December 2022

The IVenture team was able to present their final design ideas for the December presentations. The IVenture team created design inputs and the respective validation and verification summary protocols that will be utilized to check the requirements and specifications.

Here are the presented design requirements:

Design Input Requirement	Design Specifications
1. The device must reduce the work required to move intravenous equipment.	1.1 Device must the reduce work needed to mobilize intravenous equipment by at least 50% compared to the work needed of a common IV pole.
1. Therapy walks can require the user to walk with their necessary infusion accessories. If substantial energy is required to move the IV devices, it can impact patient recovery and morale.	1.1 The work needed to mobilize intravenous equipment varies based on form, load, and wheel friction. The device is intended to demonstrate mechanical advantage by reducing the work needed to move the medical accessories in comparison to the control IV pole.
Verification:  A pull force gauge will be used over a specified distance to calculate the work used to move the device compared to that of common IV poles.	Validation:  Users will be asked to move both  common IV poles and this device, and assess if the device reduces work

Design Input Requirement	Design Specifications
2. The device structure must support a weight of common intravenous infusion equipment.	2.1 Device must withstand a vertical load of at least 133 Newtons.
2. Infusion accessories, such as infusion pumps, baskets, and infusion liquids are attached to infusion stands which apply a vertical force onto the device.	2.1 On the market infusion stands have load capacities around 30lbs (13.6kg) under normal use. [2a]
Verification:  Weights will be attached to the structure to up to the specified vertical load and measuring if device deforms.	Validation: Put equipment up to a load of 133 Newtons and have device used with a post-use survey.

Design Input Requirement	Design Specifications
3. The device must be stable.	3.1 The device will remain balanced while the angle of the vertical axis is 10° off center.
3. The device would be subject to moments if contact is made with device above the center of mass. If a great enough moment is applied, the device may be liable to tipping over, harming the patient.	3.1 An IEC 60601-1 safety requirement regarding overbalance of medical transport devices dictates that devices must demonstrate stability when on a 10° plane when no transport warning is demonstrated [3a].
Verification: A CAD model of the device will be rotated 10° off center to determine if the center of mass is offset from the tipping point.	Validation: Subjects will use the device and walk through environments that are similar to hospital settings and will be given a survey to see if the device is stable.

Design Input Requirement	Design Specifications
4. The device must be adjustable.	4.1 The device’s adjustable range must encompass 60 to 74 inches.
4. Adjustable device heights accommodate a wide range of human heights.	4.1 According to the CDC for the “Statue-for-age percentiles”, the 5th percentile of women is 60 inches while the 95th percentile of men is 74 inches in the United States [4a]. On average, men are taller than women, thus this range will cover most of the spectrum.
Verification: Measure the minimum, maximum and nominal heights of device.	Validation: Have users from lower to higher height range and have them to adjust the pole to various heights.

Design Input Requirement	Design Specifications
5. The device must be maneuverable.	5.1. The device’s turning radius about the patient must be less than 16 inches.
5. Maneuverability refers to the ability of the patient to move the device easily in any direction within hospital setting. The device’s maneuverability is vital during patient’s movement. This ensures a safety posture for turning motion, and walking speed [5a].	5.1. A shorter turning radius ensures that the IV lines are not pulled out of the patient during turning and navigation. The 16 inches is the minimum IV tube length from the cannula to infusion pump [5b].
Verification: The turning radius is calculated by the base size of the device, the maximum angle of turn, and the area of navigation.	Validation: Use a survey from patients when it is functioning.

Design Input Requirement	Design Specifications
6. The device must meet IEC 60601-1 medical device safety ratings.	6.1 The allowable DC leakage current must not exceed 10µA.
6. Patients and operators must be protected from leakage current paths from an enclosure or accessible parts of the device [6a].	6.1 Per IEC 60601-1 clause 6.2 The IEC requires insulated devices to ensure MOOP (Means of Operator Protection) and MOPP (Means of Patient Protection) upon subject to DC testing. Double insulation provides the means of protection for both patients and operators.
Verification: The leakage current is measured with respect to open ground connectors, circuits that simulate patient impedance and measurement of ground wire resistance.	Validation: N/A

Design Input Requirement	Design Specifications
7. The device must have self contained power.	7.1 Battery must have a capacity of 4,500 mAh.
7. Approximately 90% of hospitalized patients utilize an infusion pump. It would be not be feasible to have patients wear or carry the IV equipment. A fully manual device would not be able to accomplish the force reduction objective, thus the explored solutions include a motorized component [7a].	7.1 Studies have shown that just 30 minutes of walking per day can be beneficial in increasing muscular strength without overexerting the body [7b]. The load current of all electrical components was determined to be 4,500mA. Thus, the target battery life was set to at least 1 hour before charging is required to allow patients to move freely for the recommended walking time.
Verification: Power system on and have it operate under normal and continuous walking to determine if it runs for a minimum of 1 hour.	Validation: Have the device be used solely on the capacity of the battery.

Design Input Requirement	Design Specifications
8. The device must be compact.	8.1 The device must have a maximum horizontal distance of less than 26 inches.
8. The device is intended to be used within a hospital setting, thus having a compact design will minimize that amount of surface area needed as well as allow it to freely pass through current, regulated building dimensions.	8.1  According to the Americans with Disabilities Act of 1990, all hospitals must follow specified standards to allow for patients in wheelchairs to have full accessibility. These standards were developed using the assumption that a standard adult-sized wheelchair has a width of 26 inches from the outside of the rear wheels [8a]. Thus, remaining below this regulation will allow the device to meet all the standards for maneuverability within current hospital settings.
Verification: Measure the max horizontal distance of the device.	Validation: Have the user maneuver the device through standard hospital rooms/doorways/halls and see if the size is an inconvenience.