Contraindications - Covidien DAR Gebrauchsanweisung

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CLEAN/STERILE (CHECK LABEL) AND READY FOR USE: unless package has been opened or damaged. Single-use device to be used on a single patient.
Discard after use.
Identification of a substance that is
not contained or present within the
product or packaging.
This product cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse, and is therefore intended for single use. Attempts
to clean or sterilize these devices may result in a bio-incompatibility, infection or product failure risks to the patient.
This product contains DEHP. When used as indicated, very limited exposure to trace amounts of DEHP may occur. There is no clear clinical evidence that
this degree of exposure increases clinical risk. However, in order to minimize risk of DEHP exposure in children and nursing or pregnant women, this
product should only be used as directed. Refer to primary labeling.
DESCRIPTION:
The large, compact and small mechanical filters are mechanical bacterial/viral filters for breathing circuits, that help to protect patients, equipment, and
hospital staff from cross-contamination. These devices also include a Luer lock fitting, Luer lock cap, and a non-threaded cap mount for use during CO
monitoring.
INDICATIONS:
These filters are indicated for single use on adult patients (the small mechanical filter is indicated on pediatric patients) under anaesthesia or in intensive
care. They must be connected on patient's side, between the tracheal tube and breathing circuit in position A or for ventilator protection on the machine's
side, as indicated in B. For tidal volumes (Vt), physician judgement prevails. These filters are not equipped with heat and moisture exchanger (HME) for this
reason they have limited humidification functionality. For proper humidification and for long-term application, it is advisable to evaluate whether active
humidification systems/devices or Filter/HME's are needed.

CONTRAINDICATIONS:

• Do NOT use these devices placed between the patient and the heated humidifiers or nebulizers.
• Do NOT use this device in a position different from the intended one.
DIRECTIONS FOR USE:
1. Remove the Filter from its protective package.
2. Firmly connect the device to the breathing circuit and the tracheal tube. Check air seal of all connections.
3. Adjust tidal volume to account for dead space.
4. For CO monitoring, attach the monitoring line to the Luer lock port.
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Periodically inspect for any increase in the resistance to flow, and replace the device if necessary.
Maximum Filter use: 24 hours. Do not reuse. Discard after use.
Precautions should be taken when discarding this device and disposal of the device shall be made in accordance with applicable hospital or national
regulations for biologically hazardous waste.
NOTE: These devices are latex-free and non conductive.
WARNINGS:
• Prescription device to be used only under medical supervision.
• The product is guaranteed only if the package has not been damaged. Check integrity of the filter package; any damage or opening may
compromise sterility and/or performance of the device. In this case, do not use the filter concerned.
• Excessive secretions/bleedings can block the Filter, making breathing difficult; in this case, replace the device immediately.
• Ensure that the connections to the breathing circuit are secure to reduce risk of accidental disconnection.
• Ensure the patency of the device.
• If these Filters are used on the patient's side, do not use them on patients having a tidal volume lower than those indicated in the table.
• If the device is used during anaesthesia with circle breathing systems with soda lime canister, it is necessary to periodically monitor the resistance
to flow. It is recommended not to use the device in this condition for more than six hours.
• Before use, check that the Luer lock cap on the CO
• Do not connect to the Luer lock port tubes different from monitoring CO
could be dangerous for the patient.
• The hydrophobic membrane does not allow the passage of liquid in either direction under normal pressure conditions.
• To reduce the risk of damage and obstruction by small objects, keep wrapped until required for actual use.
PRECAUTIONS:
• Do not try to refurbish. Do not reuse. Do not soak, rinse, wash, sterilize or treat with any disinfectants (in particular phenolic and alcoholic-based
solutions are to be avoided).
• Do not attach CO monitoring line to the non-threaded Luer lock cap mount.
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• Adjust ventilator to account for added dead space, especially for those patients with small tidal volumes (Vt). The effect of mechanical dead space
should be evaluated individually for each patient.
• Use only with devices having ISO standard connectors.
POTENTIAL ADVERSE REACTIONS:
The following adverse reactions may result from the use of Filters: mucus plugging and/or complications due to device occlusion including difficult
breathing, dyspnea, hypercapnia, and hypoxia. The order of listing is alphabetical and does not reflect anticipated frequency or severity.
Identification of a substance that
is contained or present within the
product or packaging.
monitoring port is in place and secure.
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sampling line. Connections to other devices, i.e. gas administration tubes,
2
3
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