Summary of Contents for SUNSET VC1114 Series
- Page 1 Instructions for Use Passive Heated Breathing Circuit VC1114 Series Distributed by Sunset Healthcare Solutions 180 N Michigan Ave Ste 2000 Chicago, IL 60601 IFU-00040 Rev 2.01 www.sunsethcs.com 2022-08-10...
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Page 2: Table Of Contents
The Passive Heated Breathing Circuit is intended to convey moistened breathing gas between the humidifier and adult patient. The user has to ensure, that the physical properties of the circuit are suitable for the humidifier, ventilator and application. The circuit consists out of a connection tube and inspiratory limb. -
Page 3: Symbols On The Packaging
1. Symbols on the Packaging Observe the warning and safety instructions in the user’s manual. Follow the user’s manual Manufacturer Catalog number Batch number CAUTION: U.S. Federal law restricts this device to sale by or Rx only on the order of a physician Single Use Use-by date Do not use the product if the package is damaged. -
Page 4: Warnings And Cautions
2. Warnings and Cautions • Only use the Passive Heated Breathing Circuit in combination with the MR850 Heated Humidifier from Fisher & Paykel Healthcare. • Retain these instructions for use for future reference. • Always connect-disconnect the tubes from the humidifier, ventilator and mask by using the grips on the cuff. -
Page 5: Intended Use
• Do not reuse the Passive Heated Breathing Circuit. The Passive Heated Breathing Circuit is a single use product. Multiple use could lead to contamination of the product and the patient. • The Passive Heated Breathing Circuit should always be replaced after 30 days of use. -
Page 6: Device Description
4. Device Description Passive Heated Breathing Circuit: 1. Short tube 2. Inspiratory limb Patient Insp interface Inspiratory Ventilator limb Airway probe port Short tube Heating wire cable Chamber probe port Humidi er 5. Directions for Use System compatibility The Passive Heated Breathing Circuit is available for the patient category Adult. -
Page 7: Cleaning And Disposal
How to connect 1. Remove the Passive Heated Breathing Circuit from the packaging. 2. Before setup, check your tubing and connectors for any damage. Also ensure that there is sufficient water in the reservoir of the MR850 Heated Humidifier. 3. Connect the short tube to the ventilator and MR850 Heated Humidifier chamber. 4. -
Page 8: Operating Conditions
7. Operating Conditions Ambient Temperature: 18°C – 26°C, 64.4°F - 78.8°F Relative humidity: 5% – 95% Atmospheric pressure: 800 - 1200 hPa Maximum operating pressure: 60 hPa 8. Storage and Transport Conditions The device and its components should be transported and stored in their original packaging and protected from direct sunlight and dust. - Page 9 Immunity levels Immunity test levels Phenomenon Professional healthcare Home facility environment healthcare environment Immunity Test Compliance + 8 kV contact Electrostatic Discharge IEC 61000-4-2 + 2 kV, + 4 kV, + 8 kV, + 15 kV air 3 V/m 10 V/m Radiated Immunity IEC 61000-4-3 80 MHz-2,7 GHz 80% AM at 1 kHz 80 MHz-2,7 GHz 80% AM at 1 kHz...
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Page 10: Product Specifications
10. Product Specifications Patient Inspiratory Expiratory Product Specification Short tube category limb limb Length 0.6m / 2ft 1.6m / 5ft 0.25" Internal 19mm / 0.75" 19mm / 0.75" diameter Adult VC1114 n.a. Flow resistance, <0,06hPa/l/min <0,06hPa/l/min R@30l/min Compliance, <5ml/hPa <5ml/hPa C@60hPa 11.
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