Medical Oxygen Generator & Hyperbaric Chamber OEM/ODM Manufacturing Services

 

Scope:

VPSA/VSA oxygen generators, medical gas systems, hyperbaric oxygen chambers (soft, rigid, custom)

01

Facility:

30,000 m2 R&D and manufacturing base, Chengdu, China

02

Compliance:

ISO/medical device quality management system frameworks; national standard drafter (hyperbaric oxygen chambers)

03

IP/Tech:

68 national patents (7 invention patents, 33 software copyrights); low-pressure oil-free VPSA/VSA process architecture

04

 

 

Engagement Models

 

 

Model

Scope

MOQ / Threshold

Validation / Deliverables

OEM / Private Label

LBYL-engineered core assemblies rebranded to buyer specification

Project-dependent

Factory acceptance test (FAT), technical file transfer, legal manufacturer TCF handover support

ODM / Custom Dev

Flow/pressure profile redesign, structural enclosure, PLC/HMI localization

NRE + volume commitment

Prototype build, 3D STEP/IGES release, chamber hydro/pressure test, CE/ISO technical dossier input

 

 Customization Matrix

 

Dimension

Standard Baseline

Customization Range

Engineering Constraint

Oxygen Output / Flow

5-60 Nm3/h per unit

Skidded modular scaling (up to acute-care central plant integration)

Footprint, power load (380V/440V, 3-phase)

Purification / Purity

93% +/- 3% (VPSA/VSA)

Dew point control, multi-stage medical filtration

Molecular sieve aging curve vs. cycle pressure

Chamber Pressure / Volume

Soft: 1.3-1.5 ATA / Rigid: 1.5-3.0 ATA

Chamber geometry, port configuration (EEG/ECG feedthroughs), seating/stretcher layout

ASME/GB/ISO pressure vessel code compliance

Control System

Siemens/Delta PLC + touch HMI

Multi-language UI, Modbus/BACnet hospital BMS integration

Watchdog timer, failsafe pneumatic dump valve

Enclosure / Branding

Powder-coated steel / industrial white

Custom RAL color, laser-etched nameplates, silk-screened user interface graphics

UV/abrasion resistance rating

 

Packaging & Logistics Specifications
 

Hyperbaric Chambers:

Fumigation-free plywood crate; desiccant vacuum barrier bag; shock-absorbing foam blocking for acrylic/steel doors.

Oxygen Skids:

Open-frame containerized or palletized skid; anti-condensation wrapping; exposed instrumentation capped.

Traceability Labeling:

Laser-marked serial plate (UID, input voltage, max working pressure, manufacturing date); barcode/QR asset tags per client SKU map.

 

Engineering & Production Workflow

 

 

Specs Freeze: Freeze P&ID, electrical schematic, gas purity targets, and regulatory target market.
DFM / NRE: Component sourcing verification (compressor/molecular sieve/vessel plate certificates), 3D STEP/IGES model release for buyer mechanical integration, control logic sign-off.
Prototype / FAT: Functional run-in (72-hour continuous test for oxygen plants; hydro-pneumatic pressure test for pressure vessels).
Bulk Production: Batch material traceability (mill test certificates for steel, valve/sensor lot logs).
QC Gate: Leak check (helium/soap bubble protocol), electrical hipot test, calibration certificate generation.
Documentation Package: As-built P&ID, user/service manual, CE/ISO technical construction file excerpts, spare parts catalog.

 

 
Technical Fact-Base for Buyer Technical Evaluation
 
01/

VPSA Energy Profile: Low-pressure cycle (<0.05 MPa gauge blower discharge) yields ~40% specific energy reduction vs. traditional PSA (proven across 3,000+ equivalent large-scale acute care tertiary hospital deployments).

02/

Noise Mitigation: Acoustic enclosure dampening down to <65 dB(A) at 1 meter for skid-mounted oxygen units.

03/

Vessel Safety Factor: Hyperbaric pressure hulls calculated per cyclic fatigue load standards (minimum yield/tensile safety factor compliant with national medical pressure vessel code).

04/

Regulatory & Legal Accountability: Provision of risk management file (ISO 14971 framework), electrical safety (IEC 60601-1 alignment data where applicable), pressure vessel design calculations, and complete technical construction file (TCF) handover supporting the client acting as Legal Manufacturer for local Notified Body or regulatory audits.

 

Lifecycle & Field Support Model

Consumables / Wear Schedule:

Molecular sieve replacement interval: 5-8 years (operating-hour and dew-point dependent).
Compressor overhaul / ring-seal service: 16,000-24,000 runtime hours.

Field Support:

Remote PLC/HMI telemetry diagnostics, modular drop-in replacement skids, and regional partner/factory direct spare-parts dispatch (compressor valves, sensor calibration kits).

 

RFQ Checklist & Technical Alignment Intake

 

 

Intended application (clinical central supply, mobile/containerized, hyperbaric multi-place/monoplace)
Flow rate (Nm3/h) & delivery pressure (MPa) or chamber ATA & patient capacity

Electrical grid standard (voltage/frequency/phase)
Target regulatory framework (CE-MDD/MDR roadmap, ISO 13485 alignment, local import registration support needed)
Estimated annual volume / batch size for bulk pricing tier