Philips Respironics DreamWear Page 15 Instructions For Use Manual Download

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Symbol

Title and Meaning

Reference

Reorder number

Indicates the manufacturer’s catalogue

number so the medical device can be

identified.

ISO 7000-2493

Symbol 5.1.6,

ISO 15223-1

Operator’s manual; operating

instructions

Consult instructions for use.

ISO 7000-1641

Symbol 5.4.3,

ISO 15223-1

Wash by hand

Indicates that cleaning the textile article

is allowed only by washing by hand.

ISO 7000-3125

Do not bleach

Indicates that bleaching textile article is

not allowed.

ISO 7000-3124

Do not tumble dry

Indicates that tumble drying is not

allowed in the drying process.

ISO 7000-3109

Do not iron

Indicates that ironing is not allowed.

ISO 7000-3113

Do not dry clean

Indicates that dry cleaning is not

allowed.

ISO 7000-3114

ISO 7000:2014, Graphical symbols for use on equipment - Registered

symbols
ISO 15223-1:2012, Medical devices - Symbols to be used with medical

devices labels - General requirements
IEC/TR 60878: 2015, Graphical symbols for electrical equipment in

medical practice

Summary of Contents for Respironics DreamWear

Page 1: ...l rubber latex or DEHP Contraindications This mask is not for use on patients with the following conditions recent eye surgery or dry eyes hiatal hernia excessive reflux impaired cough reflex and impaired cardiac sphincter function This mask is not for use on patients who are dependent on mechanical ventilation for their life support This mask is not for use on patients who are taking a prescripti...

Page 2: ...um of 3 cm H2 O hPa must be maintained when using this mask Do not overtighten the headgear straps Watch for signs of overtightening such as excessive redness sores or bulging skin around the edges of the mask Loosen the headgear straps to alleviate symptoms The headgear clips and mask cushion contain magnets Contact your healthcare provider before you use this mask Some medical devices may be aff...

Page 3: ... B Magnetic headgear clip C Mask frame fabric sleeves optional D Mask cushion available in S M L MW E Mask frame available in small SM medium MED large LG F Elbow with built in exhalation do not block G Tubing quick release may remain in the CPAP hose ...

Page 4: ...4 Back of the Cushion Front of the Cushion H Guards I Magnetic Clips J Flaps K Large Holes Two in the Cushion do not block L Small Holes in the Cushion do not block J L H H I K K J ...

Page 5: ... are blocked shut by the flaps or anything else for example mucus a Warning Do not block any of the mask holes Note The flaps should cover the two large holes when the device is on Before Use Read and Understand the Instructions Completely Hand wash the entire mask before use see Mask Care section Wash your face Do not use moisturizer or lotion on your hands or face Inspect the entire mask daily D...

Page 6: ...ith sizing 2 The cushion opening will be directly under your nostrils The cushion will hug your nose and mouth and leak will be minimal 3 At no time should your nose be inside of the cushion opening If any part of the cushion overlaps your nose the cushion is being worn incorrectly A different size cushion may be needed Contact your healthcare provider for additional information Philips Respironic...

Page 7: ...gnetic headgear clips to the mask cushion e Adjusting the Mask 1 Peel the headgear tabs away from the fabric Adjust the length of the top straps Press the tabs back against the fabric to reattach Repeat this step with the bottom straps f Note Do not overtighten the headgear Signs of overtightening include redness sores or bulging skin around the edges of the mask 2 Position the mask until it fits ...

Page 8: ...k frame will comfortably fit most faces If the MED frame does not fit your face contact your healthcare provider to see if a small SM or large LG mask frame would better suit your needs Tip If the mask frame falls backward and is too close to your ears you may need a smaller mask frame ...

Page 9: ... loose with the tubing i Removing the Mask To keep your adjustments remove the mask by grasping the cushion and pulling forward away from the nose Then pull the cushion and mask up and off of the head j 5 Mask Care Cleaning Instructions Daily Hand wash the non fabric parts Weekly Hand wash the fabric parts 1 Disassemble the mask see Disassembly section 2 Submerge and hand wash the mask in warm wat...

Page 10: ...ke sure the mask is dry before use Caution Do not use bleach alcohol cleaning solutions containing bleach or alcohol or cleaning solutions containing conditioners or moisturizers 6 Assembly and Disassembly Assembly 1 Cushion Press into the mask frame until the cushion clicks into place kl Note The end of the cushion and the opening in the mask frame are D shaped The cushion end should match the fr...

Page 11: ...4 Elbow Pull the elbow from the top of the frame 5 Cushion Pull the cushion away from the mask frame 7 Healthcare Provider Clinician Information Useful Life The useful life of the DreamWear Full Face mask depends on the use conditions and maintenance cleaning institutional disinfection and component replacement of the device Inspect the mask parts regularly for damage or wear Replace components as...

Page 12: ...ts may vary Pressure Flow Curve Flow Rate SLPM 0 0 10 0 20 0 30 0 40 0 50 0 60 0 70 0 0 5 10 15 20 25 30 Pressure cm H2 O Resistance with Flaps Closed to Atmosphere Drop in Pressure cm H2 O at 50 SLPM at 100 SLPM All Cushion Sizes 0 9 3 1 Closed to Atmosphere A minimum of 3 cm H2 O must be maintained to ensure that the flaps close Open to Atmosphere At an airway pressure less than 1 cm H2 O the fl...

Page 13: ... 201 3 L 204 3 L 207 2 MW 185 2 MW 188 2 MW 191 1 Sound Levels dBA A weighted Sound Power Level 24 0 A weighted Sound Pressure Level at 1 m 16 5 Disposal Dispose of in accordance with local regulations Storage Conditions Temperature 4 F to 140 F 20 C to 60 C Relative Humidity 15 to 95 non condensing ...

Page 14: ...s the medical device manufacturer IEC 60878 ISO 7000 3082 Symbol 5 1 1 ISO 15223 1 Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed IEC 60878 ISO 7000 2620 Symbol 5 3 8 ISO 15223 1 Temperature limit Indicates the storage temperature limits to which the medical device can be safely exposed IEC 60878 ISO 7000 0632 Symbol 5 3 7 ISO 15223 1 Caution ...

Page 15: ... 7000 3125 Do not bleach Indicates that bleaching textile article is not allowed ISO 7000 3124 Do not tumble dry Indicates that tumble drying is not allowed in the drying process ISO 7000 3109 Do not iron Indicates that ironing is not allowed ISO 7000 3113 Do not dry clean Indicates that dry cleaning is not allowed ISO 7000 3114 ISO 7000 2014 Graphical symbols for use on equipment Registered symbo...

Page 16: ...hat may have been repaired or altered by anyone other than Respironics Respironics disclaims all liability for economic loss loss of profits overhead or indirect consequential special or incidental damages which may be claimed to arise from any sale or use of the Product Some jurisdictions do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or ex...

Page 17: ...ght cost of transporting the product between the authorised Philips Respironics dealer and Philips Respironics Philips Respironics reserves the right to charge an evaluation and postage fee for any returned Product as to which no problem is found following investigation 5 This warranty does not cover damage caused by accident misuse abuse alteration and other defects not related to materials or wo...

Page 18: ...d for a major failure and for compensation for any other reasonably foreseeable loss or damage You are also entitled to have the good repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure 10 The following statement is provided to a Buyer who is a consumer under the Consumer Guarantees Act 1993 New Zealand Our goods come with guarantee...

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