affidavit of christopher butler... 415.561.6767 415.840-0391 e-fax internet archive 300 funston...

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www.archive.org 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager at the Internet Archive, located in San Francisco, California. I make this declaration of my own personal knowledge. 2. The Internet Archive is a website that provides access to a digital library of Internet sites and other cultural artifacts in digital form. Like a paper library, we provide free access to researchers, historians, scholars, and the general public. The Internet Archive has partnered with and receives support from various institutions, including the Library of Congress. 3. The Internet Archive has created a service known as the Wayback Machine. The Way back Machine makes it possible to surf more than 450 billion pages stored in the Internet Archive's web archive. Visitors to the Way back Machine can search archives by URL (i.e., a website address). If archived records for a URL are available, the visitor will be presented with a list of available dates. The visitor may select one of those dates, and then begin surfing on an archived version of the Web. The links on the archived files, when served by the Wayback Machine, point to other archived files (whether HTML pages or images). If a visitor clicks on a link on an archived page, the Wayback Machine will serve the archived file with the closest available date to the page upon which the link appeared and was clicked. 4. The archived data made viewable and browseable by the Wayback Machine is compiled using software programs known as crawlers, which surf the Web and automatically store copies of web files, preserving these files as they exist at the point of time of capture. 5. The Internet Archive assigns a URL on its si te to the archived files in the format http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in hh:mm:ss]/[Archived URL]. Thus, the Internet Archive URL http://web.archive.org/web/l 9970126045828/http:/lwww .archive.org/ would be the URL for the record of the Internet Archive home page HTML file (http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28 seconds (1997/01/26 at 04:58:28). A web browser may be set such that a printout from it will display the URL of a web page in the printout's footer. The date assigned by the Internet Archive applies to the HTML file but not to image files linked therein. Thus images that appear on a page may not have been archived on the same date as the HTML file. Likewise, if a website is designed with "frames," the date assigned by the Internet Archive appli es to the frameset as a whole, and not the individual pages within each frame. 6. Attached hereto as Exhibit A are true and accurate copies of printouts of the Internet Archive's records of the HTML fi les or PDF files for the URLs and the dates specified in the footer of the printout (HTML) or attached coversheet (PDF). 7. 1 declare under penalty of perjury that the foregoing is true and correct. DATE: q /<P (ere Christopher Butler Page 1 Fisher & Paykel Ex. 1417 IPR Petition - USP 9,119,931

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Page 1: AFFIDAVIT OF CHRISTOPHER BUTLER... 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager

www.archive.org

415.561.6767

415.840-0391 e-fax

Internet Archive

300 Funston Avenue

San Francisco, CA 94118

AFFIDAVIT OF CHRISTOPHER BUTLER

1. I am the Office Manager at the Internet Archive, located in San Francisco, California. I make this declaration of my own personal knowledge.

2. The Internet Archive is a website that provides access to a digital library of Internet sites and other cultural artifacts in digital form. Like a paper library, we provide free access to researchers, historians, scholars, and the general public. The Internet Archive has partnered with and receives support from various institutions, including the Library of Congress.

3. The Internet Archive has created a service known as the Wayback Machine. The Way back Machine makes it possible to surf more than 450 billion pages stored in the Internet Archive's web archive. Visitors to the Way back Machine can search archives by URL (i.e., a website address). If archived records for a URL are available, the visitor will be presented with a list of available dates. The visitor may select one of those dates, and then begin surfing on an archived version of the Web. The links on the archived files, when served by the Wayback Machine, point to other archived files (whether HTML pages or images). If a visitor clicks on a link on an archived page, the Wayback Machine will serve the archived file with the closest available date to the page upon which the link appeared and was clicked.

4. The archived data made viewable and browseable by the Wayback Machine is compiled using software programs known as crawlers, which surf the Web and automatically store copies of web files, preserving these files as they exist at the point of time of capture.

5. The Internet Archive assigns a URL on its site to the archived files in the format http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in hh:mm:ss]/[Archived URL] . Thus, the Internet Archive URL http://web.archive.org/web/l 9970126045828/http:/lwww .archive.org/ would be the URL for the record of the Internet Archive home page HTML file (http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28 seconds (1997/01/26 at 04:58:28). A web browser may be set such that a printout from it will display the URL of a web page in the printout's footer. The date assigned by the Internet Archive applies to the HTML file but not to image files linked therein. Thus images that appear on a page may not have been archived on the same date as the HTML file. Likewise, if a website is designed with "frames," the date assigned by the Internet Archive applies to the frameset as a whole, and not the individual pages within each frame.

6. Attached hereto as Exhibit A are true and accurate copies of printouts of the Internet Archive's records of the HTML fi les or PDF files for the URLs and the dates specified in the footer of the printout (HTML) or attached coversheet (PDF).

7. 1 declare under penalty of perjury that the foregoing is true and correct.

DATE: q /<P (ere Christopher Butler

Page 1Fisher & Paykel Ex. 1417 IPR Petition - USP 9,119,931

Page 2: AFFIDAVIT OF CHRISTOPHER BUTLER... 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager

CALIFORNIA JURA T

See Attached Document.

State of California County of San Francisco

l <> ................. ..,. ..... <>-<" = 1 e KYLE DEVIN EISENBERG ,... ·:l~ COMM# 2067666 )> Z ":J,J; _ SAN FRANCISCO COUNTY )> ~ -· ':('.. NOTARY PUBLIC-CALIFORNIA Z l MY COMMISSION EXPIRES l

MAY 10, 2018

A notary public or other officer completing this certificate verifies only the identity of the individual who signed the document to which this certificate is attached, and not the truthfulness, accuracy, or validity of that document.

Subscribed and sworn to (or affirmed) before me on this

(o day of '31l 1>T€Mt?:;£fl- 7..u1 ~ , by

Christopher Butler,

proved to me on the basis of satisfactory evidence to be the person who appeared before e.

Page 2

Page 3: AFFIDAVIT OF CHRISTOPHER BUTLER... 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager

Exhibit A

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Page 4: AFFIDAVIT OF CHRISTOPHER BUTLER... 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager

AexiFitni 431

Interfaces

FlexlFlt"' 405

Flexlflt'M 406

Flexlflt•M 407

FlexlFlt"' 4 31

lnflnlty'M 481

Oracle'" 452

• CPAP

• Humidifiers

Register and become a member of our Vigor8"' Lifestyle Program.

L v19ora:._

TULL fACE MASK

Interface Performance Feature

Fit-and-Forget

Out-of-Box Solution

FlexiFit'"' Technology

Auto-contouring Fit

Glider"' Strap

Premium Frosted Silicone Seal

Efficient Blas Diffuser

Under-Chin Design

Crown Strap

Easy-Release Strap

https://web .arc hi ve.org/web/20061016042115/http:/lwww J phcare .com/osa/ftex i Fi t43 I .asp

I of I

• Foam Cushion

Air Cushion •

• Material Filter

Maintenance Free •

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Page 5: AFFIDAVIT OF CHRISTOPHER BUTLER... 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager

https: / /web.archive.org/web /20061016050014 /http:/ /www.fphcare.com/ osa/pdf /HC431/431 %20English.pdf

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Page 6: AFFIDAVIT OF CHRISTOPHER BUTLER... 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager

FlexiFi 31 FULL FACE MASK

Specification Sheet

A Full Face Delivery Mask

Sleep Style SLU:P PUFOlMAlllc:E FOR AR UERGIZ£D LIHSTYLI:

Incorporating tht F/c;r.ifit ™

Technology 1v1fl• auro (()11tourinq

µropert1i>c:, the Fl .... ,m ,,. 4 ~1

Fwl Face Masx ,omeit wit"' an Under·C.hin flt and ft1ghlv

contoured S11iwne $ea/ for

maxm1u111 comfort e1nd stability.

Fisher&~el HEALTHCARE

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Full Face Delivery - FlexiFit™431

The FlexFit™ 431 Full Face Mask offers a comfortable

alternative to nasal or oral delivery and comes as an

Out-of-Box Solution fully assembled and ready for use.

UNIQUE MASK FEATURES FOR GREATER FREEDOM, COMFORT AND COMPLIANCE

With Air Cushion FlexiFit™ Technology automatically adjusts to a wide range of nasal and facial contours with simple one· step ease of fitting and no complicated adjustments.

This seal technology has a soft, smooth feel to slide onto the face, and its frosted texture optimizes the mask seal.

The sliding Glider™ Strap provides freedom of movement while maintaining a seal. Mask force remains equal when the head rotates from side to side, minimizing the occurrence of leaks.

Complements the Under-Chin Design to maximize stability and eliminate the need for a chin strap.

An Under·Chin tit provides stability by providing a constant point of reference and maintains the seal even with movement of the jaw during the night.

Simply pull the Easy·Release Cord for one·step removal of headgear. No ongoing headgear adjustments required.

FOR MORE INFORMATION, PLEASE CONTACT YOUR LOCAL FISHER ANO PAYKEL HEALTHCARE REPRESENTATIVE:

Maintenance Free This advanced air diffuser system prevents air from blowing onto the sleeping partner and decreases noise that could potentially disrupt sleep.

• Complete mask with headgear assembled and ready for use

• Alternate size Silicone Seals included (S,M,L)

• User friendly Fitting Guide

REORDER CODE: HC431

International P 0 Sox 14 348, Panmure, Auckland n34, New Zealand Tel: +64 9 574 0100 Fax: +64 9 574 01s8 Email: [email protected] Web: www.fphcare.com

~ USA Tel: 1800 446 39o8 +i 949 470 3900 Fax: +1949 470 3933 Australia Tel: +6139879 5022 Fax: +61 3 9879 5232 Austria Tel: 0800 29 31 23 Fax: o8oo 29 31 22 Benelux Tel: +31 78 644 0924

a Fax: +Jl 78 644 0914 China Tel: +86 20 8363 4286 Fax: +86 20 8363 3595 France Tel: +33 1 6446 5201 Fax: +33 1 6446 5221 Germany Tel: +49 7182 93777 o Fax: +lf9 7182 93777 99 §: India Tel: +91 80 5123 6o41 Fax: +91 8o 5123 6o44 Irish Republic Tel: 18oo 409 011 Italy Tel: •39 06 7839 2939 Fax: •39 o6 7814 7709 Japan Tel: +81 3 3661 7205 Fax: +81 3 3661 72o6 ~ Spain Tel: +34 902 013 346 Fa:ic: +34 902 013 379 Swltzertand Tel: o8oo 83 47 63 Fax: 0800 83 47 S4 UK (EU Authorised Representative) Tel: +44 1628 626 136 Fax: +44 1628 626 146

Nthn Ireland Tel: 0800 132 189

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https://web.archive.org/web/20061016050114/http://www.fphcare.com/osa/pdf /HC431/185043239.pdf

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Page 9: AFFIDAVIT OF CHRISTOPHER BUTLER... 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager

FISHER & PAYKEL HEALTHCARE INTERNATIONAL PO Box 14 348, Panmure, Auckland 1134, New Zealand

Tel: +64 9 574 0100Fax: +64 9 574 0158Email: [email protected]: www.fphcare.com

USA Tel: 1800 446 3908or +1 949 470 3900Fax: +1 949 470 3933

AUSTRALIA Tel: +61 3 9879 5022Fax: +61 3 9879 5232

AUSTRIA Tel: 0800 29 31 23Fax: 0800 29 31 22

BENELUX Tel:+31 78 644 0924 Fax:+31 78 644 0914

CHINA Tel: +86 (20) 8363 4286Fax: +86 (20) 8363 3595

FRANCE Tel: +33 (0)1 64 46 52 01Fax: +33 (0)1 64 46 52 21

GERMANY Tel: +49 7182 93777 0Fax: +49 7182 93777 99

INDIA Tel: +91 80 5123 6041Fax:+91 80 5123 6044

IRISH REPUBLIC Tel: +1800 409 011

ITALY Tel: +39 06 7839 2939Fax: +39 06 7814 7709

JAPAN Tel:+81 (3) 3661 7205Fax:+81 (3) 3661 7206

SPAIN Tel: +34 902 013 346Fax: +34 902 013 379

SWITZERLAND Tel: 0800 83 47 63 Fax: 0800 83 47 54

UK Tel: +44 1628 626 136(EU Authorized Representative) Fax: +44 1628 626 146

NTHN IRELAND Tel: +0800 132 189

185 043 239 Rev E

HC 431FULL FACE MASK

INSTRUCTIONS FOR USE

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Page 10: AFFIDAVIT OF CHRISTOPHER BUTLER... 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager

FlexiFitTM Series - HC431 Full Face MaskInstructions

The FlexiFitTM HC431 Full Face Mask is intended for multiple patient or single patient adultuse by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level

ventilator treatment.

FITTING YOUR MASKRefer to the mask assembly diagram

1) Remove plastic cover from Silicon Seal.2) Unclip the Headgear (K) from the GliderTM strap (E) by pulling the Release Cord (I) down.

Holding your Mask Base (A) in one hand, spread the Headgear with your free hand just enoughto fit comfortably over your head.

3) Lightly hold the mask against your face, with the bottom of the seal under your chin, and spreadthe Headgear over your head with your free hand.

4) Re-attach the Headgear Clip (H) to the GliderTM strap.5) Gently adjust the Top Horizontal straps, then the Lower Horizontal straps, then the Top Crown

straps. Ensure the top of the seal remains stable on the bridge of the nose, and the bottom ofthe seal remains fixed under the chin. Ensure that the GliderTM strap is centred.

6) Connect the CPAP machine hose running at the prescribed pressue to the mask.• If necessary pull the mask slightly away from your face while the straps are still attached. This

allows the silicon seal to inflate. Put the mask back on your face• If leaks occur around the upper half of the mask gently tighten the top horizontal straps. It is

not necessary for the Forehead Cushion to touch your forehead if it does not.• If leaks occur around the lower half of the mask gently tighten the lower horizontal straps.

(Avoid over tightening the straps.)• If leaks persist, change to the alternate size Silicone Seal, which is found in your FlexiFit™

HC431 Mask box.• When you need to remove your mask unclip the Headgear from the GliderTM strap by pulling

the Release Cord forward or down.

ASSEMBLING YOUR MASKYour FlexiFitTM HC431 Mask is fully assembled and ready to use. However, when you need to cleanyour mask follow these instructions for reassembly.1) Place Silicone Seal (C) into Mask Base (A)2) Push the Non-Rebreathing Valve (J) onto the Elbow (B), and attach to Mask Base.3) Lay the Headgear (K) flat with the label side down. Position the assembled mask over the

Headgear and attach the four straps in to the corresponding slots in the Mask Base and theGliderTM strap (E). This can be done without undoing the Velcro® Tabs by sliding the Headgearinto the slots.

The FlexiFitTM HC431 and accessories are Latex free.Many people find CPAP therapy causes dryness of the nose and throat. Heated humid-

ification can substantially reduce these symptoms.Contact your supplier and ask about Ambient Tracking Plus®.

CLEANING YOUR MASKTo ensure continuing safety and comfort for your FlexiFitTM HC431 Mask:Before each use:1) Inspect the mask for deterioration. Do not use if aged or damaged.2) Inspect the Non-Rebreathing Valve (J). Ensure the silicone flaps occlude the pipe when

the CPAP is off.After each use:1) Disassemble the Silicone Seal (C), Elbow (B), Non-Rebreathing Valve (J) , and the

Headgear (K) from the Mask Base (A).2) Wash the Silicone Seal, Elbow, Non-Rebreathing Valve and Mask Base in warm soapy

water then rinse in fresh water. 3) Leave all parts to dry, away from direct sun light before reassembling.Every 7 days:1) Hand wash the Headgear in lukewarm water using a mild detergent. Allow to air dry out

of direct sun light. It is not necessary to remove the Clip (H) from the headgear whenwashing.

Caution: Do not clean the mask in the dishwasher.Do not clean the mask with alcohol, chlorine or bleach.Do not store the mask in direct sunlight.

The above actions may deteriorate or damage the mask and shorten it’s life. If yourFlexiFitTM HC431 weakens or cracks, seek replacement immediately.

2 3

54

C

H E

A

J

K

J PT

SQ

R

WARNINGS• This CPAP mask should be used only with CPAP systems recommended by your physician

or respiratory therapist. A mask should not be used unless the CPAP system is turned on andoperating properly. The vent slots associated with the mask should never be blockedExplanation of Warning: CPAP systems are intended to be used with special masks with con-nectors which have vents holes to allow continuous flow of air out of the mask. When theCPAP machine is turned on and functioning properly, new air from the CPAP machine flush-es the exhaled air out through the attached mask exhalation port. However, when the CPAPmachine is not operating, enough fresh air will not be provided through the mask, andexhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutescan in some circumstances lead to suffocations.

• At low CPAP pressures the flow through the exhalation port may be inadequate to clear allexhaled gas from the tubing. Some rebreathing may occur.

• Operating pressure range is 3-25 cm H2O.• Do not use the mask without the Non-Rebreathing Valve in place. This valve ensures CO2

rebreathing is kept to a minimum in the event of power failure.• Do not use the mask if vomiting or feeling nauseous.• Discontinue using the mask if there is an allergic reaction to any part of the mask. Consult

your physician if this occurs.• If re-using the FlexiFitTM HC431 between different patients, refer to the Multi Patient Cleaning

Instructions for the FlexiFitTM HC431 mask.• Replace the Non-Rebreathing Valve every 12 months.• Do not use the FlexiFitTM HC431 elbow on other Fisher & Paykel Masks.• Use the FlexiFitTM HC431 mask only with the headgear provided.

CAUTION• Use the mask for its intended use only as directed in this booklet. • US Federal Law restricts this device to sale by, or on order of a physician.• Operating temperature range is 40-140˚ F (5-50˚C).

CONTRAINDICATIONSThis mask should also not be used by anyone incapable of removing the mask unaided, in thecase of vomiting and aspiration, without continuous supervision.

US Patent Number 6 615 834Other Patents Pending

BIAS FLOW INFORMATIONThe FlexiFitTM HC431 has a unique bias diffuser system which vents the expelled CO2through two fine vents above and below the elbow.

It is important that these vents are not blocked by any object. This controlled leakensures all exhaled CO2 is expelled from the mask.

Pressure (cm H20) 3 5 7 9 11 13 15 17 19 21 23 25

Bias Flow (LPM) 23 27 32 37 41 44 48 50 54 57 60 63

RESISTANCE TO FLOWPressure drop through mask @ 50 l/min 0.25 cm H2OPressure drop through mask @ 100 l/min 0.48 cm H2O

FlexiFitTM Series - HC431 Full Face Mask Multi-Patient Cleaning Instructions

Your FlexiFitTM Series HC431 Full Face Mask is provided patient ready. To reusebetween patients please follow the guidelines below.

MASK FRAME

SILICONE SEAL

ELBOW

NON-REBREATHING VALVE

WASH IN WARM SOAPY WATER AND LEAVE TO DRY

The FlexiFitTM Series HC431 Mask has been validated to withstand 20 cycles of the aboveparameters. Do not use if badly damaged.

Disclaimer: It is the user’s responsibility to qualify any deviations from the recommended methods of reprocessing.

Contact your local homecare dealer for additional information.

I

B

Pressure (cmH20)

FlexiFit TM HC431 Bias Flow

OXYGEN / PRESSURE PORT CONNECTORIf pressure readings and/or additional oxygen are required, an Oxygen/Pressure PortConnector is available. (Code 900HC452)1) Connect the large end of the Connector (T) to the Non-Rebreathing Valve (J) on the mask

and the small end of the Connector to the Breathing Tube (R).2) Open the Port Cap(s) (P) and place the Pressure and/or Oxygen Tube (S) firmly over the

Port(s) (Q).

(The two Ports are identical; either Port may be used for oxygen or pressure measurement.Only remove the Port Cap from Ports that are being used.)

• Note: At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary,depending on the pressure settings, patient breathing pattern, mask selection, and the leak rate.

• Warning: If oxygen is used with this CPAP machine, the oxygen flow must be turned off when theCPAP machine is not operating.Explanation of Warning: When the CPAP device is not in operation, and the oxygen flow is lefton, oxygen delivered into the ventilator tubing may accumulate within the CPAP machineenclosure. Oxygen accumulated in the CPAP machine enclosure will create a risk of fire.

• Warning: Do not smoke while using or in the vicinity of someone using oxygen with thismask.

THERMAL DISINFECTIONSoak parts in hot water bath for:

30 minutes at 70°C (158°F)or

30 minutes at 75°C (167°F)

OR

CIDEX® OPAFollow manufacturer instructions for high level

disinfection.Immerse for 30 minutes at 20°C (68°F).

Rinse thoroughly in potable water.

Flo

w (

l/m

in)

HEADGEAR WITH CLIP

CLEANING / DESOILINGBefore disinfecting, disassemble all components from the mask base (The GliderTM strap and GliderCover do not detach from the Base). Clean all surfaces of mask and components thoroughly with amild detergent solution and a soft bristled brush. Ensure all visible soil is removed. Rinse thorough-ly under running potable water to remove detergent solution.

FAILURE TO PROPERLY CLEAN THIS DEVICE MAY RESULT IN INADEQUATE DISINFECTION

HIGH LEVEL DISINFECTION PARAMETERS

FlexiFit™ Series - HC431 Full Face MaskMode d’emploi

Le Masque Facial FlexiFit™ HC431 a été conçu pour un usage multiple à l'intention depatients sous Pression positive continue ou VNDP.

DÉBIT À SENS UNIQUE DE FUITE EXPIRATOIRELe FlexiFit™ HC431 possède un système diffuseur à sens unique permettant d'expulserle C02 à travers deux petits orifices placés au-dessus et dessous du coude.

Il est important que ces orifices ne soient pas obstrués. Cet échappement contrôléassure l'expulsion de toute exhalation de C02 à l'extérieur du masque.

Pressio\n (cm H20) 3 5 7 9 11 13 15 17 19 21 23 25

Débit (LPM) 23 27 32 37 41 44 48 50 54 57 60 63

RÉSISTANCE AU DÉBITBaisse de pression via le masque à 50LPM 0.25 cm H2OFlexiFit™ Series - Masque Facial HC431 à 100LPM 0.48 cm H2O

FlexiFit™ Series - HC431 Full Face MaskInstructions de Nettoyage pour

reconditionnementVotre Masque Full Face FlexiFit™ HC431 est vendu prêt à l’emploi. Pour une

utilisation collective entre divers patients, veuillez suivre les instructions suivantes.

NETTOYAGE/DESINFECTIONAvant de désinfecter le masque, détacher tous les composants de la coque (glissière et son capotne se détachent pas de la coque). Nettoyer toutes les surfaces du masque et les composantssoigneusement à l'aide d'un détergent doux et une brosse à poils souples. S'assurer de ladisparitionde tout contaminant. Rincer soigneusement à l'eau courante et potable pour supprimer toute tracede détergent.

LA DESINFECTION NE SERA PAS TOTALE SI LE NETTOYAGE N'EST PAS EFFECTUE CORRECTEMENT.

PARAMETRES DE DESINFECTION DE HAUT NIVEAU

DESINFECTION A CHAUDTremper les pièces dans un bain d'eau chaude :

30 minutes at 70°C (158°F)ou

30 minutes at 75°C (167°F)

OU

CIDEX® OPASuivre les instructions du fabricant du produit pour une

désinfection totale.Immerger 30 minutes à 20°C (68°F).Rincer abondamment à l'eau potable.

COQUE DU MASQUE

JUPE EN SILICONE

ROTULE

VALVE ANTI-REINHALATION

NETTOYER À L'EAU SAVONNEUSE ET LAISSER SÉCHER

La durée de vie du Masque FlexiFit™ HC431 est certifiée pour 20 cycles dans les conditionsd'utilisation précitées. Ne pas utiliser le masque s'il est endommagé.

Responsabilités : Il incombe à l'utilisateur de demander conseil pour toute autre utilisationque celle recommandée dans ce manuel.

Contacter votre prestataire de service pour plus ample information.

MISE EN PLACE DU MASQUEVeuillez vous référer au schéma de mise en place

1) Retirer la protection de la jupe.2) Détacher le Harnais (K) de glissière (E) en tirant vers le bas sur le Cordon (I). Tenir la

base du Masque (A) dans une main, étirer le Harnais avec la main libre de façon à l'a-juster confortablement sur la tête.

3) Appliquer délicatement le masque sur le visage, en plaçant le bas de la jupe (C) sous lementon et étirer le Harnais sur la tête avec la main libre.

4) Accrocher de nouveau l'attache du Harnais (H) à la glissière.5) Ajuster les sangles horizontales supérieures, puis les inférieures et enfin celle sur le crâne.

Assurez vous que la jupe soit bien positionnée sur l'arête nasale et sous le menton.Centrer la glilssière.

6) Connecter au générateur de PPC fonctionnant à la pression prescrite.• Si nécessaire retirer le masque légèrement du visage pour regonfler la jupe. Puis remettre

le masque.• Si une fuite apparaît sur le haut de la jupe, serrer un peu plus les lanières du haut. L'appui

frontal ne doit pas nécessairement toucher le front.• Si nécessaire, serrer les lanières du bas afin d'éliminer tout risque de fuite. (Eviter de serrer

les lanières à l'excès)• Si la fuite persiste, remplacer avec l'autre Jupe en Silicone que vous trouverez dans l'em-

ballage du Masque FlexiFit™ HC431.• Pour retirer le masque, détacher le Harnais de la glissière en tirant le cordon vers le bas ou

vers l'avant .

NETTOYER VOTRE MASQUEPour garantie la sécurité et le confort de votre Masque FlexiFit™ HC431.

Avant chaque utilisation:1) Vérifier l'état du masque. Ne pas utiliser de masques anciens ou endommagés.2) Contrôler la valve Anti-Réinhalation (J). S'assurer que les clapets ferment le tuyau lorsque

le PPC est éteint.

Après chaque utilisation:1) Désassembler la jupe en Silicone (C), le Coude (B), la valve Anti-Réinhalation (J) et le

Harnais (K) de la base du Masque (A).2) Nettoyer la jupe en Silicone, le Coude, la Valve Anti-Réinhalation et la coque du Masque à

l'eau savonneuse puis rincer à l'eau fraîche.3) Laisser sécher tous les composants à l'abri du soleil avant de remontage.

Chaque semaine:1) Nettoyer à la main dans de l'eau tiède à l'aide d'un détergent doux. Laisser sécher à l'abri

du soleil. Il n'est pas nécessaire de retirer l'Attache (H) du harnais lors du nettoyage.

PrécautionsNe pas nettoyer le masque dans le lave-vaisselle.Ne pas nettoyer le masque avec de l'alcool, du chlore ou de la javel.Ne pas placer le masque en plein soleil.

Si le masque est placé dans les conditions précitées, il se détériorera et sa duréede vie s'en trouvera réduite. Si votre FlexiFit™ HC431 se détériore ou craque, remplacerle immédiatement.

MISE EN PLACE DU MASQUEVotre Masque FlexiFit™ HC431 est complètement assemblé et prêt à l'emploi. Vous devezcependant suivre les instructions suivantes lors du montage après nettoyage.1) Placer la jupe (C) dans la base du Masque (A).2) Pousser la Valve Anti-Réinhalation (J) sur le Coude (B) et attacher à la coque du Masque.3) Poser le Harnais (K) à plat avec l'étiquette vers le bas. Placer le masque assemblé sur le

Harnais et attacher les quatre lanières dans les emplacements sur la coque du Masque etla glissière (E). Ceci peut être fait sans avoir à détacher les Bandes Velcro en glissant leHarnais dans les emplacements.

Le FlexiFit™ HC431 et accessoires ne sont pas composés de Latex.Certains patients constatent un desséchement du nez et de la gorge consécutif àl'usage de PPC. Les humidificateurs chauffants réduisent considérablement ces

symptômes. Contacter votre fournisseur et demander conseil au sujet du systèmeAmbient Tracking Plus®.

RACCORD PRESSION/OXYGENEUn raccord pression/oxygène est disponible si vous nécessitez une mesure depression et/ou davantage d'oxygène. (Code 900HC452)1) Connecter l'extrémité large du Connecteur (T) à la Valve Anti-Réinhalation (J) sur le

masque et la petite extrémité du Connecteur au circuit (R).2) Retirer le(s) bouchon(s) (P) et placer le Tuyau de Pression et/ou d'oxygène (s) fermement

sur le(s) Orifice(s) (Q).(Les deux orifices sont identiques ; vous pouvez utiliser l'un ou l'autre indifféremment

pour l'oxygène ou la mesure de pression. Retirer uniquement le capuchon duConnecteur que vous utilisez)

• Note: A un débit d'oxygène fixe pour un débit constant, la concentration d'oxygène inhaléepeut variée selon la pression réglée, les caractéristiques respiratoires du masque et lesfuites.

• Attention: Lors de l'utilisation d'oxygène sous PPC, le générateur d'oxygène doit être éteintquand la machine est arrêtée; car l'oxygène peut s'accumulée dans la machine elle-mêmeavec le risque de s'enflammer.

• Attention: Ne pas fumer prêt d'une personne sous oxygène.

RECOMMANDATIONS

• Ce masque ne doit être utiliser que dans le cadre des recommandations de votre médecinou installateur ; la machine en marche et correctement mis en place. Ne jamais boucher lesfentes de la fuite expiratoire. Celles-ci permettent la vidange du masque lors la PPC tourne.Par contre lorsque la machine est stoppée, des risques de réinhalation peuvent apparaîtreet provoquer une suffocation.

• A une faible PPC la vidange du masque peut ne pas être complète, une réinhalation des gazexpirés peut apparaître.

• La pression varie entre 3-25 cmH20.

• Ne pas utiliser le masque sans la Valve Anti-Réinhalation en place. Cette valve permet deminimiser la réinhalation de C02 en cas de coupure de courant.

• Ne pas utiliser le masque en cas de nausées ou vomissement.

• Si des réactions allergiques se produisent, ne pas utiliser le masque et consulter votremédecin.

• En cas de reconditionnement du FlexiFit™ HC431 entre plusieurs patients, consulter lesInstructions de Nettoyage du FlexiFit™ HC431 pour le reconditionnnement.

• Remplacer la valve Anti-Réinhalation tous les ans.

• Ne pas utiliser le coude du FlexiFit™ HC431 sur d'autres Masques Fisher & Paykel.

• N'utiliser le FlexiFit™ HC431 qu'avec le harnais fourni.

PRÉCAUTION

• Le masque doit être strictement utilisé de la façon décrite dans ce manuel.

• Les lois Fédérales américaines n'autorisent la vente de ces appareils que par prescriptionmédicale ou directement par un médecin.

• La température varie entre 40 et 140 °F (5-50 °C).

CONTRE-INDICATIONSCe masque ne doit être utilisé que sous une continuelle supervision si le patient estincapable de retirer le masque de lui-même en cas de vomissement et d'aspiration.

Numéro de brevet américain 6 615 834Autres brevets en instance

HARNAIS ET ATTAHARNAISET ATTACHECHE

Instrucciones de uso mascarillaoronasal FlexiFit™ Series - HC431

La Mascarilla oronasal FlexiFitTM HC431 puede ser utilizada por un único o múltiplespacientes adultos, que hayan sido diagnosticados por un médico del tratamiento de

CPAP o de ventilador BPAP.

COMO COLOCAR SU MÁSCARILLADirigirse al diagrama para ensamblar la máscara

1) Retire la cubierta plástica del sello de silicona.2) Desabroche el arnés (K), tirando hacia abajo el cordón de desenganche. Sujetando la Base

de la mascarilla (A) con una mano, colocar el arnés con la otra mano para que se ajuste demanera cómoda a su cabeza.

3) Sostener suavemente la mascarilla contra el rostro con la parte inferior del sello (C) bajo sumentón y colocar el arnés en la cabeza con la mano libre.

4) Abrochar el broche del cordón (H) al broche de la mascarilla.5) Ajustar suavemente la cinta horizontal superior, luego la cinta horizontal inferior, luego la

cinta superior de la corona. Asegúrese de que el sello superior esté bien colocado en elpuente de la nariz y el sello inferior esté correctamente ajustado al mentón. Verifique que elbroche de la mascarilla esté centrado.

6) Conectar el equipo de CPAP a la mascarilla, con la presión prescrita. • Si fuere necesario apretar las cintas inferiores para eliminar cualquier fuga. (no apretar

demasiado las cintas)• Si las fugas persisten, apretar suavemente las cintas superiores. No es necesario que la

almohada frontal toque su frente.• Si las fugas persisten en la parte inferior, apretar suavemente las cintas inferiores horizon-

tales. (No apretar demasiado las cintas)• Si las fugas persisten, cambie el tamaño del sello de silicona, por el que se encuentra en la

caja de su mascarilla FlexiFit™ HC431.• Para sacarse la mascarilla desabroche el arnés, tirando el cordón de desenganche hacia

adelante o hacia abajo.

COMO LIMPIAR SU MASCARILLAPara mantener continuamente, seguridad y comodidad con su mascarilla FlexiFitTM HC431:Antes del uso:1) Inspeccionar la mascarilla para verificar si ha sufrido deterioro. No utilizar la mascarilla si

estuviera dañada2) Inspeccionar la válvula de no reinhalación (J) Asegurarse de que las aletas de silicona

tapen el tubo cuando el equipo de CPAP esté desconectado.Después del uso1) Desmontar el sello de silicona (C), el codo (B), la válvula de no reinhalación y el arnés (K)

de la base de la mascarilla (A).2) Lavar el sello de silicona, el codo, la válvula de no reinhalación y el marco de la mascarilla

con agua caliente y jabón. Enjuagar inmediatamente con agua. 3) Dejar secar todas las partes, evitando la luz del sol directa, antes de armarla nuevamente.Cada 7 días:1) Lavar el arnés a mano con agua tibia utilizando un detergente suave. Dejar secar al aire evi-

tando la luz del sol directa. No es necesario remover el broche (H) del arnés para lavarlo.

Precaución No lavar la mascarilla en el lavaplatosNo limpiar la mascarilla con alcohol, cloro u otro químicoNo guarde la mascarilla en lugares con luz directa del sol

Lo mencionado anteriormente puede deteriorar o dañar la mascarilla y disminuir su vidaútil. En caso de que su FlexifitTM HC431 se debilite o rompa, reemplácela de inmediato.

COMO ARMAR SU MASCARILLASu mascarilla FlexiFitTM HC431 está completamente armada y lista para ser usada. En caso de

limpieza, siga las instrucciones de armado.1) Colocar el sello de silicona (C) en la base de la mascarilla (A).2) Empujar la válvula de no reinhalación (J) hacia el codo (B) y unirlo a la base de la

mascarilla3) Colocar el arnés (K) horizontal con la etiqueta hacia abajo. Colocar la mascarilla armada

sobre el arnés y abrochar las cuatro cintas en las aperturas correspondientes a la base dela mascarilla y el broche GliderTM (E). Puede hacerlo sin abrir el velcro, colocando el arnésen las aperturas.

El FlexiFitTM HC431 y sus accesorios no contienen látex.Muchas personas consideran que la terapia de CPAP causa sequedad de la nariz y garganta.

La humidificación calefaccionada puede reducir considerablemente estos molestos síntomas. Contacte a su proveedor y consulte acerca de Ambient Tracking Plus®.

CONECTOR DEL PUERTO DE OXÍGENO/PRESIÓNSi se requiere lectura de presión y/o oxígeno adicional, está disponible el conector de puerto deoxígeno/presión.(Código 900HC452)1) Conectar el extremo ancho del conector (T) a la válvula de no reinhalación (J) de la mas-

carilla y el extremo pequeño del conector al tubo.2) Abrir la(s) tapa(s) (P) y colocar firmemente el tubo de presión y/o tubo de oxígeno (S)

sobre el (los) puerto (s) (Q).(Los dos puertos son idénticos; los dos puertos pueden ser utilizados para medir el

oxígeno o la presión. Sólo remover la tapa de los puertos que están en uso.)• Nota: Al fijar un flujo de oxígeno suplementario, la concentración de oxígeno variará, depen-

diendo de la presión ajustada, patrón respiratorio del paciente, mascarilla seleccionada yrangos de fuga.

• Advertencia: Si el oxígeno es usado con este equipo de CPAP, el flujo del oxígeno debe sercerrado cuando el equipo no está operativo. Explicación de la advertencia: Cuando el equipo de CPAP no está operativo y el flujo deoxígeno continua, el oxígeno entregado se acumulará en los tubos respiratorios. El oxígenoacumulado en el equipo de CPAP puede producir un incendio.

• Advertencia: No fume durante el uso o cerca de alguien que esté recibiendo oxígeno, através de esta mascarilla.

ADVERTENCIAS• Esta mascarilla de CPAP puede ser usada solamente con un sistema recomendado por un

terapista respiratorio. Una mascarilla no debe usarse si el CPAP no está encendido y funcio-nando apropiadamente. Las ranuras de ventilación de la mascarilla jamás deben bloquearse. Explicación de la advertencia: El sistema de CPAP debe ser usado con mascarillas especialesy conectores con ranuras de ventilación para permitir la expulsión del flujo continuo de aire.

• Cuando el equipo de CPAP está encendido y funcionando apropiadamente, el aire que entregaexpulsa el aire exhalado fuera de la mascarilla a través de los puertos de exhalación.

• Al contrario, cuando el equipo de CPAP no está funcionando el flujo de aire no será suficientepara expulsar el aire expirado fuera de la mascarilla, y el aire exhalado se reinhalaráposiblemente. La reinhalación prolongada del aire exhalado durante muchos minutos puedesofocar.

• Si el equipo de CPAP es ajustado a bajos niveles de presión, el flujo a través del puerto de exhalación puede no ser suficiente para evacuar los gases exhalados. Puede ocurrir reinhalación.

• La presión de operación varía entre 3-25 cm H20.• No utilizar la mascarilla en caso que la válvula de reinhalación no esté correctamente colocada.

Esta válvula asegura la no reinhalación de CO2 en caso de cortes en el suministro de la energíaeléctrica.

• No utilizar la mascarilla en caso de vómito o nauseas.• Deje de usar la mascarilla en caso de reacciones alérgicas. Consulte al terapista si esto llegara

a ocurrir.• En caso de reutilizar la Flexi FitTM HC 431 en diferentes pacientes, revise las instrucciones de

limpieza de múltiples pacientes para la FlexiFitTM HC 431.• Reemplazar la válvula de no reinhalación cada 12 meses. • No utilizar el codo de Flexi Fit HC431 en otras mascarillas Fisher & Paykel• Utilice la FlexifitTM HC431 con el arnés suministrado.

PRECAUCIÓN• Usar la mascarilla sólo para el uso indicado en este folleto.• Según las leyes federales de los Estados Unidos de América este dispositivo sólo puede ser

vendido por un médico o por su recomendación.• La temperatura de operación varía entre 40 y 140°F (5-50°C).

CONTRAINDICACIONESEsta mascarilla no debe ser usada por personas que no sean capaces de retirarse la mascarillasin ayuda en caso de vómitos y aspiración, sin una continua supervisión.

Patente americana número 6 615 834Otras patentes pendientes

INFORMACIÓN DEL BIAS FLOWLa FlexiFitTM HC431 posee un sistema difusor parcial único que libera el CO2 exhalado por mediode las ranuras sobre y bajo el codo.

Es importante que estas ranuras no estén bloqueadas por ningún objeto. Esta fuga controlada asegura que todo el CO2 sea evacuado desde el interior de la mascarilla.

Presión (cm H20) 3 5 7 9 11 13 15 17 19 21 23 25

Flujo (LPM) 23 27 32 37 41 44 48 50 54 57 60 63

RESISTENCIA AL FLUJOCaída de presión a través de la mascarilla @ 50 l/min 0.25 cm H2OCaída de presión a través de la mascarilla @ 100 l/min 0.48 cm H2O

FlexiFit™ Series – HC431 Mascarilla oronasal Instrucciones de limpieza para uso en

múltiples pacientesSu mascarilla oronasal viene lista para ser usada. Para reutilizarla en diferentespacientes, le rogamos seguir las siguientes instrucciones.

LIMPIEZA/SACAR MANCHASAntes de desinfectar, desmontar todos los componentes de la base de la mascarilla (El GliderTM yGlider Cover no se desprenden de la base). Limpiar bien todas las partes de la mascarilla y suscomponentes con una solución de detergente suave y un cepillo blando. Asegurarse que toda lasuciedad haya sido removida. Enjuagar bien con agua potable para retirar la solución detergente.

EN CASO DE QUE EL DISPOSITIVO NO SE LIMPIE CORRECTAMENTE, LA DESINFECCIÓNSERA INADECUADA

PARÁMETROS DE ALTO NIVEL DE DESINFECCIÓN

DESINFECCIÓN TÉRMICARemoje las partes en agua caliente por:

30 minutos a 70 0C (1580F)o

30 minutos at 75°C (167°F)

O

CIDEX® OPASiga las instrucciones para altos niveles de desinfección.

Sumerja por 30 minutos a 20 0C (68 0F)Limpie con agua potable.

MARCO DE LA MASCARILLA

SELLO DE SILICONA

CODO

VÁLVULA DE NO-REINHALACIÓN

ARNÉS CON BROCHE

LAVAR CON AGUA Y JABÓN, LUEGO DEJARLO SECAR

La mascarilla FlexiFitTM Series HC431 puede soportar 20 ciclos de limpieza cumpliendo losparámetros mencionados anteriormente. No utilizar si está muy dañada.

Descargo de responsabilidad: es de responsabilidad del usuario cualquier método de reprocesamiento distinto a los aquí recomendados.

Contactar a su proveedor local para obtener más informaciones.

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https://web.archive.org/web/20061016041625/http://www.fphcare.com/osa/pdf /interface/185043711.pdf

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04 Fisher & Paykel Healthcare

A Holistic Approach to Sleep Therapy from the Pioneers of Humidification Technology

Fisher & Paykel Healthcare is a leading designer and manufacturer of an

impressive range of innovative healthcare devices. Fisher & Paykel Healthcare products are used in more than 90 countries worldwide.

Fisher & Paykel Healthcare entered the respiratory care market in 1971 with the development of a

unique respiratory humidifier system for use in critical care and have since built on a reputation

as a leader in humidification technologies. Fisher & Paykel Healthcare now offers a broad range of products for use in Intensive Care Respiratory Medicine, Neonatal Care, Hospital Operating Rooms and in the treatment of OSA.

Our solutions for the treatment of OSA include a comprehensive range of CPAP units and

humidification technologies in addition to interfaces (masks). Leading-edge technologies combine with rigorous R&D to provide a line-up

of high-performance products for sleeping well and living welt.

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Only Fisher & Paykel

Healthcare offers

an interface in all

delivery categories.

Fisher & Paykel Healthcare 05

When it Comes to a Broad Family of Interface Choices, We've Got You Covered

In the delivery of CPAP treatment, a patient wilt have preferences in an interface type that may be the product of many influences.

For example, they may be sensitive to enclosed spaces or they may prefer to breathe through their mouth. For this reason Fisher & Paykel Healthcare offers a broad family of interface choices, categorized by the way OSA treatment is delivered to the patient.

Delivery Categories

• Nasal Delivery • Direct Nasal Delivery

Oral Delivery Full Face Delivery

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o6 Fisher & Paykel Healthcare

Choosing the Right Fisher & Paykel Healthcare Interface

There are four different delivery categories which should be considered when

choosing an interface. The first thing to establish is the way the person naturally breathes while they sleep.

Some people may experience chronic nasal obstruc· tion and prefer to breathe through the mouth only,

others through the nose only and some may breathe partly or intermittently through both. Choosing a mask by delivery category is likely to provide for

Our range of interfaces and their inherent tech­

nologies give you greater flexibility. We designed them that way to meet the needs of every sleeper.

Use the chart below as a guide to choosing the right mask.

a more natural transition to therapy and therefore lead to greater acceptance and compliance.

1 Breathing Mode

How do you predominantly breathe while you sleep?

Helpful hints on mask choice:

• Do you have a nasal obstruction? If so, an oral or full [ace mask is the best option.

• Do you naturally breathe through your nose or mouth? Choosing a mask on this basis will aid a more natural transition to therapy.

• Do you breathe through your nose and mouth? A full face mask will allow mixed delivery as your breathing patterns change through the night.

. . . ...

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Fisher & Paykel Healthcare 07

FlexiFit™ 405

HIGH PERFORMANCE FROM OUR FAMI LY OF INTERFACES

The Fisher & Paykel Healthcare range of interface

solutions has been designed with innovative features

to enhance sleep performance and provide for:

• 'Fit and Forget' quick and hassle-free fitting

without time-consuming adjustments.

- Facial comfort through unique cushioning

· Alternative delivery methods for those who may

feel claustrophobic.

FlexiFit™ 407 technologies (whether on the bridge of t he nose,

through the mouth, around the face or directly

into the nose).

• 24-hour wellness through maximizing comfort

and minimizing side effects.

- An optimal mask seal to minimize mask leakage.

· Quiet and considerate usage by decreasing noise

that could potentially wake the user or their

bed-partner.

I 3 Mask Models

Standard FlexiFit"" 405 Over-the-nose nasal mask P . Fl ·F· •• rem1um ex1 1t 407

Direct nasal mask Infinity'" 481

Oral mask OracleN 452

Helpful hints on mask choice:

• Do you ever feel claustrophobic? If so, a mask that provides a tree field of vision may suit you better.

• Do you scuba-dive or snorkel? An oral mask slips into your mouth in a similar manner to a diver's mouthpiece.

• Are you comfortable with the feel of a hat or cap? Masks with headgear are not dissimilar in feel to a hat. Each is designed for lightweight, personalized comfort.

• Would you prefer the freedom of little or no headgear? If so, a direct nasal or oral mask may suit you best.

Information on mask models:

• The Flexifit'" 405 and 407 offer an over-the-nose solution that ftts well and is easy to ftt and forget.

• The Infinity™ 481 is smaller and lighter than other masks, delivering pressure directly to the nasal passages.

• The Oracle- 452 is unique - the only mask on the market to deliver pressure through the mouth with minimal headgear.

The Flexifit- 431 is for those who prefer full face delivery for a mix of nasal and oral therapy.

Infinity- 481

Oracle" 452

rlulfll'" 431

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o8 Fisher & Paykel Healthcare

Unique Mask Features for Greater Freedom, Comfort and Compliance

These unique performance features appear in our range of interfaces. All have Fit-and-Forget Technology and are supplied complete as an Out-of-Box Solution. Refer to our handy table for guidance on which interface contains each feature.

FIT-AND-FORGET TECHNOLOGY

Using our anthropometric database with thousands

of facial contours. our designers have created a

combination of technologies that adjust to the

user for personalized comfort - such as: auto­

contouring cushioning technologies and an auto­

sliding Glider' " Strap that compensates for head

movement to maintain a seal. Simply fit and forget.

AN OUT-OF-BOX SOLUTION

All interfaces in the family come assembled

(all sizes included) - ready to use for a simple

application straight from the box. There is no

requirement for a dealer or lab to hold a range

of sizes and no requirement for difficult manual

adjustments once you have the mask home.

PERFORMANCE FEATURES ............................................................................... ................................................... .

FlexiFit'" Technology Auto-contouring fit

With Foam or Air Cushion FlexiFit™ Technology automatic­ally adjusts to a wide range of nasal and facial contours with simple one-step ease offitting and no complicated adjustments.

Microgear- Headgear Minimal intrusion

Virtually 'strap free'. the most minimal headgear in the range. Microgear™ Headgear holds the mask securely in place with min­i mal presence and all the holding advantages of full headgear.

The sliding Glider'" Strap provides freedom of movement while maintaining a seal. Mask force remains equal when the head rotates from side to side, min­imizing the occurrence of leaks.

Efficient Bias Diffuser Quiet usage on vented elbow

With Material Filter or Mainten­ance Free. This advanced air diffuser system prevents air from blowing onto the sleeping partner and decreases noise that could potentially disrupt sleep.

This seal technology has a soft, smooth feel to slide onto the face, and its frosted texture optimizes the mask seal.

An Under-Chin fit provides stability by providing a constant point of reference and maintains the seal even with movement of the jaw during the night.

Stretchgear™ Headgear Deluxe mask suspension system

This is a special elastic headgear segment that maintains an equal mask force when the head tilts up or down.

:~ Crown Strap al Extra stability ,

Complements the Under-Chin Design to maximize stability and eliminate the need for a chin strap.

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Easy-Release Strap One-step removal

Simply pull the Easy-Release Cord for one-step removal of headgear. No ongoing headgear adjustments required. Convenient for quick removal of the mask.

Interface Performance Features

Flt-and-Forget

Out-of-Box Solution

FlexiFitN Technology

llJ Glider"' Strap

m Premium Frosted Silicone Seal

Ill Stretchgear'" Headgear

m Microgear"' Headgear

m Efficient Bias Diffuser

Under-Chin Design

Crown Strap

Easy· Release Strap

Anatomically Designed Mask Base

Rotating Adjustment Dial

This ball-and-socket-styled joint (used only in the Direct Nasal Mask) allows the user to select the Ftexitube position ·providing greater freedom to choose any sleeping position.

'

I

Rotating Adjustment Dial

Offers continuous adjustment of the distance between the SnapF\ap'" Cover and SoftSeal Mouthpiece for a personalized fit. Easy to use· just rotate the adjustment dial. This can even be adjusted while the mask is fitted .

Nasal Delivery

lil•i'llti'''

Foam Cushion

Air Cushion

Material Filter

Maintenance Free

• • • • • •

0

0

0

0

0

0

0

0

0

m m m m m m SoftSeal Mouthpiece/SnapFlap"' Cover Interaction

Fisher & Paykel Healthcare 09

Holds the lips snugly between the inner SoftSeal Mouthpiece and outer SnapF\ap'" Cover providing a leak-free combination. These technologies work together to provide a simple, superior seal and maximum comfort.

..... •· . .

''l'*W'·lii* • ©

• e 0

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10 Fisher & Paykel Healthcare

Nasal Delivery - FlexiFit™ 405 & 407 NASAL MASKS

Each of these nasal masks offers an over-the-nose

mask solution that fits better, feels lighter and is easier to use. When you study the foam cushion of the new FlexiFitN Series you can immediately see

why these nasal masks are so user-friendly.

comes fully assembled with a unique GliderN Strap

mechanism to stop the mask being pulled askew during the night. The FlexiFitN 407 Nasal Mask

comes with premium features including a frosted Silicone Seal and StretchgearN Headgear for even greater comfort and a maintenance-free bias

diffuser for quieter operation.

The FlexiFir Series' comfort technology with its

auto-contouring properties provides a perfect fit for faces of every shape and size. Each mask

Interface Performance Features

Fit-and· Forget

Out-of-Box Solution

m FlexlFitN Technology

m GliderN Strap

m Premium Frosted Silicone Seal

m StretchgearN Headgear

l,ll Efficient Bias Diffuser

Foam Cushion Air Cushion

Material Filter Maintenance Free

Nasal Delivery

Mi§tiEilj§iji§i • • • • •

• • • • • •

Full Face Delivery - FlexiFifM 431 Pl•I I .. r'r IE°

For those who prefer a full-face delivery for a mix of

nasal and oral CPAP therapy, the FlexiFitN 431

with an Under-Chin fit and highly contoured

Silicone Seal for maximum comfort and stability. The Glider'" Strap integrates with Easy-Release Straps for one-step removal and no need for

ongoing adjustments. The FlexiFit™ 431 Full Face Mask comes fully assembled and ready for use.

Full Face Mask offers a comfortable alternative to nasal or oral delivery. Still incorporating

the FlexiFitN Technology with auto-contouring properties, the FlexiFit™ 431 Full Face Mask comes

Interface Performance ~atures

Fit-and-Forget

Out-of-Box Solution

FlexiFit™ Technology

m Glider™ Strap

m Premium frosted Silicone Seal

m Efficient Bias Diffuser

Under-Chin Design

Crown Strap

m Easy-Release Strap

0

0 Foam Cushion Air Cushion 0

0 0

Material Filter Maintenance Free 0

0

0

0

Page 21

Page 22: AFFIDAVIT OF CHRISTOPHER BUTLER... 415.561.6767 415.840-0391 e-fax Internet Archive 300 Funston Avenue San Francisco, CA 94118 AFFIDAVIT OF CHRISTOPHER BUTLER 1. I am the Office Manager

Infinity~ 481

Oracle• 452

Fisher & Paykel Healthcare 11

Direct Nasal Delivery - Infinity™ 481 DIRECT NASAL MASK

The Infinity'" 481 Direct Nasal Mask is smaller and

lighter than all other masks to offer the patient total

sleeping freedom. The Infinity'" 481 differs from other

over-the-nose nasal masks by delivering pressure

directly into the nasal passages via an anatomically

shaped Silicone Seal direct to each nostril.

Interface Performance features

Fit-and-Forget

Out-of-Box Solution

IJ Premium Frosted Silicone Seal

m Microgear'" Headgear

A maintenance-free vent disperses the air

quietly and efficiently, while a ball-and-socket·

styled joint allows infinite movement for comfort.

This freedom of movement, combined with

minimalist Microgear'" Headgear, provides for

unprecedented comfort and ease of use.

Direct Nasal Delivery

• • • • ma Efficient Bias Diffuser Material Filter

Maintenance Free • • m Anatomically Designed Mask Base

Oral Delivery - Oracle™ 45 2

FULL FACE MASK

The Oracle'" 452 Interface is a unique oral mask

for the delivery of positive pressure therapy. The

Oracle'" 452 delivers pressure through the mouth

rather than the nose, offering the patient yet another

choice of delivery. Clinically proven to function as

effectively as a nasal mask, the Oracle'" 452 is a

Interface Performance features

perfect solution for mouth breathers and patients

with chronic nasal obstruction who find therapy

difficult with a nasal mask. With nothing covering

the field of vision, the Oracle'• 452 provides

freedom of movement equivalent only to that of

the Infinity'" 481 Direct Nasal Mask.

Oral Delivery

Oracle'" 452

Fit·and·forget

Out-of-Box Solution

m Efficient Bias Diffuser Material Filter

Maintenance Free

0

0 0

IJ Easy-Release Strap

Ill Rotating Adjustment Dial

m SoftSeal Mouthpiece/SnapFlap™ Cover Interaction

(i)

0

0

Page 22

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