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Implement Maintenance Procedure LO3

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35 views7 pages

Implement Maintenance Procedure LO3

Uploaded by

Qarchube
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Information Sheet HARAMBEE UNIVERSITY 2022

Information Technology Support

Service
Level II

Learning Guide 35
Unit of Implement Maintenance
Competence: Procedure
Module Title: Implementing Maintenance
Procedure
LG Code: ICT ITS2 LO3-LG-35

TTLM Code: ICT ITS2 MO2 TTLM 1019v1

LO 3: Identify and analyze IT system components


to be maintained

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Information Sheet HARAMBEE UNIVERSITY 2022

Information sheet-1 Determining and documenting Warranty Status

1.1. Documenting Warranty Status


General: Legally binding assurance (which may or may not be in writing) that a good
or service is, among other things, fit for use as represented, free from defective
material and workmanship, meets statutory and/or other specifications.

A warranty describes the conditions under, and period during, which the producer or
vendor will repair, replace, or other compensate for, the defective item without cost to
the buyer or user. Often it also delineates the rights and obligations of both parties in
case of a claim or dispute.

Contracting: Expressed or implied undertaking that a certain fact regarding the


subject matter of a contract is, or will be, true.

Unlike conditions (the central points), warranties are deemed incidental points, and a
breach of warranty is usually not a valid reason for voiding a contract but it entitles
the aggrieved party to damages. See also in nominate term and intermediate term.

Insurance: Written pledge by the insured party that a specified condition exists or
does not exist. Breach of warranty entitles the insurer to treat the insurance contract
as void even if the actual loss is unaffected by the breach. See also representation.

ICT equipment companies guarantees that all the products undergo backbreaking
quality control testing before delivery and installation. In the event that any product of
these manufacturers is found to be defective, the company will provide service for
product repair and/or component replacement as may be necessary within the
warranty period as per the terms mentioned here under.

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Information Sheet HARAMBEE UNIVERSITY 2022
Information sheet-2 Reviewing system architecture and configuration documentation

2.1. Architecture overview


Give general description of the system, from the point of the user:
 In what environment it works (home, near patient bed, operating rooms….)
 Who the users are
 What it is for
 The main functions
 The main interfaces, input and outputs

If your soft ware is integrated in a large system, you may reference a document that
describes this system.

 Physical architecture overview


Describe the hardware components on which software runs and their
interactions/relationships
Use components diagrams, deployment diagrams, network diagrams, interface
diagrams…

 Hardware Component description


Describe the content of each hardware component in the architecture
- Its identification
- The purpose of the component
- The software component it receives
- Its technical characteristics: type of machine, CPU, RAM, disk and so on.
- Its network hardware interfaces

 Logical architecture overview


- Describe the top level software components and their interactions/relationships.
- Use UML package diagrams and/or layer diagrams and/or interface diagrams.
- Describe also the operating systems on which the software runs.

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Information Sheet HARAMBEE UNIVERSITY 2022

 Software Component description


Describe the content of each top-level software component in the architecture
The description should contain:
- Its identification
- The purpose of the component,
- Its interfaces with other components,
- Its network interfaces,

The hardware resources it uses, for example: average RAM usage, peak RAM usage
and peak frequency and duration, disk space for permanent data, disk space for
cache data, average CPU usage, peak CPU usage and peak frequency and duration
…

o Software SOUP
If you use SOUP (Software of Unknown Provenance), list them here.
For each SOUP, describe:
- Its identification and version
- Its purpose
- Where it comes from: manufacturer, vendor, university …
- Whether it is maintained by a third party or not
If this is an executable,
- What are the hardware / software resources it uses
- Whether it is insulated in the architecture and why
- Its interfaces and data flows
- Which SOUP functions the software uses
- How the SOUP is integrated in the software
- What hardware/software resources it requires for proper use

Note: have a look at FDA Guidance « Off-The-Shelf Software Use in Medical


Devices » to determine if you need specific or special documentation for your
COTS.

If there is a list of known bugs on your COTS, you may add here this list with a
review of their consequences in terms of software failure and patient safety. If

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Information Sheet HARAMBEE UNIVERSITY 2022

there are concerns about known bugs, they should be treated by the risk
analysis process.

2.1. Dynamic behavior of architecture


The architecture was designed to answer to functional requirements.
For each main function of the system, add a description of the sequences / data
flow that occur.
Use sequence diagrams, collaboration diagrams

Workflow / Sequence 1
Describe here the workflow / sequence of a main function
For example, the user queries data, what happens, from his terminal to the
database.

Workflow / Sequence 2
Repeat the pattern for each main function of the system

2.2. System architecture capabilities


Describe here the rationale of the hardware / software architecture in terms of
capabilities:
- Performances (for example response time, user mobility, data storage, or any
functional performance which has an impact on architecture)
- User / patient safety
- Protection against misuse
- Maintenance (cold maintenance or hot maintenance),
- Adaptability, flexibility
- Scalability, availability
- Backup and restore
- Hardware and Software security : fault tolerance, redundancy, emergency stop,
recovery after crash …
- Administration,
- Monitoring, audit
- Internationalization

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Information Sheet HARAMBEE UNIVERSITY 2022

2.3. Network architecture capabilities


If the medical device uses/has a network, describe here the rationale of the hardware
network architecture:
- Bandwidth
- Network failures
- Loss of data
- Inconsistent data
- Inconsistent timing of data
- Cyber security (see FDA Guidance on Cyber Security of networked medical
devices)

Risk analysis outputs


If the results of risk analysis have an impact on the architecture, describe here for
each risk analysis output what has been done to mitigate the risk in the architecture.
Use diagrams if necessary, like architecture before risk mitigation and architecture
after risk mitigation, to explain the choices.

Human factors engineering outputs


If the results of human factors analysis have an impact on the architecture, describe
here for each risk human factors output what has been done to mitigate the risk in the
architecture.

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Information Sheet HARAMBEE UNIVERSITY 2022
Information sheet-3 Identifying critical components and/or software and
documenting recommendations
3.1. Definition of Critical Components
Critical Components means a component or system of components that, due to
their importance in the continued proper operation of the device, have been
designated by the manufacturer as requiring special fabrication, maintenance,
inspection or operation.
To document recommendations first of all we must identify the critical components
and soft ware from the followings.

 Computer hardware
This is the physical technology that works with information. Hardware can be as small
as a smart phone that fits in a pocket or as large as a supercomputer that fills a
building. Hardware also includes the peripheral devices that work with computers,
such as keyboards, external disk drives, and routers. With the rise of the Internet of
things, in which anything from home appliances to cars to clothes will be able to
receive and transmit data, sensors that interact with computers are permeating the
human environment.

 Computer software
The hardware needs to know what to do, and that is the role of software. Software
can be divided into two types: system software and application software. The primary
piece of system software is the operating system, such as Windows or iOS, which
manages the hardware’s operation. Application software is designed for specific
tasks, such as handling a spreadsheet, creating a document, or designing
a Web page.

 Telecommunications
This component connects the hardware together to form a network. Connections can
be through wires, such as Ethernet cables or fiber optics, or wireless, such as
through Wi-Fi. A network can be designed to tie together computers in a specific
area, such as an office or a school, through a local area network (LAN). If computers
are more dispersed, the network is called a wide area network (WAN).
The Internet itself can be considered a network of network
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