Maintenance and Calibration

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1 Maintenance and Calibration PeriFlux 6000 peripheral pressure made intelligent

2 Disclaimer The information contained in this document is intended to provide general information only. It is not intended to be, nor does it constitute, medical advice. Under no circumstances is the information contained in this document to be interpreted as a recommendation for a particular treatment for specific individuals. In all cases it is recommended that clinicians perform their own interpretations of data in conjunction with the clinical assessment of their patient. Due to Perimed s commitment to continuous improvement of our products, all specifications are subject to change without notice. All information and content in this document is protected by copyright. All rights are reserved. Users are prohibited from modifying, copying, distributing, transmitting, displaying, publishing, selling, licensing, creating derivative works, or using any information available in or through the document for commercial or public purposes. All responsibility for any liability, loss or risk, personal or otherwise, which is incurred as a consequence, directly or indirectly, of the use and application of any of the material in this document is specifically disclaimed.

3 Diagnosing Peripheral Arterial Disease (PAD), Critical Limb Ischemia (CLI) and Nonhealing Wounds Hands on, Tips and Tricks Interpreting Curves and Results Maintenance and Calibration

4 Introduction The aim of this document is to summarize the basic maintenance requirements for laser Doppler probes and pressure cuffs used for pressure measurements.

5 Cleaning laser Doppler Probes 1. Wipe down the probe/holder with a disposable cloth/paper. For probes and probe holders that are attached using tape, tape remnants may be removed by repeated applications of clean adhesive tape, for instance Transpore or Blenderm. 2. Immerse the probe holder and/or probe head and cable in a mild detergent and water solution. Normally approximately 15 minutes is enough. 3. Rinse the probe holder and/or probe head and cable thoroughly under clean running water. Let dry or wipe dry with a lint-free cloth. 4. Clean the probe connectors with a lint-free cloth moistened with alcohol to ensure good optical transmission. Alternatively, the probes and probe holders may be cleaned with a cloth moistened with alcohol (<70%).

6 Disinfection of laser Doppler Probes The following disinfectants are recommended for the probes and probe holders: Alcohol (70%) Rely+On PeraSafe (DuPont ) CIDEX OPA (Johnson&Johnson) MadaCide-FD (MADA Inc.) Sekusept Plus (Ecolab) Note! Do not immerse the probe connectors in any liquid.

7 Cleaning of Cuffs If possible, all straight segmental cuffs should be washed daily or at minimum once a week. This can be accomplished by hand wash or by using a washing machine with a mild detergent and gentle cycle. Using a soft brush is useful to remove any organic or inorganic material without damaging the cuff fabric. If there is a lot of protein contamination, such as blood, an enzyme detergent will help remove the organic material.

8 Cleaning of Cuffs cont. 1. If cuffs are grossly contaminated, keep the cuffs wet or moist to prevent the material from drying, making cleaning more difficult. 2. Remove the bladders from the cuffs. 3. If the bladder is contaminated, wash it with soapy water and then rinse. Do not get water inside the bladder or tubing. 4. Add a laundry soap or mild detergent to either warm or cold water and put the cuff covers in. 5. After washing, open the end of the cuff, where the bladder is placed, and hang the cuff up to dry. 6. Make sure both the outside and inside are dry, including the Velcro, before reinserting the bladders. Do not disinfect until cuffs are completely dry.

9 Disinfection of Cuffs The following disinfectants may be used on straight segmental and digit cuffs: Hydrogen peroxide Hydrogen peroxide with silver (Sanosil ) Hydrogen peroxide Peroxyacetic acid Silver (Steriplex ) Silver with citric acid (PureGreen24 & SpectraSan 24) Octyl decyl dimethyl ammonium chloride with dioctyl dimethyl ammonium chloride with didecyl dimethyl ammonium chloride with dimethyl benzyl ammonium chloride (Protex ) 99 % isopropyl alcohol T-Spray Steriplex SD

10 Cleaning of Tubing The tubing (Tygon S-50-HL Hospital and Surgical tubing) can be cleaned with soap and water, or sterilized with autoclave (steam 30 minutes at 15 psi, 121 C) or radiation.

11 Checking laser Doppler Calibration To obtain reliable measurements, a monthly check of the calibration of the probe and the PF 6010 unit is recommended. 1. Start the instrument at least 5 minutes before check of calibration. 2. Select MENU Maintenance PF6010 Check Calibration. 3. In the dialog that opens, select the function unit(s) to be checked. In case of several units, they will be checked in sequence.

12 Checking laser Doppler Calibration cont. 4. Check that the serial number on the connected probe is the same as the serial number indicated in the dialog. If not, close the dialog and go to the Change Probe procedure. Otherwise, tap Next. 5. Place the probe in the motility standard: Shake the bottle containing the motility standard gently. Carefully fill the glass container with motility standard. Avoid bubbles. Place on a vibration free surface. Place the probe tip 5 mm into the liquid. Tap cautiously to remove potential air bubbles at the tip. Note! When checking calibration of a PROBE 407, the probe should be placed in the motility with a probe holder attached in order to achieve an accurate result.

13 Checking laser Doppler Calibration cont. 6. Tap Start to start the check. Wait for the first step to complete. 7. If the first step is completed successfully, place the probe on the zeroing disc using a double adhesive tape strip. Tap Start. 8. Wait for the second step to complete. 9. In case of successful verification, continue with the next unit (step 4 9). When finished with all units, close the wizard by tapping Close. 10. If the check fails, follow the instructions on the screen. 11. When finished, drain the motility standard back into the bottle and secure the container lid tightly.

14 Changing laser Doppler Probe When swapping laser Doppler probes, the correct probe, identified by probe must be identified by probe type and serial number, and set, using the Change Probe procedure. To change probe: 1. Start the instrument at least 5 minutes before calibration. 2. Insert the probe to be used. 3. Select MENU Maintenance PF6010 Change Probe. 4. In the dialog that opens, select the function unit(s) to be changed. Tap Next. 5. In the dialog that opens, select the serial number of the new probe using the drop down menu. Tap OK. 6. Perform a check of calibration of the probe by following the instructions on the screen.

15 Verification of Pressure Measurements Enter the PF 6050 Verification Mode. 1. Select MENU Settings Advanced. 2. Check the Use verification mode check box. Close the Advanced dialog by tapping OK. 3. Connect an external pump with manometer to one of the outlets. 4. Check that the instrument displays 0 ± 0.5 mmhg. 5. Pump up to a value of 150 ± 30 mmhg. Check that the external manometer and the instrument display the same value ± 3 mmhg.

16 Verification of Pressure Measurements cont 6. Pump up to a value of 280 ± 10 mmhg. Check that the external manometer and the instrument display the same value ± 6 mmhg. 7. Repeat the procedure for all pressure outlets. 8. Select MENU Settings Advanced and un-check the Verification mode check box. 9. Close the Advanced dialog by tapping OK. If the external manometer and the instrument display different values outside the given intervals, contact your Perimed representative.

17 Thank You! PeriFlux 6000 peripheral pressure made intelligent

General Warnings! A warning statement in this manual identifies a condition or practice which, if not corrected or discontinued immediately could lead

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