Gima 32696 Manuale del proprietario

32696
Gima
Marca
Gima
Modello
32696
Tipo
Manuale del proprietario

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1
BEDIENUNGSANLEITUNG
BLUTDRUCKMESSGERÄTE ANEROID
0124
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XXL Guarantee.
You have trusted in us
FOR 130 YEARS.
Thank you.
Trust must be earned. Through
continuity and sustainability.
As a fourth generation family
company, we at ERKA. stand
by our promise of „Quality Made
in Germany“. Those who choose
an ERKA. product are consciously
seeking the highest quality and
durability. We are convinced of
the quality of our products – as
demonstrated by the ERKA. XXL
Guarantee. Register your product
up to 4 weeks after your purchase
at www.myerka.de and get an
additional warranty of up to five
years – free of charge. NO IFS OR
BUTS.
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XXL Garantie.
Sie vertrauen auf uns
SEIT 130 JAHREN.
Vielen Dank.
Vertrauen muss man sich
erarbeiten. Durch Kontinuität und
Nachhaltigkeit. Als
Familienunternehmen in der
vierten Generation stehen wir bei
ERKA. zu unserem Versprechen
Qualität „Made in Germany“. Wer
sich für ein ERKA. Produkt
entscheidet, sucht bewusst
höchste Qualität und
Langlebigkeit. Wir sind von der
Qualität unserer Produkte
überzeugt –
das beweist die ERKA. XXL
Garantie. Registrieren Sie Ihr
Produkt nach dem Kauf unter
www.myerka.de und sichern Sie
sich eine zusätzliche Garantiezeit
von bis zu fünf Jahren – zum
Nulltarif. OHNE WENN UND ABER.
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3
360° SERVICE
Global expertise
from a single source
Do you have any questions about
our products, their use or
maintenance?
For all your needs concerning
ERKA. products and services, our
expert ERKA. Service Team is
happy to provide advice and
support at the following phone
number +49 8041 8009-0.
or by E-mail to [email protected].
*Our telephone consultation
service can be reached on
weekdays between 8:00 a.m. and
5:00 p.m.
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360° SERVICE
globale Kompetenz
aus einer Hand
Sie haben Fragen zu einem unserer
Produkte,
zu dessen Anwendung oder
Instandhaltung?
Von A wie Auftragserteilung bis Z
wie Zertifiziert nach DIN EN ISO
13485 - unser kompetentes ERKA.-
Serviceteam berät und unterstützt
Sie gerne persönlich unter der
Rufnummer +49 8041 8009-0*
oder per E-mail an [email protected].
*Unsere Telefonberatung ist für Sie
werktags von 08:00 bis 17:00 Uhr
erreichbar.
4
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USER MANUAL
ANEROID SPHYGMOMANOMETERS
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Register your device at
www.myerka.de
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EXPLANATION OF SYMBOLS I LÉGENDE I
ERKLÄRUNG DER SYMBOLE I EXPLICACIÓN DE SÍMBOLOS I
SPIEGAZIONE DEI SIMBOLI:
Please pay attention to the accompanying User Manual.
Veuillez lire le mode d‘emploi ci-joint.
Bitte beiliegende Bedienungsanleitung beachten.
Por favor, tenga en cuenta el manual de instrucciones adjunto.
Si prega di osservare le allegate istruzioni per l‘uso.
This product complies with the Council Directive 93/42/EEC
concerning medical devices
Ce produit est en conformité avec la directive 93/42/CEE
du Conseil pour les dispositifs médicaux
Dieses Produkt entspricht der Richtlinie 93/42/EWG
des Rates über Medizinprodukte
Este producto se corresponde con la directiva 93/42/CEE
del Consejo relativa a productos sanitarios.
Questo prodotto è conforme alla Direttiva 93/42/CEE
del Consiglio in materia di prodotti medicali.
Serial number
You will nd the serial numbers of our devices on the front or on the back side of
the device. The rst two digits correspond to the year of production.
Numéro de série
Vous trouverez les numéros de série de nos appareils à l‘avant ou à l‘arrière de
l‘appareil. Les deux premiers chires correspondent à l‘année de production.
Seriennummer
Die Seriennummern unserer Geräte nden sie entweder auf der Skala oder auf der
Geräterückseite. Die ersten beiden Ziern geben das Herstellungsjahr wieder.
Número de serie
Encontrará los números de serie de nuestros dispositivos en la parte anterior o en la parte
posterior del dispositivo. Los primeros dos dígitos corresponden al año de producción.
Numero di serie
Troverete i numeri di serie dei nostri dispositivi sul lato anteriore o sul retro del dispositivo.
Le prime due cifre corrispondono all‘anno di produzione.
Latex free
Sans latex
Latexfrei
Libre de látex
Privo di lattice
PVC free
Sans PVC
PVC-frei
Libre de PVC
Privo di PVC
DEHP free
Sans DEHP
DEHP-frei
Libre de DEHP
Senza DEHP
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EXPLANATION OF SYMBOLS I LÉGENDE I
ERKLÄRUNG DER SYMBOLE I EXPLICACIÓN DE SÍMBOLOS I
SPIEGAZIONE DEI SIMBOLI:
Catalogue number
Numéro de catalogue
Katalognummer
Número de catálogo
Numero di catalogo
Caution
Attention
Achtung
Atención
Attenzione
Fragile: Handle with care!
Fragile,
à manipuler avec précaution
Zerbrechlich,
mit Sorgfalt handhaben
Frágil, manipular con cuidado
Fragile, manipolare con cura
Temperature threshold
Limite de température
Temperaturbegrenzung
Limitación de la temperatura
Limitazione della temperatura
LOT number
Thanks to the lot numbers on the bladders the products can be traced.
Número de lote
La traçabilité est assurée par le biais du numéro de lot sur les poches.
LOT Nummer
Die LOT Nummer ist auf den eingezogenen Blasen der Manschetten zu nden
und dient zur Nachverfolgbarkeit
Lot numéro
Los números de lote en las cámaras de aire sirven para asegurar la trazabilidad
de los productos.
Numero di lotto
Grazie al numero di lotto sulle camere d’aria i prodotti possono essere rintracciati.
Manufacturer
Fabricant
Hersteller
Fabricante
Produttore
Store in a dry place
À stocker dans un endroit sec
Trocken aufbewahren
Conservar en seco
Conservare in luogo asciutto
Humidity threshold
Limite d‘humidité de l‘air
Luftfeuchte Begrenzung
Limitación de la humedad
del aire
Limitazione umidità dell‘aria
Limb circumference, length,
width
Circonférence du bras/
de la jambe, longueur, largeur
Extremitäten Umfang
Spannung, Bereich, Weite
Circunferencia del brazo/
de la pierna, longitud, anchura
Circonferenza del braccio/
della gamba, lunghezza,
larghezza
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USER MANUAL
ANEROID SPHYGMOMANOMETERS
1. IN GENERAL
Dear Customer,
With this blood pressure cu, you have purchased a quality product
from ERKA. We are delighted that you have expressed your condence in ERKA. qua-
lity and we thank you for doing so. We have a wide range of blood pressure cus in
various models. High quality materials that are suitable to the task guarantee optimal
operation. If you have questions regarding the right choice or the operating of your
blood pressure cu,
you can direct them to [email protected]. We would be happy to help you.
Please read this user’s manual before use carefully and thoroughly and
follow the instructions for maintenance and keep the manual for further
use. Important for home users: Consult your doctor at regular intervals. He
will tell you your individual values for normal blood pressure, as well as the
value at which the level of the blood pressure is considered hazardous.
2. PRODUCT DESCRIPTION
PURPOSE
The aneroid sphygmomanometers of ERKA. are used for measuring blood
pressure as per the method of auscultation of measurement on healthy skin
on the upper arm and/or on the thigh.
MEASURING RANGE
The reading scale has a measurement of 0 - 300 mmHg. The accuracy of
measurement is +/- 3 mmHg over the entire measuring range.
TABLE OF CONTENTS:
1. In General
2. Product description
3. Implementation of the
measurement
4. Selection of the cu size
5. Important information
6. Maintenance and care
7. Warranty
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MEASURING RANGE
The reading scale has a measurement of 0 - 300 mmHg. The accuracy
of measurement is +/- 3 mmHg over the entire measuring range.
SIDE EFFECTS
No side eects are known so far.
BLOOD PRESSURE MONITORS
VARIO
Sphygmomanometer with a very large scale (140 mm) for optimum
readability. In addition to the model as a desktop device, the Vario also
that complies with all the requirements of modern medicine as a rail unit,
wall-mounted or stand-mounted device.
PERFECT ANEROID Ø 48 MM
The reference in precision and durability with membrane-friendly dual
tube technology.
PERFECT ANEROID Ø 56 MM
The reference in precision and durability with membrane-friendly dual
tube technology with extra large scale.
PERFECT ANEROID CLINIC MODEL Ø 48 MM
Specially developed for the sometimes hectic daily hospital routine with
protective cap for pressure gauge.
PERFECT ANEROID CLINIC MODEL Ø 56 MM
Especially for the sometimes hectic daily hospital routine with protective
cap for pressure gauge designed with extra large scale.
PROFI Ø 48 MM
Precision instrument with membrane-friendly dual-tube technology.
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PROFI Ø 56 MM
Precision instrument with membrane-friendly dual tube-technology and
extra large scale.
PROFESSIONAL CLINIC MODEL Ø 48 MM
Precision instrument with membrane-friendly dual tube technology and
cap, specically for the needs of the day-to-day routine at the hospital.
KOBOLD Ø 48 MM
Robust and reliable measurement instrument for the professional user with
single tube technology. The special hardened copper-beryllium dia-
phragm for long life with consistently high precision.
KOBOLD SMART Ø 48 MM
The innovative Smart concept with single tube technology for 100%
hygiene in dealing with patients.
SWITCH 2.0 COMFORT Ø 56 MM
Functional and convincing in daily use. Meets the requirements for use in
an MR space. Sparing resources by changing quickly within seconds of
the load cell by the user on site.
SWITCH 2.0 SMART Ø 56 MM
Flexible and in function, the SMART SWITCH 2.0 can be transformed
with a movement from a right-handed to a left0handed device. Meets the
requirements for use in an MR space.
SWITCH 2.0 SIMPLEX Ø 56 MM
Maximum innovation characterizes this instrument. Fast and intuitive
change of the load cell to be carried out by the user.
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OVERVIEW OF DEVICES AND CUFFS
Green Cu Superb Rapid, 2 separate tubes
VARIO Green Cu Superb Haken, 2 separate tubes
Classic Rapid, 2 separate tubes
Green Cu Superb Rapid, Double tube
PERFEKT ANEROID Green Cu Superb Haken, Double tube
Classic Rapid, Double tube
Green Cu Superb Rapid, Double tube
PROFI Green Cu Superb Haken, Double tube
Classic Rapid, Double tube
Green Cu Superb Rapid, 1 tube
KOBOLD Green Cu Superb Haken, 1 tube
Classic Rapid, 1 tube
KOBOLD SMART Green Cu Smart Rapid, 1 tube
Green Cu Superb Rapid, 1 tube
SWITCH 2.0 COMFORT Green Cu Superb Haken, 1 tube
Classic Rapid, 1 tube
SWITCH 2.0 SMART Green Cu Smart Rapid, 1 tube
SWITCH 2.0 SIMPLEX Green Cu Superb D-Ring, 1 tube
ERKATEST Green Cu Superb D-Ring, Double toubulure
SWITCH 2.0 HOMECARE Green Cu Superb D-Ring, 1 tube
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3. PUTTING ON THE CUFF
Select appropriate cu size for the extent of the extremities. The cu is applied in
such a way that the lower edge of the cu is found about.
2 to 3 cm above the crook of the arm o approx. 5 cm above the knee joint. Note
the marking for the location of the artery while doing so.
Do not wrap the cu too loose and not too tight around the limb and make sure
that the edge of the mark is within the permissible range. Close the valve of the air
release valve. With a few pumping of the fan of the ball, the necessary pressure
(ca. 30 mmHg above the systolic pressure to be expected) is created in the cu.
The valve is opened slowly and speed deation rate is measured out from 2 to
3 mmHg per second. With the aid of a stethoscope the Korotko ow sounds can
be auscultated. After the measurement is completed, open the valve for complete
deation of the cu.
TO ENSURE A CORRECT READING
Blood pressure measurement must be taken in sitting position.
Take a comfortable sitting position
Do not cross your legs
During the measurement, sit in a chair with your feet on the oor and
your back and arm supported
Make sure the middle of the cu is placed at the level of the right atrium
For measurement in seating position: Be calm. Sit quietly for ve minutes
before the test begins. Your arm should rest on a table. Be still during the
measurement: do not move and do not speak, otherwise measurement
results will not be correct.
RECCOMENDATIONS ON AUSCULTATORY METHOD OF
MEASURING BLOOD PRESSURE:
Adults, mode V (K5)
Children from 3 to 12 years old, mode IV (K4)
Pregnant women - mode V (K5), except those cases where some sounds
appear as the blood pressure cu is deated in this case the mode IV (K4)
of the Korotko sounds must be used.
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K5 is the point where the sounds normally heard with the stethoscope
are no more audible.
K4 is the point where the sounds heard with the stethoscope change from
clear tapping sounds to dull sounds.
4. SELECTION OF THE CUFF SIZE
The following table provides information on the relevant Application:
Size 1 Infant 10.0 to 15.0 cm Free of PVC, DEHP and
circumference latex
Size 2 Toddler 14.0 to 21.5 cm Free of PVC, DEHP and
circumference latex
Size 3 Adults 20.5 to 28.0 cm Free of PVC, DEHP and
Small circumference latex
Size 4 Grown-ups 27.0 to 35.0 cm Free of PVC, DEHP and
circumference latex
Size 5 Adults 34.0 to 43.0 cm Free of PVC, DEHP and
Large circumference latex
Size 6 Thigh 42.0 to 54.0 cm Free of PVC, DEHP and
circumference latex
5. IMPORTANT INFORMATION
Check the aneroid sphygmomanometers before each use as to its proper
function. Do not use this product when it shows visible damage.
The Medical Products Operator Ordinance is applicable for Germany
It is a preventive healthcare measure, it doesn´t substitute the regular
monitoring of the blood pressure by healthcare professionals
The interpretation of the results of the measurement should only be
done by qualied persons
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Do not pump up the manometer above 300 mmHg by any means
Infants have a lower blood pressure than adults, do not pump too
strong
The measurement time should not exceed two minutes
The cu should be used with hygiene protective strips or cleaned
before it is used for the next patient
The products should not be placed in a strong magnetic eld (except
SWITCH 2.0 and SWITCH 2.0 SMART) and used, such as: MRI
Avoid using your device outdoors or in an ambulance
Only use original ERKA spare parts
Avoid unnecessary vibrations of the instrument
Avoid damaging the rubber parts with sharp or pointed objects
Changes to the device are not permitted
DISPOSAL
The devices must be disposed of in accordance with the regulations in force
in your country.
SWITCH 2.0: EXCHANGE OF MANOMETER HEAD
1.
4.
2.
5.
3.
6.
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1. 2.
SWITCH 2.0: ADJUSTMENT FOR LEFTHANDER OR RIGHTHANDER
MR SUITABILITY OF THE SWITCH 2.0 COMFORT
AND SWITCH 2.0 SMART
In combination with the Rapid cus, the manometer was tested for operational
capability in magnetic resonance space (MR) according to the requirement of
ASTM F2052 - 06e1 (Standard Test Method For Measurement Of Magnetically
Induced Displacement Force on Medical Devices
In Magnetic Resonance Environment). Both the functionality requirements,
as well as electromagnetic attractive force were in an area lled with
3 Tesla. This is indicated by the marking „MR Conditional“ on the scale
CALIBRATION
On the back of the manometer, there is a square sticker with the words „MTK“ and
the „year specication“, in which the next calibration of the instrument is required.
The metrological control (MTK) must be performed every 2 years, according to the
latest Medical Devices Operator Ordinance (MPBetreibV). This can be done by the
manufacturer or authorized maintenance services.
You can contact the ERKA. service team at +49 8041 8009-0 or by email to
ser[email protected]g.
Even for private use, we recommend that you perform a metrological check in
2-year intervals through the company ERKA.
Please note that instead of MTK in the model SWITCH 2.0, the manometer head is
easily replaced by a new one. The manometers of SWITCH2.0 are not designed
for a readjustment.
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6. MAINTENANCE AND CARE
MANOMETER
The manometer is basically maintenance-free. We recommend that you use a damp
cotton or microber cloth netted with disinfectants, if necessary. Avoid the penetration
of liquids into the cabinet.
CUFFS
CARE Green Cu Green Cu Classic Cu
INSTRUCTIONS Superb Smart
Rapid Rapid Rapid
Hook Rapid
D-Ring one piece
Home
WASHING After removing After removing After removing
the bladder up the bladder up the bladder up
to 30° C mild to 30° C mild to 90° C mild
detergent detergent detergent
(not Green Cu
Smart Rapid
one piece)
Fold covers with Rapid stopper before washing, so that the
Velcro tape and the hook tape are closed to each other.
CLEANING BY SPRAY DISINFECTANT OR WIPE DISINFECTANT
We recommend the following cleaning agents and disinfectants:
Mild Soap, Bacillol AF, Meliseptol, Oxivir Plus Spray, Terralin Protect
70% isopropyl alcohol, Fugaten® Spray (Lysoform-Spray)
After cleaning/disinfecting, wipe with clean water to remove any residue and allow to
air dry. Please only use soft cotton or microber cloths.
Never use autoclaving!
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ENVIRONMENTAL CONDITIONS
Optimal is a storage/use at temperatures between 0° C and +40° C
and a relative humidity of less than 85%.
Do not expose the cu and the appliance directly to direct UV irradia-
tion, this is particularly applicable for all plastic parts.
7. XXL-WARRANT Y
Those who opt for a ERKA. product, is deliberately seeking the highest
quality and durability. We are condent in the quality of our products -
as demonstrated by the ERKA. XXL Warranty! Register your product after
purchase and ensure an additional warranty period of up to 5 years,
apart from the statutory warranty of 2 years - at no cost. An overview
about the warranty periods for dierent blood pressure monitors on
our homepage. Each aneroid sphygmomanometer is provided with a unique serial
number on the chest piece and should be appropriately registered on our website
www.myerka.de.
At our discretion, we shall remove all defects, which refer to the material
or manufacturing defects by repairing or exchanging the device free of
charge. Parts that have undergone wear and tear as well as damages
due to improper treatment/handling are exempted from the warranty.
The warranty expires for interventions that were not performed by autho-
rized service partners, as well as while using replacement parts that are
not from ERKA. With proper care, there can be a usage far beyond the
warranty period.
If you have any questions, one of our friendly sta will be happy to help you at
+49 8041 8009-0.
In the event of a warranty claim, please send the complete device with
your purchase receipt.
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NOTES I NOTES I NOTIZEN
I NOTAS I NOTITIAS:
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Date / Stand: 06/2021
www.myerka.de
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Gima 32696 Manuale del proprietario

32696
Gima
Marca
Gima
Modello
32696
Tipo
Manuale del proprietario
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