Humphrey Zeiss Field Analyzer Cleaning Guidance May 2020

COVID-19 Memo As of May 1, 2020, our updated guidance is as follows: Ventilation guidance • The HFA2, HFA2-i, and HFA3 perimeters all have fans which circulate air, so that the air in the bowl is exchanged through the front of the bowl. This circulation, which occurs continuously while the HFA instrument is powered up, pushes air past the patient and out of the bowl of all HFA 2-i and HFA3 models. Minimal filtering occurs. • The perimeter does not require complete darkness to operate and is designed to notify the user if the room is too bright. Thus, it is possible to leave testing room doors partially or even completely open if you wish to increase the flow of fresh air into the testing area. Avoid any light shining directly into the bowl. Conforming to Clinic Policy and Public Health Guidelines • Follow local public health department infection control guidelines such as the U.S. CDC (https://www.cdc.gov/infectioncontrol), or in Europe - the European Center for Disease Prevention and Control (https://www.ecdc.europa.eu/en) for instruments in general. • In concordance with CDC and local government agency recommendations, the use of face coverings, to mitigate the spread of disease via exhaled airborne particles can be used during testing. Please observe all recommendations from your local and national authorities and other relevant good hygiene practices.

Cleaning the HFA (Full instructions documented below) •

Between each patient use, all patient and technician interface surfaces, excluding the bowl, may be wiped down using isopropyl alcohol. These include the eyepatch, patient chinrest, headrest, patient response button, trial lens holder and trial lenses, as well as all technician user interfaces.

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If there is a desire to clean the bowl of the HFA, the bowl surface may be treated by spraying it with a 70% isopropyl alcohol (IPA) solution. An atomizing type sprayer is necessary to avoid drips and to achieve good coverage.

The Bowl Itself: •

Do not rub anything onto the bowl, as this may damage the surface.

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Before the bowl is sprayed, the trial lens holder will need to be retracted and covered with a folded paper and the light projection turret at the top of the bowl will need to be covered with a folded paper. Spray until the bowl surface appears wet, but before drips form. Then, allow the bowl to air dry; any drips should be gently captured with a lens tissue.

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The use of UV-C light to sanitize the bowl should be avoided because the exposure limits of HFA family optics have not yet been assessed.

Frequently Asked Questions •

How do I set up my Visual Field room with the door open so that I still get an accurate test result? The HFA calibrates itself before and during each test. Typically, if the HFA instrument is oriented so that there is no direct or bright reflected source of light behind the patient, the test should operate properly. Over-head lights should be left off. As a result, the testing room door may be left somewhat open or completely open depending on the brightness conditions outside the testing room. The HFA will give a message if lighting is too bright.

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My bowl surface looks dusty. How can I clean it? Follow the HFA Instructions for Use, which describes that occasional wiping with a soft cloth and isopropyl alcohol may be performed.

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My patients will be wearing masks in the clinic. How do I ensure that this does not interfere with the visual field test? Check to ensure that the trial lens is not being fogged by the patient. Check that the top of the patient’s mask is properly fitted to limit breath from moving out the top of the mask.

COVID-19 guidance: Cleaning your HFA perimeter Between each patient use, all patient and technician interface surfaces excluding the bowl, may be wiped down using isopropyl alcohol. These include the eyepatch, patient chinrest, headrest, patient response button, trial lens holder and trial lenses, as well as all technician user interfaces.

This document provides updated guidance from ZEISS on how to treat the Humphrey® perimeter to promote patient safety during visual field examinations and guidance is provided on how to clean the bowl, should the clinic determine that such cleaning is desired.

If there is a desire to clean the bowl of the HFA, the bowl surface may be treated by spraying it with a 70% isopropyl alcohol (IPA) solution. The following are step-by-step instructions on the recommended procedure for sanitization of the HFA between patient tests. This procedure is applicable to all HFA models including HFA3, HFA II-i, and HFA II. In order to reduce the possibility that repeated misting of IPA70 could affect sensitive optical and electromechanical components in the HFA bowl area, we recommend using simple paper coverings during the misting process as described in this procedure.

Preparation Steps Step 1: Gather the appropriate materials for cleaning •

70% Isopropyl alcohol (IPA70)

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Fine misting sprayer – see recommendations

in References •

Printer paper – size: US Letter, A4, or similar

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Soft cloth, lens tissue, or cotton swab

Step 2: Prepare cleaning materials •

Prepare a 70% IPA solution using 7 parts IPA (100%) and 3 parts distilled water. Alternatively, commercially available 70% IPA is also acceptable.

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Fill the fine misting sprayer with IPA70 solution. Perform a test spray away from the instrument to ensure that the sprayer produces a gentle, fine mist. See references, item A for product information.

Step 3: Prepare Paper Coverings Chin rest paper cover: Fold the paper approximately 5” (20 cm) from the edge, then fold the other edge in half.

Forehead-optics paper cover: Fold the paper approximately 3” (8 cm) from the edge.

this part into bowl behind headrest 2nd fold line

Chin rest / Electronic cover

Forehead rest / Optics cover

1st fold line

fold line

(5 in, 20 cm)

(3 in, 8 cm) this part into bowl

this part into headrest

HFA Sanitization Procedure •

Notes: •

The HFA instrument should remain powered ON during the sanitization procedure and between patients.

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The normal airflow through the bowl will help to circulate the IPA70 mist within the bowl and in general, circulate air through the bowl.

If in your judgment the bowl appears dusty, follow the HFA Instructions for Use, which describes that occasional wiping with a soft cloth and isopropyl alcohol may be performed.

Step 1 Between patients, wipe the forehead rest, chin rest, patient response button, trial lens assembly and lenses, operator interfaces and exterior panels near patient area in accordance with CDC or local public health guidelines and your own infection control procedures (alcohol wipes or similar).

Step 2 Lower the trial lens holder into the area behind the chin rest. Step 3 Place the chin rest paper cover over the chin rest so it covers the opening behind the chin rest in order to protect electronics from getting wet.

Step 4 Insert the short side of the forehead-optics paper cover into the gap between the forehead rest and the instrument.

Step 5 Hold the IPA70 mist spray bottle in one hand. With your other hand, roll the forehead-optics paper cover in and hold at the free edge to cover the optics area behind the head rest.

Step 6

Hold the misting sprayer in the bowl maintaining a distance of about 15 cm from the bowl surface.

Spray in a sweeping motion so that the entire bowl surface develops a wet appearance, but stop before droplets form.

Step 7 Blot dry any drips or puddles in the bowl with

Step 8

Wait until the IPA70 dries (approximately 5 - 10 minutes).

Step 9

Remove paper coverings. Raise trial lens holder if needed for next test.

a clean soft cloth or lens tissue. Avoid wiping or rubbing the bowl surface.

Step 10 The HFA is now ready for testing the next patient.

References and Material sources Note: These are suggestions of materials sources, not a requirement for specific models. Fine Misting Sprayers: https://www.amazon.co.uk/s?k=continuous+misting+bottle&crid=3RUF3FH9ZMM8 2&sprefix=continuous+mistinig%2Caps%2C176&ref=nb_sb_ss_sc_1_19 For additional resources on COVID-19, please visit our MED Support now website, www.zeiss.com/med-support-now

Paper cover templates: Print the next two pages on separate pieces of paper to use as templates for your Chin Rest and Forehead Rest covers.

Please always refer to User Manual for any further instruction on operation of device. EN_31_025_0409I;HFA.12434 ©Carl Zeiss Meditec, Inc. 2020. All rights reserved.