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en
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.
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.
DESCRIPTION:
The Adult Pediatric Large and Small Filter HMEs, Infant-Pediatric Electrostatic Filter HME Small and the Pediatric-Neonatal Electrostatic Filter HME
Small are electrostatic bacterial/viral Filters with Heat and Moisture Exchanger (Filter/HME) for breathing circuits. These Filter/HMEs help to protect
patients, equipment, and hospital staff from cross-contamination while minimizing heat and moisture loss from patient airways. These devices
also include a luer lock fitting, luer lock cap, and a non-threaded cap mount (except for Infant-Pediatric Electrostatic Filter HME Small and Pediatric-
Neonatal Electrostatic Filter HME Small) for use during CO
INDICATIONS:
These Filter/HMEs are indicated for single use on patients under anesthesia or in intensive care as follows:
•
A dult Patients: Adult-Pediatric Electrostatic Filter HME Large; Adult-Pediatric Electrostatic Filter HME Small; Adult-Pediatric Electrostatic Filter
HME Small, Angled Port
•
P ediatric Patients: Adult-Pediatric Electrostatic Filter HME Large; Adult-Pediatric Electrostatic Filter HME Small; Adult-Pediatric Electrostatic
Filter HME Small, Angled Port, Infant-Pediatric Electrostatic Filter HME Small
•
Neonatal Patients: Pediatric-Neonatal Electrostatic Filter HME Small
These Filter/HMEs must be placed at the patient's side, between the tracheal tube and breathing circuit in the positions indicated in figures A and B.
Consult the attending physician for tidal volumes (Vt).
CONTRAINDICATIONS:
•
Do NOT use these devices in conjunction with heated humidifiers or nebulizers.
•
Do NOT use these devices in a position other than described.
DIRECTIONS FOR USE:
1.
Remove the Filter/HME from its protective package.
2.
Firmly connect the device to the breathing circuit as close to the patient as possible. Check all connections for an airtight seal.
3. Adjust tidal volume to compensate for dead space.
4.
For CO
monitoring, attach the monitoring line to the Luer lock port.
2
Periodically inspect any increasing in the resistance to flow and replace the device if necessary.
Maximum Filter/HMEs 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.
•
T he 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.
•
E xcessive secretions/bleedings can block the Filter/HMEs, 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.
•
Do not use on patients having a tidal volume (Vt) lower than those indicated in the table.
•
I f the device is used with spontaneously breathing patients on assist-control or intermittent mandatory ventilation (IMV), keep the
ventilation parameters monitored.
•
Before use, check that the Luer lock cap on the CO
•
T o reduce the risk of damage and obstruction by small objects, keep wrapped until required for actual use.
PRECAUTIONS:
•
D o 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.
2
•
A djust 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 Filter/HMEs: 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 frequency or severity.
Identification of a substance that
is contained or present within the
product or packaging.
monitoring.
2
monitoring port is in place and secure.
2
3
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