Ambu SPUR II, Instructions For Use Manual

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en
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CAUTIONS
1. Never store the resuscitator in a deformed state other than as folded when
delivered by the manufacturer, otherwise permanent distortion of the bag could
occur, which may reduce the ventilation efficiency. The folding zone is clearly
visible on the bag (only Adult and Pediatric versions may be folded).
2. Always watch the movement of the chest and listen for the expiratory flow from
the patient valve, in order to check the ventilation. Switch immediately to mouth-
to-mouth ventilation if ventilation with the resuscitator cannot be achieved.
3. Do not soak, rinse, or sterilize this device, as these procedures may leave harmful
residues or cause malfunction of the device. The design and material used are not
compatible with conventional cleaning and sterilization procedures.
4. Use the M-Port only for one of the two; EtCO
2
measuring or drug administration,
as this can modify the measured values.
5. If applicable, please see accessory packaging for more specific information about
the individual accessory as incorrect handling may lead to malfunction of the
entire product.
6. The use of third-party products and oxygen delivery devices (e.g. filters and
demand valves) with the Ambu SPUR II Resuscitator may influence product
performance. Please consult the manufacturer of the third-party device to verify
compatibility with Ambu SPUR II Resuscitator and obtain information on the
possible performance changes.
7. The oxygen reservoir bag is permanently attached to the inlet valve on adult and
pediatric resuscitators, except on demand valve versions. Do not attempt to
disassemble. Do not pull the oxygen reservoir bag, as it may result in malfunction
of the device.
1.8. Potential adverse events
Potential adverse events related to resuscitation (not exhaustive): barotrauma, volutrauma,
hypoxia, hypercarbia and aspiration pneumonia.
1.9. General notes
If, during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and to your national authority.
2. Device description
The Ambu SPUR II Resuscitator can be connected to the Ambu® Disposable Pressure
Manometer, the Ambu® PEEP Valves and the Ambu® Face masks, as described in section 4.3
Operating the Resuscitator.
3. Explanation of symbols used
Symbol indication Description
Adult
Intended ideal body mass greater than 30 kg
Pediatric
Intended ideal body mass from 6 to 30 kg
Infant
Intended ideal body mass up to 10 kg
MR conditional
CN
Country of Manufacturer