User Manual & Safety Guidelines

User Manual & Safety Guidelines

LUNG DEVICE

USER MANUAL & SAFETY GUIDELINES

Compliant with ISO Principles & CE Marking Requirements
Version: 18 June 2025

1. Scope

This document defines the instructions, safety requirements, and operational procedures for the Lung Device. It is intended to ensure safe use in accordance with applicable ISO standards and CE conformity principles.

2. Normative Compliance

This device is designed and documented in alignment with the following general standards:

  • ISO 12100 – Risk Management and Safety Principles
  • ISO 20417 – Information Supplied by Manufacturer
  • ISO 14971 – Application of Risk Management to Devices
  • CE Marking Requirements – Safety, Health, and Environmental Protection

3. Intended Use

The Lung Device is intended for controlled air inflation and deflation in a regulated environment.

⚠ Restriction:
The device must be operated exclusively using a manual air pump.
Use of electric, automated, or alternative pumping systems is strictly prohibited.

4. Definitions

  • Device: The Lung System including all components.
  • Manual Air Pump: A hand-operated pump used as the sole air source.
  • Operator: Any trained individual using the device.

5. Safety Information

5.1 General Safety

⚠ WARNING
Failure to follow instructions may result in device malfunction or injury.

  • Use only the specified manual air pump.
  • Do not modify or alter the device.
  • Ensure all connections are secure before operation.

5.2 Operational Hazards

⚠ CAUTION

  • Over-pressurization may damage the device.
  • Improper handling may lead to air leakage or rupture.

5.3 Prohibited Use

❌ The following are strictly forbidden:

  • Use of electric pumps
  • Use of compressed air systems
  • Use of automated inflation devices

6. Device Description

The Lung Device includes:

  • Lung Chamber
  • Air Tubing
  • Pressure Control Valve
  • Manual Air Pump
  • Sealing Components

7. Installation

  1. Place the device on a stable, level surface.
  2. Connect tubing securely to the chamber.
  3. Attach the manual air pump to the inlet valve.
  4. Verify all seals and fittings.

8. Operation

8.1 Inflation

  • Operate the manual air pump gradually.
  • Monitor expansion continuously.

8.2 Deflation

  • Open the valve slowly.
  • Ensure controlled release of air.

⚠ WARNING
Only manual operation is allowed. Any alternative method voids compliance and safety certification.

9. Maintenance

  • Inspect components before each use.
  • Replace worn or damaged parts immediately.
  • Clean using approved, non-corrosive materials.

10. Risk Management

Residual risks include:

  • Air leakage
  • Overpressure damage
  • Improper assembly

Mitigation measures:

  • Routine inspection
  • Controlled manual operation
  • Operator training

11. Storage & Transport

  • Store in a dry, controlled environment.
  • Avoid exposure to extreme temperatures.
  • Protect from mechanical damage.

12. Traceability

Each device must include:

  • Serial Number
  • Manufacturing Date
  • Manufacturer Identification

13. Manufacturer Responsibility

The manufacturer ensures compliance with applicable safety standards when the device is used as intended.

Liability is void in cases of:

  • Unauthorized modification
  • Use of non-approved equipment
  • Failure to follow instructions

14. CE Conformity Statement

This device complies with essential CE requirements when used strictly according to this manual.

15. Final Notes

Safe operation depends on strict adherence to:

✔ Manual Air Pump Only
✔ Proper assembly
✔ Regular inspection