Specification Document

The Needs Table

No. The IV Need Importance
Protector
1 The IVP must allow the IV to be easily accessible to nurses 1
2 The IVP must be comfortable 2
3 The IVP must stay in place 1
4 The IVP band must be adjustable 3
5 The IVP must be entertaining 2
6 The IVP must be sanitary 1
7 The IVP must block IV from child’s sight 3
8 The IVP must be inexpensive to produce 2
9 The IVP must not interfere with the function of the IV 1
10 The IVP must comply with regulations 1

The Metric Table

Metric Need Metric Imp. Units Marginal Ideal
No. No. Value Value
1 1 After 5 practice trials, the s <5 3
average person should be able
to remove or attach the IVP in
3 seconds
2 2 Maintains a BP of 120/80 mmHg 5% over No
(average BP of the person), hr average change in
less than 2 people out of 100 BP BP
complain of comfort after 5 4/100 2/100
hours of use, and no redness
or chafing
3 3 Band doesn’t move more than cm 1 <0.2
1 cm in either direction
4 4 Band can fit arm circumference in <6 & >9 8
from 5-10 inches
5 5 Must hold a child’s attention Min 10 min 20 min
for more than 20 min, and an % 75% 85%
80% approval rate from a approval
survey of parents and children
6 6 Meets class 1 medical device n/a Barely Exempt
cleanliness specifications considered from
class 1 class 1
(almost
class 2)
 7 7 Material lets less than 10% of cm2/g 10% < 5%
light through
8 8 Must cost less than $5 to $ $5 $2
produce
9 9 < 0.1% difference in flow rate Drops/min 0.15% < 0.05%
for an IV difference
10 10 Gets FDA approval/ approval in n/a Approved Approved
more than 10 countries in 2 in > 10
countries countries

Proposed Specification for IV Protector Device (IVPD)

The following design specification is to be applied to the design of the IV Protection Device
(IVPD) for use in hospitals throughout the US and other countries.

1. The device must be accessible to nurses so that they may be able to remove or apply the
device in less than 5 seconds.
2. The IVPD must be comfortable so that the blood pressure is not affected and less than
2/100 users complains of discomfort or irritation after 5 hours.
3. The IVPD must stay in place such that it does not move more than 1 cm in either
direction during use.
4. The band must be adjustable so that it fits an arm with a circumference between 5 and
10 inches.
5. The band must be entertaining enough to hold the child’s attention for 20 minutes
and/or have an 80% approval rating from a survey taken of children and parents.
6. The IVPD must be sanitary by meeting Class 1 Medical Device cleanliness specifications.
7. The IVPD must block the IV from the child’s sight by letting less than 10% of light
through during a light test.
8. The device must be inexpensive to produce by keeping production costs under $5.
9. The device must not interfere with the function of the IV by maintaining less than a 0.1%
difference in flow rate.
10. The IVPD must comply with regulations by gaining FDA approval and the approval from
agencies in 10 other countries.