Smiths Medical Portex Thermovent 600 Mode D'emploi page 2

Compilation Date - 24 Aug 10
English
Portex® Thermovent® 600/1200
Heat and Moisture Exchangers
INSTRUCTIONS FOR USE
These instructions contain important information for safe use of the product.
Read the entire contents of these Instructions For Use, including Warnings and Cautions,
before using this product. Failure to properly follow warnings, cautions and instructions
could result in death or serious injury to the patient and/or clinician.
NOTE: DISTRIbUTE THIS INSERT SHEET TO ALL PRODUCT LOCATIONS.
These instructions are intended for use with the following Portex® products:
100/580/015 Thermovent® 600 Heat and Moisture Exchanger
100/582/000 Thermovent® 1200 Heat and Moisture Exchanger
Description
thermovent® 600 and 1200 are sterile, single use, heat and moisture exchangers for use with intubated
patients using a ventilator or other positive-pressure breathing system.
where bacterial/viral filtration is required an appropriate filter should be used.
Indications for use
the Portex® thermovent® 600 and 1200 heat and Moisture exchangers are indicated for:
•
Preserving humidity and minimising damage to tracheal epithelial cells
•
reducing heat loss through the bronchopulmonary tree
•
helping to prevent thickened secretions and changes in lung function during long term anaesthesia or
ventilatory support.
the thermovent® 600 has a deadspace of 11ml and is indicated for use in patients whose tidal volume is less
than 600ml including paediatric patients weighing more than 10kg.
the thermovent® 1200 has a deadspace of 32ml and is indicated for use in adult patients whose tidal volumes
are greater than 600ml and less than 1200ml.
Instructions for use
1 the device should be placed between the patient's tracheal or tracheostomy tube and the 'y' piece of the
breathing system.
2 ventilator pressure should be monitored at all times.
any increase in respiratory pressure may indicate blockage of the device, in which case, the device should
be replaced immediately (see warnings).
3 this device is intended to replace the humidifying functions of the upper respiratory tract. where
tenacious secretions or mucus plugging develop, suitable therapy must be instituted.
4 the maximum recommended period of use for this device is 24 hours.
5
If the patient requires nebulization therapy then the device should be removed from the breathing circuit
during nebulization.
Precautions
1 as with all airway management products, the security of any connections and the patency of the
breathing circuit and device should be checked before use.
2 the device should not be used in conjunction with heated or nebulized water humidification systems or
nebulizers.
3 thermovent® 600 should not be used on patients whose body weight is less than 10kg or whose tidal
volume is greater than 600ml. thermovent® 1200 should not be used on patients whose tidal volume is
2
Issue 1
less than 600ml or greater than 1200ml.
-
4 the device should not be used on spontaneously breathing patients who could present difficulties in
weaning from mechanical ventilation due to low spontaneous tidal volumes or co2 retention.
5
the effect of additional deadspace volume of this device should be evaluated on an individual
patient basis.
6 the device can only provide a heat and moisture level equivalent to the patients exhaled gas.
for patients requiring additional heat and moisture, the device should be replaced with another means
of humidification.
Warnings
1 The device is intended for single use only and must not be reused or cleaned. Wetting of the heat
and moisture exchange element with any cleaning solution may dangerously increase resistance to
breathing, or may result in the retention of harmful residues or transmission of infectious agents.
2 Expert clinical judgement must be used in assessing the patient's humidification requirements. This
device must be used as described in these instructions and in accordance with currently accepted
medical techniques.
3 The device may block if the patient develops copious secretions, pulmonary oedema or bleeding
when the device is in use. If the device becomes blocked it must be replaced. Under no
circumstances should any attempt be made to clear the blockage as this may damage the heat and
moisture exchange element and could lead to further blockage.
Technical Specification
THERMOVENT® 600
1 Moisture Output
27mg/L h2o @ 20 breaths/min tidal volume 500ml
2 Temperature Output
32.8°c @ 20 breaths/min tidal volume 500ml
3 Resistance to flow
1.0 hPa (cmh2o) at gas flow rate 0.5L/sec (30L/min)
2.9 hPa (cmh2o) at gas flow rate 1.0L/sec (60L/min)
5.7 hPa (cmh2o) at gas flow rate 1.5L/sec (90L/min)
4 Compressible Volume
11ml (Dead space)
THERMOVENT® 1200
1 Moisture Output
24mg/L h2o @ 10 breaths/min tidal volume 1000ml
2 Temperature Output
33.0°c @ 10 breaths/min tidal volume 1000ml
3 Resistance to flow
0.4 hPa (cmh2o) at gas flow rate 0.5L/sec (30L/min)
1.2 hPa (cmh2o) at gas flow rate 1.0L/sec (60L/min)
2.4 hPa (cmh2o) at gas flow rate 1.5L/sec (90L/min)
4 Compressible Volume
32ml (Dead space)
Thermovent, Portex, Portex design mark and Smiths Medical design mark are trademarks of the Smiths Medical family of
companies. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other
countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners.
© 2010 Smiths Medical family of companies. All rights reserved.
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