trophon® EPR Operation Training Guide ENG

Operation Training Guide How to

CLEAN D ISINFECT STORE

an endocavitary or a surface u ltrasound probe

Operation Training Guide This training guide is designed to help you ensure you are across all operation aspects when using trophon® EPR for the first time.

This training guide is to be read in conjunction with the trophon® EPR Training video.

Please note there is a video to demonstrate how to reprocess an endocavitary ultrasound probe and a surface ultrasound probe.

Complete the quiz after watching the video and reviewing this guide.

1. trophon EPR Operation

1.1 Watch the trophon EPR training video (if not previously completed). This will take approximately 5 minutes.

1.2

BK Medical

Complete and pass the online trophon EPR quiz.

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8811

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8816 8818

8819

8822

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8820e

8824

Esao te AC2541

CA123

IOT332

LA533

SB2C41

SP2430

AL2442

CA430

IOT342

PA023

SC3123

SP2442

BC431

CA431

LA332

PA121

SE3123

BC441 BE1123 BL433 CA1123

CA541 CA631 EC1123 EC123

LA424 LA435 LA522 LA532

PA122 PA220 PA230 PA240

SL1543 SL2325 SL3235 SL3332

GE

1.3 Check the trophon EPR Validated Probes List at your local Nanosonics/trophon website, under the trophon menu/trophon Probe compatibility.

A hard copy of the list can be downloaded.

http://www3.gehealthcare.com/en/Products/Categories/Ultrasound/Ultrasound_Probes#tabs/tab6CA9FAEDA44545338871 10BB6E5CA68C

10L 10LB 10Lb-RS 11L 11L-D 12L 12L-RS 12L-SC 12S-D 12S-RS 2.5FPA

4C-A 4C-D 4C-RS 4C-SC 4D10L 4D16L 4D3C-L 4D5C-L 4D8C 4DE7C 4S

9L-D 9L-RS AB2-5 AB2-7 AB2-7-D AB2-7-RS AB4-8 AC2-5 BE9C BE9CS C1-5-D

3.5C

4V-D

C1-5-RS

3.5C gray lens 3.5CS 348C gray lens 3C 3C-RS 3Cb 3CRF 3CRF-D 3S 3S-02 3S-D 3S-LC 3S-RC 3S-RS 3S-SC

546L 5C 5CS 5S 5S-02 5S-LC 5S-RS 6S 6S-D 6S-RS 739L 7L 7S 7S-02 7S-RS

C1-6-D C2-5-RC C2-9-D C31 C358 C36 C364 C386 C4-8-D C55 C551 C721 CAE CBF CS

E8CS E8CS-RC E8CS-SC ERB ERB7 G3S i12L i12L-RS I739 I739-RS IC5-9 IC5-9-D

M12L RAM3-8 M12L-HTROPHON EPR RIC5-9 Validated Ultrasound Probes M12L-MIH RIC5-9-D M3S RIC5-9-RS M4S RIC5-9H M4S-D RIC5-9W M4S-RS RIC5-9W-RS M5Sc-D RIC6-12-D M6C RM14L M7C RM6C M7C-H RNA5-9 ML6-15 RNA5-9-D ®

The following probes have been approved for use with the trophon EPR following extensive compatibility testing performed in conjunction with the Original Equipment Manufacturers (OEMs). Approved probes are listed by brand and then by model number below.

A new Probe Cable Clamp (“T-Clamp”) has been developed to fit Ultrasound Probe cables ranging from Ø5mm to Ø11mm. Refer to Figure 1.

This design will enable the use of smaller cable Ultrasound probes with the trophon EPR. The trophon EPR with Serial Numbers beginning 24100 or higher includes this new TClamp and can be identified visually by the T symbol as shown in Figure 1.

T Model types listed below with symbol are recommended for use with the new T–Clamp. Please contact your trophon EPR representative for further information.

CPP

IC5-9H IC5-9W-RS L3-12-D L39 L4-12t-RS L546 L6-12-RC L6-12-RS L76 L764 L8-18i-D L8-18i-RS L8-18i-SC LA39 LB

ENGLISH

®

Figure 1

Special Conditions:

ML6-15-D ML6-15-RS MTZ MZ PA2-5 PA2-5P PA4-7 PA6-8 PA6-8-D PCW4.0 RAB2-5 RAB2-5-D RAB2-5-RS RAB2-5L RAB2-6-RS

RNA5-9RS RRE5 -10-D RRE6 -10 RRE6 -10-D RSM5-14 RSP5-12 RSP6-12 RSP6-16 RSP6-16-D RSP6-16-RS S220 S222 S316 S317 S611

Model types labelled with symbols have special conditions when used with the trophon EPR. Please take note of these special conditions when using these probes.

* Zonare (E9 -4): The trophon EPR is qualified for use with the E9-4 Transducer running software version 4.7.323L or higher on the z.one ultra Ultrasound System and all software versions on the ZS3 Ultrasound System. Running software versions prior to 4.7.323L on the z.one ultra after using the trophon EPR disinfection system can result in acoustic output levels exceeding FDA limits. Note: The software version on the z.one ultra can be verified by pressing the service key. ** Prosonic (L5-10/40EPN) : Only probes manufactured after December 30 2011 are compatible. ***

Ultrasonix (L14-5/38) : Only transducers with the serial number format TRA1.1-L145RP.xxx are compatible.

If uncertain, confirm with your Ultrasonix representative. #

Hitachi Aloka Medical: Only probes with serial numbers specified in brackets e.g. (M00621~) are compatible for use with the trophon EPR. CPP

trophon Curved Probe Positioner (CPP) is an accessory to the trophon EPR to improve the positioning of

CPP are recommended for use approved curved probes in the device chamber. Model types listed below with symbol with this new accessory. Refer to trophon CPP Instructions For Use for more information on setup and use.

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1.4

ENGLISH

Put gloves on.

Note: Wear gloves at all times when required as described in the trophon® EPR User Manual.

trophon ® EPR User Manual

trophon

®

EPR User Manual – N00020

L00033 1.0 03/2014

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1.5 Pre-clean the probe before the high level disinfection (HLD) cycle, following the probe manufacturer’s instructions.

TROPHON® EPR TECHNOLOGY: WHY PRE-CLEAN THE TRANSDUCER

X A pre-clean process is essential to ensure effectiveness of High Level Disinfection (HLD) process and should be done at POC immediately following ultrasound procedure to minimize cross contamination risk

1.6

Cleaning Process Step

Step

Step

Step

1

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3

4

Ensure the probe is clean and free of all visible debris, bioburden, gel or other soil.

S Check the probe manufacturer’s pre-clean instructions

Wear fresh gloves

Remove all excess gel from the transducers

Use single-use cloth, dampened in a mild, soapy solution or a detergent wipe to perform pre-cleaning

Step

Step

Step

Step

5

6

7

8

Wipe the transducer cord and all surfaces of the transducer until it is visually clean – use friction and work from cleanest to dirtiest sections

Dry the transducer with single-use cloth or wipe

Visually inspect the transducer to ensure it is both clean and dry prior to HLD

Dispose of soiled wipes/lint-free cloth, gloves and required PPE according to your facility guidelines

AIUM guidelines recommend probes be cleaned after each examination with soap and water or quaternar ammonium (a low-leve disinfectant) sprays or wipes.

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1.7 Dry the probe – ensure there is no visible moisture or drops of liquid on the probe.

1.8 Load the clean, dry probe into the trophon EPR disinfection chamber, ensuring: • Probe is secured high in the chamber with tip of probe above embossed line

No contact

• Probe does not contact the chamber wall at any point If you have a curved probe, check the trophon EPR Validated Probes List at your local Nanosonics/trophon website or download the list from the Nanosonics training site, to see if you need the CPP accessory.

1.9 Place a Chemical Indicator into the locator at the base of the chamber door, red side up.

Note: A new Chemical Indicator to be used for every cycle

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1.10 Close the chamber door and confirm whether the probe is both clean and dry.

• If yes, select “Yes” then press Start • If no, follow the LCD screen prompts

1.11 At the end of the seven minute HLD cycle, trophon EPR’s LCD screen states: CYCLE COMPLETE REMOVE AND WIPE PROBE.

1.12 Wear new gloves.

1.13 Open the chamber door.

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1.14 Remove CI, check CI colour against the colour chart on the CI box and discard.

Note: BOTH the CI and LCD screen must indicate a successful cycle for the probe to be ready for use. If either the CI or Trophon LCD screen indicates a fail, repeat the cycle.

1.15 Remove and wipe the probe using a dry, single use cloth.

1.16 Insert the probe into a trophon Clean Ultrasound Probe Cover and wrap the securing tie around the cable stain relief.

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1.17 Record the high level disinfection cycle on the log or printed sticker. Store the probe correctly for later use.

Disinfection / Sterilisation Requirements

Spaulding Classification

Procedure

What procedure will your probe be used for?

Probe may contact sterile tissue or blood

Probe may contact mucous membranes and non intact skin

Probe will only contact healthy, intact skin

Critical

Semi-Critical

Non-Critical

• Intraoperative procedure • Drainage • Biopsy • Needle guidance

Sterilise* or high level disinfection

• Transvaginal oocyte retrieval • Venous catheter placement • Vascular ablation

Intracavity • Transvaginal scan • Transrectal scan

High level disinfection

Surface ultrasound (broken skin) • Wound scanning • Burn evaluation

• Surface ultrasound (intact skin)

Low level disinfection or High level disinfection

PROBE IS TROPHONED AND READY FOR PROCEDURE * Critical probes should be sterilised, or can also be high level disinfected and used with a sterile sheath.1 1

utala WA, Weber DJ, HICPAC. Guideline for Disinfection and Sterilization in Healthcare Facilities. USA: Centers for Disease Control; R CDC 2008 (https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfectionguidelines.pdf)

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Notes: At the completion of a cycle, remove probe immediately to ensure faster warm-up times.

If probe remains in chamber, the trophon EPR will shut down heaters to ensure probe is protected. Therefore, warm-up times may be longer.

Sleep mode – to save power, trophon EPR will enter sleep mode after two hours of inactivity.

Purging the trophon EPR of disinfectant is required if the device is to be moved or if NanoNebulant®/Sonex-HL® has expired. This involves removal of all disinfectant from the system. Purging may be implemented manually via trophon LCD screen (if relocating or transporting trophon) or it may be prompted automatically (if NanoNebulant®/Sonex-HL® cartridge has expired).

Empty the waste drawer when prompted by the trophon EPR LCD screen.

Note: Wear gloves when handling the waste drawer.

Nanosonics Limited (Manufacturer)

Nanosonics Europe Limited (Distributor)

Nanosonics, Inc. (Distributor)

Nanosonics Europe GmbH (EU Representative)

14 Mars Road Lane Cove NSW 2066 Australia T +61 2 8063 1600 E info@nanosonics.com.au www.nanosonics.com.au

Unit 2, Linfit Court, Colliers Way Clayton West, Huddersfield HD8 9WL United Kingdom T +44 1484 860581 E ukinfo@nanosonics.co.uk www.nanosonics.co.uk

7205 E 87th Street Indianapolis, IN 46256 USA T 1-844-TROPHON 1-844-876-7466 E info@trophon.com www.nanosonics.us

Poppenbütteler Bogen 66 22399 Hamburg Germany T +49 40 46856885 E info@nanosonics.eu www.nanosonics.eu

© 2018 Nanosonics Limited. All rights reserved.

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