FRENZEL UFGP0100BEU User manual

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Frenzel Video Goggles - Medical 
REF: UFGP0100BEU 
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USER MANUAL 
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INTRODUCTION 
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Thank you for purchasing the μFrenzel® Video Goggles - Medical. 
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The μFrenzel® Video Goggles - Medical are designed for daily use           
in hospitals and clinics. This reusable medical device allows         
precise, real-time visualization of eye movements in complete        
darkness. The removal of eye-fixation is critical to aid professional          
medical doctors diagnose the following syndromes: 
●Acute Vestibular Syndrome; 
●Benign Paroxysmal Positional Vertigo (BPPV); 
●Ménière’s Disease; 
●Migrainous Vertigo. 
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This manual contains several important health and safety        
considerations, as well as important usage instructions. 

Please read the latest version of this manual thoroughly before          
using this medical device. You can find the latest version of this            
manual in the μFrenzel site at www.ufrenzel.com. 
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INTENDED USE 
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The μFrenzel® Video Goggles - Medical are intended EXCLUSIVELY: 
●for professional medical doctor use; 
●to aid diagnose the syndromes described above; 
●to be used in hospitals or in medical clinics; 
●for adult patients. 
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KEY FEATURES 
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Figure A - Frenzel video goggles (front). 
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A.1 - Single use disposable comfort Foam Pad 
A.2 - Fixation strap 
A.3 - Status LED 
A.4 - Right LCD Screen 
A.5 - Left LCD Screen 
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Figure B - Frenzel video goggles (side). 

B.1 - 3.5mm Jack for Dual Analog Video Output 
B.2 - 3.5mm/1.5mm 5V DC Charger Input 
B.3 - ON/OFF switch 
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Figure C - Frenzel video goggles with comfort foam pad. 
Page 1 
© 2018 μRoboptics®. All Rights Reserved. 

BOX CONTENTS 

This package contains the following items: 
●Frenzel medical video goggles; 
●Fixation strap; 
●USB power adapter (EU mains); 
●USB power cable; 
●Single use disposable comfort foam pads (x4); 
●User manual. 


HOW TO OPERATE THE DEVICE 

Before the first use: 
1. Remove the device from the protection plastic bag; 
2. Use the ON/OFF switch (B.3) to turn OFF the device          
(outer position). The Status LED (A.3) turns off; 
3. Connect the USB power cable to the device (B.2); 
4. Connect the USB power cable to the USB power adapter; 
5. Plug the USB power adapter to a wall plug. The Status           
LED (A.3) turns solid red; 
6. Leave the device charging until full charge. The Status         
LED (A.3) turns solid blue. 

Charging: 
1. Use the ON/OFF switch (B.3) to turn OFF the device          
(outer position). The Status LED (A.3) turns off; 
2. Connect the USB power cable to the device (B.2); 
3. Connect the USB power cable to the USB power adapter; 
4. Plug the USB power adapter to a wall plug. The Status           
LED (A.3) turns solid red; 
5. Leave the device charging. At full charge the Status LED          
(A.3) turns solid blue. 
Note: It’s recommended to put the device charging after each use. 
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Operating: 
1. Before each use, carefully clean the device with a tissue          
embedded in alcohol based or other cleaning solution        
compatible with the application. Use the cleaning       
solution with care and moderation to prevent damage to         
the electronics (e.g. LCDs, cameras, LEDs, etc.); 
2. Remove any residues on the device with a clean tissue; 
3. Replace the single use disposable comfort foam pad        
(A.1) as attach it as shown in Figure C; 
4. Use the ON/OFF switch (B.3) to turn ON the device (inner           
position). The Status LED (A.3) turns solid red; 
5. Loosen the fixation strap (A.2), place the device on the          
user’s head and tighten the fixation strap again; 
6. Adjust the device to correctly to observe both eyes; 
7. Execute the recommended medical procedures; 
8. Loosen the fixation strap (A.2) and remove the device         
from the user’s head; 
9. Use the ON/OFF switch (B.3) to turn off the device (outer           
position). The Status LED (A.3) turns unlit; 
10. Remove the single use disposable comfort foam pad        
(A.1) . 
Note: For safety, this device cannot be operated while charging. 

Connecting the goggles to an external medical monitor: 
1. Use the ON/OFF switch (B.3) to turn ON the device (inner           
position). The Status LED (A.3) turns solid red; 
2. Connect the device (B.1) to the external monitor using         
the specified cable (under 3m length, not included); 
3. Operate the device as described in Operating; 
4. Disconnect the device from the external monitor; 
5. Use the ON/OFF switch (B.3) to turn OFF the device          
(outer position); The Status LED (A.3) turns unlit. 
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TECHNICAL SPECIFICATIONS 
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Features: 
Reusable medical device 
Built in dual 3.5’’ TFT LCD display 
Integrated lithium-ion battery (non-replaceable) 
Latency under 30ms 
3.5mm jack connector for dual analog video output 
5V DC connector 
Fixation strap 
Single use disposable comfort foam pads 
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Dimensions: 
Height x Width x Depth 
72 x 160 x 105 mm 
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Weight 
450g 
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Power: 
100-240V 50-60Hz AC power adapter input 
5V DC device power input 
3.3V DC 3400mAh lithium-ion battery 
Autonomy: ~30 min 
Full charge: ~120 min 

Environment: 
Operation: 0ºC to 45ºC 
Storage/Transport: -20ºC to 50ºC 
Humidity Range: <90%RH 

Status LED states: 
Solid Red: Device is ON - battery level normal 
Blinking Red: Device is ON - battery level low 
Solid Red: While charging - battery charging 
Solid Blue: While charging - battery charged 
Solid Purple: While charging - battery charging (critical       
low level, battery overheated or may be depleted) 

Connection cable to external medical monitor: 
3.5mm jack to dual RCA cable (UFE0200BEU) 

SAFETY AND CARE INSTRUCTIONS 

Please take into account these safety instructions while using and          
operating your goggles: 

●This device is intended to aid medical diagnosis only; 
●This device is intended for professional medical doctor        
use only; 
●This device is intended for adult patients only; 
●This device is intended for non-intrusive visualization of        
the patient’s eyes only, and is intended to be used on a            
person’s head and for this function only; 
●Do not begin or end medical treatment based solely on          
the information provided by this device. Consult a        
physician for treatment advice; 
●This device isolates the patient’s eyes in such a way that           
visible light does not reach them, and as such the patient           
is in complete darkness. To prevent falls and other         
darkness-related accidents, do not operate alone; 
●Use only the supplied USB power adapter and USB power          
cable for charging this device; 
●Use only the specified cable to connect this device to an           
external medical monitor; 
●This device is not suitable for use during medical         
emergencies or operations. 
Page 2 
© 2018 μRoboptics®. All Rights Reserved. 

To maximize the lifetime of this product, please follow these care           
instructions: 

●When not in use, store the unit in a cool and dry place,             
away from direct sunlight; 
●Do not immerse or splash the unit with water. If it comes            
in contact with water, dry immediately with a soft cloth; 
●Use a soft microfiber cloth to clean the device; 
●This device contains a non-replaceable battery. Do not        
replace the battery on your own. If the battery is          
depleted, contact μRoboptics after-sale service; 
●Do not open the plastic casing. Doing so voids the          
product’s warranty and may cause damage; 
●Do not subject the unit to excessive force, shock, dust,          
temperature changes or humidity. Such treatment may       
result in shortening the unit’s life span, and even in          
malfunctions or in completely breaking the unit; 
●This unit contains no user-serviceable parts; 
●Protect the environment: if you no longer need this unit,          
please deposit it at an appropriate disposal location. 


HOW THE DEVICE WORKS 

This reusable medical device isolates the patient’s eyes in such a           
way that visible light is not able to reach them. In front of the              
patient’s eyes there are two infrared cameras, one for each eye, that            
capture and transmit the video to the two LCD panels at the front of              
the unit. 

APPLICATIONS 

This device allows precise, real-time visualization of eye        
movements in complete darkness. The removal of eye-fixation is         
critical to aid professional medical doctors diagnose the following         
syndromes: 
●Acute Vestibular Syndrome; 
●Benign Paroxysmal Positional Vertigo (BPPV); 
●Ménière’s Disease; 
●Migrainous Vertigo. 

This device was tested in 40 patients by professional medical          
doctors to aid diagnose the syndromes listed above. For more          
information, please contact μRoboptics. 

For professional medical doctor use only. For adult patients use          
only. To be used in hospitals and medical clinics only. To aid            
diagnose the syndromes listed above only. 


ABOUT MANUFACTURER 

For information about the manufacturer, please visit μRoboptics®        
website (www.roboptics.pt) and learn more about the company,        
provided services and products. 

For specific information about the μFrenzel® Video Goggles -         
Medical, please visit the product’s website (www.ufrenzel.com). 

To contact our Customer Care, please email to [email protected]. 


WARRANTY 

Without prejudice to any applicable statutory warranty, μRoboptics        
warrants that the μFrenzel® Video Goggles - Medical will be free of            
any defects in material or manufacture for 6 months from the initial            
date of purchase upon presentation of proof of purchase to the           
retailer or μRoboptics (receipt or invoice). 

During the contractual warranty period, any defective product        
should be returned in its original packaging to the retailer’s or           
μRoboptics after-sale service. After inspection of the product,        
μRoboptics will, at its sole discretion, either repair or replace the           
defective part or product, excluding any other indemnification of         
any nature. 

μRoboptics warranty does not cover: 
●accessories and consumables; 
●defects due to damage caused by an accidental fall; 
●defects due to non-intended use of the product, use of          
non-original accessories or other misuses; 
●defects caused by actions of the end-user; 
●defects caused by any reason other than a defect in          
material or manufacture; 
●the gradual power loss of the μFrenzel® Video Goggles -          
Medical rechargeable battery over time, which does not        
constitute as a defect in the material or manufacture. 

If upon execution of technical tests, a product is considered non           
defective, μRoboptics reserves the right to return such product to          
the sender at the sender’s cost and charge a fee for the performed             
technical tests. 

Upon expiration of μRoboptics warranty or if the defect is not           
covered by the warranty, any defective product can be returned to           
μRoboptics after-sales service in order to be repaired or for a           
defective part to be replaced at the sender’s costs. Repair will only            
be carried out after acceptance of the corresponding quotation. 


DISPOSAL OF THIS PRODUCT AT THE END OF ITS LIFE 

At the end of this product’s life, please do not dispose of this             
product in your general household waste. Instead, in order to          
prevent possible harm to the environment or human health from          
uncontrolled waste disposal, please dispose of this product        
separately in accordance with your local laws and regulation. For          
more information on the separate collection systems for waste         
electrical and electronic equipment that are available for        
consumers, near your home, free of charge, please contact your          
local municipality authority. You can also contact the retailer from          
which you purchased your μFrenzel® video goggles – he might          
have put in place recycling services or he may be part of a specific              
recycling scheme. 

This product will be then treated in an environmentally sound          
manner at a licensed recycling plant and its components will be           
recovered, recycled or reused in the most efficient manner, in          
accordance with the requirements of the Directive on Waste         
Electrical and Electronic Equipment (2002/96/EC) of 27 January        
2003 (as subsequently amended or replaced). 


Page 3 
© 2018 μRoboptics®. All Rights Reserved. 

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DECLARATION OF CONFORMITY CE 
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μRoboptics - Technical Consulting and Research, Lda., based in Rua          
Luís Vaz de Camões, Edifício S. José, n.º 9 C, 3400-129 Oliveira do             
Hospital, Portugal, declares under its sole responsibility that the         
product described in this user manual complies with the EU          
directive 93/42/EEC, ISO 9001:2008, ISO 13485:2012, ISO       
14971:2007 and IEC 60601:2011. 
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U16-71-009LMT 
Version: 1.4 
Date: 2019-10-15 
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© 2018 μRoboptics®. All Rights Reserved.