QuickFit TTFM Probes PV Series Instructions for Use

1. Medistim Probes

2. Intended Use

The Medistim Transit Time Flow Measurement (TTFM) Probes utilize ultrasound transit time to measure blood flow in patients’ vessels.

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 Systems User Manual for indications for use statement and contraindications.

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. DISCLAIMER: The availability of the products described in this manual may vary from country to country.

1.1

Medistim QuickFit™ TTFM Probes (PS & PQ)

Medistim QuickFit™ TTFM Probes are specifically designed to meet the demands of CABG surgery and are subdivided into two series, the PQ and PS probe series. The PQ and PS probe series have identical outer design, but the PS probes are designed for steam sterilization. To tell them apart, the handle of the PQ probes are white while the PS probes have blue handles.

Flexible neck

3.1

Cable

Connector

Checking Mechanical Integrity

3.2

Medistim Vascular TTFM Probes (PV)

INTERPRET GEOMETRIC TOLERANCING PER:

PROPRIETARY AND CONFIDENTIAL

MATERIAL

Repeat this cleaning procedure if any remaining debris is observed on the probe. Ensure that the probe is dry before proceeding with sterilization.

PROBE DIMENSION TABLE

COMMENTS:

A

Medistim Cardiac Output Probes (PR) VIEW

Check part for:

UNLESS OTHERWISE SPECIFIED:

SIGN

The Medistim Cardiac Output DIMENSIONS Probes designed to Knut Kristiansen ARE INare MILIMETER DRAWN TOLERANCES: NS-ISO 2768-1 FINE FRACTIONAL CHECKED measure blood flow in the ascending aorta. ANGULAR: MACH BEND APPROVED

TWO PLACE DECIMAL THREE PLACE DECIMAL

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 IS PROHIBITED.

Locking slide NEXT ASSY USED ON

INTERPRET GEOMETRIC TOLERANCING PER:

COMMENTS:

MATERIAL FINISH

APPLICATION

Knut Kristiansen

DO NOT SCALE DRAWING

PV PROBES With HANDLE ASSEMBLY

DATE

22.12.2014

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

INTERPRET GEOMETRIC TOLERANCING PER:

ROPRIETARY 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 S PROHIBITED.

Probe Manual

MATERIAL

NEXT ASSY USED ON APPLICATION

PM499001EN Rev C

SIGN

DRAWN

Always perform the Manual Cleaning procedure as precleaning before using an automated washing machine. All Medistim TTFM probes can be cleaned in an automatic washing machine under the following conditions: 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

4. Handling and Reprocessing

Thermal rinse

5 minutes

90°C

All Medistim TTFM Probes are reusable. See the packaging DATE label for declaration of intended number of reuses. On 22.12.2014 the probe the number of reuses is marked by a post-fix after the part-number. If there is no post-fix, this indicates 06.01.2015 TITLE: The probes are validated for the specified num50 reuses. PROBE DIMENSION TABLE ber of SIZE sterilization cycles and warranted against manufacDev.Dwg.No Prod.Dwg.No REV 105042 Connector turing defects for one year from the date of first use. Prod.Part.No Dev.Assy.No

Dry

15 minutes

100°C

A4

A

100212

SCALE: 1:2

WEIGHT:

DATE

SHEET 1 OF 1

06.01.2015

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. 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 and may ultimately damage the probe. If, nonetheless, disinfection is performed, ensure that the disinfection agent is allowed for use by Medistim. For an updated list of disinfection agents visit the Medistim homepage: www.medistim.com.

CHECKED

APPROVED

COMMENTS:

07.01.2015

Dev.Dwg.No

Prod.Dwg.No Prod.Part.No

FINISH

DO NOT SCALE DRAWING

Automatic Washing Machine

Time

A

VIEW

The above described procedure has been validated by the independent test lab NAMSA®1 .

Cycle phase

To ensure optimal performance and longevity of the probe, please note the following handling guidelines: Cable • Do not use force on the steel reflector. Knut Kristiansen 06.01.2015 • Do not stretch the cable. TITLE: Reflector PROBE DIMENSION TABLE • Do not rotate the flexible neck of the probe around Dev.Dwg.No Prod.Dwg.No REV SIZE 105042 the probe center axis. Connector ROBES A4 Dev.Assy.No 100212 Prod.Part.No • Use care when coiling the probe cable - the cable HANDLE MBLY should be wound in large loose loops, not tightly SCALE: 1:2 WEIGHT: SHEET 1 OF 1 wrapped. • The flexible neck of the probe can be bent carefully to a 900 angle. Do not use instruments or excessive Check part for: Knut Kristiansen Illustration of PR probes force when bending as this may damage the probe. Knut Kristiansen • Use care when cleaning the probe. TITLE: PROBE DIMENSION • TABLE Clean the probe immediately after use. Do not let REV SIZE 105035 blood dry on the PR PROBE A probe. A4 Dev.Assy.No 100212 ASSEMBLY • Use care not to cut or crush the cable. SIGN

Knut Kristiansen

Cleaning

Thoroughly rinse the probe under warm (30-43°C) running tap water for a minimum of one (1) minute and until visibly clean.

A

1.3

PV

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.

Dev.Dwg.No Prod.Dwg.No REV Follow theseSIZE steps to perform 105011a probe functionality test: PQ & PS PROBES1. Remove Prod.Part.No Dev.Assy.No the sterile probe from the container it has A4 FINISH 104971 NEXT ASSY USED ON W/ HANDLE been stored in. Handle ASSEMBLY DO NOT SCALE DRAWING Reflector APPLICATION SCALE: 1:2 WEIGHT: SHEET 1 OF 1 2. Connect the connector plug to the system. Cable TITLE: PROBE DIMENSION TABLE 3. Place the probe in a container with sterile saline Connector solution. Prod.Dwg.No REV SIZE Dev.Dwg.No 105011 PS PROBES 4. Observe the ACI value of the probe on the measProd.Part.No Dev.Assy.No A4 104971 ANDLE urement screen. The value should be minimum 90% MBLY SCALE: 1:2 WEIGHT: SHEET 1 OF 1 when measuring in saline. 5. If the saline is still, the measurement offset for the probe should be low relative to the measurement Illustration of PV probes range for the probe in use. (Smaller sizes do not have locking slide)

THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF MEDISTIM ASA. ANY REPRODUCTION IN DATE THE PART SIGN OR AS A WHOLE WITHOUT WRITTEN PERMISSION OF MEDISTIM ASA 22.12.2014 Knut Kristiansen IS PROHIBITED.

4.3

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.

Medistim recommends that a probe functionality test is always performed before a TTFM probe is used. This simpleDATE test will reveal any reduction in functionality the UNLESS OTHERWISE SPECIFIED: SIGN 22.12.2014 Knut Kristiansen DIMENSIONS ARE IN MILIMETER DRAWN probe may have suffered. By performing this check before TOLERANCES: NS-ISO 2768-1 FINE FRACTIONAL CHECKED Cable every use, the user can be sure that the probe and system ANGULAR: MACH BEND Locking slide APPROVED TWO PLACE DECIMAL Connector Cable THREE PLACE DECIMAL is functioning optimally. TITLE: Flexible neck

Check part for:

PR

SCALE: 1:2

WEIGHT:

SHEET 1 OF 1

Warning The connector must not be left to soak for an extended period of time in disinfection solution. Damage due to

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

Steam Sterilization The PV and PS probe series 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 double-wrapped 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 specifically warranted 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.

Sterilization Process STERRAD ® 2

Warning Damage due to use of disinfection solutions not listed by Medistim are not covered under warranty.

Manual Cleaning

The Vascular TTFM Probes are specifically designed to meet the requirements of vascular surgery. VIEW

Probe Series

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.

Warning Cleaning must always be performed prior to sterilization.

Probe Functionality Test

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.

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

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.

Illustration of PQ and PS probes

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.

4.1

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,Cable which could damage them. Connector • 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.

Cable

1.2

Warning Never insert a wet connector to the system as this could cause the system to malfunction.

3. Test Before Use

Handle

Reflector

•

V-PRO ® 5

PQ

Validated process Will destroy probe No mark = Not yet validated by Medistim * PQ probes are only validated for System 1E®3. See Chapter 4.3 LCS sterilization for details.

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.

The PV, PS and PQ probe series 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.

Liquid Chemical Sterilization (LCS)

SYSTEM 1®7

LCS system

Probe families

SYSTEM 1E®7

PQ, PS, PV

SYSTEM 1 EXPRESS

PS, PV

Validated systems and cycles:

SYSTEM 1 Plus®7

PS, PV

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 PS, PQ and PV probe series can be sterilized using EtO.

Setting

Value

Concentration

883mg/L, 100% EtO*

Temperature

550C

Relative humidity

50-80%

Full cycle exposure time

62 minutes

Aeration inside chamber, 550C

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.

PS, PV

All Medistim TTFM probes can be sterilized in STERRAD systems.

Standard

Ethylene Oxide (EtO) Gas Sterilization

Follow the manufacturer’s instructions for use, and ensure that the EtO sterilizer has the following settings:

V-PRO® 5 Sterilization

STERRAD® 3 Sterilization

STERRAD 50

Steam

PS

The following liquid chemical sterilant processing systems have been validated for the corresponding probe families:

Cycle

EtO

*

Warning Only the PV and PS probe series 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.

STERRAD System

LCS

®7

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

1 NAMSA

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

2 Neodisher

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.

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

3 STERRAD

4 HIGHPOWER Labs is an ISO 17025 accredited labora®

tory and is ASP factory trained to perform STERRAD functionality and efficacy validation testing. ® is a registered trademark of the company STERIS Inc.

5 V-PRO

6

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

8 STERIS

Probe Manual PM499001EN Rev C