CHAPTER 4

CONSTRAINTS, TRADE OFFS, STANDARDS

A. Design Criteria and Constraints

The table below specifies the design criteria and its corresponding design constraint. The right
column defines the design criteria. These are the attributes that are desired in the proposed project. The left
column describes each criterion according (whichever is applicable) to the following constraints: Reliability,
Economic Cost, and Accuracy. These constraints are necessary in determining which design option is best
suited for the development of the project.

DESIGN
DESIGN CRITERIA
CONSTRAINT

Failure Rate
It is used to determine the reliability of a system or a component in a system. To calculate
Reliability a failure rate, you need to observe the system or the component and record the time it
takes to break down.

Total Time Cost

Accuracy The algorithm used on how long it will take to send information to the microcontroller. It is
important that the information should send immediately to process the drop rates.

Installation and maintenance cost

Economical The project should only cost around 5000 php in which installation does not cause any
amount and the institution whom are using the said device would handle the maintenance.
Table 4.1 Design Criteria and Constraints

Constraints Criterion of Importance

Economic Cost 5

Accuracy 4

Reliability 5

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Reliability

Failure Rate

0.70552

0.99974

Design 1 Design 2

It shows on the graph that the Design 2 has the highest percentage in failure rate due to the several
components involved on the system.

Accuracy

TOTAL TIME COST

20000000
18000000
16000000
14000000
12000000
10000000
8000000
6000000
4000000
2000000
0
Design 1 Design 2
Total Time Cost 18291372 28

Total Time Cost

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 The result is the design 2 wins for being accurate. Design option 2 has lesser total time cost in giving the
information to the microcontroller.

Economical

ECONOMICAL
9000
8000
7000
6000
5000
4000
3000
2000
1000
0
ECONOMICAL
Design 1 8568.63
Design 2 4862.5

Design 1 Design 2

It shows on the graph that Design 2 achieved the lower cost of Php 4862.50. The budget of the
project is around Php 5000 in which installation does not cause any amount and the institution whom are
using the said device would handle the maintenance.
Sensitivity Analysis

Sensitivity analysis plays a crucial role in assessing the robustness of the findings or conclusions based on
primary analyses of data in clinical trials. It is a technique used to determine how different values of an
independent variable impact a particular dependent variable under a given set of assumptions.

To determine the equivalent ranking of each criteria, the researchers used the following equations:
𝑽𝒂𝒍𝒖𝒆 𝒕𝒐 𝒃𝒆 𝑹𝒂𝒏𝒌𝒆𝒅
Ranking value=⌊𝟏 − ( )⌋
𝑮𝒐𝒗𝒆𝒓𝒏𝒊𝒏𝒈 𝑽𝒂𝒍𝒖𝒆

 If governing value is less than the value to be ranked use:

𝑮𝒐𝒗𝒆𝒓𝒏𝒊𝒏𝒈 𝑽𝒂𝒍𝒖𝒆
Ranking Value=⌊𝟏 − (𝑽𝒂𝒍𝒖𝒆 𝒕𝒐 𝒃𝒆 𝑹𝒂𝒏𝒌𝒆𝒅)⌋

1. Reliability (criterion value = 5 points)

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 Design 1
0.96922
Design Ranking Value=⌊1 − ( 1 )⌋ = 0.03078 points
Design 2
0.99974
Design Ranking Value=⌊1 − ( 1 )⌋ = 0.0026 points

2. Total Time cost (criterion value = 4 points)

Design 1
18,291,372
Design Ranking Value=⌊1 − (20,000,000)⌋ = 0.0854314 points
Design 2
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Design Ranking Value=⌊1 − (20,000,000)⌋ = 0.99999986 points

2. Economic (Criterion’s Importance = 5 points)

Design 1
8568.63
Design Ranking Value=⌊1 − ( 10000 )⌋ = 0.143137 points
Design 2
4862.50
Design Ranking Value=⌊1 − ( 10000 )⌋ = 0.52 points

Summary of Trade offs

Design Option 1 Design Option 2

Economic cost 0.143137 0.52

Accuracy 0.0854314 0.99999986
Reliability 0.03078 0.0026
Total 0.2575814 1.52259986

Summary of Trade offs with Criterion of Importance

Criterion of Design Option 1 Design Option 2
Importance
Economic cost 5 0.715685 2.6
Accuracy 4 0.3417256 3.99999944
Reliability 5 0.1539 0.013
Total 1.2113106 6.61299944

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4.3 APPLICABLE STANDARDS

Table 4.3.1: Standards for Wireless Fidelity Standard

Wireless Fidelity Standard

IEEE 802.11b Created in 1999, this standard uses the more typical 2.4 GHz band and can achieve
a maximum speed of 11 Mb/s.

IEEE 802.11a Created in 1999, this version of Wi-Fi works on the 5 GHz band. This was done with
the hope of encountering less interference, since many devices (like most wireless
phones) use the 2.4 GHz band as well. 802.11a is fairly quick too, with maximum data
rates topping out at 54 megabits per second. However, the 5GHz frequency has more
difficulty with objects that are in the signal’s path, so the range is often poor.

IEEE 802.11g Designed in 2003, the 802.11g standard upped the maximum data rate to 54
megabits per second while retaining usage of the reliable 2.4 GHz band. This resulted
in widespread adoption of the standard. Wireless g remains common even today, as
it is adequately fast and routers lacking support of the new n standard are incredibly
cheap.
IEEE 802.11n The newest Wi-Fi standard, n was actually introduced in 2009. It’s been adopted
slowly, but it now common on routers and laptops. 802.11n can operate at both
2.4GHz and 5 GHz and it supports multi-channel usage. Each channel offers a
maximum data rate of 150 megabits per second, which means the maximum data
rate of the standard is 600 megabits per second. However, this requires hardware
support, and I have yet to see a Wireless n router with more than three channels. The
support must be on both ends as well, so you can’t make use of a dual or tri-channel
router if your laptop only supports a single channel.

The following table above demonstrates the different standards that the proponents can use in
designing their online system. The standards that you can see are list of standards that are applicable
when using the technology of Wireless Fidelity.

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Table 4.3.2: Standards for Cloud Computing

Cloud Computing Standards

IEEE P2301 Cloud computing ecosystem participants (cloud vendors, service providers, and users)
of standards-based choices in areas such as application interfaces, portability interfaces,
management interfaces, interoperability interfaces, file formats, and operation
conventions. This guide groups these choices into multiple logical profiles, which are
organized to address different cloud personalities.

ISO/IEC Possible but not obligatory. Some organizations choose to implement the standard in
27001 order to benefit from the best practice it contains while others decide they also want to
get certified to reassure customers and clients that its recommendations have been
followed. ISO does not perform certification.

The following table above demonstrates the different standards that the proponents can use in designing
their online system. The standards that you can see are list of standards that are applicable when using the
technology of Cloud Computing.

Table 4.3.3: Standards on Medical Devices

Medical Standards
The goal of ISO 10993 is to protect patients from biological risks arising from
ISO 10993-1, “Biological
the use of medical devices. The standard covers testing for nontoxicity,
evaluation of medical carcinogenicity, cytotoxicity and a variety of other areas of concern. While the
devices.” standard covers specific areas of testing to be evaluated, it is meant to be a
framework for a biological evaluation, not a list of required testing and
specifications. Jordi Labs routinely assists its clients in the design and analytical
testing involved in the evaluation of medical devices under ISO 10993.

EN 20594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and
BS EN 20594-1:1994,
certain other medical equipment - Part 1: General requirements - Specification
“Standardized of the requirements for conical (Luer) fittings for use with hyperemic syringes
connector types.” and needles and with certain other apparatus for medical use such as
transfusion and infusion sets. It covers fittings made of rigid and semi-rigid
materials and includes test methods for gauging and performance. It excludes
provision for more flexible or elastomeric materials. The annex on liquid leakage
is given as an example.

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 The simplest devices, gravity controllers, employ a clamping action to vary the
DB2003 (02) v2.0,
flow of liquid under the force of gravity. More complex systems use a positive
“MHRA Infusion System pumping action for infusion. The simplest of these is an elastomeric pump which
Device Bulletin” has a balloon reservoir which contracts delivering the infusion at a constant
rate. Powered volumetric infusion pumps, together with an appropriate
administration set, are intended to provide an accurate flow of fluids over a
prescribed period. Volumetric pumps may employ a linear peristaltic pumping
mechanism applied to the infusion tubing (‘giving set’) or use a special cassette
within the set. Powered syringe pumps work by pushing the plunger of a
disposable syringe along at a predetermined rate. The type of pump used will
depend on the required volume and speed of infusion. Appendix 1 gives more
detailed descriptions of the different types of pumps.
The Design for Patient Safety series looks at how better design can reduce risk,
NPSA Handbooks,
improve the working environment, and ensure better, patient-centered care.
“Design for patient The series is based on the belief that human beings make mistakes because
safety” the systems, tasks and processes they work within are poorly designed.
Effective design can deliver products, services, processes and environments
that are intuitive, simple to understand, simple to use, convenient and
comfortable. Consequently they are less likely to lead to errors. There is a
wealth of knowledge and methods from the design world that can be applied to
improve healthcare products and processes, and the series seeks to explore
some of these.
EN ISO 14971:2012, E Application of risk management to medical devices, replaced EN ISO
“Risk Management” 14971:2009 as the European harmonized standard. The 2009 version was
considered obsolete as of the same date. The 2012 version allows the
presumption of conformity to the applicable Essential Requirements of the three
Medical Device Directives, 90/385/EEC, 93/42/EEC and 98/79/EC. EN ISO
14971:2012 applies only to manufacturers placing devices on the market in
Europe; for the rest of the world, ISO 14971:2007 remains the applicable
standard. We describe below the steps BSI as a medical devices notified body
plans to take to meet the requirements of EN ISO 14971:2012. This should help
manufacturers update their risk management procedures and files to maintain
compliance with the Essential Requirements of the directives.

EN 60601-2-24:1998, In general, an infusion pump is operated by a trained user, who programs the
“Safety Infusion rate and duration of fluid delivery through a built-in software interface. Infusion
Devices” pumps offer significant advantages over manual administration of fluids,
including the ability to deliver fluids in very small volumes, and the ability to
deliver fluids at precisely programmed rates or automated intervals. They can

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 deliver nutrients or medications, such as insulin or other hormones, antibiotics,
chemotherapy drugs, and pain relievers.

There are many types of infusion pumps, including large volume, patient-
controlled analgesia (PCA), elastomeric, syringe, enteral, and insulin
pumps,. Some are designed mainly for stationary use at a patient’s
bedside. Others, called ambulatory infusion pumps, are designed to be
portable or wearable.

Because infusion pumps are frequently used to administer critical fluids,

including high-risk medications, pump failures can have significant implications
for patient safety. Many infusion pumps are equipped with safety features, such
as alarms or other operator alerts that are intended to activate in the event of a
problem. For example, some pumps are designed to alert users when air or
another blockage is detected in the tubing that delivers fluid to the patient.
Some newer infusion pumps, often called smart pumps, are designed to alert
the user when there is a risk of an adverse drug interaction, or when the user
sets the pump’s parameters outside of specified safety limits.

EN 60601-1:2006/AC: Invention of the first practical electrocardiogram in the early 1900s (for which
2010, “Basic Safety and he received the Nobel Prize in Physiology or Medicine in 1924), medical
professionals are able to accurately measure the activity in the four-chambered
Essential Performance”
heart through the non-invasive method of placing electrodes on the patient’s
skin. Because of this ability to analyze the organ that grants us life, ECGs must
follow a standard practice to prevent any threats to the patient and accurately
collect data. IEC 60601-2-25 ED. 2.0 B:2011 calls for preparation of the ECG
machine through appropriate testing of it and its accessories in service
activities. These tests should be conducted under appropriate humidity, as
specified in the standard, and are intended to calibrate the ECG for accuracy.
Tests used to check the voltage of the ECG with the use of a circuit board are
thoroughly detailed in the standard

Read more at the ANSI Blog: Basic Safety and Essential Performance of
Electrocardiographs.

Table 4.3.4: Standards on Dextrose

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 Standards on Dextrose

USP revised General Notices: In accordance with section 7.02 of the 2010–2015 Rules and
Section 5.60.30, “Elemental Impurities Procedures of the Council of Experts, the Council of Experts
in USP Drug Products and Dietary Executive Committee (CoE EC) has revised General Notices
Supplements Section 5.60.30 Elemental Impurities in USP Drug Products and
Dietary Supplements as a Revision Bulletin published on March
27, 2015. The revised text will become official April 1, 2015. The
intent of this revision is to establish an implementation date of
January 1, 2018 for General Chapters Elemental Impurities–
Limits and Elemental Contaminants in Dietary Supplements.
This date more closely aligns the implementation date of
Elemental Impurities standards with that of the ICH Q3D
Guideline for Elemental Impurities.

INS: 2016, “Infusion therapy standards Infusion therapy standards are applicable to any patient care
are applicable to any patient care setting in which vascular access devices (VADs) are placed
setting in which vascular access and/or managed and where infusion therapies are administered.
devices” Infusion therapy is provided in accordance with legal, ethical and
cultural principles, Local organizational policies, procedures,
protocols and guidelines for infusion therapy are available and
provide the health care professional with an acceptable course
of action including performance, accountability and clinical
decision making. The HCP ensures that infusion therapy is
patient-specific and is tailored towards the needs of the patient,
their personal circumstances, co-existing conditions and
personal choices. The HCP maintains patient confidentiality,
safety, and security; and respects, promotes, and preserves
patient autonomy, dignity, rights, and diversity.

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Calculating maintenance fluid

Patients weight Full Maintenance mls/day mls/hour

3 to 10kg 100 x wt 4 x wt

10 - 20kg 1000 plus 50 x (wt-10) 40 plus 2 x (wt-10)

>20kg 1500 plus 20 x (wt-20) 60 plus 1 x (wt-20) [S1]

 100mls/hour (2400mls/day) is the normal maximum amount.

 Based on the Clinical Practical Guidelines in Intravenous Fluids

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