Parker Porter Silhouette Disposable Breathing Circuit, Second..., Instructions For Use And Installation

Page 1: ...ument com Silhouette 22JAN2024 Parker Hannifin Corporation Porter 245 Township Line Road Hatfield PA 19440 Office 215 723 4000 Silhouette Disposable Breathing Circuit Second Generation Instructions fo...

Page 2: ...Failure to properly operate and maintain this device may result in patient user harm and or damage to equipment Table Of Contents 1 Device Information 3 1 1 Intended Use 3 1 2 Models and Packages 3 1...

Page 3: ...otherwise Part Numbers Part Description SIL ADPT PKG Silhouette Breathing Circuit Accessory Package SIL SIZER 4 Silhouette Sizers SIL2 RETRO PKG Silhouette Retrofit Package SIL2 LG 12 Silhouette Large...

Page 4: ...Slide Bolo 3 Inhalation right and Exhalation left Lines 4 H Union 5 Capnography Barb 1 3 2 Silhouette Retro Fit Package SIL2 RETRO PKG Reusable Description 1 Silhouette Sizers Pediatric Small Medium L...

Page 5: ...used by a healthcare professional trained in the use and administration of N2O and O2 gases The device is designed for use with a gas delivery and scavenging system intended for pain management and or...

Page 6: ...uency sources or other heat sources the user must adhere to the instructions for use of those devices to avoid ignition of combustible materials NOTE If a serious incident death or any intervention ha...

Page 7: ...bing from the vacuum control device Do not disconnect vacuum tubing from vacuum controller to HVE 2 Push the Cannula Adapter 1 on to the front of the bag tee fresh gas port with the cannula barb facin...

Page 8: ...ger diameter Connect VBA as shown and attach to vacuum controller AVS 5501 RK 2 3 Compatible Vacuum Controllers Porter In Line Vacuum Control Matrx Scavenger Control Valve AVS Automatic Vacuum Switch...

Page 9: ...h 1 Attach one end of the larger diameter of the Fresh Gas and Vacuum Hose 1 to the larger diameter of the H Union of the Silhouette Breathing Circuit 2 2 Following the steps in Section 2 1 Vacuum Blo...

Page 10: ...3 1 Setup and Prechecks WARNING The user should observe the patient to prevent over sedation in the event of an O2 failsafe malfunction or a crossed lines situation If a patient becomes overly sedated...

Page 11: ...um flow using vacuum control knob 2 and sight glass 3 Adjust vacuum flow by using the vacuum control knob 1 and sight glass 2 Adjust vacuum flow by using vacuum control knob 1 and pressure gauge 2 6 S...

Page 12: ...barb into the right nostril Ensure nasal barb is inserted fully 5 Rotate the nasal hood down over the nose until contact is made and release the mask so that it wraps down on the bridge of the nose 6...

Page 13: ...ocedure and adjust vacuum flow as necessary to maintain effective scavenging as described in Section 3 2 14 Upon completion of the procedure remove the breathing circuit from the patient and dispose o...

Page 14: ...ontroller until all visible dirt and soil is removed Take extra care to wipe the outside of the connection port area and vacuum control knob as these are the most handled areas of the device A soft br...

Page 15: ...izer type Prevacuum Preconditioning Pulses 4 Full Cycle 4 minutes at 270 oF 132 oC dry time 30 minutes Full Cycle 3 minutes at 273 oF 134 oC dry time 40 minutes Configuration Individually wrapped in t...

Page 16: ...catalog number of the device and is used for identification of the device EN ISO 15223 1 2021 clause 5 1 6 Serial Number Indicates the manufacturer s serial number of the device and is used for ident...

Page 17: ...ortant cautionary information such as warnings and precautions that cannot be presented on the medical device itself EN ISO 15223 1 2021 clause 5 4 4 Caution Warning Indicates important cautionary or...

Page 18: ...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 2 repaired altered...