maxtec EyeMax2 Micro Instruction Manual

MICRO: OFC 20 – 25 CM (8 – 10 IN)

Indications for Use:

The EyeMax2 provides neonatal eye protection during ultraviolet (UV) phototherapy treatment of jaundice. The EyeMax2 conforms with 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 the 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 the application process beginning with step 1.

Precautions:

CAUTION: Improper EyeMax2 sizing may lead to patient airway obstruction or inadequate eye protection. The Eyemax2 should only be used while the patient is under the continuous, direct supervision of healthcare professionals.

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

DO NOT over tighten – causing excessive pressure on the eyes. Make sure the strap is covering 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 cause cross-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:

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SGS United Kingdom LimitedUnit 202B, Worle ParkwayWeston Super Mare BS22 6WAUnited Kingdom

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

Maxtec I 2305 South 1070 WestSalt Lake City UT 84119801.266.5300 I www.maxtec.comR111P16-003 Rev. R

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