maxtec EyeMax 2 Phototherapy Protection Masks User Manual

EyeMax 2 Phototherapy Protection Masks

PREEMIE: OFC 26 – 32 CM (10 – 13 IN)

Indications for Use:

The EyeMax2 provides neonatal eye protection during ultraviolet (UV) phototherapy treatmentof jaundice. The EyeMax2 conforms with EN 170:2002 Clause 5.2 (Scale Number 2-5) for spectral transmittance as appropriate for the indication for use.

Instructions for use:

  1. Measure Occipital-Frontal Circumference (OFC) of the patient.
  2. Select the appropriate EyeMax2 size based on the OCF. See chart for appropriate sizing.
  3. Disconnect the Velcro.
  4. Position the eye pads over the eyes.
  5. Pass the lower strap under the small of the neck and attach velcro.
  6. Secure the Velcro of both straps and position the EyeMax2 as shown.
  7. Make sure the strap completely covers the ears.
  8. If the eye patch rides up away from the nose, tighten the lower strap.
  9. If the eye patch rides down towards the nose and mouth, repeat application processbeginning with step 1.

Precautions:

CAUTION: Improper EyeMax2 sizing may lead to patient airway obstruction or inadequate eye

The EyeMax2 provides neonatal eye protection during ultraviolet (UV) phototherapy treatment protection. The Eyemax2 should only be used while the patient is under the continuous, direct of jaundice. The EyeMax2 conforms with EN 170:2002 Clause 5.2 (Scale Number 2-5) for spectral supervision of healthcare professionals.

DO NOT tug on the EyeMax2 to reposition it. A premature infant’s skin is very delicate andcan easily rupture. Avoid obstructing the nose. Check regularly to ensure the EyeMax2 isnot blocking the patient’s airway. The EyeMax2 is not a bandage. Cover any existing skinabrasions with appropriate bandages before use.

DO NOT over tighten – causing excessive pressure on the eyes. Make sure the strap iscovering the ear, not hooked over the ear, and that the ear is not folded over. Replace theEyeMax2 with a new one if it becomes over-stretched. Reuse of this device could causecross-contamination or product malfunctions.Catalog # R300P01 Regular: occipital-frontal circumference 33-38 cm in packs of 20.Catalog # R300P02 Preemie: occipital-frontal circumference 26-32 cm in packs of 20.Catalog # R300P03 Micro: occipital-frontal circumference 20-25 cm in packs of 20.Single Patient Use OnlyNon-Sterile, Latex-Free

The Eyemax2 is dually noted as a Class I Medical Device and Category 2 PPE device. EC Type-examination for Directive 89/686/EEC by Notified Body No. 0120:L’eyemax2 est classé dispositif médical de Classe I et dispositif EPP de Catégorie 2. Dispositif CE d’examen selon la “Directive 89/686/CEE par l’organisme notifié No. 0120:Eyemax2 wurde als Medizinisches Gerät der Klasse I und Kategorie 2 PPE notiert. EG-Untersuchung für Richtlinie 89/686/EWG für benannte Stelle Nr. 0120:Eyemax2 è sia un dispositivo medico di Classe I che un dispositivo PPE di Categoria 2. Esame di tipo CE per Direttiva 89/686/CEE da Ente Certificato No. 0120:Eyemax2 está registrado como Dispositivo Médico de Clase I y como dispositivo EPP Categoria 2. Inspección tipo CE para la Directiva 89/686/CE por el organismo notificado no. 0120:

SGS United Kingdom Limited Unit 202B, Worle Parkway Weston Super Mare BS22 6WA United Kingdom

EC REP QNET BV: Kantstraat 19NL-5076 NP Haaren I The Netherlands

Maxtec I 2305 South 1070 West Salt Lake City UT 84119 801.266.5300 I www.maxtec.comR111P16-002 Rev. R

References

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