Instructions For Usemedistim.com/wp-content/uploads/2016/01/pm499001gb-ttfm-prob… · Phone +49 (0) 89 62 81 90 33 Medistim UK Limited 34 Nottingham South Ind Est Ruddington Lane

Medistim Probe Manual

PM499001 Rev A

Medistim Probe Manual

PM499001 Rev A

Instructions For UseMedistim QuickFit™ TTFM Probes

(PS and PQ Probe Series):PS101011 / PS101012PS100021 / PS100022PS100031 / PS100032PS100041 / PS100042PS100051 / PS100052PS100071 / PS100072PQ101011 / PQ101012PQ100021 / PQ100022PQ100031 / PQ100032PQ100041 / PQ100042PQ100051 / PQ100052

Medistim Vascular TTFM Probes (PV Probe Series):

PV101011 / PV100021PV100031 / PV100032PV100041 / PV100042PV100051 / PV100052PV100061 / PV100062PV100081 / PV100082PV100101 / PV100102PV100121 / PV100122PV100141 / PV100142PV100161 / PV100162

Medistim Cardiac Output TTFM Probes (PR Probe Series):

PR100251/PR100301/PR100351

Medistim ASA (Head office)Økernveien 940579 OsloNorwayPhone +47 23 05 96 60

Medistim ASA (Manufacturing)Moloveien 103194 HortenNorwayPhone +47 33 03 17 10

Medistim Norge ASØkernveien 940579 OsloNorwayPhone +47 23 03 52 50

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

Medistim Danmark ApSGøngetoften 132950 VedbækDenmarkPhone +45 2276 5669

Medistim Deutschland GmbHBahnhofstr. 3282041 DeisenhofenGermanyPhone +49 (0) 89 62 81 90 33

Medistim UK Limited34 Nottingham South Ind Est Ruddington Lane Wilford, NG11 7EPNottingham, UKPhone +44 (0) 115 981 0871

[email protected]

Explanation of symbols on probe- and package labeling:

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

“Follow instructions for use”

Protected against the effects of temporary immer-sion in water

Quantity

Date of Manufacture

Manufacturer address

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

Shipped NON-STERILE

Serial Number

Catalog number

SN

REF

STERILE

only

IPX7

1 NAMSA® is a registered trademark.

2 STERRAD® is a registered trademark of the company ASP.

3 RENO Plasma Sterilizers are manufactured by RENOSEM CO., LTD.

1. Medistim ProbesThe Medistim Transit Time Flow Measurement (TTFM) Probes utilize the ultrasound-based transit time principle to measure blood flow in patient’s vessels.

The probes are available in multiple sizes and can be de-livered with and without handles in order to accommodate vessels for many types of procedures.

Before use, plug the probe connector into a Medistim MiraQ™ or VeriQ™ quality assessment system, and perform a probe functionality test as described in Section 3.2. After the function has been verified, the probe is ready for use. When the head of the probe is placed on the vessel to be measured, the flow measurement will be displayed on the screen of the Medistim system in real time.

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. Cable

Handle

Flexible neckConnector

Reflector

PROBE DIMENSION TABLE

PQ & PS PROBESW/ HANDLEASSEMBLY

Knut Kristiansen

DO NOT SCALE DRAWING SHEET 1 OF 1

UNLESS OTHERWISE SPECIFIED:

SCALE: 1:2 WEIGHT:

REVDev.Dwg.No

A4SIZE

TITLE:

SIGN DATE

COMMENTS:

APPROVED

CHECKED

DRAWN

FINISH

MATERIAL

INTERPRET GEOMETRICTOLERANCING PER:

DIMENSIONS ARE IN MILIMETERTOLERANCES: NS-ISO 2768-1 FINEFRACTIONALANGULAR: MACH BEND TWO PLACE DECIMAL THREE PLACE DECIMAL

APPLICATION

USED ON

PROPRIETARY AND CONFIDENTIAL

THE INFORMATION CONTAINED IN THISDRAWING IS THE SOLE PROPERTY OFMEDISTIM ASA. ANY REPRODUCTION INPART OR AS A WHOLE WITHOUT THEWRITTEN PERMISSION OF MEDISTIM ASAIS PROHIBITED.

Check part for:

NEXT ASSYDev.Assy.No

Prod.Dwg.No

Prod.Part.No

VIEW

A104971

105011

22.12.2014

Cable

Handle

Flexible neckConnector

Reflector


PQ & PS PROBESW/ HANDLEASSEMBLY

Knut Kristiansen



SCALE: 1:2 WEIGHT:

REVDev.Dwg.No

A4SIZE

TITLE:

SIGN DATE

COMMENTS:

APPROVED

CHECKED

DRAWN

FINISH

MATERIAL



APPLICATION

USED ON



Check part for:


Prod.Dwg.No

Prod.Part.No

VIEW

A104971

105011

22.12.2014

Cable

Technical drawing of PQ and PS probes

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

Cable Connector Locking slide

Flexible neck

HandleReflector


PV PROBESWith HANDLEASSEMBLY

Knut Kristiansen

Cable



SCALE: 1:2 WEIGHT:

REVDev.Dwg.No

A4SIZE

TITLE:

SIGN DATE

COMMENTS:

APPROVED

CHECKED

DRAWN

FINISH

MATERIAL



APPLICATION

USED ON



Check part for:


Prod.Dwg.No

Prod.Part.No

VIEW

A100212

105042

Knut Kristiansen 06.01.2015

22.12.2014

Connector Locking slide

Flexible neck

HandleReflector


PV PROBESWith HANDLEASSEMBLY

Knut Kristiansen

Cable



SCALE: 1:2 WEIGHT:

REVDev.Dwg.No

A4SIZE

TITLE:

SIGN DATE

COMMENTS:

APPROVED

CHECKED

DRAWN

FINISH

MATERIAL



APPLICATION

USED ON



Check part for:


Prod.Dwg.No

Prod.Part.No

VIEW

A100212

105042


22.12.2014

Technical drawing of PV probes

1.3 Medistim Cardiac Output Probes (PR)The Medistim Cardiac Output Probes are designed to meas-ure blood flow in the ascending aorta.

Cable



PR PROBEASSEMBLY

Reflector



SCALE: 1:2 WEIGHT:

REVDev.Dwg.No

A4SIZE

TITLE:

SIGN DATE

COMMENTS:

APPROVED

CHECKED

DRAWN

FINISH

MATERIAL



APPLICATION

USED ON



Check part for:


Prod.Dwg.No

Prod.Part.No

VIEW

A100212

105035

06.01.2015Knut Kristiansen


Cable



PR PROBEASSEMBLY

Reflector



SCALE: 1:2 WEIGHT:

REVDev.Dwg.No

A4SIZE

TITLE:

SIGN DATE

COMMENTS:

APPROVED

CHECKED

DRAWN

FINISH

MATERIAL



APPLICATION

USED ON



Check part for:


Prod.Dwg.No

Prod.Part.No

VIEW

A100212

105035

06.01.2015Knut Kristiansen


Technical drawing of PR probes

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 Systems User Manual for indications for use statement and contraindications. WarningNever insert a wet connector to the system as this could cause the system to malfunction.

3. Test Before Use3.1 Checking Mechanical IntegrityPrior 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 repre-sentative or Medistim directly with a report of the damaged probe.

3.2 Probe Functionality TestMedistim recommends that a probe functionality test is always performed before a TTFM probe is used. This simple test will reveal any reduction in functionality the probe may have suffered. By performing this check before every use, the user can be sure that the probe and system is function-ing optimally.

Follow these steps to perform a probe functionality test:

1. Remove the sterile probe from the container it has been stored in.

2. Connect the connector plug to the MiraQ™ / VeriQ™.3. Place the probe in a container with sterile saline

solution.4. Observe the ACI value of the probe on the measure-

ment screen. The value should be minimum 90% when measuring in saline.

5. If the saline is still, the measurement offset for the probe should be low relative to the measurement range for the probe in use.

4. Handling and ReprocessingAll Medistim TTFM Probes can be used up to 50 times. They are validated to withstand up to 50 sterilization cycles with-out loss of functionality, and are warranted against manufac-turing 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.

• When needed, the flexible neck can be bent carefully. If the neck is bent sharply, damage can occur.

• 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.

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

WarningCleaning must always be performed prior to sterilization.

Automatic Washing MachineAll Medistim TTFM Probes can be cleaned in an automatic washing machine at a maximum temperature of95°C, using non-aggressive detergents and at a dryingtemperature of maximum 100°C for up to 20 minutes.

Manual CleaningAfter use, immerse the probe in a fresh, pH-neutral, enzy-matic 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.

Wipe the probe with 70% isopropyl alcohol (IPA) and allow to air dry. Repeat this cleaning procedure if any remaining debris is observed on the probe.

4.2 DisinfectionSubsequent to the cleaning procedure described in Section 4.1, the probe must be sterilized according to the applicable method described in Section 4.3. Additional disinfection is not required and may ultimately damage the probe. If, nonetheless, disinfection is per-formed, ensure that the disinfection solution used is listed by Medistim for use with the probe models covered by this manual. For an updated list of disinfection solutions visit the Medistim homepage: www.medistim.com.

WarningThe 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 manufacturers instructions applicable to the disinfection solution.

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

Probe Series Sterilization Process

STERRAD® RENO EtO Steam

PQ

PR

PS

PV

Validated process

Will destroy probe

No mark = Not yet validated by Medistim

4.3 SterilizationWarning Only use sterilization techniques validated by Medistim. Using invalidated sterilization techniques may cause dam-age to the probes or incomplete sterilization.

Steam SterilizationThe 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 steriliza-tion process to protect the probe from accidental damage during handling. When sterilizing multiple de-vices, 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 steri-lization chamber according to manufacturer’s loading instructions and close the chamber door. Start the preprogrammed sterilization cycle per the manufac-turer’s instructions.

4. The probe is ready for use after the sterilization cycle is complete including a minimum drying time of 30 minutes.

The validation of an effective sterilization was tested by the independent test lab NAMSA®1. For the validation, the aforementioned settings have been taken into consideration.

WarningOnly the PS and PV probe series may be steam auto-claved. 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®2 Sterilization The PS, PQ and PR probe series can be sterilized using STERRAD®, a rapid, low-temperature and low-moisture technology designed for delicate instrument sterilization.

The following models can be used to sterilize the probe:

1. STERRAD® NX2. STERRAD® 100S3. STERRAD® 100 NX4. STERRAD® 2005. STERRAD® 50

The sterilization cycle involves the following steps:

1. Follow instructions for use for the sterilization process to protect the probe from accidental damage during handling.

2. 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.

3. Place the instrument tray(s) in the sterilization cham-ber according to manufacturer’s loading instructions and close the chamber door. Start the prepro-grammed sterilization cycle per the manufacturer’s instructions.

4. The probe is ready for use after the sterilization cycle is complete. Normal cycle time is 28 - 75 minutes depending upon the model.

The validation of an effective sterilization was tested by the independent test lab NAMSA® and further evaluated by ASP. For the validation, the aforementioned settings have been taken into consideration.

RENO3 Plasma Sterilization The PS, PQ and PV probe series can be sterilized using a RENO Plasma Sterilizer.

The following RENOSEM models can be used to sterilize the probe:

• RENO-S20• RENO-S30• RENO-D50• RENO-S130• RENO-S130D

The sterilization cycle involves the following steps:

1. Follow instructions for use for the RENO Plasma Sterilizer to protect the probe from accidental damage during handling.

2. Clean the probe as described in Section 4.1. Place the dry probe in the probe box and double wrap the box in CSR wrap.

3. Place the instrument tray(s) in the sterilization cham-ber according to manufacturer’s loading instructions and close the chamber door. Start the prepro-grammed sterilization cycle per the manufacturer’s instructions.

4. The probe is ready for use after the sterilization cycle is complete. Normal cycle time is 28 - 62 minutes depending upon the model.

The validation of an effective sterilization was tested by the RENOSEM test lab. For the validation, the aforementioned settings have been taken into consideration.

Ethylene Oxide (EtO) Gas SterilizationThe PS, PQ and PV probe series can be sterilized using EtO. Follow the manufacturers 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 4.1.3. Package the probe box in gas-permeable packag-

ing material specifically warranted by the manufac-turer for EtO sterilization.

The validation of an effective sterilization and residuals of EtO was tested by the independent test lab NAMSA®. For the validation, the aforementioned settings have been taken into consideration.

Warning In-chamber aeration cycles as specified above should be followed before the probes are removed from the sterilization chamber.

Documents

Instructions For Usemedistim.com/wp-content/uploads/2016/01/pm499001gb-ttfm-prob… · Phone +49 (0) 89 62 81 90 33 Medistim UK Limited 34 Nottingham South Ind Est Ruddington Lane