Esophageal Probes (CFM) Reprocessing Instructions

Esophageal Probes (CFM) Levels of reprocessing requirements Depending on the application of the product and with regard to risk evaluation the user has to classify the medical device according to the current Medical Device Directive for processing of medical devices as non-critical, semi-critical or critical. Supporting information concerning this topic is listed in the following Table 1. The user is responsible for correct classification of the medical device.

Classification Non-critical

Semi-critical

Critical

Definition

Processing

Application part only contacts intact, not pathological altered skin

Cleaning Disinfection Cleaning

Application part contacts mucosa

Disinfection (disinfectant with bactericidal, fungicidal and virucidal effect)

(intracavitary application) Application part contacts intracorporeal tissue directly

Cleaning

(operative application)

Sterilization

Disinfection

Table 1: Classification prior reprocessing

Additional information The Instructions provided above have been validated by the medical device manufacturer as being capable of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the processing as actually performed using equipment, material and personnel in the processing facility achieve the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.

Containment and transportation Put the contaminated probe into exclusive shock and damage proof container for transportation. Instruments should be reprocessed as soon as possible, but not later than 4 hours after usage.

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Esophageal Probes (CFM) INSTRUCTIONS

Manual reprocessing by immersion procedure Pre-cleaning in the examination room (point of use) after application of the probe: Initially remove used optional parts like protective covers from the probe. Flush patient’s blood or fluid by tap water directly after use until the surface looks visually clean. Wipe the surfaces of the probe with patient contact by gauze pad and remove superficial visible impurities. Prepare following items before manual cleaning and disinfection: a)

Detergent: Cidezyme®/ENZOL® (Johnson & Johnson, #2258) or another cleaning agent with approved material compatibility for this medical device

b)

Disinfectant: Cidex® OPA (Johnson & Johnson, #20391) or another disinfectant with approved material compatibility for this medical device

c)

2 tanks, 1 for cleaning and 1 for disinfection - optional: 1 additional tank for rinsing with deionized/tap water (sufficient size for immersion of the submergible part of the probe at full length)

d)

Soft, fluff free cloth or single use towel

e)

Personal protective equipment (gloves, water repellent protective skirt, face protection mask or protective glasses, see also instructions of the manufacturer for the detergent and the disinfectant)

Cleaning: 1)

The temperature of the detergent solution should be between 15-30°C, concentration is 1.6%. Please note the minimum contact time of the detergent in the manufacturer’s instruction. If a differing detergent is used, please also note the approved material compatibility for the medical device.

2)

Immerge the submergible part of the probe (permitted depth of immersion has to be considered, see Figure) into the diluted detergent.

3)

Wipe the submergible part of the probe under the surface of the detergent solution with a single-use fluff free soft cloth to remove all visible soil. Be sure that all grooves of the probe are implemented during the cleaning process. Particular attention is required for the cleaning of the lock lever and adjusting knob of the probe. Every column of the adjusting part should be wiped with a soft cloth dipped with detergent solution to assure that no soil is left in the cavities of the handling part.

4)

Rinse the submergible part of the probe with running water (minimum tap water quality) for 1 minute.

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Esophageal Probes (CFM) (alternatively: suspend the submergible part of the probe in a tray filled with water (permitted depth of immersion has to be considered, minimum tap water quality, see Figure) for 5 minutes). 5)

Visually check the outer surface of the probe for cleanness. If necessary, use magnifying glass for visually check. If there is still soil visible, repeat all above steps.

Figure: Immerge the submergible part of the probe into water, detergent or disinfectant solution

Disinfection: 1)

It is recommended to test the concentration of disinfectant solution before each usage. The solution Cidex® OPA is ready for use and does not need to be diluted. Test strips to verify that the appropriate concentration of Cidex® OPA is correct are available by manufacturer. Test strips will indicate a concentration above the Minimum Effective Concentration (MEC). Please also note the expiration date of the test stripes. Temperature of disinfectant solution should be minimum 20°C. The minimum contact time is 5 minutes. If a different disinfectant is used, follow the manufacturer’s instructions. Please also consider the material compatibility for the medical device.

2)

Immerge the submergible part of the probe into the disinfectant (permitted depth of immersion has to be considered, see Figure). Set a clock to insure the recommended contact time is observed. Wipe the columns and cavities of the adjusting knob and the lock lever of the probe with a soft cloth dipped with disinfectant solution.

3)

Rinse the submergible part of the probe with running deionized water for 1 minute. (alternatively: suspend the submergible part of the probe in a tray filled with deionized water (permitted depth of immersion has to be considered, see Figure) for 5 minutes).

4)

Visually check the surface of the probe that there are no leavings of the disinfectant. If necessary, repeat the rinsing.

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Esophageal Probes (CFM) Drying: 1)

Wipe the probe with a single use, fluff free wipe or towel for removing moisture on the surface of the probe. Dry until no visible moisture is left. Dry the cavities and columns of the lock lever and the adjusting knob of the handling part carefully.

2)

If using natural drying, temperature range should be between 15-30°C for a minimum time of 4 hours.

Cable and connector Wipe the cable in 20 cm intervals with gauze dipped in ethyl alcohol or water and dry it after wiping. If the entire length of the cable is wiped at once, a part of the cable may be wrinkled. Always wipe the cable in 20 cm intervals. Clean the connector with gauze dipped in ethyl alcohol and dry it after cleaning.

Inspection, maintenance and testing Confirm following items: 1)

The correct function of mechanical moving parts.

2)

An efficient image performance of the monitor when the probe is connected to the ultrasound system.

3)

Look for cracks, scratches, or deformations on the surface of the probe tip, cable, and connector. Don’t use the probe in case of existing damage. Contact your local manufacturer’s service immediately.

Storage Store the probe in a cool, dust free and dry space to avoid high temperature, humidity, and direct sunlight.

Manufacturer contact Find your local contact under: https://www.fujifilm.com/hce

Manufacturer

European Representative

Importer

FUJIFILM Healthcare Corporation

FUJIFILM Healthcare Deutschland GmbH Otto-von-Guericke-Ring 3 65205 Wiesbaden, Germany

FUJIFILM Healthcare Europe Holding AG Sumpfstrasse 13 6312 Steinhausen, Switzerland

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