Warranty; Exemptions; Notification Of Adverse Events; Important Information - Mindray ZONARE z.one pro Instructions For Use Manual

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR ANY PARTICULAR PURPOSE.

Exemptions

Mindray's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the
improper use or application of the product or the use of parts or accessories not approved by
Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:

Malfunction or damage caused by improper use or man-made failure.

Malfunction or damage caused by unstable or out-of-range power input.

Malfunction or damage caused by force majeure such as fire and earthquake.

Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.

Malfunction of the instrument or part whose serial number is not legible enough.

Others not caused by instrument or part itself.

Notification of Adverse Events

As a health care provider, you may report the occurrence of certain events to SHENZHEN
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the
Member state in which the user and / or patient is established.
These events, include device-related death and serious injury or illness. In addition, as part of our
Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
requests to be notified of device failures or malfunctions. This information is required to ensure that
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only the highest quality
products.

Important Information

According to the conclusion of clinical evaluation and residual risk evaluation, for the intended patients,
there is no known side effects that can occur during or after the use of the medical device. And there is no
need for the operator to make extra preparations. Besides, the residual risks are disclosed in the
corresponding chapter of this manual as precautions or warnings.
V