Weinmann COMBIBAG Manual de usuario

COMBIBAG

Resuscitator

Instructions for use

2Overview

Overview

COMBIBAG

Accessories

Patient valve

Safety valve

Squeeze bag

(compressable unit)

Intake valve

PEEP valve Oxygen reservoir DEMAND valve

Contents 3

Contents

1. Basic principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.1 Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.2 Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.3 Special Features of the COMBIBAG. . . . . . . . . . 5

2. Description of the resuscitator . . . . . . . . . . . . . . 7

2.1 COMBIBAG components . . . . . . . . . . . . . . . . . . 7

3. Safety instructions . . . . . . . . . . . . . . . . . . . . . . . . 9

4. Operating instructions . . . . . . . . . . . . . . . . . . . . 11

4.1 Introductory remarks. . . . . . . . . . . . . . . . . . . . . 11

4.2 Checking the function . . . . . . . . . . . . . . . . . . . 11

4.3 Guide values for ventilation . . . . . . . . . . . . . . . 12

4.4 Mask ventilation . . . . . . . . . . . . . . . . . . . . . . . . 13

4.5 Ventilation via an endotracheal tube. . . . . . . . 14

4.6 Increasing the oxygen concentration. . . . . . . . 14

4.7 PEEP ventilation . . . . . . . . . . . . . . . . . . . . . . . . . 15

4.8 Volume measurement. . . . . . . . . . . . . . . . . . . . 15

4.9 Use of HME-Filters . . . . . . . . . . . . . . . . . . . . . . . 16

5. Hygienic preparation . . . . . . . . . . . . . . . . . . . . . 17

5.1 Cleaning during use . . . . . . . . . . . . . . . . . . . . . 18

5.2 Maintenance and service . . . . . . . . . . . . . . . . . 18

6. Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

6.1 Standard scope of supply . . . . . . . . . . . . . . . . . 19

6.2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

6.3 Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

7. Technical and performance data . . . . . . . . . . . 24

8. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

9. Declaration of conformity . . . . . . . . . . . . . . . . . 26

4Basic principle

1. Basic principle

1.1 Purpose

The COMBIBAG is for the manual ventilation of chil-

dren (from a body weight of 10 kg) and adults via a

face mask or endotracheal tube. The respiratory air

can be enriched with oxygen.

1.2 Function

On squeezing the bag, a volume of gas (air, air en-

riched with oxygen or pure oxygen) is forced

through the resuscitation valve into the patient’s

lungs.

As soon as the elastic bag is released, it fills up again

via the inlet valve, resuming its former shape. At the

same time, the diaphragm in the patient valve closes

the connection to the bag and opens the expiration

passage. The patient then exhales into the atmo-

sphere and expired air cannot flow back into the

bag. In case of spontaneous breathing, the patient

Basic principle 5

can breathe independantly in and out via the expira-

tion passage.

1.3 Special Features of the COMBIBAG

COMBIBAG, the first manual resuscita-

tor with segmental division for adults

and children.

Hitherto, at least 2 resuscitation bags were required

to ventilate patients of all age groups, a child resus-

citation bag and a large adult resuscitation bag.

Now the special design featuring the COMBIBAG

covers both functions. The bag is divided into two

segments (one large and one small) by two longitu-

dinal troughs, marked with appropriate symbols.

The tidal volume required can be obtained by

squeezing the adult or child segment:

• up to 500 ml in child ventilation

• 500 - 1200 ml in adult ventilation.

The usual, separate child bag becomes unnecessary.

The principle of “two bags in one” is extremely eco-

nomical and saves space in each emergency kit.

••••••

Exspiration Inspiration

Intake valve

Patient valve

(non-rebreathing valve)

Bag filling up

Squeeze bag

Compression

••••

6Basic principle

COMBIBAG, the first manual resuscita-

tor with a 2-stage safety valve.

By now, pressure relief as a function of the variable

risks present in ventilation via face mask or endotra-

cheal tube remained unsolved.

The majority of manual resuscitators only have a

pressure limit at 50 - 60 mbar (5-6 kPa (≈50-

60 cmH2O)), a reasonable limit adapted to healthy

lung conditions.

With use of manual resuscitators and face mask ven-

tilation in inexperienced hands, however, there is al-

ways the risk that anxiety of the administrator and

the eager trial to produce very effective ventilation

may lead to an inflation of the stomach at pressures

above 20 mbar (2 kPa (≈20 cmH2O)) resulting in re-

gurgitation with following apiration. Moreover,

there is the risk with ventilation of children indepen-

dant from face mask or endotracheal tube that high

ventilation pressures may hurt the lungs.

With the COMBIBAG 2-stage safety valve it is now

possible to set a pressure limit:

• of 20 mbar (2 kPa (≈20 cmH2O)) for mask

resuscitation child ventilation and

• one of 60 mbar (6 kPa (≈60 cmH2O)) for resus-

citation via an endotracheal tube with adults.

••••

Description of the resuscitator 7

Hazards in ventilating non intubated patients

2. Description of the resuscitator

2.1 COMBIBAG components

The COMBIBAG resuscitator for adults and children

consists of 4 working parts:

Patient valve

The patient valve consists of:

• the valve body with bag adapter,

• inspiration cone for connection of the mask or

endotracheal tube connector (diameter

22/15 mm)

• valve diaphragm for separating inspiration and

expiration

• safety valve (pressure-relief valve).

•7•U•D•F•K•H•D

pressure > 20cm H2O Õpressure < 20cm H2O Íeffect

stomach

contens of the

stomach

diaphragm

lungs

esophagus

trachea

Patient valve (non-

rebreathing walve)

Safety valve

Squeeze bag

(compressable

unit)

Intake valve

8Description of the resuscitator

Safety valve

The safety valve (pressure-relief valve) consists of:

• the valve body with valve fittings and

• white pressure marks (20 and 60 mbar / 2 and

6 kPa (≈20 and 60 cmH2O)) and the red valve

ring with white arrows and the figures 20 and

60.

Because the safety valve can be accurately adjusted

only by the manufacturer WEINMANN Emergency,

replacement is possible only with delivery of a com-

plete unit. Removal of the safety valve is not permit-

ted.

Squeeze bag

The squeeze bag (compressable unit) is divided into

segments by two asymmetrical troughs, marked

with pictograms (symbol of a child and of an adult),

and creates the gas volume required on squeezing

the corresponding segment.

Intake valve

The intake valve consists of:

• valve intake port inner part with connecting

socket for oxygen enrichment

• intake port cover

• valve plate to allow the inlet of fresh gas and

forming a seal when the bag is squeezed

• silicone ring for hanging up the COMBIBAG.

Safety instructions 9

3. Safety instructions

For your own safety, the safety of your patients, and

to comply with the requirements of EU Directive 93/

42 EEC, please observe the following points:

• Carefully observe the operating instructions,

which is part of the instrument and must be

available all the time.

• The detailed knowledge and attention of this

operating instructions are the basis for proper

use of the COMBIBAG. The instrument is just de-

termined for the field of use stated.

• Malfunctions and a lack of biocompatibility may

result if third-party articles are used. Please bear

in mind that in these cases any warranty entitle-

ment and liability shall lapse where the accesso-

ries recommended in the instructions for use or

original spare parts are not utilised.

• To prevent infection or bacterial contamination,

please observe section “5. Hygienic prepara-

tion” on page 17.

•Warning: The unit takes in ambient air so it may

not be used in a toxic atmosphere.

• The unit is only allowed to be used by experi-

enced personell trained in resuscitation and well

acquainted with the instrument.

• In operation with oxygen it is imperative that

smoking and open fire around the oxygen fit-

tings is strictly prohibited.

• Oil and grease should not be used in conjunction

with the resuscitation unit.

• Not for infants and children with a body weight

below 10 kg.

10 Safety instructions

• More copies of this operating instructions are

available from the manufacturer WEINMANN

Emergency.

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