PD Doppler Probe Instructions for Use

1. Medistim Doppler Probe The Medistim Doppler Probe uses ultrasound Doppler to measure blood flow velocity. The use of Pulsed-Wave Doppler (PW) allows the user to select the depth at which the velocities are measured. Handle

Housing

Stabilizer

Cable

Handle

To ensure optimal performance and longevity of the probe, please note the following handling guidelines: • Do not stretch the cable. • Use care when coiling the probe cable - the cable should be wound in large loose loops, not tightly wrapped. • 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. Connector • It is highly recommended to use the probe’s original packaging (the probe box) during shipment, handling, sterilization and storage.

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 by the warranty.

Probes that have been damaged due to careless handling Cable are not covered under warranty.

4.4

4.2 Connector

Housing

Stabilizer

Cable

Warning Cleaning must always be performed prior to sterilization.

Cable

Illustration of the Doppler Probe VIEW

Check part for:

2. Intended Use

Manual Cleaning

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

SIGN DRAWN

Knut Kristiansen

CHECKED APPROVED

The Medistim quality assessment systems with probes are INTERPRET GEOMETRIC designed to perform intraoperative TOLERANCING PER: guidance and quality COMMENTS: THE INFORMATION CONTAINED IN THIS MATERIAL DRAWING IS THE SOLE PROPERTY OF control during surgical procedures and meet the demands MEDISTIM ASA. ANY REPRODUCTION IN PD PROBE PART OR AS A WHOLE WITHOUT THE FINISH for documentation of surgical procedures. To successfully USED ON NEXT ASSY WRITTEN PERMISSION OF MEDISTIM ASA ASSEMBLY IS PROHIBITED. UNLESS OTHERWISE SPECIFIED: SIGN DATE operate the systems, at leastDOtwo persons are required, APPLICATION NOT SCALE DRAWING Knut Kristiansen 07.01.2015 DIMENSIONS ARE IN MILIMETER DRAWN TOLERANCES: NS-ISO 2768-1 FINE one controlling the probe and the other controlling the FRACTIONAL CHECKED ANGULAR: MACH BEND APPROVED system. Refer to the applicable Medistim Systems User TWO PLACE DECIMAL THREE PLACE DECIMAL ManualTITLE: for PROBE indications for useTABLE statement and contraindicaDIMENSION tions. SIZE Dev.Dwg.No 105662 Prod.Dwg.No COMMENTS: REV PROPRIETARY AND CONFIDENTIAL

Check part for:

VIEW

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.

INTERPRET GEOMETRIC TOLERANCING PER: MATERIAL

NEXT ASSY USED ON APPLICATION

FINISH

DO NOT SCALE DRAWING

PD PROBE ASSEMBLY

A4 Dev.Assy.No 100212

Prod.Part.No

A

Warning SCALE: 1:2 WEIGHT: SHEET 1 OF 1 Never insert a wet connector to the system as this could cause the system to malfunction.

3. Check Mechanical Integrity Before Use 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. 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.

4. Handling and Reprocessing The Medistim Doppler probe is 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. Subsequent to the cleaning procedure described in Section 4.2, the probe must be sterilized according to the applicable method described in Section 4.4.

4.1

Handling

The Medistim probes are delicate instruments made with very high precision and should be handled with care. Damage to the probe can cause measurements to be inaccurate or even impossible.

Medistim Probe Manual PD499001 Rev E

Cleaning

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

Warning Damage due to use of disinfection agents not listed by Medistim are not covered by the warranty.

Sterilization

The following list of validated sterilization alternatives is not exhaustive and other sterilization procedures have also 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. ®3

DATE 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.

07.01.2015

TITLE:

PROBE DIMENSION TABLE Use a soft-bristled brush moistened with cleaning solution Prod.Dwg.No REV SIZE Dev.Dwg.No to remove all traces 105662 of debris, being particularly thorough Prod.Part.No Dev.Assy.No A4 of in the area the probe head and locking slide. 100212

A

SCALE: 1:2

WEIGHT:

SHEET 1 OF 1

Thoroughly rinse the probe under warm (30-43°C) running tap water for a minimum of one (1) minute and until visibly clean. Ensure that the probe is dry before proceeding with sterilization. Repeat this cleaning procedure if any remaining debris is observed on the probe.

Automatic Washing Machine Always perform the Manual Cleaning procedure as precleaning before using an automated washing machine. The Medistim Doppler probe 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

Hot tap

Rinse 1

15 seconds

Hot or heated tap

Rinse 2

2 minutes

Hot or heated tap

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. Drying temperatures may exceed 100°C in short intervals.

The above listed process has been validated by the independent test lab NAMSA®1 using 0.5% Neodisher® 2 MediClean forte during washing, Neodisher Z during neutralization and Neodisher MediKlar during Thermal Rinse.

4.3

When disinfection is performed, follow the manufacturer’s instructions applicable to the disinfection solution.

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.

STERRAD

Sterilization

The Medistim Doppler probe 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 4.2. 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 The Medistim Doppler probe 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 4.2. 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 was tested by the STERIS® 7 test lab using the above described process.

Liquid Chemical Sterilization (LCS) The following liquid chemical sterilant processing systems have been validated for the Medistim Doppler probe: • SYSTEM 1E® 8 • SYSTEM 1 • SYSTEM 1 EXPRESS • SYSTEM 1 Plus The sterilization cycle involves the following steps: 1. Clean the probe as described in Section 4.2 before placing the probe in the sterilization tray. The Medistim Doppler probe 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 was tested by the independent test labs, NAMSA and HIGHPOWER using the process described above.

Ethylene Oxide (EtO) Gas Sterilization The Medistim Doppler probe 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, 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 4.2. 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.

® 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

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

3 STERRAD

4 HIGHPOWER Labs is an ISO 17025 accredited laboratory ®

and is ASP factory trained to perform STERRAD nality and efficacy validation testing.

5

functio-

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

6 Tyvek

®

7 STERIS

is a registered trademark of the company DuPont. ®

is a registered trademark of the company STERIS

Inc. 8 SYSTEM 1E

®

, SYSTEM 1® , SYSTEM 1 EXPRESS ® and

SYSTEM 1 Plus ® are registered trademarks of the company STERIS Inc. Medistim Probe Manual PD499001 Rev E