RC ART DENS-GLASSES User manual

LLC “RC ART”, Yekaterinburg, Russia
EXTERNAL PARAORBITAL ELECTRODE
“DENS-GLASSES”
OPERATING MANUAL
TU 9444-002-35266303-2005 RC ART 06.1-03.71-01 RE
EN

CONTENT
Part 1. Specification
1.1. General Description.....................................25
1.2. Technical Specifications..............................26
1.3. Package Contents......................................26
1.4. Safety Requirements...................................27
1.5. Care and Maintenance................................30
1.6. Warranty....................................................30
1.7. Manufacturer’s Address.............................32
Part 2. User’s Instructions
2.1. General Information........................................33
2.2. Terms of Treatment........................................34
2.3. Course of treatment.....................................34
Appendix 1. Recommended application
of the External Paraorbital Electrode
in Ophthalmology.................................................39
Certificate of Acceptance.....................................45
Warranty Card......................................................47

PART 1. SPECIFICATIONS
1.1. General Description
The External Pararobital Electrode (EPE) provides dynamic electric non-invasive neurostimulation of bio-
logically active points located in the paraorbital area for a prophylactic and therapeutic effect.
Dynamic electric neurostimulation facilitates recovery from visual impairments caused by some eye dis-
eases. Additionally, electric neurostimulation has a general regulating effect on the physiological systems of
human organism.
The unit is intended for household and clinical use.
The External Paraorbital Electrode should only be used in combination with the DENAS*, DENAS+ and Dia-
DENS (DiaDENS – T, -DT, PK, -PKM) electric stimulation devices.
* The unit is connected to the DENAS device via an holder to be purchased additionally (not included in the original package).

1.2. Specifications
Weight……………………………..…….............................................................................................0,2 kg
Dimensions………...………………..………....................................................................…..190х65х50 mm
Cable length………………….………………….............................................................................…600 mm
1.3. Package Contents
The package includes:
Name Quantity
External Paraorbital Electrode “DENS-Glasses” 1
Nose Bridge 5
Owner’s manual 1
Package 1

1.4. Safety Requirements
Please read the following safety instructions! They are designed to prevent damage to prop-
erty and the user! The manual contains important recommendations on proper use and
care of the unit.
The unit must not be used for treatment of patients with implanted electronic devices (such as car-
diac pacemaker) as well as of people with electric sensitivities.
Warning: Do not operate the unit while using another electrical medical device. This can lead to
burns and irreparable damage to the device.
Before you begin stimulation, make sure the patient is not connected to any high-frequency elec-
tronic device!

The unit contains fragile components! Prevent from shock.
The unit is not waterproof. Keep away from liquids and moisture.
Do not repair the unit yourself. Refer all servicing to the manufacturer.
Terms of Transportation
The unit should be transported at a temperature between -500С and +500С, relative air humidity from
30% to 93% and pressure from 70 to 106 kPa.

Terms of storage
Store the unit at a temperature from-500С to +400С, relative air humidity from 30% to 93% and
pressure from 70 to 106 kPa.
Operating environment
The unit shall be operated at about +100С to +350С, relative air humidity from 30% to 93% and
pressure from 70 to 106 kPa.
Warning: If stored at a temperature below +100C, to keep the device in favourable environmental
conditions to warm up for at least two hours before application.
Recycling:
All the packaging materials are environmentally-safe and can be reused.
The device is made of materials that can be recycled.

1.5. Care and Maintenance
Maintenance of the unit should include the following:
— visual check of the device;
— cleaning of electrodes (use standard disinfection detergents and a soft cloth to clean electrodes);
— check of the unit’s readiness for operation when connected to the DENAS or DiaDENS devices.
1.6. Warranty
1.6.1. The manufacturer guarantees the compliance of the device with Technical Conditions TU
9444-002-35266303-2005, provided the terms of operation, transportation and storage are observed.
1.6.2. The operation lifetime of the unit is 5 years.

Observation of regulations governing the device application can considerably increase the lifetime set by
the manufacturer.
1.6.3. This product is warranted for the period of 12 months from the original date of purchase.
1.6.4. The consumer is to check the package contents and perform the visual control of the device in the
presence of the retailer. Complaints about the incomplete set and appearance of the device are not accepted
after sale.
1.6.5. In case any defects are discovered within the warranty period, the retailer/manufacturer is under an
obligation to handle the consumer’s claim in line with the Consumer Protection Law.
The warranty doesn’t cover the following:
1) Damage caused by any failure on the part of the consumer to comply with the rules of transportation,
storage, care and operation provided by the owner’s manual;
2) Damage caused by actions of the third party;

3) Damage caused by force majeure.
1.6.6. If warranty servicing is required (i.e., in case of some parts missing or malfunction of the device),
an application for repair or replacement should be fully and properly filled in by the customer and presented
to the manufacturer. The application must include the following information: customer’s name, address, tel-
ephone number, brief description of the problem, time and conditions of its occurrence.
Warranty repairs must be carried out by the Manufacturer or Manufacturer’s Service Centers.
1.7. Manufacturer’s Address
Manufacturer: LLC “RC ART”, 620146 Russia, Yekaterinburg, 15 Postovskogo Str. Tel: [phone]
Distributor: DENASMS.COM Tel.: [phone] http://www.denasms.com/ E-mail: [e-mail]