Medel Elite Manual Del Usuario página 19

EN
Temperature : +5°C to +40° C;
Operation Relative Humidity: 10 - 85% (non condensing, but not requiring a
conditions: water vapour partial pressure greater than 50 HPa)
Pressure: 80 to 105 kPa
Temperature : -20°C to +60°C ;
Transport/Storage Relative Humidity : < 95% (non condensing, at a water vapour
conditions: pressure up to 50 HPa)
Pressure: 80 to 105 kPa
Weight of main unit : 390 g (without batteries)
External dimensions: 171 X 131 X 62 mm
Applied part: Type BF applied part (cuff)
Protection against Internally powered ME equipment /adaptor class II
electric shock:
Potection against har- I
P22 : The first number 2: protected against solid foreign objects of 12,5
mful ingress of water or mm and greater. The second number: protected against vertically falling
particulate matter:
water drops when enclosure titled up to 15º vertically falling drops.
Mode of operation Continuous operation
Software version A7
NOTE:
Specifications are subject to change without prior notice.
Not intended to be sterilized.
Not for use in an OXYGEN RICH ENVIRONMENT.
ATTENTION!
• To avoid measurement errors, please avoid the condition of strong electromagnetic
field radiated interference signal or electrical fast transient/burst signal.
• This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS.
• Wireless communications equipment such as wireless home network devices, mo-
bile phones, cordless telephones and their base stations, walkie-talkies can affect
this equipment and should be kept at least a distance d away from the equipment.
The distance d is calculated by the 800 MHz to 2.5GHz column of Table 6 of IEC
60601-1-2:2007, as appropriate.
• If you have any problems with this device, such as setting up, maintaining or using,
please contact with SERVICE PERSONNEL of MEDEL. Don't open or repair the
device by yourself. This device must only be serviced, repaired and opened by
individuals at authorized sales centers.
• Please report to MEDEL if any unexpected operation or events occour.
• After drop/shock,etc., that may cause changes in the performance, please contact
with SERVICE PERSONNEL of MEDEL. Don't open or repair the device by yourself.
The use of heat and cold producing devices, such as electric heating blankets,
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heating pads or ice packs, may impair the performance of device and increase the
risk of injury to the patient.
ATTENTION!
• Keep the device out of the reach of children/pets to avoid inhalation or swallowing
of small parts.
• Be careful to strangulation due to cables and hoses, particularly due to excessive
length.
• Do not use the device if it is damaged in any way. The continuous use of a damaged
unit may cause injury, improper results, or serious danger.
• Please use ACCESSORIES and detachable parts specified /authorised by MANU-
FACTURER. Otherwise, it may cause damage to the unit or danger to the user/
patients.
• At least 30 min required of equipment to warm from the minimum storage tempe-
rature between uses until it is ready for intended use. At least 30 min required for
ME equipment to cool from the maximum storage temperature between uses until it
is ready for intended use.
• When not in use, store the device with adaptor in a dry room and protect it against
extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects
on the storage case.
• Do not use solvents to clean this device. Switch off the device and disconnect it from
the power supply. The device can be cleaned with a damp cloth. Use lukewarm
water and a non-abrasive liquid household cleaner (no abrasive, no alcohol content
solution).
• During using, the patient will contact with the cuff. The materials of the cuff have
been tested and found to comply with requirements of ISO 10993-5:2009 and ISO
10993-10:2010. It will not cause any potential sensization or irritation reaction.
• Warning: No servicing/maintenance while the ME equipment is in use.
• The patient is an intended operator. The patient can measure data and change
battery under normal circumstances and maintain the device and its accessories
according to the user manual.
• Adaptor is specified as a part of ME equipment.
• The plug/adaptor plug pins insulates the device from the main supply. Do not posi-
tion the device in a position where it is difficult to disconnect from the supply mains
to safely terminate operation of ME equipment.
• If the pressure of the cuff exceeds 40kPa (300mmHg), the unit will automatically
deflate. If the cuff don't deflate when its pressure exceeds 40kPa (300mmHg),
detach the cuff from the arm and press the O/I button to stop inflation.
• Before every use, check the device, do not use the device if it is damaged in any
way. The continuous use of a damaged unit may cause injury, improper results, or
serious danger.
• Warning: No modification of this equipment is allowed.
• Manufacturer will make available on request circuit diagrams, component parts
list etc.,.
• The operator shall not touch output of batteries/adaptor and the patient simulta-
neously.
• The user must check that the equipment does not have visible evidence of damage
that may affect patient safety or monitoring capability before use.
EN
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