KaWe MASTERMED A1 Instrucciones De Uso página 13

Dear Customer, thank you for choosing our innovative aneroid
blood pressure measuring device. Our products are known for
their high quality and longevity.
This KaWe product meets the requirements of the Standard
ISO 81060-1 and the Regulation (EU) 2017/745 (European
Medical Devices Regulation) and belongs to the medical
device class Im according to this Regulation.
Please read this User's Manual thoroughly
and completely before use and follow the
given application and care instructions.
1. Explanation of the symbols
Caution!
Follow the User's Manual
Temperature limits
Air humidity limit
For reuse on a single patient
No latex contained
Manufacturer & production date, if necessary
Production date
Item number
Batch description
Serial No.
Medical device
UDI data carrier
CE marking of conformity
Natural rubber latex contain
2. Application
This blood pressure measuring device and its accessories are
only to be used by physicians and trained professionals for
monitoring blood pressure.
3. Intended use
This device is intended for the non-invasive measurement of
systolic and diastolic blood pressure in humans.
4. Intended patient group
People with arm circumference of min 13.8 cm (infants) to
max 46 cm (large adults).
5. Contraindications
Any use other than described in the intended use shall be
deemed improper. The manufacturer shall not be liable for any
resulting damages. The user alone bears the risk.
6. Warnings and precautions
• When the cuff is not connected to the gauge, always use
a tube stopper to prevent accidental penetration of liquid.
The penetration of liquid into the tube may cause damage
to the gauge.
• The device must not be used in the area of strong magnetic
fields (MRI).
• Periodically inspect and replace damaged or used cuffs.
• Use only the appropriate size cuffs. The arterial pointer must
be in the marked area, otherwise the measurement readings
may be incorrect.
• Single-patient cuffs are intended for use only on one
single patient.
• Do not immerse the device in liquid to clean it.
• Do not sterilize the device.
• The blood pressure measuring device and the cuff must be
handled carefully and must not be exposed to sharp objects
(scissors, needles etc.) because they can damage the device
and the cuff.
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ENGLISH
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