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Exemplo Design e Manufatura
Exemplo Design e Manufatura
Version: V2.1
Total Pages: 9
Compiled:
Date: 2019-1-21
Check:
Date: 2019-1-21
Approved:
Date: 2019-1-21
1. Device designprocess
For the risk and difficult project, or for the project need to be
The review result reviewed, then "Middle design and development review" should
be performed and documented ("Risk analysis is needed if Review result: Stop
should be revised.
necessary").
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Device Technical Documents Design and Manufacturing Information V2.0
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Device Technical Documents Design and Manufacturing Information V2.0
2. Manufacturing process
2.1. Components/parts stocking and checking
The process of electronic components stocking is very important in keeping the product quality.
a. Identify the qualified procurement sources according to the procurement procedure. And then,
placethe orders according to the technical specification and the quantity of the output from BOM list.
b. The components will be checked according to the general inspecting procedure, and the
disqualifiedcomponents will be disposed according the reference documents. The qualified
components will betransferred to the storehouse following the stocking procedure.
b. Establish the order according the PCB quantity derived from output after the confirmation.
c. Prepare the components according to the BOM list and the intended output (including the
single-chipprogramming of various modules).
d. After the PCB assistant processing, the PCB board should be inspected before finishing
thestockingprocedure.
b. After the PCB assistant assembling, the assembled PCB needs to be inspected. The main items
includethe inspection of assembling failure, insecure soldering, and short-circuit. The qualified
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assembledPCB will be transfer to the storehouse and the disqualified group will be disposed according to
thereference flow.
quality.
a.Carry out the adjustment according to 3-channel ECG module test procedure. The main adjustment
equipments are test-bench, signal generator, multi-meter, constant temperature water bath, variable
b. The main adjusting indexes include ECG gain, bandwidth, respiratory measuring function, probe off
Device Technical Documents Design and Manufacturing Information V2.0
alarm function, temperature measuring accuracy, etc.
c. The modules that have been adjusted must pass the 3-channel inspection procedure before transferring
to storehouse.
a. Carry out the adjustment according to CAS blood pressure adjusting procedure. The main adjusting
b. The main adjusting indexes include functional test, static pressure calibration, blood pressure
accuracyadjustment, over-pressure protection test, etc.
c. The modules that have been adjusted must pass the CAS blood pressure inspection procedure before
transferring to storehouse.
a. Carry out the adjustment according to digital SpO2 adjusting procedure. The main adjusting
b. The main adjusting indexes include SpO2 accuracy, SpO2 accuracy under hypo-perfusion condition.
c. The modules that have been adjusted must pass the digital SpO2 inspection procedure before
transferring to storehouse.
Carry out the inspection according to general power supply inspection procedure with the tools such as
multi-meter, oscilloscope, booster, etc. The main inspecting indexes include loading capability, voltage
inputting range, power supply noise, etc. The modules must pass the inspection procedure before
transferring to storehouse.
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2.4.5. Main processor board test and inspection
a. Install the testing software and connect to the test-bench. The main test equipment is oscilloscope.
c. Industrial main-board, which is the central part of the device, need to be controlled strictly in the
stocking process.
a. Connecting the CO2 sensor to the test-bench which supplied by the CO2 manufactory. Examining the
values and states of the sensor according to the checking procedure of the RESPIRONICS® CO2.
b. Examine voltage range of the CO2 power supply board according to CO2 power supply board
a. Plastic parts:
The enclosure, the handle of enclosure, buttons & the knob, transparent button covers, sockets, etc.
The inspection is complied in the document “CNC-603” (plastic part check and inspectionprocedure).
b. Metal parts
Connector panel, power socket panel, fan support, main frame, main-board insulating box,
screensupporter, battery supporter, speaker supporter, etc. The inspection is complied in the
document“CNC-620” (structure/parts check and inspection procedure).
c. Cables:
Screen cable, keyboard cable, NIBP lead, switching wire, indicator wire, TEMP internal lead,
ECGinternal lead, ECG signal lead, SpO2 internal lead, SpO2 signal lead, CO2 signal cable, CO2
internalcable ,speaker cable, inverter cable, encoder cable, grounding wire, etc. The inspection is
complied inthe document “CNC-623” (wires and cables check and inspection procedure).
The general assembly of Patient Monitor includes: the assemblies of the bottom enclosure, the
handle,sockets, the fan, the battery, power socket panel, the power supply, Function Board(Main
board,SpO2/NIBP/ECG module, and CO2 power supply board), main board screen mask assembly,
the LCDsupport, the front enclosure, main frame & the rear enclosure, the bottom & front panel, etc.
Theinspection of general assembly according to “performance test procedure of finished
product”(CNC751)“Layout and structure test procedure of finished product” (CNC-752) “Electric
safety testprocedure offinished product”(CNC-753).
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2.7. Aging test and leaving factory test
a. Comply with the indexes and the requirements of the high temperature aging test procedure.
b. After the aging test, the qualified products will go to the next procedure, which complies with
theperformance test procedure for finished product; the non-conformed products will be
reviewedaccording to control procedure for non-conformed product, and be decided if there is any
possiblemodification and preventive method can be carried out, and then verify the validity. The re-
qualifiedproducts must be approved by the general engineer, and it must be recorded by Quality
ManagementDepartment and Production Department for the purpose of recall while some incident
happens.
c. Each device will be tested and recorded according to indexes, requirements and standards specified in
the performance test procedure for finished product. The qualified product will accompany with
Device Technical Documents Design and Manufacturing Information V2.0
theQualify Certification.
c. The package must be checked by the QC member before the sealing & storing procedure
2.9 The flow chart of the production process for Patient Monitor