20220615eh1en02 Ifu Eh-1

MDT sp. z o.o.
ul. Skosna 12A

30-383 Krakow
Polska/Poland
www.mdt.pl
Instructions for Use
Hess Screen
EH-1
© MDT sp. z o. o., ul. Skosna 12A, 30-383 Krakow, Polska/Poland rev. 20220615EH1EN02
1
Please read the Instructions for Use before assembling or using the device to ensure
correct and safe operation. Always follow the procedures in the Instructions for Use. If you
have any questions or concerns, please contact the distributor or manufacturer. Keep the
Instructions for Use at hand for quick reference. If you have lost the Instructions for Use,
please contact the distributor or manufacturer to obtain a new copy.
Due to continuous improvements and to ensure the highest quality of our products, the
manufacturer reserves the right to modify and make improvements to the device.
Therefore, the actual dimensions and weight of the product may differ slightly from the
specifications.
Contents
1. General ................................................................................................................................... 3
1.1 Intended purpose ............................................................................................................. 3
1.2 Description of the device .................................................................................................. 3
1.3 Indications......................................................................................................................... 3
1.4 Contraindications .............................................................................................................. 3
1.5 User................................................................................................................................... 3
1.6 Medical device class.......................................................................................................... 3
2. Technical specifications ........................................................................................................... 3
2.1 Physical specifications ....................................................................................................... 3
2.2 Electrical specifications ..................................................................................................... 4
2.3 Operating conditions ........................................................................................................ 4
2.4 Storage conditions ............................................................................................................ 4
3. Assembly and use ................................................................................................................... 5
3.1 Set content:....................................................................................................................... 5
3.2 Assembly ........................................................................................................................... 6
3.3 Use .................................................................................................................................... 8
3.4 Course of the examination .............................................................................................. 11
4. Disinfection ........................................................................................................................... 12
4.1 COVID-19 disinfection ..................................................................................................... 12
5. Cleaning ................................................................................................................................ 12
6. Maintenance ......................................................................................................................... 13
7. Service inspections ............................................................................................................... 13
8. Lifetime ................................................................................................................................. 13
9. Warnings ............................................................................................................................... 13
10. Disposal............................................................................................................................... 13
11. Table of symbols ................................................................................................................. 14
12. Manufacturer contact information ..................................................................................... 16
13. Distributor contact information .......................................................................................... 16
2
1. General
1.1 Intended purpose

EH-1 is a diagnostic device used to test eye muscle coordinometry.
1.2 Description of the device

Testing with EH-1 is based on the detection of a false location for the action of the paralysed
muscle. The test is most commonly used in paralytic strabismus and muscle paralysis and
paresis.
EH-1 takes the form of an array - a graph of intersecting parabolic lines of a strictly fixed shape,
forming a grid. At the intersection of the lines, 25 test points in the form of green LEDs were
applied. The patient's task is to indicate individual points displayed in random order by the
doctor.
1.3 Indications
In accordance with the recommendations of an ophthalmologist or an orthoptist.
1.4 Contraindications
None
1.5 User
The device has been designed for use by health care professionals only.
1.6 Medical device class

Class I medical device, CE marked, EU declaration of conformity provided.
2. Technical specifications
2.1 Physical specifications

External dimensions [mm]:
3
Mounting hole spacing1 [mm]:
Net weight: 4.80 kg

Gross weight: 9 kg ±10%
External packaging dimensions: 103x91x9 cm
2.2 Electrical specifications

 safety class: II,
 supply voltage: ~100-240V AC; 50/60 Hz,
 power 6W,
 power supply via switch mode power supply 12V DC/0.5A
 remote control power supply: 3V DC - 2x AAA alkaline batteries (2x 1.5V)
 laser pointer power supply: 3V DC - 2x AAA alkaline batteries (2x 1.5V)
 IP rating: IPXO.
2.3 Operating conditions

The device is intended for indoor use.
 room temperature: +10  +40C
 average humidity: 30  75% RH
2.4 Storage conditions

The product should be stored in an original, firmly secured bulk packaging provided by the
manufacturer.
 temperature: 0  +70C
 average humidity: 10  80% RH
1
For wall mounting of the device.
4
3. Assembly and use
EH-1 is supplied in a cardboard box as a ready to use product after unpacking and hanging on
the wall2 or stand.
3.1 Set content:

1. An array with a graph and test points
2. Remote control
3. Red-green glasses
4. Laser pointer
5. 12V power supply, type C plug
6. Form for recording results (left eye, right eye)
7. 4x AAA battery
2
The set does not include wall plugs or mounting tools.
5
3.2 Assembly
You will need the following tools to hang the EH-1 on the wall3:
 hammer drill
 knife or scissors
 measure
 marker
 level
 flat or Phillips (PH) screwdriver
1. Remove EH-1 from the box and unpack all the accessories
Maintain caution when unpacking the device so that it does not slip out of your
hands, which may lead to mechanical damage.
Do not use sharp tools to unpack the device to prevent damage. Mechanical damage
due to careless unpacking is not covered by the warranty.
3
If the screen is hung on the stand (not included in the set), installation is done without using any tools.
6
2. Install the wall plugs in the wall according to the following spacing4. EH-1 should be
mounted at the patient's eye level.
3. Install the AAA batteries included in the set into the remote control and the laser pointer.
Be sure to connect the correct poles (+/-).
4
When using a hanger, set the specified distance between hooks and hang the EH-1. Dimensions are given in
[mm].
7
4. Hang EH-1 as indicated above, plug the power adaptor into the socket on EH-1, and then
connect the power adaptor to a power source.
After the final step, EH-1 is ready for use.
3.3 Use
If necessary, consult a qualified personnel of the distributor, Authorised Service

Partner (ASP) or the manufacturer.
The manufacturer and the relevant body of the EU membership country of the user
or the patient must be notified of each serious incident related to the device.
1. Unpack the device and mount it in the exercise area.

2. Plug the power adaptor into the power socket on the unit housing.
3. Plug the power adaptor into an AC outlet.
4. The unit is operated by remote control (2+25 buttons):
 red button puts the device into STANDBY mode
 green button activates the device and the test point in the central position
8
 grey buttons on the remote control correspond to the position of the green LED test
points on EH-1 array
 after pressing the grey button on the remote control, the green test point will light up
on the array in the position corresponding to the position on the remote control.
 the patient's task is to indicate the point using a laser pointer5.
5
The indicator emits a red light beam.
9
 the examiner enters the patient's indications on the results form
left eye right eye
5. When you have finished exercising, turn the EH-1 off with the red button on the remote
control, switching it to STANDBY mode.
Before performing any operations that are not related to the normal use of the
device (e.g.: cleaning, maintenance, disinfection) it is mandatory to disconnect the
device from the mains supply.
10
3.4 Course of the examination
Both the examination and diagnosis can only be performed by an ophthalmologist

or an orthoptist.
1. The patient sits 1 m away from the EH-1 array, having the central test point in her/his
line of sight. It is recommended to use a chin rest6 to immobilize the patient's head,
making the examination more accurate and meaningful.
2. The patient wears the reversible red-green glasses included in the EH-1 set: when
examining the right eye, the patient has a red filter in front of the right eye; when
examining the left eye, the patient has a red filter in front of the left eye.
3. The doctor highlights the test point.

4. The patient indicates the location of the point with a pointer.
5. The doctor records the result of the test on a result recording form (OS - left eye, OD -
right eye).
Disconnect the device from the power supply before carrying out any operations
not associated with normal use of the device (e.g.: cleaning, maintenance).
6
The chin rest is not included.
11
4. Disinfection
Use commercially available dedicated products for disinfecting surfaces of medical devices and
products recommended by the manufacturer (see below).
The materials used are not resistant to long-term exposure to disinfectants
containing ≥48% ethanol.
Do not use disinfectants containing ≥70% ethanol to clean the information and
warning labels (notices, labels, logos etc.). After disinfecting the device with an
alcohol-free disinfectant (according to the manufacturer’s instructions), remove
any remaining disinfectant residue from the device surface, see chapter 5.
4.1 COVID-19 disinfection

Use products with reduced ethanol content and non-alcohol based products listed in the table
below.
Disinfectant name NOTES
1. Asepticare TB + II
2. Caviwipes XL Packed *)
3. Clorox Healthcare Bleach Germicidal Wipes *)
4. Hydrogen Peroxide Cleaner Disinfectant Wipes
5. Lysol Foaming Disinfectant Cleaner
6. OPTIM 1 WIPES
7. Oxivir TB Wipes *)
8. Oxycide Diluted - 3 oz/gl in water *)
9. PDI SANI-CLOTH BLEACH WIPES *)
10. Sanicloth AF 3
11. Septalkan Wipes
12. Sodium Hypochlorite Disinfectant / Bleach cleaner - Dilution: 1:10 (bleach : water)
13. VELOX FOAM EXTRA
14. VELOX WIPES NA
15. Virex II 256 *) (1:256 dilution)
16. Virox 5 Rtu
17. Wex Cide 128 *) (1:128 dilution)
*) the cleaning products and disinfectants were classified by the EPA (U.S. Environmental
Protection Agency) as effective against coronaviruses. Other disinfectants without *) are
effective as specified in the product description and the information provided by the
manufacturer/distributor.
5. Cleaning
The use of chemical solvents, free oxygen or chlorine is prohibited as it may
permanently damage the surface to be cleaned and cause permanent
discoloration. For any doubts about the use of your chosen cleaner or disinfectant,
contact the manufacturer for the details.
A lint-free damp cloth is recommended for cleaning. Use of dishwashing liquid is permitted.
12
6. Maintenance
The condition of cable insulation must be checked daily before use. Report any damage or
wear to the Authorised Service Partner or the manufacturer, immediately. If you observe any
damage, do not use the device until the problem is solved.
7. Service inspections
The product does not require periodic inspection.
8. Lifetime
5 years from the date of purchase.
9. Warnings
The device must be used in accordance with the Instructions for Use.
Service inspections and repairs must be carried out by a qualified Authorised
Service Partner’s or manufacturer’s personnel.
The manufacturer and the relevant body of the EU membership country of the
user or the patient must be notified of each serious incident related to the device.
Do not:
- use the device if it is damaged or faulty;
- remove the data plate and warning labels.
10. Disposal
The owner of the device is responsible for safe and environmentally-friendly disposal of the
device.
Medical devices and used packaging should be disposed of in accordance with applicable
environmental regulations.
This device is an electrical and electronic equipment covered by Directive 2012/19/EU (WEEE).
The individual components must be disposed of separately and may not be disposed of with
the household waste. The device does not include any hazardous materials.
Correct disposal is not harmful to the environment and is not a hazard to the personnel
handling the disposal.
Make sure the device is disinfected before use in accordance with the hygiene guidelines for
health care facilities, ophthalmology centres and hospitals.
13
11. Table of symbols
Symbol Description
Manufacturer
Date of manufacture (year - month)
Electrical and electronic waste for separate disposal
Refer to the Instructions for use
CE marking
Type/model
Serial number
Medical device
Warning
Maximum load
Main switch
Initial position (minimum height)
Maximum position (maximum height)
Packaging content
Tools
External power supply
Risk of electric shock
Protective earth
Safety class II
Manual cleaning
Manual movement
14
Check
Service conditions
This way up
Fragile, handle with care
Keep dry
Do not stack
~ Alternating current (AC)
Direct current (DC)
Do not open with sharp tools
Application type part B
15
12. Manufacturer contact information
MDT sp. z o. o.
ul. Skosna 12A
30-383 Krakow
Polska/Poland
www.mdt.pl
 +48 12 655 30 65
 biuro@mdt.pl
 office@mdt.pl – queries in English
Service and technical support:

 serwis@mdt.com.pl
 support@mdt.com.pl – queries in English
13. Distributor contact information
16

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MDT sp. z o.o.

ul. Skosna 12A

Instructions for Use

1.1 Intended purpose

1.2 Description of the device

1.6 Medical device class

2.1 Physical specifications

Net weight: 4.80 kg

2.2 Electrical specifications

2.3 Operating conditions

2.4 Storage conditions

3.1 Set content:

After the final step, EH-1 is ready for use.

If necessary, consult a qualified personnel of the distributor, Authorised Service

1. Unpack the device and mount it in the exercise area.

 the patient's task is to indicate the point using a laser pointer5.

left eye right eye

Both the examination and diagnosis can only be performed by an ophthalmologist

3. The doctor highlights the test point.

4.1 COVID-19 disinfection

Date of manufacture (year - month)

Electrical and electronic waste for separate disposal

Refer to the Instructions for use

Initial position (minimum height)

Maximum position (maximum height)

External power supply

Risk of electric shock

Fragile, handle with care

~ Alternating current (AC)

Direct current (DC)

Do not open with sharp tools

Application type part B

Service and technical support:

13. Distributor contact information

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