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Summary of Contents for Parker Porter Silhouette Disposable Breathing Circuit, Second Generation
- Page 1 Parker Hannifin Corporation Porter 245 Township Line Road Hatfield, PA 19440 Office 215-723-4000 Silhouette™ Disposable Breathing Circuit, Second Generation Instructions for Use and Installation Guide FM-1500 Rev. A www.PorterInstrument.com/Silhouette 22JAN2024...
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Page 2: Table Of Contents
READ INSTRUCTIONS FOR USE COMPLETELY BEFORE OPERATING THIS DEVICE This document contains warnings, cautions, instructions for use, and maintenance information that the user must completely comprehend before using this device. Failure to properly operate and maintain this device may result in patient/user harm and/or damage to equipment. Table Of Contents Device Information.......................... -
Page 3: Device Information
1. Device Information 1.1. Intended Use The Silhouette Breathing Circuit, second generation, (referred to as Silhouette Breathing Circuit) is intended to deliver a mixture of nitrous oxide and oxygen gases to a patient through an inhalation route and to scavenge waste analgesic gas through an exhalation route. 1.2. -
Page 4: User Interface
1.3. User Interface 1.3.1. Silhouette Breathing Circuit (disposable) Description Nasal Hood (Pediatric, Small, Medium, Large) Slide Bolo Inhalation (right) and Exhalation (left) Lines H-Union Capnography Barb 1.3.2. Silhouette Retro-Fit Package (SIL2-RETRO-PKG) (Reusable) # Description Silhouette Sizers (Pediatric, Small, Medium, Large) 2 Fresh Gas and Vacuum Hose 3 Cannula Adapter 4 Bag Tee Cap... -
Page 5: General Description/Principles Of Operation
1.4. General Description/Principles of Operation The Silhouette Breathing Circuit is a second-generation device composed of an inhalation tubing line, exhalation tubing line, and nasal hood. The device features a form-fitting design with a tight fit at the interface between the patient's face, cannula barb, and capnograph port. The device is available in four sizes (pediatric, small, medium, and large) for proper fit onto a patient's nose. -
Page 6: Warnings And Cautions
1.7. Warnings and Cautions Warnings and cautions are listed where relevant to a certain section of this document. A WARNING is an instruction, procedure, or explanation of hazards that may result in injury. A CAUTION is an instruction, procedure, or explanation of hazards that may result in damage to a product, equipment, or the environment. -
Page 7: Specifications
1.10. Specifications Dimensions Weight See Section 5 See Section 5 Connections Environmental Mixed Gas: Connect to 0.250 in. tube. Temperature Vacuum: Connect to 0.400 in. tube. Storage/Transport: 50°F - 80°F (10°C - 27°C) Operational: 50°F - 100°F (10°C – 37.78°C) Relative Humidity Storage/Transport: 40-60% Operational: ambient, non-condensing... -
Page 8: Vacuum Block Adjuster Installation
2.2. Vacuum Block Adjuster Installation Vacuum Block Adjuster Optional - Only if using Porter In-Line 5501-RK (5501-RK) or Porter AVS (AVS-5000) Vacuum Control: Connect Vacuum Block Adjuster (VBA) (1) in line with the Silhouette vacuum hose and either In- Line or AVS controller. VBA must be on the breathing circuit / mask side of the vacuum controller. - Page 9 Matrx Scavenger Control Valve Attach one end of the larger diameter of the Fresh Gas and Vacuum Hose to the larger diameter of the H-Union of the Silhouette Breathing Circuit. Attach the other end of the larger diameter hose of the Fresh Gas and Vacuum Reusable hose to the White Adapter on the front of the Scavenger Control Valve (1).
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Page 10: Connecting The Conscious Sedation Flowmeter
2.5. Connecting the Conscious Sedation Flowmeter Note: Conscious Sedation Flowmeter shown is an MDM, however steps are the same with all flowmeters that have a 22mm fresh gas port. Conscious Sedation Flowmeter Connection Attach one end of the smaller diameter Fresh Gas and Vacuum Reusable Hose (1) to the smaller diameter of the H-Union of the Silhouette Breathing Circuit (2). -
Page 11: Operating Instructions For Vacuum Controller
3.2. Operating Instructions for Vacuum Controller Matrx Porter Automatic Vacuum Switch In-Line Vacuum Control Scavenger Control Valve The In-Line Vacuum Control The AVS will automatically The Matrx Scavenger Control is manually operated and open with a minimum of 1.5 Valve is manually operated must be opened by pushing L/min of gas flow. -
Page 12: Operating Instructions For Silhouette Breathing Circuit
3.3. Operating Instructions for Silhouette Breathing Circuit Before the procedure starts, begin flowing 100% O2. Place the colored sizer masks over the patient’s nose to determine appropriate mask size patient. Select appropriate size Silhouette circuit. Note: The Sizers are resuable, refer to Section 4 for cleaning instructions. -
Page 13: Maintenance
Use the Clip Strap to secure the Fresh Gas and Vacuum Hose to side of chair or to patient clothing. If End tidal CO (EtCO ) monitoring is being used, attach capnography barb (SIL2-CAPNO - sold separately) to sample line luer lock, then insert capnography barb into capnography port of the Silhouette nasal hood. -
Page 14: Cleaning
4.1. Cleaning Silhouette Breathing Circuit is a single-use disposable device and should not be cleaned. The accessories (Silhouette Sizers Mask and Fresh Gas and Vacuum Tube) are reusable and must be cleaned between each use. Cleaning of the Silhouette Breathing Circuit accessories has been validated with the following instructions. -
Page 15: Disposal
Hold the product upright to allow water to drain from the product. Rinse under running water for three minutes per component. Thoroughly rinse all lumens and internal surfaces. For Manual Cleaning: Dry product with clean, dry, lint free cloths. For Automated Cleaning: Place the products onto the washer’s rack system and run the washer. -
Page 16: Symbols Glossary
6.Symbols Glossary The following symbols may be used throughout this document, as well as on device labels and packaging. Symbol Title of Symbol Description of Symbol Indicates the medical device manufacturer and is accompanied by the name and address of the Manufacturer manufacturer. - Page 17 Symbol Title of Symbol Description of Symbol Indicates the need for the user to consult the instructions important cautionary information such as warnings and precautions that Caution cannot be presented on the medical device itself. [EN ISO 15223-1:2021, clause 5.4.4] Indicates important cautionary or warning information Caution/Warning to the user that is presented in the instructions for use...
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Page 18: Warranty
Parker Hannifin Corporation. Parker Hannifin Corporation shall not be liable for any damage, injury or loss arising out of the use of the product, whether as a result of a defect in the product or otherwise, if, prior to such damage, injury or loss, the product was (1) damaged or misused;...
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