Weinmann COMBIBAG WM 11000 Manual

COMBIBAG
Resuscitator WM 11000
Description and Operating Instructions

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

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 . . . . . . . . . . . . . . . . . . . . 10
4.1 Introductory remarks . . . . . . . . . . . . . . . . . 10
4.2 Checking the function . . . . . . . . . . . . . . . . 10
4.3 Guide values for ventilation . . . . . . . . . . . . 11
4.4 Mask ventilation. . . . . . . . . . . . . . . . . . . . 12
4.5 Ventilation via an endotracheal tube . . . . . . 12
4.6 Increasing the oxygen concentration . . . . . . 13
4.7 PEEP ventilation . . . . . . . . . . . . . . . . . . . . 14
4.8 Volume measurement . . . . . . . . . . . . . . . . 14
4.9 Use of HME-Filters . . . . . . . . . . . . . . . . . . 14
5. Hygienic preparation . . . . . . . . . . . . . . . . . . . . 15
5.1 Cleaning during use . . . . . . . . . . . . . . . . . 16
5.2 Maintenance and service . . . . . . . . . . . . . 16
6. Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.1 Standard scope of supply . . . . . . . . . . . . . 17
6.2 Accessories. . . . . . . . . . . . . . . . . . . . . . . 18
6.3 Spare parts. . . . . . . . . . . . . . . . . . . . . . . 19
7. Technical and performance data . . . . . . . . . . . . 22
8. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
9. Declaration of conformity . . . . . . . . . . . . . . . . . 25

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 atmosphere
and expired air cannot flow back into the bag. In case
of spontaneous breathing, the patient can breathe in-
dependantly in and out via the expiration passage.
••••••
••••••
Exspiration Inspiration
Intake valve
Patient valve
(non-rebreathing valve)
Bag filling up
Squeeze bag
Compression

Basic principle 5
1.3 Special Features of the COMBIBAG
COMBIBAG, the first manual resuscitator
with segmental division for adults and chil-
dren.
Hitherto, at least 2 resuscitation bags were required to
ventilate patients of all age groups, a child resuscita-
tion bag and a large adult resuscitation bag.
Now the special design featuring the COMBIBAG
covers both functions. The bag is divided into two seg-
ments (one large and one small) by two longitudinal
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.
COMBIBAG, the first manual resuscitator
with a 2-stage safety valve.
By now, pressure relief as a function of the variable
risks present in ventilation via face mask or endotrache-
al tube remained unsolved.
The majority of manual resuscitators only have a pres-
sure limit at 50 - 60 mbar (50 - 60 cm H2O), a rea-
sonable limit adapted to healthy lung conditions.
With use of manual resuscitators and face mask venti-
lation 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
••••
••••

6Basic principle
20 mbar resulting in regurgitation with following api-
ration. Moreover, there is the risk with ventilation of
children independant 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 (20 cm H2O) for mask resuscitation
child ventilation and
• one of 60 mbar (60 cm H2O) for resuscitation via
an endotracheal tube with adults.
Hazards in ventilating non intubated patients
•7•U•D•F•K•H•D
pressure > 20cm H2O
pressure < 20cm H2O !! !! effect
stomach
contens of
the stomach
diaphragm
lungs
esophagus
trachea

Description of the resuscitator 7
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 en-
dotracheal tube connector(diameter 22/15 mm)
• valve diaphragm for separating inspiration and
expiration
• safety valve (pressure-relief valve).
Safety valve
The safety valve (pressure-relief valve) consists of:
• the valve body with valve fittings and
• white pressure marks (20 and 60 mbar/cm H2O)
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, replacement
is possible only with delivery of a complete unit. Re-
moval of the safety valve is not permitted.
Patient valve (non-re-
breathing walve)
Safety valve
Squeeze bag
(compressable
unit)
Intake valve

8Description of the resuscitator
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 cor-
responding 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 form-
ing 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 oper-
ating instructions are the basis for proper use of the
COMBIBAG. The instrument is just determined for
the field of use stated.
• Malfunctions and a lack of biocompatibility may re-
sult if third-party articles are used. Please bear in
mind that in these cases any warranty entitlement
and liability shall lapse where the accessories rec-
ommended in the instructions for use or original
spare parts are not utilised.
• To prevent infection or bacterial contamination,
please observe section “5. Hygienic preparation”
on page 15.
•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 experienced
personell trained in resuscitation and well acquaint-
ed with the instrument.
• In operation with oxygen it is imperative that smok-
ing and open fire around the oxygen fittings is strict-
ly 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.
• More copies of this operating instructions are avail-
able from the manufacturer WEINMANN.

10 Operating instructions
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 spon-
taneous breathing. This ensures that all forms of hy-
poventilation, 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 re-
lief 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.

Operating instructions 11
• Relief valve setting 20 mbar (20 cm H2O): on clos-
ing the inhalation passage with the ball of the left
thumb and squeezing the bag with the right hand,
air flows through the relief valve openings.
• Relief valve setting 60 mbar (60 cm H2O): on clos-
ing the inhalation passage with the ball of the left
thumb, the bag can only be squeezed under con-
siderable pressure and air escapes more slowly
and quietly than at the 20 mbar pressure setting.
4.3 Guide values for ventilation
When carrying out artificial ventilation with resuscita-
tors without adjustable frequency and tidal volume (un-
less additional measuring instruments such as pressure
gauges or volumeters are employed), success of the
procedure can only be judged from indirect signs, such
as clearly visible thorax movements, disappearance of
cyanosis, reduction in pallor, etc. Because of this, cer-
tain guide values should be noted after commencing re-
suscitation, in which, as a rule, some degree of
hyperventi-lation is desirable. This is important since,
with prolonged resuscitation, inadequate ventilation
(hypoventilation) leads to considerable damage and
ventilation with too high frequency and excessive tidal
volume (hyperventilation) also has serious drawbacks.
Ventilation must be carried out if spontaneous breath-
ing cannot be established once the airways are
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

12 Operating instructions
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 up-
wards (pressure limit 20 mbar/cm H2O)
• C-grip: left hand lifts the lower jaw back and seals
the mask over the mouth and nose
• rhythmically squeeze and release the appropriate
segment (adult and infant) at the recommended fre-
quency
• 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/cm H2O) in excep-
tional cases only, where adequate ventilation still
cannot be achieved. However, inflation of the stom-
ach is not then excluded and must be considered!
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:

Operating instructions 13
• Intubation
• Press the red ring on the COMBIBAG relief valve
downwards (pressure limit 60 mbar/cm H2O)
• Even with ventilation via an endotrachel tube, one
should aim for a pressure limit of 20 mbar/cm H2O
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% oxy-
gen may be indicated, since oxygen deficiency often
has to be reckoned with at the first supply phase. Any
oxygen concentration can be administered with the
COMBIBAG resuscitator. Oxygen concentrations up
to 48% can be administered directly via the oxygen
socket on the intake connection. If a higher concentra-
tion of oxygen is to be administered, an oxygen reser-
voir or a demand valve can be used.
Connect corrugated hose
• Fit the oxygen reservoir into the cone on the intake
socket and
• push the oxygen connecting tube onto the connec-
tor 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.

14 Operating instructions
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 pro-
longed manual resuscitation with the COMBIBAG, a
volumeter for measuring the expired gas volume can
be connected to the expiration branch of the patient
valve.
4.9 Use of HME-Filters
For hygienical reasons and for climatizing the breath-
ing air, the inspiratory branch of the patient valve can
be fitted with commercial 15/22 mm standard cone
HME-filters (heat and moisture exchanger). This insig-
nificantly increases the inspiratory as well as the expi-
ratory 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 instructions” on page 9.

Hygienic preparation 15
5. Hygienic preparation
COMBIBAG should undergo hygienic purification af-
ter 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 under
running water. For cleaning purposes, take apart the
bag, separating the pieces into components as de-
scribed.
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 suit-
able for rubber and polysulfone. Be sure to observe the
instructions for the disinfectant. We recommend
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.
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 cover
with holding ring

16 Hygienic preparation
5.1 Cleaning during use
Should the valve become blocked as a result of regur-
gitation, 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 Check-
ing the function” on page 10).
5.2 Maintenance and service
With proper use and maintenance of the COMBIBAG
no additional service is required. Just the intake dia-
phragm should be examined once a year. The dia-
phragm 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 car-
ried out according to Pt. “4.2 Checking the function”.

Spare parts 17
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 16009
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 16009
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 16009

18 Spare parts
*See illustration on page 21.
6.2 Accessories
*See illustration on page 21.
The following combination units with adapter are
available for WEINMANN 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 16009
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 (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

Spare parts 19
*See illustration on page 21.
6.3 Spare parts
For COMBIBAG
Ventilation mask, all-in-one, silicone
– Size 5
– Size 4
– Size 3
– Size 2
– Size 1
– Size 0
WM 5084
WM 5085
WM 5083
WM 5092
WM 5091
WM 5090
21
20
19
18
Rendell-Baker ventilation mask, silicone:
– Children, Size 3
– Children, Size 2
– Small children, Size 1
– Babies, Size 0
WM 5063
WM 5062
WM 5061
WM 5060
21
20
19
18
Set of Rendell-Baker ventilation masks, silicone,
consisting of 1 ventilation mask each
– for children from 3-12 years (WM 5063),
– for children from 1-3 years (WM 5062),
– for small children up to one year old
(WM 5061),
– for infants (WM 5060)
WM 15482
Set of oropharyngeal tubes (Guedel type)
consisting of 1 tube each
– for adults, Size 3,
– for young people, Size 2,
– for children, Size 1,
– for small children, Size 0,
– for infants, Size 000
WM 15483
Item no.* Description of component Order no.
Item no.* Description of component Order no.
COMBIBAG resuscitation bag for adults and
children WM 11000
Cord ring, Ø 42 mm (old suspension ring) WM 1145/43
1Suspension ring, new, Ø 60 mm WM 1145/49

20 Spare parts
*See illustration on page 21.
For ventilation masks
Seal 30/35 x 0.5 mm WM 1145/82
5Bellows WM 11001
Valve housing WM 11002
6– 12 Ventilation valve, without safety valve WM 11003
Guide stub WM 11004
Valve element WM 11006
Valve insert WM 11007
4Inlet membrane WM 11008
2Intake stub, inner part WM 11021
3Intake stub, outer part WM 11022
13 2-stage safety valve WM 11030
6– 13 Ventilation valve, complete WM 11035
Disk spring WM 11043
Intake stub with inlet membrane WM 11051
Adapter for OXYMAND demand valve, 17 mm
internal diameter, 24 mm external diameter WM 22169
Lockring 30 x 1.5 mm WM 50455
Item no.* Description of component Order no.
Description of component Order no.
Mask binding ring
(for WM 5074 and WM 5082) WM 11073
Sealing plug
(for WM 5074, WM 5082, WM 5086) WM 11074
Inflatable silicone mask cushion
(for WM 5074) WM 11086
Inflatable silicone mask cushion
(for WM 5082) WM 11087
Inflatable silicone mask cushion
(for WM 5086) WM 11088
Mask body (for WM 5074) WM 11097
Mask body (for WM 5082) WM 11098
Mask body (for WM 5086) WM 11099