P.H.A.M.’S REQUIREMENTS

REQUIREMENT #1
The device must be able to measure pressure at localized areas of the patient’s body.

Immobilized patients will most commonly experience increased pressure at the bony prominences of their body after a prolong period of time. Horizontally, pressures of 45-75mmHg are generated from standard hospital beds and if sustained for 3-4 hours , capillary perfusion pressure of the deep tissue is exceeded to where ulceration may begin.

REQUIREMENT #2
The device must have an algorithm to take in inputs of time, body weight, pressure at each location on the body, and prior history of ulcers.

To best satisfy the needs of the patient and medical staff, the algorithm interface will intake time, the pressure range and any ulcerations present on the body. Along with medical staff diagnosis, the severity of the patients condition is established and allows staff to be alerted in a timely manner for when to reposition.

REQUIREMENT #3
The device must have a system to alert medical staff/caretakers when the patient is at risk for pressure ulceration.

In accordance with the IEC 60601-1-8 code , the device will emit both an audible and visual alert depending on the priority of the response time needed. Low priority results in slow repeating flashes with audible alerts and if not resolved in time, medium priority is then enacted with an increase in the number of flashes and audible alerts. However, high priority that requires immediate attention will emit continuous red flashes and at least 10 repeated audible alerts

REQUIREMENT #4
The device must provide assistive support to medical staff for moving the patient.

Medical staff are often unable to physically reposition patients, especially bariatric patients, and this can lead to injury to medical staff as well as the patient. With lifting being the riskiest part of manual repositioning, assistive movement a patient at least to a 30 degree angle will aid caretakers in reducing this load.

REQUIREMENT #5
The device must be able to support the load of patients body weight in the appropriate demographic.

Medical staff are recommended to only lift up to 51 pounds and even less from an awkward angle, and this can require multiple staff tending to an individual patient several times a day depending on their condition. Supporting a patients body load will aid staff in proper reposition while helping to protect both the staff and patient from injury

REQUIREMENT #6
The device must be attached securely to a standard hospital bed.

Bed sheets tend to shift under patients when they move or are adjusted into a comfortable position, therefore the device is intended to be securely attached to the patients mattress.

REQUIREMENT #7
The device must continue to operate in the presence of moisture.

More often than not, patients bodily fluids are secreted in some manner, whether it be blood, urine, saliva, etc., and in this likely instance, the device is to continue proper function.

REQUIREMENT #8
The device must be cleanable.

Upon multiple users over time, the device is to be cleanable under hospital grade cleaning agent standard to adequately disinfect the surface for continued use. Additionally, the device must be able to undergo sterilization and maintain proper function thereafter.

REQUIREMENT #9
Device conforms to electrical safety standards.

The device will conform to electrical safety IEC60601-11 Collateral Standard for systems used within healthcare facilities while maintaining essential performance under maximum intended conditions.