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Seca Man 864 Int

This document discusses the features and operation of the seca 864 electronic personal scale. It details how to set up, power, and calibrate the scale. Instructions are provided for connecting components, adjusting the feet for leveling, and operating the control panel and display.

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syukur9301
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© © All Rights Reserved
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0% found this document useful (0 votes)
8 views

Seca Man 864 Int

This document discusses the features and operation of the seca 864 electronic personal scale. It details how to set up, power, and calibrate the scale. Instructions are provided for connecting components, adjusting the feet for leveling, and operating the control panel and display.

Uploaded by

syukur9301
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 21

seca 864

Full certification
seca products you are purchasing not only technology matured over a century, but also
quality confirmed by authorities, the legal system and by institutes.
seca products comply with European directives, standards and national laws. With seca,
you are buying the future.
The products in these operating instructions com-
ply with German legislation governing medical
products and therefore with Directive 93/42/EEC
of the Council of the European Community which
is embodied in national laws throughout Europe.
Scales carrying this symbol are approved for medi-
M cal purposes in the European Community. seca
scales with this symbol meet the stringent quality
and technical requirements placed on scales which
can be calibrated.
Scales carrying this symbol are calibrated in ac-
cordance with Precision Class III of EC Directive
90/384/EEC.

Products carrying this symbol comply with the fol-


lowing directives and standards:
1. Directive 90/384/EEC governing non-auto-
matic weighing instruments
2. Directive 93/42/EEC governing medical
devices
3. DIN EN 45501 governing metrological
aspects of non-automatic scales
seca’s professionalism has also been officially re-
cognized. The certificate from TÜV Product Ser-
vice, the body responsible for medical devices,
ISO ISO confirms that as a manufacturer of medical de-
9001 13485 vices, seca rigorously complies with stringent le-
gal requirements. seca’s quality assurance
system covers the development, production, sa-
les and service of medical scales and measuring
systems and ergometry.

seca helps the environment.


We are concerned to save natural resources. We
therefore strive to save pakkaging material where
meaningful. What is left over can conveniently be
disposed of locally via the German Dual System
(recycling programme).

Model 864 GB 3
1. Congratulations!
English

By purchasing the seca 864 electronic Weight is determined within a few sec-
personal scale, you have acquired a high- onds.
ly-accurate and sturdy piece of equip- In addition to the conventional determina-
ment. tion of weight, the seca 864 also has a
seca has been putting its experience at function for determining body mass index.
the service of health for over 150 years For this purpose, height is entered on the
now, and as market leader in many coun- keypad and the body mass index associ-
tries of the world, is always setting new ated with the weight value is output.
standards with its innovative develop- Limit values for load can be set for use in
ments for weighing and measuring. orthopaedics. An alarm sounds in the
In accordance with national regulations, the event of overload.
seca 864 electronic personal scale is used The scale is of a very sturdy construction
primarily in hospitals, doctors’ surgeries and will give you long and loyal service. It
and in-patient nursing facilities. The scales is easy to operate and the large display is
are a Class I medical product, and have easy to read.
been calibrated in accordance with the
precision class III.

2. Safety
Before using the new scale, please take a little time to read the following safety instruc-
tions.
• Follow the safety instructions in the in- • Have scale serviced and re-calibrated
struction manual. on a regular basis (see “Servicing/recal-
• Keep the operating manual and the ibration” on page 14).
declaration of conformity contained • Have repairs carried out exclusively by
therein in a safe place. authorised persons.
• Do not drop the scale or subject it to • Use only the type of battery stated (see
violent shocks. “Changing the batteries” on page 14).
• The cable between the weighing plat- • If the scale is used to monitor strain in
form and the case must be laid so that it orthopaedic applications, someone
does not present a tripping hazard. should first check the correct setting of
• Ensure that the cables are not crushed limit values and alarm function to pre-
and do not come into contact with hot vent a patient inadvertently being
objects. placed under excessive strain.
• When using the scale with a mains unit,
ensure that the supply cable is routed in
such a way as to exclude any type of
tripping hazard.

4
3. Before you start…

Unpacking
Remove the packaging and place the scale on a firm, level surface.
The scope of supply includes:
• Weighing platform with handle
• Display part with connecting cable
• Wall bracket
• Desk-top stand
• 2 Screws
• 2 Rawlplugs
• Battery holder containing 6 mignon-
type AA 1.5 V batteries
• 1 set of operating instructions

Desk-top stand
– Position the desk-top stand on the dis-
play casing from underneath.
The broad side must be located at the
top of the display. The desk-top stand
locks in position.
– Place the display casing on a desk-top.

Wall bracket
– Place the desk-top stand on the display
casing from underneath.
The narrow side must be located at the
top of the display. The desk-top stand
locks in position (1).
– Fit the wall bracket to the wall at the
desired height.
– Push the display casing onto the wall
bracket (2).

Model 864 GB 5
Power supply
The scale is powered exclusively by batteries.
The LC display has a low power consumption – 16.000 weighing operations can be per-
formed with one set of batteries. Once battery voltage is no longer adequate, the battery
symbol first appears in the display to indicate that battery power is dropping.
– Carefully turn over the scale so that the
base of the scale is accessible.
– Push the battery compartment closure
towards “Battery” and open the cover.
– Connect the cable to the holder and
batteries.
– Place the holder in the battery compart-
ment.
– Close the cover and then turn the scale
back up the right way.

Connecting the connecting cable to the weighing platform


The connecting cable of the display part is used to transmit digital data which are consid-
erably less sensitive to interference than the otherwise conventional small analog meas-
uring signals. Ageing and wear on the cable and on the plug contacts thus have no effect
on the accuracy of the scale.
To make the connection, proceed as outlined below:
– Connect the cable of the display case to
the socket under the carrying handle.
– Make a loop in the connecting cable
and clamp it in the slacking device on
the underneath of the scale.
– Then place the scale upright again.

6
4. Setting up and aligning the scale
– Place the scale on a level surface.
– Undo the locknuts using the four foot 3.
screws (1). 1.
– Align the scale by undoing the foot
screws. The air bubble in the spirit level
must be right in the centre of the 2.
circle (2).
– Then re-tighten the locknuts (3).
– Ensure that only the feet of the scale are
in contact with the floor. The scale may
not be in contact at any other point.

Important!
The alignment of the base of the scale must be checked and corrected if neces-
sary every time the location of the scale is changed.

Model 864 GB 7
5. Operation

Controls and displays


The controls and display are in a casing separate from the scale. This casing is connected
to the weighing platform by a 2.7-metre cable.

Switch scale on and off

press briefly s set display to zero, activate/deactivate tare function


in function menu s increase value, scroll

press briefly s activate hold function


in function menu s decrease value, scroll

Menu selection, Confirmation, Parameter adjustment

8
Correct weighing
– Press the Start key with no load on the
scale.
se(a, 8.8.8.8.8. and 0.0 appear consec-
utively in the display. The scale is then
automatically set to zero and ready to
use.
– Stand on the scale and keep still.
– Read the weighing result off the digital
display.
– If a load greater than 200 kg is placed
on the scale, St0P appears in the dis-
play.
– To switch off the scale, press the Start
key again.

Checking that the contents of the calibration counter are correct


This seca scale is calibrated. Calibration may be performed only by authorised centres.
To ensure this, the scale is fitted with a calibration counter which records any change to
data relevant to calibration. If you want to check whether the scale is properly calibrated,
proceed as follows:
– If necessary, switch off the scale.
– Keep any key depressed and start the
scale.
The current contents of the calibration
counter are shown on the display for a
few seconds.
– Compare the output contents of the cal-
ibration counter with the number shown
on the calibration counter sticker.
For valid calibration, both numbers must
match. If sticker and calibration counter
do not match, then re-calibration is re-
quired. Contact your service agent or Both numbers must match.
seca Customer Service.
If a supplementary calibration is necessary,
then the supplementary calibration mark il-
lustrated opposite is used to record the
calibration counter position instead of the
seca calibration mark shown above. This
mark is secured with an additional seal by
the person authorised to perform the sup-
plementary calibration. The supplementary
calibration mark is available from seca
Customer Service under the number
14-05-01-886.

Model 864 GB 9
Automatic switch-off/economy mode
The scale switches off automatically after 3 minutes.

Taring weight display (TARE)


Proceed as follows:
– Press the Start key with no load on the
scale.
– First stand on the scales yourself with-
out the additional weight and activate
the Tare function by pressing the TARE
key.
The display is reset to zero, 0.0 flashes
in the display until weight is detected to
be stable. Only then is the Tare function
fully activated. The note “NET” appears.
– Now take the additional load onto the
scale. You can leave the scale to do so,
in which case ---- appears.
The scale determines the weight of the
additional load. You can now perform
as many weighing operations as you
like.
– Press the key again to deactivate the
Tare function; the scale is then back in
normal weighing mode and the tare val-
ue has been erased.
– The tare value is likewise erased by the
scale being switched off.

Store weight value (HOLD)


You can also continue displaying the weight determined once the load has been removed.
This makes it possible to look after a patient first, before having to note the weight:
– Press the HOLD key whilst the load is
on the scale.
“HOLD” appears in the digital display. The
display starts to flash, showing that the
scale is checking the stability of the weight
values. Only once stability prevails is the
displayed value stored. The value is stored
until the scale switches off automatically.
The triangle with the exclamation mark in-
dicates that this frozen display is an addi-
tional facility which is not subject to
calibration.

10
– The HOLD function can be switched off
by pressing the HOLD key again.
0.0 appears in the display if the scale has
no load on it, otherwise the current weight.
The “HOLD“ display vanishes.

Note:
The HOLD and TARE functions can also be used simultaneously.

Body Mass Index (BMI)


Body Mass Index puts height and weight in relationship to one another, providing more
accurate information than ideal Broca weight, for example. A tolerance range is given
which is considered ideal for health.
– Press the Start key with no load on the
scale.
se(a, 8.8.8.8.8. and 0.0 appear con-
secutively in the display. The scale is
then automatically set to zero and ready
for operation.
– Press the FUNC key.
The last function used appears in the
display.
– Use the arrow keys to select the BMI
function, FU 1. Activate the function by
pressing the FUNC key again.
On the display, you will see the last
height entered.
– You can use the arrow keys to adjust
the value in increments according to the
graduations displayed.
– Once the correct value is set, press the
FUNC key again. The BMI function is
now activated.
– Step on the scale and keep still.
– Read off the BMI on the digital display
and compare it with the categories on
page 12.
– Press an arrow key if you would like to
see the weight briefly.
– To return to normal weighing mode,
press the FUNC key.
– To switch off the scale, press the Start
key again.

Model 864 GB 11
Evaluating Body Mass Index for adults:
Compare the value determined with the categories quoted below which correspond to
those used by WHO, 2000.
• BMI below 18.5:
Warning, this patient weighs too little. There could be a tendency to anorexia. An in-
crease in weight is recommended to improve well-being and performance. If in doubt,
consult a specialist.
• BMI between 18.5 and 24.9:
The patient is of a normal weight. He can stay as he his.
• BMI between 25 and 30 (pre-obese):
The patient is slightly to moderately overweight. He should cut his weight if he is al-
ready ill (e.g. diabetes, hypertension, gout, fat metabolism disorders).
• BMI over 30:
Weight reduction is essential. Metabolism, cardiovascular system and bones are all un-
der strain. A consistent diet, plenty of movement and behavioural training are all rec-
ommended. If in doubt, consult a specialist.

Limit value
The seca 864 personal scale is designed for checking strain in those with walking difficul-
ties or in patients who have had surgery on the locomotor apparatus. A weight limit value
can be set. In attempts to walk on the weighing platform, an alarm sounds if the load limit
value is exceeded. This avoids overload and allows load to be increased gradually under
controlled conditions. Applications include orthopaedic departments and physiotherapy
practices.
– Press the Start key with no load on the
scale.
se(a, 8.8.8.8.8. and 0.0 appear con-
secutively in the display. The scale is
then automatically set to zero and ready
for operation.
– Press the FUNC key.
The last function used appears in the
display.
– Use the arrow keys to select function
FU 2. Activate the limit value function by
pressing the FUNC key again.
In the display you will see the last limit
value set.
– You can use the arrow keys to adjust
the value in increments according to the
graduations displayed.
– Once the correct value is set, press the
FUNC key again.
The limit value function and the alarm
signal are now activated.
– Step carefully onto the scale.
If the limit value entered is exceeded, an
alarm sounds.

12
– To switch off the scale, press the Start
key again.

Important note:
if the scale is switched off or switches off automatically, the limit value function
has to be reactivated by the method described above.
Check yourself the settings made and that the scale is working properly before
a patient uses the scale.

6. Cleaning
Clean the rubber surface and the housing as required using a domestic cleaning agent or
commercially-available disinfectant. Follow the manufacturer’s instructions.
Under no circumstances use abrasive or acid cleaners, white spirit, benzene or the like for
cleaning. Such substances can damage the high-quality surfaces.

7. What do I do if…
… no weight display comes on?
– Is the scale switched on?
– Check the batteries.
– Is the plug contact for connecting the display to the scale correctly connected?
… 0.0 does not appear before weighing?
– Press the Start key again – there must not be any load on the scale – and only its feet
should be in contact with the floor.
… one segment is illuminated constantly or not at all?
– The relevant segment has a fault. Inform Servicing.
… the display shows ?
– Battery voltage is running low. Change the batteries in the next few days.
… batt appears in the display?
– Batteries are empty. Put in new batteries.
… St0p appears in the display?
– Maximum load has been exceeded.
… the display flashes?
– If you have just activated the Hold or Tare function, please wait until the scale has de-
tected a steady weight value. The display will then stop flashing.
– If there has been no activation of a function beforehand, remove the load from the scale
and wait until 0.0 is displayed, then weigh again.
… the display appears?
– The ambient temperature of the scale is too high or too low. Place the scale in an
ambient temperature between +10 °C and +40 °C. Wait about 15 minutes for the
scale to adapt to the ambient temperature and then weigh again.

Model 864 GB 13
… the display E and a number appear?
– Switch off the scale with the Start key and start the scale again. The scale will then
work normally again.
If this is not the case, disconnect the power supply by briefly removing the batteries. If
this measure is equally unsuccessful, inform the Service department.

8. Servicing/recalibration
Have the scale recalibrated by authorised persons in accordance with national legal re-
quirements. The year of initial calibration can be found behind the CE symbol on the rating
plate above the number of the appointed office, 0109 (Hessen Weights & Measures Of-
fice). Recalibration is essential if one or more security marks are damaged or the calibra-
tion counter does not match the number on the applicable calibration counter mark (cf.
page 9).
We recommend having your scale serviced by your local service agent before having it
recalibrated. seca Customer Service will be pleased to give you further assistance.

Changing the batteries


When or bAtt appear in the display, you should change the batteries. You need
6 type AA 1.5 V batteries.
– Carefully turn over the scale so that the
base of the scale is accessible.
– Push the battery compartment closure
towards “Battery” and open the cover.
– Take out the holder and batteries.
– Remove the used batteries and insert
new batteries in the holder.

Check that the polarity is correct.

– Place the holder and batteries in the


battery compartment.
– Close the cover.
– Then turn the scale back up the right
way.

9. Technical data
Maximum load 200 kg
Minimum load 2 kg
Graduations
0 up to 200 kg 100 g
Dimensions scale
width: 292 mm / 11.5 ins
height: 848+10 mm / 33.4+0.4 ins

14
depth: 357 mm / 14.1 ins
Dimensions weighing platform
width: 292 mm / 11.5 ins
height: 75+10 mm / 2.8+0.4 ins
depth: 300 mm / 11.8 ins
Dimensions of display part
width: 198 mm / 7.8 ins
height: 50 mm / 2 ins
depth: 157 mm / 6.2 ins
Height of figures 20 mm
Weight approx. 7,6 kg
Temperature range +10 °C to +40 °C
Power supply Battery
Batteries 6 type AA 1.5 V batteries
Power consumption approx. 25 mA
Calibration as per Directive
90/384/EEC approved for medical use, Class III
Medical product as per Directive
93/42/EEC Class I
Accuracy at first calibration
0 to 50 kg: ± 50 g
50 kg to 200 kg: ± 100 g
Functions Tare, Hold, Body-Mass-Index, limit value

10. Disposal

Disposing of the device Batteries


Do not dispose of the device in Do not throw used batteries away in do-
domestic waste. The device must mestic waste. Dispose of batteries at col-
be disposed of properly as elec- lection points in the vicinity. When buying
tronic waste. Follow the national regula- new batteries, select those low in harmful
tions which apply in your case. For further substances and containing no mercury
information, contact our service depart- (Hg), cadmium (Cd) or lead (Pb).
ment at:
service@seca.com

Model 864 GB 15
11. Warranty
A two-year warranty from date of delivery honoured only if the complete original
applies to defects attributable to poor ma- packaging was used for any transport and
terials or workmanship. All moveable parts the scale secured and attached in that
- batteries, cables, mains units, recharge- packaging just as it was when originally
able batteries etc. - are excluded. Defects packed. All the packaging should there-
which come under warranty will be made fore be retained.
good for the customer at no charge on A claim under warranty will not be hon-
production of the receipt. No further oured if the equipment is opened by per-
claims can be entertained. The costs of sons not expressly authorised by seca to
transport in both directions will be borne do so.
by the customer should the equipment be We would ask our customers abroad to
located anywhere other than the custom- contact their local sales agent in the event
er’s premises. In the event of transport of a warranty matter.
damage, claims under warranty can be

16
Model 864 GB 17
Konformitätserklärung
declaration of conformity
Certificat de conformité
Dichiarazione di conformità
Declaratión de conformidad
Overensstemmelsesattest
Försäkran om överensstämmelse
Konformitetserklæring
vaatimuksenmukaisuusvakuutus
Verklaring van overeenkomst
Declaração de conformidade
Δήλωση Συμβατότητας
Prohlášení o shodě
Vastavusdeklaratsioon
Megfelelőségi nyilatkozat
Atitikties patvirtinimas
Atbilstības apliecinājums
Oświadczenie o zgodności
Izjava o skladnosti
Vyhlásenie o zhode
Onay belgesi
17-10-07-538a /07
Die nichtselbsttätige Personenwaage
The non-automatic personal scales
Le pèse-personnes non automatique
La bilancia pesapersone non automatica
La báscula no automática pesapersona
Den ikke-automatiske personvægt
Den icke automatisk personvåg
Den ikke-automatiske personvekten
Ei-automaattinen henkilövaaka
De niet-automatische personenweegschaal
A balança não automática para pessoas
Η μη αυτόματη ζυγαριά ατόμων
Osobní váhy s neautomatickou činností
Tervishoiuteenuse osutamisel kasutatavad mitteautomaatkaalud
A nem automatikus működésű személyi mérleg
Neautomatinės buitinės svarstyklės
Manuālie (neautomātiskie) personālsvari
Nieautomatyczna waga osobowa
Neavtomatska osebna tehtnica
Nesamostatná osobná váha
Otomatik olmayan yetişkin tartısı

864

EG-Bauartzulassung D01-09-020
EC type approval D01-09-020
Homologation CE D01-09-020
Omologazione del tipo costruttivo CEE D01-09-020
Homologación CE D01-09-020
EF-typegodkendelse D01-09-020
EG-kontroll D01-09-020
EF-konstruksjonstype-godkjennelse D01-09-020
EY-tyyppihyväksyntä D01-09-020
EG-modelkeuring D01-09-020
Homologação CE de tipo de construção D01-09-020
Αδεια κατασκευαστικού τρόπου ∂.∫. D01-09-020
ES schválení typu D01-09-020
EÜ-tüübikinnitus D01-09-020
A D01-09-020 EU-típusengedély
ES kvalifikacijos patvirtinimas Nr. D01-09-020
Izgatavošanas veida atļauja D01-09-020
Dopuszczenie na rynek UE nr D01-09-020
Odobritev vzorca EU D01-09-020
Schválenie konštrukcie EÚ D01-09-020
EG üretim türü izni D01-09-020
… entspricht dem in der Bescheinigung über die Bau- ...motsvarar beskrivningen enligt mönstertillståndet.
D artzulassung beschriebenen Baumuster. S Vågen uppfyller huvudsakligen de gällande kraven i
Die Waage erfüllt im Wesentlichen die geltenden An- följande direktiv:
forderungen folgender Richtlinien: 90/384/EEG om icke-automatiska vågar,
90/384/EWG über nichtselbsttätige Waagen, 93/42/EEG över medicinska produkter samt
93/42/EWG über Medizinprodukte und den europeiska normen DIN EN 45501
die Europäische Norm DIN EN 45501. ... er i samsvar med mønsteret som er beskrevet i
…corresponds to the type described in the certificate
N sertifikatet over konstruksjonstype-godkjennelsen.
GB in respect of type approval permit. Vekten oppfyller i det vesentlige de gjeldende krav i
The scale largely fulfils the valid requirements from følgende EU-direktiver:
the following guidelines: 90/384/EEC om ikke-automatiske vekter,
90/384/EEC on non-automatic scales 93/42/EEC om medisinske produkter og
den europeiske standarden DIN EN 45501.
93/42/EEC on medical products and
European standard DIN EN 45501 ... on tyyppihyväksyntätodistuksessa kuvatun raken-
FIN nemallin mukainen.
…conforme au modèle type décrit dans le certificat Vaaka vastaa pääosin seuraavien direktiivien
F d’homologation. voimassa olevia määräyksiä:
Cette balance répond pour l’essentiel aux exigences 90/384/ETY ei-automaattisista vaaoista,
des directives suivantes : 93/42/ETY lääketieteellisistä tuotteista ja
directive 90/384/CEE concernant l'harmonisation des Euro-normi DIN EN 45501.
Etats membres relative aux instruments de pesage à
fonctionnement non automatique; ...komt overeen met de in de verklaring van over de
directive 93/42/CEE sur les produits et appareils
NL modelkeuring beschreven constructie.
médicaux; De weegschaal voldoet in essentie aan de geldende
eisen van de volgende richtlijnen:
norme européenne DIN EN 45501
90/384/EEG inzake niet-automatische weegschalen
…è conforme al campione descritto nel certificato di 93/42/EEG inzake medische hulpmiddelen en de
I omologazione costruttiva. Europese norm DIN EN 45501.
La bilancia è sostanzialmente conforme alle prescri-
... corresponde ao padrão de construção descrito no
zioni in vigore delle seguenti direttive: P certificado de homologação de tipo de construção.
90/384/CEE sulle bilanci non automatiche, A balança cumpre, no essencial, os requisitos aplicá-
93/42/CEE sui prodotti medicali e veis das seguintes directivas:
la norma europea DIN EN 45501 sobre balanças não automáticas 90/384/CEE e
93/42/CEE sobre artigos médicos do Conselho, bem
…corresponde a la muestra descrita en el certificado
E sobre el permiso de construcción.
como da norma Europeia DIN EN 45501.
La báscula cumple en esencia los requisitos aplica- ... ανταποκρίνεται στο κατασκευαστικό πρότυπο
bles de las siguientes Directivas: GR που περιγράφεται στην εγκριτική βεβαίωση του
90/384/CEE sobre básculas no automáticas κατασκευαστικού τρόπου.
93/42/CEE sobre productos médicos y Η ζυγαριά εκπληρώνει βασικά τις ισχύουσες
la norma europea DIN EN 45501 απαιτήσεις των ακόλουθων Οδηγιών:
90/384/ EOK περί μη αυτόματων ζυγαριών,
... svarer til det typemønster, som er beskrevet i atte- 93/42/EOK περί ιατρικών προϊόντων, και
DK sten over typegodkendelsen. την Ευρωπαϊκή Προδιαγραφή DIN EN 45501.
Vægten opfylder i det væsentlige de gældende krav
fra følgende direktiver:
90/384/EØF om ikke-automatiske vægte,
93/42/EØF om medicinprodukter og
den europæiske standard DIN EN 45501
…odpovídá typu popsanému v certifikátu schválení ...odpowiada typowi konstrukcyjnemu opisanemu w
CZ typu. PL świadectwie zgodności.
Váhy v podstatě splňují platné požadavky těchto Waga spełnia w podstawowych punktach obowiązu-
směrnic: jące wymagania następujących dyrektyw:
směrnice Rady 90/384/EHS o harmonizaci právních 90/384/EWG na temat wag nieautomatycznych
předpisů týkajících se vah s neautomatickou činností 93/42/EWG na temat produktów medycznych i
směrnice Rady 93/42/EHS o zdravotnických normy europejskiej DIN EN 45501.
prostředcích a evropská norma DIN EN 45501.
...ustreza potrjenemu modelu vrste izdelave.
EST ...vastab tüübikinnitustunnistuses kirjeldatud tüübile. SLO
Tehtnica je v bistvu izpolnjuje veljavne zahteve nasled-
Kaalud vastavad põhiosas alljärgneva direktiivi kehti- nje smernice:
vatele nõuetele: 90/384/EGS za neavtomatske tehtnice
90/384/EMÜ mitteautomaatkaalude kohta 93/42/EGS za medicinske izdelke in evropsko
93/42/EMÜ meditsiinitoodete kohta ja Euroopa normo DIN EN 45501.
standardile DIN EN 45501.
…zodpovedá typu popísanému v osvedčení o
...megfelel a típusengedély
HU igazolásában megadott típusnak.
megfelelőség- SK schválení konštrukcie.
Váha v podstate spĺňajú platné požiadavky týchto
A mérleg eleget tesz a következő irányelvek hatályos smerníc:
és alapvető követelményeinek: 90/384/EWG o nesamostatných váhach
90/384/EGK irányelv a nem automatikus működésű 93/42/EWG o zdravotníckych výrobkoch a podľa
mérlegekről Európskej normy DIN EN 45501.
93/42/EGK irányelv az orvostechnikai eszközökről
és a DIN EN 45501 szabvány. ...onay belgesinde üretim türü ile ilgili açıklanan
TR üretim örneğine uygundur.
...atitinka aprašytų gamybos pavyzdžių kvalifikacijos Tartı, beyan edilen direktiflerinin geçerli koşullarını
LT patvirtinimą. büyük ölçüde yerine getirmektedir:
Svarstyklės atitinka svarbiausius taikomus reikalavi- Otomatik olmayan basküller hakkında 90/384/EWG
mus, apibrėžtus šioje direktyvoje: Tıbbi ürünler hakkında 93/42/EWG ve Avrupa Normu
neautomatinių svarstyklių direktyvos 90/384/EEB DIN EN 45501.
medicinos prietaisų direktyvos 93/42/EEB ir
Europos normos DIN EN 45501.
... atbilst izgatavošanas veida atļaujas apliecībā
LV norādītājam izgatavošanas paraugam.
Svari būtībā atbilst sekojošo direktīvu spēkā esošajām
prasībām:
90/384/EWG par manuāliem (neautomātiskiem
svariem)
93/42/EWG par medicīnas produkciju un Eiropas
normu DIN EN 45501.

Sönke Vogel
Geschäftsführer
seca gmbh & co. kg.
Hammer Steindamm 9-25
22089 Hamburg
Telefon: +49 40.200 000-0
Hamburg: September 2006 Telefax: +49 40.200 000-50

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