DeviceTechnicalDocuments Design and Manufacturing InformationV2.

Document No. : CT-0901-16-005

Version: V2.1

Valid Date: 2019-01-21

Total Pages: 9

Design and Manufacturing

Information
For Patient Monitor

Compiled:

Date: 2019-1-21

Check:

Date: 2019-1-21

Approved:

Date: 2019-1-21

Shenzhen Creative Industry Co., Ltd.

Device Technical Documents Design and Manufacturing Information V2.0

Design and Manufacturing Information

1. Device designprocess

Flow Chart for Control Procedure of Design and Development

"The product development The design and

intention letter" from development changes
commercial department
from any department

Review "The product development intention letter", once

passed, fill in the "Reviewing approved form", then the
general manager approves it and document it.
Review "Design and
development changes" according
to the "Requirement for Design
and development changes", and
The project team compile "The product design and confirm the person in charge
development plan" first, then the general manager approves it,
appoints the project manager, "Lastly, "The product designand
development plan" should bedocumented.

Review result: Stop

Device Technical Documents Design and Manufacturing Information V2.0

The project manager or the projector in charge should make risk

analysis for the project and compile the "Risk analysis report", Review result: Stop
review it and document it.

Design input: should be in accordance with item 4.3 requirement

of "Control Procedure of Design and Development", then review
it and document it.

Process of design and development: compile and file "Product

design instruction", and design and develop the product, record it
and document it.

Small design changes

The review result
should be revised.
For the risk and difficult project, or for the project need to be
reviewed, then "Middle design and development review" should
be performed and documented ("Risk analysis is needed if Review result: Stop
necessary").

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 Device Technical Documents Design and Manufacturing Information V2.0

 Hardware: Circuit diagram, BOM, PCB drawing, Inspection standard andcriteria;

 Structure: Structure diagram, BOM, Inspection standard and criteria, Package
requirement;
Design  Software: Module designing instruction, Connector definition, Communication
and protocol,etc.
develop  Product: Electrical diagram, Installation drawing, Installation instruction, User
output: instruction(User manual), Package requirement, Test report, Processes, Inspection
standard and criteria, Software user instruction,Samples(phototype)...
Design
changes

Design and development verification:

Advise the design if the
1. Perform safety specification/performance/EMC (if applicable)test
review result fails to Review result: Stop
2. Output the required document according to the "Design and
meet the standard.
development validation". Issue the test report, review and documentit.

Technology department organizes and manufacturing department

cooperates with it. The Technology department decides the small
Revised
amount phototype trial, revise the produce process, inspection standard
requirement
and criteria.
and reset up
the project

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Device Technical Documents Design and Manufacturing Information V2.0

Design and development validation:

 (Before delivery) according to the international standard requirement (or CE Review result: Put in
requirement) to perform "Clinical test" and to get the clinicalreport.
Advise the demand
 The manufacturing department confirms the produce process, inspection
if fails to meet the
standard andcriteria.
reviewing
 The project manager holds the confirming and reviewingmeeting.
requirement. Review result: Stop
 The quality and management department issues "Product validationreport".
 Keep all document infile.

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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.

2.2. PCB out sourcing and materialpreparation

a. Confirm with the PCB provider according to the PCB version and file name of the BOM list in
thePatient Monitor.

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.

2.3 PCB out assembling out sourcing and in-coming check

a. Continue to the assistant assembling following the procedure with the prepared components,
theprogrammed single-chip, and the PCB board.

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.

2.4 Functional test and calibration for PCBA or modules

The process of Functional modules adjustment and inspection is very important in keeping the product

quality.

2.4.1. ECG module adjustment and inspection

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

resistance box, thermometer, etc.

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.

2.4.2. NIBP module adjustment and inspection

a. Carry out the adjustment according to CAS blood pressure adjusting procedure. The main adjusting

equipments are test-bench, blood pressure simulator, etc.

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.

2.4.3. SpO2 module adjustment and inspection

a. Carry out the adjustment according to digital SpO2 adjusting procedure. The main adjusting

equipments are test-bench, oscilloscope, SpO2 simulator, etc.

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.

2.4.4. Power switching module test and inspection

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.

b. The main testing index is functional realization.

c. Industrial main-board, which is the central part of the device, need to be controlled strictly in the

stocking process.

2.4.6. CO2 sensor and Power supply board inspection

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

adjusting procedure. Used the equipments are multimeter and oscillograph

Device Technical Documents Design and Manufacturing Information V2.0
2.5 Structural part assistant processing and checking
Structural parts in the Patient Monitorcan be separated into three main categories:

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).

2.6 Final assembly and inspection

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.

2.8. Packaging and storing

a. Packing List will be printed according to product configuration table and the requirement of the
contract provided by R&D department.
b. The packing cartons and the foam are produced and printed according to the designing documents.

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

3. Design and manufacturing site

Manufacturer:Shenzhen Creative Industry Co., Ltd
Manufacturing address :Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili
Street, Nanshan District,518110 Shenzhen, GD, PEOPLE’S REPUBLIC OF CHINA
Device Technical Documents Design and Manufacturing Information V2.0