Pneupac 2R Responder Users Manual Issue 5 April 2006

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2R Responder User's Manual Table Of Contents Page No.

SECTION 1: USER'S RESPONSIBILITIES... 5 (a) Summary Statement ... 5 (b) Warnings ... 8 (c) Cautions... 12 (d) Precautions ... 12 SECTION 2: GENERAL INFORMATION... 13 (a) Intended Use... 13 (b) General Description ... 13 (c) Contraindications ... 14 (d) Controls and Features (Figure 1)... 14 (e) Mounting Options ... 19 (f) Accessories ... 19 (i) Instant Action Case ... 19 (ii) Carrying Bracket ... 19 (iii) Gas Cylinders ... 19 (iv) Cylinder Regulators... 20 (v) Oxygen Therapy Unit ... 20 (vii) PEEP Valves (NOT to be used on CE units) ... 20 (viii) Clausen Harness and Hook Ring... 20 SECTION 3: SET-UP AND FUNCTIONAL CHECK... 23 SECTION 4: OPERATION... 29 (a) User's Skill ... 29 (b) Setting of the Responder ... 29 (i) General ... 30 (ii) Ventilating Patient ... 30 (c) Ventilating Intubated Patients ... 31 (d) Positive End Expiration Pressure (PEEP) -... 31 (NOT to be used on CE units) ... 31 (e) Instructions Label... 32 SECTION 5: FAULT FINDING ... 33 SECTION 6: CLEANING AND INSPECTION ... 35 504-2099

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(a) General ... 35 (b) Dis-assembly ... 36 (c) Disinfection ... 36 (d) Re-assembly ... 37 SECTION 7: MAINTENANCE ... 39 (a) General ... 39 (b) Performance Checking ... 39 (c) Service... 39 SECTION 8: ACCESSORIES AND SPARE PARTS ... 41 SECTION 9: CLEANING AND INSPECTION LOG ... 43 SECTION 10: TECHNICAL INFORMATION ... 45 (a) Principle of Operation ... 45 (b) Technical Data ... 49 (c) Accuracies ... 50 (d) Terms and Definitions... 51 (e) Explanation of Symbols ... 52 Appendix A: Accuracies of Calibration due to changes in ambient conditions for the Model 2R Responder ... 55 List Of Figures Page No.

Figure 1: 2R Control Module... 17 Figure 2: Patient Valve and Accessories... 18 Figure 3: Labels and their Locations... 21 Figure 4a: Comprehensive Instant Action Set with Accessories... 27 Figure 4b: Compact Instant Action Set ... 27 Figure 5: Instruction Label - CE and NON- CE version... 32 Figure 6: Block Schematic Diagram ... 47 Smiths Medical International Ltd. reserves the right to make changes, without notice, which may affect the information contained in this manual. Additional copies of this User’s Manual can be obtained from Smiths Medical International Ltd. "Pneupac"and “Smiths” are trademarks of the Smiths Medical family of companies. The symbol R indicates that it is registered in the U.S. Patent and Trademark Office and certain other countries. Patent pending.

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SECTION 1: USER'S RESPONSIBILITIES (a)

Summary Statement

WARNING: Failure to read this User’s Manual before first use of this device may result in death or serious injury. WARNING: Special attention must be paid to warnings and

precautions which are summarised in section 1(b), (c) and (d). Failure to observe the warnings and precautions detailed in this Manual could compromise patient/user safety. Before use for the first time, all potential users must read the complete User’s Manual, they should also familiarise themselves with the Responder and its operation to enable them to use it effectively. They should study the contents of this Manual to the extent required to supplement their training. Special attention must be paid to warnings and precautions which are summarised in section 1(b) and (d). Failure to observe these warnings and precautions could compromise patient/user safety. Special guidance on the operation and use of the ventilator is given in section 4 of this manual and basic operating instructions are provided on the label affixed to the control module. WARNING: To avoid harm to the patient, this equipment should only be used by personnel trained in the use of automatic resuscitation. WARNING: All operators who are not medically qualified should receive full and proper instruction from a qualified person, both on resuscitation and on detailed use of the equipment in the particular situations in which it might be employed. The equipment should only be used by medical personnel who have a full understanding of the techniques required for its use, or paramedical personnel who have received full and proper initial and 'refresher' instruction from a qualified person, both on resuscitation and on detailed use of the equipment in the situations in which it is likely to be employed. Information given in this manual beyond the basic operation of the Responder is only intended as a guide to supplement proper medical training and to indicate the specific operational requirements of the Responder. 504-2099 5

WARNING: Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury. WARNING: To avoid harm to the patient, blood gas levels must be monitored independently, correct operation of the ventilator will not necessarily achieve the required blood gas levels. The Responder is intended only for use in transport and emergency situations where the patient is being constantly monitored by the carer. Although use of this ventilator outside the environmental conditions specified in this Manual will not directly lead to a safety hazard the performance will become increasingly uncertain as the conditions become more extreme. Therefore the operator must exercise constant patient vigilance under these conditions. WARNING: Use of Oxygen - Avoid smoking or naked flame. To avoid the risk of ignition, do not allow oil, grease or combustible lubricants (only those approved for oxygen use) to come into contact with any part of the ventilator, regulator or cylinder. WARNING: To avoid ignition by adiabatic compression, connect the ventilator to the regulator before opening the cylinder valve slowly. Similarly, prior to changing cylinders, turn off the cylinder valve, then switch on the ventilator, to remove any residual pressure and when the ventilator stops, it is safe to release the pin index yoke. WARNING: There is a risk of unsatisfactory performance when alternative ventilator patient circuits are used. Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance. WARNING: Provision of alternative means of ventilation. Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction

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The European mandated standards specifying particular requirements for ventilators (EN 794) state that users must be advised that whenever a patient is being ventilated by means of an automatic ventilator the user should ensure that an alternative means of ventilation (eg a manual ventilator) is readily available. Servicing or adjustment of this equipment should only be carried out by competent personnel who have been trained by the manufacturer for such work. WARNING: Provision of accessories, ancillaries and spares parts for CE marked products. The Responder ventilator is manufactured and CE marked (where applicable) to the requirements of 93/42/EEC. To ensure that this equipment functions as intended only use accessories, ancillaries and spares parts authorised by the manufacturer. The CE 2R Responder ventilator described in this manual carries a CE mark to certify that is has been manufactured to conform to the requirements of the European Medical Devices Directive 93/42/EEC. To ensure that this equipment is maintained to the requirements of the Directive, only accessories, ancillaries and spares authorised by the manufacturer should be fitted. All such parts sold by Smiths Medical International Ltd. have /CE incorporated in their Order Code. Parts that are not marked in this way are only for sale outside the countries bound by the Directive. Note: Responder part No. 510A2773 is a non CE version of the Ventilator and does not have CE in its code number and therefore only for use outside the countries that are bound by the directive. The ventilators are portable devices intended for the ventilation of adults, children (above 25kg) during transportation and emergency situations. They consist of a control module and a remote patient valve, connected by means of a breathing hose. Pneumatic alarm is incorporated.

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(b)

Warnings

Warnings are given to make you aware of dangerous conditions, that could lead to death or serious injury to the user or patient, that can occur if you do not obey all of the instructions given in this manual. 1.

WARNING: User’s Manual (Section 1(a)) Failure to read this User’s Manual before first use of this device may result in death or serious injury.

2.

WARNING: Warnings and Precautions (Section 1(a)) Special attention must be paid to warnings and precautions which are summarised in section 1(b), (c) and (d). Failure to observe the warnings and precautions detailed in this Manual could compromise patient/user safety.

3.

WARNING: Trained Personnel (Section 1(a)) To avoid harm to the patient, this equipment should only be used by personnel trained in the use of automatic ventilation.

4.

WARNING: Training Requirements (see Sections 1(a) and 4 (a)) All operators who are not medically qualified should receive full and proper instruction from a qualified person, both on resuscitation and on detailed use of the equipment, in the particular situations in which it might be employed.

5.

WARNING: Patient Monitoring (Sections 1(a) and 4 (b)) Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury.

6.

WARNING: Blood Gas Levels (Section 1(a)) To avoid harm to the patient, blood gas levels must be monitored independently, correct operation of the ventilator will not necessarily achieve the required blood gas levels.

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7.

WARNING: Use of Oxygen (Sections 1(a) and 3(ii))

Avoid smoking or naked flame. To avoid the risk of ignition, do not use oil, grease or combustible lubricants (only those approved for oxygen use) in contact with any part of the ventilator, regulator or cylinder. To avoid ignition by adiabatic compression, connect the ventilator to the regulator before opening the cylinder valve slowly. Similarly, prior to changing cylinders, turn off the cylinder valve, switching on the ventilator. When the ventilator stops, it is safe to release the pin index yoke. 8.

WARNING: Potential Unsatisfactory Performance (Section 1(a)) There is a risk of unsatisfactory performance when alternative Ventilator patient circuits are used. Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance.

9.

WARNING: Provision of Alternative Means of Ventilation (Section 1(a)) Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction

10.

WARNING: Provision of Accessories, Ancillaries and Spares for CE marked products (Sections 1(a) and 8)

The ventilator is manufactured and ‘CE’ marked to the requirements of 93/42/EEC. To ensure that this equipment functions as intended, use only the manufacturer’s authorised spares. 11.

WARNING: Use of Clausen Harness (Section 2(f)(vii))

Because the operator is no longer supporting the head and chin, particular care must be taken that the patient’s airway is maintained open during these procedures and constant checks should be made for gas availability and correct ventilator function. 504-2099

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12.

WARNING: Functional Check (Section 3)

Deviations noted at functional check should be reported immediately to Smiths Medical International Ltd. and the unit must be taken out of service to avoid the risk of death or serious injury. 13.

WARNING: Pre-Use Checks (Section 4)

To avoid harm to the patient, pre-use checks must be performed before each use. 14.

WARNING: Release of Cylinder Pressure (Section 3(ii))

To avoid ignition by adiabatic compression, connect the ventilator to the regulator before opening the cylinder valve slowly. Similarly, prior to changing cylinders, turn off the cylinder valve, switching on the ventilator. When the ventilator stops, it is safe to release the pin index yoke. 15.

WARNING: Adequacy of Gas Supply (Section 4(b))

To avoid harm to the patient, ensure that ventilation can be maintained without interruption keep a constant check on the adequacy of gas supply by observing the gas cylinder contents indicator and the gas failure visual alarm. 16.

WARNING: PEEP valve (Section 4(d)) With a PEEP valve (NOT to be used on CE units) in place the casualty cannot inhale air and therefore these valves should only be used if essential and extra care needs to be taken to ensure that the casualty is not being prevented from breathing at any time.

17.

WARNING: Use in Extreme Environments (see Section 4),

Extreme environments may impair ventilator performance operator vigilance is required to monitor the patient.

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18.

WARNING: Use in Contaminated Environments (see Section 4),

To avoid harm to the patient in contaminated environment Ensure that entrainment within the patient valve is disabled, if this is not possible, use an alternative means of ventilation. 19.

WARNING: Use in Hazardous Environments (see Section 4),

To avoid harm to the patient and the user in hazardous environment where there is a risk of fire, Do Not use Oxygen as a driving gas. Use an alternative non-flammable gas or an alternative means of ventilation. 20.

WARNING: Changeover Valve (see Sections 3 & 4(b)),

The changeover valve may stop in the mid-position if the gas supply is suddenly removed, however there will be no supply to the patient as there is no input supply. The changeover valve will be closed on re-application of input supply. The user should be aware that under these circumstances for a short period of time there may be a momentary flow at the patient outlet until the changeover valve closes.

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(c)

Cautions

Cautions warn of dangerous conditions that can occur and cause damage to the ventilator or its accessories, if you do not obey all of the instructions given in this manual. 1.

CAUTION: Prevention of Gas Loss (Section 3(xi)) To ensure that the cylinder contents are not lost during storage due to small leakages, it is recommended that the valve on the gas cylinder is turned off after use.

2.

CAUTION: Microbial Filter (Section 2(d)) Although there is no net flow in the sensing line it is recommended that a microbial filter is always inserted in the sensing line to ensure that no patient contamination can enter the manometer and also eliminate the need to regularly replace the sensing tube.

(d)

Precautions

Precautions warn of actions required to avoid dangerous or undesirable conditions that can occur and cause damage to the ventilator or its accessories, if you do not obey all the instructions given in this manual. 1. PRECAUTION: Prevention of Gas Loss (Section 3(xi)) It is recommended that the valve on the gas cylinder is turned off after use to ensure that the cylinder contents are not lost during storage due to small leakages.

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SECTION 2: GENERAL INFORMATION (a)

Intended Use

The Responder is an automatic (variable) time cycled emergency ventilator delivering a pre-determined pressure limited volume of gas to the casualty. The range of emergency ventilators provides easily operated, versatile, emergency ventilatory resuscitation equipment suitable for use wherever this may be required. Each model meets the requirement for use during CPR*. The Model 2R units are suitable for the resuscitation of adults and children above 25 kg. All models are suitable for the treatment of casualties in rescues from toxic or non-respirable atmospheres as they provide 100% oxygen and entrain no air from the surrounding atmosphere. Responder ventilators are very economical in their use of driving gas, refer to Section 10(b) for details of ‘Duration of Gas Suply’. The Responder ventilators and associated equipment described in this manual comply with the requirements of the European Directive for Medical Devices 93/42/EEC. (b)

General Description

The Responder emergency ventilators consist of a control module and a remote patient valve, connected by means of a small bore, flexible hose (See Fig 1). The control module is rugged by virtue of its thick section structural foam plastics case and the use of anti-shock mountings for the internal pneumatics. The control is recessed to minimise the possibilities of damage. On the Model 2R a single calibrated control knob sets the required ventilation pattern and a detent position clearly identifies the setting for ventilation of adults during cardiopulmonary resuscitation (CPR*) and rescue breathing in accordance with JAMA guidelines*.

* See Terms and Definitions, Section 10(d)

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The Responder control module is designed to be mounted in a variety of ways as described under Section 2 (e) 'Mounting Options'. It may also be carried, together with a compressed gas cylinder, within a Pneupac 'Instant Action' carrying case. A wide range of attachments and brackets are also available. The Responder may be driven by oxygen or air from a compressed gas cylinder or pipeline system.

(c)

Contraindications

None known. (d)

Controls and Features (Figure 1)

1.

Tidal Volume and Frequency Control - This calibrated rotary control knob gives continuous simultaneous adjustment of tidal volume and frequency over a range of 1450 to 340 ml and 11 to 21 breaths per minute. There is a detent and a heart symbol at the 900 ml, 13b/min setting to give the optimum ventilation pattern for adult cardiopulmonary resuscitation (CPR*). indicates the recommended initial setting for the A child symbol resuscitation of smaller children. On all models the delivered tidal volume is unaffected by lung compliance and airway resistance.

2.

Inflation Pressure Monitor - This pressure manometer displays the patient inflation pressure, as measured at the patient connector. It will give an accurate indication of the actual patient proximal inflation pressure under all normal settings of the ventilator. A clear PVC sensing tube (11) connects the manometer to a swivelling adaptor on the patient valve.

Caution: Although there is no net flow in the sensing line it is recommended that a microbial filter (12) is always inserted in the sensing line to ensure that no patient contamination can enter the manometer and also eliminate the need to regularly replace the sensing tube.

* See Terms and Definitions, Section 10(d)

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3.

Supply Gas Failure Alarm - This visual alarm gives a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification. With low pressure it shows red, with adequate pressure it shows white. Any visible red indicates that the supply should be changed. The display may begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level.

4.

Basic Operating Instructions - This panel on the ventilator gives basic operating instructions to assist the infrequent user of the Responder. It is not intended to replace, in any way, the more comprehensive instructions and information given in this Manual and in training programmes (see Figure 5).

5.

Patient Hose - The patient valve is connected to the control module by means of a small bore, flexible, non-kink hose. The screwed fittings at each end are intended to make the connection of the patient valve to the control module a permanent connection. The thread form used ensures that it is not possible to incorrectly connect the hoses used in the Responder set.

6.

Patient Valve - This valve directs the inspiratory flow from the ventilator into the lungs during the inspiratory phase and then allows expiration to the atmosphere. The connection to the casualty is by means of a 22/15mm co-axial taper fitting (14) so that face masks or endotracheal tubes conforming to the requirements specified in EN 1281-1 may be used. This valve operates with a switching force of 4 Newtons so that it is not easily jammed. It is simple to clean and cannot be mis-assembled. The return spring is captive to avoid loss. The expiratory port is threaded in order to temporarily accept the Pneupac PEEP valves (NOT to be used on CE units) where its use is essential for the patient's support.

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7.

Relief Valve - A relief valve is fitted to a threaded port on the patient valve that is directly connected to the patient connection port. The standard set includes a 40 x100 Pa (40 cmH2O) relief valve but a 60 x100 Pa (60 cmH2O) relief valve can be supplied as either an alternative or as an additional valve which can be fitted where higher inflation pressures are required. An audible alarm (13), is provided to signal that the relief pressure has been achieved and that gas loss is occurring through the relief valve. The alarm is pneumatically operated by means of the gas vented through the relief valve and is specially designed to give a warning whenever gas loss exceeds 10% of the delivered ventilation.

8.

Inlet Connection - A compact, screw type input connection is provided which is specifically designed to take the input hose provided by Smiths Medical International Ltd. to make a permanent connection.

9.

Input hose - A range of input hoses are available with alternative probes to suit different gases and Standards requirements.

10.

Mounting Attachment Points - Four M4 x 0.7 nuts set in each of the four pockets on the sides of the control module may be used for the attachment of brackets. The plastic screws secured in each M4 x 0.7 nuts (item 10) are for transit purposes only and are not recommended for the mounting of the Responder.

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30/22mm exhaust fitting

Exhalation port Piston and spring Safety valve on this side of patient valve

PEEP valve Input hose Relief valve Hook ring

Figure 2:

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(e)

Mounting Options

The Responder is convenient to use and site as required around the patient. It may be mounted with its base on a flat surface, either free standing or restrained by straps, or it can be installed in a pocket. (f)

Accessories (i)

Instant Action Case

An Instant Action carrying case can be supplied which is specially designed to carry a Responder ventilator, a 'D' sized gas cylinder and a wide range of accessories. It enables a comprehensive set of pulmonary ventilation equipment to be carried for immediate action at the scene of an emergency. Fig 3 shows the general arrangement of the set, opened out ready for action and complete with the optional gas powered an oxygen therapy set. Velcro fasteners are used to ensure easy and reliable access even under the most extreme conditions. Pockets and straps are available for accessories such as PEEP valves, Guedel airways and alternative masks. (ii)

Carrying Bracket

A lightweight bracket is available which accepts a 'D' sized gas cylinder and is shaped to allow the control module to be slotted in. A carrying loop allows the bracket to be hung onto a bed-rail or a trolley. (iii)

Gas Cylinders

Lightweight aluminium compressed gas cylinders are available from Smiths Medical International Ltd. for use with portable ventilators. The 'D' sized version is suitable for use with the Instant Action Case but they are flat based which permits free standing use also.

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(iv)

Cylinder Regulators

The Pneupac lightweight aluminium regulator is designed to reduce the pressure of gas in high pressure gas cylinders from 137-200 x100 kPa (137-200 bar) to 400 kPa (4 bar) as required by the Responder. It will deliver flow in excess of 60 L/min at this nominal pressure. Pin index or other standard inlet connectors are available for air or oxygen. The regulator is equipped with a protected contents gauge and a gas specific, quick-release outlet connector which accepts the probe on the Responder input hose. (v) Oxygen Therapy Unit The Pneupac Oxygen Therapy Unit consists of a flow-regulating 2 metre lead with a built-in filter and disposable face masks. The lead connects to the cylinder regulator outlet connector and delivers 6 litres per minute of oxygen to the mask with a design that ensures the patient receives approximately 40-45% oxygen in the mask. This lead may also be used with a nebuliser. (vii) PEEP Valves (NOT to be used on CE units) Two preset PEEP valves are available which, if essential, can be screwed into the threaded output port of the patient valve, to achieve preset pressures of 4cmH2O or 8cmH2O respectively (4 x100 Pa and 8 x100 Pa) Before using PEEP with the Responder refer to Section 4 (d) of this Manual. (viii) Clausen Harness and Hook Ring WARNING: Because the operator is no longer supporting the head and chin, particular care must be taken that the patient’s airway is maintained open during these procedures and constant checks should be made for gas availability and correct ventilator function. A Clausen harness and Hook ring can be supplied which enables the face mask to be strapped to the patient's face for rescue from difficult situations e.g. in tunnel rescue or when hoisting. 504-2099

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NON-CE INSTRUCTION LABEL

INPUT OUTPUT PANEL LABEL

FRONT PANEL LABEL

COMMON TO BOTH CE AND NO-NCE UNITS

COMMON TO BOTH CE AND NON-CE UNITS

CE INSTRUCTION LABEL

NON-CE UNITS DO NOT HAVE THE GAS SUPPLY INDICATOR

CE UNITS HAVE THE GAS SUPPLY INDICATOR CE IDENTIFICATION LABEL NON-CE IDENTIFICATION LABEL

CE UNITS HAVE THE CE MARK NON-CE UNITS DO NOT HAVE THE CE MARK

Figure 3: 504-2099

Labels and their Locations 21