Adverse Effects - Medtronic autoLog IQ Manual Del Usuario

Size: 7 x 9 in (178 x 229 mm)
any kinks, twists, or flat areas. Examine the pump head and wash kit to confirm that all components are placed in the proper flow
direction.
• The standard waste bag for the device holds approximately 10 L. Check the waste bag volume periodically and empty as
required. The waste bag may be emptied at any time; however, 100 mL to 200 mL of fluid should be left in the bag to provide for
proper expansion during filling and emptying. A full waste bag will cause back pressure, which may cause bowl leaks to occur.
• The device includes a centrifuge that rotates at 10,000 rpm. Parts that turn at high speeds may be dangerous. Follow safety rules
related to the use of centrifuges. Do not open the centrifuge or remove the bowl before the centrifuge has completely stopped.
• Failure to respond to unusual behavior of the device could result in blood contamination or spillage.
• Choosing to wash a partially filled bowl may result in low blood quality and low red cell volume.
• Do not invert the bowl when examining for clots, as this could lead to fluid leakage.
• Do not service the device or update the device's software during use.
• Do not move the device by holding the IV pole, as this action could damage the device or cause tipping.
• Use caution when transporting the device by vehicle. Do not expose the device to extremes of temperature, shock, or vibration.
• Do not modify the device.
• Contact your Medtronic service representative, or a biomedical equipment technician trained and certified by Medtronic, to
perform preventative maintenance and calibration of the device. Preventative maintenance and calibration should be performed
on an annual basis. Blood spillage, biohazard risk, low blood quality, slip hazard, and other concerns, could result if preventative
maintenance and calibration are not performed.
• Always turn off and unplug the device prior to working inside the cabinet or changing any fuses. Inside the cabinet are various
electrical components and wiring. Physical contact with any of these components while the device is plugged in could result in
severe electrical shock. For continued protection against risk of fire, replace fuses only with the same type and rating. Fuses
should be replaced by a Medtronic service representative or Medtronic-trained and certified biomedical equipment technician.
Internal grounding is provided for safety.
• Enclosure current leakage is a primary indicator of electrical shock hazard to personnel making contact with any exposed
portion of the equipment. Each device is tested during the final quality inspection to verify enclosure current leakage is less than
100 µA (under normal operating conditions) and less than 300 µA (under single-fault conditions). Ensure that the current
leakage is tested at least once a year, or more frequently as required, by the operating facility's biomedical engineering
department or other qualified service technician. In addition, always test the enclosure current leakage and insulation after an
event such as a fluid spill, after a major voltage surge in the power source has occurred, or after any device repair.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with a protective earth ground.
• The power cord may be used to disconnect the device from electrical power. Position the device and power cord so that the
power cord can easily be accessed and disconnected.
• Although this device has been verified for EMC compliance, the potential exists that, in some situations, this device and other
devices might electromagnetically interfere with each other. Take steps to minimize this possibility.
• The device should only be used in a hospital environment away from sources of high intensity EM disturbances, such as MRI
devices.
• The emissions characteristics of this device make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is
used in a residential environment (for which CISPR 11 class B is normally required) this device might not offer adequate
protection to radio frequency communication services. The user might need to take mitigation measures, such as relocating or
reorienting the device.
• Do not stack or attach additional instrumentation to the device to minimize the potential for RF interference.
• Use of this device with accessories, transducers, and cables other than those specified or provided by the manufacturer of this
device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in
improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used
no closer than 30 cm (12 in) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation
of the performance of this device could result.
• Power cord and USB cable length must not exceed 3 m (118 in).
• Do not touch a USB port and the patient at the same time.
• Use only a USB flash drive provided by Medtronic.
• Use appropriate personal protective equipment such as eye protection, mask, and gloves when cleaning the device and
discarding used fluids. Failure to do so could result in exposure to bloodborne pathogens, blood, and cleaning fluids.
• While cleaning the centrifuge, failure to correctly install the tray for fluid collection will lead to spillage.
• While cleaning the centrifuge, failure to add sufficient volume of a 10% bleach solution or equivalent disinfectant solution for a
sufficient duration can lead to ineffective cleaning.
• Do not use bleach to clean the touchscreen, as this could discolor the screen and result in failure.
• If it is suspected that fluid has entered the device, it should be immediately examined by a trained technician. Fluid ingress could
result in electric shock to the user.
• Clean and maintain the device in accordance with this manual and hospital procedures.

6 Adverse effects

Proper or improper use of a cell salvage device can lead to the following risks to the patient and user:
Patient:
• Death
• Excessive bleeding
M967226A006 1B Medtronic Confidential
11
502431-132
English
Composed: 2018-06-08 06:06:55
PSJ - Size-selectable package manual 02-MAY-2018