Leading The Global High-end Medical Device Industries
The CONGLAY Brand Respiratory Tract Management Application Product System
Welcome To Visit CONGLAY
Wuxi Conglay Medical Technology Co., Ltd. ( CONGLAY For Short ) established in 2014, and which is near Taihu Lake, located in The Huishan Wuxi City, China, it is only 30 kilometers away from Wuxi East High-speed Railway Station.
CONGLAY has The Professional Skills & Experiences in R&D, Design, Manufacturing
Different Kinds of Medical Devices, especially Focused On The Management Application Products For
Respiratory Tract, to keep improving the constantly perfecting The Key Technology Processes & Technical
Support Services.
The CONGLAY Brand Medical Device Products Are As Following
Now The CONGLAY Medical Devices Industry formed Complete And Strict Operating System including R & D, Design,
Production And Excellent Technical Supporting for The Global Medical Applications, The Range of CONGLAY Brand Medical
Device Products System are as following:
- - - - - The Active Medical Devices: 
1）The Unique Selling Point For The Cuff Pressure Controller Device：
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The Production Processes And Equipment Standard have passed
ISO13485 Medical Device-Quality Management System ---- Requirements
For Regulatory And The EU CE Certifications.
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To Be Equipped With Two Kinds Power Sources of AC & Polymer
Lithium Battery, With The Super Ability To Work Continuously And
All-weather Operating Status, Keeping The Excellent Stability For
The Pressure.
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The Product Complies With ERS（European Respiratory Society）
Standard.
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Automatic Fault Diagnosis, Warning In Advance By Alarm And
Light Function.
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As The Key & Core Component, Equipped With The Professional
High-precision Pressure Sensor.
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Accurately, Automatic And Real-time For Controlling The Pressure.
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The Stabilized Pressure Within The Set Range.
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Digital LCD Display Screen.
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The Real-time Data Storage For Easy Traceability.
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According To The EU Medical Device MDR, Classified As Ⅱ a.
2）The Working Principle For The Cuff Pressure Controller Device:
1）The Unique Selling Point For The Hand-held Hi-Lo Cuff Pressure Gauge：
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1
Applied TPU Materials With Better Stabilities, For Example,
Among The Similar Materials The Hardness And Oxidation
Resistance Were The Best, With The Excellent Physical
Properties, Such As Hardness, Strength And Elasticity. At
Same Time, With The Excellent Chemical Resistance And Environmental
Protection.
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Increased Extension of Connecting Tube, Making The Overall
Length of Tube To Reached To 1000mm, which Makes Up For
The Defect of the Similar Products That The Length of The
Connecting Tube was 600mm-800mm, So As To Realize The
Convenience & Rapidity To Medical Staff In The Medical
Operation Process.
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2
The Product Complies With ERS（European Respiratory Society）
Standard.
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The Production Processes And Equipment Standard have
passed ISO13485 Medical Device-Quality Management
System ---- Requirements For Regulatory And The EU CE
Certifications.
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With The Excellent Cost Performance To The Medical
Treatment, It has The Strong Economic Applicability.
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Precisely Inflating & Adding The Pressure.
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Accurately Deflating & Decompressing.
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The Real-time Reading System For Gauge With Pointer.
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Precisely Controlling And Measuring The Pressure.
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According To The EU Medical Device MDR, Classified As Ⅰ.
2）The Working Principle For The Hand-held Hi-Lo Cuff Pressure Gauge:
1）The Unique Selling Point For The Connecting Tube, As The Necessary Accessories On The Cuff
Pressure Controller Device:
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1
Effectively In Order To Filter Too Much Or Too Little Momentary Sudden Pressure, For This Reason,Increased The Pressure Stabilizing
Device, Thereby, The Pressure Should Be More Stable, Reduced The Irritations And Damages To Respiratory Tract, And Improved The
Comfort For Patient.
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2
Applied TPU Materials With Better Stabilities, For Example, Among The Similar Materials The Hardness And Oxidation Resistance Were The
Best, With The Excellent Physical Properties, Such As Hardness, Strength And Elasticity. At Same Time, With The Excellent Chemical Resistance And
Environmental Protection.
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3
According To The EU Medical Device MDR, Classified As Ⅰ.
Remark:
The Applications of Above-mentioned 3 Kinds of Active Medical Device Product Systems Are As Follows:
GICU (General Intensive Care Unit)
SICU (Stroke Intensive Care Unit )
MICU (Medical Intensive Care Unit)
EICU (Emergency Intensive Care Unit)
ICU Specialisms
BICU (BurnIntensive Care Unit)
RICU (Respiratory Intensive Care Unit)
NICU (Neonatal Intensive Care Unit)
PICU (Pediatric Intensive Care Unit)
AICU (Anesthesia Intensive Care Unit)
TICU (Transplant Intensive Care Unit)
CCU (Coronary Care Unit)
CPICU (Cardiopulmonary Intensive Care Unit)
CSICU (Cardiac Surgery Intensive Care Unit)
NSICU (Neurosurgical Intensive Care Unit)
The Anesthesiology Dept. And Operating Room.
The Special Independent Division System On The Basis of
Industry 4.0 In CONGLAY
In Order To Carry Out Lean Operation System of The Medical Device Manufacturing Enterprise, Specially Set Up The
Independent Division System On The Basis of Industry 4.0, Same As German And Japanese Enterprises, In CONGLAY
Company, The Independent Divisions System Are The Core Status, And Its Details Are As Following:
- ◆ The Senior Market Development Strategy Research Support Division System.
- ◆ The R&D Investment Support Division System.
- ◆ The Professional Design, Tech. & Quality Guarantee Support Division System For Pre-sales / On-purchase Service & After-sales.
- ◆ The Professional Spare Parts Purchase Support Division System For Lean Production.
- ◆ The Manufacturing Start-up Support Division System For Enterprise Lean Operation.
- ◆ The Manufacturing Division System.
- ◆ The Export Division & Sales Center Division System ( Services From Pre-sales, On-purchase Service To After-sales )
The Key Technology of Product System For Respiratory Tract
Management Applications In CONGLAY
Act As The Key Technology Services Support In Overseas Market, The Internet of Things（IOT For Short）Applied To
CONGLAY’s Different Kinds of Respiratory Tract Management Product System At Basis of Industry4.0:
Intelligent Control Technology in Design / Production And Technical Support, and Its Details was as following: The
Professional Software System Support applied to One-stop Services In Overall Respiratory Tract Pressure
Management, Including The Control, Operation And Maintenance.
To Ensure Superior Product Quality System, Same As The Japanese HONDA Motor, Ltd Lean Management Principles
And Standards, Specially The ERP System which Complied With Manufacturing Quality Assurance Requirements, it
was The First To Be Applied In The Medical Device Manufacturing Industry.
A.
The Process Control In The Technology & Quality Guarantee
For Medical Devices Manufacturing Start-up In CONGLAY
B.
The Process Control In The Technology & Quality Guarantee
For Medical Devices Manufacturing Start-up In CONGLAY
Accordance With The En MDR, Strictly Implemented The Comprehensive Quality Assurance Control For
Manufacturing Process:
The Incoming Quality Control To The Main Materials & Main Spare Parts: To Adopt The Full-inspection System,
Prohibited The Traditional Sampling Inspection System Based On The Certain Percentage. All Storing And Delivering
To The Main Materials & Main Spare Parts Only After Having Been Past The Inspection;
For The Establishment And Operation of The Sub-Supplier’s Qualified Supply Chain Management（SCM For Short）
System, Carried Out The Professional Dynamic Evaluation Based On The Database & Its Analysis, To Set Up The
Unannounced Inspection System, So As To Eliminate The Unqualified Sub-suppliers, And Establish The Qualified Sub-
suppliers' files;
The Process Control For The Medical Device Products
Manufacturing In CONGLAY:
Established The Key Process Control Procedures For The Product Manufacturing Technology & Quality Assurance,
Set Up The Distribution of The Quality Control By The Multi-point, Developed The Perfect Combination System Which
Combined With The Self-inspection From The Former Working Procedure To After Processing And The Product
Manufacturing Process Inspection, Same As The Incoming Quality Control, Implemented The Full-inspection At The
Finished Products In Order To Ensure That The Qualified Rate of Final Product: 100%.
For The R&D, Design, Strictly To Carry Out The Full Procedure Requirements Under The ISO13485 System,
Implemented The Multi-point Reviews, And Strictly To Control All Risks By The Test & Verification Based On The
Database & Its Analysis Before The Products Put On The Markets.
The Most Distinctive Features For CONGLAY Brand Respiratory
Tract Management Product System
All Independent Designs & Manufacturing Came From Our Own.
The Main Parts Purchased From Global Leading Brands, Including One of Power Sources of Polymer Lithium Battery
Assy. / The Electromagnetic Valve / The Control Circuit Board / The Professional High-precision Pressure Sensor
Assy. / Digital LCD Display Screen Assy. ( Including LCD Display Module ). And etc.
The Excellent Management System In CONGLAY
In Order To Achieve The Full Satisfaction To Global Users, Same As Japanese HONDA Group Company, In Medical
Device Manufacturing Industries, The CONGLAY Took The Lead In Management System In The Planning Control &
Manufacturing Operation System:
- ◆ISO13485:2003 Medical Device-Quality Management System ---- Requirements For Regulatory
- ◆Management System For Conformity With European.
- ◆JIT Supplying Management To Customers ( Just In Time ).
- ◆APQP（Advanced Product Quality Planning and Control Plan).
- ◆FMEA（Failure Mode And Effects Analysis ）d-- FMEA Management System.
- ◆PPAP Management System（Production Part Approval Process).
CONGLAY, Formed Strategic High-end Double Leader Status
With Huge Market Value In Overseas Markets
The Flexible Capacities For Different Kinds of Medical Device Products At Basis of Different Kinds of Applications.
The Global Market Shares & The CONGLAY Brand Power.
The Unique Selling Point For CONGLAY Brand
Why Choose CONGLAI?
- The Most In-depth Market Research.
- Focused On The Complete Independent Intellectual Property.
- Making Statistical Analysis According To
Different Sales Area And Different Users’
Requirements.
- Excellent Stability, Convenience, High Efficiency And
Comfortable.
- Design And Tailoring For The Special
Applications.
- Safety, Stable Property, Trust & Attractive.
In The Course of Treatment, Deeply The
Patients Experienced Humanized
Psychological Comfort, Hope For The
Medical Security Support In The Spiritual.
Reliable, Durable & Long-lasting Service Life.
