{"id":45,"date":"2024-09-25T02:40:34","date_gmt":"2024-09-25T02:40:34","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/comfortlift\/?page_id=45"},"modified":"2025-05-06T14:40:55","modified_gmt":"2025-05-06T14:40:55","slug":"design-inputs","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/comfortlift\/design-inputs\/","title":{"rendered":"Design Inputs"},"content":{"rendered":"\n
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Device A – Patient Transfer Design Inputs<\/h2>\n\n\n\n
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Device A – Design Input 1:<\/h3>\n\n\n\n
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Design Input<\/span><\/td>\nVerification Activity<\/span><\/td>\nValidation Activity<\/span><\/td>\n<\/tr>\n
Requirement<\/span><\/td>\nSpecifications<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\n<\/tr>\n
A.1<\/strong> – Device must transfer patients from surface to surface.<\/span><\/td>\n\n

A1.1<\/b> – The device lifts a patient up or down a maximum of 6 in. <\/span><\/span><\/p>\n

A1.2<\/b> – The device moves a patient a minimum of 3 ft laterally. <\/span><\/span><\/p>\n

A1.3<\/b> – The device moves the patient superiorly and inferiorly a maximum of 1 ft. <\/span><\/span><\/p>\n<\/td>\n

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A.1.1\/A1.2\/A1.3<\/b> – Specific distances will be measured during the transfer process. The minimum and maximum distances specified will not be exceeded during the 10 trials. <\/span><\/span><\/p>\n<\/td>\n

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A.1 <\/b>– Patient survey assessing comfortability and sense of safety.<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n\n\n\n

A.1<\/strong> – Reduces the risk of injury and improves safety of the patient. Allows the patient to move from one place to another when in need of medical treatment [1].<\/p>\n\n\n\n

A1.1\/A1.2\/A1.3<\/strong> – Patients may need to move from gurneys to hospital beds to imaging tables and may require multi-directional movement to reach final position.<\/p>\n\n\n\n

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Verification Testing<\/h2>\n\n\n\n
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  • Line Pull Capacity 1000 lbs<\/li>\n\n\n\n
  • Accessories included: Wire rope and hook<\/li>\n\n\n\n
  • Cable Length: 32 ft<\/li>\n<\/ul>\n<\/div>\n\n\n\n
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    Validation Testing<\/h2>\n\n\n\n
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    • 10 trials successfully having the winch pull 250 lbs a distance of 3 feet<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
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      Device A – Design Input 2<\/h3>\n\n\n\n
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      Design Input<\/span><\/td>\nVerification Activity<\/span><\/td>\nValidation Activity<\/span><\/td>\n<\/tr>\n
      Requirement<\/span><\/td>\nSpecifications<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\n<\/tr>\n
      A.2<\/strong> – The device must reduce the number of nurses required to transfer a patient.<\/span><\/td>\n\n

      A2.1<\/b> – Reduces the required number of nurses by two with a minimum staffing requirement of two nurses.<\/span><\/span><\/p>\n<\/td>\n

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      A2.1<\/strong> – Compare the number of nurses required for transfers with the device to the recommended number per OSHA standard.<\/span><\/p>\n<\/td>\n

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      A.2<\/span><\/b> –<\/span><\/span>Survey the patient transfer personnel on their ability to complete transfer. <\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n\n\n\n

      A.2<\/strong> – OSHA standards require one nurse\/transfer assistant per 35 lbs of patient. The average American is 185 lb (170 lb for women 200 lb for men) meaning the average transfer requires five nurses or assistants [2].<\/p>\n\n\n\n

      A2.1<\/strong> – Device accounts for transferring a minimum of 70 lbs of weight. Requires usage of 2 nurses in order for the device to function properly.<\/p>\n\n\n\n

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      Verification Testing<\/h2>\n\n\n\n
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      • Video of person being pulled across table<\/li>\n<\/ul>\n<\/div>\n\n\n\n
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        Validation Testing<\/h2>\n\n\n\n
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        • The number of nurses required for transfers decreased by 2 nurses.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
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          Device A – Design Input 3<\/h3>\n\n\n\n
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          Design Input<\/span><\/td>\nVerification Activity<\/span><\/td>\nValidation Activity<\/span><\/td>\n<\/tr>\n
          Requirement<\/span><\/td>\nSpecifications<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\n<\/tr>\n
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          A.3<\/b> – The device must minimize patient movement.<\/span><\/span><\/p>\n<\/td>\n

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          A3.1<\/b> – Maximum hip rotation of 10 degrees.<\/span><\/span><\/p>\n

          A3.2<\/b> – Maximum hip flexion of 15 degrees.<\/span><\/span><\/p>\n

          A3.3<\/b> – Maximum hip abduction of 15 degrees.<\/span><\/span><\/p>\n<\/td>\n

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          A3.1\/A3.2\/A3.3<\/b> –<\/span><\/span>Measure the specified angles with a goniometer during transfer. <\/span><\/p>\n<\/td>\n

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          A.3<\/b> – Transfer the patients with device and survey them about how the feeling of their hips and the movement they had underwent during the transfer process.<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n\n\n\n

          A.3<\/strong> – Patients with broken hips are unable to stand, walk, or even move without experiencing intense pain [3]. <\/p>\n\n\n\n

          A3.1\/A3.2\/A3.3<\/strong> – To effectively diminish the patient\u2019s pain, the angles of hip rotation, flexion, and extension should not exceed 1\/10 of total normal range [4].<\/p>\n\n\n\n

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          Verification Testing<\/h2>\n\n\n\n
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          Trial #<\/td>\nMax Abduction (\u00b0)<\/td>\nMax Flexion (\u00b0)<\/td>\nMax Rotation (\u00b0)<\/td>\n<\/tr>\n
          1<\/td>\n0<\/td>\n0<\/td>\n15<\/td>\n<\/tr>\n
          2<\/td>\n0<\/td>\n0<\/td>\n12<\/td>\n<\/tr>\n
          3<\/td>\n0<\/td>\n0<\/td>\n8<\/td>\n<\/tr>\n
          4<\/td>\n0<\/td>\n0<\/td>\n3<\/td>\n<\/tr>\n
          5<\/td>\n0<\/td>\n0<\/td>\n11<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n<\/div>\n\n\n\n
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          Validation Testing<\/h2>\n\n\n\n
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          • 5 trials with patients surveyed on stability of the hip and comfortability with an average rating of high.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
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            Device A – Design Input 4<\/h3>\n\n\n\n
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             <\/p>\n\n\n\n\n\n
            Design Input<\/span><\/td>\nVerification Activity<\/span><\/td>\nValidation Activity<\/span><\/td>\n<\/tr>\n
            Requirement<\/span><\/td>\nSpecifications<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\n<\/tr>\n
            A.4<\/strong> – The device must support a wide range of individuals in the patient population.
            <\/span><\/td>\n            		\n

            A4.1<\/b> – The device supports a range of patients up to 250 lbs.<\/span><\/span><\/p>\n

            A4.2 – The device supports a range of individuals\u2019 height up to 6\u20193\u201d.<\/span><\/b><\/span><\/p>\n<\/td>\n

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            A4.1<\/span><\/b> –<\/span><\/span>Calibrated scale will be used to measure the weight of each participant. Observe the device for any deformation or failures during performance at maximum weight of 250 lbs.<\/span><\/p>\n

            A4.2<\/b> – Calibrated<\/span> device will be used to measure the height of each participant. Observe the mechanics of the device to conclude that it is accessible for the entire height range. <\/span><\/span><\/p>\n<\/td>\n

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            A.4<\/strong> – The device will be tested based on individuals close to one extreme of the population range for this device (95th percentile) as well as individuals below the given range.<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n\n\n\n

            A.4<\/strong> – Patients who experience broken hips can be male, female, young, old, tall, short, heavy, light weight.  <\/p>\n\n\n\n

            A4.1\/A4.2<\/strong> – The 95th percentile male is 6\u20192\u201d and 246 lbs [5]. <\/p>\n\n\n\n

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            Verification Testing<\/h2>\n\n\n\n
            \"\"<\/figure>\n<\/div>\n\n\n\n
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            Validation Testing<\/h2>\n\n\n\n
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            • 7 patients were surveyed on the comfortability and safety while being transferred with an average rating of high.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
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              Device A – Design Input 5<\/h3>\n\n\n\n
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               <\/p>\n\n\n\n\n\n
              Design Input<\/span><\/td>\nVerification Activity<\/span><\/td>\nValidation Activity<\/span><\/td>\n<\/tr>\n
              Requirement<\/span><\/td>\nSpecifications<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\nMethod \/ Protocol<\/span><\/td>\n<\/tr>\n
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              A.5<\/b> – The device must be sanitizable.<\/span><\/span><\/p>\n<\/td>\n

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              A5.1<\/b> – The device will be sanitized using hospital grade disinfectant.<\/span><\/span><\/p>\n<\/td>\n

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              A5.1<\/b> –<\/span><\/span> Follow the protocol when using the hospital grade disinfectant to clean the patient transfer device. Observe the surface for residue<\/span><\/p>\n<\/td>\n

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              A.5<\/b> – <\/span><\/span>The performance of the device or any of its respective parts should remain the same after sanitizing it a minimum of 10 times using hospital grade disinfectant. <\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n\n\n\n

              A.5<\/strong> – The device might be exposed to a number of bodily fluids during performance.  <\/p>\n\n\n\n

              A5.1<\/strong> – The CDC recommends that patient lifts and transfer device surfaces be cleaned with hospital grade disinfectant [6]. <\/p>\n\n\n\n

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              Verification Testing<\/h2>\n\n\n\n