Analgesic and Oxygen Demand Valve. Service Manual

Transcription

1 Analgesic and Oxygen Demand Valve Service Manual May 2014

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3 Contents 1. Symbols Warnings and Cautions Warnings! Cautions! Notes Functional Description Intended Use Technical Description Maintenance User Maintenance and Inspection When to Repair When to Disinfect Specification Servicing and Repair Procedures Demand Valve Disassembly Cleaning Cleaning and Inspection Procedure Reassembly Disinfection Procedure Demand Valve Assembly External Disinfection Demand Valve Component Disinfection Testing Troubleshooting Parts and Spares Demand Valve Main Components Distributor Details... 19

4 1. Symbols Warning! Caution! Note Indicates a potentially hazardous situation which, if not avoided, could result in personal injury to the user or others Indicates a potentially hazardous situation which, if not avoided, could result in damage to the equipment or property Highlights points that might allow more convenient or efficient operation of the equipment Attention, consult accompanying documents Use no oil 0120 CE Marked to Medical Device Directive 93/42/EEC as amended by directive 2007/47/CE No smoking Single use or Single patient use Service due date 1304X12345 YYMM Date of manufacture identification Use by 2. Warnings and Cautions 2.1. Warnings! Read through this entire instruction manual before using or showing others how to use this demand valve. As with all medical equipment, attempting to use this device without a thorough understanding of its operation may result in patient or user injury. In the United States of America, Federal Law restricts this device to sale by or on the order of a physician. Only appropriately trained personnel working in controlled conditions may disassemble or assemble this demand valve. Do not smoke around analgesic gas equipment. Gas specific connectors are fitted to the demand valve. Do not attempt to modify the fittings to suit other gases or fitting systems. 2

5 N 2 O/O 2 50%/50% V/V, hereinafter referred to as analgesic gas, is or should be considered a drug and should only be used for medical purposes as prescribed by a physician or authorised clinician and in accordance with the medicinal product labelling. Oxygen and nitrous oxide analgesic gas mixture is not flammable; however the presence of it will drastically increase the rate and severity of combustion. Oil and/or grease in the presence of an oxygen enriched atmosphere will become highly combustible. Analgesic gas must never be allowed to come into contact with oil, grease or other petroleum-based substances. Do not use oil or grease on this demand valve. Continuous exposure to elevated levels of nitrous oxide can be harmful. National standards for exposure levels (Time Weighted Average (TWA)), if available, should be applied. Risk controls measures such as adequate room ventilation, gas scavenging and/or environmental monitoring may be necessary. Oxygen therapy may be a critical treatment. Additional risk control measures such as SpO 2 monitoring with an alarm and a backup oxygen supply with delivery device should be provided for patients who might suffer distress or injury if their oxygen supply is not available or is stopped unexpectedly. Ensure that the medical gas supply is sufficient for the proposed therapy and is supplied within the pressure range given in the Device Specification. If the supply is a gas cylinder, check the cylinder contents gauge regularly. Do not use 100% oxygen or analgesic gas as a pressure medium to purge obstructed pipelines or equipment, to operate pneumatic tools, or to build up any pressure in tanks. Do not use or store medical gas near excessive heat (>50 C/125 F) or below 10 C (50 F). Always refer to the medical gas suppliers recommendations. Disassemble the device before cleaning. Do not submerge an assembled demand valve in any fluid. Never permit compressed medical gases to enter a pressure regulator suddenly. Always open the cylinder valve slowly. Secure cylinders to a wall, stand or cart in accordance with local safety regulations. Arrange the gas hose carefully to avoid damage to the hose and the potential for causing a trip hazard. Never pull or apply excessive force to the gas hose. A leaking hose may result in high local oxygen and nitrous oxide concentrations and an increased risk of fire. When therapy is complete, disconnect the demand valve from the gas supply. When the source of analgesic gas is from a gas cylinder, always close the gas cylinder valve when the demand valve is not in use and disconnect the demand valve from the pressure regulator (for reference only). The demand valve should not be used as a resuscitator (for reference only). If using a cylinder and regulator, ensure that the device is connected to the regulator and the cylinder valve is properly opened before beginning therapy (for reference only). Use a new exhalation valve for each new patient or after 30 days of use for the same patient (for reference only) Cautions! The performance of the demand valve may be affected if it is stored or transported in temperatures outside of the range -20 C to 60 C (-4 F to 140 F). The demand valve is not suitable for autoclaving. The handset is protected from contamination in normal use by a single patient use exhalation valve. 3

6 The single patient use exhalation valve is not suitable for cleaning. If the exhalation valve becomes visually soiled or discoloured it should be replaced for reference only) Notes Peak flow through the demand valve might be restricted resulting in increased work of breathing for the patient in the following circumstances: o o o o regulator or gas supply source does not meet the specification inlet filter is blocked an extension hose other than those listed in this manual is used hose is kinked or occluded 3. Functional Description 3.1. Intended Use The Ultraflow Demand Valve is intended to be used for self-administration of 100% oxygen or N 2 O/O 2 50%/50% V/V, hereinafter referred to as analgesic gas, in response to the patient s inspiratory effort. The demand valve is designed for use in all types of clinical environment. Always refer to the medical gas product labelling Technical Description The demand valve comprises of two main components; a demand valve handset and a single patient use exhalation valve (supplied separately). The exhalation valve is single patient use to prevent cross contamination between patients. It may be used by a single patient for up to 30 days. The demand valve handset is designed to be reused and can be cleaned and disinfected, although routine disinfection is not necessary as it is protected from contamination by the single patient use exhalation valve. The demand valve handset contains a specially designed tilt valve mechanism that opens when the diaphragm in the back of the demand valve handset moves forward as a result of the patient inhaling. When the tilt valve opens, the gas, which is under pressure behind the tilt valve, passes through the handset and is inhaled by the patient. The deeper the patient breathes, the greater the volume of gas delivered. When the patient exhales the diaphragm moves back, the tilt valve closes and no further gas is delivered. The demand valve offers a very low resistance to flow during both patient inhalation and exhalation, which means less effort for the patient. This is achieved by the unique, patented exhalation valve design that diverts exhaled gas out through a special valve, thus eliminating the need for the patient to exhale through a highly resistant patient filter as is the case with other demand valve systems. The demand valve can be driven directly from the terminal unit of a medical gas pipeline system or from a medical gas cylinder via a suitable pressure regulator. A gas hose complying with BS EN ISO 5359 carries the gas from the gas supply source to the demand valve. The demand valve should be used with either a mouthpiece or a facemask. The exhalation valve has a viral filter that allows the flow of inhaled gas to the patient and prevents contamination of the demand valve handset from the patient s expired breath. 4

7 4. Maintenance 4.1. User Maintenance and Inspection All demand valves should be inspected and tested on an annual basis to ensure correct performance. The demand valve handset must be serviced every 4 years to ensure that it continues to perform in accordance with its specification. Full details of this is covered in sections 6 through 8. Servicing must be carried out by a suitably qualified person working in a controlled environment When to Repair If form or function of the demand valve is affected. See sections 6 through When to Disinfect If contamination is suspected. See section 9. 5

8 5. Specification Specification Inspiratory Resistance Supply Pressure 1 Supply Flow Capacity 1 Demand Valve Peak Flow Environmental Regulatory Value <1.5 kpa (0.22 psi) at 200 l/min <0.25 kpa (0.036 psi) at 10 l/min Maximum 600 kpa (87 psi) Minimum 310 kpa (45 psi) >120 l/min >200 l/min Transport and Storage Temperature: -20 C to 60 C (-4 F to 140 F) Operating Temperature: 5 C to 40 C (41 F to 104 F) Humidity: 0-100% RH non-condensing CE: Medical Device Directive 93/42/EEC Active Medical Device Class IIa Applied Standards BS BS 5682 BS EN ISO BS EN ISO 5359 BS EN ISO BS EN ISO BS EN ISO NF S DIN SS CGA V-5 SANS 1409 AS 2896 Anaesthetic and analgesic machines. Specification for intermittent (demand) flow analgesic machines for use with 50/50% (V/V) nitrous oxide and oxygen Probes (quick connectors) for use with medical gas pipeline systems Anaesthetic and respiratory equipment. Conical connectors. Cones and sockets Low pressure hose assemblies for use with medical gases Medical devices. Application of risk management to medical devices Anaesthetic and respiratory equipment. Compatibility with oxygen Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements Medico-surgical equipment. Terminal units and related probes for medical fluids Supply systems for medical gases. Part 2: Dimensions and allocation of probes and gas specific connection points for terminal units for compressed medical gases and vacuum Medical gas pipeline systems. Connectors for medical gases DISS Diameter Index Safety System Outlet sockets and probes for medical (gas and vacuum) service used in hospitals Medical gas systems installation and testing of non-flammable medical gas pipeline systems 1 Indicates minium supply pressure at stated value of gas flow. Based upon an adult breathing at 30 bpm with a tidal volume of 1 litre and I:E ratio of 1:2 6

9 6. Servicing and Repair Procedures 6.1. Demand Valve Disassembly Note: A Demand Valve Service Kit contains replacement parts with the exception of the tilt valve and tilt valve seat. 1 Dispose of parts only if damaged or carrying out 4 year service. For repair, retain parts. Illustrations show blue analgesic cover, oxygen demand valves have a grey cover. Older devices have a black diaphragm. Equipment and Tools Required 2mm Allen key T-6 TORX driver 2mm steel punch Step Action Illustration 1. Ensure that the gas supply is turned off at the source (e.g. gas cylinder) and purge gas using test button. 2. Disconnect the device from the gas supply. 3. Remove lanyard retainer. 4. Remove and discard lanyard Prise the demand valve cover from the demand valve body and remove it by sliding it along the hose. 6. Remove the main label body. 7

10 7. Using a 2mm Allen key, remove and discard the hose retaining screws (2 off) from the main body Remove hose assembly whilst holding main body vertically in order to retain spring and tilt valve inside the main body. Discard the hose assembly, lanyard retaining collar and blue cover Remove the spring and tilt valve, taking care to avoid damage to the ruby seat on the tilt valve. Dispose of the spring 1. Do not dispose of the tilt valve. Caution! The tilt valve and seat are a matched pair unique to each device; they must not be mixed with similar items from other Ultraflow Demand Valves 10. Remove the tilt valve insert, taking care not to damage the seat area. Remove the O-ring from the insert and discard it 1. Do not dispose the tilt valve insert. Note If the tilt valve insert is not easily removable, push out from inside the main body neck using 2 mm punch. To prevent damage to the tilt valve seat, do not drive out from the centre of the tilt valve insert. 11. Using a T-6 TORX driver, remove and discard the finger guard TORX screws (2 off) To remove the finger guard: Feed a steel punch through the neck of the main body. Push on the locating tab located inside the neck. When the tab unseats from the locating hole in the main body, twist the finger guard and pull it out of the main body. Discard the finger guard 1. 8

11 13. Pull the centre of the diaphragm away from the body and work your fingers around the circumference until the diaphragm pulls away from the seat. Discard the diaphragm and main body Cleaning Warning! PPE should be used in line with local policy or in line with disinfectant instructions Cleaning and Inspection Procedure Warning! The cleaning procedure is not a disinfection procedure. Equipment and Tools Required Lint free swabs Isopropyl alcohol Carry out the following process to clean demand valve components in order to remove substances that may affect device performance. Step Action Illustration 1. Clean the following components using a lint free swab and isopropyl alcohol: a Tilt valve b Tilt valve ruby Note the following steps (1c thru 3) are not required for service as new parts are provided in Service Kit c Diaphragm seat d Insert area 2. Inspect all components for damage, including scratches, cracks and deformation 9

12 3. Replace components with new items where necessary. 8. Reassembly Note A Demand Valve Service Kit contains replacement parts with the exception of the tilt valve and tilt valve seat. Equipment Required IKV Fluor 70 lubricant 2mm steel punch Spare parts or service kit as required Step Action Illustration 1. Put a thin coating of IKV Fluor 70 lubricant around the circumference of the diaphragm. Note Older diaphragms are black in colour with a single rib on the top face and should always be replaced with the current blue diaphragm. 2. Insert the diaphragm into the outer groove in the main body; lining up the tab on the diaphragm with the cut-out in the main body 3. Ensure the diaphragm is fully seated by gently pressing down around the circumference of the diaphragm with the steel punch, ensuring there are no ripples. Take care not to perforate the diaphragm. 4. Push the finger guard into the main body, lining up the tab with the half cut-out. 5. Feed the steel punch through the neck of the main body and press down on tab located on finger guard. Whilst pressing down on tab, push finger guard fully home, ensuring the tab locks fully into place in the cut-out. 10

13 6. Fit replacement finger guard retaining TORX screws (2 off) (Part No ) 7. Fit a new O-ring (Part No ) to tilt valve insert. Apply a thin coating of IKV 70 lubricant to the O-ring. 8. Insert the tilt valve insert into the main body, ensuring that the holes align. 9. Fit rating label to main body. If repaired, re-use insert. If serviced, create new insert with service date 4 years from date of service. Annotate Year-Month (YYYY-MM) e.g Serial number to be copied from removed label. New label insert template available by visiting then clicking on Tools and Utilities and downloading the file Barcode label template.xlsm or you may contact cs@bprmedical.com to request a copy. Note Handset is tapered; ensure label is applied without wrinkles. 10. Feed the lanyard retainer and then the cover over the hose assembly, ensuring correct orientation of the cover. 11. Whilst holding the main body horizontally, slide the tilt valve into the tilt valve seat. Take extra care when inserting the tilt valve that it does not damage the insert seat. 11

14 12. Hold the main body vertical and locate the spring into the tilt valve head. 13. Apply IKV-Flour 70 (or equivalent) to both O- rings on hose tail. Align the screw holes on the thrust washer with the holes on the tilt valve insert. Insert the hose assembly into the tilt valve insert and fit replacement retaining screws (2 off). 14. Fit cover over the handset body. 15. Fit the lanyard over the handset body and into the groove in the cover, sliding the lanyard retainer over the lanyard. 9. Disinfection Procedure Warning! PPE should be used in line with local policy or in line with disinfectant instructions. The demand valve is not suitable for autoclaving. Do not immerse the demand valve handset in any fluid or attempt to disinfect internal parts whilst the demand valve handset is assembled. The Ultraflow Demand Valve has been tested and proven suitable for disinfection with a chlorine dioxide sporicidal fluid with ClO 2 concentrations up to 200 ppm 9.1. Demand Valve Assembly External Disinfection Step Action 1. Use a sporicidal wipe to thoroughly clean all external surfaces of the demand valve taking care to ensure all crevices are thoroughly covered. 2. Wipe all components thoroughly using a sterile cloth and water to ensure that all traces of the cleaning solution are removed. 3. Allow all components to air dry. 12

15 9.2. Demand Valve Component Disinfection Step Action 1. Dismantle the demand valve into its component parts accordance with section 6.1 (Demand Valve Disassembly). 2. With the exception of the hose assembly, carry out a cold disinfection process of the handset by submerging each of the components listed below in one of the following suitable disinfecting solutions in accordance with the solution suppliers recommendations. Pay particular attention not to exceed any recommended submersion time given: Suitable Disinfecting Solutions: Active Ingredient Sodium dichloroisocyanurate (NaDCC; 1000 ppm Cl) Sodium hypochlorite 1% (1000 ppm Cl) Chlorine dioxide (280 ppm available ClO2) Common Brands/Solutions Chlor-Clean H8950, Actichlor, Haz-Tab, Presept Bleach 0.55% ortho-phthaldehyde solution Cidex OPA Tristel Fuse for Instruments Component List: Various Demand Valve Cover Main Body Diaphragm Finger Guard Lanyard Retainer O-ring Lanyard 3. Remove the components from the solution and drain the excess back into the container. 4. Submerge the components in 8 litres of potable water and agitate each component. Leave the components submerged for 1 min. 5. Repeat section 6.2 step 4 two more times with a fresh batch of 8 litres of potable water. 6. Dry the components until no visible surface water is present. 7. Clean the tilt valve and tilt valve insert using a lint free swab and isopropyl alcohol. 8. Using an anti-bacterial wipe, clean the following components: Long socket cap head screw (2 off) Counter sunk head screw (2 off) Tilt Valve Spring Various Tilt Valve Tilt Valve Insert PVC Hose Assembly 13

16 10. Testing The testing procedure recommended for an Ultraflow Demand Valve is outlined in document Demand Valve Test Instrument, Instructions for Use. The Demand Valve Test Instrument is intended to verify that an Ultraflow Demand Valve is performing to the specifications outlined in BPR Medical s manufacturing procedures following service or repair. For further information on the Demand Valve Test Instrument or for a copy of document , please contact your local BPR distributor or visit Warnings! The demand valve is supplied with a gas specific connector that is designed to connect to a mating gas outlet. Gas outlets may be part of a terminal unit in a medical gas pipeline system or part of a pressure regulator outlet on a gas cylinder. Where the gas specific connector is dependent on a threaded fastener (e.g. DISS CGA V5 1240), make sure that the connection is tight before turning on the supply pressure. For quick connector probes (e.g. BS5682, SIS, AFNOR), ensure that the connection is secure by gently pulling the gas hose before turning on the supply pressure. If the demand valve has a regulator, this should be serviced in accordance with the Regulators for Medical Gases Service Manual ( ). Testing is required to ensure performance of device after servicing or repair. 11. Troubleshooting Fault Possible Cause Solution No gas flow Audible gas leak Demand valve handset is not connected properly. Gas cylinder empty. Medical gas terminal unit on a pipeline system is isolated. Demand valve probe blocked. Hole in diaphragm. The demand valve will work with the Test Button but not when used conventionally by inhaling through the mouthpiece or face mask. Valve or diaphragm has become dislodged. Tilt valve worn, bent or broken. Check gas supply. Check that the gas specific probe is correctly connected. Replace gas cylinder. Seek advice from someone authorised to operate the medical gas pipeline system isolation valves. Repair or service required. Repair or service required. Remove the exhalation valve and check that the diaphragm is laying flat and that it moves forwards and backwards when the Test Button is pressed Repair or service required. Constant gas flow Tilt valve damaged or blocked. Repair or service required. Insufficient gas flow Tilt valve damaged. Repair or service required. Diaphragm perforated. Supply pressure too low and/or gas cylinder nearly empty. Repair or service required. Check gas supply and/or replace gas cylinder. 14

17 Exhalation valve will not fit to or be retained on the demand valve body Single patient use exhalation valve has damaged location lugs. Check the underside of the single use exhalation valve to see if the locating lugs have been bent over or otherwise damaged. It is important to rotate the single use exhalation valve until it locates in the demand valve housing before pressing it down and engaging the locating ears. Trying to force the single patient use exhalation valve down before correctly locating it will damage the exhalation valve beyond repair. Fit a new single patient use exhalation valve. 15

18 12. Parts and Spares Demand Valve Main Components Item Part Number Quantity Description Finger Guard Diaphragm Finger Guard Torx Screw Main Body Cover Blue Analgesic Cover Grey Oxygen Tilt Valve O-ring (not shown) Tilt Valve assembly (some parts not shown) Lanyard (not shown) Lanyard Retainer Tilt Valve Spring Allen Screw 13 Various see service kit 1 Rating Label Analgesic (not shown) Various see service kit 1 Rating Label Oxygen (not shown) 14 Various see service kit 1 Retainer Label Analgesic (not shown) Various see service kit 1 Retainer Label Oxygen (not shown) 15 Various see service kit 1 Hose Assembly Various 16

19 Spare Parts and Servicing Demand Valve Factory Service (Universal) Oxygen Demand Valve Service Kit - 3m Hose - AFNOR Analgesic Demand Valve Service Kit - 2m Hose - AFNOR Analgesic Demand Valve Service Kit - 3m Hose - AFNOR Analgesic Demand Valve Service Kit - 4m Hose - AFNOR Analgesic Demand Valve Service Kit - 5m Hose - AFNOR Analgesic Demand Valve Service Kit - 6m Hose - AFNOR Oxygen Demand Valve Service Kit - 3m Hose - DIN Oxygen Demand Valve Service Kit - 3m Hose - Nordica Analgesic Demand Valve Service Kit - 2m Hose - Nordica AGA Analgesic Demand Valve Service Kit - 3m Hose - Nordica AGA Analgesic Demand Valve Service Kit - 4m Hose - Nordica AGA Analgesic Demand Valve Service Kit - 5m Hose - Nordica AGA Analgesic Demand Valve Service Kit - 6m Hose - Nordica AGA Oxygen Demand Valve Service Kit - 3m Hose - BS Analgesic Demand Valve Service Kit - 2m Hose - BS Analgesic Demand Valve Service Kit - 3m Hose - BS Analgesic Demand Valve Service Kit - 4m Hose - BS Analgesic Demand Valve Service Kit - 5m Hose - BS Analgesic Demand Valve Service Kit - 6m Hose - BS Oxygen Demand Valve Service Kit - 3m Hose - DISS Analgesic Demand Valve Service Kit - 2m Hose - DISS Analgesic Demand Valve Service Kit - 3m Hose - DISS Analgesic Demand Valve Service Kit - 4m Hose - DISS Analgesic Demand Valve Service Kit - 2m Hose - SANS Analgesic Demand Valve Service Kit - 3m Hose - SANS Analgesic Demand Valve Service Kit - 4m Hose - SANS Analgesic Demand Valve Service Kit - 5m Hose - SANS Analgesic Demand Valve Service Kit - 6m Hose - SANS Analgesic Demand Valve Service Kit - 2m Hose - SIS Analgesic Demand Valve Service Kit - 3m Hose - SIS Analgesic Demand Valve Service Kit - 4m Hose - SIS Analgesic Demand Valve Service Kit - 5m Hose - SIS Analgesic Demand Valve Service Kit - 6m Hose - SIS 17

20 Analgesic Demand Valve Service Kit - 2m Hose - BS 5682 (New Zealand) Analgesic Demand Valve Service Kit - 3m Hose - BS 5682 (New Zealand) Analgesic Demand Valve Service Kit - 4m Hose - BS 5682 (New Zealand) Analgesic Demand Valve Service Kit - 5m Hose - BS 5682 (New Zealand) Analgesic Demand Valve Service Kit - 6m Hose - BS 5682 (New Zealand) Analgesic Demand Valve Service Kit - 2m Hose - ¼ BSP Analgesic Demand Valve Service Kit - 3m Hose - ¼ BSP Analgesic Demand Valve Service Kit - 4m Hose - ¼ BSP Analgesic Demand Valve Service Kit - 5m Hose - ¼ BSP Analgesic Demand Valve Service Kit - 6m Hose - ¼ BSP Demand Valve Test Instrument Demand Valve Test Instrument Demand Valve Test Instrument supply hose - MA4 CPC (BS 5682) Demand Valve Test Instrument adaptor hose - MA4 N 2 O/O 2 (BS 5682) Demand Valve Test Instrument Adapter Hose MA4 O 2 (BS 5682) 18

21 13. Distributor Details United Kingdom BOC Healthcare Customer Service Centre Priestly Road Worsley Manchester M28 2UT T: +44 (0) F: +44 (0) Australia BOC Healthcare Customer Service Centre 10 Julius Avenue North Ryde Sydney NSW, 2113 T: +61 (0) F: +61 (0) New Zealand BOC Healthcare Customer Service Centre Great South Road Penrose 1061 Auckland New Zealand T: +64 (0) Canada BOMImed Inc. 96 Terracon Place Winnipeg MB R2J 4G& Canada T: F: BPR Medical Ltd License No: South Africa AFROX Hospital Care PO Box 5404 Johannesburg 2000 T: +27 (0) F: +27 (0) ENDV25/11/09/V2 19

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24 BPR Medical Limited T: +44 (0) Hamilton Way, Mansfield F: +44 (0) Nottinghamshire NG18 5BU, United Kingdom