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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 flush 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.

Summary of Contents for TUB06HPR

Page 1: ...Instruction Manual Heated CPAP Tube for DreamStation and PR System One TUB06HPR ...

Page 2: ...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 Specifications 10 3 6 Standards Compliance 10 3 7 Warranty 10 3 8 EMC Table 11 3 9 Symbol Glossary 12 1 1...

Page 3: ...s 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 Humidifier and Philips Respironics DreamStation Heated Humidifier CAUTION Federal law restricts this device to sale by or on the order of a physician 3 1 2 5 4 1 Humidifier connector cuff 2 Connector lead 3 Squeeze releas...

Page 4: ... the Sunset Heated CPAP Tube otherwise the humidifier 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 lamp...

Page 5: ...m 12 inches to any part of the Sunset Heated CPAP Tube including cables specified 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 b...

Page 6: ...age Discard and replace the tubing if damaged To Connect Align the Sunset Heated CPAP Tube Humidifier Connector Cuff with the air outlet port on the CPAP machine humidifier Place the Connector Lead into the mating connector located at the top of the humidifier 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 ...

Page 7: ...cian 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 humidifier manual To Disconnect Lightly squeeze Release Tabs on side of Humidifier Connector Cuff and carefully disconnect from air outlet port Caution To avoid circuit leaks do not pull or s...

Page 8: ... 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...

Page 9: ...d downward toward the floor gently tap connector cuffs to remove excess water 6 Hang Heated CPAP Tube with connector cuffs directed downward toward the floor 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 Disi...

Page 10: ...minute Manually flush 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 dis...

Page 11: ...Tube Answer The Sunset Heated CPAP Tube is designed specifically 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 cond...

Page 12: ...inuous 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 80...

Page 13: ...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 fields from RF wireless communication equipment Immunity test levels 2 Compliance with immunity test levels specified in IEC 60601 1 2 without deviations Frequency Range and Level RF wireless com...

Page 14: ...ects 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...

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Page 16: ...Sunset Healthcare Solutions 180 N Michigan Ave Ste 2000 Chicago IL 60601 www sunsethcs com IFU 00014 Rev 2 00 2021 02 01 E509738 ...

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