Ambu PEEP 20 Bedienungsanleitung

Ambu®Disposable PEEP 20 Valve

for single patient use

INSTRUCTIONS

FOR USE

Content Page

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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.

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.

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.

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

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,

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.

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,

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.

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