REF HHMPOD1

USER MANUAL

 

 

 

 

 

ZeaVision, LLC

716 Crown Industrial Ct, Ste I

Chesterfield, MO 63005

United States

+1.314.628.1000

www.EyePromise.com

 

Table of Contents

Important Information. 3

Intended Use. 3

Contraindications3

Users3

Patient/ User Safety. 3

General Warnings:3

General Precautions:4

Limited Warranty. 5

System Overview.. 6

User Interfaces6

Components and Accessories. 7

Prior to Use. 7

Operating Instructions7

Wake and Sleep. 7

Menu and Settings7

Demo Mode. 8

Test Mode. 8

Recalling Test Data. 8

Recharging. 8

Low Battery Power Off State. 9

Cleaning and Disinfection. 9

Cleaning and Disinfection Instructions9

Storage and Maintenance. 9

Storage. 9

Maintenance. 9

Troubleshooting. 10

Specifications. 10

Electromagnetic Emissions & Immunity. 10

Zx Pro Applied Parts12

Explanation of Symbols12

Compliance. 13

Contacting the Manufacturer14

Adverse Event Reporting. 14

Returns14

Contact Information. 14

 

Important Information  

Carefully read the entire Instructions for Use (IFU) prior to use. Observe all warnings and precautions noted throughout these instructions. Failure to do so may result in complications.

Conventions Used within the IFU

The words WARNING, CAUTION and NOTE carry special meanings and should be carefully reviewed.

Warning: Identifies situations in which the safety of the patient and user may be involved. Disregarding this information could result in injury to the patient and/or user.

Caution: Identifies precautions or procedures or that must be followed to avoid damaging the device or other property.

Note: Provides special information to make maintenance easier or important instructions clearer.

 

Intended Use

The Zx Pro Device is an adaptometer intended to quantify macular pigment optical density.

 

Contraindications

The Zx Pro Device is not intended for Home Use.

The Zx Pro Device is not intended for use with children or adolescents under the age of 22.

The Zx Pro Device is not intended to be used while charging and device will render itself to be inoperable when charging.

 

Users

This Device is for Prescription Only and is intended to be used only under the supervision of health care professionals general training and experience.

The intended use of this Device requires operation by the patient.

This Device is intended for use with Adults (ages 22 and up) only. No special training or ability is required of patients.

 

Patient/ User Safety

General Warnings:

·       This Device is for Prescription Only. It is intended to be used only under the supervision of health care professionals with general training and experience. Supervising professionals should be thoroughly familiar with the IFU, Intended Use, and operation of this Device. The health care provider performing any procedure is responsible for determining the appropriateness of this Device and Test Results for each patient.

·       Upon initial receipt and before each use, operate system components and inspect for damage. DO NOT use if damage is apparent. Perform recommended maintenance as indicated in the instructions for use. Only trained and experienced health care professionals should maintain this Device. Failure to comply may result in patient and/or operating room staff injury.

·       Clean and disinfect components before first and every use. See the Cleaning and Disinfection Recommendations section for specific details.

·       Use only EyePromise approved accessories. Contact your EyePromise representative for a complete list of accessories.  DO NOT modify any accessory.

·       Only use the Device while the patient is seated. DO NOT use the Device while the patient is standing or while the patient is in a vehicle in motion.

·       DO NOT use the Device while charging.

·       To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth during charging.

·       Inspect power source for visible damage and proper operation periodically. Replace power source if damage is evident.

·       No maintenance should be performed by the patient.

·       DO NOT attempt to perform any service on the device while it is in use.

·       DO NOT modify or reconfigure the Device or its accessories. DO NOT attempt to open the Device Enclosure.

·       DO NOT attempt to remove or replace the internal Battery. This is to be done by trained EyePromise service personnel only.

·       The Device must be disposed of in accordance with local waste handling codes for lithium-ion batteries.

·       Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

·       Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation

·       Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Zx Pro, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result

 

 

General Precautions:

·       The Device is intended for Indoor Use only.

·       Do not pour water or any other liquid on the Device.

·       Ensure that electrical outputs from recharging power sources are within the approved parameters for this Device.

·       DO NOT attempt to sterilize the Device. Use only approved cleaning and disinfections methods recommended by the IFU.

 

Limited Warranty

In the USA only, the Zx Pro Device is warrantied to the original purchaser for a period of 1 year from the date of purchase, with exceptions noted below. The Device is warranted to be free from defects in material and workmanship. Abnormal wear and tear or damage caused by misuse or by failure to perform normal and routine maintenance as set out in the Instructions for Use, or as demonstrated by an authorized EyePromise representative, is not covered by the warranty. Any effort at field repair or adjustment may invalidate your warranty. Using any accessory that is not an EyePromise product, except for those explicitly approved for use in the Instructions for Use, will invalidate your warranty.

The warranty extends to all purchasers and is limited to the repair or replacement of the product without charge when returned prepaid to EyePromise. There are no other expressed warranties. This warranty gives you specific legal rights and you may have other rights, which vary by state and municipality.

 

System Overview

The Zx Pro Device provides a means to quantify a patient’s macular pigment optical density in a compact, untethered package suited for ambidextrous, one-handed operation.

 

 

 

User Interfaces

Display Screen	Shows menu options and device status
Menu Navigation Buttons	Used to cycle through menu options and initiate demo mode and test mode
Reset Button	Resets device via pinhole button
Optical Path	Provides visual stimuli to patient during a test
Eyepiece	Flexible interface to seat device around patient’s eye; This is an Applied Part
Trigger	Receives patient input during a test
Corrective Lens Slot	Accepts standard Ø38 mm OD Trial Lenses (not included)
USB Port	Accepts USB-C cable for recharging and test data upload
Battery Indicator	Conveys charging status & faults, and power state

 

 

Components and Accessories

The Zx Pro Device package includes:

(1) Device

(1) USB-C to USB-A Charge Cable (6 – ft)

(1) IFU

(1) Carry Case

Trial lenses are not included or provided by EyePromise. Use standard Ø38 mm OD trial lenses to adjust for patient vision impairment.

An AC power adapter is not included. Ensure power source meets the specifications within IFU.

Eyepieces and Batteries are factory-replaceable.

 

Prior to Use

Ensure the following steps are taken prior to use:

	First Use	Every Use
Read IFU	X
Charge Battery	X
Ensure proper Function	X	X
Clean and Disinfect	X	X

 

Operating Instructions

Patients may perform all functions as operators unless otherwise noted.

Wake and Sleep

The Device can be awakened from Sleep Mode by actuating the Trigger.

The Device will automatically enter Sleep Mode after a period of 5 minutes of inactivity (no user inputs). Sleep mode can also be manually initiated via the Menu (Shut Down).

 

Menu and Settings

Use the Menu Navigation Buttons to move about the menu options. Top-level Menus are:

·       Run Test

·       Tutorial

·       Settings

·       Shut Down

User-adjustable Settings include the following:

·       Volume on/ off

Demo Mode

The Device provides a guided demonstration of a test procedure. Initiating Demo Mode will begin a guided walkthrough of what a patient will encounter during a Test. After completion of the walkthrough, the Device will automatically return to the Menu.

Test Mode

Prior to initiating a Test, set the patient’s age. This information is critical to achieving accurate test results as the Device calibrates to the patient’s age.

Perform a Right Eye test and a Left Eye test for each patient. The results of these 2 tests will be saved separately in the Device’s memory.

Observe a Demo Mode walkthrough for detailed test instructions.

Recalling Test Data

A minimum of 50 Test Results can be stored on the Device’s onboard memory. Once the test storage has reached maximum capacity, the Device will alert the user that memory is full.

Past test data is not tied to patient identity. The only identifiers for each test result are date of test and patient’s age.

Recharging

Use the provided USB Cable to connect the device to a USB power source. Ensure the power source output is within the following specifications:

·       Voltage:           5 VDC

·       Current:           1.0A minimum

WARNING: Do not operate the device while it is connected to a power supply.

WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains power source with protective earth.

WARNING: Inspect power source for visible damage and proper operation periodically. Replace power source if damage is evident.

The Device will automatically stop charging once the battery has reached 100% capacity. The Battery Indicator LED will convey the charge status while charging as follows:

·       Green, Solid:               Charging

·       Off:                              Fully charged or not connected

·       Green, Flashing:         Charging error

Low Battery Power Off State

The Zx Pro contains protective circuitry that will not allow the battery to discharge past its safe low limit. If the battery drops to this limit, the device will power off and not allow any further operation until the battery has been recharged.

If the battery has been shut off in this protection mode, the battery status LED will flash at a low duty-cycle 10-second period.

 

Cleaning and Disinfection

WARNING: Always clean and disinfect the Device between different patients and prior to use.

CAUTION: Only use the approved cleaning solutions and methods to avoid damage to the Device.

Cleaning and Disinfection Instructions

1.     Remove the Eyepiece from the device by holding the device steady in one hand and carefully pulling on the Eyepiece with the other hand.

2.     Clean the Eyepiece using water and mild detergent to remove any debris or residue.

3.     Wipe the device with a lint-free cloth lightly dampened with cleaning solution. DO NOT saturate cloth or allow fluid to penetrate device enclosure.

4.     Allow Eyepiece and Device to dry.

5.     Disinfect Eyepiece and Device using >70% Isopropyl Alcohol wipes or a lint-free cloth lightly dampened with a 1:10 (10%) Bleach-in-Water solution.

The device will withstand reprocessing by these methods under normal use conditions and frequency for a minimum lifecycle of 2 years.

 

Storage and Maintenance

Storage

The Zx Pro includes a carry case for storage of the Device when not in use. Shut down the Device via the Menu option before long-term storage. Always ensure the Device is stored or transported within the following environmental conditions:

·       Temperature:  -18°C to 60°C

·       Humidity:         0% to 85% non-condensing

Maintenance

Maintenance of the Device is not required. Clean and disinfect the Device before use. Charge the battery before use.

Eyepieces and batteries are factory replaceable.

Future device Software updates may be uploaded to the device via the USB port. Follow the detailed instructions attached to any Software update communications.

 

Troubleshooting

Problem	Corrective Action
Device powers off unexpectedly. Battery Indicator LED illuminates red (flashing or solid)	Connect to power source for charging. Device is ready to resume service if Battery Indicator LED illuminates solid green when disconnected from power source. WARNING: disconnect the Device from power source before resuming/ performing a procedure.
Device will not awake from Sleep Mode or Shut Down; Battery Indicator LED illuminates red (flashing or solid)	Connect to power source for charging. Device is ready to resume service if Battery Indicator LED illuminates solid green when disconnected from power source. WARNING: disconnect the Device from power source before resuming/ performing a procedure.
Blue/ Green circle in test sight picture is out of focus.	Use Trial Lens to adjust focal point for user.
Test Error Messages: ·       Reject	·       Excess variation in patient test feedback; repeat eye test
Device will not charge.	Return to manufacturer for service

 

Specifications

Parameter	Value
Model Name	Zx Pro
Catalogue Number	HHMPOD1
Weight	307grams (1.3 lbs)
Electrical Input	5 VDC, 1.5 A max
Ingress Protection	IP3X
Battery life	>50 tests
Compatible Trail Lenses	Ø38 mm OD, any power
Classification	Type 1 Medical Device
Applied Part	Type B

 

Electromagnetic Emissions & Immunity

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Zx Pro Device is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment.
Emissions Test	Compliance
RF emissions CISPR 11	Group 1 Class B	Normal battery operating mode

 

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Zx Pro Device is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment.
Immunity Test	IEC 60601 Test Level	Compliance Level	Electromagnetic Environment – Guidance
Electrostatic discharge (ESD) IEC 61000-4-2	± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air	± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air	N/A – no special conditions
IEC 61000-4-3	10 V/m 80 MHz – 2.7 GHz 80 % AM at 1 kHz	10 V/m	N/A – no special conditions
(50/60 Hz) magnetic field IEC 61000-4-8	30 A/m 50 Hz or 60 Hz	30 A/m	N/A – no special conditions

 

 

 

 

Zx Pro Applied Parts

 

Explanation of Symbols

Symbol Graphic	Symbol Definition
	Package Quantity
	Catalog Number
	Serial Number
	Alert the user to the presence of important operating and maintenance instructions in this manual
	Date of Manufacturer
	Device Manufacturer
	Temperature Range (Storage, Use, etc.)
	Humidity Range (Storage, Use, etc.)
	For Prescription Only
	Ingress Protection Rating
	Applied Part Type

 

Compliance

Product Safety Compliance:           International Electrotechnical Commission (IEC)

IEC 60601-1: 2020 (Ed. 3.2)

 

 

Contacting the Manufacturer

Adverse Event Reporting

Any adverse event involving the EyePromise Zx Pro Device should be reported to ZeaVision, LLC immediately. To report an event in the United States, call the telephone number or write to the address listed in the Contact Information section below.

Returns

The Device should be returned to the Manufacturer if damage, wear, failure, error, or compromised performance is observed. Ship the Device in the provided Carry Case for protection during transport. The Device may also be returned to the Manufacturer for replacement of the Battery or the Eyepiece.

Repairs are subject to the terms of the Device Warranty. Repairs costs may not be covered by Manufacturer if the Device or failure mode is outside of the warranty period or terms.

Contact the Manufacturer prior to returning the Device for any reason. Contact your EyePromise representative to request more details about accessories and device service.

Contact Information

ZeaVision, LLC

716 Crown Industrial Ct, Ste I

Chesterfield, MO 63005

United States

+1.314.628.1000

www.EyePromise.com