Pneupac VR1 & VR1 Responder Users Manual Issue 4 Oct 2005

Distributed by Smiths Medical PM, Inc., N7 W22025 Johnson Drive Waukesha, WI 53186 USA Tel: 1-800-558-2345 (USA & Canada) Tel: +1-652-628-7000

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Ventilatory Resuscitator User’s Manual Table of Contents

1. INTRODUCTION ... 1-1 1. 1. Warnings ... 1-1 1. 2. Cautions ... 1-4 1. 3. Contraindications ... 1-5

2. GENERAL INFORMATION... 2-1 2. 1. Intended use ... 2-1 2. 2. General description ... 2-1 2. 3. Controls, features and functions (see Figure 1)... 2-3 2. 4. Accessories... 2-9

3. SETTING UP AND USE OF THE VR1 ... 3-1 3. 1. User’s Responsibilities... 3-1 3. 2. Use of the VR1... 3-2 3. 2. 1. Setting up ... 3-2 3. 2. 2. Functional check ... 3-3 3. 2. 3. Pre-use checks... 3-4 3. 2. 4. Ventilating the patient... 3-4 3. 2. 5. Operation of manual (MAN) mode (Figures 5 a, b and c)... 3-5 3. 2. 6. Use in a Magnetic Resonance Imaging (MRI) environment . 3-6 3. 2. 7. Use in contaminated atmospheres... 3-7

4. CARE, CLEANING & STERILIZATION ... 4-1 4. 1. Care ... 4-1 4. 2. Cleaning, disinfection and sterilisation ... 4-1 4. 2. 1. VR1... 4-1 4. 2. 2. Oxygen hose ... 4-2 4. 2. 3. Patient valve... 4-2 4. 2. 4. Care after device subjected to dust ... 4-3 4. 2. 5. Care after device wetted... 4-3 4. 2. 6. Care after device immersed in water... 4-4 504-2105NUS

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4. 2. 7. Care after contamination with vomitus... 4-5

5. MAINTENANCE... 5-1 5. 1. General ... 5-1 5. 2. Performance check and service ... 5-1

6. SPARE PARTS AND RE-ORDERING... 6-1 6. 1. Reordering... 6-1 6. 2. Spares ... 6-1

7. TECHNICAL INFORMATION ... 7-1 7. 1. Principle of operation... 7-1 7. 2. Technical Data ... 7-3 7. 3. Accuracies ... 7-5 7. 4. End of Life ... 7-6 7. 5. Terms and Definitions... 7-6

Appendix A : Ventilator accuracy and deviations... 3 A. 1. Ventilator accuracy and deviations due to changes in ambient conditions ...3 A. 2. Vibration Testing ...4

Appendix B – VR1 accessories... 3 B. 1. Accessories...3 B. 1. 1. Device patient valve...3 B. 1. 2. Other items...4

Appendix C : Cleaning And Inspection Log ... 3 List of Figures and Tables Figure 1: Controls and features... 2-7 Figure 2. Use of VR1 with mask ... 2-10 Figure 3. Use of VR1 with transport circuit ... 2-10 Figure 4. Device labels and their locations... 2-11 Figure 5a: Automatic Mode... 3-5 504-2105NUS

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Figure 5b: Manual Mode ... 3-5 Figure 5c: Manual Mode (15:2 CPR) ... 3-5 Figure 6a. Quick-reference guide ... 3-9 Figure 6b. Quick-reference guide ... 3-10 Figure 7: Patient valve assembly ... 4-2 Figure 8: Block diagram for Pneupac VR1 ... 7-1 Figure 9. Use of PEEP valve ...1 Smiths Medical 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 VR1 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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AMENDMENT RECORD AMENDMENT

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DATE

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MODIFICATION

INITIALS

1. INTRODUCTION Warning: Failure to read the User’s Manual before first use of this device may result in death or serious injury to the patient/user. Warning: Special attention must be paid to warnings and cautions which are summarised below. Failure to observe the warnings and cautions detailed in this User’s Manual could compromise patient/user safety. 1. 1. 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. User’s Manual (Section 1. ) Failure to read the User’s Manual before first use of this device may result in death or serious injury to the patient/user. 2. Warnings and cautions (Section 1. ) Special attention must be paid to warnings and cautions which are summarised below. Failure to observe the warnings and cautions detailed in this User’s Manual could compromise patient/user safety. 3. Trained personnel (Section 3. 1) To avoid harm to the patient, this ventilator should only be used by trained operators working in accordance with correct medical practice exercised with due clinical diligence. All operators who are not medically qualified should receive full and proper instruction from a qualified person, both on ventilation and on detailed use of the equipment, in the particular situations in which it might be employed. 4. Federal Law (USA) Federal Law (USA) restricts the use or sale of this device by, or on the order of, a physician'. 5. Provision of alternative means of ventilation (Section 3. 1) Always ensure that an alternative means of ventilation is available in the event of device failure or malfunction. 504-2105NUS

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6. Use in MRI environment (Section 3. 1) To reduce the risks of potential projectile injury to the user or patient, it is the user’s responsibility to carry out routine checking of the system and accessories for magnetic attraction whenever the equipment is taken into an MRI environment, to ensure that magnetically attracted parts have not been added to the system inadvertently. Please note that the VR1 is MRI compatible (see Section 3. 2. 6). 7. Potential unacceptable performance (Section 2. 3-4, 2. 4 & B. 1) There is a risk of unacceptable performance when alternative ventilator patient circuits or accessories are used. Failure to use patient circuits and accessories recommended in this User’s Manual may lead to unacceptable device performance. 8. Provision of spares (Section 1. 1) There is a risk of unsatisfactory performance if this device is serviced by a third party other than one recommended by the manufacturer. Failure to use the manufacturers’ recommended service provider or spares may lead to unsatisfactory device performance. 9. Patient monitoring (Section 3. 2. 4) Failure to constantly monitor the patient clinically, whilst using this equipment may lead to death or serious injury. 10. Blood oxygenation and expired carbon dioxide (Section 3. 2. 4) To avoid harm to the patient, blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography as part of due clinical diligence. 11. Use of Oxygen (Section 3. 2. 1) To avoid the risk of ignition, avoid smoking or naked flames. Do not use oil, grease or combustible lubricants (except those specifically approved for oxygen use) in contact with any part of the device, regulator or cylinder. To avoid ignition by adiabatic expansion, connect the device to the regulator before opening the cylinder valve slowly.

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12. Pre-use checks (Section 3. 2. 3) To avoid harm to the patient, pre-use checks must be performed before each use. 13. Functional check (Section 3. 2. 2) To avoid the risk of death or serious injury, any malfunction noted at functional check should be reported immediately to the manufacturer and the device must be taken out of service. 14. Adequacy of gas supply (Section 3. 2. 1) To avoid harm to the patient when using gas cylinders, ensure that ventilation can be maintained without interruption by keeping a constant check on the adequacy of gas supply by observing the gas cylinder contents indicator. 15. Use in extreme environments (Section 3. 1) Extreme environments may impair device performance, operator vigilance is required to monitor the patient. 16. PEEP valve usage (Section 2. 3-10) To avoid risk of harm to the patient, the user should be aware that PEEP is not monitored, hence any malfunction in the PEEP Valve, breathing circuit or exhalation port is not indicated. 17. Dry input gas (Section 3. 2. 1) To avoid harm to the patient due to erratic performance of the VR1 in extreme environments, only dry medical gases should be used with this device. 18. Use in flammable environments (Section 3. 1) To avoid harm to the user and patient, this device is not to be used in flammable environments 19. Periodic user checks (Section 4. 1) To avoid harm to the patient, if the device remains unused for a period exceeding three months, conduct functional checks prior to returning to storage.

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20. Use of device in transport (Section 3. 2. 4) To avoid harm to the patient, inter- or intra-hospital transport should only be undertaken on the attending physician’s agreement following a careful evaluation of the risk-benefit ratio. 21. Slow oxygen supply failure (Section 3. 2. 1) To avoid harm to the patient be aware that if the gas supply is allowed to fail slowly, the ventilator may continue to cycle for a maximum of 10 seconds, without adequately ventilating the patient. See warning 14. 22. Use in contaminated atmosphere (Section 3. 2. 7) To prevent transmission of any contaminants to either user and/or patient after use in a severely contaminated environment, be aware that the Pneupac VR1 enclosure is NOT hermetically sealed against ingress of gas or liquids. The user should thoroughly decontaminate and return the device to the manufacturer with a declaration of decontamination so that the ventilator module can be reconditioned by a suitably trained person. 23. Use of airway adjuncts (Section 2. 4) To avoid harm to the patient due to laryngeal trauma, do not connect an endotracheal tube or laryngeal mask airway directly to the VR1 device patient valve internal taper. Always affix these accessories via the recommended catheter mount. 1. 2. Cautions Cautions warn of dangerous conditions that can occur and cause damage to the device or its accessories. 1. Caution: Prevention of gas loss (Section 3. 2. 1) To ensure that the cylinder contents are not lost during storage due to small leaks or unintentional operation, it is recommended that the valve on the gas cylinder is turned off after use. 2. Caution: Cylinder change (Section 3. 2. 1) Before changing gas cylinders, turn off the cylinder valve and then switch the VR1 to AUTO (automatic). After one or two cycles the VR1 will stop and it is then safe to unclamp the pin index yoke without a sudden release of pressure. 504-2105NUS

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3. Caution: Immersion in water (Section 4. 2. 6) If the device is accidentally immersed in water or any liquid, it should no longer be operated and an alternative means of ventilation used (see WARNING #5 in this User Manual). The VR1 may be returned to use by the method described in Section 4. 2. 6. 4. Caution: Silicone components (Section 4. 2. 3) DO NOT use solvents to clean any of the silicone components, particularly the patient valve components, as this may result in silicone becoming adhesive and consequently creating an obstruction in the gas path. 5. Caution: Sterilisation of the VR1 (Section 4. 2. 1) Do not attempt to sterilise the VR1 or to clean it by immersion in any fluid. 6. Caution: Vomitus contamination (Section 4. 2. 7) Ensure that no vomitus enters the device during the cleaning process. 1. 3. Contraindications To avoid serious injury to the patient due to vomit trapped in the mask, the use of Clausen Harness is strictly forbidden with the VR1.

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2. GENERAL INFORMATION 2. 1. Intended use The Pneupac VR1 range are hand held portable time-cycled, gas powered, flow generator ventilatory resuscitators that are suitable for emergency and transport use and will operate safely in a MRI environment up to 3 Tesla. They are designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions: Warning: Federal Law (USA) restricts the use or sale of this device by, or on the order of, a physician'. VR1 Responder – basic ventilatory resuscitator intended for use on adults and children above a body weight of 22lb (10kg) with no respiratory function. VR1 Standard – ventilatory resuscitator intended for use on adults and children above a body weight of 22lb (10kg) with either respiratory distress / insufficiency or no respiratory function. 2. 2. General description Pneupac VR1 is intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital. Also for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and inter- hospital transport. The Pneupac VR1 range comprises two variants – •

Pneupac VR1 (see features below)

•

Pneupac VR1 Responder (as Pneupac VR1, but without demand breathing system)

The Pneupac VR1 is housed in a tough engineering plastic enclosure which may be cleaned by the user. The user replaceable patient valve may be sterilised and re-used or exchanged by the user. The Pneupac VR1 has the following features; •

Interdependent and continuous control of tidal volume and frequency from approximately 150mL/25BPM to 1050mL/10BPM using a single rotary control

•

Automatic or manual mode selector

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Manual mode push button and omni-directional lever

•

Demand breathing system for spontaneously breathing patients

•

Spontaneous breathing under power failure

•

Audible pressure relief alarm

•

Integrated, user replaceable patient valve

The Pneupac VR1 Responder has the same features but without the demand breathing system. The devices can be deployed by attaching to an oxygen supply, selecting the tidal volume/frequency required with the rotary control and selecting automatic or manual. The VR1 has two modes of ventilation, automatic (AUTO) and manual (MAN). In automatic mode the device cycles in accordance with the setting of the rotary control that changes the tidal volume and frequency dependently whilst maintaining a constant I:E ratio of 1:2. In manual mode, preset breaths, singularly or in a controlled breathing pattern may be selected by use of an omni-directional lever or push button. The tidal volume and frequency possible are limited by the position of the rotary control. The Pneupac VR1 incorporates a pneumatic high-pressure relief valve which releases excess patient pressure according to the in-built pressure relief valve (40 cmH2O standard, 60 cmH2O optional) and simultaneously sounds an audible alarm. Pneupac VR1 is available with a wide range of accessories. The Pneupac VR1 kits typically comprise the following; Pneupac VR1

520A1125

Hose assembly DISS-DISS

510A2705

User manual (English)

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Quick-reference guide (English)

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Shelf carton

W129-006

Straps (two)

520-1155

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2. 3. Controls, features and functions (see Figure 1) 1. Inlet connection A threaded inlet connection is provided for connection of the manufacturer’s oxygen hose. The user must ensure that this connection is tightened firmly by hand. 2. Mode selector and momentary controls There is a mode selector on top of the device for selection of either automatic (AUTO) or manual (MAN) mode. When in manual mode, depressing the VENT push button on top of the device or moving the omni-directional lever on the underside of the device in any direction will deliver a manually-controlled breath. 3. Rotary control The rotary control causes interdependent and continuous change in the tidal volume and frequency whilst maintaining a constant I:E ratio of 1:2. The range is nominally 150mL/25BPM to 1050mL/10BPM. 4. Patient valve Warning: There is a risk of unsatisfactory performance when alternative ventilator patient circuits or accessories are used. Failure to use patient circuits and accessories recommended in this User’s Manual may lead to unsatisfactory device performance. The patient valve assembly is a user replaceable assembly* which allows inspiratory flow from device to patient through the lip valve and exhaled patient gas out of the exhalation port via the flutter valve, preventing possible contamination of the device by the patient. Use only patient valve components recommended by Smiths Medical International Ltd. as these are the only ones suitable and recommended for the Pneupac VR1. * Note :Tests have shown that incorrectly assembled patient valves may lead to reduced tidal volume at very low flow (10– 11 L/min.). This would be indicated by inadequate chest movements when in use. Due care should be taken when assembling the patient valve and due clinical diligence should be exercised in observing the ventilated patient at all times. Note: Other patient valves may cause damage to the VR1 or prevent it from operating correctly. 504-2105NUS

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The patient outlet is a 22/15mm swivelling, co-axial taper to ISO 5356 for face masks or endotracheal tubes conforming to EN 1281-1. Refer to care, cleaning and disassembly/reassembly instructions in Section 4. 5. Pressure relief valve and audible alarm The pressure relief valve system sounds an audible alarm to signal that the relief pressure of 40cmH2O has been reached and that gas loss is occurring through the relief valve. The alarm is pneumatically operated by gas vented through the relief valve. An optional, factory fitted 60cmH2O relief valve and alarm is available at point of order. Note that in instances of high airway resistance (eg. bronchial asthma) the pressure relief valve will activate when the airway pressure reaches 40cmH2O. Users should be aware that in this situation, the delivered tidal volume may be reduced (i.e. at 10 bpm the reduction will be a maximum of 20%) 6. Input hose (not shown) A range of oxygen hose assemblies are available with alternative colours and probes to meet different national standards. 7. Demand breathing system (if fitted - not shown) The demand breathing system allows a spontaneous breathing patient to draw oxygen ‘on demand’ from the gas supply, in any mode and in some cases, cause the ventilator cycling to inhibit. When the AUTO (automatic) mode is selected, the ventilator delivers the preset tidal volume and frequency according to the setting on the Tidal Volume/Frequency control. However, if the patient starts to breath spontaneously with an inspiratory effort of below -2 cmH2O, oxygen from the gas supply can be drawn up to a flow of 120l/min. If the demand breath volume exceeds approximately 450ml, the ventilator cycling will also be inhibited. At the end of spontaneous breathing, the ventilator recommences cycling after the expiratory time. The demand breathing system does not inhibit cycling of the ventilator if the patient takes frequent small panting breaths. Volumes demanded by a child may be insufficient to inhibit the ventilator.

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When the MAN (Manual) mode is selected, the ventilator functions as an oxygen delivery system, delivering 100% oxygen to the patient during each spontaneous breath. Note: Under certain circumstances, when the patient is drawing flow from the demand breathing system, the demand valve may ‘flutter’. This does not affect operation of the device. 8. Spontaneous breathing under power failure (not shown) Should the oxygen supply fail, the ventilator will not cycle, but the patient can breath spontaneously through the ventilator since a separate internal ‘spontaneous breathing’ valve opens to atmosphere. The patient valve flutter valve should always remain fitted to the Pneupac VR1 devices. 9. MRI compatibility (not shown) The Pneupac VR1 range are all MRI compatible to 3 Tesla (Section 3. 2. 6) 10. PEEP capability (not shown) Warning: To avoid risk of harm to the patient, the user should be aware that PEEP is not monitored, hence any malfunction in the PEEP Valve, breathing circuit or exhalation port is not indicated. External PEEP can be provided as shown in Figure 9 using a PEEP valve and exhaust collector. External PEEP cannot be fitted directly to the VR1 device. This collector is a push fit onto the body of the patient valve and connects the exhalation ring to a 30 mm male taper connection port without interfering with the function of the valve. 11. Biological filter capability (optional, not shown) A factory-fitted optional biological filter kit can be specified for the Pneupac VR1 variant only at point of order. When fitted, the air breathed through the spontaneous breathing valve is filtered. The specification for the biological filter is; •

Filter efficiency at least 99.99% efficient against a 0.3 micron mass median aerodynamic diameter aerosol challenge at 32 l/min.

•

Airflow resistance at 32 l/min. is 10-17 mm H2O

•

Connector size 40mm DIN NATO compatible threads

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12. Securing straps A pair of hook and loop straps are provided for retaining the VR1 securing lugs to, for example, a stretcher or chair arm to avoid dropping the device or creating excessive strain on an intubated patient’s ET tube or Laryngeal Mask (LM).

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13

2

3

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Figure 1: Controls and features

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