Product Design Specification

(rev.4 –4/16/08)
Ted Kastenhuber, Bradley H. Morneweck, Bailey Roche, and Christopher Withers

Project: Incubator Designed for Emerging Areas (iDEA)

Requirements:
Functions

Births that occur in developing countries, such as Haiti, do not always occur at the hospital. For instance,
in Haiti’s Hospital Albert Schweitzer, there are two to three off-site facilities that must be able to support
newborns. Thermoregulation is important due to infants’ increased susceptibility to cold stress and
vulnerability to changes in environmental temperature and convective heat loss due to air movement.
This is a greater problem in premature or low-birth weight infants. To fill this gap in medical care, we
intend to design a simple, low-cost incubator that does not rely on a power grid. These facilities have
very limited accessibility and have no electrical or water supply. The incubator will interface with a
110VAC power source or (in the case of a power outage) a series of 12V batteries. Low-cost parts that are
all available for replacement by mail order from their respective sources will be used. The unit must be
modulated and should be simple enough to be maintained by a limited infrastructure and technical support
staff.

Client Requirements

• Maintain infant temperature and avoid hypothermia

• Be able to adjust incubator temperature in the range of 35° C to 38°C with accuracy of ± 1°C
• The unit must alert staff with an alarm if the temperature inside the incubator is outside ± 1°C of
the target temperature (as entered by user)
• Incubator must be lightweight so that it can be transported 3 miles by donkey
• The patient must be visible from at least two surfaces of the device

Design:
Performance Requirements

The device must be able to heat a space (~0.07 m3) to 36.3-37.2°C (± 1°C). It must run off battery power
supply at a rate of 150 watts per hour. It must be compatible with various modes of power, including
110VAC or 12VDC battery. The device must have a regulation system, which controls power supply to
maintain a temperature from 36.3-37.2° C. The device must be able to contain an infant-sized mattress
67x36 cm. The device must have consistent, reliable ventilation. The operating noise should be less than
47 dB. Humidity range within the incubator must be 50-90%.

Accuracy and Reliability

The device must be equipped with a means of measuring air temperature within the incubator with an
accuracy of 0.1 C. This sensor must be operable within a range of 20-40C. It should be able to be in
continuous use for a minimum of 60 days without compromising accuracy.

Life in Service

The device must be able to support continuous use for 30 days. With proper maintenance the device
should have a lifetime of at least 5 years.

Operational Environment

The device must be operable under the specific environmental conditions of the Hospital Albert
Schweitzer in Haiti. The relative humidity is high, and temperatures average around 28°C. All circuit
components, structural materials, and other various device components must be operable under these
conditions:

i. Temperature range: 0 to 65°C

ii. Humidity range: 0 to 100% humidity
iii. Pressure range: 0.5 to 4.0 atmospheres

Ergonomics

The device must allow the clinician to view the infant on at least one side. It must have ample space for
the baby to move without being in danger. The device, unassembled must be easy to transport to remote
sites, able to be hauled via donkey over rough terrain.

Size

The projected weight of the device must be less than 75kg. The volumetric size of the device should not
extend beyond 200x200x200cm.

Materials

The materials must be made of smooth materials which do not elicit an immune response in the infant.
They must be durable, not easily degradable. Subject to environmental conditions, their structural
integrity must not be compromised. The materials must be suitable as insulating materials.

Production

o Quantity: For initial testing, one prototype is to be produced. Should said prototype
prove successful, one unit will be made specifically for the HAS.
o Cost: Since the product is being designed to use in impoverished and developing areas,
production cost is going to be kept as low as possible. Accordingly, consumer prices will
be set high enough only to cover operating expenses. Hopefully, clinics will be able to
purchase a unit for roughly 500 USD.
o Time: The initial prototype production will be completed by April 2007.
• Maintenance
 o Replacement parts: All replacement parts are to be modular, and able to be installed by
anyone capable of reading the instructions.
o Cleaning: All surfaces will be compatible with ethanol cleaning methods.
• Safety
o The device should be free of pointed or sharp surfaces. Also, all heating surfaces or
surfaces that are otherwise very hot will be placed in a position so as to eliminate the
possibility of contact with the infant. Additionally, the door will be constructed in such a
way as to eliminate the possibility of it shutting on the infant.

Standards and Specs

Neonatal incubators have been pre-approved by the FDA, and have been designated as class II medical
devices. Thus, it must conform to the previous FDA regulation 21 CFR 880.5400. The product will also
need to follow the regulation: IEC 60601-2-19 1996-10: Amendment 1 - Medical electrical equipment
Part 2: Particular requirements for safety of baby incubators, which pertains to the 510(k) specifics.

Competition

The modern neonatal incubator is full of functions that make it expensive and undesirable for third world
applications. However, there exists a product called the “Van Hemel Baby Incubator” that aims to solve
the same problem. The current device lacks a useful thermoregulation system, which our design aims to
include.

Company Constraints

Our team has until April, 2008 to fabricate the device, as well as a limitation of $1500. Specifically, the
device is constrained by the aforementioned client requirements, which are unique to third world
infrastructures.

Shipping

- Packing
o The device dimensions will be large, and so it will be shipped in easily assembled
pieces. The heating coil and circuit units will be isolated and packed as fragile.
- Distribution
o The product will be distributed on need basis to the developing nations that request
units (e.g. HAS).
- Shelf life/Active lifespan
o The shelf life of the unit is indeterminate, because none of the materials regularly
decay.
Revised 4/16/08 – BMR
- Formatting.