Instructions for Use
16 Pages
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Page 1
OASIS (Oxygen & Suction Integrated System) Instructions for Use
702-0012.8 May 2014
Contents 1.
Symbols ... 2
2.
Warnings and Cautions ... 2
3.
4.
5.
6.
2.1.
Warnings! ... 2
2.2.
Cautions! ... 3
Functional Description ... 4 3.1.
Intended Use ... 4
3.2.
Technical Description ... 4
Operating Instructions ... 4 4.1.
Pre-use Checks ... 4
4.2.
Connection of the Gas Pressure Regulator to a Cylinder ... 4
4.3.
Oxygen Delivery ... 5
4.4.
Suction Delivery ... 5
4.5.
Removing the Regulator from the Cylinder ... 5
4.6.
Suction Jar Systems ... 5
4.7.
Suction Jar Compatibility ... 6
4.8.
Suction Jar Compatibility ... 7
Cleaning and Disinfection ... 8 5.1.
After Every Use ... 8
5.2.
Suspected Contamination ... 8
Maintenance... 8 6.1.
User Maintenance and Inspection ... 8
7.
Specification ... 9
8.
Parts and Spares... 10
9.
Distributor Details ... 11
1.
Symbols Warning!
Indicates a potentially hazardous situation which, if not avoided, could result in personal injury to the user or others
Caution!
Indicates a potentially hazardous situation which, if not avoided, could result in damage to the equipment or property
Note
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
Service due date
1304X12345
Date of manufacture identification
YYMM
2.
Warnings and Cautions
2.1.
Warnings!
Read through this entire instruction manual before using or showing others how to use this OASIS. As with all medical equipment, attempting to use this device without a thorough understanding of its operation may result in patient or user injury.
Oxygen therapy may be a critical treatment. A flowmeter should be used in strict accordance with the prescription and instructions of a qualified clinician. The effectiveness of supplemental oxygen therapy can only be determined by continuous monitoring of blood oxygen levels.
Ensure that the oxygen cylinder is securely fastened to the trolley base. When the flowmeter is turned off isolate the patient from the equipment by disconnecting the delivery tube from either the patient or the flowmeter.
Only appropriately trained service personnel working in controlled conditions must perform disassembly, assembly and testing of this equipment.
Do not submerge in water or allow any fluid to enter the equipment. If you have reason to suspect that fluid or other ingress has occurred remove the device from use and contact the manufacturer.
Check the cylinder contents before use and at regular intervals during use as low cylinder pressure may result in poor or non-performance of the equipment. Always change the oxygen cylinder when the oxygen cylinder contents gauge is showing red. 2
OASIS has been tested with the suction jar systems indicated in this manual. The use of suction jar systems other than those listed and/or approved by the manufacturer may result in poor or nonperformance of the equipment.
The accuracy of the flowmeter and suction device may be affected if the input pressure is other than that stated in the specifications.
Oxygen is not flammable, but the presence of oxygen will drastically increase the rate and severity of combustion. Hydrocarbons such as oil or grease become highly combustible in the presence of oxygen. Oxygen must never be allowed to contact oil, grease or other petroleum-based substances.
Never administer oxygen while smoking or when near an open flame. Oxygen cylinders have fill pressures up to 20,000 kPa (200 bar). Never use medical oxygen from a cylinder without first reducing the pressure to a safe level through a suitable pressure regulator.
Ensure that the threaded fittings or indexing pins on the regulator are properly mated and tightened before opening the cylinder valve.
Never install a pin index regulator with more than one Yoke Seal between the cylinder and the regulator. Before attaching the regulator verify that the post valve is not already fitted with a Yoke Seal. Never add a second Yoke Seal to the regulator inlet while one is in place.
Make sure that the pin-indexed or threaded fittings on the regulator inlet are compatible with the gas cylinder on which it is to be fitted. Never attempt to force an incompatible connection.
The threaded bullnose connection on a UK medical oxygen cylinder may be the same as that for a UK medical air cylinder. Ensure that you have the correct cylinder for the application. OASIS and its regulator are intended for use with oxygen only and must not be connected to an air cylinder.
Before removing a regulator from a cylinder fully close the cylinder valve and release all gas from the regulator.
Never use oxygen as a pressure medium to purge obstructed pipelines or equipment, to operate pneumatic tools, or to build up any pressure in tanks.
Never permit compressed medical gases to enter a regulator suddenly. Always open the cylinder valve slowly. Do not stand in front of a regulator outlet when opening the cylinder valve.
Do not use or store oxygen equipment near excessive heat (>50 °C or 125 °F) or an open flame. Use only lubricants recommended by the manufacturer when servicing the OASIS.
The use of lubricants other than those recommended by the manufacturer may result in fire or explosion.
OASIS must always be used in an upright position. When fitting OASIS to a patient trolley ensure that the front membrane panel is vertical.
2.2.
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 device is not suitable for autoclaving.
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3.
Functional Description
3.1.
Intended Use OASIS is an oxygen flowmeter and a suction regulator integrated into one device, driven by a single oxygen cylinder. It is designed to provide controllable delivery of supplemental oxygen and suction in emergency situations (model dependent) or when patients are being moved on patient trolleys. OASIS is intended to be fitted to the head end of patient trolleys to provide easy access to both oxygen and suction where and when it is needed most. The integrated, sturdy design provides protection from damage in a harsh environment. The oxygen flowmeter is of fixed orifice type, providing eleven pre-set flow rates selectable by turning the control knob to the required position. The flow rate at each position is shown through a window in the body of the flowmeter and is given in units of litres per minute (l/min). The patient or outlet connection barb is situated underneath the OASIS directly below the flowmeter control knob.
3.2.
Technical Description OASIS comprises a fixed orifice Dialflow Meter (range 0-15 l/min) and a venturi vacuum generator mounted in a common manifold and driven by pressurised oxygen supplied from an oxygen cylinder via a suitable pressure regulator. OASIS can be supplied complete with the optional pressure regulator either permanently attached or provided with a probe (quick connector). The suction and oxygen system includes a control valve for switching suction on, a gauge to monitor the vacuum level and a back check valve to prevent positive pressure from exhausting the contents of the suction jar or tube in a hazardous manner. The suction delivery meets the requirements of BS EN ISO 10079-3:2009 Medical Suction Equipment. Suction equipment powered from a vacuum or pressure source. A Dialflow Meter can be set to deliver eleven different flow rates or turned off as detailed in section 7. The flow rate is indicated through a window at the top of the oxygen control dial. A detent system resident in the control dial assembly ensures a positive tactile setting and inadvertent adjustment. The flowmeter is permanently fitted to the OASIS module.
4.
Operating Instructions
4.1.
Pre-use Checks Check the device is securely attached or mounted. Check the oxygen supply is connected and that sufficient oxygen is available. Check that suction is available by occluding suction wand and observing the vacuum gauge. Turn the flow selection dial to its highest setting and check that gas flow can be felt at the patient end of the supply tubing.
4.2.
Connection of the Gas Pressure Regulator to a Cylinder Check that the cylinder type and regulator inlet connector are compatible. Check the presence and condition of the input connector seal on the regulator. Note: For pin-index regulators this is a washer type seal (yoke seal), for bull-nose regulators and oring. Fit the regulator to the cylinder ensuring that it is properly mated and the connectors are done up. Hand tight is sufficient. 4
Open the cylinder valve with a suitable cylinder key. Check the regulator cylinder contents gauge to verify that there is sufficient gas available. Check that the ‘Low Pressure’ indicator on the front face of the OASIS manifold does not show red (i.e. indicator fully forwards).
4.3.
Oxygen Delivery Connect a sufficient length of oxygen tubing (not supplied) to the outlet barb. Connect the other end of the oxygen tubing to the patient or patient enclosure using the appropriate connector (not supplied). Determine the appropriate oxygen flow rate in l/min required for the patient. Turn the control knob anticlockwise until the required rate is visible in the viewing window. Continue to monitor the patient as advised by the clinician. Continue to check the cylinder contents gauge on the regulator. Upon completion of the therapy turn the control knob to zero and disconnect the delivery hose from the patient.
4.4.
Suction Delivery Prepare the suction jar system in accordance with the manufacturer’s instructions. If you are intending to use an autoclavable suction jar system ensure that a hyrdophobic filter and overflow protection device is fitted. Note: Autoclavable suction jar systems have single use hydrophobic filter/overflow protection devices, which should be replaced with each new use/patient. The disposable liner systems recommended for OASIS (refer to ‘Suction Jar Systems’ table) have an integral hydrophobic filter and overflow protection device. Connect the suction hose (supplied) between the suction barb on the OASIS manifold and the barb on the suction jar marked ‘Vacuum’. Connect suction hosing and wand (not supplied) to the barb on the suction jar marked ‘Patient’. This tubing is used for removing fluids from the patient and will deposit into the suction jar. Note: If these hoses are reversed the suction device will not operate correctly. Fit the suction jar into the cradle provided on the bottom of the trolley. To activate the suction unit turn the control knob anticlockwise.
4.5.
Removing the Regulator from the Cylinder To remove the regulator from the cylinder, first ensure the cylinder valve is closed. Bleed off any residual gas pressure in the system by turning on either the oxygen or suction delivery systems until flow ceases. Undo and remove the regulator from the cylinder.
4.6.
Suction Jar Systems Suction jar systems can generally be broken down into autoclavable and disposable types. Autoclavable systems have a rigid suction jar with a sealable lid. Following cleaning and sterilisation they may be reused. A disposable hydrophobic filter is fitted to such systems and should be replaced after every use. Disposable systems comprise either a rigid suction jar into which a disposable liner is fitted (the rigid jar being reusable) or a rigid or semi-rigid canister requiring no other components and being wholly disposable. The disposable systems recommended for use with the OASIS (refer appropriate table) have integrated hydrophobic filters and overflow protection devices and no other provision need be made in this regard. 5
Components from single use or disposable systems should never be re-used and no attempt should be made to clean or sterilise them.
4.7.
Suction Jar Compatibility OASIS has been tested and found to be compatible with the suction jar systems detailed in the table provided. Some 2 litre size jars shown in the table, whilst compatible with the OASIS suction regulator, are too tall and are liable to be broken should the trolley be lowered or put into the Trendelenberg position. These suction jar systems are therefore considered incompatible with OASIS and are shown with the manufacturer’s part number crossed out (e.g. XXX XXXX). For the same reason all 3 litres and larger suction jar systems are incompatible with OASIS.
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4.8.
Suction Jar Compatibility
Manufacturer/Model Abbott Receptal
Allegiance Medi-Vac Guardian Medi-Vac Flex Advantage
Medi-Vac CRD
Tyco Sep-T-Vac
Description Re-usable suction jar for disposable liner Disposable liner OASIS Cradle Type Disposable canister OASIS Cradle Type Re-usable suction jar for disposable liner Disposable liner OASIS Cradle Type Re-usable suction jar for disposable liner Disposable liner OASIS Cradle Type
0.8/1.0 Litre
1.2/1.5 Litre
2.0 Litre
W064 L212 A
E124 F807 A
E123 F806
1230CE
65652-611 65651-910 B 65652-511 1510CE
1212CE B 65652-616 65651-920 B 65652-516 1515CE
8888-310052 B 8888-310839 8888-310821 B
8888-310151
Disposable canister OASIS Cradle Type Re-usable suction jar for disposable liner Disposable liner OASIS Cradle Type
8888-310003 B
Re-usable suction jar for disposable liner Disposable liner OASIS Cradle Type
3833-132 9910-340 B
Autoclavable suction jar OASIS cradle type Re-usable suction jar for disposable liner Disposable liner OASIS Cradle Type
MAK1000 A
8888-310813 8888-310995
VacSax
Flowmeter Spa Monokit Autoclavable Monokit Disposable
5113080 B
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3833-090 9910-208 B
5.
Cleaning and Disinfection
Ensure the OASIS is disconnected from the gas supply before attempting to clean it. Caution! This device is not suitable for autoclaving.
5.1.
After Every Use Use a mild disinfectant soap solution and hot water to clean external parts in accordance with hospital procedures.
5.2.
Suspected Contamination If you suspect that the OASIS is contaminated remove it from use and refer to the OASIS Service Manual. Never immerse the device in any fluid or attempt to clean internal parts whilst fully assembled.
6.
Maintenance
6.1.
User Maintenance and Inspection OASIS and its oxygen pressure regulator require servicing every 4 years. A Service Due date is given on both device labels as a reminder. Servicing must be carried out by a suitably qualified person working in a controlled environment. The Service Manual can be obtained from your local BPR Medical distributor, details of which can be found at www.bprmedical.com. A valid decontamination certificate must accompany equipment returned for servicing. For reasons of Health & Safety, equipment returned for service without a valid decontamination certificate will be returned without further processing.
6.1.1. Visual Inspection All devices should be inspected every 6 months or when there is reason to believe it has sustained damage or may not be working at full performance. Regulator Checklist:
Input seal integrity (o-ring or dowty seal) Cylinder contents gauge in good condition. Needle registers in the green area of the gauge on a full cylinder and zero when not connected to a cylinder
Sintered bronze filter in place and not blocked by debris Labels intact and legible Service due in the next 6 months? OASIS Manifold Checklist:
Vacuum gauge in good condition Low Pressure indicator shows when system pressure is removed and disappears when system pressure is restored
High pressure hose between regulator and manifold is in good condition OASIS is securely fixed to the trolley, no movement Is the device due to be serviced in the next 6 months?
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6.1.2. Leak Test Flowmeter Leak Through: Connect and charge the system to a full cylinder in accordance with Section 5. Check that the oxygen and suction control knobs are at zero (fully clockwise) and the OASIS low-pressure indicator is not showing red. Connect one end of a length of hose to the flowmeter outlet barb and place the other end into a container of water. Check that there are no bubbles coming from the end of the tube, which would indicate leak through. External Leak – Following on from the test above, turn off the cylinder and leave the system charged for 1 hour. At the end of this time ensure that the system pressure hasn’t dropped such that the low-pressure indicator has come forward and is now showing red. Note: If the low pressure indicator does come forward, re-charge the system and check each joint for leaks using a proprietary leak detector spray until the leak is found. 6.1.3. Flow Rate Test Verify oxygen flow rates at all flow settings against specification (i.e. within ±10% at 1 l/min and above or ± 20% below 1 l/min). 6.1.4. Suction Test Verify maximum suction capability by occluding the suction outlet, turning the control knob fully anticlockwise and checking the suction gauge.
7.
Specification
Specification
Value
Oxygen Dialflow Meter Nominal Flow Rates
0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,10, 15
Flow Accuracy
±10% of setting at 1 l/min and above, ±20% of setting below 1 l/min across the full input range
Delivery Hose
6.0 mm inside diameter Transport and Storage Temperature: -20°C to 60°C (-4°F to 140°F)
Environmental Operating Temperature: -20 °C to 60 °C (-4 °F to 140°F) Regulatory
CE: Medical Device Directive 93/42/EEC – Active Medical Device – Class IIa
Effect on accuracy as a result of: i) varying inlet pressure
Typically less than 15% change across the input pressure range
ii) varying outlet resistance
Less than 1% of reading up to 5kPa (50cmH2O) back pressure
iii) varying temperature
Less than 0.2% of reading per degree Celsius Medium
Medium/High
High
Blue Venturi
Gold Venturi
Silver Venturi
Vacuum Range
0 - 45 kPa (+5 /-30 kPa)
0 - 55 kPa (+5 /-30 kPa)
0 - 35 kPa (+5/-30 kPa)
Vacuum Flow
10 - 16 l/min
15 - 25 l/min
38 - 60 l/min
Suction
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Gas Consumption (typical)
20 l/min
30 l/min
85 l/min
Recommended Suction Hose
7.5 mm inside diameter
7.5 mm inside diameter
7.5 mm inside diameter
Pressure Regulator P1 Maximum Input Pressure
20,000 kPa
P3 Minimum Input Pressure
900 kPa
Outlet Pressure Stated at 10,000 kPa Input Pressure and Flow of 1 l/min
400 kPa
Minimum Flow Capacity
80 l/min
Q1 Standard Discharge
40 l/min
P2 Outlet Pressure Stated at Input Pressure P3 and Flow Q1
400 kPa
Applied Standards BS EN 1041
Information supplied by the manufacturer of medical devices
BS EN ISO 5359+A1
Low-pressure hose assemblies for use with medical gases
BS EN ISO 10079-3
Medical suction equipment. Suction equipment powered from a vacuum or pressure source
BS EN ISO 10524-1
Pressure regulators for use with medical gases. Pressure regulators and pressure regulators with flow-metering devices
BS EN ISO 14971
Medical devices. Application of risk management to medical devices
BS EN ISO 15223-1
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
8.
Parts and Spares
Part Number
Description
Connection
812-0026
OASIS - Bedrail Mount - 1.1m Hose - Medium Suction
Fixed to Pressure Regulator
812-0028
OASIS - No Bracket - 1.1m Hose - Medium Suction
Fixed to Pressure Regulator
812-0029
OASIS - Bedrail Mount - 1.1m Hose - Medium Suction
BS 5682
812-0030
OASIS - Medirail Mount - 1.1m Hose - Medium Suction
Fixed to Pressure Regulator
812-0031
OASIS - Medirail Mount - 1.1m Hose - Medium Suction
BS 5682
812-0034
OASIS - No Bracket - 1.1m Hose - High Suction
Fixed to Pressure Regulator
812-0035
OASIS - Bedrail Mount - 1.1m Hose - High Suction
Fixed to Pressure Regulator
812-0036
OASIS - Bedrail Mount - 1.1m Hose - High Suction
BS 5682
812-0037
OASIS - Medirail Mount - 1.1m Hose - High Suction
Fixed to Pressure Regulator
812-0038
OASIS - Medirail Mount - 1.1m Hose - High Suction
BS 5682
812-0039
OASIS - Medirail Mount - 0.6m Hose - Medium Suction
Fixed to Pressure Regulator
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812-0040
OASIS - Bedrail Mount - 2.5m Hose - Medium Suction
Fixed to Pressure Regulator
812-0041
OASIS - Bedrail Mount - 3.0m Hose - Medium Suction
BS 5682
812-0042
OASIS - Bedrail Mount - 3.0m Hose - Medium Suction
Fixed to Pressure Regulator
812-0043
OASIS - Bedmount - 0.45m Hose - Medium Suction
Fixed to Pressure Regulator
812-0044
OASIS - Medirail Mount - 1.1m Hose - 60 kPa
BS 5682
812-0045
OASIS - Hill-Rom Mount - 1.1m Hose - Medium Suction
BS 5682
812-0046
OASIS - Hill-Rom Mount - 1.1m Hose - Medium Suction
Fixed Pressure Regulator
Spare Parts and Servicing 602-0132
Cradle - Size A
602-0133
Cradle - Size B
504-0008
Exhaust Silencer
812-0027
Cradle Securing Kit
999-0004
OASIS Service – Pin Index Pressure Regulator
999-0005
OASIS Service – Bull-nose Pressure Regulator
999-0006
OASIS Service – No Pressure Regulator
9.
Distributor Details
BOC Healthcare Customer Service Centre Priestly Road Worsley Manchester M28 2UT T: +44 (0)8456 447 764 F: +44 (0)8450 870 062 www.bochealthcare.co.uk
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BPR Medical Limited
T: +44 (0)1623 628 281
22 Hamilton Way, Mansfield
F: +44 (0)1623 628 289
Nottinghamshire
NG18 5BU, United Kingdom
www.bprmedical.com