Ambu PEEP 20 User manual

Ambu®Disposable PEEP 20 Valve
for single patient use
INSTRUCTIONS
FOR USE

Content Page
English...................................................................................................................................................... 4
България................................................................................................................................................. 9
Česky.......................................................................................................................................................15
Dansk......................................................................................................................................................20
Deutsch..................................................................................................................................................25
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Italiano ...................................................................................................................................................72

Content Page
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Latviski ...................................................................................................................................................87
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Türkçe .................................................................................................................................................. 143
中文...................................................................................................................................................... 148

4
1. Important information –
Read before use
Read these safety instructions carefully
before using the Ambu® Disposable PEEP
(Positive End Expiratory Pressure) 20 Valve.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 Disposable
PEEP 20 Valve. Before initial use of the Ambu
Disposable PEEP 20 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 Disposable PEEP 20 Valve.
1.1. Intended use
The Ambu Disposable PEEP 20 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 connector throughout
the entire expiratory phase.
1.2. Indications for use
Use of the Ambu Disposable PEEP 20 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 Disposable PEEP 20 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 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.

5
en
1.7. Warnings and cautions
Failure to observe these precautions may
result in inefficient PEEP and oxygenation of
the patient or damage to the equipment.
WARNINGS
1. Do not use the Ambu Disposable
PEEP 20 Valve for more than 72
accumulated hours over a maximum
time span of 1 week in order to avoid
the risk of infection.
2. Always visually inspect the product
after unpacking, assembly and prior
to use as defects and foreign matter
can lead to no or reduced PEEP during
ventilation of the patient.
3. For single patient use only.
Use on other patients can cause
cross infection.
4. Only to be used by intended users who
are familiar with the content of this
manual, as incorrect use might harm
the patient.
5. Do not reuse the Ambu Disposable
PEEP 20 Valve if visible moisture or
residues are left inside the device in
order to avoid the risk of infection
and malfunction.
6. Do not use the product if
contaminated by external sources
as this can cause infection.
7. Always use the Ambu Disposable PEEP
20 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.
8. 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.

6
9. Do not use the product in patients
with obstructive lung disease, unless
a medical assessment indicates the
necessity, as increased airway pressure
can increase airway irritation and
inflammatory response.
10. 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.
11. 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.
12. Do not use a product with decreased
performance unless a medical assessment
indicates the necessity as decreased
performance can lead to hypoxia.
13. 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
• 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.
• Do not soak, rinse, chemical disinfect
or steam sterilize the device as these
procedures may leave harmful residues
or cause malfunction of the device.
• Be careful not to unscrew the adjustment
cap as it can detach. If this happens the
cap can be reattached again.
• US federal law restricts this device to sale
by or on the order of a licensed health
care practitioner.

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1.8. Potential adverse events
Potential adverse events related to the use
of the Ambu Disposable PEEP 20 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.
2.0. Device description
The Ambu Disposable PEEP 20 Valve is a
positive end-expiratory pressure valve with
an Ø 30 mm connector and is compatible
with breathing equipment conforming
with EN ISO 5356-1. The Ambu Disposable
PEEP 20 Valve is for single patient use. The
product can be supplied with an adaptor
for Ø 22 mm connectors.
3.0. Explanation of symbols used
Symbol
indication Description
MR Conditional
CN
Country of manufacturer
Medical Device
Single Patient Multiple Use
Rx Only
US federal law restricts this device
to sale by or on the order of a
licensed health care practitioner
A full list of symbol explanations can be found
on ambu.com/symbol-explanation.
4. Product use
4.1. Operating the PEEP valve
Operating instruction
1. Inspect the Ambu Disposable PEEP 20 Valve
to make sure it is free of obstructions.
2. Firmly attach the inlet connector of the
Ambu Disposable PEEP 20 Valve to the
resuscitator, portable ventilator,

8
or CPAP system in accordance with the
Manufacturer´s Instructions for Use.
3. Rotate the adjustment cap to the desired
PEEP setting from 1.5 – 20 cmH₂O
(0.15 – 2.0kPa).
4. For correct adjustment of the PEEP,
a pressure gauge should be connected
to the breathing device for monitoring
of the PEEP.
5. Used products must be disposed of
according to local procedures.
5. Technical product specifications
5.1. Specifications
Connector size ID 30 mm (EN ISO 5356-1).
Adapter size OD 22 mm and OD 30 mm
(EN ISO 5356-1).
Adjustment
range
1.5 – 20 cmH₂O
(0.15 – 2.0 kPa).
Dimensions Length 65 – 76 mm
(depending on adjustment),
diameter 45 mm.
Weight approx. 35 g.
Operating
temperature
limits
-18 °C to +50 °C (-0.4 °F to
+122 °F), tested according
to EN ISO 10651-4.
Storage
temperature
limits
-40 °C to +60 °C (-40 °F to
+140 °F), tested according
to EN ISO 10651-4.
Recommended long term storage in
closed packaging at room temperature,
away from sunlight.
5.2. MRI Safety information
The Ambu Disposable PEEP 20 Valve is tested
to be MR Conditional and therefore may be
safely used in the MR environment (not inside
the MR bore) under the following conditions.
• Static magnetic field of 7 Tesla and less, with
• Maximum spatial field gradient of 16,000
G/cm (160 T/m)
• Maximum force product of 721,000,000
G2/cm (721 T2/m)
Use inside the MR bore may influence MR
image quality.
RF-induced heating and MR image artifacts
have not been tested. Any metallic parts
are fully encapsulated and do not have any
contact with the human body.

9
bg
1.   –
  
Прочетете внимателно тези инструкции за
безопасност, преди да използвате клапана
за еднократна употреба Ambu® Disposable
PEEP 20 (PEEP – положително крайно
експираторно налягане). Инструкциите за
употреба подлежат на актуализиране без
допълнително предизвестие. Копия на
текущата версия са налични при поискване.
Имайте предвид, че тези инструкции
не дават обяснения и не разглеждат
клиничните процедури. Те описват само
основното действие и предпазните
мерки, свързани с работата на клапана за
еднократна употреба Ambu Disposable PEEP
20. Преди първата употреба на клапана за
еднократна употреба Ambu Disposable PEEP
20 е важно операторите да са получили
достатъчно обучение и да са запознати с
предназначението, предупрежденията,
предпазните мерки и показанията,
посочени в тези инструкции. Няма гаранция
за клапана за еднократна употреба Ambu
Disposable PEEP 20.
1.1. 
Клапанът за еднократна употреба Ambu
Disposable PEEP 20 е подходящ за употреба
с ресусцитатори, преносими апарати за
вентилация и CPAP системи, които имат
херметични връзки и могат да работят с
положително налягане в конектора за паци-
ента по време на цялата експираторна фаза.
1.2.   
Употребата на клапана за еднократна
употреба Ambu Disposable PEEP 20 е
показана, когато е необходимо да се
постигне налягане над това на околната
среда в белите дробове на пациента,
за да се подобри оксигенацията на кръвта
и за да се лекуват различни респираторни
заболявания и симптоми.
1.3.   
Клапанът за еднократна употреба Ambu
Disposable PEEP 20 е предназначен за
използване при всички възрастови групи
от недоносени бебета до възрастни хора.
1.4.   
Медицински специалисти, обучени за
обезпечаването на проходимостта на
дихателните пътища и употребата на
функцията за клапан PEEP, като например
анестезиолози, медицински сестри,

10
служители в спасителни служби и
служители на спешната помощ.
1.5. 
Не са известни.
1.6.  
Подобрена оксигенация посредством
алвеоларна стабилизация, съответствие,
увеличена повърхностна площ за обмен
на газ и остатъчен белодробен капацитет.
1.7.   

Неспазването на тези предпазни мерки
може да доведе до неефективни PEEP и
оксигенация на пациента или повреда
на оборудването.

1. Не използвайте клапана за
еднократна употреба Ambu
Disposable PEEP 20 за повече от общо
72 часа с натрупване в рамките на
максимален период от 1 седмица,
за да избегнете риска от инфекция.
2. Винаги проверявайте продукта
визуално след разопаковане,
сглобяване и преди употреба,
тъй като дефектите и чуждите
материи може да доведат до
липсващо или намалено PEEP по
време на вентилацията на пациента.
3. Само за еднократна употреба.
Използването върху други
пациенти може да доведе до
кръстосана инфекция.
4. Да се използва само от предвидената
група потребители, които са
запознати със съдържанието на
това ръководство, тъй като
неправилната употреба може да
навреди на пациента.
5. Не използвайте повторно клапана
за еднократна употреба Ambu
Disposable PEEP 20, ако в него останат
видими следи от влага или остатъци,
за да избегнете риска от инфекция и
неправилно функциониране.
6. Не използвайте продукта, ако е
замърсен от външни източници,
тъй като това може да причини
инфекция.