Seca b40 User manual

seca b40/b41
seca b30/b31
seca b10/b11/b12
ANEROID
SPHYGMOMANOMETERS

USER MANUAL
ANEROID SPHYGMOMANOMETERS
2 •

English ..............................4–11
Français ............................12–17
Deutsch ............................18–23
Español ............................24–29
Suomi ..............................30–35
Polski ..............................36–41
• 3

Follow Instructions for Use.
Observer les consignes
du manuel de l’utilisateur.
Gebrauchsanweisung beachten.
Tener en cuenta las
instrucciones de uso.
Noudata käyttöohjetta.
Przestrzegać instrukcji obsługi.
Manufacturer
Fabricant
Hersteller
Fabricante
Valmistaja
Producent
Article number
Référence de l’article
Artikelnummer
Número de artículo
Tuotenumero
Numer artykułu
Serial number
Numéro de série
Seriennummer
Número de serie
Sarjanumero
Numer seryjny
Latex-free
Ne contient pas de latex
Latexfrei
Sin látex
Ei sisällä lateksia
Nie zawiera lateksu
Fragile: Handle with care!
Fragile, à manipuler avec
precaution
Zerbrechlich, mit Sorgfalt
handhaben
Frágil, manipular con cuidado
Helposti särkyvä,
käsiteltävä huolella
Delikatny instrument, zachować
ostrożność
Store in a dry place
À stocker dans un
endroit sec
Trocken aufbewahren
Conservar en seco
Säilytettävä kuivana
Przechowywać w suchym miejscu
Humidity threshold
Limite d’humidité de l’air
Luftfeuchte Begrenzung
Limitación de la humedad
del aire
Ilmankosteusrajoitus
Ograniczenie wilgotności
powietrza
Temperature threshold
Limite de température
Temperaturbegrenzung
Limitación de la temperatura
Lämpötilarajoitus
Ograniczenie temperatury
EXPLANATION OF SYMBOLS | LĖGENDE |
ERKLÄRUNG DER SYMBOLE | EXPLICACIŌN DE SİMBOLOS |
SYMBOLIEN SELITYKSET | OBJAŚNIENIE SYMBOLI:
4 •

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.
Tämä tuote vastaa neuvoston direktiiviä 93/42/ETY lääkintälaitteista.
Ten produkt spełnia wymogi dyrektywy Rady nr 93/42/EWG w sprawie
wyrobów medycznych.
„MR Conditional“ denotes suitability for use in a magnetic resonance (MR)
environment in accordance with requirements ASTM F2052 – 06e1 (Standard
Test Method For Measurement Of Magnetically Induced Displacement Force
On Medical Devices In Magnetic Resonance Environment).
“MR Conditional » certie l’aptitude à une utilisation dans les environnements
IRM (Imagerie par Résonance Magnétique), x Method For Measurement Of
Magnetically Induced Displacement Force On Medical Devices In Magnetic
Resonance Environment).
„MR Conditional“ kennzeichnet die Einsatzfähigkeit im Magnet-Resonanzraum
(MR) gemäß der Anforderung ASTM F2052 – 06e1 (Standard Test Method
For Measurement Of Magnetically Induced Displacement Force On Medical
Devices In Magnetic Resonance Environment).
„MR Conditional“ señaliza la aptitud para el uso en la sala de resonancia
magnética (RM) según la especicación ASTM F2052 – 06e1 (Standard Test
Method For Measurement Of Magnetically Induced Displacement Force On
Medical Devices In Magnetic Resonance Environment).
„MR Conditional“ ilmaisee tuotteen toimintakykyä magneettiresonanssitilassa
(MR) vaatimusten ASTM F2052 – 06e1 mukaan (Standard Test Method
For Measurement Of Magnetically Induced Displacement Force On Medical
Devices In Magnetic Resonance Environment).
Oznaczenie „MR Conditional“ oznacza możliwość stosowania w obszarze
badania rezonansu magnetycznego (MR) zgodnie z wymogami ASTM F2052
– 06e1 (Standard Test Method
For Measurement Of Magnetically Induced Displacement Force On Medical
Devices In Magnetic Resonance Environment).
• 5

TABLE OF CONTENTS
1. Description of device ..................................... 6
2. Safety precautions....................................... 7
3. Operation .............................................. 8
4. Hygiene treatment ....................................... 9
5. Servicing .............................................. 10
6. Disposal .............................................. 10
7. Warranty .............................................. 11
8. Declaration of conformity ................................ 11
1. DEVICE DESCRIPTION
1.1 Congratulations!
With this blood pressure measuring device, you have just purchased a precise
and simultaneously robust device.
seca has used its technical expertise in the service of health care for more than
170 years and, as a market leader, has always set standards worldwide with its
innovative developments.
1.2 Intended use
seca aneroid blood pressure measuring devices are used to measure blood
pressure by auscultation on healthy skin on the upper arm or thigh.
1.3 Measuring range
The read-o scale has a measuring range from 0 – 300 mmHg.
Measuring precision across the whole measuring range is +/- 3 mmHg.
1.4 Contraindications
No contraindications are known to date.
6 •

English
2. SAFETY PRECAUTIONS
2.1 Safety precautions in these Instructions for Use
CAUTION!
Identies a hazardous situation. If you fail to take note of this information,
minor to moderate injury may result.
NOTICE!
Indicates that the product may have been operated incorrectly. If you fail to
take note of this information, the device may be damaged or the measured
results may be incorrect.
NOTE
Additional information on how to use this device.
2.2 Basic safety precautions on handling the device
• Please follow the precautions in these Instructions for Use.
• Keep the instructions for use in a safe place.
CAUTION! Avoiding injuries
• Young children have lower blood pressure than adults,
do not pump up excessively.
• Measuring time should not exceed 2 minutes.
• Either use the cu with protective hygiene strips or clean it
before using it on the next patient.
NOTICE!
• Check that the product is working perfectly before using it each time.
• Do not use the device if it is visibly damaged.
• Under no circumstances pump up the pressure gage beyond
300 mmHg.
• Except for the seca b11 and seca b12, the products may not be taken
into strong magnetic elds, for example MRI, and used there.
• Only use genuine seca spare parts.
• Avoid subjecting the device to shocks.
• Follow the care instructions.
• Avoid damaging the rubber parts with sharp or pointed objects.
• Do not expose the cu and the device to any direct UV radiation,
this applies to all plastic parts in particular.
NOTE
• Only qualied persons may interpret the measured results.
2.3 Important for domestic users
Consult your doctor regularly. He will let you know your individual normal blood
pressure values and the value above which your blood pressure level has to be
classied dangerous.
• 7

2.4 Ambient conditions
Ideal storage/use temperatures are between 0 °C and +40 °C with a relative
humidity of below 85%.
3. OPERATION
3.1 Selecting cu size
First select a suitably-sized cu for the circumference of the extremity. The table
below provides information about the relevant sphere of application.
Size 1 Infant 10.0 – 15.0 cm circumference Free from PVC, DEHP and latex
Size 2 Young child 14.0 – 21.5 cm circumference Free from PVC, DEHP and latex
Size 3 Adult/small 20.5 – 28.0 cm circumference Free from PVC, DEHP and latex
Size 4 Adult 27.0 – 35.0 cm circumference Free from PVC, DEHP and latex
Size 5 Adult/large 34.0 – 43.0 cm circumference Free from PVC, DEHP and latex
Size 6 Thigh 42.0 – 54.0 cm circumference Free from PVC, DEHP and latex
3.2 Performing a measurement
The cu is applied so that the lower edge of the cu is approx. 2 to 3 cm above
the elbow/approx. 5 cm above the knee joint. Note the marking for artery position
as you do this. Wind the cu around the extremity neither too loosely nor too
tightly, and ensure that the edge of the marking is within the permitted range. Close
the valve on the air drain screw. The pressure required (approx. 30 mmHg above
expected systolic pressure) is generated in the cu by pumping the ination bulb just
a few times. The valve is opened slowly and blow-o speed metered to 2 to 3 mmHg
per second. Using a stethoscope, it is now possible to auscultate Korotko sounds.
Once measurement is complete, open the valve to vent the cu completely.
NOTE
• Modication for left and right-handed use, seca b10, b11 and b12
1.
180°
2.
180°
8 •

English
• MR suitability of the seca b11 and b12
The seca b11 and b12 pressure gages were tested for suitability for use in a
magnetic resonance (MR) environment in combination with the cus and their
Velcro closures. Both the requirements on functionality and on electromagnetic
attractive force were met with a range using 3 Tesla. This is indicated by the
marking “MR Conditional” on the scale.
4. HYGIENE TREATMENT
4.1 Cleaning and caring for the pressure gage
NOTICE! Damage to device
Unsuitable cleaning agents and disinfectants may damage the sensitive
surfaces of the device.
• Do not use aggressive or abrasive cleaning agents.
• Do not use white spirit or petroleum spirit.
• Only use disinfectants suitable for sensitive surfaces. Suitable disinfectants
are available from specialist dealers.
• For cleaning, we recommend a damp cotton or microber cloth wetted
with disinfectant if appropriate.
• Prevent liquids from penetrating the housing.
4.2 Cleaning and caring for the cus
Care information for seca blood pressure cus with Velcro closure and D-ring:
NOTICE! Damage to device
Never autoclave the cus.
Washing Once the bladder has been removed, at up to 30 °C + detergent for delicates.
Fold covers with Velcro closures before washing so that the two halves of the
Velcro tape are in contact.
Cleaning by
spraying or
wiping with
disinfectant
We recommend the following cleaning products and disinfectants:
• mild soap
• Bacillol AF
• Meliseptol
• Oxivir Plus spray
• Terralin Protect
• 70%-strength isopropyl alcohol
• Fugaten®spray (Lysoform spray)
Following cleaning/disinfecting, wipe over with clean water to remove all residues
and then leave to air-dry. Please use only soft cotton or microber cloths.
• 9

5. SERVICING
5.1 Servicing the pressure gages
The pressure gage requires no servicing.
5.2 Calibration
seca recommends having the device recalibrated every two years. This can be
performed by seca Service or by authorized maintenance services. You can contact
the seca Service team at [email protected].
NOTE
• Please note that on the seca b10, b11 and b12 models, the head of the
pressure gage can be conveniently replaced with a new one instead of having
the metrological check [MTK] performed.
• The seca b10, b11 and b12 pressure gages are not designed to be calibrated.
• Replacing pressure gage head on seca b10, b11 and b12:
1.
90°
2. 3.
4. 5. 6.
90°
6. DISPOSAL
This device consists of high-quality raw materials which can be recycled. Dispose of
the device in accordance with the local laws and regulations applicable in your country.
10 •