Ambu PEEP 10 Manual de usuario
Ambu®Reusable PEEP 10 Valve
Ambu®Reusable PEEP 20 Valve
INSTRUCTIONS
FOR USE
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1. Important information –Readbeforeuse
Read these safety instructions carefully before using the Ambu® Reusable PEEP (Positive
End Expiratory Pressure) 10 Valve and Ambu® Reusable PEEP 20 Valve (in this document
collectively referred to as Ambu Reusable PEEP Valve unless otherwise specified). The
instructions for use may be updated without further notice. Copies of the current version
are available upon request. Please be aware that these instructions do not explain or
discuss clinical procedures. They describe only the basic operation and precautions
related to the operation of the Ambu Reusable PEEP Valve. Before initial use of the Ambu
Reusable PEEP Valve, it is essential for operators to have received sufficient training and
be familiar with the intended use, warnings, cautions, and indications mentioned in these
instructions. There is no warranty on the Ambu Reusable PEEP Valve.
1.1. Intended use
The Ambu Reusable PEEP Valve is suitable for use with resuscitators, portable ventilators,
and CPAP systems which have airtight connections and can operate with a positive
pressure in the patient connection throughout the entire expiratory phase.
1.2. Indications for use
Use of the Ambu Reusable PEEP Valve is indicated when achievement of a pressure above
ambient in the patient’s lungs is needed in order to improve oxygenation of the blood,
and to treat different respiratory diseases and symptoms.
1.3. Intended patient population
The Ambu Reusable PEEP Valve is to be used on all age groups from premature infants
to elderly.
1.4. Intended user
Medical professionals trained in airway management and use of the Ambu Reusable PEEP
Valve function such as anesthesiologists, nurses, rescue personnel and emergency personnel.
1.5. Contra indications
None known.
1.6. Clinical benefits
Improved oxygenation by means of alveolar stabilization, compliance, increased surface
area for gas exchange and residual lung capacity.
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1.7. Warnings and Cautions
WARNINGS
1. Always visually inspect the product after unpacking, assembly and prior to use as
defects and foreign matter can lead to no or reduced ventilation of the patient.
2. Do not reuse the product on another patient without reprocessing due to the risk
of cross infection.
3. Only to be used by intended users who are familiar with the content of this
manual, as incorrect use might harm the patient.
4. Professionals performing the procedure should assess the choice of size in accordance
with the patient’s specific condition(s), as incorrect use may harm the patient.
5. Always reprocess the Ambu Reusable PEEP Valve if visible residues are left inside
the device in order to avoid the risk of infection or malfunction.
6. Always reprocess the Ambu Reusable PEEP Valve after each use in order to avoid
the risk of infection.
7. Do not use the product if contaminated by external sources as this can
cause infection.
8. Always use the Ambu Reusable PEEP Valve with a manometer as the manometer
ensures correct adjustment of PEEP during ventilation. Too high or low PEEP
during ventilation may cause barotrauma and hypoxia, respectively.
9. Do not use the Ambu Reusable PEEP Valve after a maximum of 30 times of
reprocessing in order to avoid the risk of infection or malfunction of the device.
10. Always reprocess the Ambu Reusable PEEP Valve minimum once a week when
used on the same patient in order to avoid the risk of infection.
11. Do not use the product in patients with obstructive lung disease, unless a medical
assessment indicates the necessity, as increased airway pressure can accelerate
airway irritation and inflammatory response.
12. Do not use the product in patients with a medical condition causing elevated
peak and mean airway pressures, unless a medical assessment indicates the
necessity, as increased PEEP can lead to barotrauma.
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13. Do not use the product in patients suffering from conditions such as cardiogenic
shock, myocardial infarction, left heart failure, hypovolaermia or a combination
of these conditions resulting in haemodynamic instability unless a medical
assessment indicates the necessity, as high PEEP can lead to reduced cardiac
output and systemic perfusion.
14. Do not use a product with decreased performance unless a medical assessment
indicates the necessity as decreased performance can lead to hypoxia.
15. Do not use the product in patients with unilateral (one-sided) lung disease,
bronchopleural fistulae or similar conditions unless a medical assessment
indicates the necessity, as this can lead to hyperinflation of the lung tissue
reducing healing of injured site.
16. When using supplemental oxygen, do not allow smoking or use of device near
open flame, oil, grease, other flammable chemicals or equipment and tools,
which cause sparks, due to the risk of fire and/or explosion.
CAUTIONS
1. Please see packaging for more specific information about the expiration date, as
the use of an expired device might lead to decreased performance or malfunction
of the product.
2. Always keep components from same device together during reprocessing to
avoid reassembly of components with different durability leading to the risk of
product failure.
3. Be careful not to unscrew the adjustment cap as it can detach. If this happens the
cap can be reattached again.
4. U.S. federal law restricts this device to sale by or on the order of a licensed health
care practitioner.
1.8. Potential Adverse events
Potential adverse events related to the use of the Ambu Reusable PEEP Valve
(not exhaustive): Hypoxia, barotrauma including pneumothorax, volutrauma,
reduced cardiac output and systemic perfusion.
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.
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2. Device description
The Ambu Reusable PEEP Valve is a positive end-expiratory pressure valve for use with
breathing equipment conforming to EN ISO 5356-1. The product can be supplied with
a connector of either ID Ø30mm or OD Ø22mm. The Ambu Reusable PEEP Valve is
delivered non-sterile and must be reprocessed according to section 4.2.
3. Explanation of symbols used
Symbol indication Description
Global Trade Item Number (GTIN™)
Lot Number
CN
Country of Manufacturer
Medical Device
MR Unsafe
Rx Only Prescription use only
A full list of symbol explanations can be found on ambu.com/symbol-explanation.
4. Product use
4.1. Operating the Ambu Reusable PEEP Valve
1. Inspect the Ambu Reusable PEEP Valve to make sure it is free of obstructions.
2. Firmly attach the inlet connector of the Ambu Reusable PEEP Valve to the
resuscitator, portable ventilator, or CPAP system in accordance with the
Manufacturer´s Instructions for Use.
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3. Rotate the adjustment cap to the desired PEEP setting
• PEEP 10: from 0 – 10cmH₂O (0 – 1.0kPa).
• PEEP 20: from 1.5 – 20cmH₂O (0.15 – 2.0kPa).
4. For correct adjustment of the PEEP, a manometer should be connected to
the breathing device for monitoring of the PEEP.
4.2. Reprocessing: cleaning, disinfection, sterilization
Follow these reprocessing instructions after each use to reduce the risk of cross-contamination.
Disassembly
Before reprocessing, manually disassemble the Ambu Reusable PEEP Valve into three
components as shown in illustration 1. Turn the housing counterclockwise while holding the
inlet connector. Take out the internal valve assembly. No further disassembly is necessary.
Keep components from same device together during reprocessing to avoid reassembly
of components with different durability.
Recommended reprocessing procedures
For complete reprocessing of the Ambu Reusable PEEP Valve, use one of the procedures
listed below.
Recommended reprocessing procedures (select one)
• Manual cleaning followed by chemical disinfection, or
• Manual cleaning followed by sterilization, or
• Automated cleaning, including a thermal disinfection stage, followed by sterilization, or
• Automated cleaning, including a thermal disinfection stage, followed by
chemical disinfection.
Table 1: Recommended reprocessing procedures.
Product testing has shown that the Ambu Reusable PEEP Valve is fully functional after 30
full reprocessing cycles, as listed in Table 1.
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It is the user’s responsibility to qualify any deviations from the recommended cycles and
methods of processing, and to monitor that the recommended number of reprocessing
cycles is not exceeded.
Illustration 1:
g. 2
123
Inlet connector ID 30mm
or
Inlet connector OD22 mm
Housing with
adjustment cap
Internal valve
assembly
Procedures for reprocessing
MANUAL CLEANING
1. Rinse the components under running cold utility (tap) water to remove gross soil.
2. Prepare a detergent bath using a cleaning detergent solution, e.g. Neodisher®
MediClean Forte or equivalent, for the removal of residues of dried and denatured
blood and proteins, using the detergent manufacturer’s recommended concentration.
3. Fully immerse the components to keep them submerged in the solution per
detergent instruction label. During the soak time thoroughly clean the components
with a soft brush until all visible soil is removed.
4. Rinse the components with running utility (tap) water for one minute.
5. Dry the components with a clean lint-free, free cloth and compressed air.
AUTOMATED CLEANING WITH THERMAL DISINFECTION
1. Rinse the components under running cold utility (tap) water to remove gross soil.
2. Place the components onto a manifold rack or in a wire basked inside the washer.
3. Select the appropriate cycle as listed below:
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Stage Recirculation
time (minutes) Temperature Detergent type
and concentration
Pre-wash 02:00 Cold tap water N/A
Wash 01:00 43 °C (110 °F)
Tap water Neodisher® MediClean Forte
or an equivalent detergent
using manufacturer’s
recommended concentration
Rinse 01:00 43 °C (110 °F)
Tap water N/A
Thermal
disinfection 05:00 91 °C (196 °F) N/A
Dry time 07:00 90 °C (194 °F) N/A
Table 2: Automated cleaning with thermal disinfection cycles.
CHEMICAL DISINFECTION
1. Equilibrate the bath of Cidex OPA, or an equivalent OPA (ortho-phthalaldehyde),
disinfectant at the temperature specified in the OPA disinfectant manufacturer’s
instructions.
2. Ensure the minimum effective concentration (MEC) of the OPA disinfectant using
the OPA test strips specified in the OPA disinfectant manufacturer’s instructions.
3. Fully immerse the device in the OPA and ensure all air bubbles are removed from
the device surface by agitating the device.
4. Allow the device to soak for the time specified by the OPA disinfectant
manufacturer’s instructions.
5. Thoroughly rinse the device by fully immersing it in purified water, agitating and
allowing it to set for a minimum of 1 minute.
6. Repeat step 5 two more times for a total of 3 rinses using a fresh batch of purified
water each time.
7. Dry the device using a sterile lint-free cloth.
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