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PeriFlux System 5000 Extended User Manual

Manufactured by: Perimed AB
Datavägen 9A, SE-175 43 Järfälla, Sweden
Phone: +46 8 580 119 90
Fax: +46 8 580 100 28
E-mail: mail@perimed-instruments.com
Website: www.perimed-instruments.com

Revised: October 2012, ÅL
Part no: 44-00003-13
Language: English
© Perimed AB 2012

PeriFlux System 5000
Instrument version 1.70-1.79

Extended User Manual

Part no. 44-00003-13
YOUR PARTNER IN MICROCIRCULATION Language: English

PeriFlux System 5000 User Manual

INTRODUCTION...................................................................................................................... 4
INTENDED USE .................................................................................................................. 4
WARNINGS AND PRECAUTIONS ..................................................................................... 4
MANUFACTURER'S RESPONSIBILITY............................................................................. 5
WARRANTY ........................................................................................................................ 6
DISPOSAL........................................................................................................................... 6
PERIFLUX SYSTEM 5000 DOCUMENTATION.................................................................. 7
ABBREVIATIONS................................................................................................................ 7
PERIFLUX SYSTEM 5000 OVERVIEW .................................................................................. 8
MAIN UNIT TYPES ............................................................................................................. 8
FUNCTION UNIT TYPES .................................................................................................... 8
ACCESSORIES AND SPARE PARTS ................................................................................ 8
SETTING UP THE PERIFLUX SYSTEM 5000 ........................................................................ 9
UNPACKING THE PERIFLUX SYSTEM 5000.................................................................... 9
CONNECTING AND STARTING THE SYSTEM................................................................. 9
LOCATION .......................................................................................................................... 9
MAIN UNIT - PF 5001 OR PF 5002 ....................................................................................... 10
MAIN UNIT TYPES ........................................................................................................... 10
FRONT PANEL ................................................................................................................. 10
REAR PANEL .................................................................................................................... 11
MAINTENANCE OF PERIFLUX SYSTEM 5000 AND FUNCTION UNITS ....................... 12
PERIFLUX SYSTEM 5000 INTERNAL SOFTWARE ........................................................ 15
CONNECTING THE PERIFLUX SYSTEM 5000 TO EXTERNAL UNITS ......................... 15
LDPM UNIT - PF 5010 ........................................................................................................... 16
INTRODUCTION ............................................................................................................... 16
LAYOUT ............................................................................................................................ 17
ACCESSORIES AND CONSUMABLES ........................................................................... 17
CONNECTING LDPM PROBES ....................................................................................... 18
APPLICATION OF THE LDPM PROBE ............................................................................ 18
POSITIONING THE LDPM FIBER OPTIC CABLE............................................................ 19
SUBJECT PREPARATION ............................................................................................... 20
EXAMPLE ON HOW TO MAKE LDPM MEASUREMENTS .............................................. 20
CALIBRATION................................................................................................................... 21
TIME CONSTANT ............................................................................................................. 23
STANDBY/ALARM RESET ............................................................................................... 23
CLEANING/DISINFECTING/STERILIZING THE LDPM PROBES.................................... 23
LDPM THEORY................................................................................................................. 25
CLINICAL CONSIDERATIONS WHEN USING LDPM...................................................... 27
ANALYZING THE RESULTS ............................................................................................ 29
TEMP UNIT - PF 5020 ........................................................................................................... 31
INTRODUCTION ............................................................................................................... 31
LAYOUT ............................................................................................................................ 32
ACCESSORIES AND CONSUMABLES ........................................................................... 32
OPERATION OF THE PF 5020 TEMP UNIT .................................................................... 33
THERMOSTATIC LASER DOPPLER PROBES ............................................................... 33
TEMPERATURE MEASUREMENT SENSORS ................................................................ 34

Part no. 44-00003-13 Page 2
Language: English YOUR PARTNER IN MICROCIRCULATION

PeriFlux System 5000 User Manual

OVER-TEMPERATURE HAZARDS AND SAFETY ARRANGEMENTS ........................... 34
CLEANING/DISINFECTING/STERILIZING....................................................................... 35
TCPO2/TCPCO2 UNIT - PF 5040 .......................................................................................... 36
INTRODUCTION ............................................................................................................... 36
LAYOUT ............................................................................................................................ 37
ACCESSORIES AND CONSUMABLES ........................................................................... 37
MEMBRANING THE TC ELECTRODE ............................................................................. 38
CALIBRATION................................................................................................................... 40
PATIENT MONITORING ................................................................................................... 44
MAINTENANCE ................................................................................................................ 45
TCC3 CALIBRATION UNIT ............................................................................................... 46
TCC3 REAR PANEL ......................................................................................................... 47
AUXILIARY PROGRAM .................................................................................................... 48
PRESSURE UNIT - PF 5050 ................................................................................................. 50
INTRODUCTION ............................................................................................................... 50
LAYOUT ............................................................................................................................ 51
ACCESSORIES AND CONSUMABLES ........................................................................... 51
CONNECTING THE PUMP AND TUBING........................................................................ 52
PERFORMING A DIGITAL SYSTOLIC BLOOD PRESSURE MEASUREMENT.............. 54
PERFORMING A SKIN PERFUSION PRESSURE MEASUREMENT.............................. 54
PERFORMING A PULSE VOLUME RECORDING (PVR) ................................................ 55
AUXILIARY PROGRAM .................................................................................................... 55
CLEANING AND CARE..................................................................................................... 56
PRINTER DPU-3445.............................................................................................................. 57
INTRODUCTION ............................................................................................................... 57
SEIKO INSTRUMENTS USER'S GUIDE .......................................................................... 57
CONNECTION TO PERIFLUX SYSTEM 5000 ................................................................. 57
HOW TO USE DPU-3445 PRINTER ................................................................................. 57
PRINT LAYOUT ................................................................................................................ 58
AUXILIARY PROGRAM .................................................................................................... 59
TROUBLESHOOTING........................................................................................................... 60
PF 5010 LDPM UNIT......................................................................................................... 60
PF 5020 TEMP UNIT......................................................................................................... 61
PF 5040 TCPO2/TCPCO2 UNIT ........................................................................................ 62
PF 5050 PRESSURE UNIT ............................................................................................... 64
DPU-3445 PRINTER ......................................................................................................... 64
TECHNICAL SPECIFICATIONS ........................................................................................... 65
PERIFLUX SYSTEM 5000 ................................................................................................ 65
PF 5010 LDPM UNIT......................................................................................................... 69
PF 5020 TEMP UNIT......................................................................................................... 70
PF 5040 TCPO2/TCPCO2 UNIT ........................................................................................ 71
PF 5050 PRESSURE UNIT ............................................................................................... 73
DPU-3445 THERMAL PRINTER ....................................................................................... 73

Page 3 Part no. 44-00003-13
YOUR PARTNER IN MICROCIRCULATION Language: English

g. The computer must be placed at a distance of at least 1. PeriFlux System 5000 Extended User Manual Introduction PeriFlux System 5000 is a multi channel instrument for microcirculation studies in both clinical settings and research laboratories. a network isolator must be used to limit the leakage current. It can also add to understanding of the microcirculatory responses resulting from an applied stimulus. 44-00003-13 Page 4 Language: English YOUR PARTNER IN MICROCIRCULATION . Intended Use See “Intended Use” section in the chapter for the relevant Function Unit. Laser Doppler. Warnings and precautions Warnings and precautions are marked in this manual with the symbol . If the com- puter is closer to the patient. a Medical Isolation Transformer must be used to limit the leakage current If the computer is in the patient environment and is connected to a LAN (local area net- work).5 meters from the patient (Figure 1). Temperature and Pres- sure Units. Figure 1 Patient environment. remove the electrode from the patient immediately and check the error code in the trouble shooting section of the man- ual. The PeriFlux System 5000 consists of a main unit that can be equipped with one to four Function Units. The Function Units can be of different types. Only computers complying with the IEC 60950-1 standards must be used. Warning! If an error code is displayed and the acoustic alarm sounds. e. a “provocation”. Part no. tcpO2/tcpCO2. The PeriFlux System 5000 can be used to monitor microcirculatory activity in healthy and diseased tissues.

The PeriFlux System 5000 should not be adjacent to or stacked with other equipment. unauthorized repair or improper maintenance. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English .g. If the PeriFlux System 5000 does not perform as described in this manual. Authorized Perimed personnel must perform all service. Perimed AB will take full responsibility for improper functioning of this instrument ONLY if it is installed. trained personnel who have carefully read this Extended User Manual and other accompanying literature. If adjacent or stacked use is necessary. The only operation the Customer is allowed to perform inside the instrument is to change Function Units. If in doubt. Manufacturer's responsibility Perimed AB warrants that all reasonable care has been used in the manufacture of the PeriFlux System 5000. Warning! This instrument must only be operated by qualified. No preventive maintenance is necessary for the PeriFlux System 5000. In addition. Warning! Any person who connects external equipment to signal output parts or other connectors has formed a medical electrical system and is therefore responsible for the system to com- ply with the requirements of IEC 60601-1-1. normal operation must be ensured before measur- ing on patients. Page 5 Part no. The operator of this instrument is responsible for any damage or injury resulting from improper use. trained personnel who have care- fully read this manual and other accompanying literature.PeriFlux System 5000 Extended User Manual Signal Interference Cables that are connected to the PeriFlux System 5000 might pick up noise coming from other electri- cal equipment. External equipment. shall comply with relevant standards (e. used and maintained in accordance with this extended user manual and if service and repair operations have been carried out by service engineers authorized by Perimed AB. To reduce the possibility of noise entering the PeriFlux System 5000. all such combinations/systems shall comply with the stan- dard IEC 60601-1-1 (safety requirements for medical electrical systems). The system must only be used by qualified. adjusted. IEC 60950-1 for IT equipment and IEC 60601-1 series for medical electrical equipment). All warranties are voided if the equipment is not used in accordance with these instructions. it should not be used until an authorized Perimed service engineer has checked the PeriFlux System 5000. Operator's responsibility The PeriFlux System 5000 will perform as designed and intended ONLY if it is used in accordance with the manufacturer's instructions. Connected equipment that does not comply with IEC 60601-1 should not be placed within the patient area. which will be connected to signal input and signal output parts or other connectors. contact a qualified technician. Do not base diagnosis and treatment solely on data obtained with the PeriFlux System 5000. use cables sup- plied by Perimed or shielded cables no longer than 4 meters.

If the Customer does not fulfil this obligation. During this warranty period. Figure 2 The symbol for electrical and electronic equipment. to Perimed AB in Sweden. Repairs carried out by Perimed after the warranty period has expired carry a warranty period of 90 days from the date of receipt by the Customer of the repaired instrument. If the PeriFlux System 5000 is transferred to a new owner. are not covered by this warranty. shipping prepaid. For systems bought through agents. together with all com- ponents. the respective warranty conditions of that agent apply. it is recommended that the system is repackaged in its original packaging and that the shipment is insured against damage or loss. see Figure 2. which could otherwise be caused by inappropriate waste handling. The recycling of material will help to conserve natural resources. Perimed will repair or replace. This means that the producer is responsible for the collection. recovery and environmentally sound disposal of the equipment. such as fuses. subassemblies and consumables marked with the symbol for electrical and electronic equip- ment. If the instrument is shipped back to Perimed or to an agent. NOTE! Perimed is not liable for any consequential damage. at no charge. Transit damage and shipping costs are not covered by this warranty. The equipment may not be disposed of as household waste. PeriFlux System 5000 Extended User Manual Warranty The following warranty conditions apply to instruments bought directly from Perimed AB or a Perimed subsidiary by the Customer. they will be liable for any consequential damage caused to Perimed AB. Expend- able items. The PeriFlux System 5000 is guaranteed against defects in materials and workmanship for a period of 24 months from the date of shipping from Perimed or from the date of receipt by the Customer but never exceeding 27 months from the date of shipping from Perimed. The original owner should provide the new owner with proof of the original pur- chase date. This handling of waste equipment will minimize consequences for the environment and human health. to Perimed AB for recycling. Disposal This equipment shall be handled according to the European Directive 2002/96/EC on waste electrical and electronic equipment (WEEE). The new owner must notify Perimed AB in writing of the transfer of ownership. the Customer is responsible for returning the equipment. Evidence of the date of purchase must be included with the returned instrument. the Customer may take responsibility to ensure that the equipment is collected separately according to the above directive. Alternatively. components or products which prove to be defective. the warranty period remaining from the orig- inal 24-month period is also transferred. treat- ment. At the time of disposal. pro- vided that the instrument is returned. 44-00003-13 Page 6 Language: English YOUR PARTNER IN MICROCIRCULATION . Part no. The warranty does not apply if any person other than an authorized Perimed service engineer has dam- aged the PeriFlux System 5000 by accident or misuse or as a result of service or modification.

This document. Translated to several languages. User Manual Contains information regarding daily usage. Find the list on www. Perimed Literature Reference List The Perimed Literature Reference List contains more than 1200 scientific and clinical papers on laser Doppler perfusion and transcutaneous oxygen measurements.perimed. PSW PeriSoft for Windows (software) TC Transcutaneous tcpO2 Transcutaneous Oxygen pressure tcpCO2 Transcutaneous Carbon Dioxide pressure Table 2: Abbreviations. TB Total Backscatter – total amount of returning light to a laser Doppler Function Unit. as well as laser Doppler and tcpO2/tcpCO2 theory. Low Light Level – Laser Doppler Function Unit is not receiving enough returning light LLL to function properly. TB is too low. CMBC Concentration of Moving Blood Cells Overload – laser Doppler Function Unit is receiving too much returning light to func- OL tion properly. Table 1: PeriFlux System 5000 documentation. Translated to several languages. Page 7 Part no.se. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Contains detailed information regarding Extended User Manual daily usage.PeriFlux System 5000 Extended User Manual PeriFlux System 5000 Documentation The accompanying documentation for PeriFlux System 5000 consists of the following: Quick Reference Guide Quick reference guide. Only available in English. technical information and specifications. TB is too high. Abbreviations In this manual the following abbreviations are used: LDPM Laser Doppler Perfusion Monitor PU Perfusion Units – perfusion measurement used in a laser Doppler Function Unit.

g. except the PF 5010 LDPM Unit. temperature stabilization or temperature measurement. • PF 5002 Basic Main Unit Main Unit that can be equipped with all types of Function Units. Laser Doppler. Spare Parts PF 490 Cable including USB to RS 232 Adapter PF 1001 Refill Motility Standard Table 4: Spare parts for PF 5000. • Simple one-button calibration. • PF 5050 Pressure Unit Unit for monitoring and regulating pressure deflation in connected pressure cuffs. PF 5002 does not include a laser diode. 44-00003-13 Page 8 Language: English YOUR PARTNER IN MICROCIRCULATION . • Ease of use with simple push-button system. Skin Perfusion Pressure and Pulse Volume Recording measurements. Temperature and Pres- sure Units. e. • PF 5040 tcpO2/tcpCO2 Unit Unit for one tcpO2 electrode or one combination tcpO2/tcpCO2 electrode. • PeriSoft for Windows software to analyze data. Part no. • PF 5020 Heating Unit Unit for one or two heat probes/sensors. Used for heat provocation tests. Used for Toe and Ankle pressure. Accessories and Spare Parts Accessories (optional) Network Isolator NI-100 Medical Isolation Transformer 1000 VA Medical Isolation Transformer 300 VA Uni-Cart with four shelves Mobile Equipment Carrier Probe Stand for Mobile Equipment Carrier Table 3: Accessories for PF 5000. This Main Unit Type includes a diode laser emitting laser light that is transmitted to installed PF 5010 LDPM Unit(s). tcpO2/tcpCO2. The PeriFlux System 5000 offers the following: • A multi-channel. Main Unit Types There are two types of main units available: • PF 5001 Main Unit Main Unit that can be equipped with all types of Function Units. The Function Units can be of different types. Function Unit Types The Function Unit types currently available are: • PF 5010 LDPM Unit Unit for one laser Doppler probe. multi-functional system allowing different types of measurements to be made simultaneously in up to four different sites. • Printer can be connected for easy documentation. PeriFlux System 5000 Extended User Manual PeriFlux System 5000 Overview The PeriFlux System 5000 consists of a main unit that can be equipped with one to four Function Units.

Switch on the system using the ON/OFF switch. Connecting and Starting the System Install relevant function units according to “Installing a Function Unit” on page 14. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . The fiber optic cables should not be subjected to bends with a radius less than 5 mm as they may be damaged. the displays on all units should be lit. If everything is correctly installed. electrodes and cuffs is described in the following instructions for each function unit. The instrument is now ready for measurement. such as a computer or a printer. Check the setup by performing an initial calibration according to the chapter for the respective function unit. such as machines or ventilation systems. If more than one instrument is being used. 3. Allow the instrument to warm up for at least 20 minutes before making measurements. Always make sure the instrument is properly packaged before any transport. Page 9 Part no. they can be stacked on top of each other.placing the PeriFlux System 5000 in an enriched oxygen atmosphere or inside a hyper- baric chamber may cause a fire hazard. Do not place the instrument close to sources of vibration.PeriFlux System 5000 Extended User Manual Setting up the PeriFlux System 5000 Unpacking the PeriFlux System 5000 Carefully unpack and identify the various parts of the PeriFlux System 5000 as specified in the packing list. Do not place the PeriFlux System 5000 in an enriched oxygen atmosphere or inside a hyperbaric chamber . Each slot should be equipped with a function unit or covered by a blank panel. The fiber optic cables are strengthened with Kevlar but should still be handled with care. Such vibrations can cause measurement artifacts. Proceed as follows: 1. Warning! Do not use the PeriFlux System 5000 in the presence of flammable anesthetics – the presence of flammable anesthetics may cause an explosion. 4. Location Place the instrument in a convenient stable location close to the subject to be studied. 5. NOTE! Retain the packaging for future transportation of the instrument or in case it should be nec- essary to return the instrument to Perimed. Switch on any peripheral equipment. 2. any peripheral equipment to be used should be connected to the system according to “Connecting the PeriFlux System 5000 to external units” on page 15. Connect the instrument to a suitable grounded mains outlet using the mains cable. A stand can be folded down from the bottom of the instrument to angle the instrument upwards. Take special care when unpacking LDPM probes. Make sure the ON/OFF switch on the rear panel of the instrument is in the OFF position. Also. The system initializes for 30 seconds after it is powered on. Connection of probes.

Front panel The flexible design of PeriFlux System 5000 allows different Function Units to be attached.0 J 0. • PF 5002 Basic Main Unit Main Unit that can be equipped with all types of Function Units.0 J 0. PeriFlux System 5000 Extended User Manual Main Unit . PF 5002 does not include a laser diode.2 3.2 3.2 3.0 J 0. however. Figure 3 shows the front panel with four LDPM units installed. Part no. This Main Unit Type includes a diode laser emitting laser light that is transmitted to installed PF 5010 LDPM Unit(s).0 PERIMED PeriFlux System 5000 Figure 3 PF 5000 with four PF 5010 LDPM Units.PF 5001 or PF 5002 Main Unit Types There are two types of main units available: • PF 5001 Main Unit Main Unit that can be equipped with all types of Function Units. 44-00003-13 Page 10 Language: English YOUR PARTNER IN MICROCIRCULATION . similar in design. except the PF 5010 LDPM Unit. PF 5010 PF 5010 PF 5010 PF 5010 LDPM Unit LDPM Unit LDPM Unit LDPM Unit CAL CAL CAL CAL J 0.2 3.03 0. The differ- ent Function Units are.03 0.03 0.03 0.

5 . Sweden www. IX Serial number and address label. For details of replacement of fuses. VII Potential equalization connector.com X . The numeral “1” to the right of the connector indicates the position of pin number 1 in the connector.perimed-instruments.Disposal VII . 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Page 11 Part no. I Computer Printer switch.Potential equalization connector and address Figure 4 Rear panel.5 to 10 V)).00800 Perimed AB. which protect the PeriFlux System 5000 from damage caused by electrical faults.5 and 10 volts.PeriFlux System 5000 Extended User Manual Rear panel I .Analog connector to IV . Cover for the fuses. IV Classification text for instrument voltage requirements. X Manufacturing date label.Serial connector to III .ON/OFF switch 100-240 V~ : T 2AL 250 V Manufactured: May 2011 50-60 Hz PRINTER COMPUTER 70 VA + + VI . Label with serial number and the manufacturer’s ad re ss. This connector is used to connect to a computer or a digital printer.Serial number VIII .Manufacturing date IX .Computer/Printer switch II . III 15-pole female analog connector (marked (-2. but shall be returned to Perimed AB for recycling or collected separately according to the above directive. power consumption and fuse types. This is a safety require- ment for the German market. Datavägen 9A SE-175 43 Järfälla. VIII Disposal according to European Directive 2002/96/EC (WEEE) At the time of disposal.Fuse box cover SN 5001 . this product shall not be disposed of as household waste.Classification text computer chart recorder SERIAL INTERFACE (-2. V ON/OFF switch for mains power. see “Changing a fuse” on page 12. VI Fuse box cover. II 9-pole female serial interface connector. The marking indicates that the connector has an output voltage of between -2. Label with manufacturing year and month. This connector is used to connect to a chart recorder or to an analog-to-digital converter.10V) 1 1 V. The switch sets the serial interface to be either a computer or printer output. The connector is connected to the chassis to equalize the neutral potentials of different instru- ments that are connected to the system (including printer and computer). The numeral “1” to the right of the connector indicates the position of pin number 1 in the connector.

Do not allow liquids to enter the instrument. Replace the fuse with one of an identical type and close the fuse box cover. see individual chapters. 3. Disconnect the mains cable from the mains socket. Cleaning the PeriFlux System 5000 The casing of the instrument has been designed to minimize the build up of dust in corners and is thus easy to clean. If. Switch off the instrument. NOTE! Under no circumstances should a fuse with a value different from that specified be used. 2. Open the fuse box by inserting a flat blade screwdriver into the slot above the fuse box (see Figure 5). Switch off the instrument and disconnect it from the mains power supply. Part no. See the “Technical specifications” on page 65 for an exact fuse specification. Proceed as follows: 1. NOTE! For probe and electrode maintenance. 44-00003-13 Page 12 Language: English YOUR PARTNER IN MICROCIRCULATION . However. + + Slot Fuse box Figure 5 Fuse box. Removing a Function Unit Removing a Function Unit is relatively simple since the units come as slide-in replacements. the new fuse blows again. disconnect the mains cable from the instrument and contact your local authorized Perimed service engineer. PeriFlux System 5000 Extended User Manual Maintenance of PeriFlux System 5000 and Function Units No preventive maintenance is necessary and service has to be done by authorized Perimed personnel. 4. The only operation the Customer is allowed to perform inside the instrument is to change fuses and Function Units. only competent personnel or an authorized service engineer should perform the job. Remove the probes from the connectors on the front panel. on replacing a blown fuse. 2. 1. Changing a fuse Changing a blown fuse is a relatively simple procedure. The outside of the PeriFlux System 5000 can be cleaned with a lint-free cloth moistened with alcohol.

PeriFlux System 5000 Extended User Manual 3. Reassemble the instru- ment by following the instructions in reverse order.03 0. 5.2 3. Release the front frame by loosening the two screws on both sides of the instrument (see Figure 6).0 Screw Figure 7 Function unit. Slide out the Function Unit carefully (see Figure 8). Figure 6 Removing the front frame. CA L J CA L J Figure 8 Removing Function Unit. 4. PF 5010 LDPM Unit CAL J 0. 6. Insert a PF 5990 Blank Panel (to protect the instrument from dust/damage). Loosen the screw at the bottom of the Function Unit (see Figure 7). Page 13 Part no. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English .

Mount the front frame and tighten the two screws on both sides of the instrument (see Figure 11). by following the instructions for removing a Function Unit (see above).2 3. Check the installation by performing an initial calibration according to the chapter for the respec- tive function unit. Carefully push the unit as far back as possible (see Figure 9).0 Screw Figure 10 Function unit. 3. Fit the required Function Unit in the empty slot. PF 5010 LDPM Unit CAL J 0. 4. Figure 11 Fastening the front frame. PeriFlux System 5000 Extended User Manual Installing a Function Unit 1. Part no.03 0. 44-00003-13 Page 14 Language: English YOUR PARTNER IN MICROCIRCULATION . Remove a PF 5990 Blank Panel (it does not matter which one). 5. CA L J CA L J Figure 9 Inserting Function Unit. or a Function Unit which will not be required for the application. 6. Tighten the screw at the bottom of the Function Unit (see Figure 10). 2.

Connecting to a chart recorder Use the analog connector and the Perimed analog recorder cable. Connecting to other computer programs than PeriSoft It is possible to connect the PeriFlux System 5000 to computer programs using A/D Converter boards. The software version flashes on the dis- plays of all function units when the instrument is powered on. Use the analog connector and the Perimed analog recorder cable. Connecting to DPU-3445 Printer Use the serial interface connector and Seiko serial interface cable. See also the appropriate software manual. Connecting the PeriFlux System 5000 to external units The PeriFlux System 5000 can be connected to external units through the outputs on the rear panel of the Main Unit. NOTE! Set the Computer/Printer switch to Printer when connecting to DPU-3445. See section “Output signal (15-pole female analog connector)” on page 66 in this manual for cable description. the internal parameters of the system are reset to default and all Function Units need recalibration. See also section “How to Use DPU- 3445 Printer” on page 57 in this manual. NOTE! After updating the internal software. The internal software can be updated through the serial port of the instrument. The most common connections are listed below. Page 15 Part no. Connecting to computer using PeriSoft for Windows Use the serial interface connector and Perimed serial interface cable. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English .PeriFlux System 5000 Extended User Manual PeriFlux System 5000 internal software The PeriFlux System 5000 is controlled by internal software. See section “Output signal (15-pole female analog connector)” on page 66 in this manual for cable description. NOTE! Set the Computer/Printer switch (located on the rear panel) to Computer when connecting to PeriSoft for Windows.

Products containing lasers are classified internationally according to the laser light output and the radi- ation hazards to individuals exposed to the radiation. PeriFlux System 5000 Extended User Manual LDPM Unit . probe holders and sensors has been shown not to have any adverse effects on skin. It is not intended for measurement on the central nervous system or the central circulatory system. The mate- rials used have been practically tested over many years. The laser light hits moving blood cells in the microvasculature. and this scatters the light and causes the laser light to change frequency due to Doppler shift. Part of the laser light is returned to a photo detector in the instrument. 44-00003-13 Page 16 Language: English YOUR PARTNER IN MICROCIRCULATION . Indications for use (for US market only) The PF 5010 LDPM Unit is indicated for use in measuring micro-vascular perfusion in skin and muscle in humans. Perimed adhesive tapes are medical grade. The front panel of the PF 5010 LDPM Unit is shown in Figure 12. The PeriFlux System 5000 equipped with PF 5010 LDPM Unit(s) is classified in USA as a class 1 laser product according to FDA CFR 1040. and are assessed and documented according to the guidance and principles given in ISO 10993-1. LDPM is an abbreviation for Laser Doppler Perfusion Monitor. It is also intended for use in measuring micro-vascular perfusion in all tissues in animals. The classes range from 1 to 4 where class 1 covers the lowest risk laser. The frequency change will depend on the amount of blood cells in the illuminated area and the speed of those blood cells. This laser light is transmitted to the PF 5010 LDPM Unit(s). Intended Use The PF 5010 LDM Unit is intended for use in measuring micro-vascular perfusion in virtually all tissue invasively or non-invasively. and temperature sensors are only fixed to the skin for some hours. the instrument is classified as a Class 1 laser prod- uct according to IEC 60825-1:2007. The use of the probes.10. Laser light is applied to skin through fiber optics.PF 5010 Introduction The LDPM Unit measures perfusion or micro-circulatory blood flow. In Europe. The value from the photo detec- tor is electronically processed and the signal is converted into a perfusion value. The probes. Laser safety The PeriFlux PF 5001 Main Unit contains a diode laser emitting continuous divergent radiation. Biocompatibility Probes and probe holders are usually fixed to the skin using double adhesive tape. Part no. probe holders.

44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . invasive/surgical invasive use PH 07-6. Probe connectors The red probe plug fits the red Standby/Alarm Reset connector. 408. 407. 407. PH 13 Probe holders.2 or 3. Table 5: Accessories for PF 5010. 413. The buttons (Calibration. 426 Thermostatic probe holder PF 450 (including PF 451) Probe Kits 407. 412. PH 08. 418 457 Non-invasive LDPM probes with heating capability See “Temp Unit . See also “Temp Unit .PF 5020” on page 31. 404.03 0. probe holders and probe kits.03. starting on page 21.2 3. Consumables Information Probe holders. Calibration CAL Time constant 0. Figure 12 PF 5010 LDPM Unit and two probe plugs. 420. Places the instrument in standby or removes error codes. 410. Error codes in red. 0. 457 PF 5810 and PF 5810-X Allows measurement with the PF 5010 and LDPM Remote Panel PF 5020 remotely.0 Smoothing filter for best visualization.PeriFlux System 5000 Extended User Manual Layout PF 5010 Display LDPM Unit Values in green. Probe plug sleeve Cardiac Floating The instrument type is CF. 408. PH 07-8 Adhesive rings PF 105-1 Adhesive strips PF 105-3 Microtips MT B500-OL.PF 5020” on page 31 Invasive LDPM probes 404. non-invasive use PH 07-4. 411. Active laser indicator Values are 0.0. Package of 5 Fixation for microtip PH 18 Cleaning Kit - Table 6: Consumables for PF 5010. 403. Time constant and Standby/Alarm Reset) on the front panel of the PF 5010 LDPM Unit are described in detail. PH 07-7. 407. Accessories and Consumables Perimed offers a wide selection of probes. See the Perimed Probe bro- chure for more details. PH 07-5. Page 17 Part no. Accessories Information Non-invasive LDPM probes 404. 409 Surgically invasive LDPM probes 402.

When not in use. see Figure 14. These must be removed before attaching the LDPM probes and should be replaced when the instrument is stored. NOTE! If using a probe without a probe holder. lamps as this may affect the perfusion value. push the probe plug sleeve inwards and twist clockwise to lock it into position. 44-00003-13 Page 18 Language: English YOUR PARTNER IN MICROCIRCULATION . Proceed as follows: 1. the tissue is occluded and the readings will be incorrect. If pressure is applied to fix the probe. See the Perimed Laser Doppler probes brochure for fur- ther details on different probe holders. Clean the probe connectors with a lint-free cloth moist- ened with alcohol to ensure good light transmission. Figure 13 Probe holder examples.g. probe holder and probe. PROBE 408 is attached using probe holder PH 08 and double-sided adhesive rings PF 105-1. reduce all direct light from. replace dust covers on the plugs and connectors. The unmarked plug does not have any alignment key. that a plastic probe holder is attached to the tissue being studied. 1 2 3 Figure 14 Application of adhesive tape. if possible. Insert the probe plugs gently. E. Dirt on probe plugs can be transferred to the probe connectors inside the instrument and thus reduce light transmission. 2. PeriFlux System 5000 Extended User Manual Connecting LDPM probes Note that the optical plugs and connectors are shipped with dust covers. It is recommended. 3. The most common method for attachment of the probe to the measurement site is to attach a probe holder using double-sided adhesive tape. Figure 13 shows some typical probe holders. Ensure that the plug is properly secured by pulling the plug gently. Connect the red plug to the red connector and fit the alignment key to the slit. Part no. PROBE 407 is attached to the skin using probe holder PH07-4 and Adhesive strip PF 105-3. without pressure. Application of the LDPM probe The probe has to be placed so that the tip touches the tissue to be studied. Remove dust covers on plug and connector. Make sure that the holder is firmly attached. The red plug is connected to the red connector. for example.

However. It should be secured to a stable or rigid structure close to the subject to reduce artifacts caused by body movements. Although artifacts are quite easy to identify. note that this type of adhesive may cause local tissue damage. If the organ itself is moving. e. as it may break. Increasing the dis- tance between the probe tip and the tissue under study will reduce the signal value. It is not necessary for the probe to touch the tissue but this will help to minimize artifacts. Correct Wrong Figure 16 Cable positioning Page 19 Part no. the tip of the probe must not be pressed so hard against the tissue that blood flow occlusions occur. Implantable microtips (single fiber probes) can either be sutured or glued in place using a surgical grade cyanoacrylate adhesive. Avoid stretching the blood vessels. Positioning the LDPM fiber optic cable The fiber optic cable must be positioned so that it curves gently from the instrument to the probe tip (see Figure 16). In this case. An angled probe is often better for ensuring that the weight is taken off the cable. Move the probe tip until it touches the tissue or until a suitable reading is obtained. Make sure that the cable or securing tape does not distort or strain the tissue. However. allowing the probe tip to rest lightly on the tissue under study can reduce them. The cable must not be kinked. Alternatively. See Perimed Laser Doppler Probes brochure for further details. Adjust the balance so that the probe rests lightly on the surface of the organ and can follow the movements of the organ. as movement will cause artifacts.PeriFlux System 5000 Extended User Manual The probe holders PH 08 and PH 07-4 can also be sutured onto skin and muscles. If the organ to be measured is moving. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Another alternative to affix the probe to the skin or a muscle is to use the suturable angled PROBE 404 (see Figure 15). This adhesive can usually be loosened with acetone or a proprietary adhesive remover. Figure 15 Suturable probe holder and suturable Probe 404. Fit the teaspoon under the kidney and lift it up with a micro manipulator. For example a rat kidney can be immobi- lized using a teaspoon filled with cotton wool. in plastic surgery. It is possible to suture directly through the holder or holes for the sutures can be made before use. use a balance arm arrangement for the probe. NOTE! Do not allow the probe to move during the course of measurements. the tissue must not be allowed to move with respect to the probe. try to immobilize it. fit the probe into a micro manipulator.g.

5. a Printer DPU-3445 can also be connected to the instrument. 2. the perfusion decreases to a very low level. If a long time constant is used. Example on how to make LDPM measurements The following example concerns measurements on the skin of a patient. change to a shorter time constant and check that heart synchronous pulsation is visible. Secure the fiber optic cables to the nearest solid object in such a way that they will not move during the measurements. See Figure 17 below. Insert the probes into the probe holders so that the tips of the probes are just in contact with the skin. the perfusion level will return to normal after a few minutes. The best solution is to have the cables hanging down from a stand above. a hyperaemia reaction can be seen where the Perfusion (flux) increases to 150–500% of its steady resting level. the sub- ject has been outside in cold weather. 3 minutes and then release the pressure as quickly as possible. 3.2). Maintain this pressure for e. PeriSoft for Windows. Data from the instrument should be recorded. for example. This allows the heart to stabilize at its resting rate. When the cuff is released. which usu- ally have a short duration and thus are easy to recognize. or if there are tempo- rary changes in the distance between the probe tip and the tissue being studied. The most commonly used data collection system today is the dedicated software. these artifacts may be difficult to identify. the so-called Biological Zero.03 or 0. the blood flow in the skin will be considerably reduced because of the cold and the capillaries must be allowed to reopen. 1. Figure 17 Biological zero Part no. The subject should be allowed to rest. If. For simple docu- mentation when data storage is not necessary. Apply a pressure cuff around the patient's upper arm. It serves to illustrate the set- ting-up and interpretation of a typical measurement. See separate pamphlet. 6. If the latter is suspected. 4. these artifacts are in the form of upward spikes. Fix probe holders to the skin on the forearm and the ball of the hand. PeriFlux System 5000 Extended User Manual Artifacts in the measured value can arise if the cable moves during measurement. If a short time constant is used (0. relax and acclimatize in the room where the measurements will take place for at least 30 minutes. This rest time is also necessary if the sub- ject has come from an environment with a significantly different temperature. 44-00003-13 Page 20 Language: English YOUR PARTNER IN MICROCIRCULATION .g. When inflating the cuff. Subject preparation The subject under study should be correctly prepared to avoid misguiding results. as they will be integrated into the curve as a resultant apparent increase in the basal perfusion level. To create an occlusion. inflate the arm cuff quickly to about 200 mm/Hg. As a rule.

The instrument and the probes are calibrated to the measuring points 0 PU and PU. The diagram below (Figure 18) shows a generalized graph with many different types of results that may be encountered. A full calibration should be performed if the obtained values are other than: • 250 ±15 PU in Motility Standard • 0 ± 1 PU on the Zeroing Disc • Total Backscatter (TB) > 2V (if recorded) Page 21 Part no. Full calibration should be car- ried out when the values are out of the permitted range. when measuring on teeth. Typical Laser Doppler signal from measurements on human skin.5 minutes on the time axis) are artifacts possibly caused by movement of the probe tip relative to the skin.) Cuff and vasoactive drug has been used as provocation. All LDPM Function Units are using the same laser source. Check calibration Check calibration by measuring in the Motility Standard (steps 1-3 below) and on the Zeroing Disc. Calibration Calibration is performed to make sure that different PeriFlux Units measure the same values.PeriFlux System 5000 Extended User Manual 7. It is especially important to calibrate if the measuring range is low. recalibration is neces- sary. Only one LDPM Function Unit can be cali- brated at a time. Understanding this diagram will help in interpreting your experiments. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Never perform a calibration when another LDPM Function Unit is in use. If an Error Code is displayed on the instrument during calibration. (P. or movement of the fiber optic cable dur- ing measurements.U. The calibration should be checked minimum once every month. as the range can be 0-10 PU. Reactive hyperaemia 80 60 Movement artifacts Administration of vasoactive substance Cuff Inflated Vasomotion Cuff Inflated 40 20 Biological zero 0 4 6 8 (minutes) 0 2 10 12 14 Figure 18 Typical graph. The very steep spikes in the illustration (at about 3. a displaced ZERO could be very misleading. NOTE! Calibration of LDPM probes shall not be performed in strong ambient light or direct sun- light. Always check the calibration when a new probe is attached or before sending probes for sterilization. For example.

tiously to remove potential air bubbles at the tip. Tap cau- Motility Standard. e. Perfusion (Flux). drain the Motility Standard back Figure 19 Calibration device into the bottle (avoids evaporation) or secure the container lid tightly. see Figure 20 below. PROBE 457 and 404. Wait for the reading to stabilize. Carefully fill the glass container with Motility Stan- dard. 250 PU 4. The deviation in the Perfusion value (Flux) is 2-3 PU/°C (measured from a standard value of 22°C). At 22°C. CAL . The Motility Standard should be replaced annually due to possibility of contamination during regular use. PeriFlux System 5000 Extended User Manual Full calibration 1. Clamp for probe 3. Verifying Zero Check the zero level by placing the probe on the Zeroing Disc: PROBE 407 is placed in probe holder PH07-4 and attached to the Zeroing Disc with double adhesive strips.g. Remove the metal coupling part before the probe tip is inserted into the hole. The Motility Standard must not freeze. before use. Remove the coupling part Figure 20 PROBE 418 with coupling part. Allow the instrument 20 minutes to warm up. Remove the coupling part on PROBE 418 before calibration. NOTE! Make sure the probe is clean before placing it in the Motility Standard. Always avoid space between the probe tip and the Zeroing Disc! Motility Standard The PF1001 Motility Standard is a colloidal suspension of polystyrene particles. Place on a vibration free table/ floor. • When finished. However. are fastened directly on the Zeroing Disc with double adhesive strips. Make sure that the container and refill bottle are sealed well when not in use. Press the Calibration button on the instrument. Shake the bottle containing the Motility Standard. The size of the particles in the Motility Standard is such that sedimentation only occurs at an infinitesi- mal rate. Zeroing disc. Flat probes. Part no. 44-00003-13 Page 22 Language: English YOUR PARTNER IN MICROCIRCULATION . NOTE! Store the Motility Standard in room temperature. the Motility Standard produces a value of 250 ± 5% PU and the variation is mainly due to ran- dom variations in Brownian motion. 0 PU 5. see Figure 20. Evaporation of water from the Motility Standard affects the TB value. 2. Rinse out and wipe the glass container dry after use. Other probes are placed in a suitable hole. Brownian motion of these particles provides a standardized perfusion value equivalent to a perfusion of 250 PU. turn the Motility Standard container and let it stand for at least 2 min- utes. PROBE 418 is positioned in the small hole inside the largest cavity. Place the probe tip 5 mm into the liquid. Avoid bubbles. CMBC and Velocity values are affected to a lesser degree.

alcohol concentra- tions greater that 70%. The display is turned off and the buttons are inactivated. set the time constant to 3. ethyl acetate. Remove any excess soil with a disposable cloth/paper wipe as soon as possible after usage. Clean the probe connectors with a lint-free cloth moistened with alcohol to ensure good optical transmission.0. If heart synchronous pulsations are not of interest. Immerse the probe head and cable in a mild detergent and water solution. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . The following cleaning procedure is suggested: 1.0 is used. Do not immerse the probe connectors in liquid solution. benzene. Alarm Reset – Press the button to clear minor error codes. Calibrate the probes before sterilization. or other strong solvents for cleaning the probes.2 or 3. Do not use acetone. 3. Page 23 Part no. as the Motility Standard contaminates the probes. both for placing the unit in standby and also for removal of alarms.03 to observe details. Repeated artifacts may result in an elevated signal level if the time constant 3.03. 0. contact your Perimed representative. Standby – The unit is placed in Standby if the button is pressed. Arrange the fiber so that artifacts are minimized.0. Let dry or wipe dry with a lint-free cloth. If working on humans.* 2. The time between updates of the display is not influenced by changes in the time constant. set the time constant initially to 0. If not cleared. Heart synchronous pulsations can then be seen as well as artifacts. Rinse the probe head and cable thoroughly under clean running water. Cleaning After usage. Remove the black dust covers from the probe connectors before cleaning/disinfection/ sterilization. Cleaning/Disinfecting/Sterilizing the LDPM probes Warning! Temperature for probes and microtips must not exceed 65°C. disinfect probes before sending them for service. chloroform. Normally approximately 15 minutes is enough. Measuring on animals with a high heart beat frequency requires a time constant of 0. 4. Always check the error code in the trouble shooting section. NOTE! Probes must be thoroughly cleaned and sterilized between patients. For some applications only cleaning may be sufficient. Please clean and. if relevant.2.PeriFlux System 5000 Extended User Manual Time Constant Use the Time Constant button on the front panel to choose between the values 0. Standby/Alarm Reset The Standby/Alarm Reset button is a dual function button. the probes shall be manually cleaned before any disinfection or sterilization. The time constant is a filter that is used to smooth the signal so relevant data is best visualized and can be evaluated. ethyl chloride.

Do not immerse the probe connectors in any liquid. Wipe off with a lint-free cloth moistened with one of the recommended disinfectants. STERRAD® STERRAD® STERRAD® STERRAD® 100NX® 100S® 100® 50® PROBE 402    PROBE 403    PROBE 404    PROBE 407    PROBE 409    PROBE 410    PROBE 411    PROBE 420    PROBE 426     Table 7: Suitable STERRAD® methods for different invasive probes. PeriFlux System 5000 Extended User Manual Alternatively. The method uses a combination of hydrogen peroxide vapor and low-temperature gas plasma. The process temperature does not exceed 55°C. NOTE! 10 minutes immersion in PeraSafe also achieves sterilant level of decontamination for all LDPM probes. Disinfection The following disinfectants are recommended for the LDPM probes: • Rely+On™ Perasafe™ (DuPont™) • CIDEX® OPA (Johnson&Johnson) • CIDEX® Plus (Johnson&Johnson) The LDPM probes and microtips can be disinfected by immersion in one of the recommended disinfec- tants according to the instructions provided by the manufacturer of the disinfectant. tape remnants may be removed by repeated applications of clean adhesive tape. 44-00003-13 Page 24 Language: English YOUR PARTNER IN MICROCIRCULATION . Sterilization The validated method for sterilization of invasive LDPM probes is STERRAD®. for instance Transpore® or Blenderm®. The table below indicates suitable STERRAD® methods for the different probes. Part no. * For probes that are attached using tape. the LDPM probes may be cleaned with a cloth moistened with alcohol (<70%).

The physiologically most relevant parameters in the tissue under study are: Blood Perfusion.PeriFlux System 5000 Extended User Manual LDPM Theory General An optical fiber leads light generated by a laser to the LDPM probe tip. Page 25 Part no. CMBC CMBC (Concentration of Moving Blood Cells) represents the relative number of moving cells. which causes Doppler shift within the measuring range of the LDPM. Velocity Velocity represents the relative average velocity of the blood cells moving in the measured volume. It represents the product of the relative number of moving blood cells. "On Laser Doppler Flowmetry" Linköping University. which causes Doppler shift. The detailed mathematics of transforming the signal into a perfusion value. and the relative velocity of these cells in the measured volume. The TB value is normally high from forearm skin (few blood cells and lighter skin color) but low from the liver. are discussed in the academic Disser- tation by Torsten Tenland. This parameter is of interest for exam- ple when studying the effect of drugs and different provocations. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . a higher blood cell concentration causes less light to be reflected. and hence a lower TB value). The relation between the main signals is: Blood Perfusion = CMBC  Mean Velocity of these Cells Blood Perfusion Blood perfusion measured by LDPM is a relative value (semi-quantitative). The beam of light will enter the tissue and become scattered. The parameter is of interest when studying for example the effect of drugs in animals and in studies of sickle cells and other blood cell defects. Total Backscatter (TB) The Total Backscatter is the amount of light. Only a few scientific papers are discussing the CMBC signal. Blood cells moving within the volume illuminated by the beam will cause the light to change frequency. filtered and separated into different signals. No further discussion of the mathematics will be made in this manual. representing various parameters1. The value increases linearly with the velocity of the blood cells. Blood Perfusion is the most important parameter when studying the microvascular circulation. Within the tissue. 1. and the number of blood cells in the tissue (since hemoglobin in blood cells absorbs light. Concentration of Moving Blood Cells (CMBC) and Velocity. Note that dust and dirt in the optical system can affect the TB value. which rests against the tissue. there will be a mixture of non-Doppler shifted and Doppler shifted light. where it is converted to electrical signals. measured by the sys- tem. The electrical signal from the photo detector is processed. both Doppler shifted and un-shifted. This change in frequency is called a Doppler shift. The values are expressed in Perfusion Units (PU). 1982. The TB value also depends on technical parameters like laser power. Part of the light within the tissue is scattered back to the probe where it is returned via an optical fiber to a photo detector in the instrument. The CMBC is proportional to the num- ber of blood cells moving trough the tissue. The direction of the movement of the blood cells has no relevance in the microvascular bed. Only a few scientific papers are dis- cussing the Velocity signal. The ratio between shifted and non-shifted light is related to the number of moving objects within the path of the light. and the total receiving area of the fibers in the probe. The TB value depends on for example tissue properties like color. The value increases linearly with the number of cells. separation of the fibers in the probe.

PeriFlux System 5000 Extended User Manual

The TB value is mainly a technical parameter and must be within a certain range. If the TB value is too
low, the instrument will flash LLL (Low Light Level). If the TB value is too high the instrument will
display OL (Overload).

Signal output
The Perfusion Units (PU) and the TB value are available as an output from the 15-pole analogue con-
nector on the rear panel. In the PeriSoft for Windows (PSW) program version 2 or higher the Perfusion
Units (PU), TB, CMBC and Velocity are available.

Linearization of the signal
Before the signal can be displayed, another electronic process must be carried out. The linearizer elimi-
nates a systematic error, which affects laser Doppler flow values – an underestimation of the degree of
blood perfusion at high blood cell concentrations.
Output signal (PU)

300

200

100

0 100 200 300
ml
Total bloodflow min x 100g

Figure 21 Linearization.

The probability of a photon of light hitting a blood cell, and then being detected within the measuring
volume of the probe, increases with the tissue blood cell concentration. In addition, the probability that
one photon hits more than one blood cell increases, i.e. multiple Doppler shifts become more common.
This so called multiple scattering results in non-linear Doppler signals at high blood cell concentration.
This results in an underestimated CMBC and Perfusion, and an overestimated Velocity since the signal
does not follow a linear relationship to the blood perfusion at high blood cell concentrations.
The linearizer applies a correction factor to the perfusion value. This ensures that the Perimed laser
Doppler instrument produces a signal that is proportional to the blood perfusion throughout the entire
clinical blood flow range.1

1. A full description and scientific test of the patented linearizer can be found in the paper "Signal processor for
laser Doppler tissue flowmeters" Nilsson et al., Med. & Biol. Eng. & Comput., 22, 343-348 (1984) and in the paper
"In vivo evaluation of signal processors for laser Doppler tissue velocity" Ahn et al. Med. & Biol. Eng. & Comput.,
25, 207-211 (1987).

Part no. 44-00003-13 Page 26
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PeriFlux System 5000 Extended User Manual

Clinical considerations when using LDPM
General nature of the results
The laser Doppler measures movements of objects within the measuring volume of the LDPM probe.
The measuring depth in skin is such that only movements in micro vessels contribute to the value. In
tissues other than skin, movement in large vessels passing near the surface will influence the measure-
ment. However, the thickness of large vessel walls is sufficient to exclude most of the laser light. See
“Measuring depth” on page 27.
The moving objects measured are mainly red blood cells but leukocytes and platelets also contribute.
The laser Doppler does not react to the flow of fluids with a uniform refractive index such as blood
plasma.
There is also a false movement component due to oscillation of blood cells. Under normal conditions,
these are too small to be significant.
However, during complete vessel occlusion when the flow of cells drops to ZERO, these small move-
ments, caused by redistribution of blood cells, become more significant and can prevent the perfusion
value from dropping to ZERO. Some researchers refer to this value as the biological or occluded
ZERO. As an example, when measuring fingertip blood flow during a complete proximal arterial occlu-
sion, a residual perfusion value of several percent of the free-flow perfusion will be seen.
A similar signal can be observed in vitro several hours after a tissue has been removed from an animal.
Since the Perimed laser Doppler registers all movement relative to the probe tip, it is important during
measurements to avoid moving the probe tip with respect to the tissue being measured.
Due to the diffuse scattering of the light within the tissue, the signal is almost independent of the direc-
tion of cell movement. Thus, blood cells moving away from the probe tip will contribute to the signal as
much as cells passing sideways in front of the probe tip1.

The relative nature of the perfusion value
The laser Doppler will give very reliable perfusion values with respect to a reference standard which is
stable over long periods of time. Using the Perimed Motility standard, different Perimed laser Doppler
instruments can be calibrated to give the same values in perfusion units.
The basic unit of measurement used in Perimed laser Doppler instruments is the Perfusion Unit. One
Perfusion Unit (PU) equals 1/250 of the Perfusion value in Motility Standard so when a calibrated laser
Doppler instrument is measuring in Motility Standard the value will be 250 PU +/-10%. Since the PU is
arbitrary, it cannot be given any physiological definition, such as the actual number of cells flowing
through a given volume of tissue during a given time period. Thus, perfusion values from laser Doppler
instruments are not absolute.
Numerous and often successful attempts have been made to relate laser Doppler perfusion values to
physiological values. Papers on this subject are listed in the Perimed Literature Reference List.
It should be noted that such relationships are only valid for the particular tissue and configuration used.
In addition, there is a considerable physiological variation in the peripheral perfusion in and between
different, healthy individuals. There is also a variation in local tissue areas over small distances and
with time, depending on the capillary density. These factors limit the significance of a physiological
calibration of perfusion units.

Measuring depth
The measuring depth is usually defined as the depth below the tissue surface to which about two-
thirds of the surface light penetrates and returns back to the tissue surface. The measuring depth
depends on tissue properties, such as the structure and density of the capillary beds, the wavelength of
the light, and the distance between the fibers in the laser Doppler probe.

1. Further background can be found in Tenland's thesis (see Footnote on page 25) and in "Principles of Laser-Dop-
pler Flowmetry" by Bonner & Nossal, in "Laser-Doppler Blood Flowmetry", pp. 17-45, eds. Shepherd & Öberg,
Kluwer Academic Publishers, 1990.

Page 27 Part no. 44-00003-13
YOUR PARTNER IN MICROCIRCULATION Language: English

PeriFlux System 5000 Extended User Manual

The measuring volume is that volume of tissue from which a contribution to the signal is available.
Since the degree of absorption of light by the skin is influenced by blood content, degree of oxygen-
ation and pigmentation, the value of the measuring depth is an estimate.
For example, in normal skin and using the Perimed laser Doppler instruments and a probe with standard
fiber separation (0.25 mm) and 780 nm wavelength, the measuring depth is one half to one millimeter.
In blood-rich organs, such as kidney and liver, the measuring depth is considerably less than one milli-
meter.
When the blood supply to a region is occluded, the “apparent” measuring depth will increase since the
lack of blood will permit more passage of light. Thus, perfusion in other areas of tissue than those being
examined may contribute to the signal.
A light source with a wavelength of 633 nm has less penetration than a light source with a wavelength
of 780 nm1.
A short distance between the transmitting and receiving fibers results in a shallower measurement than
a wide fiber separation. Probes are available with fiber separations from 0.15 to 1.2 mm.
NOTE!
If fibers with a small fiber separation are chosen for measurements on tissues with low
perfusion, spatial variations will increase since there are fewer capillaries in the measuring
volume.

Cross-talk between LDPM probes
If two probes are placed close to each other, the laser Doppler signal may be affected if laser light from
the first probe is picked up by the second probe. This additional laser light that is picked up by the
receiving fiber has traveled a longer distance and has picked up information from a deeper vascular bed
than the probe normally would. Consequently the signal is distorted and the perfusion value is unreli-
able. The effect of cross-talk decreases as the distance between the probes increases.
The "safe" distance between probes varies to a large extent with the absorption of light in the tissue.
Consequently, dark tissue (e.g. liver or kidney) is less affected by cross-talk.
Tests have shown that a safe distance between probes (even in light tissue) is about 9 mm, and if the
distance between the probes always is kept above 9 mm there will never be any problem with the cross-
talk effect.
A simple test to investigate if the probes are influencing each other is to attach the probes and measure
the value. When a stable perfusion level is reached, unplug one of the red marked probe plugs from the
laser Doppler and see if the other signal is affected. If the signal is not affected, the distance is safe.
Local variations
If the number of capillaries in the measuring volume of the probe is small, for example in forearm skin,
local variations can occur.
These variations can be reduced by using PROBE 413 Integrating Probe to measure over a larger area,
or PROBE 412 Deep Measurement Probe which can measure on a greater depth.
Effect of temperature on perfusion
Since the blood perfusion of skin is temperature-dependent, a prerequisite for comparable measure-
ments at different times is an identical ambient temperature. This is best achieved using a temperature-
controlled room2.

1. Principles of Laser-Doppler Flowmetry, Bonner & Nossal, in Laser-Doppler Blood Flowmetry, pp. 17-45, eds.
Shepherd & Öberg, Kluwer Academic Publishers, 1990.
2. Refer also to the papers by Micheels et al. (92P, 117P) in the Perimed Literature Reference List.

Part no. 44-00003-13 Page 28
Language: English YOUR PARTNER IN MICROCIRCULATION

However.g. posture) • Biological ZERO Time Constant A time constant is a smoothing filter. smoking. no.03 s. pCO2 and pH values • Systemic blood pressure • Cardiac output • Status (e.03. The intrinsic contraction of endothelial cells in blood vessels occurs at about 8 cycles per minute. Example: Figure 22 shows a magnified sec- tion of a trace using a time con- stant of 0. 679P in the Perimed Literature Reference List). The arrow shows a clearly visible dicrotic notch.g. other information is lost (see ref.03 s is required to see the dicrotic notch of a human or to detect the faster heartbeats of rats and mice. diet) • Provocation (e. medicines. Page 29 Part no. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English .2 s is sufficient to detect a human heartbeat.PeriFlux System 5000 Extended User Manual Analyzing the results Comparing laser Doppler values To be able to compare laser Doppler values from different instruments. at this high time constant. it is essential that the measure- ments are standardized. A lower time constant of 0. • Type of instrument • Wavelength of laser light • Type of probe • Fiber separation in probe • Time constant • Temperature provocation • Bandwidth of instrument Subject parameters include: • Temperature of the subject (and ambient temperature) • Blood pO2. it is necessary to consider the following parameters. Figure 22 Dicrotic notches visible with time constant 0. Each heartbeat is clearly separated. The extrinsic muscle contraction due to the autonomic nervous system occurs at about 1-6 cycles per min- ute. A high time constant (3 s) can be used to study vasomotion of 1-6 cycles per minute. Standardization is related to both the instrument and the subject. When comparing measurements. A time constant of 0.

Part no. 44-00003-13 Page 30 Language: English YOUR PARTNER IN MICROCIRCULATION . The result is false. Figure 23 shows movement artifacts in a graph with a heartbeat trace. Movement artifacts always generate a positive addition to the signal. artifacts can be generated by movements of the LDPM probe relative to the tissue. and by fixing the fiber optic cable and the probe relative to the tissue. non-perfusion related signals which are only present while the optical fiber is being moved. Artifacts can however be reduced to a minimal level by choosing the correct type of probe for the appli- cation. In addition. Figure 23 Movement artifacts. PeriFlux System 5000 Extended User Manual Movement artifacts Most optical fibers can generate artifact signals if they are moved or knocked during measurements.

PF 5020 Introduction The PF 5020 Temp Unit is designed for one or two Thermostatic probes. Page 31 Part no. do not allow the thermostatic probe/thermostatic probe holder temperature to exceed 43 °C in tests exceeding 30 minutes. Intended Use/Indications for Use PF 5020 Temp Unit is indicated for use to maintain a constant temperature of the skin tissue thus avoid- ing influence of room temperature and keeping the skin physiology intact. The use of the probes. NOTE! The PeriFlux System 5000 internal software needs to be 1. • Heat is used to perform thermal provocation and thereby obtain maximum dilation of the microvas- cular bed to study the "reserve capacity" of the tissue. Local heating can be used in many ways. • The blood flow changes at different temperatures. It is also intended to study the vascular response in skin tissue at different temperatures. If e.PeriFlux System 5000 Extended User Manual Temp Unit . Thermostatic probe holders.20 or higher to use the PF 5020 Temp Unit. To study the change in blood flow at different temperatures the temperature is increased in steps from 30 °C to 44 °C.g. healthy subject). Skin perfusion is strongly dependent on skin temperature and as a rule the perfusion value in normal tissue will rise during increased heat. The probes. For neonates. • It takes time for skin perfusion to reach a steady state when the skin is heat stimulated. It is also intended to perform thermal provocation of skin tissue and thereby obtain maximum vasodila- tation to study the capacity of the vascular bed. • An important condition for comparing skin measurements made at different points in time is that they are made at the same temperature. The PF5020 Temp Unit is used to heat tissue locally and allow laser Doppler measurement in the locally heated area. Settings around 30-34 °C are used to avoid the influence of room temperature and other external parameters. The mate- rials used have been practically tested over many years. Warning! If an error code is displayed and the acoustic alarm sounds. or Measurement sensors per Unit. probe holders and temperature sensors are only fixed to the skin for some hours. remove the thermostatic probe/probe holder from the patient immediately and check the error code in the trouble shooting section of the manual. Biocompatibility Probes and probe holders attached to the PeriFlux PF 5001 are usually fixed to the skin using double adhesive tape. PROBE 457 Angled Small Thermostatic Laser Doppler Probe is applied to a forearm and the temperature is set to 44 °C (in room temperature) a "normal" delay time to reach a steady perfusion level is 3 to 5 minutes (in a young. Use 40-44 °C. Perimed adhesive tapes are medical grade. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . probe holders and sensors has been shown not to have any adverse effects on skin. and are assessed and documented according to the guidance and principles given in ISO 10993-1.

minor error codes are cleared. SET . and error codes in red. • Display. This means that the display is turned off and the buttons are inactivated.PF 5010” on page 16 Table 8: Accessories for PF 5020. By pressing button once. Figure 24 PF 5020 Temp Unit. Set temperature Channel selector Pressing once displays preset tem. and the Standby / Alarm reset button is pressed. . . • Probe connectors. SET 1 2 Displays temperature for probe/sen- perature. Press button to start heating to the preset temperature.PF 5010” on page 16 Temperature Measurement Sensor 442 Thermostatic probe holder PF 450 (including PF 451) Probe Kit 457 PF 5810 and PF 5810-X LDPM Remote Panel See also “LDPM Unit . PeriFlux System 5000 Extended User Manual Layout Heating On/Off PF 5020 Display Starts heating to preset tempera. Insert probe or sensor here. Press appropriate button to display the temperature for probe or sensor 1 or 2. both for placing the unit in standby and for removing alarms. 44-00003-13 Page 32 Language: English YOUR PARTNER IN MICROCIRCULATION . Press again to stop heating. Explanation: • Heating On/Off button. the value of the preset temperature is displayed in red. • Standby / Alarm reset button. When heating is on the Heater indication light is illuminated. Red digits indicate that set values or an error code is displayed. . Part no. Press again to stop heating. the unit is placed in standby. If no error code is displayed. If an error code is displayed and the Standby / Alarm reset button is pressed. Accessories and Consumables Accessories Information 457 Non-invasive LDPM probe with heating capability See also “LDPM Unit . Green digits indicate that a measurement is displayed. . removes error codes. • Set button. • Channel selector. This is a dual function button. Temp Unit Values in green. Body Floating The instrument type is BF. Press button again within 3 seconds to increase the preset temperature. Connectors Standby / Alarm Reset Connectors for thermostatic probe Places the instrument in stand-by or and sensor. Check the error code in the trouble shooting sec- tion. changes preset temperature. and pressing repeatedly sor 1 or 2. preset temperature ture. Values up to 50 can be displayed.

See separate Probe brochure. some are described below. but can also be used elsewhere. The heater elements increase the temperature until the preset temperature is reached. Push the Heater On/Off button to start the heating. Apply the probes to the patient using double adhesive tape. A standard laser Doppler probe can be inserted through a hole in the probe holder. Push repeatedly on the button to increase the temperature. 7. 8. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Push once on the Set button to display the preset temperature. The probe is water- resistant. Proceed as follows: 1. Double-sided adhesive strips (PF 105-3) are used for fixation. toes and fingers. A high pitch tone indicates that the probe is correctly attached. The heat will be turned off and the heater indicator light stops being illuminated. It has a diameter of 10 mm and is intended for use on small areas. e. The temperature can be set between 26 and 44°C. and it is thus a combined laser Doppler probe and heat probe. The temperature is increased in steps 6.PeriFlux System 5000 Extended User Manual Consumables Information Adhesive rings PF 105-1 Adhesive strips PF 105-3 Table 9: Consumables for PF 5020. or Measurement sensors per Unit. NOTE! Due to the high power consumption it is only possible to use one PF450 thermostatic probe holder per PF 5020 Function Unit and two PF450 on a PeriFlux System 5000. but it is only possible to display (not set) the temperature when the Mea- surement Sensor is used. Turn on the instrument. Connect the probes/probe holders to the instrument (clean the optical plug of the thermostatic probe 457 with a lint-free cloth moistened with alcohol before connection to the PF 5010 unit). 2. Using Thermostatic Probes/Probe holders If two Thermostatic Probes are attached to the unit.g. Thermostatic Laser Doppler Probes There are several options to create local heat provocations. 9. PROBE 457 A combined laser Doppler and thermostatic probe used for local heat provocation while blood perfu- sion is measured. The heater indicator light is illuminated to indi- cate that heating is in progress. Page 33 Part no. Using Measurement Sensors Follow the instructions above. of 1°C. 4. PF 450 Thermostatic Probe Holder By using a Thermostatic Probe Holder it is possible to create a local heating and use ordinary laser Doppler probes. 3. Operation of the PF 5020 Temp Unit The PF 5020 Temp Unit can be equipped with one or two Thermostatic probes. 5. Thermostatic probe holders. both will be heated simultaneously to the preset temperature. In the thermo- static laser Doppler probe the laser Doppler fibers are included in the heating element. Push the Heater On/Off button again to switch off the heating.

Place the PF450 thermostatic probe holder on a flat surface. The tip of the probe should now be in level with the thermostatic probe holder and lightly touch the skin when applied. • If the temperature exceeds 46°C (Error code E31). It measures the temperature in an area of about 0. Push the clamp down until it lies firmly against the top of the probe holder. Attach the clamp around the probe to be used . e. Temperature sensors are attached to the skin using adhesive tape. Over-temperature Hazards and Safety Arrangements The safety device disconnects the heater current from the thermostatic probe/probe holder and an audio signal sounds in any of the following situations. 5. • If a thermostatic probe/probe holder is short-circuited or broken (Error code E30). Part no. Temperature Measurement Sensors PF442 Skin Spot Sensor The PF442 Skin Spot Sensor is a temperature measurement sensor. Slide the probe through the centre hole in the probe holder until it reaches the bottom. Adjustment clamp Figure 25 Probe adjustment clamp. but this will help to minimize artifacts. • When a thermostatic probe/probe holder is connected to the instrument (for alarm check purpose). 4.g. PeriFlux System 5000 Extended User Manual PF451 Probe adjustment clamp The PF451 Probe adjustment clamp is used with the PF450 thermostatic probe holder to fasten the probe at the correct distance from the tissue being studied. remove the thermostatic probe/probe holder from the patient immediately and check the error code in the trouble shooting section of the manual.6 mm in diameter (fast response to temperature variations). Warning! If an error code is displayed and the acoustic alarm sounds. It is not necessary that the probe touches the tissue. 44-00003-13 Page 34 Language: English YOUR PARTNER IN MICROCIRCULATION . 3. Proceed as follows: 1. a table or on top of the instrument. This is necessary to avoid occlusion of the tissue.PROBE 408 or 412. 2.

ethyl chloride. ethyl acetate. for instance Transpore® or Blenderm®. There must not be any excess liquid. which may penetrate the holder. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . PF450 Thermostatic Probe Holder The PF450 Thermostatic Probe Holder is not watertight and should not be dipped in liquids. chloroform.PeriFlux System 5000 Extended User Manual Cleaning/Disinfecting/Sterilizing PROBE 457 The combined probe is watertight and should be cleaned as normal laser Doppler probes. Tape remnants on the probe holder are removed by repeated applications of clean adhesive tape. Do not use acetone. benzene. Warning! Temperature for probes and microtips must not exceed 65 °C. or other strong solvents for cleaning the probes. Page 35 Part no. Disinfect by rubbing the PF450 Thermostatic Probe Holder with disinfecting liquids. alcohol concentra- tions greater than 70%. See “Clean- ing/Disinfecting/Sterilizing the LDPM probes” on page 23. Do not immerse the probe connectors in liquid solution.

If you do not do this. Remove the electrode during any of these procedures.do not use transcutaneous oxygen val- ues as blood gas values. Compro- mised haemodynamic state may cause misleading transcutaneous values. non-invasive monitoring of cutaneous oxygen and carbon dioxide. PeriFlux System 5000 Extended User Manual tcpO2/tcpCO2 Unit . a certain risk of applying harmful temperatures is always present. the transcutaneous pO2 and pCO2 Monitor (PF 5040) is intended to monitor the levels of oxygen and/or carbon dioxide from tissue transcutaneously. NOTE! The PeriFlux System 5000 internal software needs to be 1. When heating the skin. Do not use or store near heat or open flame . The error may have occurred because the device has been exposed to electrocautery or other high frequency elec- trical signals. and patients with vascular constrictions. Calibration gas cylinder: Before discarding an empty calibration gas cylinder. remove the electrode from the patient immediately and check the error code in the trouble shooting section of the manual. Do not puncture. although limited due to the control system of the monitor. Calibration gas cylinder: Contents under pressure. Do always pay attention to the use of hyperthermia for special patients . Do not use tcpO2/tcpCO2 monitoring on patients in a compromised haemodynamic state.e.g.PF 5040 Introduction The PF 5040 tcpO2/tcpCO2 Unit measures the oxygen and/or carbon dioxide from a tissue transcutane- ously.30 or higher to use the PF 5040 tcpO2/ tcpCO2 Unit. For neonates. The unit provides continuous. The PeriFlux System 5000 with the pO2/pCO2 Module may be used in hospitals and physician's offices. It is used to monitor transcutaneous pO2/pCO2 in adults and infants with and without gas anesthesia. which may affect the device and cause injury to the patient. LONG-TERM HEATING MAY BLISTER SKIN. For adults. PF 5040 is used with electrodes E5250 (tcpO2) and E5280 (tcpO2/CO2). Do not allow the electrode temperature to exceed 44°C in tests of 4 hours.exposure to temperature above 54°C (154°F) may cause contents to vent or cause bursting. Do not use tcpO2/tcpCO2 monitoring together with high frequency surgical procedures or a defibrilla- tor. remove the safety valve using the Valve Key (code 922-509). Known interference HALOTHANE: If a patient is treated with the anesthetic halothane. patients with low blood pressure. the calibration gas cylinder may burst if exposed to heat. an electrode temperature ranging from 43°C to 45°C is recommended. (Printed on the gas cylinder). an electrode temperature ranging from 42°C to 44°C is recommended. patients in shock. Part no. the operator should be aware that halothane may interfere with the tcpO2 readings and cause changes in skin blood flow. The system is not designed for use by patients without the supervision of a physician. Never discard container into fire or incinerator. If an error code is displayed and the acoustic alarm sounds. 44-00003-13 Page 36 Language: English YOUR PARTNER IN MICROCIRCULATION . Intended Use/Indications for Use When installed in the PeriFlux System 5000. Do not allow the electrode temperature to exceed 43°C in tests of 4 hours.. Warning! The PF 5040 tcpO2/tcpCO2 Unit is not a blood gas device .

package of 50 Fixation ring enforcement - Contact liquid TC 560.now calibrating CAL Error codes and calibration val- ues in red. The new value is stored in the instrument’s internal memory upon releasing the button. CO2. Consumables Information Fixation ring TC 550. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . CO2 or °C. the button clears minor errors. Sets calibration values and resets minor alarms. To set a new calibration value. or hold the button down to change the value faster. pressing the button once shows the current calibration value for the selected measurement parameter. O2 CO2 °C Electrode connector Electrode holder Body Floating Set / Alarm reset SET The instrument type is BF.PeriFlux System 5000 Extended User Manual Physiological measuring ranges Transcutaneous measurements can be used for continuous.instrument ready to use No light . Recalibration of the electrode is required each time a calibration value is changed. then release when the desired value is reached. Layout Calibration PF 5040 tcpO2 / pCO2 Display Full light . When an error code is displayed. Use the button to select which parameter to view (O2. Accessories and Consumables Accessories Information tcpO2 electrode E5250 tcpO2/CO2 electrode E5280 Calibration Unit TCC3 Remote Panel PF 5840 Extension cables for remote panel (3 m. If the error is not cleared by pressing the button. Blinking light . Always check the error code in the trouble shooting section of this user manual. 20 mL Membraning kit tcpO2 D826 Page 37 Part no. or temperature). PF 5842 NRB Oxygen mask Package of 10 Table 10: Accessories for PF 5040. Parameter selector Values are O2. Explanation The Set / Alarm reset button is a dual function button. 6 m) PF 5841.uncalibrated Values in green. package of 50 or 100 Fixation ring. Pipe stub connector For calibration gas. contact your Perimed representative. non-invasive monitoring of cutaneous oxy- gen in neonates and adults at levels up to 1999 mmHg (267 kPa) of pO2. Figure 26 PF 5040 tcpO2/CO2 Unit. When no error code is present. The value is displayed in red for 5 seconds. strong adhesive TC 555. press and release the button until the desired value is reached.

Note that electrode E5250 and electrode E5280 require different membraning kits. • Insert the electrode head into the membrane unit (Figure 27. • Turn clockwise (Figure 27. then leave the elec- trode in the holder for 30 minutes before performing a second calibration. Membraning procedure 1. (A white unit for tcpO2 electrode. • Rub the electrode measuring surface carefully 2-3 times to remove the thin layer of silver that has precipitated on the electrode’s measuring surface. green tcpO2/tcpCO2 Membrane Unit with mounted membrane and O-ring. using the Cleaning Paper (Figure 27. 2) to release the O-ring. 6). • Remove the electrode and wipe off the surplus electrolyte with a soft tissue. 3. D280. Remover. pos. 1). The procedure is described below. the electrode must be calibrated twice. Fold the Cleaning Paper to clean the groove on the electrode face (Figure 27. 5). 4. on the electrode house. Electrode: E5250 E5280 Electrode for both tcpO2 and tcpCO2 mea- Function: Electrode for tcpO2 measurements surements. Clean the electrode surface: • Absorb old electrolyte solution. pos. Remove the old O-ring and membrane: • Slide the O-ring Remover under the O-ring (Figure 27. After remembraning. 9).) • Firmly press the electrode into the membrane unit until a click is heard (Figure 27. just above the arrow. pos. Includes S48016 Electrolyte Solution. electrode remembraning is recommended every week. PeriFlux System 5000 Extended User Manual Consumables Information Membraning kit tcpO2/CO2 D280 Calibration Gas TC510 Table 11: Consumables for PF 5040. NOTE! Make sure there are no air bubbles trapped under the new membrane. O-ring Remover. pos. 4). pos. Check that the electrolyte covers the entire surface without air bubbles. O-ring two pre-mounted membranes and O-rings. see Table 12. pos. Membrane the electrode: • Place the membrane unit on a hard and stable surface. and Cleaning Paper. • Peel off the membrane (Figure 27. Part no. Table 12: Electrode types. pos. Membraning the TC electrode To obtain reliable measurements. Use 2 drops of Electrolyte Solution to cover the exposed measuring surface (Figure 27. PF 5040. pos. 8). and Cleaning Paper. 3) and remove it (Figure 27. NOTE! Inadequate cleaning may result in a rejection of the electrode during calibration. 44-00003-13 Page 38 Language: English YOUR PARTNER IN MICROCIRCULATION . Leave the electrode in the holder and wait 30 minutes between the calibrations. Membraning kit: white tcpO2 Membrane Unit with one pre. pos. Includes S44316 Electrolyte Solution. 5. D826. 2. 7). the electrode must be recalibrated twice. NOTE! After remembraning. a green unit for combined tcpO2/tcpCO2 electrode. Calibrate once.

Page 39 Part no. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English .PeriFlux System 5000 Extended User Manual Figure 27 Remembraning the electrode.

9% O2) as this will result in biased oxygen measurements. Warning! Do not perform calibration in atmospheric air if the oxygen content of the room air deviates from the oxygen content of normal atmospheric air (20. see separate section). The Calibration indicator light will flash and the °C light will be illuminated until the preset temperature is reached. 5. Push the CAL button on the PF 5040 tcpO2/tcpCO2 Unit to initiate the calibration. Calibration with calibration gas Proceed as follows: 1. NOTE! If the electrode has not been used for 24 hours. or if it has been remembraned. PeriFlux System 5000 Extended User Manual Calibration Calibration ensures accurate measurements and should be performed: • prior to each monitoring period • when changing measuring sites • every four hours • when changing between patients • every time an electrode has been remembraned. 3. 3. The E5250 tcpO2 electrode can be calibrated in atmospheric air or with calibration gas TC510. (If the red light remains lit. then leave the electrode in the holder for 30 minutes before performing a second calibration. The E5280 combined tcpO2/tcpCO2 electrode is calibrated with the calibration gas TC510 supplied from the TCC3 Calibration Unit. The green light will flash to indicate that gas is flowing. 2. Press the button on the TCC3 Calibration Unit. minimum 2 bar. Setting the electrode temperature Proceed as follows: 1. 44-00003-13 Page 40 Language: English YOUR PARTNER IN MICROCIRCULATION . 2. 4. the batteries in the TCC3 are exhausted and should be replaced. When the preset temperature is reached. Calibrate once. Under these circumstances calibration gas TC510 should be used. The letter “C” is displayed. indicating that the electrode is placed correctly in the holder and the PF 5040 tcpO2/tcpCO2 Unit is ready to calibrate. The current temperature is displayed in red. Connect the electrode plug to the Electrode connector on the PF 5040 tcpO2/tcpCO2 Unit. Part no. Connect the nylon tube from the pipe stub on the TCC3 Calibration Unit to the pipe stub on the PF 5040 tcpO2/tcpCO2 Unit. Press the button twice to move the indicator light to °C. the tcpO2 or tcpCO2 value is displayed. it must be calibrated twice. Press the button. Check the gauge for an adequate supply of gas. Insert the membraned electrode into the Electrode holder on the PF 5040 tcpO2/tcpCO2 Unit and turn clockwise. Change the set temperature by pressing the button.

leave the electrode in the electrode holder for 30 minutes and redo the calibration. the Calibration indicator light on the PF 5040 tcpO2/tcpCO2 Unit will be continuously illuminated to indicate that the system is calibrated. the heat to the electrode will be switched off to minimize electrolyte drying-out. the tcpO2 value is displayed. If the electrode has not been used for 24 hours. it will automatically shut off after 20 minutes. the heat to the electrode will be switched off to minimize electrolyte drying-out. the Calibration indicator light on the PF 5040 tcpO2/tcpCO2 Unit will be continuously illuminated to indicate that the system is calibrated. 5. After approx.. instead of a pO2 or pCO2 value. A new calibration will be required.-” is displayed when the calibration is finished. Page 41 Part no.PeriFlux System 5000 Extended User Manual 6. take the electrode out of the holder on the PF 5040 tcpO2/tcpCO2 Unit. A new calibration is necessary. The letter “C” is shown in the display indicating that the electrode is placed cor- rectly in the holder and the PF 5040 tcpO2/tcpCO2 Unit is ready to calibrate. Connect the electrode plug to the Electrode connector on the PF 5040 tcpO2/tcpCO2 Unit. take the electrode out of the holder on the PF 5040 tcpO2/tcpCO2 Unit. the gas flow can be manually shut off. Calibration with atmospheric air (E5250 electrode) Proceed as follows: 1. NOTE! In order to interrupt a calibration before it is finished. If the code “. Calibration may then be restarted. When the preset temperature is reached. 2. After approx. Calibration may then be restarted. or if it has just been remembraned prior to calibra- tion. If the electrode is placed in the holder for more than 30 minutes. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . The Calibration indicator light will flash and the °C light will be illuminated until the preset temperature is reached. 4. 7. leave the electrode in the electrode holder for 30 minutes and redo the calibration. If the electrode is placed in the holder for more than 30 minutes. Push the CAL button on the PF 5040 tcpO2/tcpCO2 Unit to initiate the calibration. See section “Correction of tcpCO2 reading to PsCO2 (37 °C)” on page 43. or if it has just been remembraned prior to calibra- tion. NOTE! In order to interrupt a calibration before it is finished. If the electrode has not been used for 24 hours. 2-4 minutes. that measured parameter has been rejected. Insert the membraned electrode into the Electrode holder on the PF 5040 tcpO2/tcpCO2 Unit and turn clockwise. By pressing the button on the TCC3 Calibration Unit. The tcpCO2 value will be reduced with a metabolic correction factor when the electrode is removed from electrode holder. However. 3. 2-4 minutes.

pH2O (sat.7 3.8 4. %O2 is the percentage of oxygen in the atmospheric air.36 27 26.8 3.2 3. Next. 7. a compensated pO2 (CAL) calibration value must be calculated and manually entered in the system to avoid inaccuracies.49 22 19.3 3. pH 2 O  sat.pH 2 O  t    ------------ 100 where: B is the barometric pressure (in mmHg or kPa). The compensated pO2 (CAL) calibration value is calculated according to the following formula: %O 2 pO 2  CAL  =  B .5 2. The parameter number will flash followed by the code.24 Table 13: Saturated water vapor pressure at different temperatures. 2.7 2. Perform the calibration as described above.77 29 30.8 2. 1kPa=7.4 3. The settings will be stored also after the instrument is switched off. 3.64 23 21.0 4. see Table 13. To perform a calibration with a compensated pO2 (CAL) calibration value. proceed as follows: 1. press the button and the current pO2 (CAL) value is shown in red. Choose OFF using the button.1 2. Use the button to toggle to position 7. It can be calculated from the formula: %RH pH 2 O  t  = ------------.50 mmHg. Press the buttons and simultaneously for 5 sec. Saturated water vapor pressure °C mmHg kPa 20 17. t (°C or °F). 5.33 21 18.81 24 22.56 28 28. 4. Release the button and the value is stored in the internal mem- ory. 44-00003-13 Page 42 Language: English YOUR PARTNER IN MICROCIRCULATION .00 25 23.00 30 31. t  100 where: %RH is the actual percentage of relative humidity in atmospheric air. t) is the saturated water vapor pressure at room temperature. Part no. PeriFlux System 5000 Extended User Manual Compensation for high humidity In an environment with high humidity and high temperature. Change pO2 (CAL) by clicking the button. pH2O(t) is the actual water vapor pressure (in mmHg or kPa) in the atmospheric air at room tem- perature.17 26 25. 6.

The pO2 (CAL) calibration value is calculated according to the following formulas: %O 2 pO 2  CAL  = B  ------------ 100 %CO 2 pCO 2  CAL  = B  ---------------- 100 where B is the barometric pressure in the chamber in mmHg or kPa.9 pO 2  CAL  =  760 . 18.5 mmHg should be selected. the calibration values (pO2 (CAL) and pCO2 (CAL)) must be set manually.--------. 100 % = 1.6 % 159 This means that the tcpO2 values during measurement will be 1. Release the button and the value is stored in the internal mem- ory. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Perform the calibration as described above. 7. Press the button and the current pO2 (CAL) value is shown in red. 3.7  ---------. Hyperbaric chamber If a calibration is performed at high pressure with the instrument outside and the electrode inside the chamber. 21 C  = 18. Correction of tcpCO2 reading to PsCO2 (37 °C) The externally applied heat used in transcutaneous monitoring causes a significant increase in blood flow to the skin beneath the electrode. %O2 = 20.PeriFlux System 5000 Extended User Manual Estimation of inaccuracy when not compensating for high humidity If no compensation for relative humidity or fluctuation in barometric pressure is made.6 % inaccuracy = -----------------------. Page 43 Part no.= 156.6 % too high. The parameter number will flash followed by the code. 5. the following inaccuracy can be estimated: Barometric pressure. Use the button to toggle to position 7. 2. Change pCO2 (CAL) by clicking the button. 4. The settings will be stored also after the instrument is switched off. 8.9 % 60 20. Change pO2 (CAL) by clicking the button.5 mmHg  100  100 This means that a calibration value of 156. t: 21 °C (70 °F) Relative humidity: RH = 60 % Saturated water vapor pressure at room temperature: pH 2 O  sat.156. proceed as follows: 1. To perform a calibration with manually set calibration values. Choose OFF using the button. If the pO2 (CAL) value of 159 mmHg is used instead the inaccuracy will be: 159 .7 mmHg Percentage of oxygen in atmospheric air. B: 760 mmHg Room temperature. 9. Use the button to toggle to CO2. 6. Press the buttons and simultaneously for 5 sec.

Apply the TC550 fixation ring to the measuring site as follows: • Remove the fixation ring from the protection film. Wait for a stable reading. pos. Clean the skin with alcohol. ref. 1). The in vivo response time is increased by lower electrode temperature. pos. 44-00003-13 Page 44 Language: English YOUR PARTNER IN MICROCIRCULATION . 5. Calibrate the electrode as described in section “Calibration” on page 40. NOTE! It is recommended to secure the electrode cable with transpore tape in such a way that the electrode cannot come loose from the fixation ring.5 kPa) Patient monitoring Application of an electrode on the patient 1. This correction is auto- matically done in accordance to the following formula: . 4. A dry razor is usually sufficient. PeriFlux System 5000 Extended User Manual This increase in blood flow leads to a shorter transit time in the capillaries. 4). Longer time may indicate an incorrect attachment of the electrode or a poorly selected measuring site. p.021   T-37   PsCO 2  37 C  = tcpCO 2  10 -k where: tcpCO2: is nominal pCO2 PsCO2(37 °C): is tcpCO2 corrected to 37 °C (assuming a patient temperature of 37 °C) T: is actual electrode temperature in °C 0. 2). To compensate for this. The typical physiological stabilization time of a patient is 10-15 minutes for the tcpO2 reading. as the external heat also causes a rise in the temperature of the tissue. 8. pos. Mount the electrode in the fixation ring: • Turn the electrode 1/4 clockwise to fasten it in fixation ring (Figure 28. 1 4 Figure 28 Application of electrode on the patient.021: is anaerobic temperature coefficient of pCO2 in blood1 k: is metabolic correction factor (4 mmHg or 0. Carefully remove all body hair from the site. • Run a finger round the rim circumference (Figure 28. 7. Part no. the tcpCO2 reading will be higher than the pCO2 if measured with the same blood flow at 37 °C. Fill the hole in the fixation ring with 3–5 drops of the TC560 Contact Liquid (Figure 28. Press firmly to prevent leaks. "The Acid-Base Status of Blood" by Ole Siggard-Andersen. if possible a slightly convex area. The metabolic CO2 production in the living epidermal tissue further increases the tcpCO2 reading. Copenhagen 1976. 2. Munksgaard. Select an appropriate measuring site on intact skin. 3. thus the tissue pCO2 equili- bration is closer to the pCO2 of the incoming arterial blood. However. 89. 6. • Press the centre of the fixation ring onto the measuring site with a finger. it is possible to correct the tcpCO2 readings from the PF 5040 tcpO2/tcpCO2 Unit for both the temperature effect and the epidermal metabolic contribution. 1. 0.

1. 3. Use a timer to ensure that the time is not exceeded. Remove any remaining moisture with clean tissues. 2. Cleaning of the transcutaneous electrode Gently wipe the electrode and cable with a soft cloth or tissue moistened with water.3 °C from the preset temperature. the heat to the electrode will be switched off to minimize electrolyte drying-out. Typically 15-20 applica- tions are required before the tape remains clear. Maintenance NOTE! Always handle the electrodes. Disinfection of the transcutaneous electrode The electrode manufacturer (Radiometer Copenhagen) recommends the following water-based disin- fection solutions for disinfection of the electrode and cable: • MadaCide-FD (MADA Inc. Page 45 Part no.PeriFlux System 5000 Extended User Manual NOTE! To optimize oxygen skin diffusion the stratum corneum can be removed by repeated appli- cations of clean adhesive tape before applying the fixation ring. During monitoring. a hand lotion.) • Control III (Maril Products Inc. Immerse the electrode and only the first part of the cable in one of the recommended water-based disinfection solutions. or a disin- fection solution) based on isopropanol / propyl alcohol / alcohol as frequent exposure to these products may damage the electrode cable. NOTE! Avoid exposing the electrode cable to any product (for example. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . with care in order to avoid damage and to extend their useful life. Be careful when removing the fixation ring from fragile skin.) Disinfection of the electrode and the first part of the attached cable (that closest to the electrode) is car- ried out with a membraned electrode prior to calibration. If the electrode temperature deviates more than 0. Avoid pressure on the membrane during cleaning. Clean the electrode after use to avoid residual contact liquid in the electrode holder. Use clean tissues to remove any remaining moisture. If the electrode is placed in the instrument electrode holder for more than 30 minutes. it is recommended to change the electrode site every 4 hours to avoid the risk of skin burns. Use clean tissues moistened with water to remove any remaining disinfectant from the electrode and cable. the temperature will be displayed until the preset temperature is reached. A new calibra- tion will be required.) • Hi-Tor Plus (Ecolab Inc. and in particular the connection between the electrode head and the cable.

10 15 cylinder. Do not heat sterilize the electrode as it cannot tolerate temperatures exceeding 70 °C. Part no. For change of batteries. it may be stored in the electrode holder. Figure 29 TCC3 Front panel. Storage of the transcutaneous electrode If the electrode needs to be stored for less than one week. for storage periods longer than one week. Calibration of internal barometer Check the internal barometer against a known calibrated barometer every 3 months. Wipe off any remaining disinfectant with water and then wipe dry with clean tissue. see sec- tion “TCC3 Changing batteries” on page 47 • Green diode – flashes when the valve opens for gas flow. indicating that the cylinder must be replaced. • Manometer – shows the actual pressure in the gas cylinder. Gas flow is automatically switched off after 20 minutes. Continued red light indicates exhausted batteries (beep for refusal and continued red light for 3 sec. The pointer settles in the LOW area when the gas pressure is too low. 44-00003-13 Page 46 Language: English YOUR PARTNER IN MICROCIRCULATION . Warning! Do not immerse the plug (at the end of the electrode cable) in disinfection solution. • Pipe stub – for connection of the nylon calibration tube to the pipe stub on the electrode socket on the PF 5040 tcpO2/tcpCO2 Units. TCC3 Calibration Unit TCC3 Front panel Green diode RADIOMETER COPENHAGEN TCC3 Manometer Flashes when the valve opens Shows actual pressure in gas for gas flow. The gas can be manually switched off by pressing the button. Heat sterilization of the electrode will cause it to fail. the electrode should be kept covered by its protec- tive cap (after placing 2 drops of electrolyte solution in it). This is described in section “Calibration of internal barometer” on page 49. indicating need for battery change. To connect a tube to the pipe 25 stub on the PF 5040 Units. Red diode Indicates low battery status by flashing. If followed by flashing green light this indicates that calibration can still be carried out but batteries are low. Explanation: • Button – to switch gas flow On/Off. bar Button 5 20 Pipe stub Switch gas flow On/Off. • Red diode – flashes accompanied by a beep when the button is activated. other- wise you risk causing the electrode to fail. PeriFlux System 5000 Extended User Manual The last part of the electrode cable (the part closest to the plug) can be disinfected by wiping with a soft cloth or tissue moistened with one of the recommended disinfection solutions. However. whenever pressing the button).

• Screw . Replace the six exhausted batteries (see mounting instructions on the labels inside the TCC3). the cali- bration gas cylinder may burst if exposed to heat. balance N2). Warning! Calibration gas cylinder: Contents under pressure. It is important to place the batteries in the direction indicated on the labels inside the TCC3. Do not use or store near heat or open flame – exposure to temperatures above 54 °C (154 F) may cause con- tents to vent or cause bursting.PeriFlux System 5000 Extended User Manual TCC3 Rear panel Calibration gas cylinder Screw Contains standard gas mixture. Explanation: • Calibration gas cylinder (Figure 30) – Cylinder with calibration standard gas mixture (5 % CO2. Warning! Calibration gas cylinder: Before discarding an empty calibration gas cylinder. For changing batteries. remove the safety valve using the supplied Valve Key (Code 922-509). Remove the panel. 3. Remove the protection cap covering the valve on the cylinder. 2.Used when changing batteries. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . TCC3 Changing batteries Figure 31 Changing batteries. Do not puncture. loosen the screw on the right side panel at the rear of TCC3. See section “TCC3 Changing batteries” on page 47. Never discard container into fire or incinerator. 1.9 % O2. Screw the cylinder clockwise as far as possible into the corresponding socket in the TCC3 Calibra- tion Unit. 2. (Printed on the gas cylinder). Figure 30 TCC3 rear view. Page 47 Part no. TCC3 Mounting a calibration gas cylinder 1. Using a coin. Remove the gas cylinder (Figure 31). If you do not do this. 20. 4.

Table 14: Selection of mmHG or kPa. This parameter should in all normal cases be set to On since E5247 no longer is manufactured. NOTE! 2 This parameter should in all normal cases be set to On. Factory default values are underlined. release the button and the value is stored in the internal memory. Use the button to change the value. Batteries of different fabrication. The parameter number will flash followed by the code. type. or if electrode is of type E5247 (OFF).5 V Alkaline IEC type LR6. PF 5040. This parameter is set individually for each installed PF 5040 tcpO2/tcpCO2 Unit. Auxiliary program To enter the auxiliary program. When the correct parameter value is obtained. 44-00003-13 Page 48 Language: English YOUR PARTNER IN MICROCIRCULATION . On or OFF. PeriFlux System 5000 Extended User Manual Batteries: 1. parameters and recalibration. Table 16: Selection of electrode type. Part no. Selection of correction of tcpCO2 values Parameter Description Code in display Selection if tcpCO2 values should be corrected for metabolic factors and temperature or not. 5. Selection of electrode type Parameter Description Code in display Selection if electrode of type E5250 or E5280 is used (On). See also section “Correction of tcpCO2 reading to PsCO2 (37 °C)” on page 43. or expiration date may cause leak- age. Use the button to move to the next parameter. The settings will be stored also after the instrument is switched off. type. PF 5040. The parameter is always set to On when the instrument is turned on. press the buttons and simultaneously for 5 sec. Remount the panel and tighten the screw firmly. never use batteries of different fabrication. In this program it is possible to set if tcpO2/tcpCO2 is displayed in mmHg or in kPa.3 x 50 mm (US size AA). size diameter 14. 3 NOTE! On or OFF. Selection of mmHg or kPa Parameter Description Code in display Selection for measurement units in mmHg or in kPa for tcpO2/tcpCO2. Warning! When changing batteries. Table 15: Selection of correction of tcpO2 values. Correction is performed if the parameter is set to On. NOTE! HG (mmHg) or PA 1 Changing this parameter will require new settings of calibration (kPa). or expiration date together.

NOTE! If the PF 5040 tcpO2/tcpCO2 Unit is connected to an older ver- sion of the PF 5001/5002 without internal barometer. NOTE! Barometric pres- 8 If the PF 5040 tcpO2/tcpCO2 Unit is connected to an older ver.PF 5002). <1061 . Table 18: Calibration of internal barometer. PF 5040. Page 49 Part no.PF 5002).0 %). If needed the internal barometer value can be adjusted by pressing the button.PF 5001.9 %) On or OFF. or in normal atmospheric air. Serial no. Serial no. sure value. sion of the PF 5001/5002 without internal barometer. They control the settings for a con- nected printer. Table 17: Selection of calibration parameters. Calibration of internal barometer Parameter Description Code in display The internal barometer value is displayed and can be checked against an external reference barometer. 7 % O2 = Percentage of oxygen in CAL1 standard calibration gas (20. this parameter is not available (Serial no. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . <1273 . this parameter is not available (Serial no. NOTE! There are two other parameters available – “4” and “5”. <1061 .PF 5001. see section “Auxiliary program” on page 59.PeriFlux System 5000 Extended User Manual Selection of calibration parameters Parameter Description Code in display ON is automatic setting of pO2(CAL) and pCO2(CAL) based on the inter- nal barometer according to the following formulas: %O 2 pO 2  CAL  = B  ----------- 100 %CO 2 pCO 2  CAL  = B  --------------- 100 where: B = Barometric pressure (in mmHg or kPa). <1273 . OFF is manual setting of pO2(CAL) and pCO2(CAL). % CO2 = Percentage of oxygen in CAL1 standard calibration gas (5.

PF 5050 Introduction Many common vascular tests involve some sort of occlusion with a blood pressure cuff. On smaller limbs the pressure should not be applied for more than 15 min. This simplifies some typical laser Doppler measurements that include occlusions with blood pressure cuffs. percent change from baseline. The cuff is inflated to a pressure well above the systolic blood pressure. Part no.g.g. PeriFlux System 5000 Extended User Manual Pressure Unit . do not con- nect to compressed air. The unit is a complement to the LDPM unit and the PSW software. The cuff pressure is then deflated linearly until the laser Doppler probe detects a return of perfusion. and monitors cuff pressure and deflates cuffs linearly. Common tests are: • Digital Systolic Blood Pressure (toe/ankle/finger pressure) • Post-Occlusive Reactive Hyperemia (PORH) • Skin Perfusion Pressure (SPP) • Pulse Volume Recording (PVR) Warning! On large limbs (e. Only connect the PF 5050 Pressure Unit to pumps supplied by Perimed. The cuff is inflated to a pressure well above the systolic blood pressure for typically 3–5 minutes. slope and time to peak. frequently check that the values displayed on the PF 5050 Pressure Unit correspond to the values on the manometer.50 or higher to use the PF 5050 Pressure Unit. The pressure at the return of perfusion is known as the digital systolic blood pressure (toe/finger pressure). NOTE! The PeriFlux System 5000 internal software needs to be 1. Digital Systolic Blood Pressure (toe/ankle/finger pressure) The digital systolic blood pressure measurement (toe pressure) is performed by placing the cuff on the toe and attaching the laser Doppler probe distal to the cuff. Then the pressure is released immediately and the laser Doppler signal is evaluated. such as digital systolic blood pressure. 44-00003-13 Page 50 Language: English YOUR PARTNER IN MICROCIRCULATION . To ensure correct measurements. Intended Use/Indications for Use Use of the PF 5050 Pressure Unit is indicated for Pulse Volume waveform Recordings (PVR) on limbs and digits. The PORH measurement is performed by placing the cuff on the limb and attaching the laser Doppler probe distal to the cuff. It is also intended to measure the mean pressure in a blood pressure cuff to simplify simultaneous mea- surements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor. Post Occlusive Reactive Hyperemia (PORH) PORH is a technique to study a microcirculatory reaction after an occlusion.g. Post Occlusive Reactive Hyperemia (PORH). risetime. Stud- ied parameters are e. and Skin Perfusion Pressure (SPP). legs and arms) the occlusion should not be applied for more than 5 min. Do not inflate the cuff to more than 300 mmHg. typically 3–5 minutes. e. Do not place cuffs over wound areas. The Pressure Unit has been developed to simplify and standardize these tests.

The skin perfusion pressure measurement is performed similarly to the toe pressure measurement. PUMP CUFF Connector for Cuff Standby / Alarm Reset Places the unit in standby or removes error codes. and the pressure at the return of the perfusion is the skin perfusion pressure. Cardiac Floating The instrument type is CF.9x9 cm 2 digit cuffs (UDC 2. The PVR measurement is performed by placing the cuff and setting the pressure in the cuff to 50 mmHg for digits and 60 mmHg for larger limbs. Page 51 Part no.5x9 cm 2 penile cuffs (UPC 2. RUN Error codes in red. The pressure is inflated and linearly deflated. Pulse Volume Recording (PVR) PVR is a technique to display the shape of the heartbeat (amplitude. risetime and form) in the local macrocirculation.9) 1.5 meter) PF 5052 3 Cuff extension tubes (60 cm) 1 Cuff extension tube (150 cm) 2 Cuff extension tube (100 cm) 2 T-joints for extension tubes (all female) 1 Stopcock (valve for PVR measurements) Table 19: Contents of Standard accessory kit for PF 5050. The arterial pulsations in the limb will be trans- ferred to the cuff as changes in the cuff pressure.5) 2. Accessories and Consumables Standard Accessory Kit PF 5051 2 digit cuffs (UDC 1. Accessories Information Pump with manometer PF 5052 Rapid cuff inflator E 20 Foot switch for E 20 rapid cuff inflator - Air source for E 20 rapid cuff inflator AG 101 Table 20: Accessories for PF 5050. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English .PeriFlux System 5000 Extended User Manual Skin Perfusion Pressure Skin perfusion pressure is a technique to display the microcirculatory pressure (“capillary pressure”). Inflator Open OPEN Opens valve (instant deflation). Press again to start deflation Connector for Hand Pump or Cuff (Indicator light blinking). Figure 32 PF 5050 Pressure Unit. frequency. Layout Indicator light PF 5050 Run Pressure Unit Display Press once to close valve Pressure values in green.5) 2. The difference is that the laser Doppler probe is placed under the cuff.5x12 cm (for large toes) 1 Pump with manometer and extension tube (1. This technique is also known as airplethysmography. (indicator light continuously lit).

The cuff with extension tube is connected to the cuff connector on the module. 1.3 Segmental cuffs SC 10. 3. 60 cm or 180 cm Cuff Figure 33 One measurement site.5 Penile cuffs UPC 2. 2. SC 12RB Table 21: Consumables for PF 5050. Part no. One measurement site The hand pump with manometer is connected to the pump connector on the module. Connecting the pump and tubing The equipment is configured differently depending on the intended measurement. PeriFlux System 5000 Extended User Manual Consumable Information Rat tail cuff UDC XXS Digit cuffs UDC 1.6. 44-00003-13 Page 52 Language: English YOUR PARTNER IN MICROCIRCULATION . PF 5050 Hand pump Extension tube.5. 12 Transmetatarsal cuff TMC 7 Replacement bladders SC 10RB.9.

long range With three measurement sites. PF 5050 Extension tubes Hand pump Cuff Extension tubes T-joints Cuff Cuff Figure 34 Three measurement sites. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . the toe pressure can be measured in both toes at the same time as the bra- chial pressure is measured.PeriFlux System 5000 Extended User Manual Three measurement sites. Use two T-joints when measurements are made on three sites simultane- ously. PVR When PVR is performed it is very important to minimize dead volume in the tubing. Page 53 Part no. With the use of a stopcock it is possible to eliminate the dead volume in the hand pump. PF 5050 Stopcock Extension tubes Hand pump Cuff Figure 35 PVR setup.

since the pressure gradient between the inside and the outside of the cuff decreases. This saves time and minimizes the influence on the tis- sue. 1. This may be apparent when the Pressure Unit is used to deflate a cuff with a large inner volume. the deflation may not be linear all the way down to 0 mmHg. Deflate the cuff instantly by pressing OPEN . 11. 1. 7. 9. Inflate the cuff well above the systolic blood pressure. Close the valve by pressing RUN . 2. Wait 10 seconds with an empty cuff to let the tissue recover. Wait until the perfusion returns. Connect the instrument to a computer program or pen recorder where the Pressure signal and the laser Doppler signal are recorded simultaneously. Start cuff deflation by pressing RUN . Wait 10 seconds with an empty cuff to let the tissue recover. 4. 4. Wait a few seconds until the perfusion stabilizes. Another measurement may now be performed (start with step 5. for instance 200 mmHg. Performing a skin perfusion pressure measurement Proceed as follows. The Indicator light will start flashing. The Indicator light will be lit. The Indicator light will start flashing. 10. 11. 10. 44-00003-13 Page 54 Language: English YOUR PARTNER IN MICROCIRCULATION . The Indicator light will be lit. 12. Apply the laser Doppler probe under the cuff. seen as a significant increase of the laser Doppler signal. 3. 7. 12. 5. 2. Connect the hand pump and cuff to the instrument. If an inflated cuff deflates into the open air. Apply the laser Doppler probe distal to the cuff. Deflate the cuff instantly by pressing OPEN . Apply the cuff on the measuring site and let the patient rest in a supine position. Inflate the cuff well above the systolic blood pressure. for instance 200 mmHg. reject it and perform an additional measurement. 6. NOTE! During the inflation the perfusion may rise because of the mechanical action applied on the finger by the cuff. Part no. Wait a few seconds until the perfusion stabilizes. Another measurement may now be performed (start with step 5. The pres- sure when this occurs is the digital systolic blood pressure. 8. This saves time and minimizes the influence on the tis- sue. PeriFlux System 5000 Extended User Manual Performing a digital systolic blood pressure measurement Proceed as follows. 3. Close the valve by pressing RUN . Apply the cuff on the measuring site and let the patient rest in a supine position. Wait until the perfusion shows a significant increase. The pressure when this occurs is the digital systolic blood pressure. 6. Connect the hand pump and the cuff to the instrument. It is recommended to perform at least 3 measurements to obtain a reliable mean value. 5. above). above). If a measure- ment diverts significantly from the rest in a test. 9. Connect the instrument to a computer program or pen recorder where the Pressure signal and the laser Doppler signal are recorded simultaneously. 8. Start cuff deflation by pressing RUN . Thus. the pressure will drop fast in the beginning and slower at the end.

Table 22: Selection of mmHg or kPa. Selection of mmHg or kPa Parameter Description Code in display Selection for measurement units in mmHg or in kPa for pressure. Attach the supplied stopcock to the pump inlet on the instrument. release the button and the value is stored in the internal memory. Close the valve by pressing RUN . Auxiliary program In the auxiliary program it is possible to calibrate the Function Unit and set if the pressure should be displayed in mmHg or kPa. If an inflated cuff deflates into the open air. NOTE! It is important to minimize dead volume. If a measure- ment diverts significantly from the rest in a test. Performing a Pulse Volume Recording (PVR) Proceed as follows. press the buttons OPEN and simultaneously for 3 seconds and a program parameter will appear on the display. Apply the cuff on the measuring site and let the patient rest in a supine position. 7. since the pressure gradient between the inside and the outside of the cuff decreases. (kPa). Thus. 3. Page 55 Part no. especially for digit cuffs because of their small size. 2. Inflate the cuff to 50 mmHg for digits and 60 mmHg for larger limbs. Use the OPEN button to move to the next parameter. Thus. To enter the auxiliary program. Close the stopcock to minimize dead volume.PeriFlux System 5000 Extended User Manual It is recommended to perform at least 3 measurements to obtain a reliable mean value. 5. PF 5050. only use 60 cm extension tube between instrument and cuff. 6. thus the PVR waveforms are only visible with a computer program or pen recorder. reject it and perform an additional measurement. the deflation may not be linear all the way down to 0 mmHg. When the correct parameter value is obtained. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Record the pressure fluctuations in the computer system or pen recorder. NOTE! HG (mmHg) or PA 1 Changing this parameter will require recalibration. the pressure will drop fast in the beginning and slower at the end. The display on the instrument always shows the absolute cuff pressure. NOTE! During the inflation the perfusion may rise because of the mechanical action applied on the finger by the cuff. Factory default values are underlined. 8. Connect the hand pump to the stopcock and the cuff to the instrument (only use the 60 cm cuff extension tube). The Indicator light will be lit. 4. Connect the instrument to a computer program or pen recorder where the Pulse Volume Recording signal is recorded. Use the button to change the value. 1. This may be apparent when the Pressure Unit is used to deflate a cuff with a large inner volume.

and sterilized with Ethylene oxide at temperatures up to 60°C. PeriFlux System 5000 Extended User Manual Calibration Normally there is no need for calibration of the pressure unit. or dip in alcohol and let dry in air. Wipe with a cloth moistened with alcohol. They may be disinfected by wiping with alcohol. NOTE! Do not autoclave cuffs. Alcohol may be used as a disinfectant only for polyurethane cuffs. They control the settings for a con- nected printer. Ventilate to ensure that the cuffs are completely dry. Disposable cuffs are thrown away after use. Part no. plasma (e. Ventilate to ensure that the cuffs dry com- pletely. PF 5050. STERRAD®. ASP) and radiation. They may be sterilized with a solu- tion of 5% chlorine bleach in water. NOTE! There are two other parameters available – “4” and “5”.) can be used as a disinfectant for the cuff bladders. Cleaning and care The blood pressure meter can be disinfected by wiping with conventional agents. see section “Auxiliary program” on page 59. Parameter Description Code in display 1.g. Inflate cuffs only when applied to a subject. T-Spray II (Pharmaceutical Innovations Inc. Do not use alcohol products to clean latex cuffs (models DC and PC). Table 23: Calibration. penile and rat tail cuffs can be cleaned with soap and water. or with gas at temperatures up to 60°C (Ethylene oxide). Cal starts blinking. if the unit for some reason does not display a pressure of zero with no cuff attached. 6 CAL 3. Remove the tubes from the unit and click OPEN to open the valve. Change the parameter to "6". Wait until the display turns green (approx. However. Click . Ethylene oxide. Medically approved plastic film can be used under non-dis- posable cuffs to avoid contamination and transmission of infection from ulcerated or infected areas. 44-00003-13 Page 56 Language: English YOUR PARTNER IN MICROCIRCULATION . Digit. Penile and Rat Tail Cuffs Digit. 5 sec). These are marked UDC or UPC (PolyUrethane Digit/Penile Cuff). Segmental and Transmetatarsal Cuffs The segmental (arm and ankle) and transmetatarsal (metatarsus or wrist) cuffs have removable nylon covers that can be machine washed and line dried. The tubing (Tygon S- 50-HL Hospital and Surgical tubing) can be cleaned with soap and water or sterilized with autoclave. Do not expose to prolonged sunlight or heat. you need to perform a zero pressure calibration. 4. 2.

Activate the Function Units to be included in the printout and calibrate probes and sensors if needed. This means that it is NOT possible to inactivate a PF 5010 or PF 5020 or to check parameters for PF 5040 during printout. When the printer is turned on again the new settings will be active. Attach probes and sensors to the subject. NOTE! Read the Seiko Instruments USER'S GUIDE for DPU-3445 carefully before connecting the printer to the PeriFlux System 5000. NOTE! During printing it is not possible to add or remove data channels. To change the number of channels in the printout it is necessary to power the printer off and activate or deactivate the appropriate channels. then power the printer on again. 3. Power on the PeriFlux System 5000. See marker section. Seiko Instruments USER'S GUIDE Read the USER'S GUIDE supplied with the DPU-3445 carefully before using the printer. Stop the printout before inactivating or checking parameters. Power on the DPU-3445 Printer. 2. Connect the SC-3445 interface cable between the DB9M-M Mini Gender Changer and the DPU-3445 Printer. the printer may automatically be turned off after a few seconds. Page 57 Part no. 4. Connect a DB9M-M (Male-Male) Mini Gender Changer to the Serial Port and secure it using the screws. This is due to down- load of new parameters and communication settings to the printer. 6. 5. The printout contains graphs and numerical data. When printing has started the or buttons can be used for adding markers. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Connection to PeriFlux System 5000 Please check that the Printer/Computer switch on the back of the PeriFlux System 5000 is set to Printer. Function Units not to be included in the printout should be placed in Standby or not calibrated. How to Use DPU-3445 Printer Do the following to start the printout: 1. All instruc- tions on handling and maintenance of the printer are found in the DPU-3445 USER'S GUIDE. NOTE! The first time the printer is connected to the PeriFlux System 5000 and the printer is turned on.PeriFlux System 5000 Extended User Manual Printer DPU-3445 Introduction PeriFlux System 5000 can be equipped with a Seiko DPU-3445 Thermal Printer to allow easy docu- mentation when there is no need for data storage and advanced analysis. The printing will start and continue until the printer or the PeriFlux System 5000 is powered off.

they are only presented as numeri- cal values. even if other channels are activated during the printout. started or stopped heating. Instrument Settings: The Instrument Settings block contains information regarding active and non-active Function Units. date and comments to later identify the recording. Part no. 44-00003-13 Page 58 Language: English YOUR PARTNER IN MICROCIRCULATION . Not all information will be presented as graphs. NOTE! To change the configuration of the printout it is necessary to turn the printer off and to turn it on again when the correct number of active channels is set. or for PF 5040 Unit to set Calibration parameters. etc. Table 24: Printed information. The button will add a marker during printout. * Total Backscatter is only printed when table values are printed. and for the PF 5040 tcpO2/tcpCO2 Unit only values from calibrated electrodes are printed. However. Patient Information: The Patient Information block allows the user to fill in patient name. When a re-scaling is done a new scale-bar is printed.g. Place in standby using the button PF 5020 Temp Unit Temp 1. Printed data channels Only active channels are printed. NOTE! When printing has started. See Table 24 below. A marker is used to document something. If more data channels are printed. Only channels that are active when the printer is powered on will be printed. Automatic scaling of Graphs To obtain good resolution the graphs are automatically re-scaled when the values are too large or too small. an elevation of the measured limb. 2. PeriFlux System 5000 Extended User Manual Print layout The printout is built up of three separate blocks that are described below in the order they are printed. For the PF 5020 Temp Unit and the PF 5040 tcpO2/tcpCO2 Unit only channels with attached sensors are printed. 1. Function Unit type Table printout Graph printout To exclude from printout Perfusion Place in standby using the button PF 5010 LDPM Unit Perfusion Total Backscatter* before starting printout. started or stopped occlusion. opera- tor. due to limited paper width it is not possible to present a combination of graphs and numerical values for more than 4 channels of graphs and 5 channels of numerical values. type of electrodes. 3. used temperatures. Data is normally pre- sented as both numerical values and graphs. it is not possible to inactivate a PF 5010 or PF 5020 Unit. tcpCO2 Do not calibrate or remove electrode before starting printout. Markers A marker is an asterisk (*) that is placed in the tracing when the or button is pressed on an active Function Unit. Measurements: The Measurements block contains the data to be printed. e. PF 5040 tcpO2/tcpCO2 Unit tcpO2. Temp 2 No graph printout or remove sensors before starting print- out. tcpCO2 tcpO2.

Press the buttons SET and simultaneously for 3 sec. Setting Action 10 1 Value/10 min. release the button and the value is stored in the internal memory. Use the button to move to the next parameter.PeriFlux System 5000 Extended User Manual Auxiliary program In this program it is possible to set the print language and print speed. Function Unit type To enter auxiliary program Press the buttons and simultaneously for 3 sec. When the correct SET parameter value is obtained. Table 27: Selection of print speed. printer. Table 25: Auxiliary program. Selection of Print Language Parameter Description Code in display 000 English 001 Swedish 4 Selection of language for the printout. NOTE! The settings displayed in this section are printer specific. Factory default values are underscored. release the button and the value is stored in the internal memory. When correct parameter value is obtained. Use the button to move to the next parameter. and 8 will also be displayed. Press the buttons and simultaneously for 3 sec. 7. 5 1 Prints the mean value every minute. Use the button to PF 5010 LDPM Unit change a value. 2. When the correct Unit parameter value is obtained. release the button and the value is stored in the internal memory. The parameter number will flash followed by the code. Use the button to move to the next parameter. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . 3. Press the buttons OPEN and simultaneously for 3 sec. 002 Italian 003 French 004 German Table 26: Selection of print language. 10 Prints the mean value every ten minutes. release the button and the value is stored in the internal memory. Page 59 Part no. On the PF 5040 tcpO2/tcpCO2 Unit the auxiliary parameters 1. and on the PF 5050 Pressure Unit the auxiliary parameters 1 and 6 will be displayed. Selection of Print Speed Parameter Description Code in display Select print speed. See separate sections for description of these parameters. When the correct OPEN parameter value is obtained. 1 1 Value/min. Use the button to PF 5020 Temp Unit change a value. Use the button to move to the next parameter. NOTE! The Print Language and the Print Speed settings cannot be changed when the printer is connected. Disconnect the printer first to change the settings. Use the button to PF 5040 tcpO2/tcpCO2 change a value. Use the button to PF 5050 Pressure Unit change a value. The settings will be stored also after the monitor is switched off.

Check that the LDPM probe is clean and the probe tip is lightly touching the tissue. If microtips are being used. 44-00003-13 Page 60 Language: English YOUR PARTNER IN MICROCIRCULATION . the output signal will be zero. Table 28: Troubleshooting PF 5010 LDPM Unit. See Calibration test section. May be caused by reflections if there is a distance between the probe tip and the tissue. read “Instructions for use of Microtips” supplied with the Master Probe. There Overload (OL) are currently three different attenuator cables: PF 425 Attenuator Cable 30 % attenuation. check that it sticks well to the tissue. If a probe holder is used. If microtips are being used. thus the LLL. If double adhesive tape is used. If so. If a probe holder is used. check that it sticks well to the tissue. check that the probe holder is well fixed to the skin. an attenuator cable is used to reduce the laser light. Check if LLL or OL indicator flashes during the signal dropout. Low light level (LLL) Check for dirt in the connector on the front panel of the instrument. check that the probe holder is well fixed to the skin. read "Instructions for use of Microtips" supplied with the Master Probe. PF 424 Attenuator Cable 50 % attenuation. PF 429 Attenuator Cable 75 % attenuation. Check that the LDPM probe is calibrated. Returned light level is too low. point the tip at a sheet of white paper). Check if light is coming through the LDPM probe (in a dark room. If so. If a probe holder is used. The signal drops to 0 during measurements Check that the LDPM probe is clean and the probe tip is lightly touching the tissue. The values seem erroneous Check that the LDPM probe is clean and the probe tip is lightly touching the tissue. check that the probe holder is well fixed to the skin. Note that during an LLL condition. PeriFlux System 5000 Extended User Manual Troubleshooting PF 5010 LDPM Unit Symptom Cause/Action Instrument fails to start Wait 2 minutes and retry. Total Backscattered light (TB) is too low. Check that the LDPM probe is clean and the probe tip is lightly touching the tissue. Note that during an OL condition. If a probe holder is used. the tissue in it self might be so “pale” that too much light is returned. If OL still exists. check that the probe holder is well fixed to the skin. If double adhesive tape is used. Check mains cables and fuses. No laser light The fiber optic cable is not properly connected. the output signal will be zero. Part no. Which level of attenuation to select depends on how pale the tissue is. Total Backscattered light (TB) is too high. see above.

ature. acous. Remove probe/probe holder from patient. acous. If error reappears. 46 °C. tic alarm).failed. The LDPM probe was not immersed in the Motility Stan- E23 dard.Laser temperature error. Reset alarm. The LDPM probe was moving during Calibration. tic alarm). OL or LLL is displayed when CAL is pressed. Table 30: Error messages. (Displayed in red for all Internal error.error in Function Unit. alarm). Switch off the instrument and restart. If error reappears. acous. contact your Perimed representative. acous. tic alarm). If error reappears. acous. tic alarm). (Displayed in red. contact your Perimed representative. Function Units. The LDPM probe is not properly connected. contact your Perimed representative. (Displayed in red. If error reappears. Internal error. E22 The LDPM probe was not immersed in the Motility Stan- (Displayed in red. The LDPM probe is not properly connected. E31 Over-temperature safety Push the Alarm Reset button on the front panel. acous. If error reappears. tic alarm). tic alarm). contact your Perimed representative. tic alarm). The LDPM probe was not immersed in the Motility Stan- E21 dard. The LDPM probe was not immersed in the Motility Stan- E20 dard. change probe and if needed contact your Perimed representative.LLL during calibration. (Displayed in red for all Push the Alarm Reset button on the front panel. Table 29: Error messages. E32 Internal communication Switch off the instrument and restart. E30 Push the Alarm Reset button on the front panel. Switch off the instrument and restart. The LDPM probe is not properly connected. E33 Switch off the instrument and restart. PF 5010. tic alarm). (Displayed in red.OL during calibration. alarm). E02 Push the Alarm Reset button on the front panel. contact your Perimed representative. Remove probe/probe holder from patient. contact your Perimed representative. If error reappears. Function Units.Internal memory error. Switch off the instrument and restart. acous.Laser temperature error. M-standard calibration (Displayed in red. Broken probe/probe (Displayed in red.PeriFlux System 5000 Extended User Manual Error messages Error code Description Action E01 Push the Alarm Reset button on the front panel. If error reappears. tic alarm). device has detected tem- (Displayed in red. acous. acoustic Switch off the instrument and restart.Zeroing failed. E02 Push the Alarm Reset button on the front panel. E34 Re-set the Set temperature parameter to preferred temper- (Displayed in red.holder. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . acoustic If error reappears. OL or LLL is displayed when CAL is pressed. Page 61 Part no. PF 5020 Temp Unit Error messages Error code Description Action E01 Remove probe/probe holder from patient. change probe and if needed contact your Perimed representative. If error reappears. acous. (Displayed in red. The LDPM probe is not properly connected. contact your Perimed representative. (Displayed in red. OL or LLL is displayed when CAL is pressed. tic alarm). tic alarm). (Displayed in red. dard. Switch off the instrument and restart.peratures exceeding Switch off the instrument and restart. PF 5020. acous.Internal memory error. acous.

Replace the electrode. Electrode is not calibrated and Calibrate electrode. Error messages Error code Description Action Continue using the electrode as a single parameter Parameter has been rejected in electrode. Table 31: Troubleshooting PF 5040. Check gas calibration. Switch (Displayed in red for all electronic disturbance or defec. Push the reset button on the front panel. trode. ble or out of limits 20 min- utes after application. tion ring.braning. The electrode has not reached E41 Recalibrate. Electrode signal ranges not Reset alarm. Remembrane and recalibrate. acous. tion. with a new one.. If an error code still Function Units. pos- suddenly without any or air leakage under fixation ring. Reset alarm. acoustic tive monitor. lyte from membraning procedure.Laser temperature error. tative. Replace the electrode. Incorrect preset calibration value. contact your Perimed representative. Remembrane and recalibrate. Defective electrode. Membrane has not been changed E43 regularly or unsuccessful mem. E02 Switch off the instrument and restart. Evaluate patient status. power off and on again. suring on cal gas. O2/CO2 readings change Artifact due to patient movements Recalibrate and reapply electrode to the skin. not in holder.. Replace the electrode. appears. acous. Check the gas source and connection.utes during calibration. Electrode stability not acceptable. Code . Detach the electrode and ensure correct applica- constantly without any trode. Check the gas source and connection. Evaluate patient status. Defective electrode. Reset alarm. acous. Poor supply of calibration gas. sibly selecting a new measuring site. physiological cause when electrode mounted Improper attachment of the fixa. ment. Patient status unstable. contact your Perimed represen- tic alarm). ment. replace it tic alarm). acous. Improper attachment of the elec- Reapply the electrode. 44-00003-13 Page 62 Language: English YOUR PARTNER IN MICROCIRCULATION . tic alarm). braning.is displayed supply. O2/CO2 readings not sta- Inadequate vasodilatation. Remembrane. E42 Membrane has not been changed (Displayed in red. Poor supply of calibration gas. Check the value and recalibrate. physiological cause. Remembrane or change electrode. remembrane and recalibrate. PeriFlux System 5000 Extended User Manual PF 5040 tcpO2/tcpCO2 Unit Symptom Description Action O2/CO2 readings drift Insufficient removal of old electro- when electrode is mea. Defective electrode. tion. acceptable. Increase the distance from the interfering equip- CO2 readout. tic alarm). Check calibration values. If the monitor still rejects the electrode. If error reappears. O2/CO2 readings drift Improper attachment of the elec. Noise appears on the O2/ Interference by nearby equip. alarm). E01 Internal instrument error due to Remove sensor from patient immediately. Detach the fixation ring and ensure correct applica- on patient. (Displayed in red. preset temperature within 7 min- (Displayed in red. (Displayed in red. Part no.regularly or unsuccessful mem.

tic alarm). pO2 (CAL) and pCO2 (CAL)) have been reset to their default values: E49 (Displayed in red. Page 63 Part no. pressing button. No indicators lit when No batteries inserted.6 °C. E48 Switch off the instrument and restart. Temp 43 °C tic alarm). (acoustic beep). If the error code still Monitor defective.2 kPa) pCO2 (CAL) 38 mmHg (5.1 kPa) Change the Temp parameter or the error will reap- pear the next time the power is turned on. Change electrode. Maximum temperature limit reached. Remembrane and recalibrate. Reset alarm. Electrode defective. If error reap- (Displayed in red. Calibration can still be carried out. Table 33: Troubleshooting TCC3 Calibration unit. Membrane has not been changed E44 regularly or unsuccessful mem. E46 exceeds 0. tic alarm). Insert batteries. NOTE! All calibration parameters (Temp. contact your Perimed repre- sentative. acous. Replace the electrode. If the error code still Monitor defective. contact your Perimed representative. change electrode and if error code still appears. Red light for 3 sec. acous. Check the gas source and connection.Internal communication error. appears. Switch power off and on again.braning. E47 Switch off the instrument and restart. appears. tic alarm). tic alarm). (Displayed in red. contact your Perimed representative. Change electrode. E45 of 46 °C or higher and stopped (Displayed in red. acous. contact your Perimed representative. acous. tic alarm). Temperature deviation between both thermistors in the electrode Remove sensor from patient immediately. Reset alarm. acous. Change batteries. Poor supply of calibration gas. Change batteries. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Batteries exhausted. If error reap- (Displayed in red. contact your Perimed representative.Electrode defective. acous. Switch power off and on again. (Displayed in red.Internal memory error.Internal memory error. If the error still reappears.PeriFlux System 5000 Extended User Manual Poor response on pCO2. pO2 (CAL) 159 mmHg (21. pears. Defective electrode. Table 32: Error messages PF 5040. TCC3 Calibration unit Symptom Description Action Flashing red light Indicates low batteries. change electrode and if error code still appears. (acoustic beep). Hardware limitation cir- cuit has detected a temperature Remove sensor from patient immediately. pears.electrode heating.

consult the DPU-3445 Function Units. brated. Communication failure (Displayed in red on all Reset alarm on PF 5000. USER'S GUIDE for more information on trouble shooting. Check tubes and Pressure decreases erro- Leakage. PeriFlux System 5000 Extended User Manual PF 5050 Pressure Unit Symptom/Error code Description Action Check that the valve is closed. contact play does not correspond the pressure sensor is out of your Perimed representative. (Displayed in red on all Reset alarm on PF 5000. acoustic appears. 44-00003-13 Page 64 Language: English YOUR PARTNER IN MICROCIRCULATION . Table 36: Troubleshooting DPU-3445 printer. PF 5050. Error code Description Action E04 Switch printer off and on again. tative. If the error still exists. representative. Replace the manometer.Internal memory error. The pressure on the dis. manometer. acoustic Thermal Printer. alarm). The Function Unit must be recali- (Displayed in red. Error messages E01 Internal instrument error due to (Displayed in red for all Switch power off and on again. DPU-3445 Printer The trouble shooting section in this manual is limited to errors detected by PeriFlux System 5000. page 56. tic alarm). E51 Reset the alarm. The unit needs to be calibrated or Calibrate the unit. Part no. acous. If error reap- (Displayed in red. acoustic USER'S GUIDE for more information on trouble shooting. to the pressure on the order. The manometer is erroneous. E05 (Displayed in red on all Refill paper in the printer. If error reappears. alarm). alarm). If an error code still electronic disturbance or defec- Function Units. contact your Perimed represen- tic alarm). Push the Alarm Reset button on the front panel. consult the DPU-3445 Function Units. pears. Table 35: Error messages. Table 34: Troubleshooting PF 5050. between PeriFlux Sys- PeriFlux System 5000 tem 5000 and DPU-3445 If an error code still appears. alarm). cuff. PeriFlux System 5000 Internal printer error.Laser temperature error. contact your Perimed neously. Contact your Perimed representative. If the error still exists.Internal communication error. tive monitor. PeriFlux System 5000 Printer out of paper. contact your Perimed representative. acous. E02 Switch off the instrument and restart. For trouble shooting the printer. E50 Switch off the instrument and restart. (Displayed in red. acous. acoustic tion. contact your Perimed representative. Consult the DPU-3445 USER'S GUIDE for more informa- Function Units. please consult the SEIKO DPU-3445 USER'S GUIDE. Calibrate according to “Calibration” on tic alarm). E06 Switch printer off and on again. Contact your Perimed representative. If an error code still appears.

Degree of protection against electric shock: BF or CF depending on the installed Func- tion Units. Mains: 100–240 Volts. Contact: 3 kV) IEC 61000-4-3:1996: Immunity to radiated field (3 V/ m) IEC 61000-4-4:1995: Immunity to fast burst/tran- sients (1kV/0.requirements and tests for Medical electrical equipment. Electromagnetic compatibility . 1040.7 kg (when fitted with 4 Function Units). Page 65 Part no. Primary: T2 AL 250 V Fuse types: Internal: T3AL (On Power Unit) Primary rated currents: 115 V is 600 mA and 230 V is 300 mA Max Power 70 VA (when fitted with 4 Function Units). Class 1 laser product. Function Unit weight: 0.10 ISO 10993-1 Biological evaluation of medical devices Table 37: Technical specifications. IEC 60601-1-1 For PeriFlux System 5000 connected to Printer DPU-3445. consumption: Operating conditions: 10–35 °C Humidity: 30–85 % RH (non-condensing). IEC 55011:1990: Radiated Emission (Class B) IEC 55011:1990: Conducted Emission (Class B) IEC 61000-4-2:1995: Immunity to Electrostatic Dis- IEC 60601-1-2 charge (Air: 8kV. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . Particular requirements on Transcutaneous partial IEC 60601-2-23:1999 pressure monitoring equipment IEC 60825-1:2007/ FDA CFR Safety of laser products. 50 or 60 Hz. PeriFlux System 5000. See Technical Specification for respective Function Unit. Instrument NOTE! Classification: The manufacturer cannot guarantee the function of the instru- ment if it is exposed to radiation above the levels tested in IEC 60601-1-2.6 kg EC Declaration of Perimed declares the compliance of the instrument PeriFlux System 5000 with the conformity / MDD: requirement of the Medical Device Directive (MDD) 93/42/EEC. Standards to which con.PeriFlux System 5000 Extended User Manual Technical specifications PeriFlux System 5000 General Type of protection against electric shock: Class I equipment.5kV) IEC 61000-4-5:1995: Immunity to surges (1kV/2kV) Safety requirements for medical electrical systems. Function Unit 70 mm x 70 mm x 180 mm Dimensions (W ×H ×D): Weight: 7. Storage conditions: 0–50 °C Expected Lifetime 10 years under normal operation Dimensions (W ×H ×D): 300 mm x 104 mm x 321 mm with instrument legs folded up. The PeriFlux System 5000 is a Class IIa product according to Annex IX (93/42/EEC). General requirements for safety for Medical electri- IEC 60601-1 formity is declared: cal equipment.

Part no. signal 2 11 Function Unit 3.5 to +10 Volts. The output range is -2. For signal descriptions. 44-00003-13 Page 66 Language: English YOUR PARTNER IN MICROCIRCULATION . • PF 571 carries signal 1 and 2 for each Function Unit.15 m maximum length: Thermostatic Probe 457 2. PeriFlux System 5000 Extended User Manual Cables Transcutaneous electrodes E5250. see separate description for each function unit.85 m maximum length: PF 490 serial cable 4m maximum length: Mains cable 2. signal 2 2 Function Unit 4. E5280 2. Output signal (15-pole female analog connector) The analog connector is used for connecting to computer programs using A/D converter boards or con- necting to a chart recorder. signal 1 9 Function Unit 4.7 kOhm) 8 CTS Clear to send In Table 40: Output signal.5 m maximum length: Table 38: Cable specification. 15-pole. 9-pole.7 kOhm) 5 SGND Signal ground Both 7 RTS Request to send Out (+12 V via 4. signal 2 15 Signal Ground Table 39: Output signal. signal 1 3 Function Unit 3. signal 1 12 Function Unit 2. • PF 570 carries signal 1 for each Function Unit. Output signal (9-pole female serial connector) Signal levels and interface circuits for the connector for serial asynchronous communication are designed to meet the EIA RS-232 standard. signal 2 5 Function Unit 2. The interface description of the connector is as follows: Pin number Name Signal In/Out 2 RXD Received data In 3 TXD Transmitted data Out 4 DTR Data terminal ready Out (+12 V via 4. NOTE! Use of cables exceeding the specified maximum length listed above may result in increased emissions or decreased immunity of the PeriFlux System 5000. The pins on the 15-pole output have the following signals: Pin number Output 14 Function Unit 1. Two analog recorder cables are available. signal 1 6 Function Unit 1.

The customer or the user of PeriFlux System 5000 should assure that it is used in such an environment. The customer or the user of PeriFlux System 5000 should assure that it is used in such an environment.guidance The PeriFlux System 5000 uses RF energy only for its internal RF emissions Group 1 function. ±2 kV for power supply ±2 kV for power supply Electrical fast Mains power quality should be that lines lines Transient/burst of a typical commercial or hospital ±1 kV for input/output ±1 kV for input/output IEC 61000-4-4 environment. lines lines Mains power quality should be that Surge ±1 kV differential mode ±1 kV differential mode of a typical commercial or hospital IEC 61000-4-5 ±2 kV common mode ±2 kV common mode environment. If floors are covered (ESD) ±8 kV air ±8 kV air with synthetic material. for 5 sec. NOTE! UT is the a.5 cycles for 0. its RF emission are very low and are not CISPR 11 likely to cause any interference in nearby electronic equipment. <5% UT <5% UT (>95% dip in UT) (>95% dip in UT) for 0. RF emissions Class A CISPR 11 The PeriFlux System 5000 is suitable for use in all establish- Harmonic emissions Class A ments other than domestic and those directly connected to the IEC 61000-3-2 public low-voltage power supply network that supplies buildings Voltage fluctuations/ used for domestic purposes. If the user of the Peri- ruptions and voltage for 5 cycle for 5 cycle Flux System 5000 requires contin- variations on power ued operation during power mains supply input lines 70% UT 70% UT interruptions. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . <5% UT <5% UT (>95% dip in UT) (>95% dip in UT) for 5 sec. short inter. Emission test Compliance Electromagnetic environment . it is recommended IEC 61000-4-11 (30% dip in UT) (30% dip in UT) that PeriFlux System 5000 is pow- for 25 cycles for 25 cycles ered from an uninterruptible power supply. Page 67 Part no. Power frequency magnetic fields Power frequency (50/60 should be at levels characteristic of Hz) magnetic field 3 A/m 3 A/m a typical location in a typical com- IEC 61000-4-8 mercial or hospital environment. Electromagnetic immunity The PeriFlux System 5000 is intended for use in the electromagnetic environment specified below.c.5 cycles Mains power quality should be that 40% UT 40% UT of a typical commercial or hospital Voltage dips. the relative IEC 61000-4-2 humidity should be at least 30%.PeriFlux System 5000 Extended User Manual Guidance and manufacturer’s declaration The PeriFlux System 5000 needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document. Flicker emissions Complies IEC 61000-3-3 Table 41: Electromagnetic emission. Therefore.(60% dip in UT) (60% dip in UT) environment. Electromagnetic environment - Immunity test IEC 60601 test level Compliance level guidance Floors should be wood. Electromagnetic emission The PeriFlux System 5000 is intended for use in the electromagnetic environment specified below. concrete or Electrostatic discharge ±6 kV contact ±6 kV contact ceramic tile. mains voltage prior to application of the test level.

2 P 80 MHz to 800 MHz IEC 61000-4-3 80 MHz to 2. Field strengths from fixed transmitters. Recommended separation distance Conducted RF 3 Vrms d = 1. field strengths should be less than 10 V/m. the PeriFlux System 5000 should be observed to verify normal operation. including cables. additional measures may be necessary. Table 42: Electromagnetic immunity. as determined by an electromagnetic site survey. than the recommended separation dis- tance calculated from the equation applicable to the frequency of the transmitter. a. Field strengths from fixed RF transmitters. the higher frequency range applies. Part no.b Interference may occur in the vicinity of equip- ment marked with the following symbol: NOTE! At 80 MHz and 800 MHz. such as reorienting or relocating of the PeriFlux System 5000. AM and FM radio broadcast and TV broadcast cannot be pre- dicted theoretically with accuracy. PeriFlux System 5000 Extended User Manual Immunity test IEC 60601 test level Compliance level Electromagnetic environment . amateur radio. NOTE! These guidelines may not apply in all situations. Over the frequency range 150 kHz to 80 MHz.5 GHz d = 2. such as base stations for radio (cellular/cordless) telephones and land mobile radios.guidance Portable and mobile RF communications equipment should be used no closer to any part of the PeriFlux System 5000.3 P 800 MHz to 2. If abnormal performance is observed. To assess the electromagnetic environment due to fixed RF trans- mitters.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recom- mended separation distance in metres (m). If the measured field strength in the location in which the PeriFlux System 5000 is used exceeds the applicable RF compliance level above.2 P 150 kHz to 80 MHz 3 Vrms IEC61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m 3 V/m d = 1. Electromagnetic propagation is affected by absorption and reflection from structures. objects and people. 44-00003-13 Page 68 Language: English YOUR PARTNER IN MICROCIRCULATION . b. a should be less than the compliance level in each frequency range. an electromagnetic site survey should be considered.

NOTE! These guidelines may not apply in all situations.8 7.12 0.10 class I) Complies with ISO 10993-1 biological evaluation of medi- PF 105:1 Adhesive Rings cal devices. the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter.38 0. Display: 3 digit LED display.2 P d = 1. Page 69 Part no.PeriFlux System 5000 Extended User Manual Recommended separation distances Distances between portable/mobile RF communications equipment and PeriFlux System 5000 The PeriFlux System 5000 is intended for use in an electromagnetic environment in which the RF disturbances are controlled. TB (Total Backscattered Light). where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.3 100 12 12 23 For transmitters rated at a maximum output power not listed above.8 3.2 2. according to the maximum output power of the communications equipment. PF 5010.01 0.3 P 0.73 1 1.23 0. PF 5010 LDPM Unit General Perfusion (Flux).3 10 3. Table 43: Separation distances. objects and people.12 0.38 0. Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2. CMBC (Concentration of Moving Output: Blood Cells) and Velocity.0 PU Solid-state diode laser: 780 nm Laser: IEC 60825-1:2007 class 1 (FDA CFR 1040. Bandwidth: Range for Doppler shift measurements = 20 Hz to 15 kHz Probe Inputs: One fiber optic probe.2 P d = 2. Electromagnetic propagation is affected by absorption and reflection from structures.1 0. Power consumption: 6W Table 44: Technical specifications.2 1. The customer or the user of the PeriFlux System 5000 can help prevent electromagnetic interfer- ence by maintaining a minimum distance between portable and mobile RF communications equipment (transmit- ters) and the PeriFlux System 5000 as recommended below. Controls: Pressure sensitive buttons on front panel. the separation distance for the higher frequency range applies. NOTE! At 80 MHz and 800 MHz. Biocompatibility: All Perimed probe holders comply with ISO 10993-1 bio- Probe holders compatibility classification.0±1.5 GHz Rated maximum output power of transmitter (W) d = 1. Classification: Type CF Mean value: Accuracy: Motility standard: 250±20 PU Zeroing disc: 0. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English .

and are assessed and documented according to the guidance and principles given in ISO 10993-1. Signal Output Measurement Unit Analog Output Value Signal 1 Perfusion (flux) PU 1 PU = 10 mV Signal 2 TB Volts 1 TB Unit = 1 volt Table 45: Output signals. probe holders and temperature sensors. Controls: Pressure sensitive switches on front panel.0 or newer is used. Output signal – serial connector The available signals from the serial connector of the PF 5010 LDPM Unit are Perfusion (PU) and Total Backscattered light (TB). 44-00003-13 Page 70 Language: English YOUR PARTNER IN MICROCIRCULATION . probe holders and temperature sensors are only fixed to the skin for some hours. are fixed to the skin using double adhesive tape. PF 5010. Display: 3 digit LED display. which are electronically attached to the PF 5020 Heat Unit. CMBC and Velocity are also available if PSW 2. Part no. Heating Range: 26–44 °C (increments of 1 °C) Sensor Range: 0–50 °C Scaling factor: 100 mV/°C. Accuracy: ± 0. PF 5020. The use of the probes. probe holders and sensors has not shown to have any adverse effects on skin. PSW 2. Biocompatibility: The probes. PF 5020. 5 V = 50 °C Table 47: Output signals. 5 V = 50 °C Signal 2 Temperature channel 2 °C 0 V = 0 °C. which enables the use of the signals also with old PF 5010 units. The signals are only available through the Serial Interface connector and not on the analog connector. PF 5020 Temp Unit General Type: PF 5020 Temp Unit Classification: Type BF Probes.5 °C. The materials used have been practically tested during many years. Output signal – analog connector Signal Output Measurement Unit Analog Output Value Signal 1 Temperature channel 1 °C 0 V = 0 °C.0 updates the internal software in PeriFlux System 5000 automatically. PeriFlux System 5000 Extended User Manual Output signal – analog connector The available signals from the analog connector of the PF 5010 LDPM Unit are Perfusion (PU) and Total Backscattered light (TB). Table 46: Technical specifications. The recom- mended tape is a medical grade tape manufactured by 3M and is intended for stetho- scope and electrode attachment.

5 mmHg Internal barometer: Accuracy ± 5 mmHg Table 48: Technical specifications. Output signal – analog connector Signal Output Measurement Unit Analog Output Value mmHg: 1 Unit = 5 mV Signal 1 tcpO2 MmHg or kPa kPa: 1 Unit = 20 mV mmHg: 1 Unit = 50 mV Signal 2 tcpCO2 MmHg or kPa kPa: 1 Unit = 200 mV Table 49: Output signals. Output range: tcpCO2: 5–200 mmHg (0. PF 5040. Dimensions (WxHxD): 120 mm x 80 mm x 230 mm. Display: 3. Classification: Type BF. Range: 112. Accuracy: ± 0. PF 5040. Gas outflow: 8. Temp. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English . TCC3 Calibration unit. Settings: Range 37–45 °C in increments of 0.7–26. Table 50: Technical specifications.5–862. Temp.PeriFlux System 5000 Extended User Manual PF 5040 tcpO2/tcpCO2 Unit General Description: For measurement with one tcpO2/tcpCO2 measurement electrode.0 ± 0. 20 bar (2000 kPa. TCC3 Calibration Unit Use always when calibrating tcpCO2.2 mL/min. Description: Use when calibrating tcpO2 if the oxygen content of the room air deviates from the oxygen content of normal atmospheric air (20. 290 psi).7 kPa). Classification Type BF tcpO2: 0–1999 mmHg (0–267 kPa).. Page 71 Part no.9 % O2). Pressure of gas source: Max.5 °C.1 °C.5 digit LED display.

drift per hour at 10 % O2: 0.19 % Max. drift per hour at 10 % CO2: 2.9 % O2.The following max drift per hour has been measured at an electrode temperature of 43 °C. The following drift per hour has been measured at an electrode temperature of 43 °C: pCO2 Max. drift per hour at 20.9 % O2: 0. Response time (10 % to 90 % response) The following max.9% O2: 0.9 % O2 to full scale.49 % Calibration interval: 4 hours Accuracy The device indicates the partial pressure of carbon dioxide (cutaneous pCO2) to within 5 mmHg over the measurement range. Drift The requirement to drift ≤ 5 % of initial reading over the calibration interval is fulfilled.7 % Table 51: Technical specifications tcpO2/tcpCO2 electrodes. Drift The requirement to drift < 5 % of initial reading over the calibration interval is fulfilled. The device maintains linearity within –1. The device maintains this linearity up to 26 % CO2.9 % O2.2 mmHg of the nominal values when tested between 3 % and 10 % CO2. Max. the accuracy is better than ±10 %.08 % Max.18 % Calibration interval: 4 hours Accuracy The device indicates the partial pressure of oxygen (cutaneous pO2) to within 5 mmHg over the range from 0 % O2 to 20. Drift The requirement to drift ≤ 10 % of initial reading over the calibration interval is fulfilled. PeriFlux System 5000 Extended User Manual tcpO2/tcpCO2 Electrodes E5280 Combination electrode tcpO2/tcpCO2 solid state Non-linearity and hysteresis The requirement to non-linearity and hysteresis (±6 mmHg) is fulfilled for gas concentrations between 6 % O2 and 12 % O2. response times have been measured at an electrode temperature of 43 °C: 5 % CO2 to 10 % CO2: 16 seconds E5250 Electrode tcpO2 solid state Response time The following max. The device maintains linearity within 1. drift per hour at 20. The device maintains this linearity up to 90 % O2. response times have been measured at an electrode temperature of 43 °C: 6 % O2 to 12 % O2: 11 seconds Non-linearity and hysteresis The requirement to non-linearity and hysteresis (±6 mmHg) is fulfilled for gas concentrations between 5 % and 10 % CO2. Part no. response times have been measured at an electrode temperature of 43 °C. Response time (10 % to 90 % response) The following max.0 % Max. * At zero % O2 the linearity is better than 1 mmHg * At 90 % O2 the linearity is better than 25 mmHg (equal to 4 %) The above linearity data was obtained at an electrode temperature of 43 °C. The following drift per hour has been measured at an electrode temperature of 43 °C: pO2 Max.7 mmHg of the nominal values when tested between 2 % and 20. In the range from 20. 6 % O2 to 12 % O2: 10 seconds 12% O2 to 6 % O2: 10 seconds Linearity The IEC 60601-2-23:1999 requirement to linearity (± 6 mmHg) is fulfilled for gas concentration between 6 % O2 and 12 % O2. drift per hour at 5 % CO2: 2. drift per hour at 10% O2: 1. 44-00003-13 Page 72 Language: English YOUR PARTNER IN MICROCIRCULATION .

4 mmHg/sec. Page 73 Part no. 13. PF 5050. DPU-3445 Thermal Printer Contact a local Seiko representative or your Perimed representative for accessories and local require- ments. 101–200 ±3 mmHg.8–40 ±0. 44-00003-13 YOUR PARTNER IN MICROCIRCULATION Language: English .4–26.53 kPa) Display: 3 digit LED display.PeriFlux System 5000 Extended User Manual PF 5050 Pressure Unit General Type: PF 5050 Pressure Unit Classification: Type CF Cuff pressure 0–300 mmHg (0–40 kPa) Output range: PVR from -2. 26. (0.27 kPa. PF 5050.40 kPa.3 ±0.7 ±0.5 to +10 mmHg (only available on digital and analog output) Inflation range: 0–300 mmHg (0–40 kPa) Deflation rate: 3. 201-300 ±4 mmHg Accuracy: (0-–3.45 kPa/sec) 0–00 ±2 mmHg. Table 52: Technical specification. Output signal – analog connector Signal Output Measurement Unit Analog Output Value mmHg: 1 Unit = 25 mV Signal 1 Pressure mmHg or kPa kPa: 1 Unit = 100 mV PVR (Pulse volume mmHg: 1 Unit = 1 V Signal 2 mmHg or kPa recording) kPa: 1 Unit = 4 V Table 53: Output signals.