GAS FLOW TESTER (Certifier FA Plus)

STD EIMTVETE1--

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Former Code(s): EANEANAE74-
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
The order of this product needs to be justified and is only acceptable under certain conditions.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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GAS FLOW TESTER (Certifier FA Plus)

Definition

Device designed to check the correct calibration of anaesthesia, intensive care and emergency ventilators. It allows precise control of the various respiratory parameters, such as flow, pressure, frequency, tidal volume, I/E ratio, oxygen concentration, etc...

This tester is capable of testing virtually all types of ventilators (Anaesthesia, Resuscitation, Emergency) as well as all types of ventilation modes (Adult, Child, Neonatal, Controlled Volume, Controlled Pressure...).

This test tool is intended for technical staff (technician, biomedical specialist) in order to carry out a control at least once a year. This device with flow and pressure sensors must be calibrated every year. It is composed of an acquisition module to be connected to the respiratory line between the Y-piece and the test lung, and a tactile reading module for taking measurements.

It can also test a variety of other medical equipment such as anaesthesia gas delivery machines, insufflators and oxygen concentrators.

TSI flowmeters should NEVER be used for human measurements.

Specifications

TEST PARAMETERS

  • Flow
  • Peak & minimum flow
  • Tidal volume (Inhaled and Exhaled)
  • Minute volume
  • Low pressure (differential)
  • Peak & PEEP pressure
  • Mean airway pressure
  • Barometric pressure
  • Inspiratory time
  • Expiratory time
  • I:E Ratio
  • Respiratory rate
  • Gas temperature
  • Oxygen concentration (with included 4073 Kit)
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Components

1

Interface Module

4088

1

2

High Flow Module

4081

1

3

Bacteria filter, 22-mm ´22-mm male/female, for use with High Flow Module

1602341

1

4

Adapter, 22-mm ´6-mm (for interfacing High Flow Module to Low Flow filter)

1102091

2

5

Adapter, 15-mm ID ´22-mm OD

1102093

1

6

Airway pressure fitting with screen

1611330

1

7

Pressure tubing,silicone, 3.2 mm ID ´6.4 mm OD ´122cm

3002053

1

8

Velcro strapfor use on High Flow Module

2913133

1

9

Adapter, high pressure port

1611221

1

10

Cable, flow module

1040219

1

11

Soft carrying case

1319289

1

12

Power supply 90/260 VAC to +12 VDC

2613237

1

13

Stylus

1319420

2

14

Certifier®FA Test System Operator's Manual

1980560

1

15

Battery—Lithium-Ion SBL-160

1208056

1

16

Connector, different types:

AC EURO/IEC320, right angle

AC UK/IEC320 fuse, right angle

1302014

1302015

1

17

SD flash memory card

1500108

1

18

Protective Rubber boot for Interface module

6001503

1

19

Computer Cable—USB standard A to mini B

1303754

1

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Technical specifications

  • Colour touch screen graphical user interface
  • Real-time graphing mode
  • Bi-directional flow measurement
  • Gaz calibrations: Air, O2, Air/O2 mixtures, N2, CO2, N2O
  • Flow & Volume Modes: STP, ATP, BTPS, BTPD, plus user-defined
  • Max Breath Rate = 1500 BPM
  • High Pressure: -10 to 150 PSI (-7 to 10 bar) Gauge
  • Low Pressure: -25 to 150 cm H20 Differential
  • Oxygen concentration: 21 to 100% (± 2%)
  • Data storage using SD Flash card and internal memory 1MB
  • Access stored data through USB interface
  • Report printing capability
  • Rechargeable Li-Ion battery plus AC operation

Transport Dangerous Goods

Contains one Li-ion battery (7.2 V 2200 mAh) of the section II

This battery is referenced by the IATA guide as UN3480. The article will therefore be filled in with UN3481 (lithium-ion battery with or in equipment).

Transport class 9.

The shipment does not require a package approved for dangerous goods.

However, the following labels are required:

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To be Ordered Separately

EIMTVETE02- TEST LUNG, 1 l, for ventilator

Instructions for use

To be used by a biomedical flying technician (MIO, RTR, MST, ...) (or someone trained for) for performing the annual control of ventilators.

DO NOT use if the input and/or the output of the high flow module are not protected by the protection caps !

For the pressure measurements, ensure that you are using the good connection, on the high flow module, according to the pressure of the system (high or low pressure).

ALWAYS respect the direction of the flow indicated by the arrow on the high flow module !

ALWAYS use an antibacterial filter BEFORE the high flow module !

In case of using the O2 cell, ALWAYS perform a 21% O2 calibration BEFORE making any measurement.

An annual calibration has to be performed. Send the device back to your biomed referent to perform it.

The device is supplied with different electrical plugs. Choose yours according to your mission electrical system !

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Precautions for Use

  • To avoid the risk of explosion, do not use in the presence of flammable anaesthetic gases.
  • Only TSI qualified and trained service technicians are authorised to service the Certifier® FA Test System.
  • To avoid inaccurate test readings, do not obstruct tubing or inlet or exhaust ports, and always use dry gas.
  • To avoid damage to the Certifier® FA Test System components, always use bacteria filters upstream of the flow modules, and always cap flow module ports when not in use.
  • Always connect the additional adapter for connecting the pressure transducer (marked "+" on the acquisition module) to the breathing circuit through the small tubing provided for this purpose.
  • Always ensure that the equipment has been calibrated less than one year before use.

MSF requirements

For testing the anaesthesia ventilators (Glostavent Helix, Neptune..) as well as the intensive care ventilators (Monnal T60, Elysée 350...)

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