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]

PART 2. USER’S INSTRUCTIONS
2.1. General Information
The majority of eye diseases are evidence of adaptive dysfunction. The course of an eye disease depends
on the patient’s general well-being and presence of concomitant conditions.
Dynamic electric neurostimulation (DENS) delivered by the External Paraorbital Electrode is regarded as a
constituent part of the prophylactic and therapeutic program in ophthalmopathy treatment.
The stimulation of the paraorbital area has a healthy influence on visual functions as well as optimizes gen-
eral health.
All patients should be supervised by an ophthalmologist for making a diagnosis, adjusting multimodality
treatment and monitoring and evaluating the results.
Contraindications to treatment with the EPE are described in Operation Manuals and User’s Instructions to
the DENAS devices.

2.2. Terms of Treatment
The application of the External Paraorbital Electrode doesn’t require special conditions. During the session
the patient should sit or lie in a comfortable position.
2.3. Procedural information and arrangement of the EPE
Prior to the start of treatment, wipe the surface of the electrode with a soft cloth moistened with a disinfect-
ing liquid, (e.g. ethyl alcohol 70 %).

Figure 1. External Paraorbital Electrode. Front View

Figure 2. External Paraorbital Electrode. Top View Figure 3. Nose Bridges.

1. Choose and set a nose bridge (see Fig. 3) supplied with the device.
2.Put on and anchor the unit.
3. Connect the unit:
— via a holder to the DENAS device;
— via an adaptor to the DENAS+ device;
— directly to the DiaDENS devices.
4. Turn on the device.
5. Select the operating regime and power of stimulation (see Appendix 1).
6. Start the session.
Duration of stimulation depends on the patient’s age, diagnosis and intensity of symptoms (see Appendix 1).
7. When the treatment session is completed, turn off the device, put it off and disconnect of the apparatus
(DENS, DENAS+ or DiaDENS).

Attention!
It is recommended that treatment schemes of chronic eye diseases with the use of the EPE include therapy
of segmental and reflexogenic zones. The zones are be selected and treated with the use of inbuilt electrodes
of the DENAS and the DiaDENS apparatuses in accordance with general rules described in the Operation
Manuals of the appropriate apparatus*.
*See “Guidelines for Dynamic Electroneurostimulation with the DENAS, DiaDENS-T and DiaDENS-DT devices” edited by V.V. Cherny-
shev, Yekaterinburg, 2005.

Appendix1
Recommended ways of operating External Paraorbital Electrode in Ophthalmology
Diagnosis Device Regime
Session
Notes
Duration Frequen-
cy, Hz Power Level Number
Visual Asthenopia.
Visual fatigue caused
by intense eye strain
(reading, writing, work-
ing at a computer, etc.)
DENAS Therapy 3-5 minutes 77 Comfortable
power level.
For children
under 7– min-
imal power
level
1 session
a day
within
10-14
days
Repeated courses
are recommended
in case of intense
eye strain,
or 3-4 courses a
year
Dia-
DENS
Therapy 3-5 minutes 20 or 77
MED Pro-
gram*
Time to be
set by the
program
10
* MED programme is also available in the Denas+ device.

Diagnosis Devise Regime
Session
Notes
Duration Frequen-
cy, Hz
Power
Level Number
Presbyopy
(age long-
sightedness or
hypermetropia)
DENAS Therapy 3-5 minutes 77
Comfort-
able power
level.
1 session a
day within
10-14 days
Repeated course rec-
ommended in 30-40
days. After 2-3 month-
interval the course
should be repeated.
Up to 3 or 4 courses
a year
DiaDENS
Therapy 3-5 minutes 20 or 77
MED pro-
gram
Time to be
set by the
program
10
* MED program is provided for the DENAS+ device as well.

Diagnosis Devise Regime
Session
Notes
Duration Frequen-
cy, Hz Power Level Number
Accomodation
spasm, Myopia
(short-sighted-
ness), Hypermetro-
pia, Astigmatism,
Amblyopia
DENAS Therapy Children under 7 -
3-minutes; 8-12 years
old – 5 minutes; over
12 years of age – 5-7
minutes.
77 Comfortable
power level.
For children
under 7– mini-
mal energy
level
1 session
a day
within
10-14
days
3-6 re-
peated
courses
a year
DiaDENS
Therapy 20 or 77
MED pro-
gram*
Time to be set by the
program 10
* MED program is provided for the DENAS+ device as well.

Diagnosis Devise Regime Session Notes
Duration Frequency, Hz Power Level Number
Cataract
DENAS Therapy 3-5 minutes 77
Comfortable
power level.
1 session a
day within
7-10 days
5-6 courses
with 10-20 days
interval
DiaDENS Therapy 3-5 minutes 20 or 77