Warnings And Precautions - CardioQuip MCH-1000 Operators & Service Manual

Cardiopulmonary bypass temperature controller
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CardioQuip Modular Cooler-Heater Operator/Service Manual

Warnings and Precautions

WARNING: To avoid the risk of electrical shock, this equipment must only be connected to a supply
mains with protective earth.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the MCH.
Otherwise, degradation of the performance of this equipment could result.
Read this complete Operator's Manual before using this device.
No modification of this equipment is allowed.
Explosion Hazard. Do not use in the presence of flammable anesthetics.
Electric Shock Hazard. Access panels should be removed only by qualified service personnel.
Use a dedicated 20 Ampere AC "Hospital Grade" grounded (protectively earthed) outlet for the MCH.
This equipment is designed to function properly in the presence of radio frequencies typically
encountered in a hospital operating room environment. Some RF communications equipment can
affect medical electrical equipment. The operator should assure that this equipment functions properly
in the specific environment in which it will be used.
The MCH is not fully automatic. Monitoring of patient temperature and rate of temperature change
remains the responsibility of the operator.
If the unit is in an over-temperature condition and the emergency cool system is used, it is crucial that
the operator monitor the output water temperature.
It is the operator's responsibility to use and maintain this device according to the labels of the product,
accompanying instruction manuals, and any revisions of the labeling or instructions that may be
subsequently issued.
Proper surgical procedures and techniques are the responsibility of the operator.
The servicing of this unit should be performed by qualified medical equipment service personnel.
Improper repair can result in patient injury and/or damage to the system.
This device must not be connected to a heat exchanger or blanket with a manufacturer recommended
maximum pressure rating of less than 83 kPa (<12 psi). Rupture or leakage may occur in the heat
exchanger, resulting in patient injury and/or damage to the system.
This device must be disconnected from the power source before inspecting, cleaning or preparing this
device for use.
The MCH must be properly cleaned prior to operation or storage to prevent high microbial count or
residual chemicals that could cause equipment damage.
During clinical operations, do not drain equipment connected to the MCH. Draining attached
equipment will drain the entire heat exchanger network.
U.S. law restricts this device for sale to, or use by or on the order of, a licensed physician.
Do not operate the system with less than 4 inches (10cm) of water in the ice tank, or completely drain
the system while in an operating mode. Dry operation will cause equipment damage.
The cold water tank should remain covered to prevent debris from entering the system or water vapor
from escaping, and to minimize the loss of ice temperature.
Do not use acetone-based cleaning solutions to clean the unit. Acetone-based cleaning solutions will
cause equipment damage.
Use only Hospital-Approved Bactericidal Agents which are non-acidic and non-foaming. Operation
with unapproved agents may cause equipment damage.
Do not use sharp objects to adjust or select switches on the control panel.
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