Heru PRIME Manuale utente
HERU PRIME
INSTRUCTIONS FOR USE
PDPROJ-1_IFU
PDPROJ-1_DHF
Instructions for Use
Heru Prime
Document No:
PDPROJ-1_IFU
Rev 4
QSF-0007; Instructions for Use Template Rev. 2
Page 2 of 31
Contents
1. INTRODUCTION ..................................................................................................................................... 4
2. DEVICE DESCRIPTION .......................................................................................................................... 4
3. INTENDED USE ...................................................................................................................................... 4
4. SYMBOLS AND LABELS ....................................................................................................................... 5
5. GENERAL AND INSTALLATION SAFETY PRECAUTIONS ................................................................. 6
5.1. General Precautions ....................................................................................................................... 6
5.2. Installation Safety Precautions ....................................................................................................... 6
6. PRE-USE REQUIREMENTS AND DEPENDENCIES ............................................................................. 6
7. HERU PORTAL REGISTRATION ........................................................................................................... 7
8. SOFTWARE INSTALLATION, UPGRADE, AND CONFIGURATION .................................................... 7
9. CLEANING THE DEVICE ........................................................................................................................ 7
10. HARDWARE OVERVIEW ..................................................................................................................... 8
11. OVERVIEW OF TESTS AND REPORTS .............................................................................................. 9
11.1. Visual Field: Suprathreshold ......................................................................................................... 9
11.2. Extraocular Motility (EOM) .......................................................................................................... 11
11.3. Pupil Test .................................................................................................................................... 12
11.4. Cover Test .................................................................................................................................. 14
12. STEP-BY-STEP INSTRUCTIONS ....................................................................................................... 15
Instructions for Use
Heru Prime
Document No:
PDPROJ-1_IFU
Rev 4
QSF-0007; Instructions for Use Template Rev. 2
Page 3 of 31
12.1. Logging into the Heru Portal ....................................................................................................... 15
12.2. Heru Portal Overview ................................................................................................................. 16
12.3. Adding a New Patient and creating an appointment (testing session) ....................................... 17
12.4. Taking a Test .............................................................................................................................. 20
12.5. Viewing the Results .................................................................................................................... 24
12.6. Printing or Saving Test Results .................................................................................................. 25
12.7. Powering the HMD On and Off ................................................................................................... 26
13. TROUBLESHOOTING ........................................................................................................................ 27
14. TECHNICAL SPECIFICATIONS ......................................................................................................... 29
15. CONTACT US ..................................................................................................................................... 30
Instructions for Use
Heru Prime
Document No:
PDPROJ-1_IFU
Rev 4
QSF-0007; Instructions for Use Template Rev. 2
Page 4 of 31
INSTRUCTIONS FOR USE
1. Introduction
Heru Prime (previously Heru re:Vive) is a platform that provides functional and anatomical diagnostic
data for the purpose of supporting the diagnosis of various eye conditions. Heru Prime is a system that
works with commercially available Head Mounted Display devices (HMDs). The Heru Prime system
provides speed, flexibility, and precision not available with legacy non-wearable devices.
2. Device Description
The complete system is comprised of the following items:
• Heru Prime Application
• Browser-based Heru Portal Application (see Section 14 for browser details)
• Approved HMD hardware
• Bluetooth patient response controller
• Any approved compatible computing platform including a PC or Mac, desktop or tablet (see
Section 14 for details).
Access the Heru Portal via a web browser to start, store, and review patient’s clinical test results. Stable
internet connection with a minimum of 10 Mbits/sec download and 5 Mbits/sec upload speed is
recommended.
Please read this instruction manual thoroughly before using Heru Prime. Please keep
these instructions for future reference.
3. Intended Use
Heru Prime is a multi-modal testing system with the following tests and indications for use:
Visual Field: The Heru Prime visual field test is intended to measure the field of view of the eye for the
purpose of mapping the visual field utilizing commercially available head mounted display devices
(“HMDs”).
Pupil Test: The Heru Pupil Test is indicated to provide measurements of pupil size and reactivity to aid
in the diagnosis and monitoring of various eye conditions.
Extraocular Motility: The Heru Extraocular Motility Test is indicated to provide measurements of a
patient’s ocular motility to aid in the diagnosis and monitoring of various eye conditions.
Cover Test: The Heru Cover Test is indicated to track eye positions and movements to aid in the
diagnosis and monitoring of ocular alignment abnormalities.
Instructions for Use
Heru Prime
Document No:
PDPROJ-1_IFU
Rev 4
QSF-0007; Instructions for Use Template Rev. 2
Page 5 of 31
Heru Prime is intended for use on adults 18 years of age or older.
Test results provided by the Heru Prime system are intended to be an aid to interpretation, not a
diagnosis. Heru Prime is not intended for diagnosis. Diagnosis and patient management decisions are
the responsibility of the healthcare provider.
4. Symbols and Labels
Manufacturer
See Instructions for Use
This software is a medical device
Catalog Number
Units within Package
Keep dry
Temperature limit
Waste Electronic and Electrical
Equipment Directive
Human Contact
Fragile
Caution
Not MRI safe
Instructions for Use
Heru Prime
Document No:
PDPROJ-1_IFU
Rev 4
QSF-0007; Instructions for Use Template Rev. 2
Page 6 of 31
5. General and Installation Safety Precautions
5.1. General Precautions
• Periodically change your password to the Heru Portal.
• Always log out after your session is over.
• Heru Prime is intended to be an aid to interpretation, not a diagnostic tool. Products and
Services made available through Heru Prime do not make clinical, medical, or other
professional decisions. Diagnosis and patient management decisions are the responsibility of
the healthcare provider.
• Heru Prime is not intended for use on patients under 18 years of age.
• DO NOT administer a test to a patient who is not in a stable sitting position.
• The clinician is solely responsible for obtaining necessary consents for use and disclosure of
patient information.
• Please read the general safety precautions and the manufacturer’s instructions for use for the
head mounted display (HMD) prior to use.
• Do not expose the optical lenses to direct sunlight or other strong light sources. Exposure to
direct sunlight may cause permanent yellow spot damage to the screen. Screen damage
caused by sunlight exposure or other strong sources of light is not covered by the warranty.
• Use an optical lens micro-fiber cloth dipped in water to clean lenses. Do not wipe the lenses
with alcohol or other harsh or abrasive cleaning solutions as this may lead to damage not
covered by the warranty.
5.2. Installation Safety Precautions
• A Heru representative will schedule a training appointment upon receipt of your Heru Prime
equipment. During this training appointment, you and your staff will be guided through the basic
operations of configuring, using, and maintaining your Heru Prime equipment. Users should
obtain training before clinical use.
• Use only those parts provided by Heru to achieve optimum performance and safety.
• Make sure that your computer meets the technical specifications in section 14.
• For Technical Support or Customer Care: Please see section 15.
6. Pre-Use Requirements and Dependencies
The Heru Prime application is intended for use in healthcare provider offices and other clinical
environments. The operators are healthcare providers with professional training or experience in the
use of ophthalmic equipment.
The operator should be a licensed practitioner, trained in at least one of the following professions:
Ophthalmologist, Optometrist, Nurse, Medical Technician, or Ophthalmic Technician/Photographer.
Instructions for Use
Heru Prime
Document No:
PDPROJ-1_IFU
Rev 4
QSF-0007; Instructions for Use Template Rev. 2
Page 7 of 31
The operator must have training and the ability to carry out the system’s operation.
7. Heru Portal Registration
An authorized Heru administrator will create your account and assign a username during initial setup.
At this time, the email address associated with the account will be sent a link to set a password.
8. Software Installation, Upgrade, and Configuration
An authorized Heru representative will install and configure the Heru Prime application prior to
shipment. To ensure optimal customer experience, Heru will remotely push software updates to both
the HMD and the Heru Portal.
A full power-down at the end of each day is recommended. Updates to the Heru Prime application will
require the operator to fully power-down and restart the HMD.
Learn how to power down the HMD in Section 12.7.
9. Cleaning the Device
To minimize cross-contamination and optimize eye-tracking performance, please clean and disinfect
the device before each use, taking care to clean the areas that come in contact with the patient,
including the face pad and controller.
Component
Clean with
HMD screen
Lens cloth (do not use a solvent of any kind)
HMD face pad
70% isopropyl alcohol
Controller
70% isopropyl alcohol
Instructions for Use
Heru Prime
Document No:
PDPROJ-1_IFU
Rev 4
QSF-0007; Instructions for Use Template Rev. 2
Page 8 of 31
10. Hardware Overview
Instructions for Use
Heru Prime
Document No:
PDPROJ-1_IFU
Rev 4
QSF-0007; Instructions for Use Template Rev. 2
Page 9 of 31
11. Overview of Tests and Reports
11.1. Visual Field: Suprathreshold
Heru Prime performs a static, suprathreshold visual field test to identify central visual field defects.
Stimuli are presented over the patient’s central 30° field of view, and according to the response of the
patient, a map of the visual field is created to indicate the presence and locations of visual field defects.
Fixation monitoring is employed to ensure test reliability.
Details of the test pattern and parameters can be found below:
The report displays patient data, test reliability indices, and test results.
Test Pattern
Fast Pattern
Test Strategy
Suprathreshold, static
Extent of Visual Field Tested
30 degrees
Number of Points Tested
40 points
Stimulus Duration
200 msec
Stimulus Size
Goldmann Size V
Stimulus Color
White
Stimulus Intensity
Age corrected
Fixation Monitoring
ActiveTrackTM (gaze tracking)
ONH (blind spot monitor)
Instructions for Use
Heru Prime
Document No:
PDPROJ-1_IFU
Rev 4
QSF-0007; Instructions for Use Template Rev. 2
Page 10 of 31
Patient information
Test information
Reliability indices
Fixation Monitor
Heru Prime employs two types of
fixation monitoring: ActiveTrackTM and
ONH monitoring. If the test was
conducted with ActiveTrack, there are
no fixation losses since the patient’s
gaze is continuously monitored.
Fixation Losses
If ONH monitoring is used, the Heijl-
Krakau method is used to estimate
the patient’s fixation loss (FL) rate by
presenting stimuli at the patient’s
blind spot. FL rates that exceed 40%
may indicate an unreliable test.
False Positives
False positives (FP) are patient
responses during small gaps in the
rhythm of perimetric testing (positive
catch trials) in which no stimulus is
presented. The False POS Error rate
is calculated as the ratio of FP
answers to the total number of catch
trials presented. FP rates that exceed
40% may indicate an unreliable test.
Visual field test locations and
results
HMD serial number and
software version
1
2
3
4
5
1
2
3
4
5
Indice
