The MRI Patient Monitoring System provides monitoring for the following vital sign parameter: non-invasive blood
pressure.
Indications for Use
The NBP cuffs are indicated for use when non-invasive blood pressure monitoring of systolic, diastolic, and mean arterial
pressures is required during MRI procedures.
14 In the "Maintenance and Troubleshooting" chapter, in the "Cleaning, Disinfection, and Damage Inspection" section, in the
"Cleaning, Disinfecting, and Inspecting the Accessories" subsection, edited text to read as follows:
During the cleaning process, inspect the accessory for damage. The accessories are exposed to potentially damaging
situations during use and cleaning. Before each use, carefully inspect the accessories and packaging for the signs of
damage listed below.
Device lifetime is considered to end once the device shows signs of damage such as:
• Cracks, holes, tears, gouges, cuts, et cetera.
• Cracks or other signs of damage to the connector, including bent or damaged pins.
• Soil that cannot be removed following the cleaning instructions.
Disposable accessories must be discarded after each use.
15 In the "Maintenance and Troubleshooting" chapter, in the "Cleaning, Disinfection, and Damage Inspection" section, in the
"Cleaning, Disinfecting, and Inspecting the Accessories" subsection, edited the following warning:
WARNING: Cracks, tears, cuts and gouges interfere with standard cleaning procedures and therefore pose a potential
risk to patients and personnel. Before each use, carefully inspect the accessories and packaging for damage. If you see
any sign of damage to any accessory, immediately discontinue use
16 In the "Maintenance and Troubleshooting" chapter, in the "Cleaning, Disinfection, and Damage Inspection" section, in the
"Cleaning, Disinfecting, and Inspecting the Accessories" subsection, added the following caution statement:
CAUTION: To prevent fluid ingress, do not subject the accessory to automated cleaning.
17 In the "Maintenance and Troubleshooting" chapter, in the "Cleaning, Disinfection, and Damage Inspection" section,
added the following subsection:
Accessory Cleaning and Disinfection
This section applies to all reusable
accessory before use and between patients.
CAUTION: Do not submerge, soak or immerse the device in liquid, and do not allow liquid or soil to enter the device or
you may damage the device. Do not disconnect the accessory.
CAUTION: Clean and disinfect
Otherwise, exposure to hazardous chemicals may cause a skin reaction, and improper disinfection may cause infection.
Requirements:
• Enzymatic detergent cleaning solution
prepared according to the manufacturer's
instructions
• Deionized water
Procedure:
4
SpO
clips, ECG cables, and NBP cuffs and hoses. Clean and disinfect the
2
SpO
clips, ECG cables, and NBP cuffs and hoses according to this procedure.
2
Expression Model MR400 MRI Patient Monitoring System, Instructions for Use Addendum
• 70% isopropyl alcohol
• Lint-free cloths
• Soft-bristle brush or cotton swabs
