L15 Ultrasound Imaging Probe Instructions for Use

1. Medistim L15 High-Frequency Ultrasound Imaging Probe The Medistim L15 High-Frequency Ultrasound Imaging Probe (L15 probe) provides high-resolution images for intraoperative surgical guidance and improved quality assessment. The probe is optimized to provide images in the extreme near field that allows the surgeon to assess morphology.

2. Intended Use The Medistim quality assessment systems with probes are designed to perform intraoperative guidance and quality control during surgical procedures and meet the demands for documentation of surgical procedures. To successfully operate the systems, at least two persons are required, one controlling the probe and the other controlling the system. Refer to the applicable Medistim System User Manual for indications for use statement and contraindications.

3. Safe reprocessing of the L15 probe The L15 probe is a reusable medical device and require reprocessing to make it ready for the next use. The L15 probe can follow one of two procedures for reprocessing. Option A consists of cleaning, optional disinfection, terminal sterilization, and storage. Option B consists of cleaning, disinfection, and storage. If this procedure is followed, the probe will not be sterile and must be used together with a sterile transducer cover.

The cleaning, disinfection and sterilization processes described in following sections have been validated to be effective. The safe use of the device is relying on the user’s ability to understand the associated risk factors and being able to remove the probe from use when non-acceptable degradation or damage are observed. The actual lifetime of the probe will be affected by how the product is handled, and gentle handling will extend the lifetime beyond the warranted number of reuses.

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3.1 Risk factors The L15 probe is designed to be used intraoperatively and to image directly on the heart. The main risk factors related to reprocessing of the device is continued disinfection and sterilization efficacy, continued biocompatibility, mechanical integrity, image quality and electrical safety. The next sections describe how the identified risk factors should be addressed by inspection and testing.

3.2 Inspection Mechanical integrity The mechanical integrity of the probe’s exterior is important for the safe use. Inspect both the scan head and probe cable for any cuts, cracks or sharp edges. Pay special attention to the seals between the probe cable and the scan-head and the glue-lines of the scan-head and ensure that these are intact. Also ensure that the seals and hinges of the seal-cap are intact.

Material degradation The patient contact materials of the probe are repeatedly exposed to chemicals and temperatures during reprocessing. Material degradation can occur during the washing, disinfection and sterilization processes. Signs of material degradation could be significant discoloring of the probe cable, changed surface structure (cracks, lines), or the surface of the probe cable getting sticky.

Image quality The main reasons for image quality degradation are loss of ultrasound elements in the transducer and overall reduction of transducer sensitivity. Loss of single transducer elements are normally not visible in the image. When multiple lost elements are close together this may lead to loss of sensitivity, resolution and contrast. Loss of sensitivity can be counteracted by increasing the gain setting available in the user interface.

Electrical safety The probe is designed to meet the requirements of a patient applied part type CF, ensuring very low electrical leakage current through the probe during use. To maintain this patient isolation throughout the life time of the probe, it is important to inspect the probe for damage to the probe’s exterior as described above. The probe’s exterior is validated to withstand 100 reprocessing cycles without the isolation being degraded. Once the probe has been used 100 times, the user is reminded by the system to do an electrical test as described in section 8 to ensure continued electrical safety. It is recommended to do periodical electrical test also prior to reaching 100 cycles. For more information, refer to the hospital’s rules for checking and maintaining other devices with CF and BF type applied parts such as endoscopes and TEE ultrasound probes.

4. Handling and guidance for safe use The purpose of this procedure is to guarantee that the probe performance is in accordance with the specifications during the entire life cycle of the probe. The probes are warranted against manufacturing defects for one year or 100 reprocessing cycles, whichever comes first. The L15 probe is a delicate high precision instrument and should be handled with care. Damage to the probe can compromise patient safety, reduce image quality, and cause measurement inaccuracies. A probe that is handled with care will last longer and perform better. Please note the following: • Do not stretch the cable. • Use care when coiling the probe cable and make sure it is laid in large loops. Avoid tight wrapping around the palm of the hand. © Medistim 2025

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• • • •

Use care when cleaning the probe. Clean the probe immediately after use so that blood does not dry on the probe surface. Use care and avoid cutting or pinching the cable with sharp tools. It is highly recommended that the probe’s original packaging or a suitable reprocessing tray is used during shipment, handling, and storage.

Note Probes with damage due to careless handling will not be covered by the warranty.

5. Cleaning Warning Cleaning must always be performed as the first step in the reprocessing. Attach the connector cap to make sure fluids do not enter the probe connector during reprocessing. Wear protective gloves when removing the probe from the sterile field and when cleaning, as it may be stained with blood.

5.1 Manual Pre-Cleaning Always perform the following pre-cleaning procedure before automatic disinfection described in section 6.1 1. Attach the connector cap and ensure the latches are locked on both sides. 2. Wipe the probe to remove excess soil. 3. Immerse the probe in a fresh, pH-neutral, enzymatic cleaning solution and soak for a minimum of fifteen (15) minutes as per the manufacturer’s instructions. 4. Use a soft-bristled brush moistened with cleaning solution to remove all traces of debris, being particularly thorough in the area of the probe head. 5. Thoroughly rinse the probe under warm (30 - 43°C) tap water for a minimum of one (1) minute and until visibly clean. For the validation of the process described above Tristel Pre Clean Wipes were used for step 2 and Prolystica x2 Concentrate Enzymatic prepared at 4ml/L was used for step 3 and 4. The procedure described above has been validated by the independent test lab 20/30 Labs Ltd®10 .

5.2 Manual Cleaning 1. Immerse the probe and soak for a minimum of five (5) minutes in a fresh, pH-neutral, enzymatic cleaning solution per the manufacturer’s instructions. 2. Use a soft-bristled brush moistened with cleaning solution to remove all traces of debris. 3. Pay close attention to crevices, matted surfaces, and any hard-to-reach areas. 4. Thoroughly rinse the probe under running warm (30-43°C) tap water until visibly clean. 5. Wipe the probe with 70% isopropyl alcohol (IPA) before the next step of reprocessing. 6. Check probe for any remaining debris and repeat cleaning procedure if necessary. Ensure that the probe is dry before proceeding with sterilization. The procedure described above has been validated by the independent test lab NAMSA®1 .

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5.3 Automatic Cleaning Automatic cleaning can be performed according to the following process or as part of the automatic cleaning and disinfection process described in Section 6.1. Always perform the following manual pre-cleaning procedure before using an automated washing machine: 1. After use, immerse the probe (not the connector) in a fresh, pH-neutral, enzymatic cleaning solution and soak for a minimum of five (5) minutes as per the manufacturer’s instructions. 2. Use a soft-bristled brush moistened with cleaning solution to remove all traces of debris, being particularly thorough in the area of the probe head. 3. Thoroughly rinse the probe under warm (30-45°C) running tap water for a minimum of one (1) minute and until visibly clean. The L15 probe can be cleaned in a low temperature automatic washing machine under the following conditions: Cycle phase

Time

Temperature

Prewash

2 minutes

Cold tap

Wash

10 minutes

60°C

Neutralize

2 minutes

60°C

Rinse 1

15 seconds

Hot or Heated

Rinse 2

2 minutes

Hot or Heated

Rinse 3

5 minutes

43.3°C

Thoroughly dry the probe with clean, dry lint-free wipes. The temperatures in this table represent the minimum values to ensure adequate cleaning. Using higher values will result in a more thorough process, but can also decrease the life expectancy of the probe. Specifically it is therefore not advised to exceed a temperature of 60°C for washing.

The process listed above has been validated by the independent test lab NAMSA using 0.5% Neodisher® 2 MediClean forte during washing, and Neodisher Z during neutralization.

6. Disinfection Disinfection can be performed as an intermediate stage in the reprocessing cycle with end stage sterilization or as end stage disinfection. If disinfection is an intermediate stage in the reprocessing cycle, continue with sterilization as described in section 7. If disinfection is the end stage of the reprocessing cycle, follow the hospital’s normal procedures for storing disinfected devices for use in the operating room. Disinfected reusable devices should be used immediately or stored in accordance with hospital protocols to minimize the risk of recontamination. Warning Damages due to use of disinfection agents that are not validated by Medistim are not covered by the warranty. For an updated list of disinfection agents visit the Medistim homepage: www.medistim.com.

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6.1 Automatic cleaning and disinfection The L15 probe can be disinfected in an endoscopic washer-disinfector compliant with ISO 15883-4. Always perform the Pre-Cleaning procedure as described in section 5.1 prior to disinfection in an endoscopic washer-disinfector.

Conditions when using an endoscopic washer-disinfector: Cycle phase

Time (minutes)

Temperature

Water Quality

Prewash

01:40

N/A

RO***

Wash

03:00

20-40°C - 40ml Detergent*

RO***

Rinse

02:15

N/A

RO***

Disinfect

05:00

20-40°C - 140ml Disinfectant**

RO***

Rinse

05:00

N/A

RO***

Air Purge

00:30

N/A

N/A

*Intercept Plus®11 was used as detergent during washing. **Rapicide®11 PA High-Level Disinfectant was used during disinfection stage. The active ingredient in this HLD is peracetic acid and the minimum recommended concentration in the use solution is 1000 ppm. ***RO=Reverse osmosis.

The process listed above has been validated by the independent test lab 20/30 Labs Ltd., UK10.

7. Sterilization The following list of validated sterilization alternatives is not exhaustive and other sterilization procedures have been validated by Medistim. Contact Medistim for further information. Warning Unlock the latches and remove the cap from the connector during sterilization. Only use sterilization techniques validated by Medistim. Using invalidated sterilization techniques may cause damage to the probes or incomplete sterilization. Steam autoclave sterilization will destroy the Medistim L15 Ultrasound Imaging Probe and is not covered by the warranty.

7.1 STERRAD® 3 Sterilization The L15 probe can be sterilized in the following STERRAD®3 systems: STERRAD System

Cycle

STERRAD 50

Standard*

STERRAD 100S

Short*

STERRAD 200

Short*

STERRAD NX

Standard

STERRAD 100NX

Standard

* Short cycle is the standard and the only cycle available in the US for STERRAD 100S and STERRAD 200.

The sterilization cycle involves the following steps: 1. Follow instructions for use for the Johnson & Johnson sterilization process to protect the probe

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from accidental damage during handling. 2. Clean and, if needed, disinfect the probe as described in Section 5 and 6 and dry thoroughly. 3. Remove cap from the connector. 4. Place the dry probe in a STERRAD instrument tray and double wrap tray in CSR wrap. 5. Place the instrument tray(s) in the sterilization chamber according to manufacturer’s loading instructions and close the chamber door. Start pre-programmed sterilization cycle per manufacturer’s instructions. The probe is ready for use after the sterilization is complete. The validation of an effective sterilization was tested by the independent test labs, NAMSA and HIGHPOWER4 using the process described above. For the validation, the probe was placed in an APTIMAX®5 instrument tray (20x30x5 cm). It is recommended to use the same, or similar standard tray during sterilization. Contact Medistim for further information.

7.2 V-PRO® 7 Sterilization The L15 probe can be sterilized in STERIS®6 V-PRO®7 systems. Validated systems and cycles: V-PRO System

Cycle(s)

V-PRO 1

Standard

V-PRO 1 Plus

Non Lumen

V-PRO maX

Non Lumen and Flexible

V-PRO 60

Non Lumen

The sterilization cycle involves the following steps: 1. Clean and, if needed, disinfect the probe as described in Section 5 and 6 and dry thoroughly. Place the dry probe in separate Tyvek®8 pouches. 2. Follow instructions for use for the sterilization process to ensure sterility and protect the probe from accidental damage. The validation of an effective sterilization was tested by the independent test labs, NAMSA and HIGHPOWER using the process described above. For the validation, the probe was placed in an APTIMAX instrument tray (20x30x5 cm). It is recommended to use the same, or similar standard tray during sterilization. Contact Medistim for further information.

7.3 Liquid Chemical Sterilization (LCS) The following liquid chemical sterilant processing systems have been validated: • SYSTEM 1E® 9 • SYSTEM 1® 9 • SYSTEM 1 EXPRESS®9 • SYSTEM 1 Plus® 9 The sterilization cycle involves the following steps: 1. Clean and, if needed, disinfect the probe as described in Section 5 and 6 before placing the probe in the sterilization tray. 2. Follow instructions for use for the sterilization process to ensure sterility and protect the probe from accidental damage. The validation of an effective sterilization using all versions of SYSTEM 1 was tested by the STERIS test lab using the process described above. © Medistim 2025

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7.4 Transducer covers The L15 probe can be used with a sterile transducer cover. For instructions on how to apply transducer covers, see the instructions provided with the covers. When applying a sterile cover, ensure that no air is trapped between the cover and the probe scanning surface as this will decrease image quality. Note Ensure that only sterile transducer covers indicated for the surgical application are used. In the United States of America, it is recommended to use transducer covers that have been market cleared. In Canada, use only licensed transducer covers. In Europe, transducer covers must be CEmarked. Cleaning and disinfection must be done in accordance with the instructions in Section 6.1 of this document when a sterile transducer cover is used. The use of sterile transducer covers does not change the requirements related to inspection of the probe after use or for retaining electrical safety as described in this document.

8. Electrical Leakage Current Test The Medistim L15 Ultrasound Imaging Probe has been validated to withstand 100 sterilization cycles without the electrical patient insulation being weakened. After 100 cycles, a manual electrical leakage current test is required for continued electrical safety. The system will alarm the operator when the probe needs to be tested. Next time the same probe is connected to the system, the operator will be asked to confirm that the probe has passed the test after last use. The test can be performed using an ultrasound probe electrical test system during disinfection of the probe after use, as illustrated in Figure 1 under Section 8.2. This test setup is identical to the test setup prescribed for the electrical test of trans-oesophageal ultrasound probes established as a standard procedure in the market.

8.1 Test Equipment for Electrical Leakage Current Testing A typical test system for electrical leakage currents of ultrasound probes includes the following items (See also Figure 1): • Soaking tray and liquid (0.9% saline solution or any conducting disinfection liquid such as CidexTM). • Adapter for the ultrasound probe being tested (see Table 2). • Dual electrode. • Test unit capable of setting up the correct voltages for the testing as well as checking the electrical conductivity of the liquid used for immersing the probe. Note If test equipment is already set up for trans-oesophageal probes, the same equipment can be used for testing the Medistim L15 Ultrasound Imaging Probe, provided the correct probe adapter is used: A 260 pin Tyco Electronics miniaturized connector, like the one used on GE LogiqBook platform and Philips Medical CX50 platform. (See also Table 2)

8.2 Test Procedure for the Medistim L15 High-Frequency Ultrasound Imaging Probe: 1. Measuring from the tip of the probe, submerge 250 mm length of the probes’ nosepiece and cable into the saline solution. 2. Connect the probe connector to the probe adapter of the test system. 3. Ensure that the fluid used in the soak tray has sufficient electrical conductivity for performing the test procedure. 4. Perform the probe leakage current test.

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Note Procedural details may vary depending on the type of test equipment used. Make sure you consult the test systems’ operator manual. Warning The test system must be set up and verified by qualified personnel from the Medical Technical Service Department according to individual hospital policy and regulations for safety testing.

250 mm

Figure 1 - Ultrasound probe electrical current leakage test setup. Medistim also recommends electrical safety test prior to 100 times use as part of the inspection procedure described in Section 3, as the integrity of the insulation material cannot always be confirmed by visual inspection alone. Probe adapter

The L15 probe is defined as patient applied part type CF (Cardiac Floating). The probe must meet patient leakage current requirements as provided in Table 1. The test system should be programmed accordingly. Patient applied part type

Allowed patient leakage current

Test voltage

CF

50μA

110% of the AC mains voltage

Table 1 - Patient leakage current requirements Type

Manufacturer

Web

Probe adapter for L15 Probe

ULT 800

Fluke Biomedical

www.flukebiomedical. com

Not available, compatible to ULTPA-25 (see below)

ULT-2000 series

BC Biomedical

www.bcgroupintl.com

ULT-PA-25

C-10

KMT Külzer Medizin Technik

www./k-m-t.com

System specifically intended for TEE probes. Use adapter for GE LogiqBook

Table 2 - Approved probe adapters

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Explanation of symbols on probe and package labeling:

2460

Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive 93/42/EEC.

Rx only

Refer to instruction manual

IPX7

Manufacturer

Protected against the effects of temporary immersion in water

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Shipped NON-STERILE

“N” number of probes in package

SN

Serial number

Date of Manufacture

REF

Catalog number

1

NAMSA® is a registered trademark.

2

Neodisher ® is a registered trademark of Chemische Fabrik Dr. Weigert GmbH & Co. KG, Hamburg.

3

STERRAD ® is a registered trademark of the company ASP (a Johnson & Johnson company).

4

HIGHPOWER Labs is an ISO 17025 accredited laboratory and is ASP factory trained to perform STERRAD ® functionality and efficacy validation testing.

5

APTIMAX® is a registered trademark of Advanced Sterilization Products (ASP).

6

STERIS ® is a registered trademark of the company STERIS Inc.

7

V-PRO ® is a registered trademark of the company STERIS Inc.

8

Tyvek® is a registered trademark of the company DuPont.

9

SYSTEM 1E® , SYSTEM 1® , SYSTEM 1 EXPRESS ® and SYSTEM 1 Plus ® are registered trademarks of the company STERIS Inc.

10

20/30 Labs Ltd is an ISO 17025 and UKAS accredited testing laboratory.

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Intercept Plus™ and Rapicide™ PA High-Level Disinfectant are registered trademark of Medivators, a subsidiary of Cantel Medical Corp.

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