Sunset Healthcare TUB06HPR User manual

Instruction Manual
Heated CPAP Tube
for DreamStation and PR System One
TUB06HPR

Table of Contents
Introduction
The Sunset Heated CPAP Tube is designed to prevent condensation of
humidied air during CPAP treatment, also known as “rainout.”
When combined with a heated humidier, the Sunset Heated CPAP Tube
controls humidication by ensuring that air temperature does not cool prior
to inhalation. This supports comfortable and consistent treatment.
The Sunset Heated CPAP Tube is manufactured exclusively for use with the
Philips Respironics DreamStation and Philips Respironics System One.
2.3 Institutional Cleaning and Disinfection ......................................................7-8
2.4 Errors and Troubleshooting ............................................................................8
3.1 Operating Conditions ......................................................................................8
3.2 Storage and Transport Conditions ..................................................................8
3.3 FAQ ....................................................................................................................9
3.4 Replacement Components .............................................................................9
3.5 Product Specications ................................................................................. 10
3.6 Standards Compliance ................................................................................. 10
3.7 Warranty ........................................................................................................ 10
3.8 EMC Table ........................................................................................................11
3.9 Symbol Glossary ........................................................................................... 12
1.1 Components.....................................................................................................1
1.2 Indications for Use .........................................................................................1
1.3 Warnings and Cautions ..............................................................................2-3
2.1 Directions for Use........................................................................................4-5
2.2 Home Cleaning and Disinfection ..................................................................6
1. Understanding the Heated CPAP Tube
2. Use and Care
3. Additional Requirements

1
1.2 Indications for Use
The Sunset Heated CPAP Tube is a heated wire breathing tube intended to
provide warmed and/or humidied breathing gases before they enter a
patient's airway. It is indicated for single-patient reuse in the home and in
clinical settings, such as hospitals, institutions, sleep laboratories, and sub-
acute care facilities. It may be used with non-invasive ventilation for adult
patients. It is compatible with the Philips Respironics System One Heated
Humidier and Philips Respironics DreamStation Heated Humidier.
CAUTION: Federal law restricts this device to sale by or on the order of
a physician.
3
1
2
5
4
1. Humidier connector cuff
2. Connector lead
3. Squeeze release tabs
4. Mask-end cuff
5. Flexible tubing
1.1 Components
1. Understanding the Heated CPAP Tube

2
1.3 Warnings and Cautions
• WARNING: The Sunset Heated CPAP Tube is validated for use with two specic
humidiers: Philips Respironics DreamStation and Philips Respironics System One.
Do not use the Sunset Heated CPAP Tube in combination with other Humidiers.
• WARNING: The Sunset Heated CPAP Tube used with incompatible parts can result
in degraded performance.
• WARNING: Failure to use a mask or accessory that minimizes rebreathing of
carbon dioxide or permits spontaneous breathing can cause asphyxiation.
• WARNING: The user is accountable for the compatibility of the Sunset Heated CPAP
Tube and the humidier and all of the parts and accessories used to connect to
the patient before use.
• WARNING: Always connect-disconnect the tube from the humidier by using the
grips on the cuff. Do not pull directly on the tube.
• WARNING: To prevent disconnection of the tubing or tubing system during use,
only use accessories in compliance with ISO 5367 or ISO 80601-2-74.
• WARNING: Do not add any attachments to the Sunset Heated CPAP Tube,
otherwise, the humidier and its accessories might not function correctly,
affecting the quality of the therapy or cause injury to the patient.
• WARNING: When used routinely, check the tube daily for holes, deformation, or
any other form of damage. When damaged, replace the tube immediately.
• WARNING: Operating the Sunset Heated CPAP Tube close to other heat sources
including lamps, electric blankets, etc., can cause elevated airow temperatures
that can affect the quality of the therapy or cause injury to the patient
• WARNING: The tube shall be replaced after 90 days of use. Using the Sunset Heated
CPAP Tube after the maximum 90 days duration of use can affect the quality of
therapy or cause injury to the patient.
• WARNING: Do not sterilize the Sunset Heated CPAP Tube.
• WARNING: The Sunset Heated CPAP Tube is for single patient reuse only. Using the
Sunset Heated CPAP Tube on multiple patients can lead to contamination and injure
the patient.
• WARNING: Do not subject the tube to pressure, crushing or other mechanical stresses,
as damage to the tube can affect the quality of the therapy or cause injury to the
patient.
Please retain these instructions for use for future reference.

3
• WARNING: Replace damaged (having holes, kinks, tears, exposed heating wires,
etc. or is not functional) tube immediately. Do not try to repair the tube yourself.
Damaged CPAP tubes can affect quality of the therapy or injure the patient.
• WARNING: Using brushes or objects to clean the inside of the tube can damage the
tubing and can affect the quality of the therapy or cause injury to the patient. See
cleaning instructions.
• WARNING: Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is required, this
equipment and the other equipment should be observed to verify normal operation.
• WARNING: Use of accessories, transducers, and cables other than those specied
or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment
and resulting in improper operation.
• WARNING: Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of the Sunset Heated CPAP Tube, including cables specied by the
manufacturer. Otherwise, degradation of the performance of this equipment could
result.
• WARNING: MR Unsafe and should remain outside the MRI scanner room.
• CAUTION: Dispose of the Heated CPAP Tube in accordance with your local government
regulations. Upon permanent disposal, mark the tube so that it cannot be re-used by
another patient.
• CAUTION: When using electrical products, always follow applicable safety precautions.
• CAUTION: The Sunset Heated CPAP Tube complies with applicable Radiated RF
Emission levels to prevent adverse events to the patients and operator due to
electromagnetic disturbances. In order to prevent adverse events to patient and
operator due to electromagnetic disturbances do not modify or change The Sunset
Heated CPAP Tube.
• CAUTION: Patients undergoing CPAP therapy may be susceptible to airway infections.
Single patient reuse 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.
• CAUTION: Do not use (microwave) ovens, fans, heating devices or any other
appliances to dry the tube after washing. See cleaning instructions.

4
2.1 Directions for Use
The Sunset Heated CPAP Tube features a Mask-end Cuff and a Humidier
Connector Cuff.
Before connecting, remove Sunset Heated CPAP Tube from packaging.
Inspect tube for any damage. Discard and replace the tubing if damaged.
To Connect
Align the Sunset Heated CPAP Tube Humidier Connector Cuff with the air
outlet port on the CPAP machine humidier. Place the Connector Lead into
the mating connector located at the top of the humidier air outlet port.
Press until the tabs on each side of the connector click into place.
2. Use and Care
Mask-end Cuff Humidifier Connector Cuff

5
Connect the Mask-end Cuff to your mask connector. For proper placement,
please consult instructions included with your mask. Ensure there is airow
through the tubing.
Apply mask and use as directed by your physician or respiratory therapist,
and in accordance with the instructions in your CPAP or mask ventilator
system user manual.
For extended directions for use, please refer to your DreamStation or PR
System-One CPAP humidier manual.
To Disconnect
Lightly squeeze Release Tabs on side of Humidier Connector Cuff and
carefully disconnect from air outlet port.
Caution: To avoid circuit leaks, do not pull or stretch tubing.

6
1.Disconnect Heated CPAP Tube from CPAP machine and mask.
2.Thoroughly rinse inside and outside of Heated CPAP Tube with cold
tap water to remove excess soil.
3.Gently wash Heated CPAP Tube and connectors by immersing in
a solution of warm water and mild unscented liquid dish soap,
gently agitating by hand and using a soft bristle brush to remove
contaminants.
4.Thoroughly rinse Heated CPAP Tube with clean water to remove all
soap residue.
5.With connector cuffs directed down, toward the oor, gently tap
connector cuffs to remove excess water.
6.Hang Heated CPAP Tube with connector cuffs directed downward,
towards the oor, for drying.
7.Allow Heated CPAP Tube to air dry thoroughly prior to next use.
8.Visually inspect Heated CPAP Tube for cleanliness. Repeat cleaning
process if not visually clean.
9.Inspect Heated CPAP Tube for damage or wear. Discard and replace if
necessary.
Caution: Do not use harsh soaps, detergents, solvents, or alcohols to
clean the Sunset Heated CPAP Tube. Do not attempt to clean Heated CPAP
Tube in a dishwasher, ultrasonic cleaner or any other cleaning device.
Only reuse the Heated CPAP Tube when fully dry.
Home Disinfection
The disinfection procedure described is recommended for a maximum of
60 cycles.
Thermal Disinfection (Pasteurization)
Immerse Heated CPAP Tube in 75°C ± 2°C (167°F) water bath for 30
minutes.
Post Disinfection
Repeat steps 5-9 of the Home Cleaning procedure prior to use.
2.2 Home Cleaning & Disinfection
Home Cleaning
Clean Sunset Heated CPAP Tube before rst use and daily during use.

7
2.3 Institutional Cleaning & Disinfection
Institutional Cleaning Prior to Disinfection
Clean Sunset Heated CPAP Tube before rst use and daily during use.
1.Disconnect Heated CPAP Tube from CPAP machine and mask.
2.Thoroughly rinse inside and outside of Heated CPAP Tube with cold tap
water to remove excess soil.
3.Gently wash Heated CPAP Tube using an institutionally approved
enzymatic cleaning solution and a soft bristle brush to remove
contaminants.
Caution: Be sure all hard to reach surfaces, corners and crevices
have been thoroughly cleaned.
4.Thoroughly rinse Heated CPAP Tube by submersing in clean water and
vigorously agitating. Repeat as necessary until all residue has been
removed.
5.With connector cuffs directed downward, toward the oor, gently tap
connector cuffs to remove excess water.
6.Hang Heated CPAP Tube with connector cuffs directed downward,
toward the oor, for drying.
7.Allow Heated CPAP Tube to air dry.
8.Visually inspect Heated CPAP Tube for cleanliness. Repeat cleaning
process if not visually clean.
9.Inspect Heated CPAP Tube for damage or wear. Discard and replace if
necessary.
Institutional Disinfection
The disinfection procedures described below are recommended for a
maximum of 60 cycles.
Thermal Disinfection (Pasteurization)
Immerse Heated CPAP Tube in 75°C ± 2°C (167°F) water bath for 30
minutes.
Chemical Disinfection
Immerse device completely in CIDEX® OPA, lling all lumens and
eliminating air pockets, in CIDEX® OPA Solution for a minimum
of 12 minutes at 20°C (68°F) or higher to destroy all pathogenic
microorganisms. Remove device from the solution and rinse
thoroughly following the rinsing instructions on next page.

8
3.1 Environmental Operating Conditions
• Ambient Temperature: 41°F – 86°F (5°C – 30°C)
• Relative humidity: 5% – 95%
• Altitude: less than 6,561 feet (2,000 meters)
3. Additional Requirements
2.4 Errors and Troubleshooting
Consult your CPAP machine user manual.
Rinsing Instructions
Following removal from CIDEX® OPA Solution, thoroughly rinse the
medical device by immersing it completely in a large volume (e.g. 8
liters) of sterile water.
• Keep the device totally immersed for a minimum of 1 minute.
• Manually ush all lumens with large volumes (not less than
100ml) of rinse water.
• Remove the device and discard the rinse water. Always use
fresh volumes of water for each rinse. Do not reuse the water
for rinsing or any other purpose.
• Repeat the procedure TWO (2) additional times, for a total of
THREE (3) RINSES, with large volumes of fresh water to remove
CIDEX® OPA Solution residues.
• Refer to the disinfectant solution manufacturer’s instructions
for use for additional information and cautions.
Caution: Follow disinfectant solution manufacturer’s instructions for
use. Failure to do so may result in inadequate disinfection.
Review all manufacturer cautions and warnings.

9
3.3 Frequently Asked Questions
Question: Can I connect the heated tube directly to the CPAP machine?
Answer: Yes, the tubing will act like a standard CPAP tube. However,
rainout might occur.
Question: When do I replace my Sunset Heated CPAP Tube?
Answer: The heated tubing is intended to be replaced every 3 months, or
according to your provider’s recommended schedule. If damaged, leaking
or malfunctioning, replace your heated tube immediately.
Question: With what humidiers or ow generators can I use my Sunset
Heated CPAP Tube?
Answer: The Sunset Heated CPAP Tube is designed specically for use
with the Respironics DreamStation and Philips Respironics System One.
3.4 Replacement Components
Please ask your physician, respiratory therapist, or home care provider for
advice on replacement schemes. The Sunset Heated CPAP Tube should not
be used for longer than 3 months.
3.2 Storage and Transport Conditions
Environmental conditions for transport and storage:
This device should be transported and stored in its original packaging and
protected from direct sunlight, dust, or any other form of contamination. .
Temperature during storage and transport should not exceed 140°F (60°C)
or fall below -4°F (-20°C) with Relative humidity can range from 5 % to
95%.

10
3.6 Standards Compliance
This device is designed to conform to the following standards:
• IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical
Equipment
• EN 60601-1-2 Electromagnetic Compatibility
• ISO 80601-2-70 Sleep Apnea Breathing Therapy Equipment
• ISO 80601-2-74 Respiratory humidifying equipment
IEC 60601-1 Classification
• Degree of Protection Against Electric Shock: Type BF Applied Part
• Degree of Protection against Ingress of Water: Drip Proof, IPx2
• Mode of Operation: Continuous
Electrical
• Power Consumption 3.3 Vdc, max. 5A.
3.7 Warranty
The Sunset Heated CPAP Tube warranty is 30 days under normal operating
conditions. This is based on daily usage of 8 hours.
3.5 Product Specifications
Description Specification
Sunset Heated CPAP Tube Length 6ft (1.83m)
Internal Diameter 19mm
Flow resistance @60 l min-1 ≤ 0.1 kPa
Tubing Compliance Standards
ISO 5367:2000
ISO 8185:2007
ISO 80601-2-70:2015
ISO 80601-2-74:2017
Water resistance IP22
Compatible
CPAP Machine Humidiers
• Philips Respironics DreamStation
• Philips Respironics System One
Periodic visual safety inspections
that should be performed by the
OPERATOR
Daily
HUMIDIFIER classication
according to the ISO 80601-2-74 Humidier classication: 2

11
3.8 EMC Table
Radiated RF Emission levels
Immunity levels
1 Complies without any deviations from IEC 60601-1-2
and normative references.
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
Phenom-
enon
Immunity test levels
Professional
healthcare facility
environment
Home
healthcare
environment
Immunity
Test Compliance1
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
Proximity elds from RF wireless communication
equipment, Immunity test levels:
Compliance with immunity test levels specied in IEC
60601-1-2, without deviations.
Frequency Range and Level: RF wireless
communication equipment
Frequency
(MHz) Modulation
Immunity
Level
(V/m)
Test Compliance2
385 Pulse Modulation: 18Hz 27
450 FM + 5Hz deviation: 1kHz sine 28
710
745
780
Pulse Modulation: 217Hz 9
810
870
930
Pulse Modulation: 18Hz 28
1720
1845
1970
Pulse Modulation: 217Hz 28
2450 Pulse Modulation: 217Hz 28
5240
5500
5785
Pulse Modulation: 217Hz 9

12
Symbol Meaning
Attention, consult accompanying documents
Read instruction manual carefully
Catalog item number
Batch code
Name and address of manufacturer
Date of manufacture
Prescription device
Caution: U.S. federal law restricts this device to sale by or
on the order of a physician
Protected from touch by ngers and objects greater than
12 millimeters. Protected from water spray less than 15
degrees from vertical.
Keep away from direct sunlight
Keep dry
Do not use if the package is damaged
MR Unsafe and should remain outside the MRI scanner room.
Standard References
ISO 15223-1:2012, Medical Symbols to be used with medical device labels, labeling, and information to be
supplied - General requirements
IEC 60601-1, Medical electrical equipment - General requirements for basic safety and essential performance
3.9 Symbol Glossary
REF
LOT
Rx only
IP22

Sunset Healthcare Solutions
180 N Michigan Ave Ste 2000
Chicago, IL 60601
www.sunsethcs.com
IFU-00014 Rev 2.00
2021-02-01
E509738