QuickFit TTFM and Vascular TTFM Probes Instructions for Use

1. Medistim Probes The Medistim Transit Time Flow Measurement (TTFM) Probes utilize ultrasound transit time to measure blood flow in patients’ vessels. In order to achieve optimal measurements, it is important to use an appropriately sized probe. The probe should have a snug fit but not compress, bend or twist the vessel. The probes are available in multiple sizes and can be delivered with and without handles in order to accommodate vessels for many types of procedures. Refer to the applicable Medistim Systems User Manual for a list of suggested probe sizes for the most common vessels. DISCLAIMER: The availability of the products described in this manual may vary from country to country.

1.1 Medistim QuickFit™ TTFM Probes (PS) Medistim QuickFit™ TTFM Probes are specifically designed to meet the requirements of CABG surgery. Cable

Cable

Connector Connector

Flexible Flexible neck neck

Handle Handle

Reflector Reflector

Illustration of PS probes

1.2 Medistim Vascular TTFM Probes (PV) The Vascular TTFM Probes are specifically designed to meet the requirements of vascular surgery.

Cable Cable

Lockingslide slide Locking

VIEW

Check part for:

Check part for:

Reflector Reflector

Connector Connector

Cable

Flexible Flexibleneck neck UNLESS OTHERWISE SPECIFIED:

DIMENSIONS ARE IN MILIMETER DRAWN TOLERANCES: NS-ISO 2768-1 FINE FRACTIONAL CHECKED ANGULAR: BEND UNLESS MACH OTHERWISE SPECIFIED:APPROVED TWO PLACE DECIMAL

SIGN

DATE

Knut Kristiansen

22.12.2014

Handle Handle

VIEW

THREE PLACE DECIMAL DIMENSIONS ARE IN MILIMETER

TOLERANCES: NS-ISO 2768-1 FINE

DRAWN

SIGN

DATE

Knut Kristiansen

22.12.2014 TITLE:

Illustration of PV probes BEND APPROVED TWO PLACE DECIMAL (Smaller sizes do not have locking slide) PQ & PS PROBES THREE PLACE DECIMAL INTERPRET GEOMETRIC FRACTIONAL TOLERANCING ANGULAR:PER: MACH

PROPRIETARY AND CONFIDENTIAL

THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF MEDISTIM ASA. ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF MEDISTIM ASA PROPRIETARY AND CONFIDENTIAL IS PROHIBITED.

INTERPRET GEOMETRIC TOLERANCING PER:

APPLICATION

DO NOT SCALE DRAWING

PROBE DIMENSION TABLE Dev.Dwg.No

REV

Prod.Dwg.No

105011

TITLE: A A4 Dev.Assy.No 104971 DIMENSION TABLE PROBE Prod.Part.No

W/ HANDLE ASSEMBLY COMMENTS:

FINISH

2. Intended Use

SIZE

COMMENTS:

MATERIAL

NEXT ASSY USED ON

CHECKED

SCALE: 1:2SIZE

Dev.Dwg.No

WEIGHT:

105011

SHEET 1 OF 1 Prod.Dwg.No

REV

PQ &probes PS PROBES A Prod.Part.No A4 Dev.Assy.No 104971 The Medistim quality assessment systems with intraoperative W/ HANDLE are designed to perform guidance and quality control during surgicalASSEMBLY procedures and meetSCALE: the 1:2 demands for documentation WEIGHT: SHEET 1 OF 1 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 Systems User Manual for indications for use statement and contraindications.

THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF MEDISTIM ASA. ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF MEDISTIM ASA IS PROHIBITED.

MATERIAL

NEXT ASSY USED ON

FINISH

APPLICATION

DO NOT SCALE DRAWING

Warning Never insert a wet connector theSPECIFIED: system as this could cause the system to malfunction. UNLESS to OTHERWISE

Check part for: Check part for:

VIEW VIEW

DIMENSIONS ARE IN MILIMETER DIMENSIONSNS-ISO ARE IN MILIMETER TOLERANCES: 2768-1 FINE TOLERANCES: NS-ISO 2768-1 FINE FRACTIONAL FRACTIONAL ANGULAR: MACH BEND ANGULAR: MACH BEND TWO PLACE DECIMAL TWOPLACE PLACEDECIMAL DECIMAL THREE THREE PLACE DECIMAL

INTERPRET GEOMETRIC INTERPRET GEOMETRIC TOLERANCING PER: TOLERANCING PER: MATERIAL MATERIAL

PROPRIETARY AND CONFIDENTIAL PROPRIETARY AND CONFIDENTIAL THE INFORMATION CONTAINED IN THIS THE INFORMATION IN THIS DRAWING IS THE SOLECONTAINED PROPERTY OF DRAWING IS THE SOLE PROPERTY OFIN MEDISTIM ASA. ANY REPRODUCTION MEDISTIM ANY WITHOUT REPRODUCTION IN PART OR AS ASA. A WHOLE THE PART OR AS A WHOLE WRITTEN PERMISSION OF WITHOUT MEDISTIM THE ASA PERMISSION OF MEDISTIM ASA IS WRITTEN PROHIBITED. IS PROHIBITED.

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UNLESS OTHERWISE SPECIFIED:

FINISH NEXT ASSY USED ON FINISH NEXT ASSY USED ON

APPLICATION APPLICATION

DO NOT SCALE DRAWING DO NOT SCALE DRAWING

SIGN SIGN

DRAWN DRAWN

DATE DATE

22.12.2014 Knut Kristiansen 22.12.2014 Knut Kristiansen

CHECKED CHECKED APPROVED Knut Kristiansen APPROVED Knut Kristiansen

COMMENTS: COMMENTS:

06.01.2015 06.01.2015

PV PVPROBES PROBES With WithHANDLE HANDLE ASSEMBLY ASSEMBLY © Medistim 2020

TITLE: TITLE:

PROBE TABLE PROBEDIMENSION DIMENSION TABLE

SIZE Dev.Dwg.No SIZE Dev.Dwg.No105042 105042

Prod.Dwg.No Prod.Dwg.No

SCALE: 1:2 SCALE: 1:2

WEIGHT: WEIGHT:

A4 Dev.Assy.No 100212 A4Dev.Assy.No 100212

Prod.Part.No Prod.Part.No

REV REV

AA

SHEET 1 OF 1 SHEET 1 OF 1

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3. Test Before Use 3.1 Checking Mechanical Integrity Prior to use and during the cleaning process, check each probe for mechanical integrity. The probes are delicate medical devices that may experience mechanical abrasion, which could damage them. • Probes that show external signs of abrasion (visible cracks, small cuts in the probe cable, etc.) should be checked for mechanical integrity. • Carefully examine the section between the flexible part of the probe and the probe handle. • Check the flexible part for cuts or tears in the silicone cover. • Verify that the reflector is firmly attached to the probe head. Probes with mechanical malfunctions should not be used and should be replaced. Please contact your local representative or Medistim directly with a report of the damaged probe.

3.2 TTFM Probe and System Functionality Test Before every use, a TTFM probe a functionality test should be performed. This test will reveal any reduction in functionality the probe may have suffered during handling and reprocessing, and ensures an accurate measurement. Performing this check before every use will ensure that the probe and system is functioning optimally and will also improve the acoustical coupling of the probe when placed on a vessel.

Preparing a probe for use: 1. Remove the sterile probe from the sterile packaging it has been stored in. 2. Connect the connector plug to the system. For each connected probe, a graft dialog may appear depending on how the system has been configured. It is not necessary to fill in a vessel name at this point, press Cancel to close the dialog. 3. When the probe is connected a measurement trace will appear on screen. The probe properties button will show the channel name corresponding to the name on the probe connector. If the system is set up to start in probe test mode, the probe test view will be shown for the connected probe until the probe is activated. 4. Place the probe in a container, preferably plastic, with sterile saline solution. Note Due to their acoustic properties, glass and metal containers can disturb the measurement and introduce an error in the test. Glass or metal containers should therefore be used with caution. If a metal container is used, cover the bottom with gauze or cotton to reduce disturbances in the measurement.

Verify good ACI: With the probe immersed in saline, look for the green Acoustic Coupling Index (ACI), which indicates appropriate contact between the probe and the vessel. All TTFM probes should obtain an ACI value of >90% in sterile saline to ensure an acceptable value when used on a graft where the signal is attenuated more. If the ACI value is lower than this during testing, ensure that there are no air bubbles surrounding the probe, as this can significantly affect the ACI value. Simply shake the probe gently in the saline solution to remove.

Check zero-point offset: Take note of the zero-point offset value when the probe is stationary in still saline. The observed offset value will be part of all measurements and is included in the systems stated accuracy. For applications with very low flow volumes, the zero-point offset value can however be significant and needs to be considered when evaluating the flow measurement.

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Probes that fail to register an ACI value of >90% in sterile saline or exhibit a large zero-point offset are not working properly and should be replaced. Notifiy Medistim and necessary repair or replacement of the defective components should be performed.

Troubleshooting: Should the probe and system functionality test fail, either due to low ACI or large zero-point offset, the system can in most cases still be used. Follow these steps to troubleshoot the failure and continue using the system. Change the channel Plug the probe into a different flow measurement channel (example: Q2 instead of Q1) and repeat the test. If this resolves the problem the system can be used as per usual with flow probes plugged in the functioning channel. Change the Probe Change to a different TTFM probe and perform the probe and system functionality test. If this test passes the initial failure is due to the previously tested probe. The system and the functioning probe can be used as per usual.

4. Handling and Reprocessing All Medistim TTFM Probes are reusable. See the packaging label for declaration of intended number of reuses. On the probe the number of reuses is marked by a post-fix after the part-number. If there is no post-fix, this indicates 50 reuses. The probes are validated for the specified number of sterilization cycles and warranted against manufacturing defects for one year from the date of first use. To ensure optimal performance and longevity of the probe, please note the following handling guidelines: • Do not use force on the steel reflector. • Do not stretch the cable. • Do not rotate the flexible neck of the probe around the probe center axis. • Use care when coiling the probe cable - the cable should be wound in large loose loops, not tightly wrapped. • The flexible neck of the probe may be adjusted for easier attachment. Avoid bending the neck of the probe more than 90° as this may damage the probe. • Use care when cleaning the probe. • Clean the probe immediately after use. Do not let blood dry on the probe. • Use care not to cut or crush the cable. • It is highly recommended to use the probe’s original packaging (the probe box) during shipment, handling, sterilization and storage. Probes that have been damaged due to careless handling are not covered under warranty. After the cleaning procedure described in Section 4.1, the probe must be sterilized according to the applicable method described in Section 4.3. Disinfection as described in Section 4.2 is not required for terminal sterilization.

4.1 Cleaning Wear protective gloves when removing the probe from the sterile field and when cleaning, as it may be stained with blood.

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Warning Cleaning must always be performed prior to sterilization.

Manual Cleaning After use, immerse the probe in a fresh, pH-neutral, enzymatic cleaning solution and soak for a minimum of five (5) minutes as per the manufacturer’s instructions. 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 and locking slide. Thoroughly rinse the probe under warm (30-43°C) running tap water for a minimum of one (1) minute and until visibly clean. Repeat this cleaning procedure if any remaining debris is observed on the probe. Ensure that the probe is dry before proceeding with sterilization. The above described procedure has been validated by the independent test lab NAMSA®1 .

Automatic Washing Machine Always perform the Manual Cleaning procedure as pre-cleaning before using an automated washing machine. All Medistim TTFM probes can be cleaned in an 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

45°C

Rinse 2

2 minutes

45°C

Thermal rinse

5 minutes

90°C

Dry

15 minutes

100°C

The above temperatures 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. By performing the tests described in chapter 3 the user can ensure that the probe is safe to use. Drying temperatures may exceed 100°C in short intervals.

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

4.2

Disinfection

Additional disinfection is not required for sterilization efficacy. If disinfection is performed, an appropriate disinfection agent should be used. Check with the manufacturer of the disinfection agent that the product is appropriate for use with products containing PPSU plastic, silicone and stainless steel.

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Warning The connector must not be left to soak for an extended period of time in disinfection solution. Damage due to use of too strong concentration of disinfection solution or too long exposure time are not covered under warranty. When disinfection is performed, follow the manufacturer’s instructions applicable to the disinfection solution.

4.3 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. Probe Series

Sterilization Process STERRAD ® 2

V-PRO ® 5

LCS

EtO

Steam

PS PV Validated process

Warning Only use sterilization techniques validated by Medistim. Using non-validated sterilization techniques may cause damage to the probes or incomplete sterilization.

Steam Sterilization All Medistim TTFM probes can be sterilized using steam autoclave for full cycles of four (4) minutes at 132ºC or three (3) minutes at 134ºC using prevacuum air removal in a double-pouched or doublewrapped probe box. The steam sterilization cycle involves the following steps: 1. Follow instructions for use for the autoclave sterilization process to protect the probe from accidental damage during handling. When sterilizing multiple devices, do not exceed the maximum load as indicated in the manufacturer’s instructions. 2. Clean the probe as described in Section 4.1. Place the dry probe in a pouch approved by the steam autoclave sterilization manufacturer or in the probe box delivered with the probe. 3. Place the pouch or probe container in the steam sterilization chamber according to manufacturer’s loading instructions and close the chamber door. Start the preprogrammed sterilization cycle per the manufacturer’s instructions. 4. The probe is ready for use after the sterilization cycle is complete including a minimum drying time of 30 minutes. The procedure described above has been validated by the independent test lab NAMSA. Warning Only the TTFM probes may be steam autoclaved. Attempting to steam autoclave any of the other Medistim probes will cause severe damage to the probe and will not be covered under warranty.

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STERRAD® 3 Sterilization All Medistim TTFM probes can be sterilized in STERRAD systems. Validated systems and cycles: 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. Clean the probe as described in Section 4.1. Place the dry probe in the probe box delivered with the probe or a STERRAD instrument tray. Double wrap the tray or box in Central Supply Room (CSR) wrap. 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 HIGHPOWER4 and further evaluated by ASP (a Johnson & Johnson company) using the process described above.

V-PRO®5 Sterilization All Medistim TTFM probes can be sterilized in V-PRO systems. Validated systems and cycles: V-PRO® System

Cycle(s)

V-PRO 1

Standard

V-PRO 1 Plus

Lumen and Non Lumen

V-PRO maX

Lumen, Non Lumen and Flexible

V-PRO 60

Lumen and Non Lumen

The sterilization cycle involves the following steps: 1. Clean the probe as described in Section 4.1. Place the dry probe in separate 8x12 inch Tyvek®6 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 using V-PRO®5 sterilization was tested by the STERIS®8 test lab using the process described above.

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Liquid Chemical Sterilization (LCS) The following liquid chemical sterilant processing systems have been validated for the corresponding probe families: LCS systems

Probe families

SYSTEM 1E®7 , SYSTEM 1®7 , SYSTEM 1 EXPRESS® 7 a nd SYSTEM 1 Plus®7

PS, PV

The sterilization cycle involves the following steps: 1. Clean the probe as described in Section 4.1 before placing the probe in the sterilization tray. All the Medistim TTFM probes will fit in all the SYSTEM 1 sterilization trays. 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®8 test lab using the process described above. Ethylene Oxide (EtO) Gas Sterilization All Medistim TTFM probes can be sterilized using EtO. Follow the manufacturer’s instructions for use, and ensure that the EtO sterilizer has the following settings: Setting

Value

Concentration

883mg/L, 100% EtO*

Temperature

550C

Relative humidity

50-80%

Full cycle exposure time

62 minutes

Aeration inside chamber, 55 C 0

Minimum of 8 hours

* Only 100% EtO is covered by this document. Other methods may also be used. Please contact Medistim for more information.

1. Use the supplied boxes for sterilization to protect the probes from accidental damage during handling. 2. Clean the probes as described in Section 4.1. 3. Package the probe box in gas-permeable packaging material specifically warranted by the manufacturer for EtO sterilization. The validation of an effective sterilization and residuals of EtO was tested by the independent test lab NAMSA. using the process and settings described above. Warning In-chamber aeration cycles as specified above should be followed before the probes are removed from the sterilization chamber.

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Explanation of symbols on probe and package labelling:

2460

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

Manufacturer

Rx only

Refer to instruction manual

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

Shipped NON-STERILE

Protected against the effects of

IPX7 temporary immersion in water

SN

Serial number

REF

Catalog number

“N” number of probes in package

Date of Manufacture

Sufficient for “n” applications

n

1 NAMSA

®

is a registered trademark of the company North American Science Associates, Inc. ®

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

®

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

2 Neodisher 3 STERRAD

4 HIGHPOWER Labs is an ISO 17025 accredited laboratory and is ASP factory trained to perform STERRAD

®

functiona-

lity and efficacy validation testing. 5 V-PRO 6

®

is a registered trademark of the company STERIS Inc.

Tyvek® is a registered trademark of the company DuPont.

7 SYSTEM 1E

®

, SYSTEM 1® , SYSTEM 1 EXPRESS ® and SYSTEM 1 Plus ® are registered trademarks of the company

STERIS Inc. 8 STERIS

®

is a registered trademark of the company STERIS Inc. © Medistim 2020

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PMTTFMINen 2.0.0 01/20

[email protected] www.medistim.com

2460

Medistim ASA (Head office) Økernveien 94 0579 Oslo Norway Phone +47 23 05 96 60

Medistim Danmark ApS Gøngetoften 13 2950 Vedbæk Denmark Phone +45 2276 5669

Medistim Spain S.L. Calle Balmes 173, 4º, 2 08006 Barcelona, Spain Phone +34 911 238 318

Medistim ASA (Manufacturing) Bromsveien 17 3183 Horten Norway Phone +47 23 05 96 60

Medistim USA Inc. 14000 25th Ave N. Ste. 108 Plymouth, MN 55447 USA Phone +1 763 208 9852

Medistim UK Limited 34 Nottingham South Ind Est Ruddington Lane Wilford NG11 7EP Nottingham, UK Phone +44 (0) 115 981 0871

Medistim Norge AS Økernveien 94 0579 Oslo Norway Phone +47 23 03 52 50

Medistim Deutschland GmbH Bahnhofstr. 32 82041 Deisenhofen Germany Phone +49 (0) 89 62 81 90 33