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Intended Use

The Interchangeable Anti-Asphyxia  with Leak Elbow is an accessory to the BiTrac MaxShield 
Select™ Pediatric Mask.  A minimum pressure of >3.0cm of H

2

O at the mask is required.  

Contraindications 

1. This device should not be used on uncooperative or unresponsive patients.

2. This device may not be suitable for use on patients unable to remove the mask or 

are taking medication which may cause vomiting.

Warnings

1. This mask has an integral leak port that provides a continuous leak path in the patient 

circuit. It is recommended that the circuit have an additional exhalation device. You may 

need to adjust the pressure level and oxygen therapy to compensate for the additional 

leak of the exhalation device.

2. This device is designed to be used only in conjunction with a BiTrac MaxShield Select

Pediatric Interchangeable Elbow compatible mask.

Before Use

Verify entrainment valve function on Interchangeable Anti-Asphyxia Elbow 

• 

With the valve unit turned OFF; the entrainment valve flap should be open, allowing user to 

breathe room air

• Turn CPAP or Bilevel unit ON

• 

The flap valve should close, allowing the user to receive airflow from the unit

• If the valve does not function in this manner; replace the elbow

• Check the valve before each use for malfunction or blockage caused by patient secretions.

Use of Interchangeable Elbow Feature: 

1. Remove the existing elbow from the mask by holding the adapter ring and twisting the

elbow counter clockwise to disengage the bayonet lock (Refer to Figure B.)

2. Gently pull the elbow from the mask. (Refer to Figure C.)

3. Gently press the desired Interchangeable Compatible Elbow into the mask adapter ring and 

turn clockwise until fully seated. Do not use excessive force. 

Bayonet Lock References:

1 of 15

Pediatric Interchangeable 

Anti-Asphyxia 

With Leak Elbow 

22mm Male

Interchangeable Elbow

Compatible

2746C 07-01-2021

Pulmodyne is a registered trademark of Pulmodyne, Inc. BiTrac 

MaxShield Select are trademarks of Pulmodyne, Inc. 

Made in USA

Pulmodyne Inc.

2055 Executive Drive

Indianapolis, IN 46241 USA
www.pulmodyne.com

M

P

Caution:

  Federal Law (USA) restricts this device to sale 

by or on the order of a licensed physician.

Latex Free

Single Patient Use

Made in USA

Pulmodyne Inc.

2055 Executive Drive

Indianapolis, IN 46241 USA
www.pulmodyne.com

M

P

Caution:

  Federal Law (USA) restricts this device to sale 

by or on the order of a licensed physician.

Latex Free

Single Patient Use

Pediatric Interchangeable 

Anti-Asphyxia 

With Leak Elbow 

22mm Male

Interchangeble 

Elbow Compatible

BiTrac MaxShield

Select

BiTrac MaxShield

Select

Operating Specifications:

 5°C to 40°C 

at humidity range of 15% to 95%

Storage Specifications:

 -20°C to 

60°C at relative humidity up to 95% 

non-condensing

Figure A.

Figure B.

Figure C.

Intended Use

The Interchangeable Anti-Asphyxia  with Leak Elbow is an accessory to the BiTrac MaxShield 
Select™ Pediatric Mask.  A minimum pressure of >3.0cm of H

2

O at the mask is required.  

Contraindications 

1. This device should not be used on uncooperative or unresponsive patients.

2. This device may not be suitable for use on patients unable to remove the mask or 

are taking medication which may cause vomiting.

Warnings

1. This mask has an integral leak port that provides a continuous leak path in the patient 

circuit. It is recommended that the circuit have an additional exhalation device. You may 

need to adjust the pressure level and oxygen therapy to compensate for the additional 

leak of the exhalation device.

2. This device is designed to be used only in conjunction with a BiTrac MaxShield Select 

Pediatric Interchangeable Elbow compatible mask.

Before Use

Verify entrainment valve function on Interchangeable Anti-Asphyxia Elbow 

• 

With the valve unit turned OFF; the entrainment valve flap should be open, allowing user to 

breathe room air

• Turn CPAP or Bilevel unit ON

• 

The flap valve should close, allowing the user to receive airflow from the unit

• If the valve does not function in this manner; replace the elbow

• Check the valve before each use for malfunction or blockage caused by patient secretions.

Use of Interchangeable Elbow Feature: 

1. Remove the existing elbow from the mask by holding the adapter ring and twisting the 

elbow counter clockwise to disengage the bayonet lock (Refer to Figure B.)

2. Gently pull the elbow from the mask. (Refer to Figure C.)

3. Gently press the desired Interchangeable Compatible Elbow into the mask adapter ring 

and turn clockwise until fully seated. Do not use excessive force. 

Bayonet Lock References:

1 of 15

Pulmodyne is a registered trademark of Pulmodyne, Inc. BiTrac 

MaxShield Select are trademarks of Pulmodyne, Inc. 

Operating Specifications:

 5°C to 40°C 

at humidity range of 15% to 95%

Storage Specifications:

 -20°C to 

60°C at relative humidity up to 95% 

non-condensing

Figure A.

Figure B.

Figure C.

Medical Device

Medical Device

2746C 07-01-2021

Summary of Contents for BiTrac MaxShield Select

Page 1: ...aw USA restricts this device to sale by or on the order of a licensed physician Latex Free Single Patient Use Pediatric Interchangeable Anti Asphyxia With Leak Elbow 22mm Male Interchangeble Elbow Compatible BiTrac MaxShield Select BiTrac MaxShield Select Operating Specifications 5 C to 40 C at humidity range of 15 to 95 Storage Specifications 20 C to 60 C at relative humidity up to 95 non condens...

Page 2: ...estdruck von 3 0 cm H2 O an der Maske ist erforderlich Kontraindikationen 1 Dieses Gerät sollte nicht bei Patienten verwendet werden die unkooperativ sind oder keine Reaktion zeigen 2 Dieses Gerät ist evtl nicht geeignet für Patienten die nicht in der Lage sind die Maske abzunehmen oder die eine Medikation erhalten die Erbrechen verursachen kann Warnhinweise 1 Diese Maske hat eine integrierte Undi...

Page 3: ...f en læge eller på dennes anvisning BiTrac MaxShield Select Figur A Figur B Figur C 3 of 15 Latexfri Til brug hos en enkelt patient Pædiatrisk Udskifteligt anti asfyksi vinkelstykke med udåndingsåbning 22 mm hankobling Anvendelsesområder Det udskiftelige anti asfyksi vinkelstykke med udåndingsåbning er tilbehør til BiTrac MaxShield Select Pædiatrisk maske Et minimumstryk på 3 0 cm H2O ved masken e...

Page 4: ...tomando medicamentos que puedan provocar vómitos Advertencias 1 Esta mascarilla dispone de orificio para fugas integrado Por lo tanto no es preciso ningún dispositivo de exhalación independiente 2 Este dispositivo está diseñado para utilizarlo únicamente junto con una mascarilla compatible con el codo intercambiable para la Mascarilla BiTrac MaxShield Uso de la función de codo intercambiable 1 Ret...

Page 5: ...n médecin dûment agréé 5 of 15 BiTrac MaxShield Select Figure A Figure B Figure C Utilisation prévue Le raccord coudé à fuite anti asphyxie interchangeable est un accessoire qui s adapte au masque BiTrac MaxShield Select Pédiatrique Une pression minimale 3 0 cm de H2 O dans le masque est obligatoire Contre indications 1 Cet appareil ne doit pas être utilisé sur des patients peu coopératifs ou inco...

Page 6: ...i lääkärin määräyksestä 6 of 15 BiTrac MaxShield Select Kuva A Kuva B Kuva C Lateksiton Yhden potilaan käyttöön Lasten Vaihdettava anti asfyksia aukolla varustettu vuotomutkakappale 22 mm miehet Käyttötarkoitus Vaihdettava anti asfyksia aukolla varustettu vuotomutkakappale on ja BiTrac MaxShield Select Lasten maskin lisävaruste Maskissa tulee olla 3 0 cm H2 O minimipaine Vasta aiheet 1 Tätä laitet...

Page 7: ...ς ή με συνταγή ιατρού 7 of 15 BiTrac MaxShield Select Σχήμα A Σχήμα B Σχήμα C Προοριζόμενη χρήση Η εναλλάξιμη βαλβίδα αντι ασφυξίας με γωνιακό σύνδεσμο διαρροής είναι εξάρτημα της μάσκαςBiTrac MaxShield Select Παιδιατρική Η ελάχιστη πίεση που απαιτείται στη μάσκα είναι 3 0cm H2 O Αντενδείξεις 1 Η συσκευή αυτή δεν πρέπει να χρησιμοποιείται σε μη συνεργάσιμους ή μη ανταποκρίσιμους ασθενείς 2 Η συσκε...

Page 8: ...ro prescrizione medica 8 of 15 BiTrac MaxShield Select Figura A Figura B Figura C Uso previsto Il gomito per la fuoriuscita dell aria anti asfissia intercambiabile è un accessorio della maschera BiTrac MaxShield Select Pediatrica Ė necessaria una pressione minima di 3 0 cm di H2 O alla maschera Controindicazioni 1 Il dispositivo non deve essere utilizzato in pazienti non collaboranti o non coscien...

Page 9: ... bruk på én enkelt pasient Lateksfri BiTrac MaxShield Select Figur A Figur B Figur C Pediatrisk Utskiftbar antikvelningsalbue med 22 mm hann Tiltenkt bruk Utskiftbar antikvelningsalbue med lekkasjeport er BiTrac MaxShield Select Pediatrisk maske Det kreves et minimumstrykk på 3 0 cm med H2O i masken Kontraindikasjoner 1 Denne enheten skal ikke brukes på motvillige eller passive pasienter 2 Denne a...

Page 10: ... verkocht 10 of 15 BiTrac MaxShield Select Afbeelding A Afbeelding B Afbeelding C Bevat geen latex Voor gebruik bij één patiënt Pediatrisch Uitwisselbaar antiasfyxie elleboogstuk met lek 22 mm mannelijk Beoogd gebruik Het uitwisselbare anti asfyxie elleboogstuk met lek is een accessoire bij het BiTrac MaxShield Select Pediatrisch masker Aan het masker is een minimale druk van 3 0 cm H2O vereist Co...

Page 11: ...enciados ou sob receita médica BiTrac MaxShield Select Figura A Figura B Figura C 11 of 15 Sem látex Para utilização num único doente Pediátrica Conector Macho de 22 mm anti asfixia com cotovelo de fuga intercambiável Utilização prevista O conector anti asfixia com cotovelo de fuga intercambiável é um acessório da Máscara BiTrac MaxShield Select Pediátrica É necessário que exista uma pressão mínim...

Page 12: ...do 60 C przy wilgotności względnej do 95 bez skraplania Rysunek A Rysunek B Rysunek C Nie zawiera lateksu Do użytku u jednego pacjenta Pediatryczna Wymienny przewód z kolankiem przeciekowym zapobiegającym utracie przytomności z powodu braku tlenu 22 mm męskie Przestroga Według przepisów prawa federalnego USA urządzenia te mogą być sprzedawane wyłącznie lekarzowi lub na jego zlecenie 12 of 15 BiTra...

Page 13: ...s av eller på begäran av läkare BiTrac MaxShield Select Figur A Figur B Figur C Avsedd användning Det utbytbara anti asfyxihuset med läckageknärör är ett tillbehör till BiTrac MaxShield Select Pediatrisk mask Det krävs ett minimitryck på 3 0 cm H2 O i masken Kontraindikationer 1 Detta instrument ska inte användas på icke samarbetsvilliga eller oemottagliga patienter 2 Denna enhet kan vara olämplig...

Page 14: ...iparişi üzerine yapılmasını gerektirir BiTrac MaxShield Select Şekil A Şekil B Şekil C 14 of 15 Kullanım Amacı Sızıntı Dirsekli Değiştirilebilir Anti Asfiksi BiTrac MaxShield Select Pediyatrik Maskenin yardımcı bir parçasıdır Maskede minimum basıncın 3 0 cm lik H2 O olması gerekir Kontrendikasyonlar 1 Bu cihaz koopere olmayan veya tepki göstermeyen hastalarda kullanılmamalıdır 2 Bu cihaz maskeyi ç...

Page 15: ...Notes 15 of 15 Notes 15 of 15 ...

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