EyeMax2 Preemie Neonatal Eye Protection
Model: R300P02
Indications for Use
The EyeMax2 provides neonatal eye protection during ultraviolet (UV) phototherapy treatment of 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
Diagram Description: An illustration shows the EyeMax2 device being worn by a baby, with straps positioned around the head and under the chin, covering the eyes.
- Measure Occipital-Frontal Circumference (OFC) of the patient.
- Select the appropriate EyeMax2 size based on the OCF. See chart for appropriate sizing.
- Disconnect the [Velcro fastener].
- Position the eye pads over the eyes.
- Pass the lower strap under the small of the neck and attach [Velcro fastener].
- Secure the [Velcro fastener] of both straps and position the EyeMax2 as shown.
- Make sure the strap completely covers the ears.
- If the eye patch rides up away from the nose, tighten the lower strap.
- If the eye patch rides down towards the nose and mouth, repeat 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 the EyeMax2 with a new one if it becomes over-stretched. Reuse of this device could cause cross-contamination or product malfunctions.
Product Information
Available Sizes and Catalog Numbers:
- 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.
Usage: Single Patient Use Only
Sterility: Non-Sterile, Latex-Free
Regulatory Information
The Eyemax2 is 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.
Manufacturer: Maxtec | 2305 South 1070 West, Salt Lake City UT 84119 | 801.266.5300 | www.maxtec.com
Distributed by: SGS United Kingdom Limited, Weston Super Mare, BS22 6WA, United Kingdom
EC REP: QNET BV, Haaren, The Netherlands
Model Number: R111P16-002 Rev. R