Mark III Instructions for Use V04 Feb 2018

1. Warning and caution statements WARNING

CAUTION

• Insufficient, reduced, or no airflow may result in brain damage to the patient being ventilated.

• U.S. federal law restricts this device to sale by or on the order of a physician.

• For use by CPR-trained personnel only. A tight seal between face and mask is essential. Failure to achieve atight seal may result in reduced or no ventilation. Make sure that the personnel are made familiar with the contents of this manual.

• Following unpacking and any disassembly of the resuscitator it is important to check that all parts are in perfect condition and then to reassemble them correctly. A complete test for correct operation should be performed before use or storage of the resuscitator.

• Watch the movement of the chest and listen for the expiratory airflow from the valve to check the efficiency of the ventilation. Failure to do so may result in insufficient ventilation. • IMMEDIATELY switch to mouth-to nose or mouth-to mouth ventilation according to local recommendations if efficient ventilation cannot be obtained with this device. Failure to do so may result in insufficient ventilation. • Do not smoke or use near open flames when using oxygen. Fire may result. • Do not use the resuscitator in a toxic or hazardous atmosphere unless a gas filter is connected to the inlet valve of the bag. Injury may result. See section 5.4 for details.

• The check for correct operation, according to section 8.1 3), should also be performed immediately prior to use. • If the resuscitator with attachments is placed on standby for emergency use, such kit should be inspected at regular intervals to assure integrity. • Avoid contact with oil and grease. Such products may affect the integrity of the resuscitator materials. In case of exposure, clean thoroughly. • Oil or grease should not be used in close proximity to oxygen equipment - fire may result.

9

2. Intended use

The Ambu® Mark III resuscitator is intended for pulmonary resuscitation of adults and children with a body weight of more than approx. 15 kg (3 years old).

3. Specifications The Ambu Mark III resuscitator is in conformity with the product specific standard EN ISO 10651-4. The Ambu Mark III resuscitator is in conformity with Council Directive 93/42/EEC concerning Medical Devices

Inspiratory resistance:

≤ 0.39 kPa (3.9 cm H2O) at 50 l/min

Inspiratory resistance of oxygen reservoir bag:

≤ 0.25kPa (2.5 cm H2O) at 50 l/min without inlet of oxygen

Pressure limitation systeme**:

The elasticity of the outer cover will limit airway pressure to max. approx. 7 kpa (70 cm H2O) during one hand compression

Expiratory resistance at 50 l/min:

Resuscitator volume:

Approx. 1850 ml

≤ 0.37 kPa (3.7 cm H2O)

Volume of oxygen reservoir bag:

Approx. 1500 ml

Delivered volume one hand*:

600 ml

Operating temperature range:

Delivered volume two hands*:

1100 ml

-18 °C to 50 °C (-0.4 °F to 122 °F)

Dimensions (length x diameter) w/o reservoir and accessory:

300mm x 125mm (11.8 in. X4.9 in.)

Storage temperature range:

Tested at - 40 °C (-40 °F) and +60 °C (140 °F) according to EN ISO10651-4

Weight w/o reservoir and accessory:

Approx. 357 g

Patient connector:

Outside 22 mm male (ISO 5356-1) Inside 15 mm female (ISO 5356-1)

Expiratory connector:

30 mm male (ISO 5356-1)

Bag inlet connector:

(EN ISO 10651-4) 32 mm female taper for attachment of Ambu O2 reservoir bag or ISO bag refill valve

Dead space:

≤ 5ml + 10 % of the deivered volume

Forward and backward leakage:

Not measurable

10

* Tested according to EN ISO 10651-4

Parts / Materials Inner bag Outer cover of bag Valves, transparent plastic parts Valves, non transparent plastic parts Valve bellows and membranes Gas filter adapter (Option) Oxygen reservoir bag (Option) Connector for reservoir

EPDM rubber Chloroprene rubber Polysulphone Polyacetal Silicone rubber Polyacetal Coated nylon material Polyacetal

Hanging strap Oxygen supply tubing (Option) Tube adapter (Option) Extension tube (Option)

EPDM rubber EPDM rubber Polyacetal EPDM rubber

patient valve via the membrane (3.1) to the patient. During spontaneous inspiration the expiratory membrane (3.4) is closed so that all inspiratory gas passes through the bag. Expiration follows as described above.

4. Principles of operation

5. Operating instructions

When the bag is compressed, the airflow forces the membrane (1.1) of the patient valve to open. The mushroom bellows (1.2) is forced towards the seat (1.3), closing the passage to the expiratory port. The air now flows via the patient connector to the lungs of the patient. The positive pressure created in the bag keeps the bag inlet valve (1.5) closed.

Clear mouth and airway of foreign bodies, if any visible. Use recommended techniques to position the patient correctly to open the airways. Apply the mask firmly to the patient’s face to achieve a tight seal. Hold the mask tight against the face while maintaining the correct head tilt to keep the airway open.

4.1 lnsufflation – see Q

4.2 Expiration – see W The valve membrane (2.1) is already closed when insufflation ceases and prevents back flow into the bag. The mushroom bellows (2.2) moves away from the seat (2.3) and allows the expired air to pass out through the expiratory port via the expiratory membrane (2.4). The negative pressure created in the bag during expansion opens the bag inlet valve (2.5) and allows fresh air to be drawn in. The ventilation air can be enriched with oxygen, which is supplied via the tube nipple (2.6), the reservoir bag attachment or the gas filter adapter.

4.3 Spontaneous breathing – see E During the patient’s inspiration, fresh air or oxygen-enriched air is drawn in via the bag inlet valve (3.5) and O2 nipple (3.6) through the

5.1. Ventilation with a face mask – see R

WARNING Proper training on the correct application of the facemask is crucial before attempted use of any resuscitator. Failure to do so may result in no or reduced airflow. Squeeze the bag with one hand. During insufflation observe the rise of the patient's chest. Release the bag abruptly, listen for the expiratory flow from the patient valve and observe lowering of the chest. If continued resistance to insufflation is encountered, check for airway obstruction or correct the backward head tilt. The correct ventilation frequency may vary. Please follow the current ventilation frequency recommended by national or international guidelines. If the patient vomits during mask ventilation, immediately clear the patient’s airways of vomitus, then freely compress the bag a few times before resuming ventilation.

11

Check that inflation and expiration occur without obstruction. Usually it is not necessary to disassemble the valve immediately for cleaning. If the valve is disassembled and cleaned, be sure to perform a pre-operation test before continuing ventilation. (See section 8.1) Administer oxygen according to medical indications. See section 5.2 to 5.4.

5.2. Oxygen administration without reservoir – see T Supplementary oxygen can be administered by connecting the O2 nipple on the inlet valve to an oxygen flow meter. Examples of O2 percentages, which can be obtained with different volumes and frequencies, can be seen in Y. VT : Ventilation volume, f : Frequency

5.3. Oxygen administration with reservoir bag attachment – see U By connecting the oxygen reservoir bag attachment, optimal oxygen economy is obtained, and the ventilation gas will be 100 % O2 when the oxygen flow is equal to or greater than the minute ventilation. U 7.1: Filled, 7.2: Empty Examples of O2 percentages, which can be obtained with different volumes and frequencies, can be seen in I. VT : Ventilation volume, f : Frequency These values correspond to the theoretically possible, i.e. higher O2 concentrations cannot be reached. For quick reference a simplified chart is printed on the reservoir bag. See O. The indicated oxygen concentrations will be obtained and exceeded as long as the minute ventilation is equal to or less than 1000 x 15 = 15 l/min. and 300 x 20 = 6 l/min., respectively.

12

Examples Introduce an oxygen flow at 13 l/min. into the inlet of the reser­­­­­­­­­­­­v­oir bag attachment. With a ventilation volume of max. 1000 ml and a compression frequency of max. 15 per minute, an adult will receive an oxygen concentration of no less than 85 %. Introduce an oxygen flow at 2 l/min. into the inlet of the reservoir bag attachment. With a ventilation volume of max. 300 ml and a compression frequency of max. 20 per minute, a child will receive an oxygen concentration of no less than 40 %.

inlet valve housing (12.5 and 12.6) seals the large opening. A hanging strap (12.7) is attached to the inlet valve housing allowing the unit to be conveniently hung. The Ambu Mark III resuscitator is based on the original Ambu doublewall design principle. During single-hand operation of the bag the elasticity of the outer cover will prevent the airway pressure from rising above 7 kPa (70 cmH2O). This pressure limitation effect without loss of stroke volume is a unique feature of the Ambu Mark III resuscitator.

The O2 inlet of the gas filter adapter is equipped with a valve that prevents unfiltered air from entering the bag during ventilation when an O2 supply is not connected.

5.4. Oxygen administration with gas filter adapter and protective mask filter – see P

6.2. Patient valve – see q

Parts exposed to expiratory gases: Clean – disinfect – sterilise after each patient * t 17.1: Patient valve

Examples of O2 percentages, which can be obtained with different volumes and frequencies and with a gas filter attached to the resuscitator, can be seen in {. VT : Ventilation volume, f : Frequency

6. Description The basic Ambu Mark III resuscitator consists of the following parts: Bag with inlet valve and patient valve. Masks, oxygen reservoir bag attachment, gas filter adapter and PEEP valve are accessories, which make the Mark III resuscitator a most versatile resuscitation unit.

6.1. Bag – see } The bag consists of a self-expanding inner bag (12.4) made from EPDM moulded rubber. The thin-walled outer cover (12.2) has a large opening at one end to facilitate insertion and removal of the inner lining. The rigid neck section (12.1) at the opposite end of the outer cover makes an airtight fit with the outlet connector (12.3) of the bag and the flanged

The function of the valve is described in section 4. q 13.1: 30 mm ISO male expiratory connector for direct attachment of the Ambu PEEP valve, 13.2: 24 mm female inspiratory connector, 13.3: 22/15 ISO Patient connector

6.3. Inlet valve – see w w 14.1: Hanging strap, 14.2: Identification tag, 14.3: ISO 32 mm female connector for attaching O2 reservoir or gas filter adapter, 14.4: O2 inlet nipple for use when O2 reservoir or gas filter is not connected

6.4. Oxygen reservoir bag attachment (optional) – see e

7. Cleaning – disinfecting – sterilising t shows the resuscitator disassembled for cleaning, disinfecting and sterilising. Caution: Do not disassemble parts further than shown.

Parts not exposed to patient expiratory gases: Clean – disinfect – sterilise regularly as needed to remove dust etc. **

t 17.2: Bag, 17.3: Oxygen reservoir attachment, 17.4: Gas filter adapter, 17.5: Extension tube, 17.6: Oxygen supply tube

Clean – disinfect – sterilise the complete resuscitator after use for patients/environments with infectious diseases.

The O2 reservoir bag assembly consists of a lightweight air tight nylon bag attached to a valve connector, which fits into the inlet valve housing of the resuscitator. The valve connector contains two silicone rubber membranes, which allow ambient air to be drawn in when the bag is empty and surplus oxygen to spill out when the bag is full.

6.5. Gas filter adapter (optional) – see r 13

Cleaning

Applicable methods l applicable m not applicable

Washing

Disinfecting

Manual washing

Washing machine (W.M.)

W.M. heat disinfecting

Boiling

* 17.1

l

l

l

** 17.2

l

l

** 17.3

l

** 17.4

Autoclaving

7.2. Cleaning of parts

Chemical

121 °C (244 °F)

134 °C (273 °F)

l

l

l

l

l

l

l

l

l

m

m

m

m

m

m

l

l

l

l

l

l

l

** 17.5

l

l

l

l

l

l

l

** 17.6

l

l

l

l

l

l

l

Parts

Detergents and chemical disinfectants Numerous brands of detergents and chemical disinfectants are available. Use only brands that are compatible with the resuscitator materials to avoid reduction in the lifetime of the materials. See list of materials in section 3. Follow the instructions of the manufacturer of the detergent or chemical disinfectant for dilution and exposure time. Substances containing phenol should be avoided. Information on selected detergents and chemical disinfectants verified for compatibility with the resuscitator materials is available on request from the local Ambu representative or Ambu International A/S. Caution: Avoid using substances containing phenol to clean the product. Phenol will cause premature wear and degradation of the materials or reduced product life span.

14

Note: When the outlet connector of the inner bag is pressed into the outer cover, a clicking sound should be heard.

Disinfecting - sterilising

Caution: Promptly remove all residue of cleaning materials from the resuscitator. Residues may cause premature wear or reduced product life span.

The cleaning, disinfection and sterilising process The following steps are generally recommended. Select proper methods for the resuscitator parts in question according to the table above.

7.1. Disassembly of the resuscitator The resuscitator must always be disassembled for cleaning as shown in t. Caution: Do not disassemble parts further than shown. For further information, please refer to y.

Manual washing or automatic washing machine Wash the parts in warm water using a detergent suitable for the resuscitator materials. See section 3. Rinse all parts thoroughly in clean water to remove all detergent residues. If surface cleaning and/or disinfecting of the outer surfaces of the resuscitator are carried out, make sure that the detergent and/or disinfectant is compatible with the materials of the resuscitator and be sure to remove the detergent/disinfectant by rinsing with water. If residues are allowed to dry on the resuscitator, the lifetime of the materials may be reduced. An automatic washing machine with a programme designed for washing anaesthesia breathing equipment may be used.

7.3. Disinfecting and/or sterilising Select heated or chemical disinfection according to local standards for disinfection and the table of applicable methods. Washing machine – heat-disinfecting program: Automatic washing machines designed for medical equipment will normally include program cycles for heat disinfection. Boiling: Use clean water, heat and boil parts for e.g. 10 minutes to disinfect. Chemical disinfecting (Ex.: Cidex, chemical with sodium hypochlorite, etc.): Follow the instructions of the manufacturer of the chemical disinfectant for dilution and exposure time. After exposure of the resuscitator parts to the chemical disinfectant, rinse thoroughly in clean water to remove all residues. Note: Because it is very difficult to thoroughly rinse it afterwards it is not recommended to immerse the oxygen reservoir attachment in chemical disinfectants.

Autoclaving: Use standard autoclaving equipment adjusted for 121 °C (244 °F) or 134 °C (273 °F) respectively for resuscitator parts according to the table above.

7.4. Drying and cooling Leave the parts to dry and/or cool completely before reassembling the resuscitator.

7.5. Inspection of parts After cleaning, disinfecting and/or sterilising carefully inspect all parts for damage or excessive wear and replace if necessary. Some methods may cause discoloration of rubber parts without impact on their lifetime. In case of material deterioration e.g. cracking, the parts should be replaced.

7.6. Assembling and testing – see u When inserting the inner bag in the outer cover: Check that the connector is locked to the outer cover bushing (click function). When inserting the inlet valve housing: Make sure that the edge snaps into the groove of the flange. Carry out the test for correct operation. See section 8 of this manual.

8. Test for correct operation 8.1. Resuscitator

1. Connect a 1.5 – 2 litre breathing bag to the patient connector. Squeeze and release the resuscitator several times and check that the test bag fills.  During continued ventilation, expansion and relaxation of the test bag must be visible. See i.

15

2. Squeeze the resuscitator and hold. In this way a positive pressure should be created which remains in the test bag until the resuscitator is released.

WARNING Perform the test below immediately prior to each use of the resuscitator. Failure to do so may result in no or reduced ventilation. 3. Close the patient connector with one finger and compress the bag firmly to check tightness and proper valve fitting. See o.

8.2. Oxygen reservoir bag attachment Supply a gas flow of 3 l/min. to the inlet nipple. Close the outlet with one hand. The bag should now fill in approx. 20 seconds. See p. Close off the flow. Squeeze the bag and check that the gas is easily vented into the ambient air via the spill valve slots. See [.

9. Service The Ambu Mark III resuscitator requires no scheduled main­tenance other than regular cleaning, inspection and testing. Careful inspection of all parts is recommended after disassembly for cleaning, disinfecting or sterilising. If parts are lost or become defective, spare parts are available (see list in section 11). Caution: The resuscitator must be checked for proper operation according to this manual before being released for use again (see section 8).

16

10. Storage

12. Accessories – see S

For compact storage, e.g. in an emergency case, the inlet end can be pushed halfway into the bag as shown in ]. Caution: Never store the resuscitator in a compressed state other than folded as shown in ]. Caution: Never excessively squeeze the bag during storage. When the resuscitator is ready for use it should not be kept in direct sunlight or in a heated atmosphere. Storage temperature: Tested at - 40 °C (-40 °F) and +60 °C (140 °F) according to EN ISO10651-4. For long-term storage the resuscitator should be kept in closed packing in a cool place away from direct sunlight.

Cat. No. 230 000 001 000 137 000 000 213 000 209 000 701 209 000 702 209 000 703 000 059 274

11. Spare parts – see A Cat. No.

See

208 000 502 Patient valve housing with outlet valve 25.1 208 000 501 Patient inlet valve, complete 25.2 209 000 502 Outer cover, assembly 25.3 209 000 504 Inner bag with outlet connector 25.4 000 209 010 Inlet valve membrane 25.5 209 000 505 Inlet valve housing with membrane and strap 25.6 209 000 503 Flange nut 25.7 000 210 000 O2 reservoir, complete 25.8 000 208 000 Patient valve, complete 25.1-25.2 000 209 000 Bag, complete 25.3-25.7

000 059 276 000 210 000 000 211 000 000 171 004

 mbu Pack with transparent cover, A empty L x H x D: 350 x 280 x 140 mm Weight empty: 0.705 kg. PEEP 10 valve PEEP 20 valve Extension tube, length 30 cm, with 2 adapters. Extension tube, length 90 cm, with 2 adapters. Extension tube, length 105 cm, with 2 adapters. Tube adapter 28/32 mm, 28 mm female connector for fitting on inlet connector of the Mark III patient valve, 32 mm male connector for fitting on inlet valve of the Mark III bag Tube adapter 24 mm female for fitting on outlet connector of the Mark III bag O2 reservoir, complete Gas filter adapter (filter thread EN 148) Oxygen supply tube

See 26.1 26.3 26.4 26.5 26.6 26.7 26.8

26.9 26.10 26.11 26.12

WARNING By adding accessories, it may increase inspiratory and/or expiratory resistance. Do not attach accessories if increased breathing resistance would be detrimental for the patient.

17