1. Inspect the accessory. If it is damaged or broken, discard it. Otherwise, go to the next step.
2. Do not disconnect the accessory from any other part of the system. Use a lint-free cloth dampened (not dripping)
with deionized water to remove excess soil.
3. Dampen another lint-free cloth with the prepared enzymatic cleaning solution.
4. Gently clean the accessory. Ensure you remove all visible soil.
5. Repeat steps 3 and 4, using a swab or brush to access crevices or small areas.
6. Use a clean, lint-free cloth or swab, dampened (not dripping) with deionized water to remove any excessive
detergent residue.
7. Inspect for cleanliness. Repeat steps 3 through 6 until the surfaces are visibly clean.
8. Allow to dry completely.
9. Use a lint-free cloth to wipe the alcohol onto the accessory, thoroughly wetting the surfaces.
10. Keep wet 12 minutes.
11. Allow to air dry.
12. Inspect the accessory. If liquid has entered the accessory, if it is damaged or broken, or if soil remains visible,
discard it.
18 In the "Maintenance and Troubleshooting" chapter, in the "Cleaning, Disinfection, and Damage Inspection" section,
added the following subsection:
Universal Gating Interface Cleaning and Disinfection
CAUTION: Do not submerge, soak or immerse the device in liquid or damage may occur to the device.
The Universal Gating Interface should be cleaned via the hospital's cleaning and disinfecting policies for MRI
housekeeping surfaces.
19 In the "Maintenance and Troubleshooting" chapter, in the "Anesthetic Oxygen (O2) Sensor Depletion" section, in the
"Replacing the O2 Sensor" subsection, step 11 was changed to read:
11. Calibrate the O2 sensor by performing the following steps:
a.
Press the Setup key and then the Monitor key.
b.
On the Monitor Setup menu, select Service (Bio-Med).
c.
On the Service (Bio-Med) menu, select Service Utilities.
d.
Enter the service password and select the green check. For password information, your biomedical technician
should contact technical support.
e.
Select Gas Cal.
f.
On the Gas Cal menu, select O2 Cal.
g.
When prompted: Flow Room Air for 10 Seconds, Do you wish to continue? Select Yes to proceed.
20 In "Appendix A: Specifications," in the "General" section, the following ingress protection specification changes were
made:
SpO
w
and wECG Modules: Rated IP21. Protected against access to hazardous parts and the ingress of solid foreign
2
objects greater than 12.5mm (0.5 inch); and, protected against vertically dripping liquid.
MR400 Cart: Rated IP20. Protected against access to hazardous parts and the ingress of solid foreign objects greater
than 12.5mm (0.5 inch); not protected from liquid ingress.
WARNING: The MR400 cart is not protected against liquid ingress. Do not allow liquid to enter the equipment. Don't
immerse any part of the equipment in liquid or pour liquid onto the equipment. Failure to do so could affect device
performance.
21 In "Appendix A: Specifications," in the "General" section, added the following note related to radio performance:
Expression Model MR400 MRI Patient Monitoring System, Instructions for Use Addendum
5
