Requirements & Specifications practice

1. Light
Requirements: The equipment needs to be light in order to carry it
Specifications: The equipment shall weigh less than 600 grams.

2. The FGH fits in a laptop case.

Requirements: The FGH needs to fit in a laptop case.
Specifications: The FGH shall measure less than 21 cm high x 33 cm long x 1 cm
deep.

3. Should work from 30-250 BPM

Requirements: The AB needs to provide a wide range of pulse rate display.
Specifications: The AB shall measure a pulse in a range between 30 and 250 BPM.

4. The screen should be readable

Requirements: The screen needs to be readable
Specifications: The display shall have a mínimum 1000 Nits LCD panel.

5. The XYZ should be easy to use

Requirements: The XYZ needs to be easy to use
Specifications: The XYZ must include user roles, so that each user can have specific
tasks for the different roles.

6. The software runs under Windows

Requirements: The application needs to work on Android and be free.
Specifications: The application must be done in Appypie

7. The ABC needs to be biocompatible

Requirements: The knee prosthesis needs to have biocompatible material
Specifications: The knee replacement must be made of polyethylene, titanium alloys,
hydroxyapatite and calcium oxide.

8. Shelf Life: 3 years

Requirements: The digital baumanometer needs to measure approximately 300
measurements before changing its battery.
Specifications: (The digital baumanometer must include 1.5V AA size batteries

9. Non-sterile, reusable
Requirements: The surgical gown needs to be worn only 1 time and discarded.
Specifications: The surgical gown must be made of polypropylene material covered
with polyethylene

10. Display and Power Cables are available as accessories.

Requirements: The connecting cable between monitors needs to be easy to find in
the supermarket.

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Specifications: The connection cable between monitors must be HDMI type for easy
search.

11. Warn user if unit overheats

Requirements: The equipment needs to take action if it overheats
Specifications: The equipment must include a ventilator with a temperature sensor
that when detecting a temperature greater than 38 °, is automatically activated

12. Warning not to remove Box cover.

Requirements: For safety, the steam autoclave needs to be kept closed when it is
working.
Specifications: The autoclave must have a latch that keeps the door locked until the
end of its sterilization cycle, likewise the following indication must be shown on the
screen: "A sterilization cycle is being carried out, please wait for it to end."

13. -40 to +70 C.

Requirements: The equipment needs to withstand low and high temperatures.
Specifications: The equipment must withstand low temperatures of -35 ° to high
temperatures of 80 ° C.

14. Repair instructions

Requirements: Scale needs to include calibration.
Specifications: The scale must include a user manual in which it indicates the
instructions to perform the calibration, said scale must include a button called "CAL"
so that when it is held down for 5 seconds a calibration message appears, which you
have to ask for. some specific weight to correctly perform the calibration.

15. RoHS compliant

Requirements: The medical device needs to hide the battery so that it is not exposed to
the patient.
Specifications: The medical device must hide the battery inside a space, it can only be
opened with a special screwdriver, this so that not anyone can misuse the battery.

16. Labels must meet regulatory requirements in all countries in which the
device is marketed or used clinically.
Requirements: The label of the medical device needs to comply with the NOM-137-
SSA1-2008 standard.
Specifications: The label must contain the following information: - Generic name of
the product, Distinctive name of the product, Manufacturer's data, Country of origin,
Registration number granted by the Ministry of Health, Expiration date of the product,
Serial number, Content, Instructions for use of the medical device, etc.

17. Should work in conjunction with an absorbent secondary dressing.

Requirements: Ultrasound equipment needs the image to be as sharp as posible.
Specifications: The ultrasound equipment must include a conductive gel that is water
soluble and has no fat components.

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 18. Inner layer composed of a nylon knitted fabric
Requirements: The laptop backpack needs to withstand high temperatures and not
absorb wáter.
Specifications: The laptop backpack must be made of polypropylene material.

19. The DFG is individually packaged 24 in a case

Requirements: The masks need to be individually packaged 5 in a case.
Specifications: The mask box is 1000 pieces, it must contain 200 packages with 5
face masks each.

20. IFU provided with each package

Requirements: Infrared thermometer needs to have instructions for use
Specifications: The infrared thermometer should include a user manual containing
the following instructions: Point the thermometer at the center of the forehead and
keep a vertical distance of approximately 3 cm to 5 cm.

21. The BCG receives its timing information and number of treatment cycles
from an external software table
Requirements: The system needs to have an indicator which knows how long it took
the doctor to give a consultation
Specifications: The system must include a window where the doctor can record his
consultation data, which has a button to start and end the consultation, which will be
a timer that records the time that the doctor started and ended his consultation.

22. Each package is labeled

Requirements: All kits need to be individually packaged and labeled.
Specifications: All equipment will be sent to a general warehouse but must be
individually packaged and labeled according to the final destination hospital.

23. The set of BCG treatment protocols are downloaded into nonvolatile
memory through a pc connection.
Requirements: System X needs to receive the results of Laboratory studies from
system Y.
Specifications: System X must communicate HL7 with system Y to carry out the
integration.

24. BCG Treatment Tables set Upper and Lower limits of the peristaltic pump.
Requirements: An application is required in which the fluid types of peristaltic pumps can
be recorded.
Specifications: An application will be made in which a suitable person will write down the
type of fluid that will be moving through the peristaltic pump, to carry out a certain control.

25. When a fault is detected, the machine ceases operation, the error LED
blinks, the LCD backlight turns red, and the fault is displayed.
Requirements: The computer would need to restart if a virus is detected.

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Specifications: The computer's antivirus should be examining the files and items
every 5 minutes, and if it detects a virus, a window should be displayed with the
warning that the computer needs to be restarted.

26. Run time watchdog timer (WDT) is run in parallel with the software.
Requirements: The application needs to record how long it was used.
Specifications: The application must have a statistics section, where a specific
statistic of how long the user has been occupying the application is shown, it must
have a filter in case you want to review a specific range of dates.

27. Accuracy: +/- 1ml/min

Requirements: The medical team needs a device to know the patient's pressure.
Specifications: The medical team will have a blood pressure monitor to know the
patient's pressure.

28. The JKL needs to run on battery for 8 hours for 3 years.
Requirements: The device needs to work with the screen on for 15 hours.
Specifications: The device must have a battery with a capacity of 5,000 mAh.

29. Uses regular power.

Requirements: The equipment needs to always be in use.
Specifications: The equipment must always be connected to electrical power, but it
must include a battery which will supply the energy to the equipment when there is
a failure or absence of the commercial network that supplies the electricity

30. Power Cord: 6 ft.

Requirements: The device power cord needs to be long so that the patient can
navigate their entire room.
Specifications: The device's power cord should be 20 ft. Long.

In this task I learned the importance of carrying out the requirements and
specifications, this plays a fundamental role in the development process,
since the generation of correct specifications that clearly, unambiguously and
compactly describe the customer's needs, fulfilling as soon as possible.
expressed, a project will be obtained that will minimize the problems related
to the management of these requirements. Obtaining quality requirements
shows that the work carried out will culminate successfully.

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