Weinmann COMBIBAG User manual

COMBIBAG
Resuscitator
Instructions for use

2Overview
EN
Overview
COMBIBAG
Accessories
Patient valve
Safety valve
Squeeze bag
(compressable unit)
Intake valve
PEEP valve Oxygen reservoir DEMAND valve

Contents 3
EN
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
EN
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
EN
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
EN
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
EN
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
EN
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
EN
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
EN
• More copies of this operating instructions are
available from the manufacturer WEINMANN
Emergency.

Operating instructions 11
EN
4. Operating instructions
4.1 Introductory remarks
Although it is commonly assumed that resuscitation
should be carried out only after respiratory failure
has been confirmed, it must be emphasized that it
should be commenced as soon as symptoms such as:
• cyanosis and/or
• visibly reduced respiratory movements and/or
• very low respiratory frequency and/or
• diminished respiratory murmur and/or
• diminished air flow
indicate dangerous suppression or restriction of
spontaneous breathing. This ensures that all forms
of hypoventilation, such as dead space breathing
and breath “rattling” are covered.
4.2 Checking the function
The function of the COMBIBAG resuscitation bag
should be proven before each use and can be
checked in a few seconds as follows:
• Squeeze the bag with the right hand and cover
the patient valve with the left hand: regardless
of the relief valve setting, air can be felt and
heard to flow into the left hand.
• Release the bag: it expands rapidly and air can
be heard to flow through the inlet valve.

12 Operating instructions
EN
• Relief valve setting 20 mbar (2 kPa
(≈20 cmH2O)): on closing the inhalation pas-
sage with the ball of the left thumb and squeez-
ing the bag with the right hand, air flows
through the relief valve openings.
• Relief valve setting 60 mbar (6 kPa (≈
60 cmH2O)) : on closing the inhalation passage
with the ball of the left thumb, the bag can only
be squeezed under considerable pressure and air
escapes more slowly and quietly than at the
20 mbar (2 kPa (≈20 cmH2O)) pressure setting.
4.3 Guide values for ventilation
When carrying out artificial ventilation with resuscita-
tors without adjustable frequency and tidal volume
(unless additional measuring instruments such as
pressure gauges or volumeters are employed), suc-
cess of the procedure can only be judged from indi-
rect signs, such as clearly visible thorax movements,
disappearance of cyanosis, reduction in pallor, etc.
Because of this, certain guide values should be noted
after commencing resuscitation, in which, as a rule,
some degree of hyperventilation is desirable. This is
important since, with prolonged resuscitation, inade-
quate ventilation (hypoventilation) leads to consider-
able damage and ventilation with too high frequency
and excessive tidal volume (hyperventilation) also has
serious drawbacks.
Cycles per min. Tidal volume in ml
– Children (from a body
weight of 10 kg)
– Childgen, 5 years old
– Childgen, 10 years old
–Juveniles
– Adults
40 - 60
20 - 35
18 - 25
16 - 20
12 - 16
20 - 35
150 - 200
300 - 400
300 - 500
500 - 1000

Operating instructions 13
EN
Ventilation must be carried out if spontaneous
breathing cannot be established once the airways
are cleared and the patients spontaneous breathing
must be assisted or controlled if it is inadequate.
4.4 Mask ventilation
Proceed as follows:
• lay the patient on his back
• extend the head and neck
• pull the red ring on the COMBIBAG relief valve
upwards (pressure limit 20 mbar (2 kPa
(≈20 cmH2O)))
• C-grip: left hand lifts the lower jaw back and
seals the mask over the mouth and nose
• rhythmically squeeze and release the appropri-
ate segment (adult and infant) at the recom-
mended frequency
• if necessary, insert a Wendl-airway through the
nose or use a Guedel-airway to improve access
to the nasopharyngeal cavity
• the mask must seal tightly
• the red ring on the relief valve should be pushed
down (pressure limit 60 mbar (6 kPa
(≈60 cmH2O))) in exceptional cases only, where
adequate ventilation still cannot be achieved.
However, inflation of the stomach is not then ex-
cluded and must be considered!

14 Operating instructions
EN
4.5 Ventilation via an endotracheal tube
To prevent additional complications (overinflation of
the stomach with consequent aspiration), ventilation
via a correctly placed endotracheal tube is to be
aimed at wherever possible:
• Intubation
• Press the red ring on the COMBIBAG relief valve
downwards (pressure limit 60 mbar (6 kPa
(≈60 cmH2O)))
• Even with ventilation via an endotrachel tube,
one should aim for a pressure limit of 20 mbar
(2 kPa (≈20 cmH2O)) in order to limit the drop in
the heart circulation time caused by increase in
resistance in the pulmonary circulation.
4.6 Increasing the oxygen concentration
In emergency situations, oxygen concentrations
above that in the ambient air (21 vol. %), or even
100% oxygen may be indicated, since oxygen defi-
ciency often has to be reckoned with at the first sup-
ply phase. Any oxygen concentration can be
administered with the COMBIBAG resuscitator. Oxy-
gen concentrations up to 48% can be administered
directly via the oxygen socket on the intake connec-
tion. If a higher concentration of oxygen is to be ad-
ministered, an oxygen reservoir or a demand valve
can be used.
Connect corrugated hose
• Fit the oxygen reservoir into the cone on the in-
take socket and

Operating instructions 15
EN
• push the oxygen connecting tube onto the con-
nector at the end of the corrugated hose.
Connect demand valve
• Attach demand valve with appropriate adapter
WM 22169.
• Follow the instructions for use for the demand
valve.
4.7 PEEP ventilation
Many disturbances in lung function (disturbances in
distribution, exudation, atelectasis, etc.) can be pre-
vented, or their effects reduced, by application of a
Positive-End-Expiratory-Pressure (PEEP).
A PEEP valve can be fitted directly to the exhalation
passage of the patient valve.
4.8 Volume measurement
To prevent hypo- or hyperventilation in the case of
prolonged manual resuscitation with the
COMBIBAG, a volumeter for measuring the expired
gas volume can be connected to the expiration
branch of the patient valve.

16 Operating instructions
EN
4.9 Use of HME-Filters
For hygienical reasons and for climatizing the
breathing air, the inspiratory branch of the patient
valve can be fitted with commercial 15/22 mm stan-
dard cone HME-filters (heat and moisture exchang-
er). This insignificantly increases the inspiratory as
well as the expiratory resistance. The extend of the
death space volume has to be considered particularly
with children. Observe the operating instructions of
the manufacturer and chapter “3. Safety instruc-
tions” on page 9.

Hygienic preparation 17
EN
5. Hygienic preparation
COMBIBAG should undergo hygienic purification
after every use.
Upon completion of the purification process, carry
out a functional test.
Individual parts of the COMBIBAG resuscitator are
made of silicon or polysufone.
Use soapy water to clean COMBIBAG and rinse un-
der running water. For cleaning purposes, take apart
the bag, separating the pieces into components as
described.
Warning: When assembling or disassembling
COMBIBAG, do not use any sharp-edged objects.
The patient valve does not have to be dismantled in
order to be cleaned!
Should you choose to dismantle the valve anyway,
do not unscrew the cap of the valve since that could
change the pressure setting of the valve.
To disinfect the equipment, use a disinfectant that is
suitable for rubber and polysulfone. Be sure to ob-
serve the instructions for the disinfectant. We rec-
ommend GIGASEPT FF.
Sterilization with steam, hot air or gas should be car-
ried out according to standard practices after careful
cleaning of the individual parts. All parts can be au-
toclaved at 134 °C.
The oxygen reservoir cannot be sterilized. It should
be cleaned and disinfected.
Valve cage with
expiration cone
Patient valve
Safety valve
(relief valve)
Squeeze
bag
Intake port inner
part with
diaphragm
Intake port cov-
er with holding
ring

18 Hygienic preparation
EN
5.1 Cleaning during use
Should the valve become blocked as a result of
regurgitation, clean it as follows:
• Unscrew the valve cage.
• Clean the valve element and valve body with the
finger or by gentle tapping.
• Rapidly squeeze the bag several times to blow
out any foreign particles.
• Screw in the valve cage, check the function and
continue ventilation.
Note: Always check the function of the resuscitator
after cleaning and re-assembly!
• Partially cover the patient connection.
• Squeeze the bag and check the valve element
for correct function and leak-tightness (see “4.2
Checking the function” on page 11).
5.2 Maintenance and service
With proper use and maintenance of the
COMBIBAG no additional service is required. Just the
intake diaphragm should be examined once a year.
The diaphragm is ready for proper use if no cracking
spots are visible.
Wavy, distorted or sticked items have to be replaced.
A frequent functional check is recommended to be
carried out according to Pt. “4.2 Checking the func-
tion”.

Spare parts 19
EN
6. Spare parts
6.1 Standard scope of supply
Item no.* Description of component Order no.
COMBIBAG resuscitation bag for adults and
children, without face masks WM 11090
22
COMBIBAG resuscitation bag for adults and
children with 1 face mask,
consisting of:
– COMBIBAG resuscitation bag
– ventilation mask with inflatable silicone
cushion for adults, Size 5
– COMBIBAG operating instructions
WM 11020
WM 11000
WM 5074
WM 16013
22
23
COMBIBAG resuscitation bag for adults and
children with 2 masks,
consisting of:
– COMBIBAG resuscitation bag
– ventilation mask with inflatable silicone
cushion for adults, Size 5
– ventilation mask with inflatable silicone
cushion for children and young people, Size 3
– COMBIBAG operating instructions
WM 11025
WM 11000
WM 5074
WM 5082
WM 16013
COMBIBAG resuscitation bag for adults and
children with 2 face masks,
consisting of:
– COMBIBAG resuscitation bag
– silicone ventilation mask for adults, Size 5
– silicone ventilation mask for young people,
Size 3
– COMBIBAG operating instructions
WM 11026
WM 11000
WM 5084
WM 5083
WM 16013

20 Spare parts
EN
*See illustration on page 23.
6.2 Accessories
*See illustration on page 23.
The following combination units with adapter are
available for WEINMANN Emergency COMBIBAG
DEMAND resuscitation bags:
22
23
24
COMBIBAG resuscitation bag for adults and
children with 3 face masks,
consisting of:
– COMBIBAG resuscitation bag
– ventilation mask with inflatable silicone
cushion for adults, Size 5
– ventilation mask with inflatable silicone
cushion for children and young people, Size 3
– ventilation mask with inflatable silicone
cushion for babies, Size 1
– COMBIBAG operating instructions
WM 11050
WM 11000
WM 5074
WM 5082
WM 5086
WM 16013
Item no.* Description of component Order no.
Item no.* Description of component Order no.
PEEP valve with tapered connector, infinitely
adjustable from 0 - 10 mbar (0-1 kPa (≈0-
10 cmH2O)) (22 mm external diameter)
WM 3215
14 – 17 Oxygen reservoir for COMBIBAG WM 11052
Item no.* Description of component Order no.
Spiracle demand valve with pressure tube
1,500 mm, G 3/8” connection WM 22127
Spiracle demand valve with pressure tube
1,500 mm, sealing nipple, Walther type WM 22128
Spiracle demand valve with pressure tube
1,500 mm, DIN 13260 connector WM 22129
22
23
24
Ventilation mask, transparent, with inflatable
silicone cushion:
– Adult size 5
– Children and young people, Size 3
– Babies and small children, Size 1
WM 5074
WM 5082
WM 5086