COVID-19 Procurement of mechanical ventilators

An affidavit and/or technical documents must be attached to verify the following:

1. Does the supplier have technical service (own or subcontracted) to carry out training and maintenance work?
   • The technical service must be proportional to the number of types of equipment offered
2. Does the supplier have a stock of accessories and spare parts? 
   • The quantities of the stock must be consistent with the offer presented.
   • Also, indicate if the supplier has the feasibility to deliver consumables. 
3. Does the offer include a product guarantee of at least 24 months?
4. Does the equipment have a Free Sales Certificate (FSC) in any of the following countries or jurisdictions: Australia, Canada, Japan, the United States, or the European Union? For example, the CFS from the US FDA and/or CE mark must be granted by a certified body and must be specific to the equipment offered (not only include a declaration of conformity).
   • In the event that the equipment has a FSC from another regulatory authority, it must be supported by the quality and performance standards indicated in items 2 and 3. It may indicate equivalent national standards.

Provide the technical documentation to verify conformity to:

5. Proof of compliance of each manufacturer site involved in the manufacturing process with ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, an equivalent quality system standard; or a certificate of Good Manufacturing Practice (GMP).

Provide the technical documentation to verify conformity to:

6. ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications

7. ISO 20789:2018 Anaesthetic and respiratory equipment

8. ISO 80601-2-12 Medical Electrical Equipment - Part 2-12: Particular Requirements for the Safety of Lung Ventilators - Critical Care Ventilators.

9. IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic

10. National standards that are equivalent to the standards listed above

Select the type of ventilator and complete the information as appropriate:

12. Type of ventilator

Item 4: Technical information

• Brand and model

Requested Specifications:

1. Ventilation modes
   • Pressure regulated volume control (PRVC), or similar.
   • Pressure control ventilation (PCV)
   • Volume control ventilation (VCV)
   • Synchronized intermittent mandatory ventilation (SIMV)
   • Pressure support ventilation (PSV)
   • Non-Invasive ventilation capability
2. Monitored and controlled parameters (by user)
   • FiO2: 21% - 100%
   • Tidal volume: 20 - 2000 mL
   • Inspiratory flow: 1 -160 L/min
   • Inspiratory pressure: 0 - 40 cmH2O
   • I:E ratio; I:E inverse ratio;
   • RR: 10 to 60 [breaths/min]
   • Inspiratory pause manoeuvre capability to measure plateau pressure;
   • Peak pressure limitation/pressure-cycling mechanism adjustable range of 5 - 20 cmH2O above measured peak pressure
   • PEEP: 0 to 20 [cmH2O], minimum.
3. Displayed parameters (colour and graphic are preferable)
   • Display easily readable in low ambient light and sunlight.
   • 3 scalar waveforms: pressure, volume and flow.
   • 3 loop (axis) displays: pressure-volume, flow-volume and pressure-flow, preferable.
   • Status indicators for ventilator mode, battery status, patient data, alarm settings
   • FiO2.
   • Airway pressures (peak, plateau mean and PEEP).
   • Tidal volume (inspired and expired).
   • Minute volume (inspired and expired).
   • I:E ratio
   • RR (spontaneous and mechanical)
4. Alarms, related to gas delivered
   • High/low FiO2;
   • High/low inspiratory pressure and PEEP;
   • High/low tidal volume (not achieved or exceeded);
   • Apnoea, adjustable from 10-30 sec;
   • High/low respiratory rate;
   • Continuously high pressure/occlusion;
   • Breathing circuit disconnect.
5. Alarms, related to equipment operation
   • Gas supply failure;
   • Power failure;
   • Low battery;
   • Self-diagnostics failure alarm.
6. Consumables labeled “single-use”
   • Breathing circuits: double-limb with standard outlet/inlet connectors with 22 mm of outside diameter.
   • Bacterial/Viral filters.
   • Exhaled gas filter
7. Accessories, reusable
   • Breathing circuits: double-limb with standard outlet/inlet connectors with 22 mm of outside diameter. Expiratory housing with in-built bacteria filters; as well as the possibility to accommodate heat moisture exchangers (HMEs).
   • Flex adapters for placement between the circuit way-adapter and the ETT (protects from unnecessary trauma from eve small circuit repositioning.
   • Exhalation valve.
   • CO2 sensors.
   • Servo-controlled heated humidifier; alternatively access to HMEs.
   • Internal air compressor capacity (or high-performance turbines).
   • Connector 30 mm, if required for the gas exhaust port.
   • Standard connectors to air and oxygen wall pipelines.
8. Portability
   • Mounting tray and support stand (cart for transport with at least 2 castors fitted with breaks).
9. Power supply and battery
   • Operates from AC power electric line: 100 to 240 V~ / 50 to 60 Hz.
   • Built-in rechargeable battery.
   • Automatic switch from AC power electric-line mode to battery operating mode and vice versa.
   • Continuous in battery operating mode with standard ventilation not less than 1 hour.
   • Total re-charging time not greater than 6 hours.

Item5: Labeling and user manuals

Complete the information about the equipment according to the following structure:

1. The supplier must provide information on labeling, including:
   • a) Instructions for use
   • b) Training material
   • c) Service manual
   • d) Technical description of the equipment
   • e) Intended use
   • f) Any other material with instructions for the clinical user and technical personnel.
2. Present documentation that identifies at least:
   • a) Brand and commercial name of the ventilator
   • b) Product model or reference
   • c) Catalog number
   • f) Manufacturer contact information
   • g) Recommendations for risk minimization
   • h) Recommendations for transportation
   • g) Warnings and precautions
   • i) Any other particular condition of the equipment
3. Preferably, the instructions for use should be following the labeling principles for medical devices indicated in IMDRF / GRRP WG / N52 FINAL: 2019
4. All supporting documentation, operation, service, and user manuals must be presented in the official language of the country in which the equipment will be used.