300008312591
Rev A 10/2021
© 2021 Invivo Corporation All rights
Page 34
Instructions for Use dS HiRes Hand/Wrist 16ch
Disinfection is the process of eliminating or reducing harmful microorganisms from inanimate objects
and surfaces.
Spaulding classification
The appropriate treatment of medical devices should be based upon how a device is used. Levels of
processing are defined based upon whether a device comes in contact with intact skin, mucous
membranes, or is introduced into the sterile cavity of the body. The Spaulding Classifications are
defined as follows:
Critical
- Devices that are introduced directly into the bloodstream or which contact a normally
sterile tissue or body-space during use.
Semi-critical
- Devices that contact intact mucous membranes or non-intact skin.
Non-critical
- Instruments and other devices whose surfaces contact only intact skin and to not
penetrate it. Non-critical devices are such that do not directly contact the patient but may
become contaminated with microorganisms and organic soil during patient care (e.g., blood body
fluids).
The dS HiRes Hand/Wrist 16ch MRI coil and accessories are classified as Non-Critical Diagnostic Coil
devices and require intermediate or low-level disinfection for contact with intact skin.
Recommended cleaning agents
Cleaning should be performed using a neutral or near neutral pH detergent, especially in situations of
heavy contamination or where blood or bodily fluids are present. Use a detergent such as ENZOL®
Enzymatic Detergent, diluted in utility water (1oz ENZOL® per 1 gallon of water) at room temperature
(15°C-25°C or 59°F-77°F).
Recommended disinfection agents
Disinfection should be performed using one of the following disinfection agents:
Table 1
Disinfectant
Disinfection Level
Exposure Time
Temperature
Isopropanol 70%
Intermediate
1 minute
minimum
Room temperature
(15°C-25°C or 59°F-
77°F)
Ethanol 70%
Intermediate
1 minute
minimum
Room temperature
(15°C-25°C or 59°F-
77°F)
Chlorohexidine 0.5% in 70%
ethanol
Intermediate
2.5 minutes
minimum
Room temperature
(15°C-25°C or 59°F-
77°F)
1:200 Bleach solution (250 ppm
chlorine) (5ml household bleach
in 1 L water
Low
5 minutes
minimum
Room temperature
(15°C-25°C or 59°F-
77°F)