Ambu Mark IV User manual

English 3
1. Warnings and cautions
WARNINGS
• Insufficient, reduced or lack of ventilation may lead to brain
damage in the ventilated patient.
• Should only be used by personnel trained in performing resusci-
tation. It is important to obtain a tight seal between the face and
the mask. Otherwise, this may cause reduced ventilation or no
ventilation. Make sure that such personnel are made familiar
with the contents of these instructions for use.
• Watch the movement of the chest, and listen for the expiratory
flow from the valve to check the efficiency of the ventilation.
Failure to do so may result in insufficient ventilation.
• Switch IMMEDIATELY to mouth-to-nose or mouth-to-mouth ven-
tilation in accordance with local guidelines if efficient ventilation
cannot be obtained with the device. Failure to do so may result
in insufficient ventilation.
• Do not smoke or use open flames when using oxygen - fire may
result.
• Do not use the resuscitator in toxic or hazardous atmospheres as
this may harm the patient. See Section 5.4 for further details.
• Once the override cap has been mounted on the pressure-limit-
ing valve and the whole hand is used for compressing the Ambu
Mark IV Baby resuscitator, the pressure-limiting outer cover is
prevented from expanding, meaning that in case of extremely
heavy compression, a pressure as high as 8-10 kPa (80-100
cmH2O) is created in patients with low lung compliance.
CAUTIONS
• According to US federal regulations, this product may only be
sold by or on the order of a physician (only applies in the USA
and Canada).
• It is important to check that all parts of the resuscitator are in
good condition, that it is properly assembled, and that a com-
plete functional test is carried out every time the device has been
disassembled - also before the initial use.
• This functional test, which is described in chapter 8.1, should
also be carried out every time the device is taken into use. Check
of correct function of the pressure-limiting valve according to
Section 8.2 should also be performed immediately before use.
• If the resuscitator and its accessories are kept on standby for
emergency situations, the entire equipment should be checked
regularly to ensure that it is functional.
• Avoid the use of or contact with oil or grease as they may dam-
age the materials of the resuscitator. In case of contact, the sur-
face must be thoroughly cleaned.
• Do not use oil or grease in close proximity to oxygen equipment
- fire may result.
• Do not force the outer cover of the bag to bulge locally by clos-
ing the patient connector and pressing the bag so hard with
your hand that a local bulge appears on the outer cover - this
has an extreme impact on the material.
• The tube connector may only be used for pressure monitoring.
The cap must always be put on the connector when pressure
monitoring does not take place.

2. Application
The Ambu Mark IV Baby resuscitator, is intended for pul-
monary resuscitation of neonates, infants and children with a body
weight of up to 20 kg, approx. 4-5 years.
3. Specifications
The Ambu Mark IV Baby resuscitator complies with the follow-
ing standards:
ASTM F 920-93 and EN ISO 10651-4:2002.
The Ambu Mark IV Baby resuscitator is in conformity with
Directive 93/42/EEC concerning medical devices.
Application: Neonates, infants and children with a body weight
of up to 20 kg, approx. 4-5 years.
Max. volume delivered: Approx. 300 ml
Length x bag diameter with patient valve: 265 mm x 85 mm
Weight of resuscitator with patient valve (without mask):
190 g
Max. frequency of ventilation: Depends on the tidal volume
used. The expansion rate of the bag is more than sufficient for
all practically applicable frequencies.
Patient connector: 22/15 mm (ISO)
Expiratory connector (for PEEP valve connection):
30 mm male (Ambu specified)
Dead volume: < 6 ml
Leaks (both ways): Non-measurable
Inspiratory resistance (with or without oxygen reservoir tube):
At 50 l/min: approx. 0.42 kPa (-4.2 cmH2O)
At 5 l/min: approx. 0.05 kPa ( 0.5 cmH2O)
Pressure-limiting valve:
Opening pressure: approx. 4 kPa (40 cmH2O)
Maximum attainable delivery pressure with compliance of
0.01 l/kPa when the pressure limiting valve is overridden:
approx. 11.5 kPa (115 cmH2O).
Expiratory resistance:
At 50 l/min: approx. 0.45 kPa (4.5 cmH2O)
At 5 l/min: approx. 0.06 kPa (0.6 cmH2O)
Oxygen reservoir tube:
Length: 250 mm
Volume: 100 ml
Oxygen reservoir bag:
Inspiratory resistance:
With 50 l/min: approx. 0.1 kPa (1.0 cmH2O)
With 5 l/min.: approx. 0.01 kPa (0.1 cmH2O)
Volume: approx. 1500 ml
Application temperature: -18°C to 50°C (0°F to 122°F)
Storage temperature: -40°C to 70°C (-40°F to 158°F)
Parts / Materials
Inner bag Silicone rubber
Outer cover Silicone rubber
Patient valve housing PSU
O-ring (internal part of
patient connector) Silicone rubber
Patientconnector PSU
Pressure-limiting valve PSU/stainless steel
Override cap Silicone rubber
Expirations connector Reinforced PP
Cap for manometer port PP/EPDM rubber
0086
4 English

English 5
Inlet valve housing POM
Screw cap (two parts) POM
Reservoir tube PE
Valve discs Silicone rubber
Ambu mask shell PSU
Ambu mask 0A edge Chloroprene with sealed
foam inner lining
Ambu mask 0 edge Silicone rubber
Rendell-Baker mask Rubber
Hanging strap Silicone rubber
Nameplate Aluminium
Window with snap fastener PSU
Oxygen reservoir bag
(optional accessory) PES/TPU
Reservoir housing incl. cap and
screw cap (optional accessory) POM/Reinforced PP
Adapter Silicone rubber
Connector POM
4. Operating principles
Qshows how the ventilation air flows into the resuscitator and to
and from the patient during manual ventilation as well as when
the patient respires spontaneously. Qshows the operating princi-
ple of using an open reservoir tube 1.7 and oxygen reservoir bag
(optional) 1.8.
O2reservoir system: During compression of the resuscitator, oxy-
gen flows through the O2connector into the reservoir. When the
resuscitator is released, oxygen is drawn from the reservoir into the
resuscitator itself.
Q1.1: Pressure-limiting valve, 1.2: Air, 1.3: Excess oxygen,
1.4: Oxygen in, 1.5: Patient, 1.6: Expiratory.
The valve disc guide pin in the patient valve is a visible indicator of
correct functioning of the unit. The user should always - before as
well as during use - check that the valve guide moves forward on
inspiration and backward on expiration. See W.
W2.1: Guide pin (forward), 2.2: Insufflation or spontaneous inspi-
ration, 2.3: Guide pin (backward), 2.4: Expiration
5. Instructions for use
5.1. Ventilation with face mask
Clean mouth and airways using recommended techniques.
Use approved techniques for placing the patient's head, obtaining
the correct head position for open airways. Place the mask so that
it makes an airtight fit with the patient's face. Hold the mask firm-
ly against the face while maintaining correct tilting of the head
backward for the airways to be kept open.
WARNING
It is very important to practice correct application of the face mask
before any attempt is made to use the resuscitator. Otherwise, the
result may be no or reduced airflow.
Squeeze the bag with the tip of your fingers.
While insufflating, check that the patient's chest rises. See E.
Loosen the grip on the bag. Listen for the expiratory air from the
patient valve, and watch the chest lowering. See E. Check at the
same time whether the valve disc guide pins are moving in the
transparent valve housing. If you feel constant resistance against
the insufflation, check for blocked airways, or check the head's
backward-tilted position.

6 English
The correct ventilation frequency may vary. Follow the current
nationally or internationally recommended ventilation frequencies.
A pressure gauge can be connected to the tube connector on the
side of the patient valve for monitoring the ventilation pressure.
Remove the cap and connect the tube from the pressure gauge.
See T.
WARNING
The tube connector may only be used for pressure monitoring. The
cap must always be put on the connector when pressure monitoring
does not take place.
In case of the patient vomiting under mask ventilation, the
patient's airways must be immediately cleared of vomit. Squeeze
the bag freely a few times without the mask being in contact with
the face. Check that insufflation and expiration are unhindered.
The patient valve can be disassembled and cleaned if large vol-
umes of vomit block the free airflow in the valve.
Perform functional test, see Section 8.1.
Administer oxygen according to medical indications. See Sections
5.3 and 5.4.
5.2. Pressure limitation - see U
The patient valve is fitted with a pressure-limiting valve, which
opens when the pressure in the valve reaches approx. 4.0 kPa
(40 cmH2O). This happens if the neonate's lungs are excessively
full, the insufflation is too powerful or the airways are blocked.
When the pressure-limiting valve opens, excess ventilation air is
released into the atmosphere.
If a pressure above 4.0 kPa (40 cmH2O) is required, the pressure-
limiting valve can be overridden by pressing the override cap 7.3
onto the pressure-limiting valve. 7.1 shows the patient valve with
the override cap off. 7.2 shows the patient valve with the override
cap on. Mark IV Baby is supplied with the closing cap off.
The insufflation pressure can be fairly precisely controlled via the
number of fingers used to compress the bag, see (4).
By using a tracheal catheter immersed in water you can get a
sense of the feel of the insufflation pressure through the thin outer
cover, see Y.
WARNING
The pressure-limiting valve must never be overridden, unless a
medical and professional evaluation indicates the necessity. High
ventilation pressures may cause lung rupture in certain patients.

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5.3. Oxygen enrichment - see
I
Administer oxygen according to medical indications.
I8.1: Oxygen connector (6 mm - this opening may only be
occluded if a closed reservoir is mounted using an adapter),
8.2: Inlet connector (this opening may never be occluded),
8.3: Oxygen reservoir tube, 8.4: Adapter,
8.5: Oxygen reservoir bag, 8.6: Oxygen connector on oxygen
reservoir bag (6 mm).
Oxygen enrichment is performed by connecting the oxygen supply
tube to the connector on the back of the inlet valve and connect-
ing the oxygen reservoir tube to the inlet connector.
When using the oxygen reservoir bag, use an adapter. Place the
adapter over the inlet connector and close the oxygen connector
using the cap (see O). Oxygen supply takes place through the
oxygen connector on the reservoir housing. Obtainable oxygen
concentrations using an oxygen reservoir bag are as minimum
what can be obtained by using the oxygen reservoir tube, see {.
Oxygen enrichment of the inspiratory air in case of spon-
taneous respiration
• Without an oxygen reservoir tube:
Attach a mask to the resuscitator, set the oxygen flow to
between 2 and 4 l/min, and place the mask over the child's
mouth and nose, creating an airtight seal. If the spontaneous
respiration is sufficient, an oxygen concentration close to 100%
will be obtained.
• With an oxygen reservoir tube:
The end of the resuscitator with the oxygen reservoir tube that
normally faces away from the patient can also be used for oxy-
gen enrichment of the inspiratory air in case of spontaneous res-
piration. Again, the oxygen flow should be set to between 2 and
4 l/min, and the free end of the oxygen reservoir tube (1.3)
should be held as tightly as possible against the child's head.
Again, the oxygen concentration will be very close to 100% at
the end of the tube. Depending on the distance between the
reservoir tube and the child's head, there will be significantly
more or less inhalation of atmospheric air, and thus lower oxygen
concentrations should be expected.
5.4. Oxygen concentrations - see {
In case of controlled ventilation, the inspiratory oxygen concentra-
tion depends on frequency and tidal volume. The oxygen concen-
tration which is normally desirable (of 30-50%) can usually be
obtained without oxygen reservoir. If higher concentrations are
indicated, the oxygen reservoir must be connected to the bag's
inlet valve.
Examples of oxygen concentration that can be obtained using an
oxygen reservoir at different volumes and frequencies, are shown
in {.
A simplified table is printed in the oxygen reservoir bag for fast
guidance (see P). The oxygen concentrations indicated are
obtained as a minimum as long as the minute ventilation is equal
to or less than 300 x 20 = 6 l/min.
Example:
Administer 2 l/min of oxygen through the inlet of the oxygen
reservoir bag. With a tidal volume of max. 300 ml and a compres-
sion frequency of max. 20 per minute, a child receives an oxygen
concentration of at least 40%.

8 English
6. Description
The Ambu Mark IV Baby resuscitator is based on the original
Ambu double wall principle which transfers the ventilation pres-
sure directly to operator's fingers. During normal operation, the
outer cover expands, and the airway pressure is thereby limited to
approx. 4.5 kPa (45 cmH2O).
The Ambu Mark IV Baby consists of the following main parts:
resuscitator bag 12.1, patient valve 12.2, inlet valve 12.3, reservoir
tube 12.4 or closed reservoir 12.5 with adapter. Mask, tubes and
PEEP 10 valve are accessories, see }.
6.1. Bag - see q
The Ambu Mark IV Baby resuscitator is designed in accordance
with the original Ambu double wall principle. The resuscitator bag
consists of a self-expanding inner bag made from shaped silicone
rubber with a thin-walled outer cover, which fits airtight around
the outlet connectors.
The outer cover is made from highly resilient silicone rubber which
expands in operation and thus reduces the risk of creating danger-
ously high pressures in the patient's airways. The bag is provided
with a hanging strap with nameplate (see q). The plate can be
stamped or engraved.
13.1: Connector, 13.2: Outer cover, 13.3: Inner bag, 13.4: Inlet
valve, 13.5: Hanging strap incl. a window with a snap fastener,
13.6: Nameplate, 13.7: Outlet connector.
6.2. Patient valve - see w
The function of the valve is described in Section 4.
w14.1: 30 mm expiratory male connector, 14.2: valve disc,
14.3: 22/15 mm patient connector, 14.4: manometer port
6.3. Inlet valve - see e
The inlet valve has an oxygen tube connector and connection for
standard 22 mm open reservoir tube.
e15.1: Oxygen tube connector for tubes with inside diameter of
6 mm, 15.1: To be closed by adapter when using oxygen reser-
voir bag, 15.2: connection for reservoir tube.
6.4. Masks - see r
The Ambu Baby resuscitator can be supplied with one or more of
the masks below, as desired.
Ambu mask 0A with transparent shell (16.1) and removable,
extremely soft mask bead made from rubber with a sealed foam
inner lining. Connection cone: 15 mm ISO. Dead volume: approx.
25 ml.
Rendell-Baker mask in black rubber (16.2). Connection for 22 mm
ISO patient connector.
Size: 0: Dead volume: approx. 4 ml
Size: 1: Dead volume: approx. 6 ml
Other mask types can be supplied as accessories.
6.5. Oxygen reservoir bag (optional) - see t
The oxygen reservoir bag (17.12) is connected to a reservoir hous-
ing (17.10) with cap (17.11), which fits the inlet valve connector
on the resuscitator using an adapter (17.9).
The valve has two silicone rubber valve discs that enable intake of
external air when the bag is empty, and discharge of excess oxy-
gen when the bag is full.

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7. Cleaning - disinfection - sterilisation
tshows the resuscitator disassembled for cleaning, disinfection
and sterilisation purposes.
Note: The parts should not be further disassembled than shown in
the picture.
Clean - disinfect - sterilise after each patient or in accordance
with local procedures.
t17.1: Patient valve, 17.2: 0A mask, 17.3: Rendell-Baker mask,
17.4: Inner lining, outer cover and connector, 17.5: Inlet valve,
17.6: Reservoir tube, 17.7: Oxygen reservoir bag and adapter,
17.8: Oxygen supply tube.
Clean - disinfect - sterilise the entire resuscitator equipment
after use on patients or in environments containing infec-
tious diseases.
Applicable
methods
●Applicable
❍Not applicable
Parts
17.1 ●●●●●●●
17.2 ●❍❍❍●❍❍
17.3 ●●●●●●●
17.4 ●●●●●●●
17.5 ●●●●●●●
17.6 ❍❍❍❍●❍❍
17.7 ●●●●●●●
17.8 ●●●●●●●
Manual
washing Washing machine Heat disinfection Boiling Chemical 121°C
(250°F) 134°C (273°F)
Cleaning Disinfection - sterilisation
Washing Disinfection Autoclaving

10 English
Detergents and chemical disinfectants
There are a wide range of detergents and chemical disinfectants
available on the market. Use only detergents or chemical disinfec-
tants that are compatible with the materials of the resuscitator.
Otherwise, the life of the equipment may be reduced. See the
materials list in Section 3. Follow the manufacturer's guidelines for
dilution and exposure time of the detergent or the chemical disin-
fectant. Agents containing phenol should be avoided.
On request, information on the compatibility of a selection of
detergents and chemical disinfectants with the materials of the
resuscitator is provided by the nearest Ambus dealer or Ambu A/S.
Note: Avoid cleaning the product with agents containing phenol.
Phenol causes rapid wear and deterioration of the materials or a
reduced life of the equipment.
Note: Immediately remove all detergent or disinfectant residues
from the resuscitator. These residues may result in rapid wear or a
reduced life of the device.
Cleaning, disinfection and sterilisation procedure
The following items should be followed. Use the table to select
methods that are appropriate for the individual parts.
7.1. Disassembly of the resuscitator
The resuscitator must always be disassembled before cleaning as
shown in t.
Note: Do not attempt to disassemble the outlet connector from
the inner bag (permanently assembled).
Note: The parts should not be further disassembled than shown in
the picture. See tfor further information.
Note: To remove the outer cover of the bag, first unscrew the inlet
valve cap. Then roll off the valve housing with the inlet valve disc,
see y.
Snap the connector off the inner lining and expand the outer
cover at the back, pulling the inner lining out while the bead in
front is pulled over the snap cuff, see y.
Removing the strap u:
Disengage the strap at the back of the transparent nameplate
cover. Pull the cap over the strap and remove the nameplate. Pull
the strap through the slot.
Note: The parts should not be further disassembled than shown.
7.2. Cleaning of parts
Manual washing or automatic washing machine
Wash the parts in water using an appropriate detergent in accor-
dance with the materials list in Section 3. Rinse all parts
thoroughly in clean water to remove all detergent residues.
If the exterior faces of the resuscitator bag are to be cleaned
and/or disinfected, check that the detergent and/or disinfectant
used is compatible with the materials of the resuscitator. Make
sure that all residues are removed completely by rinsing with clean
water. Otherwise, the life of the materials can be significantly
reduced.
An automatic dishwasher with a programme for washing anaes-
thetics equipment is applicable.

English 11
7.3. Disinfection and/or sterilisation
Select heat treatment or chemical disinfection according to local
practice for disinfection and the table of applicable methods.
Washing machine - heat disinfection programme: Automatic
washing machines designed for medical equipment are usually
equipped with heat disinfection programmes.
Boiling: Use clean water. Heat the parts, and boil them for 10
minutes to disinfect them.
Chemical disinfection (e.g. Cidex, chemicals with sodium
hypochlorite etc.): Follow the disinfectant manufacturer's guide-
lines for dilution and exposure time. Rinse all parts thoroughly in
clean water to remove all disinfectant residues.
Note: As it is very difficult to thoroughly clean the oxygen reservoir
bag, it is recommended not to immerse it in chemical disinfectants.
Autoclaving: Use standard autoclaving equipment set to 121°C
or 134°C (250°F or 273°F), respectively, for the individual parts of
the resuscitator according to the table above.
7.4. Drying and cooling
Let the parts dry and cool completely before the resuscitator is
reassembled.
7.5. Inspection of parts
After cleaning, disinfection and/or sterilisation, all parts must be
checked for damage or wear. Replace if necessary. Certain meth-
ods can lead to discolouring of rubber parts without affecting the
life of these parts. In case of onset of deterioration of the materi-
als, e.g. crack formation, the parts should be replaced.
In case of autoclaving, the oxygen reservoir bag can look slightly
wrinkled. This has no impact on its life or function.
7.6. Assembly and functional testing - see i
Press the inner bag firmly together while expanding the outer
cover opening and slide the inner bag into the outer cover. Snap
the outer cover bead over the snap cuff at the front of the inner
bag. Allow the inner bag to expand and pull the outer cover into
its correct position. Check that the outer cover is not inside out
(the lot no. on the outer cover must be on the outside). Also check
that the outlet connector is intact and positioned correctly. Snap
the connector in place at the front. Press the valve housing with
the valve discs into the inner bag and screw the inlet valve disc
back on.
Patient valve: Before assembling the patient valve, all parts -
especially the valve disc - should be checked. Assemble the patient
valve in reverse disassembly order.
When inserting the patient valve disc, check that the butt of the
pin goes through the hole in the middle of the patient valve hous-
ing, and then the expiration connector is screwed in.
Press the patient valve into the bag while turning it.
Perform test for correct function. See Section 8 of these directions
for use.
8. Functional test
8.1. Resuscitator
1) Connect an 0,5 l breathing bag to the patient connector.
Compress and release the resuscitator several times.
Squeeze and release the resuscitator repeatedly. Check that the
breathing bag is filled.
By continued ventilation, the breathing bag must be visibly filled
and emptied. See o.

12 English
8.2. Pressure-limiting valve
WARNING
Perform the test below immediately before every use of the resus-
citator. Otherwise, the result may be no or reduced airflow.
1) Close the pressure-limiting valve with the locking cap and the
patient connector with the thumb, while squeezing the resusci-
tator to check for tightness and proper valve fitting, see p.
2) Open the pressure-limiting valve by removing the locking cap,
and repeat the procedure. The pressure-limiting valve should
now be activated, and it should be possible to hear the expira-
tory flow from the valve.
8.3. Oxygen reservoir system
Reservoir tube:
Set a flow of approx. 5 l/min through the oxygen supply tube.
Check that the oxygen flows out at the end of the reservoir tube.
If not, check for a blocked oxygen tube.
Oxygen reservoir bag:
Set a flow of approx. 5 l/min, occlude the patient connector on
the patient valve and check that the reservoir bag unfolds. Shut
the flow. Compress the oxygen reservoir bag and check that the
gas leaks unhindered through the holes in the pressure-limiting
valve.
9. Service
The Ambu Mark IV Baby resuscitator requires no scheduled main-
tenance other than regular cleaning, inspection and testing.
It is recommended to thoroughly check all parts after disassembly
for cleaning, disinfection or sterilisation.
If any parts are missing or defective, spare parts are available (see
the list in Section 11).
Note: The Ambu Mark IV Baby resuscitator must be checked for
correct function in accordance with these instructions for use
before being released for use again (see Section 8).
10. Storage
The Ambu Mark IV Baby resuscitator should not be exposed to
direct sunlight or elevated temperatures during storage.
Never store the resuscitator in close proximity to products contain-
ing oil or grease.
Storage temperature: -40°C to 70°C (40°F to 158°F).
Note: Never squeeze the bag too hard on storage.
In case of long-term storage, the resuscitator should be packed
away in a cool place away from direct sunlight.