QRS Opti 24-hour ABPM, Руководство пользователя

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Warnings and Contraindications
Precautions for Use
This monitor is designed to perform in conformity with the description
contained in this manual when operated, maintained and repaired in
accordance with the instructions provided. The monitor should not be
modified in anyway. Ensure pressure compatibility to all patients. If any
abnormality occurs in the monitor, suspend the operation immediately
and disconnect it from the patient. If the monitor has been used or stored outside of its
acceptable range (see Specifications page), it may not meet performance specifications. If the
cuff fails to deflate, the patient should be instructed on its proper and safe removal.
DO NOT use in the presence of flammable anesthetics; this could cause an explosion.
DO NOT immerse the monitor in any fluid, place fluids on top, or attempt to clean the
unit with any liquid detergents or cleaning agents. This may cause an electrical hazard. If
accidental wetting occurs, please return to QRS (see Limited Warranty, page 21). Refer to
page 19, Maintaining and Cleaning the Opti ABP System, for care instructions.
DO NOT remove unit covers. The monitor does not contain any user serviceable
components.
DO NOT use the monitor if it has failed its diagnostic self test, or if it displays a greater
than zero pressure with no cuff attached. The values displayed by such a unit may be
inaccurate.
DO NOT use on neonates or children, and patients known to be readily susceptible to
bruising.
DO NOT attach the cuff to a limb being used for IV infusions or any other intravascular
access, therapy or an arterio-venous (A-V) shunt. The cuff inflation can temporarily block
blood flow, potentially causing harm to the patient.
CAUTION: Substitution of a component different from that supplied may result in
measurement error. Repairs should be undertaken only by personnel trained or authorized
by QRS.
CAUTION: If cuff fails to deflate within two and a half minutes, instruct the patient on
manual removal of cuff.
CAUTION: Check that operation of the unit does not result in prolonged impairment of
the circulation of the patient.
CAUTION: A compressed or kinked connection hose may cause continuous cuff
pressure resulting in blood flow interference and potentially harmful injury to the patient.
WARNING: Ensure batteries are inserted with the correct polarity. Improper installation is
a hazard.
WARNING: Too frequent measurements can cause injury to the patient due to blood
flow interference.
WARNING: The cuff should not be applied over a wound as this can cause further
injury.
WARNING: The cuff should not be placed on the arm on the side of a mastectomy. In
the case of a double mastectomy use the side of the least dominant arm.
WARNING: Pressurization of the cuff can temporarily cause loss of function of
simultaneously used monitoring equipment on the same limb.
Safety and E ff ectiveness Considerations
The following safety and effectiveness issues are to be considered
prior to the usage of the
Opti unit.
• This device is defibrillator protected.
NOTE: No precautions specific to the Opti are required during defibrillation,
and defibrillation discharge has no effect on the Opti .
• The monitor is intended for use following consultation and instruction by a
physician.
• The reliability of the device is dependent upon conformance with the operation
and service instructions, as detailed in this manual.
• This device has been designed for use on patients with normal sinus rhythms.
• The interpretation of blood pressure measurements should only be made by a
physician. The accuracy of any blood pressure recording may be affected by
the position of the subject, his or her physical condition, and use outside the
operating instructions detailed in this manual.
• Safety and effectiveness on pregnant women and neonates
have not been tested.
Disposal
This symbol indicates that the monitor contains materials (such
as electrical components) which are hazardous. Please return
to QRS for proper disposal.
Adverse Reactions
Allergic exanthema (symptomatic eruption) in the area of the cuff may result,
including the formation of urticaria (allergic reaction including raised edematous
patches of skin or mucous membranes and intense itching) caused by the fabric
material of the cuff.
Petechia (a minute reddish or purplish spot containing blood that appears in the
skin) formation or Rumple-Leede phenomenon (multiple petechia) on the forearm
following the application of the cuff, which may lead to Idiopathic thrombocytopenia
(spontaneous persistent decrease in the number of platelets associated with
hemorrhagic conditions) or phlebitis (inflammation of a vein) may be observed.
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