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BiTrac Select
MaxShield™ Mask with
Anti-Asphyxia
With Leak Elbow
22mm Female
Interchangeable Elbow
Compatible
C
Single Patient Use
2797
Latex Free
Caution:
Federal Law (USA) restricts this device to sale
by or on the order of a licensed physician.
M
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
Pulmodyne is a registered trademark of
Pulmodyne, Inc. BiTrac MaxShield
is a registered trademark of Pulmodyne,
Inc.
Intended Use
The BiTrac MaxShield™ mask is an accessory for use with CPAP or Bilevel systems
of >3.0cm of H2O 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, have nocturnal vomiting, hiatal hernia or impaired cardiac sphincter function.
3) This mask may not be suitable for use on patients with the following conditions: glaucoma, recent eye surgery or dry
eyes.
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 not suitable for providing life support ventilation.
3) Any unusual chest discomfort, shortness of breath, stomach distension, belching, severe headache, drying eyes, eye
pain, eye infections or blurred vision when receiving positive airway pressure or upon awakening should be reported to
the clinician.
4) To minimize risks of vomiting during sleep, avoid eating or drinking for three (3) hours before use.
5) Make sure the mask and headgear are the correct size for the patient's face. If excessive discomfort is experienced,
adjust the mask and head gear. If the discomfort continues, consider an alternative mask.
6) This CPAP mask should only be used with CPAP systems recommended by your physician or respiratory therapist. A
mask should not be used unless the CPAP system is turned ON and operating properly. The vent hole or holes
associated with the mask should never be blocked.
Explanation of the Warning: CPAP systems are intended to be used with special masks with connectors which
have vent holes to allow continuous flow of air out of the mask. When the CPAP machine is turned on and functioning
properly, new air from the CPAP machine flushes the exhaled air out through the attached mask exhalation port.
However, when the CPAP machine is not operating, enough fresh air will not be provided through the mask, and
exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances
lead to suffocation. This warning applies to most models of CPAP systems.
Before Use
Verify entrainment valve function on anti-asphyxia elbow:
• With the unit turned OFF, the entrainment valve flap should
be open, allowing user to breathe room air.
EN-Medical Device
• 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 mask.
P
Do not block the opening on the entrainment valve.
Check 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
Made in USA
fully seated. Do not use excessive force.
Bayonet Lock References:
Figure A.
Figure B.
Figure C.
for ventilatory support. A minimum
Operating Specifications: 5°C to 40°C
at humidity range of 15% to 95%
Storage Specifications: -20°C to
60°C at reltive humidity up to 95% non-
condensing
1

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Resumen de contenidos para Pulmodyne BiTrac Select

  • Página 1 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.) Pulmodyne is a registered trademark of 3. Gently press the desired Interchangeable Compatible Elbow into the mask adapter ring and turn clockwise until Pulmodyne, Inc. BiTrac MaxShield Made in USA fully seated.
  • Página 2 Mindestens 3,0 cm H O an der Maske sind erforderlich. Kontraindikationen BiTrac Select ™ 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, die nachts erbrechen müssen oder an einer Hiatushernie oder einer Beeinträchtigung des unteren...
  • Página 3 Es preciso un mínimo de >3 cm de H O en la mascarilla. Contraindicaciones BiTrac Select ™ 1) Este dispositivo no debe utilizarse en pacientes no cooperativos o inconscientes. 2) Este dispositivo puede no ser adecuado para pacientes que no puedan quitarse la mascarilla o que estén tomando medicamentos que puedan provocar vómitos, sufran vómitos nocturnos, padezcan hernia de hiato o insuficiencia del cardias.
  • Página 4 Käyttötarkoitus BiTrac MaxShield™ -maski on CPAP- tai kaksoispainejärjestelmien kanssa ventilaatiotukeen käytettävä lisävaruste. BiTrac Select ™ Maskissa tulee olla yli 3,0 cm H O minimipaine. Vasta-aiheet 1) Tätä laitetta ei tule käyttää yhteistyöhaluttomilla tai reagoimattomilla potilailla. MaxShield™-maski anti- 2) Tämä laite ei ehkä sovi käytettäväksi potilaille, jotka eivät pysty poistamaan maskia tai jotka käyttävät mahdollisesti oksentelua aiheuttavaa lääkitystä...
  • Página 5 Controindicazioni 1) Il dispositivo non deve essere utilizzato in pazienti non collaboranti o non coscienti. BiTrac Select ™ 2) Il dispositivo non è adatto all'uso nei pazienti che non sono in grado di rimuovere la maschera, assumono farmaci che possono causare vomito, presentano vomito notturno, ernia iatale o danneggiamento funzionale dello sfintere cardiale.
  • Página 6 Aan het masker is een minimale druk van >3,0 cm H O vereist. Contra-indicaties BiTrac Select ™ 1) Dit hulpmiddel mag niet worden gebruikt bij patiënten die niet meewerken of niet reageren. 2) Dit hulpmiddel kan ongeschikt zijn voor gebruik bij patiënten die het masker niet zelf kunnen afnemen of die geneesmiddelen gebruiken die braken kunnen veroorzaken, ’s nachts overgeven, of hiatus hernia of een defecte hartsfincterfunctie hebben.
  • Página 7 Przeznaczenie Maska BiTrac MaxShield™ stanowi element dodatkowy do stosowania z systemami CPAP lub przeznaczonymi do terapii dwupoziomowej stosowanymi do wspomagania oddechowego. Wymagane jest minimalne ciśnienie na masce wynoszące >3,0 cm H Przeciwwskazania 1) Urządzenia nie wolno stosować u pacjentów, którzy nie współpracują lub nie reagują na bodźce. BiTrac Select ™ 2) Urządzenie może nie nadawać się do stosowania u pacjentów niezdolnych do zdjęcia maski lub przyjmujących leki, które mogą spowodować wymioty. 3) Maska może nie nadawać się do stosowania u pacjentów z następującymi stanami: jaskra, niedawna operacja oka lub suchość w oku. Maska MaxShield™ z kolankiem Ostrzeżenia przeciekowym zapobiegającym utracie 1) Maska posiada wbudowane ujście wydechowe, które umożliwia ciągły wyciek z obwodu pacjenta. Zaleca się, aby obwód posiadał dodatkowe urządzenie wydechowe. Konieczne może być dostosowania poziomu ciśnienia i terapii tlenowej, aby skompensować dodatkowy przytomności z powodu braku tlenu, wyciek z urządzenia wydechowego.
  • Página 8 Kullanım Amacı BiTrac MaxShield™ maske, suni solunum cihazı desteği için CPAP veya Bilevel sistemleri ile kullanılan yardımcı bir parçadır. Maskede minimum >3,0 cm'lik H O olması gerekir. Kontrendikasyonlar BiTrac Select ™ 1) Bu cihaz, koopere olmayan veya tepki göstermeyen hastalar üzerinde kullanılmamalıdır.‎ ‎ ‫‏‬ 2) Bu cihaz, maskeyi çıkaracak durumu olmayan veya kusmaya, gece kusmasına, mide fıtığına veya kardiyak sfinkter disfonksiyonuna sebep olacak ilaçlar alan hastalarda kullanmak için uygun olmayabilir. 3) Bu maske aşağıdaki durumlara sahip olan hastalar için uygun olmayabilir: glokom, yeni yapılmış göz ameliyatı veya gözlerde kuruluk. 22 mm Dişi Sızıntı Dirsekli Anti-Asfiksili MaxShield™ Maske Uyarılar 1) Bu maskenin hasta devresinde sürekli bir sızıntı yolu sağlayan entegre bir sızıntı portu vardır. Devrede ilave bir nefes verme cihazının olması tavsiye edilir. Nefes verme cihazının neden olduğu ilave sızıntıyı telafi etmek için basınç seviyesini ve oksijen tedavisini ayarlamanız gerekebilir.