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Related Manuals for Penlon Sigma Delta Vaporizer MRI
Summary of Contents for Penlon Sigma Delta Vaporizer MRI
- Page 1 Sigma Delta Vaporizer MRI User Manual ANAESTHESIA SOLUTIONS...
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Page 3: Servicing And Repairs
The vaporizer is used in a The user should maintain a record MRI environment of the vaporizer’s performance. For any enquiry regarding the service or repair of this vaporizer, contact the nearest accredited Penlon agent*, or contact the Service Department at Penlon Limited. - Page 4 Information contained in the manual qualified anaesthetist. is correct at the date of publication. The policy of Penlon Limited is one There can be considerable variation in the effect of of continued improvement to its anaesthetic drugs on individual products.
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Page 5: Table Of Contents
CONTENTS Page USER RESPONSIBILITY WARNINGS AND CAUTIONS PURPOSE DESCRIPTION Operating Principles Controls SPECIFICATION Physical Dimensions Weight Capacity Filling System Concentration Control Dial Scale Environmental Flow Range Pressure Range FILLING AND DRAINING Key Filler System Quik-Fil System Screw Cap Fill System (Pour Fill) INSTALLATION Gas Port Transit Seals 6.2. - Page 6 CONTENTS PERFORMANCE CHARACTERISTICS Performance Graphs 8.1.1 Halothane Models 8.1.2 Isoflurane Models 8.1.3 Sevoflurane Models Temperature Compensation Pressure Effects 8.3.1 Ambient Pressure 8.3.2 Back Pressure Summary of Performance Specifications 8.4.1 Output Accuracy 8.4.2 Resistance to Gas Flow Effect of IPPV on Output Effect of Gas Composition on Output Output when Control is in the ‘Off’...
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Page 7: User Responsibility
Penlon Limited this manual and/or accompanying or its appointed agents. labels and notices when checked, This vaporizer must only be assembled, operated, maintained... -
Page 8: Warnings And Cautions
For Key-fill vaporizers (see an unauthorised person. It section 5.1) check that the key should be regularly serviced filler adaptor is labelled MR by a Penlon-authorised service Conditional. agent, trained technician or Note that Penlon MR Conditional engineer and by no other person adaptors are listed in section 11. - Page 9 WARNINGS AND CAUTIONS Do not use an unlabelled, the instructions given in the early-type key filler adaptor that User Maintenance section. may have been brought to the 10. The vaporizer must be filled only MRI facility from your hospital’s by suitably skilled and trained operating theatre.
- Page 10 Withdraw the vaporizer from use a secured upright position must if it has been overfilled. elapse before connection to an Contact Penlon Service anaesthetic breathing system. Department for advice. Movement during transport can result in over-dosage unless 19.
- Page 11 WARNINGS AND CAUTIONS 25. Anaesthetic machine designs 28. Check the liquid level frequently are constantly evolving, and new when using the vaporizer and models may differ dimensionally maintain the level between the from existing equipment. minimum and maximum marks. It is the user’s responsibility to The vaporizer control must be in ensure that the configuration the zero (0) position during the...
- Page 12 2. Penlon Sigma Delta vaporizers distributed by a drug company 36. An alternative means of should only be filled with drug delivering anaesthetic agent...
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Page 13: Purpose
PURPOSE The Sigma Delta MRI Vaporizer is designed for incorporation in the fresh gas supply system of continuous flow anaesthetic machines, directly connected between the flowmeter unit and the common gas outlet of the machine. The vaporizer is unsuitable for use within a breathing system ‘in circuit’... -
Page 14: Description
DESCRIPTION Operating Principles Each model is uniquely designed and tested for use only with the drug specified on the control dial knob. The vaporizer contains a chamber, the base of which holds the anaesthetic agent in liquid form. A wick ensures that the upper part of the chamber is filled with the saturated vapour of the agent. -
Page 15: Controls
DESCRIPTION Controls The vaporizer has a single, forward facing calibrated control (1) to regulate the vapour concentration delivered. The dial is locked at zero when not in use. To set a concentration level, push the dial assembly in and rotate anti-clockwise. -
Page 16: Specification
SPECIFICATION Physical Dimensions Width x Height x Depth Cagemount Selectatec Compatible with Interlock Drager Compatible Weight Approximate weight: 4.8 kg. Capacity Volume at MAX mark 250 ml (nominal) Volume at MIN mark 35 ml (nominal) After draining, approximately 60 ± 10 ml of liquid is retained by the wick. Filling System Key Filler (Agent Specific) Used with corresponding agent specific filler adaptor, see section 11 for... -
Page 17: Flow Range
Prima 451 MRI anaesthesia system. Specified MR environment The Sigma Delta Vaporizer MRI is validated for use in proximity to the 1000 gauss line, with scanners rated at 1.5 tesla and 3 tesla when used in compliance with user instructions.. -
Page 18: Filling And Draining
MRI scanning room. The key filler adaptor must be labelled MR Conditional. Penlon MR Conditional adaptors are listed in section 11. Remove any unlabelled, early-type key filler adaptors that may have been brought to the MRI facility from your hospital’s operating theatre. - Page 19 FILLING AND DRAINING Filling the Vaporizer This system manufactured compliance with ISO 5360. Check that the vaporizer concentration control (1) is in the 0 (zero) position as illustrated. Attach the keyed filler adaptor (2) to the bottle (3). Agent specific filler adaptors are listed in section 11.
- Page 20 FILLING AND DRAINING If the vaporizer has been inadvertently overfilled, excess liquid agent will spill from the drain hole in the keyed slot in the filler block. DO NOT REUSE THIS AGENT. Allow all the excess liquid to drain from the vaporizer before inserting the plug (5).
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Page 21: Draining The Vaporizer
FILLING AND DRAINING Draining the Vaporizer CAUTION To reduce atmospheric pollution in the operating room, it is recommended that vaporizer drainage should be performed in a fume cupboard or under an extractor hood. WARNING The vaporizer must be either secured to the anaesthetic machine or free standing on a level table so that in either case it is upright during the draining process. -
Page 22: Quik-Fil System
CAUTIONS 1. Penlon Sigma Delta vaporizers Firmly secure the vaporizer in a distributed by a drug company vertical position before filling. should only be filled with drug... - Page 23 FILLING AND DRAINING Quik-Fil System - Filling the Vaporizer Check that the vaporizer concentration control is in the off (‘0’) position. Remove the yellow protective cap from the anaesthetic agent bottle filler, checking that the bottle and filler mechanism are not damaged. Remove the vaporizer filler block cap and insert the bottle nozzle into the filler block, Rotate the bottle to align...
- Page 24 FILLING AND DRAINING Quik-Fil System - Draining the Vaporizer WARNING Do not drain the vaporizer or keep the drain funnel and key assembly (1) in the MR facility. To avoid spillage, check that the bottle to be used for draining has sufficient capacity for the volume of liquid to be drained.
- Page 25 Do not operate the vaporizer if the filler compatibility before using cap is not secured in position. vaporizers supplied by Penlon, its Incorrect concentration may be delivered distributors, or agents. to the patient and pollution may result.
- Page 26 FILLING AND DRAINING Draining the Vaporizer CAUTION To minimise atmospheric pollution in the operating room, perform vaporizer drainage in a fume cupboard or under an extractor hood. WARNING The vaporizer must be either secured to the anaesthetic machine or free standing on a level table, so that in either case it is upright during the draining process.
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Page 27: Installation
6. INSTALLATION Gas Port Transit Seals All new vaporizers CAUTION Inlet and outlet ports are sealed for delivery transit. Ensure that these seals are removed from the vaporizer before installation on the anaesthetic machine. Installing the Vaporizer on the Anaesthetic Machine WARNING Anaesthetic machine designs are... -
Page 28: Selectatec Compatible Models (With Interlock)
INSTALLATION 6.2.2 Selectatec Compatible Models - with Interlock Anaesthetic machine layout WARNING Anaesthetic machine designs are constantly evolving, models differ dimensionally from existing equipment It is the user’s responsibility to ensure that the configuration of the anaesthetic machine allows correct installation of the vaporizer. There must be sufficient clearance between the Selectatec manifold and the rear panelling/ frame of the machine to allow the vaporizer... - Page 29 INSTALLATION Pre-use Checks Interlock System - check that the interlock bolt (1) has moved outwards and only one vaporizer at a time can be turned on. Observe the WARNINGS below and carry out pre-use checks: (a) Section 7.1 (installing a new vaporizer) (b) Section 7.2 (reinstalling a vaporizer).
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Page 30: Cagemount (23 Mm) Taper Models
INSTALLATION 6.2.3 Cagemount (23 mm) Taper Models WARNINGS 1. If a vaporizer is transported when filled with liquid drug the control must be in the 0 (zero) position during transport and a period of at least ten minutes in a secured upright position must elapse before connection to an anaesthetic breathing system. -
Page 31: Drager Auto Exclusion Compatible Models
INSTALLATION 6.2.7 Drager Auto Exclusion Compatible (Interlock) Installation Carefully offer the vaporizer up to the manifold. Align the gas connection ports with the valve capsule on the manifold. (The capsule is referred to as the valve ‘cartridge’ in some user literature). -
Page 32: Pre-Use Checks
Output concentration tests should be (approximately 92 mmHg). carried out only by trained persons Remove the vaporizer. or a Penlon–trained engineer, using Use the flowmeter to set a suitable purpose-made calibrated a flow of 60 to 80 ml/min, agent analyser, e.g. -
Page 33: Daily Pre-Use Check List
PRE-USE CHECKS Please contact Penlon Check correct agent Technical Service or your delivery concentrations – use local Penlon-trained an agent analyser. engineer if you have any questions or issues regarding the installation and test procedures. Daily Pre-use Check List WARNING... -
Page 34: Performance Characteristics
PERFORMANCE CHARACTERISTICS Performance Graphs NOTE Variation of concentration output with (a) flow rates and (b) tem- perature are shown in this section. The output from individual units may vary slightly from the performance curve shown. 8.1.1 Halothane Models Variation of output with flow rate (Temperature: 20°C) value 0.6% 0.2%... -
Page 35: Isoflurane Models
PERFORMANCE CHARACTERISTICS 8.1.2 Isoflurane Models Variation of output with flow rate (Temperature: 20°C) value 0.6% 0.2% 0.2 1 12 13 14 15 Flow rate L/min Variation of output with temperature (Flow rate : 4 L/min) value 0.6% 0.2% Temperature °C... -
Page 36: Sevoflurane Models
PERFORMANCE CHARACTERISTICS 8.1.3 Sevoflurane Models Variation of output with flow rate (Temperature: 20°C) value 0.6% 0.2% 0.2 1 12 13 14 15 Flow rate L/min Variation of output with temperature (Flow rate : 4 L/min) value 0.6% 0.2% Temperature °C... -
Page 37: Temperature Compensation
PERFORMANCE CHARACTERISTICS Temperature At any other pressure the true output will be modified according Compensation to the equation: Temperature compensation C = S% x 101.3 provided by the operation of a variable resistance valve in the bypass passage. P is absolute pressure in kPa. The design provides compensation C is delivered concentration vol%, full... -
Page 38: Summary Of Performance Specifications
PERFORMANCE CHARACTERISTICS Summary of Effect of IPPV on Performance Output Specifications IPPV: Intermittent positive pressure ventilation. 8.4.1 Output Accuracy When tested in accordance with ISO 80601-2-13*, output will not deviate Under calibration conditions from the set concentration by more (temperature at 22°C ±1°C at sea than +30% / -20%. -
Page 39: Output When Control Is In The 'Off' (0) Position
PERFORMANCE CHARACTERISTICS 8.7 Output when Control is in the ‘Off’ (0) position Output vapour concentration when the control is in the ‘Off’ position (i.e. set at 0) will not exceed 0.05% vol., when tested in accordance with ISO 8835-4. Effect of Flush Valve Operation When tested in accordance with ISO 8835-4 the operation of the flush... -
Page 40: User Maintenance
The output of the vaporizer (see section 9.2). should checked other maintenance periodically, either: servicing must be carried out only (i) as part of a Penlon Service by Penlon-trained engineers. Contract (UK only). (ii) by Penlon-trained CAUTION engineer. Do not attempt to dismantle the... -
Page 41: Cleaning And Sterilisation
Do not use water or other liquids. shaft is suspected, the device must be referred to a Penlon- Draining - trained engineer. Halothane Models Interlock system vaporizers -... -
Page 42: Training Course
Returning the Vaporizer for Service or Repair Returning the vaporizer to Penlon The vaporizer must be drained and allowed to dry out before packing. Always use the original packaging, to prevent damage during transit. -
Page 43: References
Anaesthetic and respiratory equipment - conical connectors - Part 1: Cones and sockets (b) Agent Specific (Keyed) Filling System ISO 5360 Anaesthetic vaporizers - agent specific filling systems Trademarks Penlon, InterMed, Delta, and Sigma Delta are trademarks of Penlon Limited. Selectatec and Quik-Fil are GE trademarks. -
Page 44: Ordering Information
11. ORDERING INFORMATION Contact your distributor, or Customer Service at Penlon Ltd. Always state that the vaporizer is used in a MRI environment when ordering accessories or spares. Agent Specific (Keyed) filler adaptor WARNING - Refilling the vaporizer in the MRI facility: Always use a key filler adaptor that is labelled MR Conditional, as listed below. -
Page 45: Labels
12. LABELS Labelling Operating instructions (this user manual) Refer to user manual MR Conditional (i.e. poses no known hazard in a specified MR environment, with specified conditions of use, and specific configurations - see section 1, Warning 6). This label has a yellow background. - Page 48 56556-en D linkedin.com/company/penlon-ltd facebook.com/PenlonGlobal twitter.com/PenlonGlobal © Penlon Ltd. 2021. All rights reserved. Penlon and InterMed are trademarks of Penlon Limited. All other trademarks are the property of their respective owners. Penlon Limited Technical Support Sales Abingdon Science Park t +44 (0) 1235 547060 t +44 (0) 1235 547001 OBELIS S.A.
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