Product Design and Development

Assignment 6
X

Temperature Monitoring System

Daniel Terra
Helena Pereira
Inês Gomes
Micael Gonçalves
Roberto Barbosa

Team Leader: Roberto Barbosa X X

June 2018
 Product Design
Assignment 6:

1. Consulting partners
After a first approach to the concept selection, the team discarded six of the proposed concepts,
remaining the four ones with the best score in the referred analysis. During this screening phase, a
set of criteria established having the previously identified need statements as reference was used to
score all the concepts that were then ranked. This process allowed to evaluate the proposed
solutions regarding factors such as the comfort during its use, the possibility of measuring other
biosignals and the facility to operate it, among others. At that stage, the team considered the arm
band, the pulse band, the auricular device and the core patch the most promising concepts that
deserved to be further analyzed to select the one with the greatest potential.

Once the opinion of the team members had already been considered in the first approach, the
opinion of experts and directly interested people appeared as a crucial element to proceed to the
final decision of the product to be developed.

At this stage of the development of the work, when several scenarios are being studied in order to
select the best path to follow, the team has found interesting and advantageous to consult
representatives of those that are considered the main stakeholders of this project, to be able to take
more conscious and informed decisions. In this way, it was considered important to establish a
closer contact with a group of health professionals, as well as with nursing home caregivers and
elderly people, once this segment is considered one of the most sensitive ones among the potential
users. Each consultant may bring relevant information and contribute in different domains, not only
the technical ones, essentially provided by doctors and nurses, but also on that associated with the
point of view of the end user. Towards the afore-mentioned, the team got in touch with a group of
consultants to perform tailored interviews and gather information concerning specific topics with
great impact on the next stages of the process of development of the product.

To perform this last evaluation of the concepts, only four criteria were used, once they were found
to be the most important ones for taking the final decision: level of invasiveness, intimately related
to the comfort provided during the use of the product, accuracy of the obtained results, associated
essentially with the part of the body used to measure the temperature, and the facility in using it,
considering the multiplicity of clinical conditions that may be found among the patients.

1
 Product Design
Assignment 6:

2. Target Specifications
The information collected along the competitive benchmarking process may be used as a start-
point to set the target values for the metrics since it allows to build some sensitivity on the subject.
In this stage, two types of target value are useful: an ideal value and a marginally acceptable value.
While the first is the best result that may be expected to reach, the second one represents a more
conservative goal that would just barely make the product commercially viable (Ulrich and
Eppinger 2012). In this scope, the product must have a benefit proposition at least as good as that
of the options available in the market, but the ideal scenario is that the new solution standout and
offers more advantageous conditions or functionalities. This is the path to follow to have a
successful product able to conquer the market. The establishment of boundaries for the target
specifications gives some flexibility to the design team that sets the limit values with confidence
that the product is still a good bet even if it exhibits one or more marginally acceptable
characteristics.

The target specifications must be reviewed during the subsequent phases of the development of the
work in order to make some adjustments. These modifications are required to reach a compromise
between what the team desires to offer as benefit proposition to the customers and the achievable
characteristics and performance, imposed by factors such as cost, materials, components and
processes.

Thus, the target specifications, which included the marginal and the ideal values, were revised and
changed according to the information collected since their first definition, being the result of such
process presented in.

Metric Marginal Ideal

Needs Metrics Importance Units
No Value Value
1, 2, 3, 4,
6, 7, 9, 10, Range of
1 5 °C 35.5-41 0-50
24, 26 and temperature
27
2 8 Total mass 3 g <100 <50
11, 19 and Intensity of emitted
3 4 dB 20-35 20-25
24 sound signals
17, 18 and
4 Battery capacity 4 mA.h >620 >1000
19
5 2 and 21 Resistance to water 4 Subj. >3 >4

2
 Product Design
Assignment 6:

7, 12, 15,
Velocity of data
6 23, 24, 25 5 Mb/s >1* >2*
transmission
e 29
26, 27 and Distance to
7 4 cm 0 >0
28 measurement
Reliability on the
8 30 4 0 1
presence of humidity Boolean
13, 16 and Selling price per
9 1 €$ <30 <20
22 user
4, 7, 10,
10 15, 22 and Number of users 5 UN >20 >50
25
4, 5, 6, 7,
Level of
11 26, 27 and 5 Subj. <3 <2
invasiveness
28
Maximum distance
7, 9, 23, between the
12 5 m >10 >20
25 and transmitter and the
receiver
Interval between
13 9 5 min <45 <20
measurements
9 and 29 Measurement time 5 s <60 <5
Recording capacity
– number of
14 7 and 9 5 UN >3600 Unlimited
measurements per
user
1, 7, 29 Measurement
15 5 ºC 0.1 <0.1
and 30 accuracy
1, 7, 29
16 Resolution 4 ºC 0.1 <0.1
and 30

3. Standard Specifications and Requirements

ASTM E1112-00: Standard Specification for Electronic Thermometer for Intermittent
Determination of Patient Temperature

Scope: This specification covers electronic instruments whose purpose is monitoring the
patient temperature in an intermittent way, excluding the infrared thermometers.
Requirements: the electronic instruments must obey to the following requirements.
3.1.Temperature range
For body temperature monitoring, the device shall display temperatures of the range from 35.5
to 41.0 ºC.
3.2.Accuracy

3
 Product Design
Assignment 6:

The individual reading shall not be in error more than the values presented in Table 1, when
the device is used within the manufacturer’s specified temperature range.
Table 1 Maximum error according to the temperature range.
Temperature Maximum error
Less than 35.8 ºC  0.3 ºC
35.8 to less than 37 ºC  0.2 ºC
37.0 ºC to 39.0 ºC  0.1 ºC
Greater than 39 ºC to 41 ºC  0.2 ºC
Greater 41 ºC  0.3 ºC

3.3.Environment
3.3.1. Operating environment: the accuracy requirements must be met when the device
operates in an environment of 16 ºC to 40 ºC, with a relative humidity of 15% to 95%
noncondensing.
3.3.2. Storage environment: the device must meet the accuracy requirements after having
been stored or transported, or both, at any point in an environment of  20ºC to 50 ºC,
with a relative humidity of 15% to 95% noncondensing, for a period of one moth.
3.4.Labelling
The user’s manual must include a statement to inform if the functioning and/or performance of
the instrument may be negatively affected by one or more of the following situations:
 Operation outside the manufacturer’s stated temperature and humidity range.
 Storage outside the manufacturer’s stated temperature and humidity range.
 Mechanical shock such as drop it.
 Patient temperature is below ambient temperature.
3.5.Resolution
1.5.1. Analog display: since it is not aimed to develop a device that uses analog display, this
point will not be discussed herein.
1.5.2. Digital display
1.5.2.1. Resolution: the digital display shall have incremental steps of not more than 0.1 ºC.
1.5.2.2. Readibility: the numerals must appear to be at least 2.5 mm high and 1.5 mm wide
and appear to be separated from one another by a space of at least 0.7 mm, at the outside
of the surface of the device.
3.6.Battery condition

4
 Product Design
Assignment 6:

The device accuracy and functioning shall not be affected by the battery condition unless a
continuous automatic indication of unreliable operation is provided, which must remain
until this situation is corrected. If a rechargeable battery is used, a position indication
shall be provided with the instrument system to inform that the battery is charging.
3.7.Construction
1.7.1. Electrical: the instrument and accessories such as battery chargers shall meet the
electrical safety requirements presented in UL 544.
1.7.2. Material
1.7.2.1. Case material: the case material used in the device and in the non-disposable
accessories must withstand biological and physical cleaning without performance
degradation as well as dropping without constitute an electrical safety hazard.
1.7.2.2. Patient contact materials: the materials which may be in contact with anatomical sites
to measure the temperature as specified by the manufacturer shall be non-toxic.
3.8.Marking
All markings for purposes of identification or instruction must be clear and legible and shall
not suffer deterioration when subjected to cleaning.
3.8.1. Instrument marking: the device shall be marked with the manufacturer’s or
distributor’s name, model designation, serial number or lot number in order to indicate
the specific period, not exceed 90 days, in which the thermometer was calibrated), as
well as the temperature scale in Celsius or Fahrenheit.
3.8.2. Probe marking: the detachable non-disposable probes shall be marked also with at
least the manufacturer’s or distributor’s name or identification and serial or lot number.
3.8.3. Operating instructions: operating instructions shall be provided on the device,
according to the available space to do so.
3.8.4. Care and use instructions: the instruction for the care, use, and biological and physical
cleaning of the device must be provided. Proper use and application of the attachments
such as oral or rectal probes and probe covers must be indicated. The manufacturer shall
provide instructions to decontaminate, following each use, any part in contact with the
user not intended for single use.

5
 Product Design
Assignment 6:

3.8.5. Health and safety hazard marking: important information must be displayed on the
device whenever possible. If the instrument or accessories do not meet the requirement
od UL 913, referring to environmental concerns, a warning label shall be used.
3.9.Identification
In order that purchasers may identify products conforming to all requirements of this
specification, producers and distributors may include a statement of compliance in
conjunction with their name and address on product labels, invoices, sales literature,
and the like. The following statement is suggested when sufficient space is available:
This thermometer conforms to all of the requirements established in ASTM standard
E1112. Full responsibility for conformance of this product to the specification is
assumed by (name and address of producer or distributor). The following abbreviated
statement is suggested when available space on labels is insufficient for the full
statement: Conforms to ASTM E1112 (name and
address of producer or distributor).
3.10. Documentation
3.10.1. Detailed instructions: detailed instructions for use shall be provided namely in terms
of means for training in the operation, application, care, and biological and physical
cleaning od the device and its accessories.
3.10.2. Service and repair manual: in the case that the user repair is permitted by the
manufacturer, a service manual shall be available, which must provide theory of
operation, maintenance information, test procedures, test equipment requirements,
detailed diagrams, parts list, and specifications.
3.10.3. Accuracy determination: manufacturer shall make available specific instructions for
test to determine the accuracy of the instrument, including the temperature probe.
Manufacturers of predictive thermometers must specify corrections to compensate for
the difference between in vivo and vitro conditions if required.
3.10.4. Recalibration: The manufacturer shall recommend a periodic recalibration cycle
to ensure continuous performance to the requirements. The manufacturer shall provide specific
instructions for the adjustment of the instrument if user adjustment is permitted by the
manufacturer. Test equipment or fixtures required for adjustment must either be

6
 Product Design
Assignment 6:

described in sufficient detail to permit fabrication or purchase; or, manufacturer’s

equipment or fixtures must be made available to users.
3.10.5. Detailed specifications: The manufacturer shall provide specifications of the
instrument’s temperature range, accuracy, and environment.
3.11. Performance tests
Several tests must be performed in order to assure that the products are conform to all
requirement of each specification. However, this is not part of the work core to be
developed at this moment and, therefore, this section will not be further detailed herein.

7
 Product Design
Assignment 6: