Warranty
This Limited Warranty covers any defects in materials or workmanship under normal use during the Warranty Period. iProvèn will
either replace the product or repair the product at no charge, using new or refurbished replacement parts. The Warranty Period of this
iProvèn product is 2 years from the date of purchase. A replacement product or product part assumes the remaining warranty of the
original product purchase. This Limited Warranty does not cover batteries and packaging, nor any problem that is caused by conditions,
malfunctions, or damage not resulting from defects in material or workmanship.
To obtain warranty service, contact our customer support at www.iproven.com to determine the problem and the most
appropriate solution for your situation.
iProvèn owns and reserves the rights comprised in the copyright of this document. No part of this document may be changed, copied,
reproduced, or imitated in any form or by any means without prior written consent of iProvèn. All statements, information, and
recommendations in this document are provided “AS IS” without warranties, guarantees or representations of any kind, either express or
implied. The information in this document is subject to change without notice. iProvèn reserves the right of final interpretation of this
document.
DISTRIBUTED BY
NETDIRECT DISTRIBUTION, LLC
9360 Federal Blvd
Denver , CO 80260
Phone: 1-503-974-0913
HEADQUARTERS
Ebweg 12D
2991 LT Barendrecht
The Netherlands
Phone: +31 (0)84-8838876
CAUTIONS
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This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
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The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide.
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Warning: No servicing/maintenance while the ME equipment is in use.
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The patient is an intended operator.
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The patient can measure data under normal circumstances and maintain the device and its accessories according to the user manual.
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To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or
electrical fast transient/burst signal.
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The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment.
If you are allergic to polyester, nylon or plastic, please don’t use this device.
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During use, the patient will be in 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.
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Adaptor is specified as a part of ME EQUIPMENT.
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If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the START/STOP button to release the air immediately
from the cuff. Loosen the cuff and remove it from your arm.
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If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures reaches 40 kPa (300 mmHg),
detach the cuff from the arm and press the START/STOP button to stop inflation.
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Before use, make sure the device functions safely and is in proper working condition. 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.
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Do not wash the cuff in a washing machine or dishwasher!
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The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.
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It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in
limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
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Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.
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Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions,etc.,
to assist to service personnel in parts repair.
CAUTIONS
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The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from
the supply mains to safely terminate operation of ME equipment.
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The operator shall not touch output of batteries /adapter and the patient simultaneously.
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Cleaning :Dust environment may affect the performance of the unit. Please use the soft cloth to clean the whole unit before
and after use. Don’t use any abrasive or volatile cleaners.
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The device doesn’t need to be calibrated within two years of reliable service.
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If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL
of iProvèn. Don’t open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by
individuals at authorized sales/service centers.
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Please report to iProvèn if any unexpected operation or events occur.
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Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal.
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Be careful to strangulation due to cables and hoses, particularly due to excessive length.
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At least 30 min required for ME equipment to warm from the minimum storage temperature 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.
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This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;
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Wireless communications equipment such as wireless home network devices, mobile 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 caculated by the
MANUFACTURER from the 80 MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
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Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or
danger to the user/patients.
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There is no luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to
intravascular fluid systems, allowing air to be pumped into a blood vessel.
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Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be
impacted and reduced.
