INTENSIVE CARE VENTILATOR (Monnal T60), 230V 50-60Hz
STD
EEMDVICE4--
Valid Article
Account code:
60100
HS Code:
901890
Last Updated on:
09/11/2024, 22:01:49
Former
Code(s):
EEMDVICE+++
Z12030105 - Pulmonary ventilators for hospital use
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
INTENSIVE CARE VENTILATOR (Monnal T60)
Definition
Turbine ventilator dedicated to emergency and intensive care services, suitable for intra- and extra-hospital travel. It is a mixed, barometric and volumetric fan. It can be used in invasive and non-invasive ventilation. The possibilities of combining ventilatory modes in controlled, assisted, intermittent or aid allow the ventilation of a wide range of pediatric or adult patients.
Specifications
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Quality standards
- EN 794-3, 1998, +A2 2009 Lung ventilators. Part 3: Particular requirements for emergency and transport ventilators
- EN 1789, 2020, Medical vehicles and their equipment - Road ambulances
- EN 13718-1, 2014, +A1 2020 Medical vehicles and their equipment. Air ambulances. Part1: Requirements for medical devices used in air ambulances
- ISO 80601-2-12, 2020, edition 2, Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Components
- 1 x Ventilator Monnal T 60 ref. KA010000
- 2 x Paediatric patient circuit double branch with water trap VB095100
- 2 x Adult patient circuit double branch with water trap VB095200
- 2 x Expiratory valve Monnal with membrane KY694500
- 200 x SCTDBRCF3A- FILTER, BREATHING CIRCUIT + HME, 22M/15F, adult, s.u.
- 100 x SCTDBRCF3C- FILTER, BREATHING CIRCUIT + HME, 22M/15F, child, s.u.
Technical specifications
General
- Type of gas fitting: NF, DISS, NIST
- O2 supply: 2.8 to 6 bars
- O2 low range: 0 à 1.5 bars / 0 - 85L/min
- Max. Blower flow (air): 230L/min
- Max. rotation speed: 70 000rpm
- Noise: 48dBA at 1m
Screen
- LCD color resistive touch-screen
- Dimensions: 21.3 cm
- Display resolution 640 * 480 pixels
- Luminosity: 800 cd/m2
Power supply
- Voltage: 100 - 240V AC (tolerance -25%; +15%)
- Consumption: 115 VA
- Battery type: Lithium-ion 24V - 2.6Ah - < 100 Wh
- Running Time: 2h30 for each battery
- Full charge battery time:
- 2h30 in stand-by
- 5h30 in ventilation
Operating conditions:
- Temperature -10°C to +40°C (14°F to 104°F)
- Relative humidity: 0 to 95% without condensation at 40°C max.
- Atmospheric pressure: 600 to 1150hPa
Dimensions
- External dimensions (L x W x H): 29 x 25 x 11 cm
- Weight: 3.7kg (ext. battery +300g)
Transport Dangerous Goods
- UN3481 Lithium ion batteries contained in equipment
- Class: 9
- Packing Instructions: 967 Section II
- The label must include the UN code of the battery + an emergency number to contact in case of an incident
- Limit per package:
- Pax A/C (Passengers & Cargo Aircraft) = 5 kg
- CAO (Cargo Aircraft Only) = 5 kg
To be Ordered Separately
- Trolley for Monnal T60: support for humidifier, cylinder, articulated arm, autoclavable basket.
- Wall-mounted charging station
Instructions for use
- Available ventilation modes: (A)VCV, (A)PCV, PSV, VSIMV, (invasive and non-invasive) CPAP, Duo-Levels (NIV only)
- Automatic emergency modes: by simple adjustment for weight.
- Automatic monitoring of Plateau Pressure for lung protection.
- Automatic leak detection and compensation.
- Monitoring of CO2 is optional.
Maintenance
Regular replacement:
- Circuit patient: replacement depends on hospital protocol
- Air inlet filter Monnal Clean'In HEPA (KY691400): replaced every 6 months
- Expiratory assembly (flow sensor and expiratory valve):
- KY694500: autoclavable (max. 50 cycles)
- KY694800: single use
- O2 Cell (YR049700)): replacement recommended every year (lifetime = 5000h), also dependent on O2 concentration and ambient temperature.
- Bacteriological filter (KV103300): replacement as often as possible.
- Interchangeable battery (KY692800)
- replacement every 3 years
- Indicate date of entry on label
- Lip seal, expiratory valve (YJ105706): replace every year.
- Intake inlet filter (KY696100): replace every year.
Storage
- Temperature -30°C to +70°C (-22°F to +158°F)
- Relative humidity: 0 to 95% without condensation at 40°C max.
- Atmospheric pressure 500 to 1150hPa
MSF requirements
For non-invasive and invasive ventilation in Intensive Care Unit, Critical Care and in a high level ambulance system.
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