"user manual"
Contents
1. 2kV for mains cable 1kV for input and output cables 1KV differential mode voltage 2kV common mode voltage 6KV contact 8kV atmosphere 2kV for mains cable 1kV for input and output cables 1kV differential mode voltage 2kV common mode voltage Pr cise 8008 The ground should be wood concrete or ceramic tiles If the floor is covered with synthetic material the relative air humidity should be at least 30 The main power supply quality should be equivalent to that of a typical business or hospital environment The main power supply quality should be equivalent to that of a typical business or hospital environment 25 Voltage drops temporary interruptions and fluctuations of the supply voltage in accordance with IEC 6100 4 11 gt 5 Ut gt 95 drop in Ut for period 40 Ut 60 drop in Ut for 5 periods 70 Ut 30 drop in Ut for 25 periods gt 5 Ut gt 95 drop in gt 5 Ut gt 95 drop in Ut for period 40 Ut 60 drop in Ut for 5 periods 70 Ut 30 drop in Ut for 25 periods gt 5 Ut gt 95 drop in The power supply quality should be equivalent to that of a typical business or hospital environment If the user of the Pr cise 8008 needs continued operation even during interruption of the energy supply Ut for 5 s Ut for 5 s powering the Pr cise 8008 from an uninterruptible power supply2. Clean also the measurement skin area with an alcohol pad Carefully remove the blue fixation adhesive ring from the tape In the process do not soil the adhesive surface Apply the fixation adhesive ring on the skin site to be measured Qualified manufacturers disinfection recommendations DESCOTON FORTE conc max 4 SEKUSEPT AKTIV conc max 20g 1 Rev D 2015 07 Pr cise 8008 13 Use only ONE TWO drops of contact fluid into fixation adhesive ring as large as a pinhead The probe can be fixated by rotation in clockwise direction using the thread on the fixation adhesive ring approx 1 2 turn Note that during this fixation rotation no pulling tension is caused at the cable To avoid tension we recommend that the cable runs to the palms of the hands Fixation adhesive ring has to be placed without leakages onto the skin s surface As an option it is recommended to use following disposable fixation tape for fixation of the probe head and cable course Art Nr 802 224 Disposable Fixation Tape red 2 5 cm Art Nr 802 225 Disposable Fixation Tape blue 5 cm Rev D 2015 07 Pr cise 8008 3 Operation 3 1 Switching On the unit Switch on by pressing the touch screen The welcome display appears for a few seconds Pr cise 8008 The initial menu screen appears directly afterwards The Pr cise 8008 is now ready for operation when the probe tcpO values reach the va
3. 1 2 Functional description The tcpO gt measurement is a non invasive procedure to determine the tcpO2 of the tissue over the surface of the skin During the procedure the skin will be warmed up to from 37 up to 44 C The tcpO gt measurement is based on the luminescence lifetime measurement This is dependent on the oxygen partial pressure Measurement preparations e g changing electrolyte covering the probe etc are thus obsolete The probes are suited both for the determination as well as for monitoring of tcpOz as they are also applicable for long term measurements 1 3 Important usage and safety instructions Before using the Pr cise 8008 make sure you have read and understood these operating instructions and observe them at all times The Pr cise 8008 may only be used in accordance with the general provisions for the installation and operation of medical devices 22 Medical Device Act In accordance with 22 Para 1 the user must be sure of its functional safety and proper condition Rev D 2015 07 Pr cise 8008 z4 When connecting additional devices there 1s the possibility of exceeding permitted leakage currents External electromagnetic interference poses no risk to the user The Pr cise 8008 must be checked and if necessary repaired by the authorised service technician if it has a damaged plug or cable is not working properly the device has been dropped damaged or liquid has penetrated into the unit
4. tcpO weil ii mmHg 1 46 mmHg Hyphens Probe is deactivated Rev D 2015 07 Pr cise 8008 16 c 1 E tcpO mmHg 150 Probe temperature C Target 44 Current 44 ae 27 01 11 ae 152 tepo 1 5 1 tcpO 1 19 tcpO 1 19 tcpO mmHg 1 54 mmHg mmHa mmHg mmHg EH c a Probe temperature C Probe temperature C Probe temperature Probe temperature Target Current Target Current Target Current Current 44 44 Ad 44 44 dd pri as tcpO tcpO 150 tcpO 150 tepo o 1 52 mmHg 1 5 1 mmHg mmbig mmHg i i am be IS fur C lt Probe temperature C Probe temperature C Probe temperature C Probe temperature _ Target Current Target Current Target Current Target Current 44 44 44 44 44 44 44 tcpO mmHg System Message Measurement started Storage interval After selection of the activated probes press the PLAY key to begin the measurement GRAPHIC PLAY After pressing the PLAY button a system message appears showing the tcpO value storage interval can be adjusted in the settings see 3 4 Changing Parameters section The measurement can be displayed as a graphic curve by pressing the GRAPHIC key see above During the measurement process the tcpO value course of the measurement value can be observed The measurement time can be read from the X Axis and tcpO2 measurement value can be read from the Y Axis The value of the oxygen partial pre
5. see 5 Cleaning and maintenance section The transcutaneous partial pressure of oxygen is dependent on the following conditions among others Measurement temperature selection Measurement site selection Age General physical health e g fever Smoking Coffee consumption Acclimatisation of the patient to the ambient temperature Note that this compilation is not fully consolidated The Pr cise 8008 is not a blood gas analyser The probe is protected against defibrillator discharge Use of the Pr cise 8008 together with high frequency surgical devices may result in burns on the patient and damage to the probe Only original components and spare parts must be used Protect the Pr cise 8008 from moisture and dampness Authorised maintenance technicians must only open the device To ensure reliability and longevity of the Pr cise 8008 it is recommended to maintain the device unit and its probes once a year by a medicap authorised staff Remove the wall plug in power supply if the Pr cise 8008 is not in use for longer periods Do not place adhesive tape or similar on the probe surface IMPORTANT Insert or remove the probe modules ONLY in the de energised state the Pr cise 8008 must be SWITCHED OFF Do not expose the probes to direct sunlight or UV radiation Rev D 2015 07 Pr cise 8008 5 1 4 Symbols Rev D 2015 07 ON OFF The device can be switched ON and OFF or the ongoing measure
6. 22 C the probe temperature is displayed as a numerical value If the probe temperature rises above 45 C the heating unit will be turned off and instead of the temperature the display shows Colons and the ON OFF button blinks The Pr cise 8008 must be switched off The device can be switched on again after the probe has cooled down The service must be informed if the error occurs again 5 Cleaning and maintenance Clean the unit occasionally using only a dry cloth The probe must be cleaned with an alcohol pad after every measurement Clean the probe surface gently Do not use any pointed or sharp objects to clean the probes Do not allow and liquid to penetrate the unit To ensure reliability and longevity of the Pr cise 8008 it is recommended to maintain the device unit and its probes once a year by a medicap authorised staff Do not place adhesive tape or similar on the probe surface 6 Disposal The Pr cise 8008 and its packaging can be returned to medicap for disposal free of charge medicap is taking care of environmentally friendly disposal procedures Do not dispose of used batteries with household waste Rev D 2015 07 Pr cise 8008 22 7 Symbols Attention see accompanying documents ES 8 Technical data Dimensions without handrails Weight incl 8 probes Voltage max power consumption Protection class Type MDD 93 42 EEC Classification Unit complies with Ambient temperat
7. operator of the device can help to prevent electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication appliances emitters and the device depending on the power output of the communication device as described below Protective distance in metres depending on emitter output Nominal capacity of 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2 5 GHz the d 1 2 root of MHz d 2 3 root of P emitter d 1 2 root of For emitters who maximum nominal capacity is not specified in the above table the recommended protective distance d in metres m can be calculated using the equation in the respective column whereby P is the maximum nominal output of the emitter in watts W according to the information supplied by the manufacturer Comment 1 The higher frequency range applies at 80 MHz and 800 MHz Comment 2 This guideline may not be applicable in all cases Electromagnetic propagation is affected by absorption and reflection from structures objects and people Rev D 2015 07 Pr cise 8008 27 11 Warranty From the date of delivery we guarantee the device to be free from defects in material and workmanship for a period of two years and the probes for one year If the probe is serviced the warranty will be renewed for 1 year Defects that occur under warranty shall be remedied in accordance with the terms and conditions of our warranty However the medicap warrant
8. or a battery is recommended Magnetic field of grid frequency should be 50 60Hz in equivalent to the typical accordance with values found in a business IEC 61000 4 8 or hospital environment Comment Ut is the mains alternating voltage before using the test level Magnetic field of supply frequency User manual s and manufacturer s declaration electromagnetic insensitivity The Pr cise 8008 is intended for operation in the electromagnetic environment indicated below The customer or user of the Pr cise 8008 should ensure that the device unit is used in such environments Troubleshooting IEC 60601 Conformance Electromagnetic environment tests Testing level level guidelines Portable and mobile radio sets should should not be used any closer to the device and cables than the recommended protective distance calculated using the relevant emitter frequency equation 3 V rms 150 kHz to 80 MHz Mains mediated HF interferences in accordance with IEC 61000 4 6 Recommended distance protective d 1 2 root of P Radiation mediated 3 V m HF interferences 80 MHz to 2 5 in accordance GHz with d 2 3 root of P 800 MHz to 2 5 IEC 61000 4 3 GHz d 1 2 root of P 80 MHz to 800 MHz Rev D 2015 07 Pr cise 8008 26 where P is the nominal capacity of the emitter in watts W according to the information supplied by the emitter manufacturer and d is the recommended protective distan
9. should be saved or discarded SR 3 154 153 vs ope temperature C Target Current Rev D 2015 07 Pr cise 8008 18 Measurement can be continued data can be discarded or saved by pressing the confirmation button Discard The data is lost and cannot be recovered Save All data is stored on the SD card i e image and measurement values can always be loaded again by pressing the LOAD DATA key The data can be analysed or further processed on an external PC using the SD card The measurement session can be personalised on the SD card by entering the following details First name Last name Age and Gender 1088080800 1008008006 ELLE me Carefully remove the probes from the skin when the measurement is completed Remove the adhesive fixation ring The probe must be cleaned with an alcohol pad after every measurement Rev D 2015 07 Pr cise 8008 19 3 3 Changing the probe temperature Select the desired probe by pressing the probe bar in the main menu display tcpO 0 mmH g Sondentemperatur C Soll 41440 44 The probe target temperature between 37 C and 44 C can be selected by pressing the side arrows 3 4 Changing parameters Press the SETTINGS key in the main menu display to change or reset the parameters BE AACN dn gt 149 1 54 ie 1 5 1 mr 149 Mat 14 8 dd 7 mmHg y mmHa mmHg mmg mmHg De Probe temperature C Probe temperature
10. C Probe temperature C Probe temperature C Target Current Target Current Target Current Target Current el 191 el 150 el Te 1 52 mmHg minha mintig minhig re 4 K Probe temperature C Probe temperature C Probe temperature C Probe temperature C Target Current Target Current Target Current Target Current 4 44 44 44 44 sM 4 44 The following parameters can be adjusted Date Time Storage interval System settings Rev D 2015 07 Pr cise 8008 20 3 5 USB Interface For a real time RAW DATA tcpQ values export connect the Pr cise 8008 with a USB 2 0 standard Plug B printer cable to your PC system For example with standard terminal software it is possible to export the live measured tcpO values Also the tcpO values are saved in parallel onto the SD card see 3 2 Starting measurement section Note Printing capabilities are not available with this connection gt E 3 6 Switching off the Pr cise 8008 i Press the ON OFF key to switch the unit off The message 0 appears tcpO mmHg Are you sure you want to quit After confirmation Pr cise 8008 will shut down Rev D 2015 07 Pr cise 8008 21 4 Alarms and monitoring functions The Pr cise 8008 has a microcontroller which ensures constant monitoring of the most important parameters If the probe temperature decreases under 22 C Hyphens will be displayed on the screen After reaching a temperature of
11. Operating instructions for measuring unit to determine the transcutaneous partial pressure of Oxygen tcpO2 Pr cise 8008 Table of Contents 1 Introduction 1 1 Intended use 1 2 Description of function 1 3 Important usage and safety instructions 1 4 Symbols 2 Preparation 2 1 General 2 2 Probe assignment 2 3 Power supply amp SD card 2 4 Connecting the probe modules 2 5 Fixating amp usage of the carrier handle amp the cable holders 2 6 Fixating the probe 3 Operation 3 1 Switching the unit on 3 2 Starting measurement 3 3 Changing probe temperature 3 4 Changing parameters 3 5 USB Interface 3 6 Switching the unit off 4 Alarms and monitoring functions 5 Cleaning and maintenance 6 Disposal 7 Symbols 8 Technical data 9 Accessories 10 User manual s and manufacturer s EMC declaration 11 Warranty oy Be A _4 aA _6 hz De _Q _Q 10 Le 1192 SE 15 16 20 sI 2 lee 2 DE POD 2 00 Oo Os OA Se _ 99 1 Introduction 1 1 Intended use The transcutaneous oxygen measurement unit Pr cise 8008 is intended for the measurement partial pressure of oxygen also known as tcpO on the surface of the skin The measurement values may be displayed and saved numerically or graphically The probe parameters the measurement process as well as the tcpO measurement results can be saved onto a SD card Therefore you can reliably document every tcpO2 measurement and process it at any time externally on a PC
12. ce in metres m The field strength of stationary radio frequency transmitters should be less than the agreed level for all frequencies according to a test carried out locally Interference may occur in the vicinity of devices bearing the following images Comment 1 The higher frequency range applies at 80 MHz and 800 MHz Comment 2 These guidelines may not be applicable 1 in all cases Electromagnetic 2 The field strengths of stationary emitters such as the base station of radio telephones and mobile terrestrial radio equipment amateur radio stations AM and FM radio and TV emitters cannot in theory be accurately pre determined A local study should be considered in order to assess the electromagnetic environment with regard to stationary emitters If the field strengths measured in the location where the the device is used exceed the aforementioned agreed levels then the device should be monitored in order to monitor function in accordance with requirements If unusual output values are recorded additional measures may be required e g change the direction or select a different location for the device 3 The field strength should be below 3 V rms over a frequency range of 150 kHz to 80 MHz Recommended protective distances between portable and mobile HF telecommunication appliances and the Pr cise 8008 The Pr cise 8008 is intended for use in an electromagnetic environment in which RF interference is controlled The customer or
13. g 147 mt Probe temeefature C Probe temperature C Probe temperature C Probe temperature C fget Current Target Current Target Current Target Current i Es 4 44 44 44 ag i tcpO tcpO tcpO pe ie Hyphens DAT 150 me 146 151 me Probe is Ya 5 j aay cet 7 mm Probe temperature C Probe temperature C Probe temperature C Probe temperature C 4 pe aa Target Current Target Current Target Current brig Current 44 de activated 44 44 44 43 44 44 wl 2 5 Fixating amp usage of the carrier handle amp cable holders Fixate the double jointed 180 flexible cable holders into the appropriate Pr cise 8008 main unit holders Insert the optical fibres cables carefully into the routing clips Rev D 2015 07 Pr cise 8008 11 Attention Do not bend or fold the optical fibres cables around the joints The optical fibres cables need space when assorting them to avoid cable breaks Joints Rev D 2015 07 Pr cise 8008 12 2 6 Fixating the probe The probe can be fixated on various body parts such as the arms legs chest area etc doctor in accordance with each area of application should determine the fixation site The fixation of the probe is described in the following example fixation of the probe on the forearm Clean the probe gently with an alcohol pad always before starting any measurement Do not exert much pressure to avoid damaging the probe layer
14. ket the green control lamp must lit up ONLY the original supply plug FW7405M 12 from medicap must be used Before starting the measurement insert the SD card into the SD card slot at the right hand side of the Pr cise 8008 During the usage each measurement can be reliably documented saved for any further process or analysis externally on any PC All data can be stored on the SD card as txt file separated by tabs SD Card Rev D 2015 07 Pr cise 8008 9 2 4 Connecting the probe modules Insert or remove the probe modules ONLY in the de energised state the Pr cise 8008 must be SWITCHED OFF Do NOT expose the probes to direct sunlight or UV radiation Connect the probe modules which should be used for the measurement It is possible to connect one or up to eight probes at the same time see 2 2 Probe assignment section When using only one of the probes put a blind cap on the other openings Be careful with the probe module s circuit board carefully insert the circuit board to the left hand side of the module PA Blind Cap Y S i Probe S module circuit 2 board Rev D 2015 07 Pr cise 8008 10 The de activated probes are also illustrated by Hyphens in the probe field If no probes are used Asterisks will appear in the probe field Asterisks j 4 _ dns 17 01 27 01 15 NO probe module A ko tcpO 143 tcpO topo EA connected mmHg mmHg mmbl
15. lue of the air measured with the barometer by ca 152 mmHg CT ET 154 2 151 149 149 value of the ambience air 7 al A measured with Frobe temperature Frobe temperature rrobe temperature robe temperature a cone ses Wome us Seen eae the barometer 44 TN ei Wa values of the l Probe temperature C Probe temperature Probe terr s ure 5 Target Current Target rrent Target Current aro t d N 44 di a 44 44 44 44 TO optical tcpO2 c ME M probes Rev D 2015 07 Pr cise 8008 15 3 2 Starting measurement Select the probes you will use for the measurement by pressing the numbered bar see 2 2 Probe assignment section The probe selected can be activated or deactivated by pressing the bar This current state can be recognised based on the colour intension of the bar Probe activated switched on gt intensive coloured bar Probe deactivated switched off gt Pale coloured bar The de activated probes are also illustrated by hyphens in the probe field If no probes are conncted asterisks will appear in the probe field use blind caps for the empty probe slots 17 01 Asterisks topo tepo po F ro 2 No probe module si mmhg 143 mmHg 447 connected fre C Probe temperature C Probe temperature C Probe temperature C Current Target Current Target Current Target Current ne 44 4 as 44
16. ment can be finished PLAY The measurement begins STOP The measurement can be finished BACK One may return to the previous menu without changing anything SAVE The measurement can be saved SETTINGS Various parameters can be set LOAD DATA On the SD card saved data can be loaded GRAPHIC The graphical measurement view can be entered ZOOM IN The selected image section can be enlarged ZOOM OUT The enlarged image section is turned off and the original image appears Pr cise 8008 6 2 Preparation 2 1 General Touch screen Different items in the menu can be selected or confirmed by pressing the touch screen Switching on Start the Pr cise 8008 by pressing the touch screen directly to enter the initial screen after the welcome menu Welcome menu screen Initial menu screen Rev D 2015 07 at aa i seen LEZ EE GO Pr cise 8008 7 2 2 Probe assignment Up to eight probes can be connected simultaneously to the Pr cise 8008 note the probe modules can only be inserted or removed in the de energised state The assignment of the probes is graphically represented in the following figure EN Pe P s Rev D 2015 07 Pr cise 8008 2 3 Power supply amp SD card Insert the power supply plug into the back of the housing and tighten the locking screw in the clockwise direction Connect the power supply plug with the wall soc
17. n User manual s and manufacturer s declaration electromagnetic radiation The Pr cise 8008 is intended for use in the electromagnetic environments indicated below The customer or user of the Pr cise 8008 should ensure that the device is used in such environments Irradiation test Electromagnetic environment user manual HF radiation CISPR 11 EN55011 Flicker radiation IEC EN 61000 3 3 below The customer or user of the Pr cise 8008 should ensure that the HF radiation Class B fcisperimnsson on IEC EN 61000 3 2 Voltage fluctuation User manual s and manufacturer s declaration electromagnetic insensitivity The Pr cise 8008 is intended for use in the electromagnetic environments indicated device is used in such environments The Pr cise 8008 only uses HF radiation for its internal functioning The HF radiation of this device is therefore extremely low and the equipment is unlikely to interfere with other electronic devices in its vicinity The Pr cise 8008 is suitable for use in typical healthcare environments which are directly connected to public low voltage power supply grids Insensitivity IEC EN 60601 Agreed Electromagnetic test Test level level environment user manual Electrostatic Discharge ESD IEC EN 61000 4 2 Rapid transient electrical interferences Burts in accordance with IEC 61000 4 4 Pulse voltage IEC EN 61000 4 5 Rev D 2015 07 6kV contact 8kV atmosphere
18. ssure is displayed simultaneously in the probe field tcpO value Y Axis Rev D 2015 07 tcpO tcpO 148 Er nm PL LT 152 mmHg mmHg rere tcpO mmHg SFO ey gt 17 06 27 01 15 152 mmHg 2 a measurement time je 150 krO 453 tepo mmHg Pr cise 8008 X Axis a ae Return to the initial screen at any time during the measurement by pressing the BACK button during the tcpO2 measurement without interruption Here the measurement values are displayed as values in the probe field re ee ae Mn 150 148 2 152008 mmHg mmHg mmg 1 _ ee i 160 o ft LL TRS A mm oe af BACK button for k a switching from to tcpOz graphic or value screen DS Sere x t J ae 61 TEET S9508549 ta 47 SUUG27 OT E E ETARE TETE SET 11 66 D 1152 150 o 153 se The measurement can be finished by pressing the ON OFF key or STOP button To really finish the measurement session another dialogue has to be confirmed a tcpO 150 tcpO 149 tcpO 15 aed ne nmin 192 rol temperature C Probe temperature C Probe temperature C Probe temperature C po Target Current Target Current Target Crest ad 44 ad tcpO ol tepo T 150 STOP button Probe temperature C Probe temperature c uv ON OFF button After the measurement is completed a question will appear whether the measurement value
19. ure Relative humidity Storage temperature pressure probes temperature adjustable Rev D 2015 07 Pr cise 8008 Device with applied part BF approx 400mm x 250mm x 170mm approx 3920 100 to 230 VAC 10 60 W II BF Ila MDD 93 42 EEC 15 to 35 C non condensing 10 to 95 10 to 50 C Oxygen partial 0 to 165 mmHg 6mmH g 37 to 44 C Os Rev D 2015 07 9 Accessories Name User manual Pr cise 8008 Brochure for Pr cise 8008 Carrier Handle with 1x double jointed 180 cable holder left side Carrier Handle with 1x double jointed 180 cable holder left amp right side Double jointed 180 cable holder left side Double jointed 180 cable holder right side O probe 22mm for Pr cise 8008 threaded Plug in power supply for Pr cise 8008 Contact fluid for Pr cise 8008 Fixation adhesive rings for probe 1Package 50 pieces Blind cap for probe plug Disposable Fixation Tape 2 5 cm red 5m roll Disposable Fixation Tape 2 5 cm red 5 pcs Pack Disposable Fixation Tape 5 cm red 10 pcs Pack Disposable Fixation Tape 5 cm blue 5m roll Disposable Fixation Tape 5 cm blue 5 pcs Pack Disposable Fixation Tape 5 cm blue 10 pcs Pack Pr cise 8008 Article number 808 208 808 211 802 230 808 231 808 232 808 233 802 221 808 201 802 203 802 222 802 209 802 224 802 226 802 227 802 225 802 228 802 229 DA 10 User manual s and manufacturer s EMC declaratio
20. y does not cover defects that arise through failure to comply with the instructions for use incorrect use of The Pr cise 8008 or third party intervention medicap does NOT automatically consider that the owner of the device is also authorised to perform maintenance work N B Claims under warranty can only be considered with proof of purchase medicap homecare GmbH Hoherodskopfstr 22 35327 Ulrichstein 0044 Tel 06645 970 0 Fax 06645 970 200 Complies with MDD93 42 EEC Rev D 2015 07 Pr cise 8008 28
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