DEHAG 803 User manual

User‘s instruc on
EN
v202105-01
C
LED Nystagmus Spectacle
803/823

EN v202105-01
Dear Customer,
thank you for purchasing this LED nystagmus spectacle. Please
read this instruc on carefully before using your new LED nystag-
mus spectacle carefully to ensure proper handling and long service
life.
Other languages of the instruc ons for use can be found on our
homepage www.dehag.com.
With the LED nystagmus spectacle it concerns an inves ga on ins-
trument which serves to observe spontaneous quick ocular move-
ments (nystagmus) with pa ents with disturbances of the balance
sense.
Read the safety instruc ons carefully and s ll only use the LED
nystagmus spectacle as described in this manual, so it does not
accidentally come in injury or damage. Keep this instruc on for
use to the later checking up. With passing on of the LED nystagmus
spectacle you also hand over this instruc on for use.
Note for the user
Any serious incident that has occurred in connec on with the LED
nystagmus spectacle should be reported to DEHAG Medizin-Tech-
nische Produk ons GmbH & Co. KG and the competent authority
of the Member State in which the user and/or pa ent is establis-
hed.
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823

EN v202105-01 1
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
Contents
• Safety instruc ons
• Package Contents
• Opera on
• Prepara on instruc on
• Waste disposal
• Technical data
• Guarantee terms
• Service
• Declara on of conformity
• Symbols

2
EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
Safety instruc ons
General
• Please read this instruc ons carefully and retain them
for reference.
• Use this LED nystagmus spectacle solely in accordance
with this instruc on.
• The lenses are very delicate, handle the LED nystagmus
spectacle with great care.
• Avoid placing the LED nystagmus spectacle on surfaces
that could scratch the lenses.
• Always place the LED nystagmus spectacle on the remo-
vable inlay in the outer carton.
• The LED nystagmus spectacle may only be used by me-
dical staff . This instruc on do not replace a good medi-
cal educa on.
• Misuse or any modifi ca on is not under the responsibi-
lity of the manufacturer.
• Please check the LED nystagmus spectacle for func o-
nality and integrity before each use.
• Have any repairs carried out solely by a qualifi ed elec-
trician.

EN 3
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
v202105-01
• Please remove the ba eries before sending the LED
nystagmus spectacle.
• Never try to repair the LED nystagmus spectacle your-
self.
• Repairs may only be carried out with original spare
parts which are installed according to the intended use.
• Any change leads to the exclusion of liability.
• The CE-sign looses is validity in case of the use of any
non original spare parts.
• If you transfer the LED nystagmus spectacle to a third
party, also hand over this instruc on manual.
Warnings
• Do not use damaged instruments!
• Protect the LED nystagmus spectacle and its parts
against all kind of mechanical damage or force!
• Avoid hi ng the lenses, which could break and cause
damages!
• Do not throw and use with care!
• Screen the LED nystagmus spectacle and the acces-
soires from the sun. Keep dry! The products have to
shelter from humidity about 75%!

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
4
• Misuse, damage, and wear are not covered by the war-
ranty!
• Any signs or wear and tear due to regular use are exclu-
ded from the warranty!
• Make absolutely sure that no liquid enters the ba ery
handle or the LED nystagmus spectacle.
• Make sure to use dry ba eries only and that the handle
is clean and dry before inser ng ba eries!
Intended use
Device for short-term examina ons or for mobile use in
the fi eld of ver go diagnos cs.
Indica on/Contraindica on
Whether the use of LED nystagmus spectacle is indicated
depends on the type of nystagmus examined. For example,
LED nystagmus spectacle are used to assess spontaneous
nystagmus, but are not suitable for observing direc onal
nystagmus.
Side eff ects and residual risks
Contamina on due to non-compliance with the prepara -
on instruc ons, wrong or defec ve accessories.

User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
EN v202105-01 5
Electricity
• To ensure the power supply of the LED nystagmus spec-
tacle, use three ba eries of size C LR14/AM-2 (baby
cells) á 1.5 volts.
• When inser ng the ba eries make sure the poles are
connected correctly.
Insert the ba eries
Use
• Before any use the LED nystagmus spectacle has to be
cleaned or disinfected and the good func on and the
integrity has to be checked.
• It is to use only the accessories specifi ed by the manu-
facturer.
• Unscrew the cover of the ba ery handle.
• Insert 3x 1.5 V C LR14/AM-2 size ba eries (ba eries not
inclusive) making sure the indicated ba ery polarity is
observed.
• Then, turn the ba ery cover back onto the ba ery
handle.

User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
EN v202105-01 6
• Remove ba eries from of the ba ery compartment as
soon as they are empty or if the device will not be used
for a longer period of  me.
Package Contents
• Please check the packaging and complain any damage
immediately to the carrier.
• A er opening the packaging, please check the contents
of the packaging for damage that may have occurred
due to improper handling during transport.
Your LED nystagmus spectacle package includes all of the
following items. If any of these items are missing, please
contact the dealer for assistance.
• 1x LED nystagmus spectacle type 803/823

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
7
• 1x user‘s instruc on 1x carton
• 1x inlay

DE v202105-01 EN
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
8
Opera on
General
With the purchase of the LED nystagmus spectacle type
803/823 you have the opportunity to do a short-term ex-
amina on, in mobile use. The LED nystagmus spectacle is
held directly in front of the pa ent‘s eyes, thus enabling
a quick uncomplicated search for provoca on nystagmus,
e.g. by head shaking.
The LED nystagmus spectacle is equipped with strong re-
frac ve biconvex magnifying lenses with a power of +15 to
+18 diopters. They prevent a sharp vision and the fi xa on
of objects. In this way, the pa ent‘s visual contact with ob-
jects in the environment is interrupted, which would hin-
der the fast eye movements. At the same  me the highly
illuminated eyes are easily observable under magnifying
glasses.
The LED nystagmus spectacle is equipped with a  mer
func on that facilitates the observa on of the defl ec ons
within a certain period of  me. In addi on, the glasses are
equipped with an ac vated switch-off func on. Here the
illumina on of the LED nystagmus spectacle switches off
one minute a er the  mer has expired, a renewed wearing
of the LED nystagmus spectacle automa cally switches it
on again. The LED nystagmus spectacle also has a „Low
Ba ery“ indicator, which signals that the ba eries have
been changed when empty.

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
9
Use
• Clean the LED nystagmus spectacle with a so cloth
moistened with water and a mild detergent before each
use. Then dry the glasses thoroughly with a so dry
cloth.
• Please make sure that the LED nystagmus spectacle is in
an undamaged, technically perfect condi on.
• Hold to the pa ent the LED nystagmus spectacle in
front of the eyes over the nasal bridge.
• Hold the LED nystagmus spectacle fi rmly with one hand
on the ba ery hold.
• Turn the rotary control dial clockwise to turn on the LED
nystagmus spectacle.
• By turning the rotary switch clockwise, you can dim the
brightness to the limit of the rotary switch ( about. 3/4
turn).
Make sure that you do not over turn the rotary switch,
otherwise the switch may become unusable!
• Switching off the device is done in reverse order.
• To start the  mer func on, press the  mer bu on with
the illustrated stopwatch on the ba ery handle. The
fl ashing diode indicates the sequence of the respec ve
 mes (30, 60 or 90 seconds).

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
10
• The brightness of the LED nystagmus spectacle is regu-
lated by turning the rotary switch on the ba ery hand-
le. Turning it towards 0 reduces the brightness, turning
it in the opposite direc on increases the brightness of
the LEDs.
• With the automa c switch-off and switch-on func on,
the LED nystagmus spectacle switches off a er approx.
one minute a er the  mer has elapsed. The light will
turn on again when the device are picked up.
• When you will not be using the LED nystagmus spectac-
le for a prolonged period, take the ba eries out of the
ba erie holder.
Deac va on / ac va on of the switch-off func on
• To deac vate the switch-off func on, hold down the
 mer bu on on the ba ery hold while turning on the
rotary switch at the same  me.
• Release the  mer a er turning off the 30 sec LED (ap-
prox. 1 second) and turn off the LED nystagmus spec-
tacle and then turn them on again. A short fl ash of the
30-sec-LED a er switching on signals the deac vated
automa c switch-off .
• Ac va ng the switch-off func on is the same as for
deac va ng the switch-off func on.

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
11
Low Ba ery indicator
• The „Low Ba ery“ indicator shows you an empty bat-
tery by turning the LED nystagmus spectacle on by fi ve
fl ashes of all three diodes. Insert, according to the cor-
rect polarity, three new, similar 1.5 V ba eries of size C
LR14 / AM-2 (baby cells), preferably alkaline ba eries.
• Please dispose of used ba eries according to local re-
gula ons.

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
12
Processing instruc ons
Store your LED nystagmus spectacle in a closed place, on
the supplied inlay, where it is protected from dust and dirt
to ensure their hygienic condi ons.
All surfaces of the appliance are not sensi ve to conven -
onal, mild cleaners. A so cloth or absorbent paper should
be used to apply cleaning liquids, in order to avoid scrat-
ching the surface and to dose and spread out the liquid
be er. Incorrect or incomplete cleaning may jeopardize
the pa ent or medical staff !
Restric on regarding reprocessing
The end of the product service life is usually determined by
wear and damage caused by use.
Place of use
Remove surface soiling with a so disposable cloth.
Maintenance
• Please sort damaged parts and have them repaired.
• If you send the LED nystagmus spectacle for repair, ple-
ase remove the ba eries before sending.

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
13
Cleaning / disinfec on: automa cally
• An automa c cleaning and disinfec on is not approved
for the LED nystagmus spectacle.
• Do not disinfect by spray or soak!
Cleaning / disinfec on: manual
Validated procedure:
Pre-cleaning with a cloth soaked with 80% ethanol.
Wipe disinfec on with a so , lint-free non-woven cloth
soaked with ECOLAB incidin Oxy Foam S. Reac on  me ac-
cording to the manufacturer of the disinfectant 1 minute.
Clean the LED nystagmus spectacle a er each use.
• Clean the LED nystagmus spectacle with a damp cloth
and possibly some mild detergent.
• Never use corrosive or scouring cleaning agents or
sharp objects to clean the appliance.
• Dry the LED nystagmus spectacle with a so , dry cloth
thoroughly.
• Do not immerse the LED nystagmus spectacle set in wa-
ter, or in other liquids.

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
14
Drying
Allow the device to dry for at least one hour before reuse.
Otherwise there is a risk that an explosive mixture of air
and cleaning agent may ignite when the device is switched
on.
Control and tes ng
Check the parts a er cleaning for visible dirt. You may need
to repeat the cleaning.
Packaging
The LED nystagmus spectacle must not be packaged in ste-
rile packaging. Other packages are also possible.
Steriliza on
Do not sterilize the LED nystagmus spectacle, thus elect-
ronic components can be damaged by high temperatures.

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
15
Waste disposal
A er the life me the instrument has to be li ered in com-
pliance with the local regula ons and law. The following
applies for the European Union: According to the EU Direc-
 ve 2012/19/EC on Waste Electronic and Electrical Equip-
ment (WEEE) do not dispose of this product as unsorted
municipal waste. Prepare this product for reuse or separa-
te collec on as specifi ed by the direc ve. If this product is
contaminated, this direc ve does not apply. Low ba eries
have to be removed and li ered according to the local re-
gula ons and law.

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
16
Technical data
• Type: 803 / 823
• Power supply: 3x ba eries baby cells type
LR14/AM-2; á 1.5V
• Dimensions: 223 x 150 x 70 mm3
• Weight: approx. 400 g (w/o ba eries)
• Protec on Class: IP X0
• Classifi ca on: Class I, according to Annex VIII
of Direc ve 2017/745 (EU
• Classifi ca on: Risk group I according to DIN
EN 62471
• Spaulding: according to Direc ve
2017/745 (EU)
• Classifi ca on RKI: uncri cal
• Storage and transport condi ons:
• Storage temperature: -30 bis 60 °
• Working temperature: 0 bis 25 °C
• Humidity: 30 bis 75 %
• Barometric pressure: 700 bis 1,060 hPa

EN v202105-01
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
17
Guarantee terms
DEHAG Medizin-Technische Produk ons GmbH & Co. KG
guarantees the appliance for defects caused by manufac-
turing and/or material faults for 24 months from the date
of purchase, subject to the following condi ons.
• No charges will be made for labour, materials and ship-
ping costs during the guarantee period. Any repairs car-
ried out during the guarantee period do not extend the
guarantee period.
• The importer automa cally becomes the owner of any
faulty parts or a faulty appliance (in the event of a com-
plete replacement) replaced by the importer.
• All claims submi ed under guarantee must be accom-
panied by the original bill of sale.
• Claims under guarantee must be submi ed to the dea-
ler where the appliance was purchased, or to the im-
porter.
• The guarantee does not cover damage caused by:
• Accidents, incorrect use, wear and/or neglect.
• Faulty installa on and/or use in a manner contra-
vening the prevailing statutory, technical or safety
regula ons.

EN v202105-01 18
User‘s instruc ons LED Nystagmus Spectacle
Type 803/823
• For malfunc on or damage caused by improper
handling, especially handling contrary to the inst-
ruc ons or inadequate or improper care and main-
tenance.
• Malfunc ons on electrical devices due to external
infl uences, such as voltage changes, electromagne-
 c fi elds, radio interference, etc.
• Repairs carried out by the customer or third par es.
• Careless transport, i.e. without suitable or protec-
 on.
• The warranty does not cover ba eries or other accesso-
ries that are a ached to the LED nystagmus spectacle,
if necessary.
• No claims can be submi ed under this guarantee for
damage other than repair or replacement of faulty
parts. The manufacturer can never be held responsible
for any consequen al loss or damage, or any other con-
sequences, resul ng either directly or indirectly from
the supply of the appliance by the manufacturer.
• All costs of transport, packing and transport insurance
are borne by the purchaser.
• For defects that are asserted that occur a er the war-
ranty period or are not warranted.