr>
9. The device must allow user input.<\/td>The users should be able to input and select the desired parameters.<\/td>Allowing user input ensures the device can be customized to meet the specific needs of patients and healthcare providers, enabling more effective and personalized therapy.<\/td><\/tr>
10. The device must have adjustable straps.<\/td>A) The device must have adjustable straps to accommodate different thigh circumferences, ranging from 40-70 cm.
B) The device must have adjustable straps to accommodate different knee circumferences, ranging from 30-50cm.
C) The device must have adjustable straps to accommodate different calf circumferences, ranging from 30-50 cm.\u00a0 \u00a0<\/td>		Sources emphasize the importance of a comfortable fit by accommodating various leg circumferences, ensuring the device fits securely and provides effective support, which is crucial for preventing patient discomfort8,9<\/sup>.<\/td><\/tr>
11. The device must automatically shut off in case of malfunction.<\/td>The device must automatically shut off when a temperature of 43\u00b0C is reached.<\/td>The temperature should not exceed 43\u00b0C as pain will be introduced10<\/sup>.<\/td><\/tr>
12. The device must have a functional manual shut-off button.<\/td>The manual shut-off button should be easily accessible.<\/td>The device will have a manual shut-off button to allow users to easily disable it in case of emergency, ensuring user safety and control.<\/td><\/tr>
13. The device must follow IEC 60601-1 standard for electrical safety.\u00a0<\/td>Within the device the leakage current should be less than or equal to 100 \u00b5A.<\/td>IEC 60601-1 ensures the device meets electrical safety standards for medical devices, minimizing risks of electrical shock and enhancing user trust.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Requirement Specification Justification 1.The device must monitor the motion of the knee within a clinically acceptable range of motion (ROM) for rehabilitation. The device must be able to achieve ROM between 0 and 105 degrees with an accuracy of \u571f 1.5 degrees Full knee range of motion is defined as 0 degrees extension to 105 […]<\/p>\n","protected":false},"author":620,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-262","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/engprojects.tcnj.edu\/arthrorecover\/wp-json\/wp\/v2\/pages\/262","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/engprojects.tcnj.edu\/arthrorecover\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/engprojects.tcnj.edu\/arthrorecover\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/arthrorecover\/wp-json\/wp\/v2\/users\/620"}],"replies":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/arthrorecover\/wp-json\/wp\/v2\/comments?post=262"}],"version-history":[{"count":0,"href":"https:\/\/engprojects.tcnj.edu\/arthrorecover\/wp-json\/wp\/v2\/pages\/262\/revisions"}],"wp:attachment":[{"href":"https:\/\/engprojects.tcnj.edu\/arthrorecover\/wp-json\/wp\/v2\/media?parent=262"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}