SUNSET VC1114 Series Passive Heated Breathing Circuit Instruction Manual

: June 10, 2024
: SunSet

SUNSET VC1114 Series Passive Heated Breathing Circuit

Product Information

The Passive Heated Breathing Circuit VC1114 Series is a single-use device that carries moistened gas from the humidifier to the patient requiring mechanical ventilation. The product is distributed by Sunset Healthcare Solutions and is intended for adult patients only. The product consists of a short tube, inspiratory limb, patient interface, airway probe port, heating wire cable, and chamber probe port.

Symbols on the Packaging

Observe the warning and safety instructions in the user’s manual.
Follow the user’s manual.
Manufacturer
REF Catalog number
LOT Batch number
Rx only
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
Single-Use
Use-by date
Do not use the product if the package is damaged.
Permissible storage temperature
95% Air humidity during storage and transport.

Warnings and Cautions

The Passive Heated Breathing Circuit is a single-use device that must be replaced within the prescribed frequency to avoid potential infections. Proper hand hygiene (e.g. hand washing or hand disinfection) is mandatory before and after the replacement of the device.

Product Specifications

Device Description: Passive Heated Breathing Circuit VC1114 Series
Intended Use: Carry moistened gas from the humidifier to the patient requiring mechanical ventilation.
Compatibility: Adult patients only.
Storage and Transport Conditions: Permissible storage temperature of 95% air humidity.
Cleaning and Disposal: Single-use product; dispose of the product once the patient therapy has been completed or after a maximum of 30 days of usage.

Product Usage Instructions

Remove the Passive Heated Breathing Circuit from the packaging.
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.
Connect the short tube to the ventilator and MR850 Heated Humidifier chamber.
Connect the inspiratory limb (blue tube) to the MR850 Heated Humidifier chamber.
Remove the port plug before inserting the airway probe.
Push the chamber probe and airway probe into the breathing circuit. Ensure that both probes are pushed home.
Connect the heating wires of the MR850 Heated Humidifier to the cables of the tubes.
Verify that all connections are properly made.
Ensure there is a flow of air through all of the tubing.
Connect to the patient interface (e.g. mask, endotracheal tube) and use in accordance with the instructions in your patient interface, ventilator system or MR850 Heated Humidifier operating manual.

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.
The Passive Heated Breathing Circuit can be used in a hospital or homecare environment in combination with the Fisher and Paykel MR 850 Heated Humidifier. The circuit is intended for single-use only.

PLEASE READ ALL INSTRUCTIONS CAREFULLY BEFORE USE

Symbols on the Packaging

SUNSET-VC1114-Series-Passive-Heated-Breathing-
Circuit-FIG-1

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.
Do not pull the tube when disengaging the tube from the humidifier, ventilator or mask.
When using electrical products, always follow the standard safety precautions!
Do not cover the Passive Heated Breathing Circuit with any object including a textile insulation sleeve, a plastic sleeve, a blanket, etc., in order to avoid an elevated airflow temperature that can cause irritation of the airway.
Do not operate the Passive Heated Breathing Circuit close to other heat sources including lamps, electric blankets, etc., to avoid elevated airflow temperatures.
Do not use the Passive Heated Breathing Circuit without airflow.
Do not sterilize the Passive Heated Breathing Circuit.
Do not disassemble or intentionally damage the Passive Heated Breathing Circuit.
Do not insert or drop any object in the opening of the Passive Heated Breathing Circuit.
Do not make the Passive Heated Breathing Circuit subject to pressure, crushing or other mechanical stresses, as it can damage the Passive Heated Breathing Circuit.
If any tube of the Passive Heated Breathing Circuit is damaged (having holes, kinks, tears, exposed heating wires, etc.) or is not functional, do not try to repair the tube yourself. Immediately replace your Passive Heated Breathing Circuit.
Prior to use, inspect the Passive Heated Breathing Circuit for holes, deformation or any form of damage. When damaged, replace the Passive Heated Breathing Circuit immediately.
During use, check the Passive Heated Breathing Circuit frequently for holes, deformation or any form of damage. When damaged, replace the Passive Heated Breathing Circuit immediately.
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.
Do not clean the Passive Heated Breathing Circuit.
Dispose of the tube correctly according to your local government regulation.
This is a prescription device to be used exclusively under medical supervision.
Patients undergoing ventilation support are particularly susceptible to airway infections. Single use devices that are not replaced within the prescribed frequency may be a potential source of infection. Proper hand hygiene (e.g. hand washing or hand disinfection) is mandatory before and after replacement of the device.

Intended Use

The Passive Heated Breathing Circuit is used to carry moistened gas from the humidifier to the patient requiring mechanical ventilation.
The Passive Heated Breathing Circuit is single-use only.

Device Description

Passive Heated Breathing Circuit:

Short tube
Inspiratory limb

Directions for Use

System compatibility

The Passive Heated Breathing Circuit is available for the patient category Adult.
All the cuffs of the Passive Heated Breathing Circuit are standard cuffs. As such, the Passive Heated Breathing Circuit can be connected to ventilators and masks that have standard male/female outlet connectors (ISO 5356-1).

How to connect

Remove the Passive Heated Breathing Circuit from the packaging.
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.
Connect the short tube to the ventilator and MR850 Heated Humidifier chamber.
Connect the inspiratory limb (blue tube) to the MR850 Heated Humidifier chamber.
Remove the port plug before inserting the airway probe.
Push the chamber probe and airway probe into the breathing circuit. Ensure that both probes are pushed home.
Connect the heating wires of the MR850 Heated Humidifier to the cables of the tubes.
Verify that all connections are properly made.
Ensure there is a flow of air through all of the tubing.
Connect to the patient interface (e.g. mask, endotracheal tube) and use in accordance with the instructions in your patient interface, ventilator system or MR850 Heated Humidifier operating manual.

Cleaning and Disposal

The product is delivered in a clean status and is ready for use, unless the package has been opened or damaged. This is a single use product. Dispose of the product once the patient therapy has been completed or after maximum 30 days of usage.
Upon disposal clearly mark or damage the product to ensure that the product is not reused.
Disposal of the device shall be made in accordance with applicable hospital or national regulations for biologically hazardous waste.

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

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.
Temperature during storage and transport should not exceed 40°C (103°F) or be below 0°C (32°F) at a relative humidity from 5 % to 95%, non-condensing

EMC Compliance

Radiated RF Emission levels

Phenomenon	Immunity test levels
Professional healthcare facility environment	**Home healthcare

environment
Emissions| Compliance**
Radiated RF Emissions CISPR 11| Group 1
Radiated RF Emissions CISPR 11| Class B

Immunity levels

Phenomenon	Immunity test levels
Professional healthcare facility environment	Home

healthcare environment

Immunity Test| Compliance 1
Electrostatic Discharge IEC 61000-4-2| + 8 kV contact
+ 2 kV, + 4 kV, + 8 kV, + 15 kV air
Radiated Immunity IEC 61000-4-3| 3 V/m

80 MHz-2,7 GHz 80% AM at 1 kHz

| 10 V/m

80 MHz-2,7 GHz 80% AM at 1 kHz

Power Frequency Magnetic Field IEC 61000-4-8| 30 A/m 50 Hz or 60 Hz

Complies without any deviations from IEC 60601-1-2 and normative references.
Proximity fields from RF wireless communication equipment, Immunity test levels:

Frequency Range and Level: RF wireless communication equipment

Complies without any deviations from IEC 60601-1-2 and normative references.
Compliance with immunity test levels specified in IEC 60601-1-2, without deviations.

Product Specifications

Patient category| Product| Specification| Short tube| Inspiratory limb| Expiratory limb
---|---|---|---|---|---
Adult| VC1114| Length| 0.6m / 2ft| 1.6m / 5ft 0.25″| n.a.
Internal diameter| 19mm / 0.75″| 19mm / 0.75″
Flow resistance, R@30l/min|

<0,06hPa/l/min

|

<0,06hPa/l/min

Compliance, C@60hPa| <5ml/hPa| <5ml/hPa

Warranty

The Passive Heated Breathing Circuit is a respiratory consumable product and must be checked before first use otherwise warranty claims are excluded.

Distributed by
Sunset Healthcare Solutions 180 N Michigan Ave Ste 2000 Chicago, IL 60601
www.sunsethcs.com

Documents / Resources

| SUNSET VC1114 Series Passive Heated Breathing Circuit [pdf] Instruction Manual
VC1114 Series Passive Heated Breathing Circuit, VC1114 Series, Passive Heated Breathing Circuit, Heated Breathing Circuit, Breathing Circuit, Circuit
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