Philips Wisp Pediatric Nasal Mask Bedienungsanleitung

1142915 R04

Дата останнього перегляду інструкції DLK 5/31/2019

Respironics Inc.

1001 Murry Ridge Lane

Murrysville, PA 15668 USA

GmbH & Co. KGRespironics Deutschland

Gewerbestrasse 17

82211 Herrsching, Germany

Wisp Pediatric

Nasal Mask

Respironics Inc.

1001 Murry Ridge Lane

Murrysville, PA 15668, USA

»,

-52-32

[email protected],

Wisp Pediatric Nasal Mask

EN 001 INSTRUCTIONS FOR USE

HU 008 HASZNÁLATI ÚTMUTATÓ

SK 015 NÁVOD NA POUŽITIE

RO 022 INSTRUCȚIUNI DE UTILIZARE

UK 029 ІНСТРУКЦІЯ ІЗ ЗАСТОСУВАННЯ

Wisp Pediatric Nasal Mask

Instructions for use - e

1 Safety Information

Intended Use

This mask is intended to provide an interface for application of non-invasive ventilation to patients.

The mask is for single patient use in the home and multi-patient use in the hospital/institutional

environment. The mask is to be used on patients 5 kg/11 lbs or greater (≥5 kg/11 lbs) for whom non-

invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the

compatible therapy device with respect to patient weight.

Note: This mask is not made with natural rubber latex, DEHP or BPA.

Note: This mask can be used with a variety of therapy devices which may have their own

limitations on patient population. If the therapy device itself is limited to patients greater than 5 kg,

then the use of this mask does not expand the intended use of that therapy device.

Contraindications

This mask is not intended for patients who are dependent on mechanical ventilation for their

life support.

Warnings

•When using this mask, it is the responsibility of the healthcare professional to ensure proper device

set-up in accordance with patient condition, including the use of proper alarms.

•Appropriate patient monitoring and alarms should be used for patients who are unable to remove the

mask themselves to assure the mask and tubing remain in place during therapy.

•The use of nasal or full face masks applies forces on the head and may aﬀect cranial facial growth

patterns. Regular Healthcare professional assessment is recommended when using this mask.

•Use of this mask while the system is not on and operating may cause rebreathing of exhaled air.

Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to

suﬀocation.

•Discontinue use and contact your healthcare professional if any of the following symptoms occur: skin

redness, irritation, discomfort, blurred vision, or drying of the eyes.

•Discontinue use and consult your healthcare professional if any of the following symptoms occur:

unusual chest discomfort, shortness of breath, severe headache, eye pain or eye infections.

•Discontinue use and consult your healthcare professional if any of the following symptoms occur:

tooth, gum, or jaw soreness. Use of a mask may aggravate an existing dental condition.

•The mask material should be away from eyes.

•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.

•Do not block or seal oﬀ the exhalation ports.

2 Mask Parts

Features

A Mask cushion assembly

B Leak Correction Dial

C Mask frame

D Frame bottom slot

E Headgear clip

F Quick release tabs

G Tubing assembly

H Swivel

I Elbow with built-in exhalation

(do not block)

J Frame top slot

K Headgear top strap

L Headgear crown strap

M Headgear back strap

N Headgear bottom strap

O Tube wrap (optional)

P Tubing management loop

3 Before Use

•Hand wash the entire mask (see Mask Care section).

•Wash face. Do not use moisturizer/lotion on hands or face.

•Inspect the mask. Replace the cushion if hardened or torn. Replace any parts that are broken or

worn.

4 Mask Care

Cleaning Instructions

Daily: Hand wash the non-fabric parts.

Weekly: Hand wash the fabric parts.

1. Wash in warm water with liquid dishwashing soap.

2. Rinse thoroughly.

3. Air dry completely before use. Lay the fabric parts ﬂat or hang to dry.

Caution: Do not clean the mask with bleach, alcohol, solutions containing bleach or alcohol, or

solutions containing conditioners or moisturizers.

Caution: Any deviation from these instructions may impact the performance of the product.

Dishwashing Instructions

Weekly: Additionally, the non-fabric mask parts may also be cleaned in the dishwasher.

1. Disassemble.

2. Wash the non-fabric parts in the top shelf of the dishwasher with liquid dishwashing detergent.

3. Air dry completely before use.

5 Achieving the Right Fit

Before Putting on the Mask

Sizing: Select the cushion that ﬁts the width of the nose without blocking the nostrils. The mask

sizing gauge can be used as a guide by holding the gauge under the nose (see illustration).

Putting on the Mask

1. Headgear clip: Disconnect one or both by twisting the clip outward

Note: Use of the headgear clips is optional. You can peel headgear tabs away from headgear

straps and pull through the slots in the mask frame.

2. Headgear: Pull headgear on over head

3. Cushion: With the Leak Correction Dial facing downward, place cushion over nose

. The top of

the cushion should sit at the bridge of the nose.

Note: Wisp adult cushions should not be used with the pediatric mask.

4. Headgear bottom straps or clip: Thread bottom strap through slot in mask frame or press clip

against the frame slot to reattach

Adjusting the Mask

1. Headgear: Peel the headgear tabs away from the headgear straps then press tabs against the

headgear straps to reattach

Connect the top straps to the headgear to achieve a comfortable fit.

Connect the bottom strap to the lower headgear to achieve a comfortable fit.

2. Headgear: Adjust top straps evenly

3. Headgear: Adjust bottom straps evenly

4. Headgear: Adjust crown strap so that the headgear and frame do not touch the ears

The mask should rest comfortably against face

If there are excessive air leaks adjust the headgear. For small mask leaks during sleep see Leak

Correction Dial section.

Note: Do not overtighten the headgear.

Using Tube Management (Optional)

The ﬂexible tubing may be placed over the head

. Slide the

end of the crown strap through the loop on the tube wrap. Then

route the end of the crown strap though the slot in the headgear

and fasten into place.

Using the Mask

1. Connect the flexible tubing (included with the CPAP or bi-

level device) to the swivel.

2. Turn the therapy device on. Make sure the child is lying

down and breathing normally.

Leak Correction Dial

The Leak Correction Dial should point straight downward

each

time the mask is placed on the child.

If the child experiences small mask leaks while sleeping,

move the dial to the left or right

. If leaks cannot be

corrected using the dial, re-seat the mask by pulling it directly

away from the face and gently setting it back into place.

Removing the Entire Mask

1. Disconnect a bottom headgear clip.

2. Slide the mask upward over the head.

6 Disassembly

Removing the Elbow and Tubing

Squeeze the quick release tabs and pull the elbow away from the cushion

12 13 14

Removing the Cushion

Push the cushion backwards through the frame

Removing the Headgear

1. Detach the headgear bottom clips from the frame or undo the bottom tabs and pull.

2. Undo the headgear top tabs and pull the straps through the frame.

7 Assembly

Attaching the Cushion

With the Leak Correction Dial pointing downward, push the cushion into the frame towards the

front and press into place.

The sides of the cushion will match the alignment cutouts in the

mask frame

Attaching the Elbow and Tubing

Push the elbow into the cushion until the quick release tabs click

into place.

Attaching the Headgear

1. Hold the crown strap upward.

2. Make sure the back strap that displays “Philips Respironics” is

facing outward and is right side up.

3. Slide the headgear top strap into the frame top slots.

4. Connect the headgear clips to the frame bottom slots or slide the headgear bottom strap into

the frame bottom slots.

8 Comfort Tips for Caregivers

•If the child has a preference for a certain sleeping position, consider this when choosing

placement of the machine.

•The most common mistake is overtightening the headgear. The headgear should ﬁt loosely and

comfortably. If the skin bulges around the mask or if red marks appear, loosen the headgear.

•If necessary, adjust the crown strap to move the headgear oﬀ of the ears.

•Headgear clips are optional. If you prefer, you can thread the headgear strap directly through the

frame slot.

•The quick release elbow allows the mask to be temporarily disconnected from the tubing

without the child having to remove the mask. The elbow can be quickly clicked back into place

when the child returns to bed.

•Use of the optional tube management feature moves the tube away from the front of the body

and reroutes it over the child’s head. The quick release feature cannot be used when tube is

routed over the top of the head using the tubing management loop on the tube wrap.

•The mask can be removed from the child’s head by sliding it upward frame ﬁrst or headgear ﬁrst,

according to the child’s preference. Children may accept the process more easily if the headgear

is removed ﬁrst, pulling the mask away from the face, instead of up over the face frame-ﬁrst.

9 Health Care Provider & Clinician Information

Philips Respironics System One Resistance Control

Using your mask with a Philips Respironics System One device provides optimal comfort. The

provider sets this value (X1) on your device.

Multi-Patient Use

Refer to the Disinfection Guide for Professional Users to reprocess between patients in a clinical

setting. Access the latest version of the Disinfection Guide at www.healthcare.philips.com or by

contacting customer service at +1-724-387-4000 or Respironics Deutschland at +49 8152 93060.

Specifications

The technical speciﬁcations of the mask are provided for your healthcare professional to determine if

it is compatible with your therapy device, and that alerts and alarms function properly.

Warning: Use outside of these speciﬁcations may result in ineﬀective therapy. The pressure ﬂow

curve shown below is an approximation of expected performance. Exact measurements may vary.

Pressure Flow Curve

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 H20

Flow Rate (SLPM)

Resistance

Drop in Pressure at:

50 SLPM 100 SLPM

All Sizes 0.7 cm H2O 2.8 cm H2O

Disposal

Dispose of in accordance with local

regulations.

Deadspace

SCS 18.9 mL

SCM 24.3 mL

SCL 35.9 mL

Storage Conditions

Temperature: -4° F to 140° F (-20° C to 60° C)

Relative Humidity: 15% to 95%, non-

condensing

Sound Levels

A-weighted Sound Power Level 29.8 dBA

A-weighted Sound Pressure Level at 1m 22.1 dBA

10 Symbols

Manufacturer Humidity Limits

Philips Respironics System One

Resistance Control Value Temperature Limits

Not Made with Natural Rubber Latex

11 Limited Warranty

Respironics, Inc. warrants that its mask systems (including mask frame and cushion) (the“Product”) shall be

free from defects of workmanship and materials for a period of ninety (90) days from the date of purchase

(the “Warranty Period”). If the Product fails under normal conditions of use during the Warranty Period and the

Product is returned to Respironics within the Warranty Period, Respironics will replace the Product. This warranty

is nontransferable and only applies to the original owner of the Product. The foregoing replacement remedy will

be the sole remedy for breach of the foregoing warranty.

This warranty does not cover damage caused by accident, misuse, abuse, negligence, alteration, failure to use or

maintain the Product under conditions of normal use and in accordance with the terms of the product literature,

and other defects not related to materials or workmanship.

This warranty does not apply to any Product that 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 exclusion may not apply to you.

THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS WARRANTIES. IN ADDITION, ANY IMPLIED WARRANTY,

INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IS SPECIFICALLY

DISCLAIMED. SOME JURISDICTIONS DO NOT ALLOW DISCLAIMERS OF IMPLIED WARRANTIES, SO THE ABOVE

LIMITATION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSO

HAVE OTHER RIGHTS UNDER LAWS APPLICABLE IN YOUR SPECIFIC JURISDICTION.

To exercise your rights under this limited warranty, contact your local authorized Respironics, Inc. dealer or

Respironics, Inc. at 1001 Murry Ridge Lane, Murrysville, Pennsylvania 15668, USA.

Wisp gyermekeknek való orrmaszk

Használati útmutató – h

1. Biztonsági információk

Alkalmazási terület

Az orrmaszkkal biztosítható a páciensek lélegeztető berendezésre kötése nem invazív lélegeztetés

alkalmazásához. A maszk otthoni környezetben egy, kórházi/intézményi körülmények között

pedig több páciensen történő használatra szolgál. A maszk olyan, legalább 5 kg testtömegű

(≥5 kg) páciensek esetében alkalmazható, akik számára nem invazív lélegeztetést rendeltek el.

A maszk használatát korlátozzák a kompatibilis terápiás készülék páciens testtömegére vonatkozó

felhasználási javallatai.

Megjegyzés: A maszk készítéséhez nem használtak természetes latexgumit, DEHP-t vagy BPA-t.

Megjegyzés: A maszk több terápiás készülékkel használható, melyeknek lehetnek saját

korlátozásai a betegpopulációra nézve. Ha maga a terápiás készülék használata 5 kg-nál nagyobb

testtömegű páciensekre korlátozott, akkor a maszk használata nem bővíti ki a terápiás készülék

alkalmazási területét.

Ellenjavallatok

Ez a maszk nem alkalmas olyan betegek részére, akik életfenntartó gépi lélegeztetést igényelnek.

Figyelmeztetések

•A maszk használatakor az egészségügyi szakember feladata, hogy a beteg állapotának megfelelően

biztosítsa a készülék megfelelő beállítását, beleértve a megfelelő ﬁgyelmeztetések használatát.

•A megfelelő betegmonitorozás és ﬁgyelmeztetések használata szükséges olyan betegek esetén, akik

nem tudják egyedül levenni a maszkot, annak biztosítására, hogy a maszk és a csőszerelvény a helyén

maradjon a terápia alatt.

•Az orr- vagy teljes arcmaszk használata erőt fejt ki a fejre, és hatással lehet az arckoponya növekedési

mintázatára. Egészségügyi szakember általi rendszeres értékelés ajánlott ezen maszk használatakor.

•Ha a maszkot úgy használják, hogy a rendszer nincs bekapcsolva és nem működik, előfordulhat, hogy

a beteg visszalélegzi a kilélegzett levegőt. A kilélegzett levegő néhány percnél hosszabb ideig tartó

visszalélegzése bizonyos esetekben fulladáshoz vezethet.

•Ha az alábbi tünetek bármelyikét észleli, szakítsa meg az eszköz használatát, és forduljon

a szakorvosához: bőrpír, irritáció, diszkomfort, homályos látás vagy szemszárazság.

•Ha az alábbi tünetek bármelyikét észleli, szakítsa meg az eszköz használatát, és kérdezze meg

a szakorvosát: szokatlan mellkasi diszkomfortérzés, légszomj, nagyon erős fejfájás, szemfájdalom

vagy szemfertőzés.

•Ha az alábbi tünetek bármelyikét észleli, szakítsa meg az eszköz használatát, és kérdezze meg

a szakorvosát: fog-, íny- vagy állkapocsfájdalom. A maszk használata súlyosbíthatja a fennálló

fogászati problémákat.

•A maszk anyagát távol kell tartani a szemektől.

•Ne húzza meg túlságosan a fejpánt szíjait. Figyeljen arra, hogy a maszk széleinél nem láthatók-e

a fejpánt szíjainak túl szorosra állítására utaló jelek, például túlzottan kipirosodó, kisebesedő vagy

kidudorodó bőr. A tünetek enyhítése érdekében lazítsa meg a fejpánt szíjait.

•Nem szabad elzárni vagy leragasztani a kilégzőnyílásokat.

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