Pneumatech Medical Gas Solutions (PMGS)

Class IIb Medical Device
Safeguards & Compliance

Adopting high-fidelity HTM 02-01 & SANS 7396-1 Standards. Exploring the engineering, redundancy, and digital validation required to generate life-saving breathable air for Neonatal ICUs and surgical operating theatres.

Standard SANS 7396-1:2009 South African National Standard
Directive 93/42/EC Annex II European Class IIb MDD
Engineering HTM 02-01 Code NHS Health Technical Memo
Nomenclature mAIR-2470-TGF4 Combined Compressor Plant
PMGS Instruction Book: Page 5

Dual-Chamber Heatless Desiccant Purifiers

Continuous medical breathing air demands absolute removal of moisture, toxic gases, and particulates. The PureMED Desiccant Dryer (AIB Columns) operates with two parallel towers of desiccant beads (activated alumina or molecular sieve) that cycle on a strict time-based pressure swing.

01

Continuous Redundancy (Duty / Standby)

While Column A is actively adsorbing water vapor under high pressure, Column B is depressurized and purged using a small stream of dry air to regeneratively dry the beads.

02

Water Dewpoint Control (≤ -40°C)

The inline dewpoint analyzer measures moisture level. SANS 7396-1 dictates dew point must not rise above -40°C. If dryers fail, liquid water condenses in lines, causing rapid corrosion and catastrophic bacterial risk.

PureMED Purifier Cycling CYCLING
Duty (Dry)
Tower A
Drying
Standby / Wet
Tower B
Purging
PMGS Instruction Book: Page 6

The Combined Plant Room Concept

Rather than building separate, costly compressions for surgical tools (7-11 Bar) and respiratory patient ventilators (4 Bar), PMGS leverages the Combined Plant Concept. High-pressure air from the receiver is split.

Surgical Air Stream (7-11 Bar)

Feeds the high-pressure surgical tools in the operating theatre. This line does not go through further step-down regulators.

Duplex Pressure Reducing Regulators

Two fully redundant, mechanical regulators step the pressure down to a steady, medical-grade 4 Bar (400 kPa) breathing air pipeline supplying wards and ICU terminal units.

Redundant Regulation Diagram

Dryer Exhaust: 11 Bar ICU Delivery: 4 Bar
11 BAR
Regulator Set A [ON] Step-down to 4 Bar
Regulator Set B [STANDBY] Active Backup
4 BAR
PMGS Instruction Book: Page 8

Strict Outside Air Intake Pathways

The compressor intake is the foundation of patient air quality. SANS 7396-1 and HTM 02-01 mandate that the physical intake point **must be placed away from localized hazards** like loading docks, waste storage, clinical vents, or building cooling towers.

An idling diesel truck near an air intake can inject lethal concentrations of Carbon Monoxide (CO) straight into a patient's lungs. Below, test your awareness by toggling physical hazards near a hospital's virtual intake.

Intake Hazards Simulator RISK DETECTED

HOSPITAL WALL
INTAKE
Loading Dock
PMGS Instruction Book: Page 9

Daisy-Chained CAN-Bus Loop Network

To enable seamless load sharing, cascading, and backup rotation, PMGS uses a central control system called PureLogic Control Panel. This connects to individual compressor controllers (Elektronikon) via a daisy-chained, industrial CAN-bus loop.

Centralized Load Balancing

PureLogic monitors air receiver pressure and directs compressors to cycle, ensuring even running hours and instant activation of standby compressors.

The Terminator & Communication Loss Risks

If the end-of-line CAN terminator switch is toggled OFF, electrical reflections on the network cable degrade the signals. Standby units fall offline, risking rapid depletion of hospital reserves.

Live CAN-Bus Daisy Chain Topology

PureLogic
MASTER
Elektronikon 1
Node #1
Elektronikon 2
Node #2
EOL ON
PMGS Instruction Book: Page 11-13

Commissioning Checklist Protocols

A Medical Gas Plant Room cannot feed a single neonatal patient until it goes through a rigid, SABS-approved commissioning workflow to rule out human construction and electrical installation errors.

01

Phase Rotation

Ensuring the 3-phase grid supply runs the motors in the correct direction. Running backward causes immediate mechanical seizure. Verified physically by checking if air lifts a "paper slip" at the exhaust.

02

CAN-Bus Addressing

Each Elektronikon processor must be assigned a unique node address (#1, #2, #3) to prevent bus collisions, and the terminal node's EOL resistor must be physical set to ON.

03

24H Carcass Test

Pressure decay test of the isolated pipeline at 10 Bar over 24 hours. The math is temperature-compensated (Ideal Gas Law). Drops must be under 0.025% per hour to pass.

04

Air Pathway Audit

Physical validation of the entire pathway length, including safe physical clearance of intake points relative to cooling towers and diesel engine loading docks.

The Vision

Ditching Paper for Crypotographic Assurances

The MedGas Protect system converts vulnerable, offline clipboard tracking into an integrated digital, tamper-proof audit record.

The Pen & Paper Reality

  • "Ghost" Inspections: Lack of real physical validation allows verifiers to log passes without ever stepping inside a hospital.
  • Transcription Errors: Misread analogue gauges lead to delayed alerts of pipe drops.
  • Archival Dust: Retrieving historic calibration audits during inspections takes weeks.

The MedGas Digital Twin

  • GPS & Biometric Tokens: Locks out operators whose credentials or training are expired, preventing unauthorized overrides.
  • Direct IoT Ingestion: Moisture and contaminants trigger instantaneous alerts to neonatal wards.
  • Audit-Ready Compliance: Generate cryptographically signed, secure reports ready for immediate health department audits.

PMGS Plant Room Digital Twin ONLINE

Digital twin telemetry aligned with SANS 7396-1 codes

Modular Medical Air Compressor Plant Room Layout

Interactive: Click joints, EOL switches, & valves
INTAKE
Outside Air Intake
SAFE (No CO/CO2/Freon)
Compressor 1
Elektronikon: #1 OFF
Rotation: OK
Exhaust Slip: DROOP
Compressor 2
Elektronikon: #2 OFF
EOL Switch: EOL [ON]
Exhaust Slip: DROOP
RECEIVER
0 Bar
Auto Drain
PureMED Columns
Col A
Col B
Dew Pt: -40°C
Redundant Regs
Reg A: 4 Bar
Reg B: Stby

Zone Valve

Air Valve

Neonatal ICU

Medical Air (mAIR)
400 kPa
DewPt: -40.0°C
Oxygen (O2)
20.9 %
Safe Ambient

SANS 7396-1 Commissioning Wizard Console

Status: Uncommissioned

Electrical Phase & Motor Rotation Verification

Turn on compressor and inspect the exhaust slip. If the slip droops, the phase rotation is reversed.

REVERSED

Real-Time Alerts & Commissioning Logs

Live Sync

Operator SANS Training Passport

ID: GP-84920
Simulate Training Expiry:
Operator is fully SANS 7396-1 certified.
Thabo

Thabo Molefe

SANS 7396-1 Lead Verifier

ACTIVE AIA LICENSE
Zone Valve Override: GRANTED
SANS Commissioning Authority: FULL
Mandatory SANS Refresher: Compliant (Refresher due in 8 months)
Overall Gas Purity (O2)
99.5
%
Main Line Pressure
400
kPa

Real-time Pressure Telemetry

Contaminant Detection